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Patient Safety –
Protect Yourself
from Medical Errors
Dr Aniruddha Malpani, MD
All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system,
or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or
otherwise, without the prior permission of the author.
© Dr Aniruddha Malpani
Published by
Dr Aniruddha Malpani
aniruddha.malpani@gmail.com
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Price: Rs 300
HELP – Health Education Library for People

Ashish, Tardeo, Mumbai: 400034, India
Tel. No: 65952393/65952394

www.healthlibrary.com
Helping patients to talk to doctors!
The website for this book is www.safetyforpatients.in
Cartoon by Sidney Harris – ScienceCartoonsPlus.com

Cartoons by Dr Hemant Morparia – Dr Hemant Morparia
Printed in India
2
This book is dedicated to all patients
and doctors in India – both present and
future – with the hope that we can work
together to keep patients safe !
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4
Contributors
Dinesh Chindarkar holds a degree in Life Sciences & Pharmacy. He specializes in marketing

management and has an advanced certification in Digital Marketing. He is the co-founder of
MediaMedic Communications –a health brand communication & Health PR firm. His company
MediaMedic is a part of the GLobalHealthPR group which organized the 1st International
Healthcare Social Media Summit in Washington DC. He has also co-authored the The Global
Guide to Pharma Marketing Codes. His email is dinchin@yahoo.com
Helen Osborne M.Ed., OTR/L is a health literacy expert who helps others communicate
health information in ways that patients, caregivers, and the public can understand. Helen is
president of Health Literacy Consulting, founder of Health Literacy Month, and hostess of the
podcast series, “Health Literacy Out Loud.” Helen is also author of the award-winning book,
“Health Literacy from A to Z: Practical Ways to Communicate Your Health Message, Second
Edition”. Her website is www.healthliteracy.com and her email is helen@healthliteracy.com
Reshma Ansari is a senior Hospital and Healthcare management professional. She is Manager,
Quality and Patient Safety at Breach Candy Hospital Trust, Mumbai, one of India’s leading
hospitals. She is an empanelled NABH Assessor. Her email is ansarireshma@rediffmail.com
Dr Anupama Shetty is a PhD student at the Tata Institute of Social Sciences, Mumbai. She
earned her MBBS in 1995 and Masters in Hospital administration from TISS in 2007. Her
work revolves around studying strategic change in healthcare organizations, accreditation,
and the culture of safety, with a focus on complex adaptive systems. She has been granted an
ICSSR fellowship in the course of her PhD. Her email id is mha2007@gmail.com
Salil Kallianpur is a senior executive in the pharmaceutical industry. He is an avid observer

of the health care industry and comments on the intersection of strategy and development
through his blog and twitter accounts. The views expressed here are his own and do not reflect
the views of his employer. He tweets at @salilkallianpur and can be reached at skallianpur@
gmail.com and on LinkedIn at www.linkedin.com/salilkallianpur.
Dr Reshma Nayak is the business head and editor of thehealthsite.com , a part of the Zee
media group. It is currently the most popular Indian health website in the country. She is
a dentist by profession, and a digital enthusiast by choice. Understanding online audiences
and engaging with them is what she enjoys. Her email is reshma@corp.india.com
Dr Nikhil Datar is a senior Gynaecologist practicing in Mumbai. He is also a renowned health

activist and has fought legal battles on health rights issues. He is a prolific writer on various
medical and health related subjects. He is the Founder President of Patient Safety Alliance
at www.patientsafetyalliance.in which works to empower patients and health care professionals
to prevent medical errors.
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6
Chapters
The night I nearly killed my patient 9
Background – Setting the Stage

1. Why medical errors are so common- And why we don’t talk about them 13
2. When, why and how things can go wrong –The anatomy of medical errors 17
Patient Safety from the Patient’s Perspective

3. How patient empowerment improves patient safety- Knowledge is power! 22
4. Misdiagnosis as a cause for medical errors – and how to prevent them 27
5. How overdiagnosis and overtreatment can lead to medical errors-
and how to protect yourself 33
6. Social media and the internet for reducing medical errors - how the wisdom of
the crowds can improve patient safety 38
7. Health literacy is the safety shield against errors - How can you use it? 40
8. Patient advocates- Advocating for safety 43
9. How hospitals can be made safer- How to make sure “never “ events never
occur 46
10. Protecting yourself from medical billing errors- The need for vigilance 50
11. Did the doctor make a mistake? Or was it negligence? 52
Patient Safety from the Professional and Clinical Perspective

12. The Science of patient safety – Mistake-proofing medical care 58
13. Designing for safety – Moving from Swiss cheeses to Swiss watches 63
14. How Communication helps to keep patients safe -
the importance of teamwork 69
15. How a strong patient-doctor relationship enhances patient safety-
working together to prevent errors 72
16. Managing mistakes in medicine – A guide for doctors 75
17. Risk management for doctors – When things go wrong 81
18. Protecting the impaired physician – why we need to break the conspiracy of
silence 85
19. The nurse’s role in promoting patient safety - Checking the “five rights” 87
7
Patient Safety – Protect Yourself from Medical Errors
20. Reporting errors so we can learn from them- How to stop good people from
making bad mistakes 90
21. Errors in IVF- And how we avoid them 93
22. Developing a culture of safety in hospitals- Humans are not perfect,
so improve the system 96
23. The role of a hospital patient safety officer- And how she can help to reduce
medical errors 101
24. How can hospital management engage with doctors? Convincing doctors to
commit to patient safety 104
25. A simple, low-cost method to prevent errors in hospitals- The whiteboard
solution 107
Patient Safety from the System Perspective

26. Keeping patients safe in India - What policymakers can do 111
27. How medical fraud and corruption harm patients- And why it is rampant in
India 115
28. How health insurers can keep patients safe- Creating a financial safety net 117
29. Drug safety: A huge challenge and an even bigger opportunity-
How to mitigate the risks 119
30. Pharmaceutical companies as partners in patient safety –
Time to learn from the West 125
31. How pharma can leverage technology to make care safer-
A wide range of solutions 128
32. Medical device safety- The current state of affairs 130
33. Digital health can make medical care safer- all about EHRs and apps 134
34. How media can bridge the doctor-patient gap-
Patient education is the holy grail 138
35. The Patient Safety Alliance - Keeping patients in India safe 140
Final Thoughts
36. The aftermath: The need for open disclosure to allow healing 143
37. The night I nearly killed my patient—redux 148
38. A new beginning- Challenges and opportunities 150
If you’d like to find out more 151
8
The night I nearly killed my patient
Success does not consist in never making mistakes, but in never making the
same one a second time. George Bernard Shaw
Many moons ago, I was working in King Edward Memorial (KEM) Hospital, as a junior
resident house surgeon in the obstetrics and gynecology (OB/GYN) department. KEM is
a busy public hospital in Mumbai, and we supervised over 7000 births every year. Since
we were a renowned teaching hospital, plenty of serious patients were referred to us for
emergency treatment.
Because there was so much work, we were always sleep deprived, but this was considered to
be par for the course. Our seniors felt that we had to be taught how to keep midnight vigils
– a traditional occupational hazard for obstetricians. We got to treat lots of complications
during labor, and this hands-on experience was considered to be invaluable.
The patient
The teaching program was highly unstructured, and we followed the traditional “see one,
do one, teach one” approach. During night hours, the senior staff members (lecturers and
professors) in the unit were never in the hospital premises, and the unit was managed by
a Registrar, who was 2 years senior to me. Along with my senior house surgeon and the
registrar, I was responsible for overseeing the care of all obstetric patients who were admitted
from 4 pm to 8 am.
I had been in hospital for 3 days, since we had quite a few sick patients admitted under our
care. As the junior-most doctor on the team, I was responsible for doing all the scut work and
monitoring the patients. I was on night duty when a 28 year old primigravida was referred
to us from a private hospital. She was in advanced labor and had severe preeclampsia
(pregnancy induced hypertension or PIH).
The registrar and the senior house surgeon did the emergency caesarean section, and I took
her blood to the pathology lab for testing. After the surgery, when the patient was stabilized
and the baby safely delivered, the registrar and senior house surgeon went off to bed, leaving
me to monitor her in the ward with the instruction that I was supposed to give her enough IV
(intravenous) fluids to make sure her blood pressure (BP) remained normal.
The error
She was tired and drowsy after her surgery, and so was I. I religiously checked her vital
signs, and when I noticed that her blood pressure was low, I kept on pumping in IV fluids,
to keep it in the normal range. Her BP kept on dropping, so I ordered the nurse on duty to
pour in large quantities of IV fluids to help her maintain her BP. I was so focused on making
sure her BP was normal, that I did not realize that all the extra fluid we were pumping into
9
her was leaking out of her blood vessels and getting trapped in her subcutaneous tissues,
causing her to develop systemic edema.
I was basically following the orders given to me, and wasn’t experienced enough to be aware
of the risks of a fluid overload in a patient with PIH. By the time morning came around
and the senior houseman came to check on me, she had received over 12 liters of IV fluids
in 3 hours in my attempt to keep her BP in the normal range. Her entire body had become
grotesquely swollen and distended, and she was having difficulty breathing because of the
accumulation of fluid in her larynx.
We had to do an emergency tracheostomy and transfer to the ICCU and put her on a ventilator
to stabilize her. She had a stormy course, but finally went home after 2 weeks. I still have
nightmares about her, and it was only later I found out that patients with PIH are known to
have leaky blood vessels, as a result of which the IV fluid which I was giving her was leaving
her circulatory system and getting trapped in her subcutaneous tissues.
I was mercilessly and publicly berated for my incompetence by the senior house surgeon,
registrar and professor. I was very vulnerable, and was punished for my transgression by
being forced to monitor patients every night for the remaining 3 months of my residency. I
felt that I deserved the punishment which was meted out to me, and took it quietly. I kicked
myself many times for not knowing more about how to manage a patient with severe PIH,
and was extremely grateful that the patient had survived in spite of my ignorance.
Making matters worse

I was ostracized by my colleagues, and treated like a pariah for having nearly caused a patient
to die, which would have been a blot on the hospital’s reputation. There was no one I could
talk to about what had happened and why; and I had to bottle up my mixed emotions (of
fear, guilt, shame, anger, embarrassment and humiliation) throughout the remainder of my
residency.
I needed emotional support and professional reaffirmation from my seniors and teachers
that I was still a good doctor, inspite of my mistake. However, I was abandoned and left to
fend for myself. The moment my post was over, I moved to another hospital, to try to erase
these unhappy memories.
Most doctors have had a similar experience, where they have made a mistake that caused
harm to their patient. This is one of medicine’s dirty dark secrets which doctors don’t discuss
in public. The purpose of this book is to change this approach, because unless we start talking
about medical errors, we will never be able to prevent them.
There’s a lot that could have been done to protect my patient, at many different levels; and
this is what we need to focus on. The reason for the error was not just my ignorance; it was
also the fact that I wasn’t supervised properly. In addition, the infrastructure in the hospital
wasn’t adequate to care for such a sick patient. Things would never have come to this pass
if there had been proper protocols for the management of PIH. These patients are very ill,
and should ideally have been monitored in an ICU, where close 24-hour supervision is being
10
The night I nearly killed my patient
provided by experienced clinicians. She should never have been left on a bed in the ward,
under the care of a green and inexperienced house surgeon, no matter how well meaning I
may have been.
How can we change the system, so that patients are protected from medical error? This is the question
this book will try to answer.
11
Background – Setting the Stage
Medical errors are the diseases of the healthcare delivery system.

However, a medical error does not always mean there was negligence,
and not all errors cause harm. We start from the basics, by defining
and classifying the various types of medical errors. We then take a
look at why medical errors occur; and how we can learn from them,
so we can prevent them in the future.
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Why medical errors are so common-
1
And why we don’t talk about them
To make no mistakes is not in the power of man; but from their errors and
mistakes, the wise and good learn wisdom for the future. Plutarch
In a perfect world, physicians would never get tired and never get stymied by a patient with
an unusual symptom. They wouldn’t have to hand-off their patients to the doctor working
the next shift and nurses would communicate instructions to each other with perfect clarity.
Sadly, the real world is far more error-prone, and while most medical errors are small
harmless slip-ups, occasionally they balloon into full-blown tragedies. While patients know
that doctors will not always be able to cure them, they do expect that they will at least not be
harmed; and that the treatment will not be worse than the disease.
Medical errors are the dark side of medical progress, a consequence of the ever-increasing
complexity of modern medicine. However, there’s a lot we can do to reduce their frequency
and impact, and there are plenty of success stories we can learn from.
One of the reasons the field of patient safety is vexing is that it takes a uniquely interdisciplinary
effort to protect patients from harm -one in which hospital CEOs, doctors, nurses, pharmacists,
managers, administrators and patients forge new relationships and combine their strengths
to overcome weaknesses.
Definitions
In the early years of the safety field, the target was errors, and we focused on measuring and
decreasing error rates. This model has given way to a new focus on measuring and attacking
“harm” or “adverse events” where harm is the “outcome” and errors are the “process.”
13
After all, patients, quite naturally, care more about what happens to them than whether their
doctor or nurse made a mistake.
We need to differentiate complications (adverse events that arise from the underlying disease)
from medical harm (unintended injury caused by medical care). Not all adverse events are
preventable, and those that are, usually involve errors. An error is “an act of commission
(doing something wrong) or omission (failing to do the right thing) which may lead to or
which causes an undesirable outcome.”
Many errors do not result in adverse events and these are called ‘near misses’ or ‘close calls’.
When the error is a result of care that falls below a professional standard of care, it’s called
negligence.
** Harm-Any physical or psychological injury or damage to the health of a person, either

temporary or permanent. Harm is usually classified as no harm, low harm, moderate harm,
severe harm or death.
** Near miss-Any patient safety incident that had the potential to cause harm but was prevented,
resulting in ‘no harm’
** Adverse event or error- An event involving unintended harm to a patient that resulted from
medical care. Traditionally, the term used for an adverse event was ‘iatrogenesis”.
** Preventable adverse event- An adverse event due to error. Harm is caused either by a wrong
or inappropriate action (‘error of commission’) or by failure to do the right thing (‘error of
omission’).
** Patient safety incident- Any unintended or unexpected incident that could have harmed
or did harm the patient. This includes ‘near misses’. The term ‘patient safety incident’ is
preferred to “error”, as the latter has a more negative connotation.
** Patient safety- Freedom from accidental injury. We need to establish systems to decrease
errors, and to intercept them when they occur.
** Hazardous condition- Any set of circumstances which significantly increases the likelihood
of an error.
Venn diagram depicting the relationship between errors, complications and negligence.
14
Why medical errors are so common- And why we don’t talk about them
Learning from our mistakes

We need to openly acknowledge that errors are an integral part of the human experience.
This will allow us to radically transform our approach to medical error. After all, one of
the best ways to improve oneself is to recognize mistakes and to learn from them. The same
strategy applies to providing the best patient care possible, and we need to treat medical
errors as a treasure, rather than try to hide them, or shy away from discussing them.
Medical care can be a double-edged sword. While doctors can save lives, they can also end
up harming patients. This unnerving fact that healthcare can harm us as well as heal us is the
reason why patient safety lies at the core of healthcare quality. While effectiveness, access to
care, timeliness and the other dimensions of quality are all very important, safety is always
the topmost priority.
At least 1 in 10 hospital admissions are marred by an adverse event, and about half of these
are preventable. About one-third of these adverse events cause true patient harm. The fact
that the harm was not deliberate is cold comfort for the patient who was at the receiving end.
Medical errors can result in permanent injury, and even death. The real tragedy is when the
harm could have been prevented, but was not! We cannot afford to turn a blind eye to these
errors, or adopt a “chalta hai” attitude.
While it’s easy to look for a scapegoat and blame the doctor and hospital when something
goes wrong, the truth is that medical errors do not necessarily occur because doctors are
callous or careless. The current healthcare system is complex and overloaded; it means that
the successful outcome of a medical procedure depends on a range of factors, and not just the
competence of a particular doctor!
With so many variables and healthcare personnel (doctors, nurses, pharmacists, lab
technicians, dieticians etc) involved in the care of one individual, it’s no surprise that patient
safety can sometimes become a casualty. Problems can snowball, and the term “toxic
cascades” describes how small errors which trickle by unnoticed can eventually add up to
become torrents.
What is the difference between patient safety and quality?

Patient safety is an important element of an effective, efficient health care system where
quality prevails. These two factors go hand-in-hand; there can never be any quality without
safety! Here’s how you can break it down:
** Safety has to do with lack of harm. Quality has to do with efficient, effective, purposeful
care that gets the job done at the right time.
** Safety focuses on avoiding bad events. Quality focuses on doing things well.
** Safety makes it less likely that mistakes happen. Quality raises the ceiling so the overall
care experience is a better one.
The ‘patient safety first’ culture needs to become part of the DNA of the healthcare system.
This means committing to safety at all levels of the health facility, right from the frontline
staff to doctors and nurses as well as the board of directors.
15
Medical errors from the doctor’s perspective

There are times when we doctors forget about the real identities of the people we address as
“patients.” We talk about them with clinical detachment, often presenting them as “cases”
to colleagues. We forget that they, like us, are made of flesh and blood, have families, jobs
and responsibilities, dreams, aspirations and the desire to get healthy and move on with their
lives !
Medical errors are not mere statistics. When we encounter an error, we should put ourselves
in our patients’ shoes and learn to ask, “How do I prevent this from happening again?”
Behind each event there’s a real-life story about patients and their loved ones. Some patients
who have been harmed by medical errors may take legal action against the doctors who
provided them care, and there’s a separate story about the doctors and nurses whose lives
and careers are torn apart, because of faulty systems and processes.
Doctors too will become patients one day. We will fall ill, and will need consultation, diagnosis
and medical care, just as every other mortal does. As doctors, we know a lot about everything
that can go wrong, and this can create a lot of anxiety, nervousness and fear in our hearts. It’s
probably only when we are at the receiving end that we realize how important patient safety
is. Although human error will always remain an ‘uncontrollable’ variable in the delivery of
healthcare, there’s a lot we can do to minimize errors.
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When, why and how things can go
2
wrong –The anatomy of medical errors
Amid many possibilities of error, it would be strange indeed to be always

right. Peter Latham
A complex affair
Providing medical care is a complicated affair. Given the massive number of variables
involved (the ability of the patient to provide an accurate history; the expertise of the doctor;
the number of health care professionals involved in providing medical care; the difficulty
in interpreting test results; and the unpredictable natural history of an illness), it’s hardly
surprising that things can go wrong.
Anyone who has donned a white coat will tell you what a tough job it is to dedicate your life
to the care of anxious patients, especially uneducated ones, or those who do not speak the
same language!
A good definition of medical error was provided by Dr. James Reason, a Professor of Psychology
who describes medical error as – “circumstances in which planned actions fail to achieve the desired
outcome”. However, the matter is complicated by the fact that there is no clear-cut definition
of what constitutes “gross negligence”, “medical negligence”, “error of judgment”, “accident”,
“neglect” or plain “recklessness”!
To err is human
Human error implies that if the medical team member had acted differently, the injury caused
to the patient could have been prevented. We all make errors – after all, that’s what makes
17
us human! Jens Rasmussen has suggested that errors occurred due to deficiencies in either
one of the following:
** Skills (e.g. asking an inexperienced doctor to perform a laparotomy without supervision);

** Observation of rules (e.g. not washing hands before performing a procedure); or
** Knowledge (e.g. being unaware that gentamicin levels in the blood need to be checked).
The truth is that medical errors can occur regardless of a doctor’s vigilance, good intentions,
skill, experience or expertise. This is because medical care is a complicated system, and
complex systems do fail unpredictably. What we need to do is to work on the system, so that
it becomes easier for doctors and other healthcare professionals to go about discharging their
duties in a more efficient, error-free manner.
The modern approach to patient safety hinges on “systems thinking”- recognition that most
errors are made by competent, careful, and caring providers; and that preventing these errors
often involves embedding providers in a system that anticipates glitches and catches them
before they do harm.
James Reason’s Swiss cheese model for medical error
The “Swiss cheese’ model

James Reason, an eminent psychologist, developed the ‘Swiss cheese’ model to explain the
multiple factors associated with errors. A wide range of defenses, barriers and safeguards
exist to protect patients from hazards.
These include basic tools such as alarms on syringe pumps; all the way to sophisticated
human error trapping systems, such as anesthetists who check that the surgeon has done a
thorough pre-operative work-up of the patient before bringing him to the Operating Room.
However, these defenses can be breached, like the holes in slices of Swiss cheese. However,
unlike holes in the cheese, these gaps are continually opening, shutting and shifting their
location.
18
When, why and how things can go wrong –The anatomy of medical errors
The presence of holes in any one ‘slice’ does not normally cause a bad outcome. Error
happens only when the holes in many layers momentarily line up, bringing hazards into
damaging contact with patients. This means that medical error is the result of “system flaws,
not character flaws”; and we can reduce human errors by “inserting additional layers of
protective cheese into the system”.
Types of errors
This is the dominant model for understanding the relationship between active (“sharp end”)
errors and latent (“blunt end”) errors.
** Latent errors- These are the hidden root causes in the system that make active errors more
likely to happen – for example, poorly designed medical records, making it easy for clinicians
to misunderstand reports; or inadequate staffing, making people “rush” or routinely “multi-
task”.
If an individual errs, in a sense she has been set up to fail by her environment. As Don
Berwick, President and CEO of the Institute for Healthcare Improvement, has said “every
system is perfectly designed to achieve exactly the results it gets.” These defects are
difficult to measure because they are hidden, and may exist for years before they are
detected.
** Active errors- These occur at the level of the healthcare provider – the frontline staff that
actually delivers the services, and can cause harm. These are what we think of when we think
of error, due to the focus on individual acts in medicine.
Active errors can take the form of slips (doing a familiar action in the wrong way, like
pouring salt instead of cream into coffee), lapses (failures of memory such that planned
actions do not happen), and mistakes (errors in reasoning that lead to wrong choices).
They are easier to measure because the negative outcome is much more apparent – for
example, the nurse injects the wrong medication; or the doctor amputates the wrong leg.
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Types of Medical Errors
A “safety culture” system proactively scans for latent errors all the time, and retroactively looks
for latent errors when an active error has occurred. The question should not be – “Who caused
the error”, but “What caused the error?” Bad outcomes, just like good outcomes, are a team effort.
How can we make the system safer?

Here are some basic principles.
** Automate when appropriate
** Standardize – reduce reliance on memory
** Use checklists & standard operating procedures (SOPs)
** Simplify by reducing the number of steps and handoffs
** Add redundancy (double checks) for high-risk processes to create a safety net
** Stress-test the system, and try to break it, to find out the “failure points” so that these can
be reduced and removed
** Respect the front-line staff, who are the real-life field experts, and ask them what can be
done to help them do their work safely
There is a natural tendency for things to go wrong. Safety is a dynamic non-event, and we
have to work very hard to ensure nothing bad will happen. Well designed systems can help
us to achieve this goal.
20
Patient Safety from the Patient’s Perspective
The key to patient safety lies in patient empowerment, and there’s

a lot that patients can do to protect themselves from medical errors.
Patients can use Information Therapy to reduce diagnostic errors; and
defend themselves from overtesting and overtreatment. Health literacy
is an important safety shield against errors, and patients can use social
media to tap into the wisdom of the crowds. Hospitals can be dangerous
places, and patients need to use checklists and patient advocates to keep
themselves safe when they are hospitalized. And if an error does occur,
what steps do you need to take to prevent a bad situation from becoming
worse?
21
How patient empowerment improves
3
patient safety- Knowledge is power!
Smart people learn from their mistakes. But the real sharp ones learn from
the mistakes of others. Brandon Mull
When we think of medical errors, we think about the mistakes which doctors and nurses
make when taking care of patients. However it is not uncommon for errors to be caused by
clueless patients and poorly informed care givers as well.
The first conclusion most people jump to when a medical error occurs is – It was the doctor’s
fault! Patients still think of themselves as being passive recipients of medical care who are
at their doctor’s mercy. However, you need to take an active role in your medical treatment,
and behave as an enlightened partner - after all , your doctor is not a veterinarian !
Patients can be the first line of defense against errors, and there’s a lot you can do to protect
yourself. Patient safety is not just the doctor’s responsibility – it’s the patient’s as well. Patients
must play an active role in preventing medical mistakes.
One of the commonest mistakes patients make is that they leave everything upto their doctor.
This kind of passive approach may make sense during an emergency, but is completely flawed
for most elective medical treatment, and can lead to disaster if you are unlucky enough to
end up in the hands of an incompetent doctor.
22
How patient empowerment improves patient safety- Knowledge is power!
The empowered patient

An empowered patient assumes responsibility for managing her health, and this reduces the
risk for errors. For example, she will call the clinic and make sure that she gets the results of
the lab tests her doctor has ordered, rather than wait passively for the clinic to phone her!
Patients today want to exercise the power of choice when it comes to deciding the medical
care that is being provided and the manner in which it is provided. When patients actively
participate in the treatment plan because they have crafted it in partnership with their doctor,
they are much more motivated in complying with the doctor’s advice and this helps reduce
the risk for slips and mistakes. An empowered patient is one who:
** Assumes responsibility-You know your body better than anyone else and this makes it
important for you to refer to all the resources you can lay your hands on, ranging from people
to the printed word, to make an informed and critically evaluated decision.
** Collaborates-Know that this is a challenging journey and that you will need help to traverse
this path. Support can be invaluable, so please be gracious in accepting it. Co-operate fully
with the medical staff during your diagnosis and treatment processes.
** Gathers evidence- Leave no stone unturned when it comes to learning more about your illness
and treatment options. Check with other patients, make observations, record symptoms,
take family histories, participate in clinical research, and use the internet to become well-
informed.
** Stays safe- Be vigilant; do not let your guard down. Medical errors can occur at the best of
establishments, and you need to ensure that you don’t become the victim of those errors.
** Appoints a patient advocate-If you don’t feel confident enough about handling everything
yourself, seek support from a more knowledgeable and resourceful patient-advocate, who
will be able to work the system in your favor. They can easily achieve what patients and their
families sometimes can’t – get prompt and safe medical care.
** Is firm-Once you have made prudent choices, stand by them and you will find that you are
more confident and in control
** Organizes and updates her medical records. http://www.myphr.com/ from the American
Health Information Management Association (AHIMA) is a comprehensive resource for
anyone interested in creating their own personal health record (PHR).
Sadly, most patients are still very passive, and are happy to leave everything upto the doctor.
They are scared to ask questions, because they underestimate their ability to make sense of
medical care. This can be dangerous, especially when things aren’t going well, and you need
to learn to speak up by being aware and well-informed. After all, if you don’t look after
yourself, then who will?
Do your homework – become an expert patient!

Before starting your research, you first need to obtain basic information about your medical
problem. What is your diagnosis? Your doctor can provide you with this, along with
explaining what alternative terms can be used to describe your condition; this helps you gain
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the fundamental knowledge to begin your research. Make sure you get the spellings right-
write them down! Of course, for some complex medical problems, it may not be possible to
even come to a diagnosis, but such cases are rare.
You need to spend a little time thinking about exactly what kind of questions you want
answered from your online research: remember, GIGO (garbage in, garbage out). The more
precise your questions, the easier it will be to find answers to them! Thus, it would be
counterproductive to look for ‘everything about diabetes’.
A more realistic query could be: ‘Is it possible for a diabetic to control his blood sugar levels
without medications?’ Or you might want to search for newer treatment options, such as
pancreatic transplants, or look for a world-renowned expert who specializes in treating
diabetic complications affecting the eye.
Doing a Google search can leave you lost and even more confused than when you started,
because you can get millions of results, many of which are outdated and unreliable! To make
sure you don’t get misled, you need to evaluate the credibility of the sites you visit. To learn
how to do this, watch the National Library of Medicine’s (NLM’s) short video on ‘Evaluating
Health Information’ at: http://www.nlm.nih.gov/medlineplus/webeval/webeval.html
Researching your problem is not like a single path that proceeds straight from the initial
question to the final answer; it is actually more like a cycle. Initial questions lead to references
which lead to other papers, which, in turn, again, lead to more references, and more questions;
and as the process continues, you get wiser and closer to the answers.
Eventually, you will zero-in on the information that is the most valuable to you. This process
cannot usually be completed in a single day. The research cycle may even take you to a wide
range of medical databases, doctors, and medical libraries. It is helpful to pretend that that
you are the ace detective Sherlock Holmes, looking for a vital clue!
A single site will not provide you with all the information you need. Thus, while the HELP
website at http://www.healthlibrary.com will provide you with lots of information about your
illness (in easy-to-understand terms), if you want to connect with other patients and learn
from their experiences, you will need to go to online Bulletin Boards, patient blogs and
Community Forums. Stories written by other patients will help you identify the potential
danger zones and red flags, so you are better equipped to protect yourself from these hazards.
It is important to determine beforehand how much information you actually need to

make yourself comfortable with your diagnosis and treatment options. Some patients are
infovores, and need as much information as they can possibly gather! Others are happier
with less information because they prefer leaving technical minutiae upto their doctor. Some
patients prefer to hear only the good news, while others want the whole picture, including
the negative possibilities.
Form a partnership with your doctor

Again, let your doctor know what precisely your needs are. He can provide you with printed
matter or other sources of information, as well as point you towards other resources that can
24
How patient empowerment improves patient safety- Knowledge is power!
help you gather whatever information you find necessary. You need to seek your doctor’s
help to make sense of the wealth of medical information available to you. He can explain to
you how the information you have unearthed applies to you as an individual.
You need to collaborate with your doctor, but to be treated as a well-informed partner, you
need to do your homework thoroughly first! Most good doctors would be happy to assist
and answer your queries, but the reality is they are often very busy. If you do your research,
you can ask them intelligent and focused questions. This saves them time, and will help you
to earn their respect as well.
Information Therapy can be Powerful Medicine, and can help you by:
1. Promoting SelfCare- So you can do as much for yourself as you can, without being overly
dependent upon your doctor.
2. Helping you with Evidence-Based Guidelines- So that you can ask for the right medical
treatment that you need - no more and no less.
3. Helping you with Veto Power- So you can say No to medical care you don’t need, thus
preventing over-testing and unnecessary surgery.
You can read my book, Using Information Therapy to Put Patients First, at
http://www.slideshare.net/malpani/using-information-therapy-2014-upload
An empowered patient is the CEO of her health team

Here are a few things that a well-informed, empowered patient can say:
** I feel comfortable with each of my doctors

** I believe I’m doing everything I possibly can, to be an empowered team player
** My healthcare team is supportive of my decisions to seek a second opinion when I want
to do so
** I have spoken with specialists and have conducted my own research to keep abreast of
the latest information about my disease
** I source credible websites for the information I need
** I know whom to contact if I need financial help for treatment
** I get support by connecting with other patients
** I take steps to prepare for each visit- I jot down a list of questions beforehand and bring
them with me
** I use a system to organize my health records
** I ask friends, family, or trusted coworkers to help out when necessary
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Using the acronym SPEAK UP, JCAHO (the Joint Commission on Accreditation of
Healthcare Organisations, USA) has developed a set of steps that patients and their
families can follow to ensure that they have a positive health care experience.
S: Speak up if you have questions, or if you don’t understand something;

P: Pay attention to the care you are receiving, including medications and
treatments. Don’t assume anything;
E: Educate yourself about your diagnosis, the medical tests you are experiencing
and your treatment plan;
A: Ask a trusted family member or friend to advocate for you;
K: Know what medications you take and why. This is especially crucial because
medication errors are the most common health care error;
U: Use a health care organizations that has been evaluated against current quality
and safety standards;
P: Participate in all decisions about your treatment.
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Misdiagnosis as a cause for medical errors –
4
and how to prevent them
Experience is making mistakes and learning from them. Bill Ackman
Diagnosis plays a central role in medicine, and getting it right is pivotal in helping the patient
to get the appropriate care. Making a diagnosis is a complex exercise, because patients don’t
come with labels saying I suffer from this condition or that one. There is probably no task
more challenging for a doctor than making the correct diagnosis.
The doctor needs to be a detective in order to figure out what’s wrong, and it’s because there
is so much that we still have to learn about the human body, that diagnosis is still a very
uncertain art. It takes considerable clinical acumen to make the right diagnosis, which is why
one in every ten diagnoses is wrong.
Diagnostic error is the leading cause of medical malpractice claims in the US, and is estimated
to cause 40,000-80,000 deaths annually. It’s because misdiagnosis can do so much harm, that
we need to ensure that the diagnostic process is timely, accurate, reliable, and efficient if we
want to make medical care safe.
When do diagnostic errors occur?

A diagnostic error occurs when either the diagnosis is wrong, missed or delayed. The cause
of diagnostic error is often multi-factorial, and it could be a result of cognitive errors, which
27
are mistakes in the doctor’s thought process, perhaps because he is rushed; system errors, for
example, because of a lack of communication, as a result of which an abnormal lab result is
overlooked; and a combination of both.
A diagnostic error is more closely associated with some specialties than others, such as
radiology, geriatrics and emergency medicine. They are common in the ICU (Intensive Care
Unit) as well, where patients have multiple complex problems. Interestingly, it is not only the
rare disease that is the subject of diagnostic error; it is the misdiagnosis of common diseases
such as heart attack, cancer and stroke which causes the most harm.
Differential diagnosis
Doctors are taught to follow a disciplined process in order to make the right diagnosis.
This involves collecting information from the patient by taking a history, doing a clinical
examination, and ordering lab tests. The clinical data then needs to be analyzed and processed.
The systematic method that doctors use to come to the right diagnosis is called differential
diagnosis.
The doctor makes a list of possible diagnoses in order of probability, and then tests the
strength of each diagnosis by asking further detailed questions, ordering more tests, or
referring the patient to specialists. A differential diagnosis checklist helps physicians avoid
the most common cause of diagnostic error-failure to consider the correct diagnosis as a
possibility. Ideally, a number of potential diagnoses will be ruled out as the investigation
progresses, and only one will remain at the end. Of course, given the uncertain nature of
medicine, this is not always the case.
Technology can also aid doctors to help minimize diagnostic errors. Medical digital
databases like Watson @ http://www.ibm.com/smarterplanet/us/en/ibmwatson/ and Isabel @
www.isabelhealthcare.com can be utilized intelligently to boost the doctor’s diagnostic accuracy,
by serving as diagnosis support systems. They do not replace the doctor, but act as a safety net
by reminding him to consider all possibilities, so he does not overlook a particular disease.
Why does misdiagnosis occur?

Doctor
Since the doctor has to make the diagnosis, there are many ways in which he can err:
** Most doctors know only the common diseases-There is more than 20,000 human diseases,
and most doctors don’t know about the rare ones, which is why these are often missed.
** Different doctor skill levels-Not all doctors are alike, and while a general practitioner is well
versed in common diseases, a specialist would know a lot more about the rare diseases(in his
specialty).
** Doctor bias-All doctors are human and have biases. If they see a certain disease frequently,
they tend to diagnose it frequently, and this might result in an error if the patient does not
have that disease, but something with similar symptoms.
28
Misdiagnosis as a cause for medical errors – and how to prevent them
** Saving you money-Some doctors will avoid tests, because they don’t want you to pay extra
for tests which are not likely to be helpful. This works well for the majority, but can result in
a misdiagnosis for the small percentage that might have a rare disease.
** Lack of time- It really is quite sad how little time a doctor will typically spend with a patient.
In reality, doctors have to shoot from the hip; although they’ll hit the mark with most common
diseases, they can get tricked by rarer conditions.
** Some symptoms are hard to analyze-Medicine can be complex and the human body can
fool even the smartest doctors.
Laboratory tests and imaging studies
The various medical tests that are used to confirm or rule out diagnoses can also sometimes
fail. They are useful tools, but are not perfect and the things that can go wrong are:
** Human errors- Samples could get contaminated or mixed up, or the test procedure might be
done improperly-for example, if the laboratory technician is unqualified, or the lab is poorly
equipped. This can be a major problem in India, where quality control is often lacking.
** False positives and false negatives- A problem with all medical tests, no matter how well
they are performed, is that they may give rise to false positives and false negatives. Let me
clarify. False positives are test results which are abnormal (‘positive’), even though the
patient has no disease. A false positive result causes needless anxiety, and will often lead to a
situation in which the patient will have to undergo even more tests to prove or disprove the
previous results.
Conversely, test results which are normal (‘negative’), even though the patient does have
the disease are called ‘false negatives’. These results could also cause problems, because
they may induce a false sense of security, thereby leading to a delayed or missed diagnosis.
Most tests have a wide range of normality, and can only very rarely yield a simple ‘yes’ or
‘no’ answer as to whether a patient has a particular disease or not.
** Misinterpretation-Many tests rely on the expertise of the doctor doing them-for example,
the skill of the pathologist in analyzing the tissue biopsy he receives. Errors are rare, but they
can occur. Thus, errors made by radiologists in interpreting scans fall into two groups:
• Perceptual errors (missing what is on the film)
• Cognitive errors (seeing what’s on the film, but failing to attach significance to it)
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The ABCs of Misdiagnosis – How patients can help their doctor to make the right diagnosis
Poor quality labs

The unreliability of medical tests also poses a major problem for patient safety in India today.
The most obvious reason can be attributed to laboratories whose functioning is marred by
poor quality control, unskilled manpower and obsolete equipment. There is little ‘policing’
or retesting; this results in subpar standards.
After all, even a science graduate with a six-month diploma in laboratory technology can set
up a medical lab today, if he so desires. Most people tend to rush to the nearest laboratory
to get their tests done, but such haste can be a big mistake. After all, if the laboratory is not
reliable, how can you trust its report? You should try and go to the best laboratory possible-
your life can depend upon your test results!
Patient
It may seem unfair to hold a patient responsible for a wrong diagnosis, but what the patient
does (or does not do) can contribute to a wrong diagnosis as well. This is how patients
sometimes end up shooting themselves in the foot:
** Self diagnosis-The most likely way for a patient to contribute to a misdiagnosis is attempting
to diagnose themselves, without professional medical advice.
** Not reporting symptoms-Sometimes patients don’t tell their doctor everything, either
because they are embarrassed, or they feel that it’s minor, and not worth mentioning.
** Failure to perform the ordered tests-In some cases, patients don’t get diagnostic tests done,
even when a doctor has ordered these. This can occur due to oversight, financial constraints,
complacency, laziness or embarrassment.
30
Misdiagnosis as a cause for medical errors – and how to prevent them
What can patients do to reduce diagnostic error and harm?

** See a doctor- A majority of the diagnoses made by doctors are correct , and are far more
likely to be accurate than your own. Never self-diagnose based on what you have read on the
Internet, in books, or gathered from amateur advice. Doctors are trained to see signs that
patients don’t.
** See a specialist- A trained specialist is even less likely to make a wrong diagnosis than your
family doctor.
** Ask for a diagnosis- Ask your doctor to explicitly name his diagnosis. Sometimes the
doctor may not be sure what the diagnosis is, and a good doctor will be willing to share this
uncertainty with you. He can give you a list of his top three guesses, and then describe how
he plans to eliminate them, one by one. Sometimes the doctor may not tell you what the name
of the condition he suspects is, not because he wants to keep you in the dark, but perhaps
because he doesn’t want to scare you with a serious sounding name. Other doctors feel that
patients won’t understand the diagnosis anyway, while others assume that patients don’t
want to know.
** Ask questions- It is hard to assess the accuracy of your diagnosis unless you understand
what it is, and the basis on which it was made. Exactly what is the diagnosis? How sure is
your doctor? What are the other possibilities? What other diagnoses has your doctor ruled
out? What other related diseases are possible? Which ones have been tested for or ruled out?
Dr Jerome Groopman, the author of How Doctors Think, suggests asking the following 3
questions:
1. What else could it be?

2. Is there anything that doesn’t fit?
3. Is it possible I have more than one problem?
** Get a second opinion - Getting the opinion of two or more doctors reduces the chances of
a wrong diagnosis. If the two diagnoses match, then the chances of a wrong diagnosis are
much lower. And if they don’t match, then this is a puzzle that needs to be solved in order to
get to the correct diagnosis. Many online second opinion services allow you to consult with
world-renowned specialists from the comfort of your home. Lots of health insurers also offer
their customers a free second opinion service, to help them make sure that their diagnosis is
correct.
CrowdMed (www.crowdmed.com) uses the wisdom of the crowds to help solve diagnostic
puzzles. It is an online medical crowdsourcing platform where you can submit
information about your symptoms, medical history, tests, scan results and other pertinent
data. This community of “medical detectives” then suggests diagnoses, and CrowdMed’s
algorithms aggregate these medical differentials and distill them down to a probable list
of diagnostic suggestions for you. This has an extremely high degree of accuracy, and is
well worth exploring, especially when your doctor is stumped.
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** Step back and take a second look

• Repeat the laboratory tests and scans- To reduce this risk, you can repeat the same
test. This reduces the likelihood of a simple laboratory error or administrative mix-up,
since this shouldn’t happen twice.
• Run different tests- If there are multiple diagnostic tests for your disease, consider
having another type of test done.
• Use a different laboratory- If you don’t trust your test results, you might want to get
them repeated at a different laboratory.
• Keep the originals - To reduce the risk of becoming a victim of diagnostic errors, always
make sure you have originals of your tests. Make extra copies, preferably in digital format.
These can be very helpful if you need to get a second opinion. You should also make sure
that your doctor examines your original scans and X-rays, and not just the reports, because
his interpretation may be different from the radiologist’s. If you have undergone a series
of scans, they should be arranged in chronological order, so that the doctor can compare
them easily.
• Research your disease- The best way to feel confident about your diagnosis is to be well-
informed and understand how it was made, Knowledge is power! You can use an online
symptom-checker to help you make sense of what the diagnostic possibilities are. The
trouble with many of these is that they may needlessly scare you; so you have to resist
jumping to the conclusion that you have an incurable medical disease when you go online.
Patients are often the key to the right diagnosis
Even though patients don’t have the medical tools and diagnostic skills that doctors do,
they are the experts on their illness. An accurate medical history is the most valuable tool
in helping the doctor to come to the right diagnosis, and often is far more valuable than
expensive tests and esoteric scans.
It was Sir William Osler who said–“Listen to your patient, he is telling you the diagnosis.” Sadly,
doctors are often too busy to take a proper history, and patients are often too disorganized, as
a result of which they may fail to provide the doctor with valuable medical clues. Make detailed
notes about when your symptoms started; what makes them better or worse; what treatments
you’ve tried so far; and how they are related to taking medications, eating a meal, exercising, or
a certain time of day.
By being clear, complete and accurate, and writing down your story in a structured format,
it’s easier for the doctor to review your history, so he can make the right diagnosis!
32
How overdiagnosis and overtreatment
5 can lead to medical errors-
and how to protect yourself
The medical establishment has become a major threat to health.

Ivan Illich. Medical Nemesis
Laboratory tests and scan results form the scientific basis of present-day medical practice,
because they provide a valuable window into what’s wrong with the patient. Modern
medicine is therefore largely dependent on these tests as they help doctors to come to an
accurate diagnosis.
While it is true that lab tests can be very useful, they are often misused as well. With billions
of medical tests being performed every year, modern physicians appear to be relying more
on tests results rather than on their clinical skills to make a diagnosis. And testing often
means big bucks for doctors because of the kickbacks diagnostic centers offer them to refer
patients.
The “defensive medicine” trend

Many doctors have also started practicing “defensive medicine” in order to protect themselves
in case they are sued by unhappy patients or their relatives for negligence. After all, few
lawyers will find fault with a doctor who performed too many tests, but woe betide the
doctor who fails to perform a test, if his patient falls victim to an unfavorable outcome!
33
However, testing can actually be harmful. Not only is it a financial drain, but it can also lead
to a domino effect of spiraling testing, if the initial results are abnormal! And the more the
medical interventions you are subjected to, the greater the risk for medical errors.
Remember that if your doctor performs enough tests on you, the mathematical certainty is
that he will find something wrong with you. And if he finds something wrong with you, he’ll
usually end up treating you-whether you need treatment or not! However, such diagnostic
labeling may be harmful to you, because the ‘diagnosis’ has now transformed you from a
person into a ‘patient’, even though the abnormality may be a ‘red herring’ which has no
significance to your medical problem!
Many cynics call these abnormalities ‘incidentalomas’ (for example, a small fibroid in the
uterus detected on an ultrasound scan), and these often result in unnecessary surgery as well,
which exposes you to the risk of harm. Don’t forget that tests are not always benign. Invasive
tests, that is, those that entail introducing instruments (such as endoscopes) or chemicals
(such as radio-opaque dyes) into the body, generally, involve some risk of harm, which may
include infection, allergic reaction, or injury to an internal organ.
Sometimes, a test may lead to complications which are more dangerous than the benefit to
be derived from the test results. While this is usually not the case, you need to consider the
risk-benefit ratio of all tests, especially expensive and invasive ones!
All tests have their limitations that patients need to understand. In other words, merely
conducting more tests does not ensure better medical care; after all, the value of a test to
the patient depends not only on the skill in interpreting its result, but also on the clinical
judgment exercised in ordering the test in the first place. For example, when we carry out
a semen analysis (sperm test) to check a man’s fertility, the question to which we seek an
answer is: are these sperm capable of ‘working’ or not, i.e., can they fertilize an egg?
Unfortunately, present-day tests simply cannot answer that question! A semen analysis
simply provides an accurate count of the total number of sperm and their ability to swim, but
because there is such a wide range of normality, the results cannot be used to predict a man’s
fertility. Similarly, a positive skin test for TB (the Mantoux test) simply means that the patient
has been exposed to the tubercle bacillus in the past (as most of us in India have been!) Such
a result does not mean that the patient is suffering from an active TB infection, an erroneous
conclusion many patients (and their doctors) still jump to.
How can you protect yourself from over-testing?

In the final analysis, remember that medical tests can be helpful in pinpointing your problem,
but they need to be used wisely and well; after all, doctors do not treat abnormal test results,
they treat patients. When a test is recommended, the single most important question you
must ask is-How will the result of the test change the course of your treatment? And if the
answer is that it really won’t, then maybe you don’t need the test at all!
34
How overdiagnosis and overtreatment can lead to medical errors
Here is a checklist of the important factors you need to consider before going in for a medical
test.
Medical Test checklist

Test name _____________________________________________
Description ____________________________________________
Purpose ______________________________________________
To confirm diagnosis?___________ Diagnosis _______________
To exclude diagnosis? ___________ Diagnosis ______________
Where will the test be done? Clinic? _________
Independent lab?________ Hospital? _________
Cost of test in: Clinic _______ Independent lab ________
Hospital _______
Are there risks associated with the test (i.e., is the test invasive)?
__________________________
If yes, what risks? _____________________________________
Are there less invasive tests that might give the same information? ___________________
________________________
If the test result is abnormal what will be done next? __________
If the rest result is normal what will be done? _______________
COMMENTS ______________________________________
________________________________________________
__________________________________________________
You should fill out this checklist for every medical test suggested. The more invasive
or expensive a test is, the more important this checklist becomes.
The hazards
The hazards of over-testing often go hand in hand with the risks of its first cousin,
overtreatment. The media regularly carry reports extolling the virtues of the newest
technologic tools in medicine. How is a patient to make sense of which technology may be
useful for his particular illness? New technology can be dazzling, and undoubtedly, when
medical technology is used properly, it can save many lives. However, every rose has its
thorns and technology can be a two-edged sword.
For example, the introduction of antibiotics was very quickly followed by their misuse,
leading to rampant antibiotic resistance amongst bacteria and an ever-increasing rate of
hospital-acquired infections. We need to remember that new does not always mean better,
and that time-tested medical procedures are often better than the latest gadget on the market!
35
Sadly, many new medical treatments gain popularity over older standards of care due to
clever marketing, rather than any solid science.
Most patients with complex chronic illnesses have a small army of very highly specialized
doctors, each of whom treats the abnormal lab results in his own medical domain, while
ignoring what the other specialists are doing, and not paying any attention to the patient at
all!
None of the doctors has a 360 degree overview of the treatment the patient is getting. The
result can be dangerous medical chaos because modern medicine consistently violates the
ancient advice of Hippocrates: “It is better to know the patient who has the disease than the
disease the patient has.”
Doctors love looking at medical images and doing procedures. They get paid a lot for doing
these, which is why they continue doing more of them! In a more rational world, doctors would
care about risks and harms, and wouldn’t always be rushing to order pointless dangerous
tests and treatments. Too many doctors, too many tests, and too many procedures, with no
one keeping track is a recipe for disaster, and the disasters continue to happen.
You can protect yourself by visiting the Choosing Wisely web site at
http://www.choosingwisely.org. It provides information on a wide variety of harmful tests and
treatments across many specialties. This website will teach you when to Just Say No to your
doctor! Remember that the safest surgery is the one which is not done!
Unnecessary screening tests

To add insult to injury, doctors are no longer waiting for patients to fall ill. They are now
converting well persons into patients, by “screening” them for illnesses. While this seems
like a great idea in theory, because prevention is better than cure, this “testitis” means that
even more unnecessary tests are being done on a much larger scale, and lots of blissfully
unaware people are being sucked into getting medical care they do not really need.
Unfortunately, due to the widespread fallacy that the human body is no better than a machine,
we have been taught that the body needs ‘routine maintenance’ which should be performed
by a doctor, much as your mechanic tunes up your car periodically. Many people effusively
gush: ‘Doctor, give me the works, I want a full check-up!’ Many clinics now readily pander
to this demand by providing a wide range of ‘executive health check-up schemes,’ but often
these ‘schemes’ can be more harmful than beneficial !
In fact, routine tests, such as electrocardiograms, chest X-rays and full blood screening, have
been found to provide little overall benefit for the healthy individual. The reason these health
check-up schemes have become so popular is because they bring in the ‘moolah’! After all,
much more money can be raked in by screening droves of healthy people, rather than by
only taking care of sick patients. And then there is the additional lucrative bonus that the
screening tests will ‘pick up’ abnormalities, thus converting a formerly healthy person into a
patient who needs medical attention!
36
How overdiagnosis and overtreatment can lead to medical errors
In fact, the only routine tests that the US Preventive Services Task Force recommends are
those for blood pressure, cholesterol, colorectal cancer, breast cancer and cervical cancer. This
task force refused to recommend widespread screening for other diseases for two reasons:
either the tests had been found to have no merit, or there wasn’t enough evidence to prove
their benefit (i.e., they did not help to improve either life expectancy or the quality of life). In
fact, screening tests could have a major negative impact on one’s health, which is why they
should be undertaken with a great deal of discretion and caution!
To see how much harm these apparently benign screening tests can do, let’s look at the
highly publicized controversy over the need to screen men for prostate cancer, by ordering
a blood test for determining the presence of PSA (prostate-specific antigen). The PSA test
measures the level of a specific protein in the blood that can indicate cancer and other prostate
abnormalities. The drawback with this test, as with most screening tests, is that an elevated
level of PSA is not diagnostic of prostate cancer.
In fact, a number of patients who are completely normal are found to have elevated PSA
levels. Then, in order to prove that they are not suffering from prostate cancer, they will be
subjected to a prostate biopsy, and sometimes even surgery to remove the prostate altogether.
The adverse consequences of widespread screening include:
** A large number of false positive results, causing needless anxiety and concern
** Unnecessary biopsies
** Harmful effects of aggressive treatments for slow growing cancers that may never have
caused symptoms in a patient’s lifetime and could have been left well alone.
When less is more
Modern medicine has finally realized that simple common sense measures to improve
your lifestyle are much more effective than undergoing complex and exorbitant tests and
scans for remaining healthy. The trouble is that these measures are greatly undervalued by
patients due to their simplicity! It is futile to squander money on unnecessary tests during
your check-ups.
Remember that using your common sense is more important than getting a 20-page glossy
computerized health checkup report. The reason for the current epidemic of avoidable care
is that free-market medicine treats health care just like any other business commodity, and
ends up putting profits before patients. For now, your only protection is being a well-informed
consumer.
37
Social media and the internet for reducing
6 medical errors - how the wisdom of the
crowds can improve patient safety
Dinesh Chindarkar
An old error is always more popular than a new truth. German Proverb
A friend of mine suddenly collapsed at work. He found that he was unable to get up, because
his legs were feeling like jelly. An ambulance had to be called for, to rush him to a hospital.
The doctor on duty diagnosed him as having Guillain–Barré Syndrome, a name we couldn’t
even pronounce! Had this scenario happened a few years ago, we would have worried
enormously as to whether the doctor was on the right track. Suppose his diagnosis was
wrong? We would have been forced to blindly depend on his competence.
Technology to the rescue

However, this being the 21st century, the patient’s daughter whipped out her smartphone
and did a Google search on the disease. She was able to reassure her distraught mother
that although Guillain–Barré Syndrome was a rare disease, most patients recover completely
once it runs its course, and that the doctor was providing the right treatment. Instant relief-
for both the patient and his family, and the doctor as well; because the patient’s trust in the
doctor increased considerably after they had verified that his diagnosis made sense!
There are many ways of accessing health-related information online. Many patients start by
using search engines like Google and PubMed; others participate in online discussions started
by patient health groups; while others post direct questions to doctors on their websites,
blogs and social media accounts.
Internationally, websites of well-known pharmaceutical brands such as Lipitor and Allegra

offer accurate, scientific information in a consumer-friendly language. On Facebook, there
are reams of pages dedicated to common diseases such as diabetes and arthritis, many of
which are managed by non-profit organizations and healthcare companies.
On Twitter, searching with a hashtag e.g. #diabetes, #cancer, #weightloss, #menopause can
yield a wealth of information on various health aspects. On Pinterest one can follow the latest
trends in healthcare through infographics and images. Websites such as Healthcaremagic.
com, healthtap.com, and netdoctor.com offer an online consultation with a doctor for free,
while others charge a nominal fee. However while discussing your symptoms and problems
online through live chats, messages or emails with someone who is claiming to be a healthcare
practitioner, please check the doctor’s credibility.
38
Social media and the internet for reducing medical errors
The queries on these forums are moderated by registered medical practitioners and their
profile can easily be viewed on the website. Websites such as RateMD, MedeCure and
DocSuggest provide a platform for patients to share their experiences with a doctor, and seek
their opinion on other practitioners. From answering questions on portals to running their
own blogs for educating patients, the internet enables doctors to improve their communication
with patients.
Many pharmaceutical companies have teamed up with mobile app developers for creating
smartphone applications. This includes apps such as diet trackers, symptom checkers, and
baby vaccination reminders. For instance, MuSugr is a diabetes management application that
not only helps a patient track their blood sugar levels, but also features interactive games to
improve patient engagement.
Online support groups

These are usually run by patients, and these virtual patient support groups can be very
helpful. Reading other patient’s real life experiences helps you get a clearer understanding of
what to expect during your journey, and expert patients will provide practical advice about
treatment options, and how to guard against goof-ups. They can share some of the glitches
and hurdles they have encountered, and learning how they overcame them can help you to
protect yourself during your journey.
You can choose to remain anonymous, so you feel secure. These forums also allow you to
compare notes on resources, such as doctors and alternative options. Many patients find
the advice here much more trustworthy than what they get from their doctors, because it is
unbiased, and provided without a commercial agenda. However, not all support groups are
above board, so you do need to be careful!
Being able to talk openly and honestly about your emotions when you feel your doctor has
made an error reduces distress and anxiety, because you now have a safe platform where
you can vent, and you don’t need to bottle up your angst. You will be able to find online
friends, who can counsel and support you, and will help you cope better.
39
Health literacy is the safety shield
7
against errors - How can you use it?
Helen Osborne
The greatest mistake is to imagine that we never err. Thomas Carlyle
Many patients and their caregivers find medical care complex and confusing. This is where
health literacy comes into the picture, and its goal is to ensure that patients know what to do,
when, how and why.
A common example
Let’s say your doctor has prescribed some medication for you and has told you to take 1 pill,
twice a day for 2 weeks. You nod in acquiescence and head back home. But you realize that
there are a number of questions running through your head:
** What time should I take the first pill?

** How many hours later do I take the second pill?
** What if I forget to take a pill? Can I then take two pills at once?
** Should I take my pill before, during, or after meals?
** Can I take this pill with my other medicine?
40
Health literacy is the safety shield against errors - How can you use it?
** My doctor said to call if I notice problems. What kinds of problems?

** How does this medicine help? Will it make me better? Or keep me from getting worse?
This is not an uncommon situation, and health literacy can help make it safer for patients to
take their medicines properly.
What can you do?

** Prepare for your appointment- Make notes about your symptoms. For instance, you can
note things like - “I get a dry mouth about an hour after taking this medicine. My mouth
gets so dry that I cannot even eat bread.” By being clear and concise, it’s easier for your
doctor to figure out what’s wrong and suggest what can be done to rectify it.
** Make notes during the consultation- You will be with your doctor for only a short
period. It’s best to make a list of all the questions or concerns you have and take this list
along. Don’t forget to carry a pen to jot down notes when the doctor is advising you about
something. Once you’re back home, refer to these notes; you will find that you are much
more confident about what you are supposed to do. You can also request your doctor’s
permission to record the consultation.
** Let someone accompany you- Ask a family member or close friend to accompany you
to the clinic. This is especially important if you think that the doctor will be talking
about upsetting news or giving complicated instructions. The other person can be your
auxiliary eyes and ears and he can talk with you later about what was discussed during
the consultation.
** Ask the doctor questions- One of the best ways to avoid doubt is to have clarity about
what you are supposed to do; and the best way to gain clarity is to ask the doctor questions.
Though this seems like a logical solution, the fact is that your mind sort of clams up
during appointments, and it becomes difficult to think of what to ask. Learn to ask your
doctor these three standard questions:
• What is my main problem?
• What do I need to do?
• Why do I need to do it?
** Test your understanding- The doctor may give you a large amount of information and a
lot of it may be new, complicated, or confusing. Ensure that there is no fog in your mind
before you leave the appointment. A good way to maintain clarity is to ask the doctor
something like: “I want to make sure I understand these directions correctly. When you
said, “Do _________, does this mean that I should __________?”
How can doctors make medical care safer for patients?
** Educate patients- Patients need to understand their bodies and what happens when they
are ill. This includes learning about basic biology and anatomy. You can help by keeping
them informed about what takes place inside their body when they suffer from an acute
illness like appendicitis or a chronic condition such as diabetes. Using illustrations,
sketching a picture, or demonstrating on an anatomic model makes it easier for patients
41
to understand your explanations. Our book, Decoding Medical Gobbledygook – Health

Literacy Puts Patients First at http://issuu.com/malpani/docs/healthliteracy, offer more
suggestions as to what you can do to ensure that patients understand what you tell them.
** Check for understanding- Use the teach-back technique to confirm understanding. Start
by saying something like, “I want to make sure I communicated clearly.” And then ask
the patient to tell you in her own words what the key points of your instructions were.
Ask simple things like - “When you go home, what will you tell (your brother, son, or
someone else) about what we just discussed?” If you sense that the patient hasn’t correctly
understood, then alter the manner in which you explained it the first time around. Once
again, confirm understanding by using teach-back. This will help you to improve your
patient’s safety quotient.
** Help your patients make sense of online information – Sometimes your patients may
not follow your advice because of what they read on the internet. Sadly, a lot of websites
are unreliable and outdated, and patients may get fooled and misled. To make sure your
patients don’t get confused and befuddled when they go online, you can refer your
patients to credible resources on the internet. Provide lists of websites and organizations
that offer unbiased, evidence-based, patient-friendly health information. One excellent
resource is Mumbai’s HELP (Health Education Library for People) which is online at
http://www.healthlibrary.com.
42
8 Patient advocates- Advocating for safety
A patient advocate should have the negotiation skills of a diplomat, the

curiosity of a child, the protectiveness of a mother and the courage of a
freedom-fighter. Dr Aniruddha Malpani
The poor patient’s plight

Ekta is a 60-year old widow, who has diabetes, impaired kidney function and angina. Her
family physician is under the impression that her cardiologist is tracking her health – after all,
he has referred her to him because he is the specialist, and he is happy to defer to his expertise.
Her cardiologist believes that Ekta’s care is being monitored by her family physician, as he
feels that this is the responsibility of the primary care physician. And the nephrologist has
no clue what the other two are doing! You can imagine how high the probability for medical
errors is in this kind of situation, when the left hand does not know what the right hand is
doing! She is a disaster waiting to happen.
In a perfect world, doctors would talk to each other, and everyone would be on the same
page. In real life, however, doctors are extremely busy. They have a tough time dealing with
their ever-increasing workload and rarely have the time to communicate with their patients,
or with the other treating physicians. This results in poor coordination, and the patient’s
care often suffers due to the number of specialists she has to see. This means it’s become the
patient’s responsibility to constantly be on their toes when it comes to taking care of their
health.
The patient advocate comes to the rescue

Ekta finally found a patient advocate, who acts as her protective shield from medical errors.
He is her knight in shining armor, because it’s his job to handle everything from accompanying
her to the busy specialist’s clinic, to updating her medical records. Her patient advocate is
her “go-to person”, who helps her navigate the complex healthcare maze.
Patient advocates can be pillars of strength for patients during a very challenging phase of
their lives. A patient advocate can be either a :
** Self advocate: If the patient has an adequate amount of medical knowledge and if her
health permits, she can be her own advocate
** Informal advocate: A family member (spouse, sibling, parent or friend) assumes the role
of a medical advisor
** Professional advocate: A social worker, nurse or any other health professional employed
either by the hospital or the family, to act on behalf of the patient. Progressive health
insurers now provide patients who have a complex chronic illness with a case manager,
who acts as their patient advocate
43
A good advocate should have earned the patient’s trust; must understand her medical
problems; and be assertive. He should be able to take a firm stand – after all, his job is to speak
up for his patient! An advocate needs to be well-informed, and should be able to discuss
treatment options with the doctor, on behalf of his patient. Patient advocates protect patients
from medical errors by guarding the patient’s rights. They can:
** Provide insight into how the healthcare system works, and what to do when it doesn’t
** Facilitate access to leading doctors, if a second opinion in needed
** Help the patient to speak up when things aren’t going as expected
** Cut through the hospital red-tape
** Make sense of medical research
** Ensure that the medical team puts the patient’s interests first
The patient advocate’s role during your hospitalization
When you are hospitalized, you’re not on top of your game. A patient advocate becomes
your friend, philosopher and guide, who watches over you while you are in the hospital. In
the past, this role was performed by your family physician (who sadly seems to have become
an endangered species today). Your patient advocate functions as your guardian angel, and
his most important role is to ensure that there is no slip-up in the care that you receive.
** Your advocate needs to coordinate care with the various specialists in the hospital, each
of whom seems to be in charge only of the organ system which belongs to his particular
superspecialty! It’s important that he have the phone numbers of all the doctors who are
caring for you, so he can get in touch with them directly, in case he has any questions.
** He should make friends with the nursing staff; they provide the actual hands-on care
and are responsible for administering your needs. They have the answers to most of your
questions, and are much more accessible than your doctors.
** He needs to be present at the change of shift duty, during the handoff or transition, when
the nurses who are going off duty update those who are coming on duty. Passing the
baton can be fraught with hazards, and he needs to make sure it is not dropped during
the handover.
** Before you leave the hospital, your advocate should meet up with the hospital’s discharge
planner – usually the nurse on duty. She can furnish important information about local
resources and referrals to other medical professionals. If you require continued care at
home or at a rehabilitation center, your advocate will assist with the transition.
What makes doctors wary of patient advocates?
The term advocate sounds adversarial, and doctors often get defensive when they have to
deal with one. They can create hurdles in the patient advocate’s path and this negativity
harms the patient’s care. This is why some advocates prefer calling themselves “patient
champions”.
44
Patient advocates- Advocating for safety
His training and experience enables him to understand what the patient is going through,
and he is in the right position to ensure that her unique medical needs are being properly
met. The medical staff should understand that it’s the advocate’s job to monitor and oversee
a patient’s care, so that the patient gets the care that the doctor has prescribed. They are
both on the same side–the patient’s! It’s crucial for the advocate to remain polite, positive,
encouraging, and appreciative; and to cooperate with every member of the medical team, so
that he creates a win-win for everyone.
At times, he may need to be firm, even demanding, but that cannot be an excuse to be
impatient, short-tempered, rude or confrontational. If he wants his patient to get the best
medical care, he should take care to be patient himself!
A patient advocate is a very valuable resource that patients and their loved ones can turn
to, so they can deal better with their medical challenges. Because a patient advocate can
help improve the patient’s experience with the healthcare system, he should be recognized
as an essential service provider in our healthcare system. You can learn more about what
a patient advocate does in our book, Patient Advocacy-Giving Voice to the Patient at
http://www.slideshare.net/malpani/dr-malpani-patient-advocacy
45
How hospitals can be made safer- How
9
to make sure “never “ events never occur
‘To err is human, to blame … even more so’ (unknown).
It’s easy to feel powerless when you are hospitalized. Poorly designed hospital gowns which
leave you half naked make it difficult for you to hold on to your dignity; and lying spread-
eagled on the operation table can make even the strongest patient feel overwhelmed, scared
and powerless. You are scared, and while the medical staff wants to help, they seem to be
rushed and frazzled, and you are reluctant to intrude and upset their schedule.
Unfamiliar territory
Doctors have their hands full with patients and anxious relatives pestering them with
questions. Nurses are multi-tasking and making copious notes on each patient. Residents
are doing multi-shifts and probably haven’t had a good night’s sleep in several days (or is it
weeks?). Hospitals are unfamiliar terrain, and can be a lot like a minefield. Hospital hazards
for patients are hidden, but if you don’t know where the mines are, how will you be able to
avoid them?
Even though nurses and doctors will do their best to provide the best care for all patients, the
bitter truth is that hospital care can harm – and this can be a steep price to pay, just because
you are clueless about what you can do to protect yourself. Preventable hospital hazards
can result in harm to patients, or even death. These are called “Never Events”, and include
disasters such as:
46
How hospitals can be made safer- How to make sure “never “ events never occur
** A retained instrument in the abdomen after an operation

** A mismatched blood transfusion because of the wrong blood bag being given to a patient
** Surgery performed on the wrong body part
** Surgery performed on the wrong patient
In a perfect world, these kinds of disastrous slip-ups would never occur. While hospitals
have their own safety training campaigns to improve their processes and protocols to stamp
out Never Events, the fact remains that humans are fallible and that mistakes do occur.
What can you do to ensure that these Never Events never happen to you or your loved one
in the hospital? Partnering with the healthcare team is the best way patients can get the best
care! However , some patients find that talking to their doctor can be challenging. Their fear
is that it might upset the doctor, and damage their relationship. However, such worries are
unfounded. Good clinicians routinely invite questions and help patients make intelligent
decisions, based on their personal preferences.
If you have any concerns, please ask your doctor or nurse. You have a right to ask questions
and get answers about your own health. There’s no need to be confrontational, but you do
need to be assertive. Sometimes it feels like your doctor is too busy to talk to you, or maybe
you’re embarrassed to ask some questions. If you are scared, you can ask the junior doctor
or the nurse your queries, but you need to remember that messages can get garbled during
transmission.
Remember that your nurses and doctors all want the same thing: for you to get better
quickly. As the patient, you too are part of the health care team. It’s important that you
prepare, listen carefully, and speak up when you need to. Because the time your doctor
can spend with you is limited, you will feel less rushed if you prepare your questions in
advance. Remember that Questions are the Answers, and the quality of the doctor’s answers
will depend upon the quality of your questions! You can learn how to ask good questions at
http://www.ahrq.gov/patients-consumers/patient-involvement/ask-your-doctor/index.html.
Here are some useful suggestions.
** Speak up if you have any questions or concerns, and if you don’t understand the answers,
ask again. It’s your body and you have a right to know. If you ask a question you may feel
like a fool for a short time, but if you don’t ask, you will remain a fool for ever
** Don’t shy away from asking about safety. For example, if you’re having surgery, ask the
doctor to mark the area that is to be operated upon, so that there’s no confusion in the
operating room
** Notice whether your caregivers have washed their hands before touching you. Hand
washing is the most important way of preventing hospital-borne infections. Don’t be
afraid to gently remind a doctor or nurse to do this. This should be an “always event”-
a positive behavior that improves patient safety. If truth be told, even big, established
hospitals are often understaffed and their nurses over-worked. Studies show that only
one-third of doctors and nurses comply with the hand-washing routine. However,
47
patients are hesitant to say anything because they don’t want to seem to be suggesting
that hospital staff aren’t clean. Here’s a simple solution devised by Julia Hallisy, who
is the founder of The Empowered Patient Coalition (http://empoweredpatientcoalition.org):
“When our daughter was ill, we taped an eye-catching, easy-to-read sign to the door of
her room. Using colored paper, we wrote ‘PLEASE WASH YOUR HANDS AND WEAR
GLOVES AS APPROPRIATE’ in large, black letters. This simple reminder resulted in such
an immediate and dramatic increase in compliance that the infection control specialist
made her own signs and placed them on the doors to all of the rooms in the pediatric
oncology unit.”
** Make a careful note of the time of the day when you receive your medication. If a nurse
misses out the next dosage, remind her about it
** Educate yourself about your diagnosis, the medical tests you are undergoing and your
treatment plan
** Ask health care workers to introduce themselves when they enter your room and look
for their identification badges. If you are unsure about their identity or occupation, ask!
** Make sure your nurse or doctor confirms your identity from your wristband or asks your
name, before he or she administers any medication or treatment. Don’t hesitate to tell the
health care professional if you think he or she has confused you with another patient
** Verify that blood and other specimens taken from your body are labeled in front of you.
** Go to a hospital or clinic that is accredited and routinely undergoes rigorous on-site
evaluation against established state-of-the-art quality and safety standards issued by the
local medical authorities
** If you have any type of catheter or IV line, ask every day if that catheter and IV line can
be removed. This can reduce the risk of hospital acquired infections
** Know your doctor and his team. Make friends with your nurses and the technicians –
make sure they address you by name at least once every shift.
** While hospital management discourages tipping, a lot of family members find that giving
gifts to the hospital staff helps to ensure that their patient gets VIP treatment. This isn’t
something you should be doing as it encourages the hospital staff to discriminate between
patients.
** Know whom to call for help in case of a medical emergency (how to activate a CODE
Blue).
** Checklists can be your best defense against medical errors when you are hospitalized.
They can serve as mine-detectors, and armed with the right checklists, you’ll know what
to look out for. Equally importantly, these can teach you what to do, and what to say in
order to get safe care. Even in the best hospitals, patient safety is a team effort. You can
download comprehensive checklists free at
http://patientsafetymovement.org/resources/#patient-checklists.
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How hospitals can be made safer- How to make sure “never “ events never occur
In her book, Hospital Guide for Patients and Families, Julia Hallisy writes: “Don’t wait for staff
members to breach protocol and then berate them. Avoid awkward situations by announcing
your concerns to staff well in advance of the start of the procedure.”
Your medical records

Your medical records summarize your treatment course during your hospital stay, and are
very valuable documents. While many hospitals treat these as their property, they are your
records, and it’s a good idea to review them on a regular basis, to ensure that there are no
errors in them. Some hospitals are reluctant to share the records with the patient, but this
is an archaic attitude, and needs to be changed. You need to make sure that the notes are
legible; complete and updated . All the lab results and scan reports should be filed in a timely
fashion. If something is not clear or is missing , ask the nursing staff or the doctor.
Patient complaints can improve patient safety

You need to remember that as a patient, you are not just a passive recipient of medical care,
but you can actively help to promote safety and reduce risk. One way is to complain if you
have a bad experience, because these could be a result of unsafe systems and careless doctors.
All of us have been in hospitals, either as patients or as visitors, and we know from personal
experience that many hospital processes are broken. Since patients are at the receiving end of
many near misses, patient feedback can help hospitals to promote positive changes.
Patient complaints are also useful markers of dysfunctional doctors, and the systematic
analysis of patient complaints can help the hospital management to identify high risk
physicians. Typically, 80% of the complaints will involve 20% of physicians, and these are
the ones who jeopardize patient safety, by being rude or cutting corners.
The majority of these physicians are often not aware of their risky or unsafe technical and
interpersonal behaviors. Patient complaints offer a powerful tool for identifying these error-
prone, high-risk physicians and most physicians respond positively to feedback, because
they know that this can help them to improve. Many will agree with the issues identified
and will ask for help, while others may need to be fired, to stop them from harming other
patients.
49
Protecting yourself from medical
10
billing errors- The need for vigilance
A man who has committed a mistake and doesn’t correct it is committing

another mistake. Confucius
When you get admitted in a hospital, you are not just a patient, you are also a consumer.
There could be times when the technical quality of your medical care may be great, but the
administrative hassles you encounter may be a major pain point. A big issue is the complexity
of the medical bills patients are presented with when they are discharged. These often run
into pages and pages of fine print, full of undecipherable jargon, and sadly many hospitals
slyly misuse the fact that patients cannot make sense of their bills as a ploy to pad the bills
and overcharge them. You need to be vigilant to prevent becoming a victim of this scam,
otherwise you can end up spending a pretty penny.
Why errors occur

The complex world of medical billing is ripe for errors. As many as 50 people- ranging from
the nurse to the medical coder, could be involved in generating just one bill. With all of those
hands touching your bill, it’s no wonder that as many as 80% of bills contain mistakes which
will end-up wasting your hard earned money.
It’s true that medical bills are difficult to decipher. They are loaded with numerical codes,
confusing abbreviations, charges and payments. The primary step in identifying errors lies in
understanding exactly what you’re looking at, and not being afraid to admit when something
is confusing.
The following three steps will help you make sure you pay the right amount, and are not
fleeced.
Step 1: Request itemized copies of all bills

Every line item needs to be spelled out, so you know exactly what you are being charged for.
Deciphering the bill can be a challenge, but it’s worth taking the effort to do so. As you go
through your bills, mark everything you have a question about, so that you’re able to address
these concerns later.
For example, carefully check for duplicate charges to make sure you were not billed twice
for a single service or procedure. With an itemized bill, it should be much easier to spot.
Similarly, you may be charged for a test even though it was never performed, because the
doctor cancelled it after ordering it. Going through your bill line by line will make sure you
are not taken for a ride.
50
Protecting yourself from medical billing errors
Step 2: Verify dates of hospitalization and identifying information.

Begin by checking the simple things. Ensure that all your personal information, contact details
and insurance information are correct. Also double-check your dates of hospitalization. These
seemingly small mistakes are quite common, but they can affect your insurance coverage or
how much of the bill counts toward your deductible. Billing departments play games, and
they can get creative with their billing. A common tactic is called “upcoding”, which involves
billing someone for a more serious (and expensive) charge than warranted. If any charges are
suspicious or simply seem far too high, mark them so you can ask about them later.
Step 3. Ask for help, if needed

Start by meeting the billing office staff. Take your time, and don’t be afraid to ask all of your
questions. You are the customer here, and the medical providers are being paid for a service.
You’ll get the best results if you are cordial even when frustrated, but don’t be afraid to
ask the tough questions and get clarification when the answers aren’t clear. Reviewing your
medical bills will take some time and effort, but if the tedious process saves you some money,
it will be well worth it. Don’t allow financial errors to compound your medical problems!
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Did the doctor make a mistake?
11
Or was it negligence?
Resentment is like drinking poison and then hoping it will kill your enemies.
Nelson Mandela
Most patient safety initiatives are focused on preventing medical errors from happening, and
this is the right approach. But what do you do if something does go wrong? We’ve provided
lots of information on what can be done to stop mistakes, but you also need to know what to
do when dealing with a potential medical error:
** How should you expect to be treated by the doctors, nurses, and the hospital?
** How do you find the truth? Is the hospital lying?
** Should you get a lawyer?
** How long will you have to wait to get justice?
While a lawsuit can sometimes be an effective tool, finding true resolution from medical
errors often involves more than a fight over money, and sometimes you don’t need litigation
to achieve your goals.
Sadly, most people have absolutely no idea what to do after something goes wrong. They
often don’t know how to approach the doctor or hospital, how to document events, what
52
Did the doctor make a mistake? Or was it negligence?
they can ask for, or even how to find a good lawyer. Many don’t know the difference between
a true medical error and a “complication” or “known risk.”
Was it really an error?

When something goes wrong in a hospital or a clinic, many patients and families automatically
think a mistake happened . The jump to the conclusion that the doctor committed malpractice
and want to file a lawsuit. These suspicions are compounded when the doctor and nurses
abandon you and refuse to talk to you, thus adding insult to injury. However, not every bad
result in a medical setting is due to poor care. Medicine has its limitations. Sometimes things
don’t work out, despite the best efforts of doctors and nurses.
You first need to find out if the “standard of care” was met or not. Would a competent medical
professional, armed with the same set of facts as your doctor, have made the same decisions
and choices? If the answer is “yes,” then the bad outcome was likely a “complication” or
“known risk”, and not an error. After all, medicine has always been an inherently risky
enterprise, and the hopes of benefit have always been linked to the possibility of harm.
About informed consent

Unfortunately, too many patients and families can drive themselves and their surgeons crazy
after a bad result, even where there was no error. They’ll forever point fingers and seek
revenge with no closure and healing, and too often these people are ignored by the hospital,
lawyers, and even their own friends and family. The key to avoiding this situation is to have
a frank discussion before the surgery to learn the known risks and complications.
This is called “informed consent,” and it could be the most important discussion of your
life. Sadly, most doctors are very casual with this, and patients take the process too lightly.
Informed consent has to be more than a piece of paper- it has to be a real, honest discussion
where patients, families, and doctors talk about the risks which treatment can pose.
Informed consent = Informed choice. If an injury or death was truly a known complication
and nobody’s fault, then the informed consent can help patients, families, and physicians
cope with this, and avoid a lot of unnecessary stress and fighting. The point of the consent is
to help patients and their families deal with unpleasant surprises in case things don’t go as
planned!
A major blow
What happens if your worst nightmare comes true, and your patient has a complication?
Learning that a loved one has suffered a serious medical complication can be the worst
moment of your life. This can be a gut-wrenching visceral shock, which is so emotionally
overwhelming that it can be seared into your memory, and you may experience overwhelming
grief, anger, and disbelief.
Never feel embarrassed or awkward for showing the world how you truly feel… this is one
of the worst moments of your life and you need help, so ask for it. In the USA, “Medical
53
Induced Trauma Support Services,” MITTS (www.mitss.org) offers support and counseling
for patients and families impacted by adverse events.
However, it’s NEVER acceptable for you to become violent or to threaten violence. Such
behavior closes the doors to possible reconciliation and healing for both sides - the medical
staff and the patient’s family. It will most probably just get you thrown out of the hospital
and even arrested. Don’t get instigated by “social workers” who can incite you into acting in
a way that you might regret later on.
Steps to Take
** First, make sure your patient is safe. Your first concern should be to address the medical
needs of your loved one, and this should also be the first priority of the doctors and
nurses.
** Learn about the options and what can be done to manage the complications. You are quite
likely to have a jaundiced view of the competence of the medical staff after an error. After
all, if they goofed once, what’s to stop them from making another mess? It’s quite natural
to treat them with suspicion, and you will start wondering if they are being honest, or if
they have started a cover-up in order to protect themselves.
** It’s much kinder on your part to assume positive intent – after all, doctors do not want
to cause harm to their patients! The deafening silence you may encounter is not because
they are conspiring to lie to you , but because of the dysfunctional culture of the hospital
staff, most of whom have been taught to clam up. However, if you have lost faith in the
doctor or hospital, please ask for a transfer.
** Ask for help with any immediate needs such as food, transportation, financial help and
lodging.
** Exchange contact information with your doctor so you are kept in the loop and can keep
track of what is happening.
** Write down conversations and keep notes of your observations. Make a journal, and the
more detailed it is, the better. Use dates and times where possible in your written notes.
** Ask to see the medical records – it is your right. If the staff refuses to give you access to
your medical records, escalate the issue. You need to be assertive - after all, why should
they want to hide the facts?
** Expect empathy from your doctors and nurses, along with a promise of a review, updates,
support and an open door policy.
** However, don’t expect premature apologies or admissions of fault. It’s not fair to push
doctors into saying a mistake or error happened.
** The hospital should also get your side of the story by interviewing you. If you have any
problems, questions, or concerns, always start the complaint process by returning to your
doctor. A doctor will meet you, be empathetic, and initiate a fair review. If the doctor
refuses to meet you or is dismissive of your concerns, then you need to meet the higher-
54
Did the doctor make a mistake? Or was it negligence?
ups. Demand to see the manager on duty and the CEO – the hospital owes you openness
and transparency.
Should you get a lawyer?
This depends. The Indian judicial system can be a mess, and you need to pick your battles.
Getting an opinion from a lawyer never hurts. However, do remember that legal battles
can be time-consuming and can cause considerable emotional scarring. There are easier
alternatives to achieve healing and closure. However, if you have done everything possible
to get to the truth, but the doctor and hospital refuse to talk to you, then you shouldn’t feel
embarrassed about pursuing a lawsuit.
Sometimes hospitals, insurance companies, and doctors need to be sued in order that they
take you seriously. Moreover, there are plenty of stories where apology and appropriate
compensation along with emotional remedies-including genuine apologies, have been
provided during the litigation process.
Legally, medical negligence or malpractice is defined as ‘lack of reasonable care and skill or
willful negligence on the part of a doctor in the treatment of a patient , whereby the health or
life of a patient is endangered or damaged’.
If you want to win a lawsuit for negligence, you must be able to establish the following
conditions to the satisfaction of the court:
** The doctor (defendant) owed you a duty to conform to a particular standard of medical
care
** The doctor was derelict and committed a breach of duty
** You as the patient suffered actual damage
** The doctor’s conduct was the direct/proximate cause of the damage
The burden of establishing all four conditions falls upon the patient, and failure on his part to
provide substantive evidence on any one condition may result in no compensation being paid.
This is why proving medical negligence can be so difficult. The fundamental requirement for
building up a convincing case rests on the availability of medical experts willing to testify on
your behalf; and such experts can be difficult to find, because doctors are very reluctant to
criticize other doctors.
How can you move on?

The truth is that patients and families want closure and healing and quick resolution after
something goes wrong- and so do doctors and nurses. There is nothing worse than having
a case hanging over your head and most medical malpractice cases can drag on for several
years! But, thankfully, with disclosure and more ethically-minded people working in the
healthcare, insurance, and legal worlds, cases are now being resolved quicker to the benefit
of everyone.
Sadly, after a medical complication, some patients and families are consumed by their anger
at the doctor. Don’t fall into this trap. Forgiveness is a gift you give to yourself and your family
55
by breaking free of resentment. No matter what the circumstances, forgive. The book, Did the
Doctor Make A Mistake? By Doug Wojcieszak is a very useful guide.
Be a hero by helping others

Finally, remember that life is not always fair. Consider channeling your grief and emotions
in a positive fashion. You can become a “Proactive Survivor”, as described by Trisha Torrey,
by transmuting your anger into creating something good for others. You can move from the
mindset of being a victim to the mindset of being a hero to others.
Proactive Survivorship gives you choices and helps you learn to cope, and perhaps even
thrive, improving your quality of life and others’ lives, too. You can craft your own tragedy-
turned-triumph story that shows your strength and ability to move on, and gives hope to
others that they, too, can be survivors.
Your personal tragedy may inspire you to create a uniquely Indian platform that allows
you to teach others, as you work towards the noble goals of preventing medical errors and
improving patient safety. The Empowered Patient Coalition (http://engagedpatients.org/ ) was
developed by Helen Haskell who lost her son to bad doctoring and drug errors, and Julia
Hallisey who lost her teenage daughter to cancer.
Regina Holliday’s Medical Records Advocacy (http://reginaholliday.blogspot.in) stemmed from

the horrible last days of her husband’s illness when they could not get copies of his medical
records, leaving him in terrible pain from kidney cancer. Ilene Corina lost her young son to
mistakes during his tonsillectomy and has dedicated her life ever since to making sure others
stay safe in hospitals by founding Pulse of NY (http://www.pulseofny.org/). By helping others,
you may find the closure and healing you deserve.
56
Patient Safety from the Professional and
Clinical Perspective
In order to mistake-proof medical care, we need to design the medical

system so that patient safety comes first. All the medical team members
from the boardroom to the bedside – nurses, doctors, consultants ,
managers, and paramedical staff - need to learn how to communicate
as equals , so that the patient’s safety is not compromised. A strong
patient-doctor relationship based to trust and respect can help to nip
errors in the bud. Doctors need to learn what to do when mistakes
occur, and why trying to cover them up just makes a bad situation
worse. Risk management helps to reduce professional liability; and
reporting systems allow the medical staff to learn from errors, so that
they can develop a culture of safety. When it comes to reducing errors,
everyone has a role to play- doctors, nurses, the patient safety officer
as well as the hospital management.
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The Science of patient safety –
12
Mistake-proofing medical care
Three fourths of the mistakes a man makes is because he does not really know
the things he thinks he knows. James Bryce
Traditionally, an unexpected adverse event was equated with an error. In turn, an error was
equated with incompetence or even negligence. Consequently, punishing the guilty was
considered to be the only method to improve safety of patients. We felt that we could solve
human error problems by telling people to be more careful, by reprimanding the miscreants,
or by issuing a new rule or procedure.
This is ‘The Bad Apple Theory’, where you believe your system is basically safe if it were not
for those few unreliable people in it. This old view of human error is increasingly outdated
and will lead you nowhere. In fact, this “name, blame, and shame” approach has a toxic
effect. Not only does it not improve safety, it also continues to push the issue of medical
errors into secrecy.
The new perspective

The new discipline of Patient Safety acknowledges that risk is inherent in medicine and error
is inherent in the human condition. As Dr Lewis Thomas said eloquently, “We are built to
make mistakes, coded for error.” We now understand that a human error problem is actually an
organizational problem. Finding a ‘human error’ by any other name, or by any other human,
is only the beginning of your journey, not a convenient conclusion.
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The Science of patient safety – Mistake-proofing medical care
The new view recognizes that systems are inherent trade-offs between safety and other
pressures , such as time. For example, in an understaffed hospital, a rushed doctor may be
forced to take shortcuts which jeopardize the patient’s safety, not because he is careless, but
is forced to do so because he has lots of other patients to see. The major contribution of the
patient safety movement has been to propagate the insight that medical error is the result of
“bad systems,” not “bad apples”.
Errors can be reduced by redesigning systems and improving processes so that caregivers
can produce better results. While the discipline of Patient Safety can learn a lot from other
high hazard industries, such as aviation and nuclear power, the uniqueness of health care
must not be lost. Health care is more unpredictable, complex, and nonlinear than the most
complex nuclear power plants.
Machines respond in a predictable way to a set of commands and processes; patients

don’t—their response to medications and clinical interventions is far more variable and
unpredictable. Machines don’t have families, feelings, language barriers, or psychosocial
issues; patients do. While it is vitally important for us to learn techniques and lessons from
other industries, the health care industry must produce leaders and champions from within
the clinical community to face up to this challenge and devise solutions unique to the clinical
environment.
Humans as heroes
While humans can cause problems, they are the solution as well. After all, humans are the
only ones that are going to be able to recognize the errors and prevent and correct them. We
need to be able to balance both these views of human ability and experience; one that uses
technology, design, standardization and simplicity to reduce human fallibility, while the
other stresses human adaptability, foresight and resilience as a shield against errors. Systems
and processes are important, but in the end people make the difference. We need to think not
in terms of humans as hazards, but rather in terms of humans as heroes.
In reality, what’s amazing is that inspite of the chaos, constraints, and limitations under
which hospitals in India function, doctors and nurses are able to deliver safe care to their
patients the vast majority of times. This is on account of the hard work, individual vigilance,
resourcefulness and problem solving ability which the medical staff brings to work every
single day.
Sadly, the cardinal virtues and abilities of clinical staff are being squandered on fixing
administrative and organizational inefficiencies, rather than being put at the service of
patients. Clinical staff maintains safety by adapting and working around these inefficiencies.
If we truly want safer healthcare, front line staff may have to complain more and demand
action on these inefficiencies, on behalf of themselves and their patients.
Hospitals are complex adaptive systems which means they do not respond in predictable
ways to rules and policies. It also means that efforts to improve safety must combine rules
and standards with messier activities that respect the importance of culture, innovation, and
59
iterative learning in the clinical setting. A variety of strategies have been employed to create
safer systems, including:
** Simplification
** Standardization
** Building in redundancies
** Using checklists
** Improving teamwork
** Communication
** Learning from past mistakes
As Dr Abha Agarwal describes in her text book, Patient Safety: A Case-Based Comprehensive
Guide (2014), the following are the three basic propositions we need to keep in mind when
trying to design systems to keep patients safe:
#1. “The soil, not the seed”

We have learned that the formula for errors is not bad people, but good people plus bad
systems. Even apparently egregious errors such as wrong-site and wrong-patient surgeries
happen not because of incompetent surgeons, but because of unreliable processes of patient
identification and surgical site marking.
Medication errors happen not because of inattentive nurses but because of a needlessly
complicated multistep system of medication management, from prescribing to dispensing
to administration. The Patient Safety discipline proposes that the fertile ground for medical
errors is the “soil” of the healthcare delivery system; and not the clinician, who is only the
“seed”.
#2. From “I” to “we”

The second underpinning of the Patient Safety discipline is that safer care is a function of good
teams, not good individuals acting alone. This is because the technological sophistication of
the last century has introduced unprecedented complexity and fragmentation in health care;
today, there is usually a small army of professionals who need to work together to deliver
care to the patient, especially in a hospital setting. However, hospitals can be chaotic, because
of frequent interruptions, emergencies, shift changes, and this leads to discontinuity in care.
Traditionally, physicians have been taught to take ownership of the patient’s medical care,
and they still think of themselves as being in charge- of being the “captain of the ship.” In
contrast, the discipline of Patient Safety rejects the notion of “I” in favor of “we.” It proposes
that the only possible way to deliver safe and efficient care in such a complex, fragmented
system is for various professionals to work together as a coordinated team.
#3. “Just culture”

The Just Culture model proposes that since the human condition cannot be changed, the
only hope for safer care lies in a relentless focus on improving systems of care. While it’s
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The Science of patient safety – Mistake-proofing medical care
important not to blame needlessly, this must be balanced with the need for accountability,
because no hospital can offer a “blame-free” system if it tolerates acts which show a reckless
disregard for patient safety.
A just culture provides a framework of shared accountability: healthcare institutions are

responsible for providing systems and environment that are optimally designed for safe care,
while the staff is responsible for their personal choices of behavior and for reporting system
vulnerabilities. The just culture model distinguishes between three types of errors:
** The first type is the “human error,” inadvertently doing other than what should have
been done and includes errors such as a slip or a lapse. This is now considered to be an
inevitable part of human fallibility and should be managed through designing systems
that are more error-proof and error-tolerant.
** The second is “at-risk behavior” where staff uses workarounds to bypass established
safety processes in order to get their work done efficiently. Such behavior should lead to
coaching of the staff, so they are aware of how their actions endanger safety, in addition
to improving the system to fix the broken process.
** The final is “reckless behavior,” which an individual indulges in by consciously
disregarding a substantial risk. For example, a surgeon refusing to sign the operative site
or to participate in the time-out process will be considered to be reckless, and should be
penalized.
We need to have zero tolerance for reckless behavior, and fortunately, such instances are
rare. Most errors fall into the category of human error or at-risk behavior.
Some insights
Dr Berwick, a pioneer in the patient safety research movement, had these pearls of insights
to share after spending a lifetime in studying patient safety:
** The problem is not errors, but harm. If we believe our battle is against errors, we will lose.
Errors are inevitable; they will always be there. The focus should be on ‘How can we keep
patients from being hurt?’ and less on ‘How can we keep errors from happening?’
** We used to believe that rules create safety. The truth is more nuanced, and involves both
making the rules and knowing how and when to break them in order to create safety.
Patient safety is a continually emerging property of a complex adaptive system which
means that the rules should be more like instructions for driving a car, allowing the driver
to adapt to current circumstances, rather than a point-by-point recipe for baking a cake.
** Reporting is valuable to track problems and progress, but to learn from errors, we need
to use stories. Reporting only for measurement causes us to lose the necessary context
to make sense of the numbers. The question ‘How many?’ isn’t powerful enough. The
question should be ‘What happened?’ It is impossible to have safety where transparency
is not assured.
** Every technology (even that which is used for improving safety) has hazards. Building
technology for safety is crucial, but it must be supported by conversation – a human
61
mechanism for getting control back. Technology without collective mindfulness will
make things worse, not better.
** Healthcare differs a lot from other high-hazard industries. While there is much to learn
from other industries, there are crucial differences between healthcare and other fields.
The simpleminded adoption of safety practices from other industries will not work – we
need to adapt these solutions to the unique problems healthcare throws up.
** The focus has been on preventing harm, which means that what’s important is what
happens before the injury. The reality is that what happens after the injury is equally
important. Part of our safety culture has got to focus on the healing side and we have to
heal both the injured person and the person who caused the injury.
Patient safety research is catalyzing a more holistic view of patient safety, recognizing that
the implementation of “safer systems” by itself will not create safe patient care if the medical
staff is overextended, poorly trained, or under-supervised. People are part of the reason
why errors occur, but they hold the key to the solution as well, because all medical care is
provided by people!
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Designing for safety – Moving from
13
Swiss cheeses to Swiss watches
Experience is not what happens to a man; it is what a man does with what
happens to him. Aldous Huxley
There is a growing interest in proactive approaches to safety management, where we put

systems in place to ensure safety, rather than responding only after things go wrong. In
healthcare today, we tend to wait for the harm to happen. We record the number of times
that something bad occurs – the ‘never events’ (things that should never happen) and other
serious incidents.
These reactive approaches to safety and harm tend to lead to a ‘check and correct’ design.
They do reduce harm, but they create complex, slow and inefficient processes. Proactive
safety management, on the other hand, involves preventing the harm from happening in
the first place. If we design and create systems to ensure that they are efficient, lean and
fundamentally safe, this will help to protect patients far more effectively.
The big picture

Most of the ‘niggles’ in healthcare are design flaws, such as poor scheduling, policies that
generate variation, excessive complexity, and multiple handoffs. Trying to fix problems one
at a time results in a piece-meal job, which often creates new unanticipated hazards. This is
why it is important to look at the way the whole system functions, where we study not only
the individual parts, but also the relationships between the parts.
63
System Designers start with a blank sheet of paper, asking very basic but pointed questions
like ‘What are we trying to achieve?’ ‘What does this piece of equipment have to do?’ and
‘What’s the best way for this team to achieve this task?’
There are three basic elements to improving safety:
** Design the system to prevent errors occurring in the first place

** Design the system to make errors more visible when they do occur
** Design the system to limit the effects of errors so that they do not lead to harm.
Mistake-proofing is the use of process, or design features to prevent error from being
translated into injury. Errors will continue to be made. Accidents, on the other hand, can be
prevented by using additional cues that avert errors, or announce that an error has occurred,
so that it is possible for the error to be corrected before damage has been done.
For example, medical gas connections undergo extensive mistake-proofing. Not only are
medical cylinders color coded, their pin index safety system (PISS) is designed to ensure that
the cylinder will only connect to the correct tubing, thus preventing inadvertent delivery of
the wrong medical gas to patients.
Similarly, not only will the software operating a ventilator alert us before it fails, the ventilator
also includes a back-up battery and alarms, all of which are part of safe system design. Human
factors engineering (HFE), the applied science of systems design, looks at the conditions
under which humans operate, and tries to optimize the interfaces – between a person and the
technology; a person and his environment; and a person and the other people in a team - in a
way that enhances human performance. Usability testing allows specialists to identify error-
prone devices or systems before they lead to harm.
No matter how smart and well-intentioned we are as clinicians, we cannot change our
human frailty. We are not mindless automatons, but by improving the conditions under
which humans operate, we can reduce the risk for mistakes. The initial focus of HFE in
healthcare was on the design of medical devices. Today it has evolved and become broader,
and includes efforts to create safe environments of care, by designing hospital rooms around
safety principles; and to decrease errors associated with poorly designed clinical information
systems.
Errors as seen through the eyes of system designers

Environmental factors that contribute to error include: distractions and interruptions;
noise; clutter; and poor lighting. The working environment in a hospital can be remarkably
turbulent and chaotic, and this adds to the challenge of keeping patients safe. Stress increases
fatigue and contributes to errors. Hospital architectural design can reduce stress for patients,
families, staff, and physicians. Noise reduction, natural light, a view to the outdoors with a
glimpse of nature, and calming elements inside the hospital are all important contributors to
stress reduction. They enhance the calm, healing aspects of the hospital environment and this
can help to improve patient safety and aid recovery.
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Designing for safety – Moving from Swiss cheeses to Swiss watches
Human factors that contribute to error include: fatigue; emotions such as boredom or
frustration; stress and distractions; and poor communication. For example, the night duty
resident falls asleep and does not check the lab result; the clerk may make a typo in filling out
the discharge summary, due to boredom; the doctor may forget to enter an order because he
is interrupted by a call on his mobile; and the nurse may leave the discharge file incomplete
due to an inability to find all the needed papers.
Patient factors that contribute to error include: poor literacy; fear; and ignorance. For
example, a patient cannot afford to buy the prescribed medicines due to poverty; or a patient
does not understand instructions due to a language barrier.
Equipment factors that contribute to error include: confusing design; poor quality; unclear
labeling; inadequate training; and lack of availability. For example, a patient gets the wrong
heparin dose because the nurse does not know how to setup the syringe infusion pump; or
the patient gets the wrong chemotherapy dose due to confusing labeling; or the doctor does
not wash his hands because there is no soap available.
System factors that contribute to error include: shortage of staff; inexperienced staff;
inadequate supervision; and poor workflow processes. For example, the doctor does not see
the patient when he is transferred from the ICU to the ward in a timely fashion because of
inadequate communication between the ICU nurse and the ward staff.
Reliability and standardization

Reliability is the cornerstone of patient safety and we can learn this from high-reliability
organizations (HROs) such as NASA (National Aeronautics and Space Administration), which
emphasize standardization and simplification. Today there’s too much variation in health
care practice, and this adds unnecessary complexity to an already incredibly complicated
and fragile health care system.
Everybody supports standardization—in theory. The trouble is that all doctors want things
to be standardized their way! Standardized medical practice guidelines offer a framework
which doctors can use as a reference. They can modify these, as needed, based on two things
only: the patient’s preference, and the patient’s clinical condition. Variation based on the
patient’s condition is at the heart of “the art of medicine”; and adjusting our approach based
on the patient’s preference is about the “art of service.”
Technology-A boon or bane?

Technology can both help and harm. One example where technology has helped involves
counting sponges after intra-abdominal surgery. Sponges can be radio tagged so we can
wave a wand over the patient after the nurse performs the sponge count to verify whether
the count is correct. In this case, technology is acting as our backup, providing information
that helps us reduce human error before it potentially causes harm.
The flip side might be a medication alert system that warns a doctor about a drug that may
interfere with a medication the patient is already taking. However, when there are too many
of these reminders and alerts, this results in alarm fatigue. The doctor learns to ignore them,
65
and when there’s a critical alert, he might ignore it because he’s learned over time to tune out
the multitude of false warnings.
Make safety a habit

This is why it’s so hard to put safety first in real life. We tend to ignore alarms because of
“noise”’ ; we let our guard down over time; and we bypass safety practices when they are
costly or inefficient. It’s easy to get lulled into a false sense of security when nothing bad
happens over a long time. We start assuming that we don’t need to worry about making
errors because our systems work well, and that preventing errors is someone else’s problem,
and not ours. However, this kind of complacency and hubris can be dangerous.
Research has confirmed that human factors play a huge part in the system failures that cause
harm to patients. Many of the problems that regularly turn up in root cause analysis are
attributable to the unavoidable and inevitable propensity for humans to make errors. These
could be:
** Assumptions
** Complacency
** Lapses in judgment
** Failures in communication
** Decisions made in haste
** Physiologically induced issues such as stress, fatigue and hunger
One way of understanding how human factors influence the quality of care is to ask the
questions ‘Is it easy to do the right thing?’ and ‘Is it hard to do the wrong thing?’ Poorly
designed processes encourage shortcuts and ‘workarounds’- for example, if disposable
gloves are not easily available at the bedside, the staff may draw blood without using them,
subjecting themselves to the risk of a needle stick.
These non-standard, temporary fixes mean that the staff is being forced to break a safety rule in
order to get their work done. If safety rules are being routinely violated, this means processes
are not working properly and these need to be fixed. Frontline staff should be equipped and
empowered to make changes and bureaucracy that prevents staff from improving services
needs to be stripped out.
Redundancy should also be built into the processes, so that a failure in one area does not lead
to catastrophe, but is caught by a secondary (redundant) check. In order to design hospitals
to serve patients better, we need to learn to look through the patient’s eyes. Design should
start with the people we serve and we need to include patients in the design and delivery of
services. Patients are often the best placed to identify things that are not working, and will
often have clear and direct ideas on how to improve them.
Another way of putting patients first is to use the technique of shadowing. Patients and
families can be shadowed by an observer during their medical journey to find out what can
be improved. Admission, transportation, triage, communication with nurses and physicians,
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Designing for safety – Moving from Swiss cheeses to Swiss watches
and discharge all are scrutinized to see if they fall short of ideal care. Shadowing offers
repeated real-time observation of every segment of the care experience. When this is done
by a senior doctor, it provides the emotional connection that creates the urgency to drive
change.
Making outpatient care safer by putting patients first

Until recently, the patient safety field’s focus has been on hospital safety. Attention is now
shifting to outpatient care. While the scope for serious and life-threatening errors within a
hospital is far more, the number of errors which occur in ambulatory care in the clinic is far
larger. Delay is a huge issue identified by patients across the system – they waste too much
time waiting. Healthcare that is based around patients going to different clinics to see various
specialists is inconvenient and unhelpful for patients.
It is no coincidence that healthcare organized in this way is bedeviled by wastage in the

form of missed appointments, patient non-adherence with treatment, missed diagnoses and
multiple instances of ‘repeat work’. It creates a culture of dependency and increases the
number of interactions between chronically ill patients and their healthcare providers. All
this ultimately increases the likelihood of harm caused by healthcare, as patients are more
likely to fall in between the cracks.
We need to ask patients for their opinion – they can identify ‘gaps’ in the system and show us
the places where communication should be improved. The US is now experimenting with the
“patient-centered medical home or PCMH” in order to improve patient safety. You can read
more about this initiative at http://www.safetynetmedicalhome.org/about-initiative. Implementing
care teams is a critical element of transforming a medical practice into a patient-centered
medical home (PCMH).
In the team-based care model, all care team members contribute to the health of the patients.
For example, nurses can do home visits, the receptionist can remind patients about follow
up appointment, assistants can provide patient education, and pharmacists can ensure that
medications are being supplied in a timely fashion.
The TEAM-UP approach

Enlightened doctors who want their patients to become a core part of the medical care team
use the TEAM UP approach to successfully engage with their patients. TEAM UP is an
acronym they teach their patients to remind them what they need to do optimize their care.
** Team together – Team up with the members of your medical care team and get involved in
the decisions that affect you.
** Educate yourself - While getting care, you may interact with many people—each with their
own role in delivering your care.
** Ask questions - Make sure you can answer these questions:
• Can I identify my Situation or what is going on with my care now?
• What Background information do I need to understand the situation?
67
• What is the Assessment or the options to consider?

• Do I know what my care team’s Recommendations are for the next steps?
** Manage your medications - To receive the full benefits of your medications, you should
understand what each medication is and what it is prescribed for, as well as any possible side
effects.
** Understand changes in the game plan - Make sure you’re fully aware of how the plan has
changed, why it has changed, and what your role is now.
** Provide your perspective - When something doesn’t feel right, you should tell the members
of your care team. The more they know, the more they can help.
As doctors, we need to recognize that we are constrained by our own human limitations.
Good design can compensate for this, and reduce the capacity for error that we are all prone
to. As an additional bonus, implementing people-centered design helps to counteract the
possibility for systems to become impersonal, rigid and uncaring.
The good news is that we can shape our systems around people, and when we do that, we
can be assured that we are genuinely meeting the needs of the people we care for. As Reason
explained, “We cannot change the human condition, but we can change the conditions under which
humans work.”
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How Communication helps to keep patients
14
safe - the importance of teamwork
If you shut the door to all errors, truth will be shut out. Rabindranath Tagore
Medical care is routinely delivered by a team of healthcare professionals working together.

When researchers analyze the chain of events that ended up harming a patient, they find that
often someone knew that something was wrong, but didn’t have the courage to speak up; or
they spoke up but weren’t heard.
While nurses and doctors are usually well trained in the technical aspects of their individual
jobs, they typically receive no training in how to work together, even though they have to
do this all the time. This can cause communication to break down, especially when senior
surgeons act as “prima donnas” and throw temper tantrums, resulting in a dysfunctional
atmosphere of fear, where juniors are too scared to open their mouth, even when they see
mistakes being made under their nose.
These “authority gradients” mar communication. This is why medical staff should use a
structured technique called SBAR, which is designed to convey information crisply, in an
organized manner.
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** Situation = A concise statement of the problem. What is going on at present?

** Background = Pertinent information related to the situation. What has happened so far?
** Assessment = Your analysis. What did you find?
** Recommendation = The action you are requesting. What do you want your senior to do?
The SBAR technique creates a shared mental communication model that ensures the nurse
and physician remains on the same page throughout the conversation.
Working towards a common goal

Doctors need to work together with assistants and nurses as a team. Healthy medical teams
learn to maintain “situational awareness”, so they don’t lose sight of the big picture, even
during crises. The model which a lot of hospitals have adapted from the aviation industry
is that of Crew Resource Management (CRM), which encourages effective teamwork and
communication, to help prevent errors, and allow each team member to act as a safety net.
Openness allows the free flow of information, so that members coordinate and cooperate
with each other to achieve a common goal.
Team events like Briefs, Huddles and Debriefs have been shown to improve patient safety.
** Brief-A brief is a short meeting to discuss essential information such as the clinical status
of the patient; team roles; goals and barriers, and issues affecting team operations. The
brief allows the team leader to explain what is going to happen, cover contingencies, get
input from each member of the team (including the patient), and ensure that each team
member knows his or her roles and responsibilities. An excellent example of a tool used
routinely before surgery for briefs is the WHO surgical safety checklist, that can be found at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/index.html
** Huddle- A huddle or information update can be called by any team member at any time, to
deal with new issues, added complexities, unusual circumstances, or any need to adapt the
earlier plan.
** Debrief- A debrief recounts what happened during the event; extracts lessons learned; and
adapts the current plan in order to incorporate these lessons.
The strategies
Strategies to improve communication and information exchange include the following:
** Using assertive language, to ensure the message has been properly transmitted. This is
especially important when a junior nurse is pointing out a problem to the senior surgeon,
for example. Doctors need to encourage their assistants to speak up, in order to keep their
patients safe. Effective assertion is persistent, polite, timely, and clear and solution focused.
For example, if a junior feels she is not being heard, she can escalate her concerns by using
“CUS” as a guideline - “I’m Concerned,” “I’m Uncomfortable,” “This is a Safety issue”.
** Call-out, which is used to communicate critical information during an emergency. For
example , during a cardiac arrest , the nurse “calls-out” what medication she is giving to
the patient.
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How Communication helps to keep patients safe - the importance of teamwork
** Check-back, which is used to close the loop of communication, and verify information.
An example of a check-back would be when the laboratory phones to convey a critical
laboratory result, and the nurse repeats all the information back to verify that it was
correct.
** Handoff, which allows for the exchange of necessary information during transitions in
care. An example of this would be the report from the ER (Emergency Room) to the ward
when the patient is being admitted.
The Agency for Healthcare Research and Quality (AHRQ) in the USA has developed the
TeamSTEPPS® evidence-based teamwork system that improves communication among
health care professionals. It includes a comprehensive set of ready-to-use materials and a
training curriculum to successfully integrate teamwork principles into any health care
system. These can be downloaded free at
http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/
TeamSTEPPS is composed of the following four skills:

** Leadership is the ability to direct activities of team members; assess team performance;
assign tasks; develop shared mental models; motivate team members; plan and organize;
and establish a positive team atmosphere.
** Mutual support is the ability to anticipate other team members’ needs, and to shift
workload among members to achieve balance.
** Situation monitoring is the capacity to develop a common understanding of the team
environment, and to monitor teammate performance accurately.
** Communication includes the efficient exchange of information with other team members
Historically, health care has regarded technical skills and competence as key to patient
safety, and these are indisputably important , because healthcare professionals need to know
what they are doing to maintain high standards of care. However, even the most technically
qualified experts can encounter difficulties when under stress, which is why non-technical
skills (both cognitive and social) need to be valued equally.
Speaking up in the face of a potential breach of patient safety is everyone’s business - it is not
about who is right, but what is right. In the aviation industry, professionals are taught how
to speak up, how to listen and how to respond to any concerns expressed by team members.
Similarly, we need to encourage and reward medical staff members who have the courage
to speak up, independent of their rank or role, to ensure that their priority is ensuring safety.
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How a strong patient-doctor
15 relationship enhances patient safety-
working together to prevent errors
The good physician treats the disease; the great physician treats the patient
who has the disease- William Osler
As patient care becomes increasingly demanding, sharing the responsibility with the patient
is an idea good doctors are happy to welcome. In the past , the tools for patient engagement
were very limited. However, in the networked era that we currently live in, this approach
can benefit the patient greatly.
Doctors should make sure their patients are aware of the pros and cons of a particular
procedure before they are asked to select a treatment option. Similarly, patients should not
expect their doctors to spoon-feed them, and should come armed with a list of doubts and
questions for their appointment with the doctor.
Doctors respect patients who want to take charge of their health. This approach enhances
patient safety, and patients are then committed to complying with the doctor’s advice, as the
treatment plan has been formulated after taking their preferences into consideration. This
buy-in from the patient ensures compliance.
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How a strong patient-doctor relationship enhances patient safety
Decision-making aids
Patients now have access to a range of decision-making aids such as information
leaflets, pamphlets, videos, or web-based tools. These explain the procedure in detail
and patients get a better understanding of the various options available to them. Health
Decision Tools are available free at http://www.healthlibrary.com/healthwise. Mayo Clinic
calls them Wider Choice Tools (http://shareddecisions.mayoclinic.org) while Cardiff
University has developed option grids (http://www.optiongrid.co.uk/) The website at
http://decisionaid.ohri.ca/AZinvent.php has a complete list of patient decision aids. These tools
reduce the doctor’s consultation time, help the doctor to honor the patient’s preferences, and
allow shared decision-making, where both doctor and patient participate in making medical
decisions.
Doctors can use the 5-step SHARE Approach for shared decision making.
Step 1: Seek your patient’s participation

Step 2: Help your patient explore and compare treatment options
Step 3: Assess your patient’s values and preferences
Step 4: Reach a decision with your patient
Step 5: Evaluate your patient’s decision
These are tools doctors and patients should be using regularly. They can clear the brambles
of miscommunication and misunderstanding from the patient’s path, and help doctors and
patients build stronger relationships. If doctors want their patients to become willing partners
in the quest for safer care, they need to help them to speak up.
When patients ask questions, they should receive a “Thank you for reminding me” or “I’m
glad you asked” as positive reinforcement. The patient-physician relationship is a sensitive
one and has to stand on a strong foundation of trust, honesty, respect and commitment. For
this partnership to work, it’s crucial that the physician understand the patient’s expectations;
and to maintain openness and transparency in communication from the very start.
When it comes to managing chronically-ill patients, compliance emerges as the biggest

challenge. However when patients proactively take charge of their health, there is a distinct
improvement in their condition. Today, well-informed patients use mobile health apps to set
reminders for medication and don’t miss their doses or crucial appointments.
Apps for managing chronic illnesses such as asthma and diabetes have been proven to
improve the quality of life for these patients, allowing them better control of their disease,
which is why progressive doctors are happy to prescribe these.
What can patients do?

Patients too need to do their bit and:
** Understand the doctor’s limitation in terms of his ability to help a patient – doctors are
not omnipotent
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** Learn to trust a doctor for his professional expertise

** Appreciate the fact that he may be overworked; he is human too and can sometimes snap
for no evident reason
** Have realistic expectations of the treatment. Doctors are not magicians, and it can take
time for the treatment to act
** Do their homework independently and try to find out more about their medical condition-
this makes it easier for the doctor to explain the various medical procedures and options
they can explore together
** Keep the doctor informed about any changes in their medical condition. Doctors are not
omniscient!
** Comply with the doctor’s medical advice
What can doctors do?
** Be polite, considerate, honest and patient
** Treat patients with dignity – not just as a medical statistic or another case
** Respect a patients’ right to privacy and confidentiality
** Support patients in caring for themselves
** Provide them with information and access to credible sources of medical information
A good doctor must not only be a skilled clinician, but he has to take his excellence one notch
higher, by keeping an open ear and learning how to empathize. He should constantly try to
improve the quality of the medical services he provides, and have the courage to own up to
a mistake when something goes wrong and a patient suffers. The doctor-patient partnership
is based on mutual respect. Both need to be accountable and responsible; to themselves and
to each other as well.
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Managing mistakes in medicine –
16
A guide for doctors
Next to the promulgation of the truth, the best thing I can conceive that a
man can do is the public recantation of an error.Lord Lister
While it is true that all doctors make mistakes, it is equally true that most of us refuse to admit
to or discuss them. Medical mistakes have always been shrouded in a conspiracy of silence
through the ages, and this was because it was important to give patients the impression that
doctors were infallible.
Such a strategy may have been appropriate in the past, when doctors had few effective tools
in their therapeutic armamentarium, and trust in the doctor was a vital element of the healing
process. This is why blind faith in the doctor was encouraged, and to keep the doctor on his
pedestal, it was essential that he have an aura of infallibility around him.
Given the prevalence of errors in our work, and one of our first principles being “first do no
harm,” it is strange that we talk so little about this problem. Perhaps it is because we view
most errors as human ones and attribute them to laziness, inattention, or incompetence. As a
result, when we do talk about errors, we seek to place blame, because deep down we believe
that individual diligence should prevent errors, and so the very existence of error damages
our professional self-image.
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Learning from our mistakes

We must realize that all of us pay a heavy price for trying to cover up medical mistakes. Since
we often prefer to ignore, overlook or cover up our mistakes, we fail to acknowledge them,
and so we never learn from them; many experienced doctors end up repeatedly making the
same mistakes through their lifetime. Also, since we don’t discuss our mistakes, we deprive
other doctors of the chance to learn from them. We can learn a lot from mistakes–often
knowing what not to do is more valuable than knowing what to do!
The human cost of medical errors is high. Not only do our patients pay the price of our
mistakes in the form of unnecessary complications, iatrogenic injury and even death, but so
do we, when we don’t talk about our mistakes. Hiding mistakes means we end up carrying
a burden of guilt and shame, which can become overpowering with time, especially when
compounded by the fact that we often need to lie to hide and cover up our mistakes.
All of us know what it feels like to make a bad mistake. You feel exposed – and scared in case
anyone else has noticed your goof-up. You agonize about what to do, whether to tell anyone,
and what to say or not to say. Later, the event replays itself over and over in your mind. You
question your competence, but fear being discovered. You know you should confess, but
dread the prospect of potential punishment and are afraid of having to bear the brunt of the
patient’s anger.
Making a mistake can be forgiven, but not taking action to prevent it again is unforgivable,
which is why we need to be open about them. Part of the problem lies with our medical
training , which expects residents to be perfect. When medical students and junior doctors
make mistakes, they are often scolded, ridiculed or punished, which means that we end up
being terrified of making mistakes, and often try to do our best to cover them up.
This attitude needs to change, and we need to realize that mistakes are an integral part of
every learning experience. It is important to provide a structured environment in which these
mistakes can be safely made, so patients are not harmed. There are many ways of doing so
safely (for example, providing effective supervision by countersigning a student’s medical
orders; and using animal models or virtual simulators to teach surgical skills).
The paradox
Learning and mistakes go hand in hand, and since all doctors need to be lifelong learners,
we will all make mistakes throughout our lives. All humans make mistakes, and doctors are
no exception. However, medical errors are far more complex than those which occur in other
fields.
As Hilfiker so eloquently put it- “ The drastic human consequences of medical mistakes; the
repeated opportunities to make them; the uncertainty about our own culpability when results are
poor, and the medical and societal denial about mistakes results in an intolerable paradox for the
physician. We see the horror of our own mistakes, yet we are given no permission to deal with their
enormous emotional impact.”
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Managing mistakes in medicine – A guide for doctors
On the defensive
This is why we often overreact to the mistakes we make. Most doctors are perfectionists, who
pride themselves on their professional skills and competence; and they feel uncomfortable
when these are threatened.
The fact that our patients pay a heavy price for our mistakes makes it difficult to live with
the knowledge that a patient who trusted you and placed his life in your hands may end up
losing it because of your fallibility. After making a mistake, the physicians’ initial emotional
reactions include panic, guilt, embarrassment, and humiliation.
The ability to acknowledge an error is the first and most critical step in the physician’s
healing process, but this is often hard to do. Many physicians typically justify their mistakes
by becoming defensive. They will :
** Blame the system; blame other members of the health care team; and even blame the
patient
** Discount its importance by claiming “it has no significant clinical effect”
** Exhibit emotional distancing by rationalizing that “everyone makes mistakes”
Our profession is difficult enough without us having to bear the yoke of perfection. The most
effective way for physicians to cope with their emotional reactions after making an error
is to discuss such feelings with trusted friends, colleagues or a spouse. However, medical
culture (partly because of the fear of malpractice litigation) encourages cover-ups of mistakes,
because of which most physicians bear the burden of their mistakes in isolation.
Why the cover-up?

When an error occurs, most patients would like to be informed about this error. They naturally
expect the doctor to provide an explanation or an apology and to rectify the error, and this is
what the doctor’s ethical obligation to the patient is.
However, given the fear of a malpractice lawsuit being slapped on them, most doctors today
still react to errors by trying to cover them up and hiding them from the patient. This often
makes a bad situation worse. Most patients who finally end up pursuing litigation usually
have multiple complaints including:
** Professional failure in diagnosis or treatment

** Lack of communication on the part of the doctor
** Some form of insensitivity on the part of the doctor that has emotionally upset them
This sorry state of affairs implies that insult has been added to injury. Such a development
not only destroys the relationship of trust between doctor and patient but it also makes the
patient more vengeful if he does find out about the medical botch-up through another source.
In the final analysis, remember the Golden Rule-do unto others as you would have them do
unto you! All said and done, honesty is still the best policy.
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When colleagues or employees make mistakes, please be charitable towards them–it may be
your turn to err tomorrow. Even if you are upset, please don’t exhibit your anger and shout
at them. It’s very tempting to belittle them or go on a witch-hunt to pin the blame on them at
this time, when emotions are running high, but how well you handle this difficult situation
will define your maturity. It’s very easy to berate them for their mistake, but this will just
make a bad situation worse.
The perpetrator of the error is already beating up on himself, so there’s no point in adding
to his angst. Instead, try to help to correct the mistake; and help them learn from their error,
so they are better prepared to handle similar situations in the future. When your junior or
colleague makes an error, encourage a description of what happened; acknowledge the
gravity of the mistake; and empathize with the emotions it elicits before embarking on a
more objective analysis.
A good response would be: “I am glad you are willing to discuss this error openly. This
reflects your intellectual honesty and compassion, both of which are attributes of a good
doctor. I know you feel terrible: this is normal. Let’s sit down and review the case. Now, if
you had it to do this all over again, what could be done differently?”
Preventing errors
The right response to mistakes is to use them as teaching tools, so we learn from them, and
don’t repeat them. To prevent mistakes, you need to be aware of the settings where mistakes
are more likely to occur–and be even more careful during these high-risk situations to prevent
problems. Circumstances that increase scope for error include:
** Times when you are tired, lazy or overconfident

** When it is late at night and you are sleepy
** When you are angry
** When you are dealing with an irritating patient
** When the patient has a complex medical problem
It’s important to take a proactive approach towards preventing mistakes, and you need to
work on developing systems, policies and protocols to prevent mishaps. For example:
** Instead of relying on memory, use preprinted forms. A good example is the use of
standardized forms for post-operative orders. These simply need to be ticked and
signed. They promote accurate communication; reduce variation by combining pertinent
reminders, safety alerts, and evidence-based best practices; and spare doctors the clerical
burden of having to repeatedly write the same orders.
** Flowcharts and algorithms can be helpful to prevent diagnostic errors.
** Personal digital assistants can serve as peripheral brains, since they can be equipped with
extensive drug and clinical databases.
When errors occur, we should learn from them so we can prevent them in the future , rather
than blame and hide. Reporting of errors is essential and we should allow it to be done
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Managing mistakes in medicine – A guide for doctors
voluntarily and anonymously, so doctors (and other staff) do not feel threatened when they
report errors.
A structured approach to analyzing errors and near misses allows us to systematically

examine systems and processes , rather than fall back on habitual blaming behaviors and
biases. Root cause analysis (RCA) is a useful tool, and shows that errors are not the result
of a single incident, but occur as a result of a chain of events (latent errors), which when
compounded together lead to the active error.
Ishikawa cause and effect diagram for analyzing why a wrong medication was given to a patient
A cause-and-effect diagram (Ishikawa diagram) can be used to identify specific factors that
might have contributed to the adverse outcome in a particular case. These factors are assigned
to one of six broad categories:
** Environment
** Equipment
** Leadership
** Communication
** People
** Procedures
Factors contributing to adverse events include:
** Poor communication- e.g., inadequate handoffs; incomplete clinical information

** Failure to coordinate care- e.g., involving different specialists
** Excessive workload
** Failure to escalate care-e.g., delay or failure to involve a more senior physician or nurse
79
** Failure to recognize change in clinical status- e.g., delay in recognizing changing clinical
signs and symptoms
An effective way (which is also free!) to reduce errors is to encourage patients to become
active partners in their medical care. Help your patients to seek more information and to
become an expert on their own problem. Any one doctor or nurse can make a mistake, but
the well-informed patient can prevent such errors, by acting as his own final line of defense.
You may forget and make mistakes, but a well-informed patient will not allow you to do so!
Dealing with mistakes
1. Accept responsibility for the mistake. Take ownership of the

problem – the buck stops with you!
2. Discuss it with colleagues
3. Disclose and apologize to the patient
4. Conduct an error analysis
5. Make changes in your practice to reduce similar errors in the future
The best way to put this advice into practice is to think about the last
mistake you made that harmed a patient. Talk to a colleague about it.
Notice his reactions, and your own. What helps? What makes it harder?
Physicians will always make mistakes – but how we handle them is upto
us. The best way is to be more honest about our mistakes, with our
patients, colleagues and ourselves.
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Risk management for doctors –
17
When things go wrong
It is good to learn what to avoid by studying the misfortunes of others.

Publius Syrius
Practicing medicine can be risky , because each medical procedure carries with it a probability
of therapeutic benefit, as well as risk. Risk management is the process by which the medical
team takes steps to reduce their professional liability. It has the following objectives:
** To define instances that place the physician at risk, and to determine their frequency and
significance
** To apply this awareness in the treatment of individual patients
** To develop remedial and preventative measures to prevent loss and/or injury
An important focus of risk management is to provide a safe environment for the patient while
fostering the patient-physician relationship. The patient who has had a poor outcome is like
a time bomb that may explode if she is not handled with care and tact. The most important
skill needed is that of patient communication: of being able to talk and explain to the patient
what went wrong, and why.
Risk management involves learning how to minimize the adverse impact of errors. Patients
who like their doctors feel a sense of loyalty and friendship towards them. They are much
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more inclined to resist the notion of suing even if things do go wrong. This is why the majority
of patients who experience an adverse event because of an error do not sue their doctors.
Unfortunately, arrogance seems to be second nature for some doctors in India and, as Tuthill
puts it, - “If you act like God you’ll be expected to perform like God” and that’s a sure invitation to
a lawsuit.
The doctor’s responsibility when a problem occurs

No matter how careful you are, errors will occur. After all, medicine is a messy biological
system, and you are not perfect. First, remember what not to do - don’t lie; don’t hide; don’t
pretend; and don’t push off the unpleasant duty of talking to the patient or his relatives, to
someone else- it’s your responsibility and only you can do it properly. Don’t make a bad
situation worse by running away from it! Unfortunately, the first response is often to bury
the error and hide it - but this often makes matters worse.
Here are a few things that doctors should be doing:
** Junior staff members should report all incidents to their seniors, who can take appropriate
steps. After all, with seniority comes experience-and often your seniors will have
encountered similar problems in the past, and will know exactly what to do. Their advice
and guidance can be invaluable.
** The first priority should be to attend to the patient’s medical needs. Take responsibility for
dealing with the problem, asking for consultation and making arrangements for follow-
up.
** Discuss with all staff members the factual details and sequence of what occurred, and
attempt to reconcile any opposing perceptions of what occurred. Coordinate your
response, to ensure that everyone is on the same page.
** When a serious adverse event occurs, expressing sincere sympathy and compassion to the
patient and/or family is often the most important response to help diffuse a potentially
volatile situation.
** As soon as possible after the event, factually record the incident and medical response
and document plans for further follow-up. It’s a good idea to ask the most knowledgeable
and senior staff member to do this.
** However, do not ever alter (or allow anyone else to alter) any prior documentation,
or insert backdated information. Ill-advised record alterations can render otherwise
defensible cases almost impossible to defend.
** Do not use the medical record to speculate or air grievances about other caregivers,
equipment, or administrative processes.
** Be accessible for questions from the family and the patient. Repeated requests for an
explanation of the event is a common reaction of upset patients and family members - be
empathetic and don’t get irritated!
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Risk management for doctors – When things go wrong
** Be honest with the patient and family - if you try to wriggle your way out by lying, you
may find yourself trapped in a quagmire from which it may be very difficult to extricate
yourself later.
Organize a family meeting if several relatives are involved in the patient’s care or if treatment
decisions are complicated. Empathize with the family and offer emotional support. Your
goal should be to show compassion for the patient’s distress, without admitting liability. This
can be tricky, but you need to find the right balance!
Accept responsibility for follow-up of serious complaints, but do not accept or assign blame,
or criticize the care or response of other providers. The best approach is a rational one -
describe the incident and medical response in brief, factual terms and if additional follow-up
is indicated, discuss those plans with the patient.
If the event involved a medical device or piece of equipment, preserve these materials for
investigation. Do not return defective devices to a manufacturer who may be a possible party
to a claim. Important medical data such as X-rays, ECGs and pathology slides should all be
carefully preserved following an adverse event.
Patients today have higher expectations of the medical care they receive. They expect their
doctor to have excellent technical skills and to apply his medical knowledge expertly to their
problems. They expect value for the money they spend on medical services, and they also
demand to be treated with respect, courtesy, and caring. When they find their expectations
belied, they turn into critics and even plaintiffs.
The nitty-gritty
Ensure that you have adequate professional liability insurance. Indeed, it would be foolhardy
for any doctor today to practice without taking out comprehensive coverage for malpractice
insurance, and fortunately insurance premiums in India are still reasonable. While coverage
will not prevent you from being sued, it will help to mitigate the possible financial impact on
your resources.
It has been said that the medical record is a defendant physician’s only friend, or foe. In every
malpractice case, attorneys for both sides scrutinize medical records carefully, looking for
specific types of evidence that will bolster their respective cases. Every medical record has a
potential for legal scrutiny, and it serves as a legal record of the care provided to the patient.
The rule is simple: if it is not documented it did not happen! Missing data, poorly integrated
information, or diagnostic conclusions that are not logical or are not properly recorded, leave
an impression of sloppy practice and poor physician judgment.
If you want to reduce your risk of getting sued for malpractice, follow these simple suggestions:
** Be a nice person. Be pleasant to be around. Be agreeable and friendly. While being nice
is no guarantee that a patient or family is not going to sue, they are far more likely to sue
you if you are unpleasant, obnoxious and rude.
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** Do not criticize other doctors and their care: after all, what goes around comes around,
and your criticism may backfire in the long run.
** Many doctors have now started practicing defensive medicine, in order to reduce their
risk of being sued. While a small dash of paranoia can help to reduce risk, you should not
let this get out of hand.
** When you make a mistake, admit it-promptly. The reason for this is that when we lie, we
send off signals that something’s not right, and most people can spot that a mile away.
If you are honest and forthcoming with patients and family, they are more inclined to
forgive you, and far less inclined to sue.
** Be open and accessible. Don’t hide from your patients. Don’t avoid them and don’t
abandon them. Make it a point to be reasonably available to your patients.
** If something doesn’t make sense, say so. If you don’t understand something, tell the
patient. And if you don’t have all the answers, tell the patient that, and say that you will
find someone who does have the answers.
** Keep up to date professionally, and don’t do things you are not competent to do. This is
just a part of being honest with yourself. Know what you can do, and do it. Know what
you can’t do, and don’t do it. Being competent as an individual is not enough. You are
in charge of the entire medical team caring for the patient, and you need to ensure that
your staff too is competent. They will learn from you, and it is your responsibility to teach
them well!
** Realize your own limitations, and ask for consultations and referrals to seniors when
necessary. Medical knowledge requires maintenance and the medical team needs to keep
themselves updated
Life is full of the unexpected, and this is especially true in an inexact science like medicine.
No matter how careful and conscientious you are, problems are bound to occur. If you are
prepared for these, and have a plan of action to deal with them, you will be able to cope much
better when they do crop up.
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Protecting the impaired physician –
18 why we need to break the conspiracy
of silence
We are all full of weakness and errors; let us mutually pardon each other our
follies - it is the first law of nature. Voltaire
Doctors are human, and there will always be a few bad apples amongst them. After all,
they are as vulnerable as anyone to all the maladies that can beset professionals in a highly-
demand stressful profession. In any large population of individuals there will always be a
small percentage of “problem” members, and this is true of the medical profession as well.
Unacceptable behavior
“Problem doctors” or impaired physicians, whose performance persistently falters, pose a
substantial threat to patient safety; 5% of practicing physicians could be considered problem
doctors because their performance is unsafe and substandard. This is a term that has been used
to encompass a wide range of behavior, including:
** Alcoholism
** Drug abuse
** Depression and other mental health problems
** Inappropriate sexual contact
** Burnout
** Professional incompetence
There are bad doctors (and bad nurses as well), but the fact that we tolerate them is just another
systems problem. One of the definitions of the medical profession is that it is self-policing: it
sets its own standards and enforces them through peer review. Despite this responsibility, it
is undeniable that doctors and hospitals tend to protect their own, sometimes at the expense
of patients.
Why we turn a blind eye

It can be scary to imagine that even though your personal doctor may have these problems, his
colleagues will try to protect him. While many professional medical organizations ethically
require doctors to report impaired doctors, most are party to a conspiracy of silence and turn
a blind eye to the problem. There are many reasons doctors do not turn in their colleagues:
** Most keep mum out of a misplaced sense of loyalty-they don’t want to get their friends
into trouble
85
** Others believe that it’s none of their business-that someone else should be taking care of
the problem
** Some feel that it’s not worth bothering about, as no action would be taken
** Some fear retribution if they rat-out on their peers
Technically proficient but disruptive physicians actually create an environment that is unsafe
and stifle other caregivers from stepping forward to protect patients. These physicians can
end up creating bad outcomes because they foster a culture of fear, rather than one of safety.
How to help
If physicians want to maintain their professional autonomy, they must become more involved
in the self-regulation process. Their goal is to identify problem doctors early, before they
jeopardize patient safety. A system to do so should fulfill three criteria:
** It should be objective, and should rely on data

** It should be fair, and all physicians should be evaluated on an annual basis according to the
same measures, using an open and unbiased evaluation process
** Finally, the system should be responsive. When physicians with problems are identified, they
must be treated promptly
For some physicians, feedback and internal counseling may be all that is necessary. Others
may need further assessment, and perhaps referral to a program to help them to correct their
deficiencies , so that they can continue to practice medicine, if possible. Others may be better
served by being struck off the medical register, so that they can no longer harm patients, and
are forced to pursue another career.
Most impaired physicians have difficulty with competence, conduct, or communication, and
their colleagues must be willing to intervene when they suspect a problem. Incompetent
or dangerous healthcare providers , and the institutions which harbor them, must be held
accountable. This is essential in order to protect patients from the harm these problem doctors
can cause; and to help the doctor as well.
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The nurse’s role in promoting patient safety -
19
Checking the “five rights”
Mistakes are the usual bridge between inexperience and wisdom. Phyllis Theroux
Though nurses are the primary caregivers in hospitals, in India today they are still treated
very shabbily. We need to overhaul our nursing curriculum, so that nurses can command the
respect they deserve, and act as partners in the safe delivery of patient care.
Nurses are very busy, and the more patients they have to look after, the greater their chances
of committing an error. There is a strong correlation between nurse staffing (both as regards
to the number of patients each nurse has to look after, as well as the quality of her education)
and patient outcomes. Because it’s so hard to find trained nurses in India, family members
often have to be roped in to provide nursing care for patients.
In a busy hospital, a single patient can receive more than 20 doses of medication per day,
while a nurse can administer as many as 100 medications per shift. A heavy work load and
erratic work hours can sap anyone’s energy and decrease their competence. Fatigue, stress
and complacency can all lead to deadly mistakes, and often this is a disaster waiting to
happen, especially at night-time, or on the weekend, when there are fewer nurses on duty.
This is why medication errors are so common. They occur because of:
** Illegibly written orders

** Dispensing errors
** Calculation errors
** Monitoring errors
** Administration errors
Medication points of failure
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Check the “five rights”

The right patient, the right drug, the right dose, the right route, and the right time! The five
rights don’t just describe the nurse’s responsibility for achieving medication safety; they are
also goals for which the hospital administration must accept responsibility so that it can
design failsafe ways to achieve them. Some of the measures that can be taken are:
** The prescribing process is the Achilles’ heels of medication safety. For example, illegible
prescriptions are a fertile breeding ground for error. Computerized physician order entry
(CPOE) prevents this problem. CPOE also reduces the risk of dangerous drug interactions;
the wrong dosage being prescribed; and minimizes incorrect drug choices.
** Verbal orders and those given over the phone should be verified by “reading back”. Drug
names should be spelled out using the phonetic alphabet.
** Nurses should request a colleague to double-check medications when giving high-alert
drugs
** All known allergies should be clearly documented. Nursing staff should be made aware
of various allergic reactions , and be trained to deal with them promptly.
** Protocols should be carefully followed with high-risk drugs, such as chemotherapy drugs
used for treating patients with cancer, because these can be very toxic. These include close
monitoring of the patient, good training of the nursing staff and well-maintained infusion
pumps.
** Out-of-date medicines must be immediately disposed.
** Handoffs and transitions occur when patients are moved from the ICU or OT to the ward,
or when the shift changes and new staff come on duty. These are occasions when the risk
for error is high. Handoffs should occur at designated times and without distraction. All
documentation must be complete and in order; and all medications should be reconciled.
** Particular care must be taken with elderly patients, children and pregnant women, or
with disabled patients or those who do not speak the same language
** In a busy ward, the workflow needs to be properly organized by the Head Nurse, in order
to prevent unnecessary distractions and interruptions
** Using standardized order sets and preprinted protocols helps nurses to select correct
dosing regimens and routes while eliminating ambiguous abbreviations and the risk of
misreading a prescriber’s handwriting.
** Medications for use in the hospital should be provided in clearly labeled unit-dose
packages.
** High-risk medications should be stored under lock and key.
** Patients should be taught the name of each medication they’re taking, how to take it, the
dosage, potential adverse effects and what it’s being used to treat, so they can protect
themselves from mistakes
** There are more details on how nurses can reduce medication risks at
http://www.americannursetoday.com/medication-errors-dont-let-them-happen-to-you/
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The nurse’s role in promoting patient safety -
Nurses as the first line of defense against errors

Nurses are the primary caregivers at the bedside, and since they are the ones who spend the
most time with the patient, they are often the first ones to notice when an error is being made.
What should a nurse do when she observes the doctor making a potential mistake? While it’s
easy to talk about the importance of reporting medical errors, the truth is that it is often very
hard for a nurse to speak up when she sees a doctor making an error.
Does she report the mistake? And to whom? Nurses are very junior in the medical hierarchy
in India, and it’s not easy for someone who is so low on the totem pole to report a mistake
made by a senior doctor, in order to protect her patient from harm, even though she knows it’s
the right thing to do. Nurses are understandably scared that this reporting will be considered
to be an act of insubordination, and they will have to pay a steep price if they dare to open
their mouth.
This is a thorny dilemma, because she has to choose between preventing harm to the patient,
and her loyalty to the doctor, her colleagues, supervisors, and the hospital. There is an
imbalance of power involved in the act, and although there are some cases where hospitals
have rewarded whistleblowers for their efforts, the typical response of the manager or
colleagues is harassment and mistreatment.
Nurses who have complained have often been forced to resign because the management
makes their life miserable, in order to shut them up. They are intimidated by doctors, and
the junior nurse is often uncertain about her own competence. Also, since sticking her neck
out carries a risk that she can get hurt, why should she bother? After all, if everyone else is
keeping quiet, why should she open her mouth?
She may also be unsure what the procedure for complaining is, and silence is often the easier
option, so she may choose to turn a blind eye to the error. It’s easy for a junior nurse to justify
her stance by saying – It’s not really any of my business. I should do my job, and not interfere
with what the doctor does.
The right path

However, the reality is that nurses should put their patients first, and their code of ethics
obliges them to be patient advocates and to take action when a patient’s safety is endangered.
Enlightened doctors will appreciate the nurse’s efforts to prevent harm to their patients; and
good hospital managers will make it as easy as possible for nurses to report near-misses
without fearing harm.
A qualified nurse is not the “handmaiden” of the doctor. She is an important resource
and must remain vigilant, ready to detect anything amiss in the care of the patient, who is
put under her charge. An efficient safety culture does not recognize hierarchy and allows
subordinates to speak up without the fear of retaliation. Nurses have to learn to speak up
when they feel something has gone awry.
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Reporting errors so we can learn
20 from them- How to stop good
people from making bad mistakes
Mistakes are the growing pains of wisdom. William Jordan
Given the scope of the medical errors problem, the knee-jerk response is: we need more
reporting, so we can prevent them! The hope is that transparency will drive change, and once
we understand the problem better, we will be able to fix it. This makes intuitive sense, which
is why most hospitals have error reporting systems.
Error reporting systems

These are called incident reporting (IR) systems, and the reports come from the medical staff
– the doctors and nurses who are taking care of the patient. IR systems are passive forms of
surveillance, which rely on the willingness of the medical staff to report errors. While these
systems are low cost, the experience with them has been disappointing. Medical staff often
don’t bother to report because:
** They were too busy and did not have enough time
** Did not know whom to report to or how to report
** “Forgot” to report; found the form too long and detailed
** Felt the error was too trivial
This is why only 10-20% of errors are ever reported; of those, only 5-10% actually cause
harm to patients. While well-organized IR systems can yield important insights, they can
also waste substantial resources on chasing red herrings which divert attention from more
important problems.
Medical errors are so common that the admonition to “report everything” is silly – the
system would quickly accumulate unmanageable mountains of data and result in caregivers
spending so much of their time reporting that they would not have time to care for their
patients. Good reporting systems are:
** Easy to use
** Encourage voluntary error reporting by rewarding those who report errors
(“good catch” awards)
** Use a team to review and address problems
After all, the goal of an IR system is not data collection, but meaningful improvements in
safety and quality.
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Reporting errors so we can learn from them
Error reports, whether filed on paper or through the Web, and whether sent to the hospital’s
safety officer or to a government agency, can be divided into three main categories:
** Anonymous- These reports are ones in which no identifying information is asked of the
reporter. Although they have the advantage of encouraging reporting, anonymous systems
have the disadvantage of preventing necessary follow-up questions from being answered, as
a result of which their clinical value is limited.
** Confidential- In a confidential reporting system, the identity of the reporter is known but
shielded from authorities. Such systems tend to capture more useful data than anonymous
systems, because follow-up intelligent questions can be asked.
** Open - Finally, in open reporting systems , all people and places are publicly identified. These
systems have a relatively poor track record in healthcare, because the potential for unwanted
publicity and blame is very strong, and it is often easy for individuals to cover up errors (even
with “mandatory” reporting).
We can do a better job at reporting errors if we are willing to learn from the aviation industry.
The ASRS – Aviation Safety Reporting System is the linchpin of the modern aviation industry’s
impressive record of safety. The ASRS has five traits:
** Ease of reporting
** Confidentiality
** Timely analysis and feedback
** Third party administration
** Regulatory action
These five traits have led to its success, and until we can replicate these, our medical error
reporting systems will leave a lot to be desired.
Improving safety
Sharing stories of reported errors so that we can learn from them is an important part of
improving safety; this was traditionally done in hospital M & M (morbidity and mortality)
conferences,- a generations-old ritual that provided a forum for doctors to confess their
mistakes and help their colleagues avoid making similar ones.
Increasingly, hospitals and other healthcare organizations are also compulsorily required to
submit reports of significant error to the government, accreditation bodies, and regulators.
These errors are called “sentinel events” and “never events”. They are serious, preventable
errors that should never occur if the appropriate safety measures have been properly
implemented. They are the “kind of mistake that should never happen” in the field of
medical treatment and serve as signals that the event is significant enough to trigger a full
investigation into the cause of the incident.
“Never events” are framed in the negative and carry a huge psychological burden. A
healthier alternative is the “always events” which represents a positive affirming behavior
that can motivate us to improve patient safety. Some basic examples of “always events”
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include: identifying patients using more than one source; using active identification, which
involves asking the patient to state her name; compulsory “readbacks” of verbal orders for
medications; writing down orders communicated on the phone; tracking of key imaging,
lab and pathology results; making critical information available at handoffs or transitions in
care; and transparent disclosure of adverse outcomes with patients and families;
Standardization and validation of “always events” is a better way of creating a positive long-
term culture of patient safety. Measuring errors is tricky and tracking progress in patient safety
is difficult, as we are trying to capture the absence of harm. Safety is a “dynamic nonevent”.
Given these limitations, hospitals need a more effective way to track and reduce harm. More
active methods of surveillance include retrospective chart review, direct observation, and
trigger tools.
The IHI Global Trigger Tool for Measuring Adverse Events provides an easy-to-use method
for accurately identifying harm. This is a retrospective focused review of a random sample
of inpatient hospital records using “triggers” (or clues) to identify possible adverse events.
Tracking adverse events over time is a useful way to tell if the changes which are being
implemented are improving the safety of the care process.
Analyzing the error

After we find a significant error, this needs to be analyzed, so we can prevent it from
recurring. Root cause analysis (RCA) is a structured method that is designed to answer three
basic questions: what happened, why did it happen, and what can be done to prevent it from
happening again? RCA is a tool that helps identify the underlying factors that precipitate an
error or near miss.
It repeatedly digs deeper into an issue by asking “Why” until no additional logical answers
can be identified, which means you have reached what is called a root cause. RCA focuses
on systems and processes, not on individual performance . The goal is to identify the factors
that led to the error, and to suggest solutions that can prevent similar errors from causing
harm in the future.
While the RCA is retrospective (after the event) the alternative prospective approach is based
on the failure modes and effects analysis (FMEA). This has been widely used in other high-
risk industries and has been advocated by the Institute of Medicine as a means of analyzing
a system to identify its failure modes and possible consequences of failure (effects) so as to
prioritize areas for improvement.
Finally, a very useful source of important safety insights can come from the analyses of
malpractice cases. These closed claim analyses are a rich source of information for teaching
about both medical errors and patient safety.
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21 Errors in IVF- And how we avoid them
The experience of others adds to our knowledge, but not to our wisdom; that
is dearer bought. Hosea Ballou
While the general principles of reducing errors apply to all medical specialties, since I am
an IVF specialist, this chapter describes what we do to reduce errors in our IVF clinic. This
should provide a sense of how medical specialists adapt patient safety solutions to their own
field.
IVF is as prone to errors as any other treatment because it is provided by a host of people
working together – doctors, nurses, receptionist, ultrasonographers, lab technicians and
embryologists. It requires lots of coordination, and there are few treatment processes for
which a team approach is more important than for assisted reproduction. Close, continuous
communication is required at many levels to ensure everything goes as planned.
Communication matters
Regular interaction is required to assure that infertile couples are adequately prepared, and
that scans, blood tests, egg collections and embryo transfers are performed seamlessly. IVF
offers a wide variety of mix-and-match treatment options, because there can be multiple
sources of eggs, sperms, and uteri; and lots of different physicians are involved, including
reproductive endocrinologists, urologists, anesthetists and counselors.
All of these can produce an environment of controlled chaos that must be managed. Important
to the issues of patient safety and the integrity of an ART program are the ways in which
a program handles the difficult issue of medical errors. Total freedom from error is only
possible in theory. Response to errors, when they occur, reveals the integrity of the program
and should be based on established processes.
The errors
IVF programs can be madhouses of activity, and the possibility of an error creeping in is
every IVF clinic’s nightmare. There are two primary types of errors in IVF:
** One, in which the eggs or sperm are mistakenly used with the gametes of another person;
or the wrong embryo is transferred to a patient
** The second, which leads to the loss of sperm, eggs, or embryos (for example, because of a
power failure as a result of which the incubator malfunctions).
IVF mix-ups are every patient’s and doctor’s nightmare, and lots of high profile cases have
been described where this has happened. The trouble is that eggs, sperms, and embryos look
exactly the same under the microscope ! Errors can be avoided by:
** Obsessive labeling
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** Double witnessing, where a second person double checks the identity of all the dishes in
the lab can help reduce this risk
** Electronic witnessing, using coding and RFID (radio frequency identification) technology
has also been introduced to prevent gamete mix-ups.
If a mix-up does occur and is noticed, this must be brought to the doctor’s attention
immediately. Even if the embryo has not been transferred, the patient should be informed,
so they can decide on a course of action they are comfortable with.
The second type of error may or may not lead to a reduced chance of reproduction. A loss
of part of a sperm specimen or improper handling of immature oocytes may not result in a
dramatic change in the outcome of the cycle for the patient. Although there can be a difference
of opinion about whether this should be disclosed, the ASRM Ethics committee states that it’s
best to disclose even minor mistakes that have potentially adverse effects for patients.
“If, on the other hand, there is clearly no adverse effect and if disclosure may unnecessarily
compound the stress of patients, disclosure may not be obligatory.” However, the perception
of dishonesty resulting from attempts to cover errors is often worse than the actual medical
error.
Maintaining transparency is important

Good IVF clinics have policies and procedures in place that deal specifically with medical
error. These should include definitions; statements about who should be informed, when, and
how; and mechanisms for determining the cause of the error and preventing its repetition.
Policies should encourage a culture of openness, address the ill effects of trying to cover up
errors, and very importantly, include corrective actions to minimize future errors.
They should be based on the understanding that errors can and will occur, and that a better
assessment of errors will improve the mechanisms for preventing and correcting them. This
has a positive effect on staff morale, which further enhances safety. A mechanism for reporting
both within the clinic and the laboratory allows for analysis of near misses. Incidents that do
not result in harm should also be reported to allow process optimization that can prevent
serious errors.
Process mapping
IVF care is a complex clinical process, and the clinical activity needs to be categorized into
compartments. This allows us to depict them as flow diagrams that allow study of sources
of error or risk. This promotes the ability to streamline the interaction of multiple complex
tasks performed by different clinical and administrative units such as nursing, laboratory,
and billing departments.
In addition to reducing effort, which in turn can decrease the sources of error, the process map
gives all the staff members an overview of the complete treatment cycle, so that the right hand
finally knows what the left hand is doing. This improves coordination and communication,
and allows each staff member to put patients first. Because they can see the big picture, the
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Errors in IVF- And how we avoid them
staff is now no longer just focused on doing their individual job, but understands that their
goal is to help the patient along her IVF journey.
Flow process diagrams allow us to assess the risk of error at each step in a clinical process.
For example, what would happen if the lab did not report the estradiol value in a timely
fashion to the doctor when he is timing the HCG trigger shot? The systematic evaluation of
risk points can lead to an action plan that results in minimal errors in the future.
Establishing metrics and tracking provides a means for following the success of error reduction
over time. Parameters can be as simple as checking to see what percentage of patients are
phoned the day after egg collection to make sure they are comfortable and are not developing
OHSS. Such simple proactive measures can help to make IVF safer for patients.
We use an EMR (electronic medical record) to document that we have provided treatment
correctly and safely. This allows team members to communicate with each other, and with
the patient as well.
The laboratory is the last stop in the complex process of IVF treatment and laboratory personnel
must confirm that all consents are current and complete for the intended treatments. In the
absence of these documents (whether paper or electronic), the embryology laboratory should
not perform the procedures.
Improving safety is not the responsibility of only the clinic staff. Thus, drug manufacturers
have started to provide the medications which patients need to self-inject daily in pre-filled
syringes, so that their chances of making a mistake in taking the injections is reduced.
The patient is the final line of defense against errors. Making sure the patient knows what is
supposed to happen next is the best way of reducing errors. This is why we have created the
free My Fertility Diary app (www.myfertilitydiary.com); it allows patients to track and monitor
the progress of their IVF cycle. If they know what’s going on, they are empowered to speak
up when the cycle does not progress as planned.
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Developing a culture of safety in hospitals-
22 Humans are not perfect,
so improve the system
Confession of errors is like a broom which sweeps away the dirt and leaves
the surface brighter and clearer. I feel stronger for confession.
Mahatma Gandhi
The definition of culture can be complex and wordy, but we can all recognize what it means. A
practical, easily understandable definition is - ‘the way we do things around here’. Leading five-
star hotels provide an excellent example of a great service culture. In the hospitality industry,
customers truly come first, whereas in hospitals, putting patients first is just a statement we pay
lip service to.
Design resilient systems

Along with inculcating a first class service culture, we also need to develop a culture of safety
in our hospitals. The problem is that today hospitals have a toxic culture of perfection, where
there is no margin for error. Because of the faulty way the system is designed, healthcare
professionals are trapped in a double bind. When nurses and doctors adhere to a norm that
says “hide errors,” they know they are violating another norm that says “reveal errors.”
Whichever norm they choose, they risk getting into trouble. If they hide the error, they can
be punished if the error is discovered. If they reveal the error, they run the risk of being
ostracized. The everydayness of errors means error hiding becomes a part of the culture of
the hospital.
Rather than continue fooling ourselves, we need to design error-proof and error-tolerant
systems in our hospitals - systems that are resilient and allow recovery from errors, rather
than brittle systems, which break down because of the burden of complexity and inefficiency.
In order to achieve perfection, we first need to acknowledge where we are imperfect, so we
can fix this.
A culture of safety is both proactive–built into the way the system is designed, so as to avoid
errors in the first place – and reactive – guiding the way we respond to errors when they do
occur. In pro-safety cultures:
** People willingly speak up when they see risky situations and behaviors
** Hierarchies are flat
** Workers follow critical safety rules
** The need for throughput is balanced against the need for safety
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** Not only are people encouraged to work toward change, they are empowered to take
corrective action as needed
** Keeping quiet in the face of safety problems is taboo; the encouragement to be vocal
comes from all directions - from peers as well as leaders
The balancing act
Hospitals can improve upon safety only when the CEO and the management are committed
to change. The trouble is that safety does not generate revenue – in fact, it’s a drain on
resources. Also, while buying the latest MRI scanner is glamorous and exciting and can help
to attract patients, implementing safety measures is boring and mundane.
Sadly, safety is not the overriding priority in healthcare today. The reality is that safety has
to compete with a number of other organizational objectives, and since it’s less tangible and
less valued than a shiny new cardiac catheterization lab which rakes in the moolah, it is easily
marginalized and forgotten in the daily hurly burly of running a hospital .
Healthcare, just like every other industry, has to deal with the tension between safety and
throughput. In practice, a CEO needs to balance the need for patient safety along with
the hundred other tasks which compete for his attention daily, such as costs, profitability,
efficiency, access to care, and patient satisfaction. Similarly, a nurse in charge of a ward
juggles safety with the need for having to efficiently taking care of a large number of patients.
It’s tempting to cut corners and take shortcuts. Safety is constantly being balanced against
some other aspect of the quality of care, because of costs and resource limitations. In theory,
patient safety should always take priority over other objectives, but in real life, when there is
a clash between safety measures and other objectives, safety often becomes a casualty when
drawing up the budget.
Effective safety programs blend elements of top-down management and bottom-up

engagement and innovation. Management boards and physicians must be fully-engaged in
devising safety programs for them to be successful. When a hospital does not have such a
culture, staff members are often unwilling to report adverse events and unsafe conditions
because they fear reprisal or believe reporting won’t result in any change.
Hospitals and managers have to learn not to target people in the “name and blame” culture
that existed in the past. The philosophy should be “to err is human, to forgive divine”, so
everyone can learn from the error and then move on.
The five characteristics of a positive safety culture

#1. Open culture- The staff feels comfortable discussing patient safety incidents and raising
safety issues with both colleagues and senior managers.
#2. Just culture- This blends a systems focus with appropriate individual and institutional
accountability. This promotes both reporting of medical errors and professional accountability,
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and :
** Staff, patients and caregivers are confident that they will be treated fairly, with empathy
and consideration, when they have been involved in a patient safety incident , or have
raised a safety issue.
** A critical component of improving patient safety involves analyzing medical errors. We
need to learn from close calls, sometimes called “near misses,” that occur at a much higher
frequency than actual adverse events. Near misses are easier to learn from because there
is less guilt and secrecy associated with them. Since no one has been harmed, the staff is
much more willing to discuss these more openly, since there is no blame and no fear of
litigation. Addressing these not only results in safer systems, but also focuses everyone’s
efforts on continually identifying potential problems and fixing them. However, they will
not be reported if the team is bound by a “code of silence” or if individuals are fearful of
retribution.
** Only those events that are judged to be an intentionally unsafe act can result in the
assignment of blame and punitive action. For example, intentional unsafe acts include a
doctor performing surgery when intoxicated.
#3. Reporting culture- Staff should have confidence in the local incident reporting system and
use it to notify managers of errors, including near misses:
** The reporting process should be easy

** The staff should not be punished for pointing out errors
** They need to receive constructive feedback promptly after submitting an incident report
** Reporting without learning serves no purpose and reporting systems need to include a
sense-making function, to make systems safer in the future
#4. Learning culture-The hospital is committed to learn safety lessons, which it communicates,
and remembers over time.
#5. Informed culture- The hospital has memory, because it learns from events that have already
happened (for example, through incident reports and investigations of sentinel events). It uses
this to identify and mitigate future incidents
Efforts that focus exclusively on eliminating errors will always fail. Individual errors will
always remain because of the role of fallible humans in delivering health care,; however, they
can be “trapped” or recognized before they reach the patient. The goal is to design systems
that are “fault tolerant,” so that when an individual error occurs, it does not result in harm
to a patient.
The personal qualities of the clinical staff play a key role in promoting patient safety. These
include: conscientiousness; humility and honesty; situation awareness; vigilance and open-
mindedness; anticipation and preparedness; team work and communication; and leadership.
It may seem to be a daunting list, but these are not new or mysterious skills -these are
essentially what the best healthcare professionals do in order to achieve consistently high
performance; and what the rest of us do on a good day.
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Safety - the top priority

The Leapfrog Group has developed the Hospital Safety Score @ http://www. hospitalsafetyscore.
org/your-hospitals-safety-score/about-the-score.
This grades hospitals in the US according to the safety measures they use. Process Measures
track how many patients receive the recommended treatment for a given medical condition.
For example, “Use antibiotics right before surgery” measures how often the hospital gives
patients an antibiotic within one hour before surgery to reduce postoperative infections.
Structural Measures represent the physical environment in which patients receive care For
example, “Doctors order medications through a computer” represents whether the hospital
uses a special computerized system to prevent medication errors. Outcome Measures checks
what happens to a patient while receiving care. For example, “Dangerous object left in
patient’s body” measures how many times a patient undergoing surgery had a dangerous
foreign object, like a sponge or an instrument, left behind in her body.
If we agree that the top priority in a hospital is safety and everyone is responsible for it, then we
need to ensure that the entire organization is wrapped around it, from the CEO onwards. Every
person caring for the patient has an impact on safety:
** For the surgeon, it’s making certain he adheres to specific processes, such as doing a time-
out before starting the operation
** For nurses, it’s double-checking what medications are being administered to a patient
** For the food-service worker, it’s verifying that the patient receives the correct diet
** For the environmental-service worker, it’s making sure the room is clean and uncluttered
to prevent infections and falls
The central question in safety is whether a junior staff member will have the courage to speak
up, not just when she’s sure something is wrong but, more important, when she’s not sure
that what the senior surgeon is doing is right. Safe organizations actively nurture a culture
in which the answer to that second question is always yes, and the CEO will compliment the
nurse for airing her concerns, even when it turns out that the surgeon was right. The role of
the CEO is to empower the front-line staff, and provide them with the resources they need,
so they can put patient safety first when doing their daily tasks.
Everyone has an important individual role, but we also have a collective role to promote
patient safety. The IHI (Institute for Healthcare Improvement) has some great ideas which
hospital CEOs can implement if they want to create a culture of safety. You can read these
at - http://www.ihi.org/resources/Pages/Changes/DevelopaCultureofSafety.aspx
Talk is cheap, and true commitment to patient safety requires action, not just statements. Since
an effective safety program depends on connecting the management (who control the budget
and set the priorities) with what is happening at the bedside, many hospitals have developed
strategies to connect senior leaders with caregivers. Senior managers can demonstrate their
commitment to safety by literally walking the talk! The communication should go two ways,
with both the executives and the medical staff talking honestly and listening carefully.
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The session should be for about an hour every week, and the discussions should be focused
only on safety; don’t dilute the safety message by trying to cover other topics. The staff should
prioritize 2 to 3 items to be addressed. These sessions provide a very powerful message to
the hospital staff, about how seriously the hospital leadership takes patient safety. This is
the healthcare version of the time-honored business leadership strategy of “Managing by
Walking Around” (MBWA).
Story telling is a great way of communicating safety, and a simple play, with the staff as
actors, can reenact a real-life medical error or near-miss. This is a great way of raising safety
awareness, and can teach both staff and management valuable safety lessons. You can tell
one true story, or patch together real or plausible events. A commentary from the patient
safety officer or senior manager, or the people involved in the real event , can be a powerful
ending that reinforces the management’s safety culture.
Involve patients in safety initiatives

Patients and their families provide a very valuable layer of defense against adverse events,
and in fact they are often the best sources of information. Not only do patients and families
feel valued when they are involved in safety checks, they can help to unearth errors which
would otherwise have been overlooked, because they provide a fresh unbiased outsider’s
perspective.
Staff members should always take patients and their families very seriously; and patients
should be encouraged to lead the hospital patient safety committee. There are some great
free tools which hospitals can use to can engage with patients called Patients as Partners at
http://www.h2pi.org/tools.html
A rapid response team

Hospitals need to set up a rapid response team, which can take prompt action in case a
complication occurs. This should consist of senior managers and experienced clinicians, who
can be mobilized instantly whenever there is an adverse event. They keep the atmosphere
in the unit calm; they mitigate harm to the patient; they curtail the blame game; they review
what happened; and they support the family, staff and physicians.
Not only does the medical team feel more confident with this kind of backup, the family is
also reassured when there are senior specialists who are actively engaged in the firefighting.
They are confident that the hospital is doing everything in its power to fix the problem. It’s
important to conduct drills to develop an organized response for actual events. Enough staff
members must be trained to have in-house response capability 24 hours a day, seven days a
week, along with a backup group of additional responders
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The role of a hospital patient safety officer-
23 And how she can help to reduce medical
errors
Dr. Reshma Ansari
An intelligent person is never afraid or ashamed to find errors in his

understanding of things. Bryant H. McGill
Doctors who work in hospitals have become inured to the frequency of errors, large and
small, because they see them daily. However, many patients are terrified by the possibility of
medical mistakes, which is why they dread hospitals.
We are vulnerable when we fall ill, and we want to believe that the wise doctor and the
gentle, caring nurse in the awe-inspiring hospital will help us to get better. We want to trust,
and we expect excellence.
This is why when an error occurs, the patient’s confidence in health care takes a massive
beating, and he feels betrayed and helpless. But even though the subject scares them, people
want answers as to why medical errors keep happening, particularly since so many people
have had first-hand experiences with them.
Technical aspects and human factors

** Safe health care delivery in a hospital has both technical and human dimensions.
Technical aspects include basic infrastructure, such as an uninterrupted electric supply;
air-conditioning; potable water; and the safe disposal of medical waste. For example, if
the electric power supply trips, and the hospital does not have a backup power generator,
then all the patients on ventilators in the ICU will die.
The fire in AMRI Hospitals in Kolkata in 2011 which killed 89 people highlighted how
vulnerable patients can be when they are in hospital. It is essential that the management
invest in keeping the hospital environment safe for patients. There need to be fire safety
drills, and extinguishers and fire safety equipment need to be installed, tested, inspected
and maintained.
** Human aspects are equally important, because patient care has to be delivered by people
– the doctors, nurses, paramedics and administrative staff.
The safety checklist for hospitals
Every hospital needs to have a full-time trained hospital patient safety officer, whose job is to
help hospitals to reduce medical errors. The buck stops with her, and she is responsible for
implementing measures, both to prevent errors, and to respond to them when they do occur.
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Safety should be the patient safety officer’s primary occupation, not an extra task in addition
to other jobs. She should report directly to the CEO, and should have the authority to act and
remove barriers to change.
The Safety Officer ensures that hospitals implement the following best practices.
** Displaying the Patient Rights and Responsibilities Charter so a patient knows what to
expect while receiving care at the hospital.
** Keeping two-way communication clear between the treating doctor and the patient or his
relatives by ensuring that the doctor takes regular rounds. Since these ‘busy’ doctors are
often too rushed to spend enough time at the bedside, there must be hospital-appointed
patient advocates who act as go-betweens and inform the patient’s family about the
progress the patient is making, at least twice a day.
** Making trained duty doctors and intensive care interventionists available round-the-
clock and providing backup s t a f f o n weekends, when some senior doctors may take an
unscheduled time off.
** Delivering bad news to the patients and their families about unintentional, adverse
outcomes as soon as they are spotted.
** Clearly displaying CODE numbers - when to call whom - in case of medical emergencies
(e.g.: CODE BLUE if a patient collapses).
** Creating “rapid response teams” for emergencies, when patients seem to be going
downhill. The management of the crisis following an error can be improved with help
from “extra hands” who bring an outside perspective and additional skills.
* * P r o v i d i n g clean and safe drinking water; sparkling clean restrooms and ensuring safe
disposal of hospital waste to avoid contamination.
** Providing anti-skid flooring, well lit rooms and grip bars in the corridors and along
staircases to prevent patient falls, especially in case of senior citizens.
** Having an emergency power back up system that is tested regularly.
** Segregating, treating and disposing hazardous materials and waste , to comply with the
Bio-Medical Waste (Management and Handling) Rules, to prevent the spread of infections.
** Servicing medical equipment regularly, to prevent tragedies like the horrific incident in
2009, when five newborns in an incubator were fried to death in a Punjab hospital after a
short-circuit sparked a fire in the nursery.
The National Accreditation Board for Hospitals and Healthcare Providers (NABH), under
the Quality Council of India (QCI) and the Ministry of Health & Family Welfare has set safety
standards for the health industry that hospitals need to comply with. However, medical
errors are still rampant in hospitals because the management is not convinced that investing
in safety is cost effective.
The tragedy is that hospitals would rather spend on fancy new MRI scanners and state
of the art Operation Theaters, rather than try to implement such low-tech, unglamorous
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The role of a hospital patient safety officer-
concepts as safety. This will change only when the hospital management starts to feel that
they will be rewarded in the marketplace by investing in safety. Until then, even though
they will continue to pay lip service to safety, this will always remain an after-thought in
the budget.
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How can hospital management
24 engage with doctors? Convincing
doctors to commit to patient safety
The best surgeon, like the best general, is the one who makes the fewest
mistakes. Sir Astley Cooper
Getting doctors involved is critical for ensuring the success of patient safety initiatives.
However, for most doctors, this is still a taboo topic. The subject is threatening, because it is
focused on preventing errors, and for a doctor, patient errors are synonymous with negligence
and lawsuits for malpractice, a topic they’d rather not dwell on. Also, because physicians are
so used to having to taking complete personal responsibility for all their actions, that they
find that a solution based on a system improvement approach is baffling.
The doctors’ objections

Any time hospital management wants to institute a change, there will always be resistance,
and this will often come from the senior doctors. Standard objections include the following:
** I haven’t ever had a problem so far, so why do I have to change my practice?

Why are you wasting our time?
** How can I take responsibility for someone else’s mistakes?
** I am careful and competent, and if everyone else was also equally careful, there would be
no need for all this new-fangled approach.
** We’ve never used any of these techniques all these years, and we’ve managed just fine, so
why should we change now?
** Isn’t all this safety business going to eat into my time? How will I be able to remember all
this when I have so many patients to see?
** This seems to be the latest fad that the CEO wants to win brownie points for.
** If I start disclosing errors, it will increase my liability.
** It’s all very well for the CEO sitting in his air conditioned cabin to preach, but how does
he know what’s happening in the trenches?
** If I tell the patient I goofed up, the relatives will beat me up, and who will come to protect
me?
** How much is this going to additionally cost my patient?
** Patient safety is the hospital’s headache so why should I care? Let them handle it – I have
enough problems of my own without having something new to worry about!
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How can hospital management engage with doctors?
Need for a “safety champion”

If the hospital management needs to get buy-in from its doctors (and without this, no
safety initiative will ever work), then they need to emphasize how doctors benefit when
their patients get safer medical care. Physicians are human , and their decisions have a large
emotional component. Telling stories about how unsafe systems cause needless harm can
help to sensitize doctors as to how important their role is in making hospitals safer for their
patients.
The best way to implement change is by searching for a physician champion. Find an influential
senior doctor to drive your safety initiative , and equip him with the tools needed to convert
his peers. Doctors ( especially the surgeons ) need to be taught that teamwork, vigilance,
standardized techniques, anticipation of the next step (or misstep), and compassion for our
patients are requisites to ensure successful medical outcomes. Team decisions are often more
important than neat surgical incisions!
A lot to learn
There’s a lot doctors can learn from pilots. They are both highly trained professionals,
operating in complex technological environments and their job entails being responsible for
the lives of others. However, safety levels in aviation have taken a quantum leap, but doctors
are lagging way behind. Is this because the incentive for flying safely is way more personal
than the need to practice medicine safely?
If instead of 100,000 patients in the US dying each year from medical errors, how different
would the medical profession’s approach have been if it were 100 doctors who died every year?
Because pilots sit in the cockpit and die first if the place crashes, they are highly motivated
in making sure that safety comes first. Lacking that incentive, the medical profession has
focused more on doing research and developing advanced technology; rather than on ways
of delivering care safely.
Flying has become far safer today because it emphasizes simplification and standardization;
safety training and retraining; teamwork; and safety nets are built in using checklists and
readbacks. Pilots have learned how to listen to their colleagues, and those lower in the
hierarchy have learned the importance of speaking up when they have concerns.
Physicians are still stuck in the solo mindset, and things won’t get much safer until we begin
adopting some of the lessons from high reliability organizations (HRO), such as NASA,
ISRO, nuclear power plants and the aviation industry, where the margin for error is very
small because errors can be catastrophic.
The most important trait of high reliability organizations is what Dr. Reason refers to as a
“constant preoccupation with the possibility of failure.” A highly reliable organization:
** Expects failure
** Looks for weak links
** Anticipates error before it occurs
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** Rehearses scenarios of failures and strives to think up novel problems that may arise
• Has trained its staff in the recognition of and recovery from error
• Generalizes, not isolates, errors and looks for root causes
Airlines are safer , not because they have better staff than hospitals do , but because they
equip their employees with better tools to help them make better decisions ; and systems in
place that help catch errors before they occur. We cannot guarantee perfect outcomes for our
patients, but we can commit to doing the best we can, to keep them safe and free from harm.
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A simple, low-cost method to prevent
25
errors in hospitals- The whiteboard solution
Mistakes are painful when they happen, but years later a collection of
mistakes is what is called experience. Denis Waitley
One of the biggest problems in hospitals today is a lack of communication. This occurs at
multiple levels:
** Patients and caregivers often do not understand medical jargon and are scared to tell
the doctor that they cannot make sense of anything he has said. Doctors are busy people
and are often in a rush when they are on their hospital rounds. They breeze in and out
of the room, and even before the patient or her relatives can collect their wits, they have
disappeared. The doctor is blissfully unaware of this lack of communication, and feels he
has done a good job.
** The communication gap is not only between the patient and doctor – there are gaps
between doctor and doctor as well. Typically, many medical specialists are involved in
providing care to the patient, and the care often gets fragmented. They are rarely in the
room at one time, and this lack of coordination is a huge problem. The right hand does
not know what the left hand is doing, and sometimes the information they provide to the
patient is different, leading to even more confusion.
** This is true for nursing care as well. When the shift changes and a new nurse comes on
duty, sometimes the hand-off is not done properly, and patient care suffers because of these
gaps. Ideally, the medical record is meant to ensure that the care is properly coordinated,
but this doesn’t always work well because when the record becomes voluminous, it’s
easy to miss critically important information.
** Also, patients don’t have easy access to their own medical records, which means they are
often in the dark as to what’s going on.
Adding to the confusion
This lack of communication is one of the major preventable reasons why medical errors occur.
The problem is compounded when the patient’s family members are not on the same page,
which means that they end up talking to the doctor at different times, thus wasting his time
and irritating him. Often, they may disagree with each other and this makes matters worse,
because they express conflicting wishes as to what they want done for their patient - often
behind each other’s backs.
Visitors and well-wishers are concerned about the patient’s health and have lots of questions
as well. What’s the diagnosis? What’s the treatment plan? Is he doing well? Is there anything
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they can do to help? The poor patient (or his relatives) has to keep on repeating the same
story many times, and this can be quite fatiguing. In a perfect world, we would be able to get
everyone together in the room at the same time, but this is not possible in reality.
The simple solution

Here’s a simple, low-cost solution that could be implemented easily in all hospital rooms
today:
** Every hospital room should have a whiteboard, on which everyone is free to write and
comment. The whiteboard would come equipped with markers of different colours to be
used for different purposes.
** The doctor could use it to explain to the patient what is wrong with them and how he
plans to fix it. An image is worth a thousand words, and this could help to overcome lots
of misunderstandings. Readymade anatomical medical magnetic stick-ons could be used
for doctors who are artistically challenged.
** The doctor could write down the proposed treatment plan; and the other medical
specialists and nurses could modify and edit this. For example, there could be a daily list of
medications that need to be given, along with the time they are meant to be administered.
Once the medicine is given, it could be struck off the list. In case there is a delay, the
family member could gently remind the nursing staff about this oversight.
** Checklists could be easily incorporated on the board. This is especially valuable before a
planned operation; or at the time of discharge, when there are multiple moving parts that
need to be synchronized to ensure that they work in tandem.
** Patients could write down their concerns, so that the doctor would address them on his
rounds. This ensures they don’t forget to ask a critical question; and this way they don’t
need to bother the doctor by pestering him with queries on his mobile. This board would
help to make the patient better organized as well!
** Warnings (for example, allergies) could be highlighted on the board, so that everyone is
aware of them.
Patients often forget the instructions that doctors and nurses and therapists give them.
These could be written down on the board, as a list of Do’s and Don’ts, to make sure they
are remembered correctly. It would be easy to develop readymade templates for common
problems , and these could be stuck on the board, as needed.
A section of the board would be reserved for the patient and the family members. Here they
could write down their story (of what happened, for example) and what help they need, so
they could share this with friends and loved ones. More importantly, they could write down
their doubts and concerns.
Not only will this help to make patients feel empowered, the hospital staff would get a chance
to hear the patient’s voice directly. This would prevent problems from escalating, and help to
improve patient satisfaction.
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A simple, low-cost method to prevent errors in hospitals-
The board is environmentally-friendly, as it can be reused daily. If a long term record is

needed, patients could take photos of the board, and share them as needed. A whiteboard is a
very simple tool to get everyone on the same page, and every hospital room should have one!
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Patient Safety from the System Perspective
Doctors and hospitals cannot work in isolation to keep patients

safe. This needs a systemic solution, and all the players in the
healthcare ecosystem - policymakers, the press, health insurers and
pharmaceutical companies - need to work in tandem to reduce medical
errors. How do we control the rampant medical fraud and corruption
in India which harms patients? We need to leverage digital health
technology, and learn from what other countries have done, in order
to promote patient safety.
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Keeping patients safe in India -
26
What policymakers can do
Anupama Shetty
Wise men learn by other men’s mistakes, fools by their own.

H G Brown
Concerns about patients being harmed during treatment have been echoed since centuries
in the aphorism “Primum Non Nocere” or ‘First do no harm’. Over the years there has been a
dramatic change in the regulation of physician practices. While physicians were largely self-
regulated and governed by the ethical codes defined by their respective Guilds, there are also
examples of State-imposed legal penalties for incompetence.
For example, the legal code of Hammurabi, which was inscribed around 2000 BC in Babylon,
describes penalties for medical malpractice, ranging from financial compensation to more
draconian measures such as amputating a surgeon’s hand.
The role of regulation

In ancient India, Sushruta, the surgeon-teacher code of ethical and clinical conduct made
medical students take an oath (not unlike the Hippocratic Oath), when they graduated from
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the School of Surgery. While self-regulation has been the norm over the centuries, regulatory
shifts in health governance and increased accountability to patients is now gaining precedence.
The watershed report published by the Institute of Medicine in the US in 1999- ‘To Err is
Human”, highlighted the fact that on an annual basis, between 44,000 and 98,000 deaths
occur in the US, from medical errors. This study catapulted patient safety concerns to
the fore, and catalyzed governments into taking suitable action. In 2002, the 55th World
Health Assembly adopted a resolution urging countries to strengthen their safety and
monitoring systems.
This resolution urged the World Health Organization (WHO) to establish global norms
and standards in support of countries’ efforts in developing patient safety norms, policies
and practices. Along the same lines, the World Alliance for Patient Safety (WAPS) that was
launched in May 2004 has worked with developed, developing and transitional economies
on various patient safety programs.
The Danish Act on Patient Safety came into force on 1 January 2004, and is a model for other
countries (http://patientsikkerhed.dk/in-english/act-on-patient-safety.aspx). The Danish Society
for Patient Safety also provides a comprehensive tool kit for healthcare workers to refer to
and measure their compliance with the law.
Regulation and accreditation are powerful tools to promote patient safety in that they can
make certain safety practices compulsory - after all, if the carrot does not work, then why not
use the stick? Regulation is vital in certain areas, particularly when doctors and hospitals fail
to voluntarily adopt reasonable safety standards. A law or regulation can easily seem like the
most straightforward way to fix an important safety problem, but real life is often too messy
and complex, and a “one-size-fits-all” approach is never a panacea.
For example, doctors in India were brought under the purview of The Consumer Protection
Act (CPA) in 1986. This was the first attempt at giving the consumer/patient the right to
question the quality of medical service received. Since then, there has been a lot of debate
about the CPA which has been censured for not factoring in all the complexities of our health
care system.
The problem with the legal system

Sadly, judges are still not familiar with the modern systems approach towards analyzing
medical errors. They are used to finding faults and assigning responsibility for crimes. They
are too quick to criticize individual doctors, using the “name, blame and shame” approach,
rather than seek system solutions. This often places the malpractice system in conflict with
the goals of the patient safety movement because tort law is adversarial by nature, while a
culture of safety is collaborative.
By refreshing contrast, several countries have adopted much healthier no-fault compensation
systems for medical injuries. New Zealand, Sweden, and Denmark have replaced litigation
with administrative compensation systems in which patients who sustain an avoidable
medical injury can apply for compensation without engaging the services of a lawyer. A
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Keeping patients safe in India -
panel of medical experts reviews the case and decides on compensation. Such systems allow
compensation to the injured parties without finding fault or negligence. This is a win-win,
because it is much fairer and quicker for the patient; it doesn’t put the doctor and hospital on
the defensive; it does not clog up the judicial system; it costs less; and it also helps society to
eliminate medical errors.
This kind of system encourages openness, so that these errors can be analyzed and the lessons
learned can be used to prevent errors in the future. The system is now designed to ask- not
who caused the accident but what caused the accident? The single greatest impediment to
error prevention in healthcare today is that we punish people for medical mistakes.
In India, it is unfortunate that the police mindlessly applies criminal law statutes to cases
where the patient suffers from medical complications. Judges, in their turn, blindly follow
the letter of the law, and don’t differentiate between regular criminal offences and the injuries
resulting from medical treatment. The law needs to be amended, so that what should be
a matter of professional inquiry is not distorted into an adversarial argument in criminal
courts by lay persons before judges, who are also lay persons.
It’s not that the law is an ass. The tragedy is that the two sections in the Indian Penal Code
(Section 80 and 88, which relate to accidents in doing a lawful act) which are appropriate
to medical negligence cases are usually ignored in daily practice. Medicine is a profession
dealing with life-and-death situations, and criminalizing adverse outcomes of treatment
would be a great disservice to society.
Accreditation
Accreditation is the external assessment of an organization to ensure they meet established
standards. Recent efforts at standardization of healthcare include setting up of a national
voluntary accreditation structure- the National Accreditation Board for Hospitals and
Healthcare Providers (NABH). This was set up by the Quality Council of India (QCI) in 2006.
NABH accreditation is voluntary and has to be renewed every 3 years.
These standards help hospitals to deliver quality medical care safely. In addition to scheduled
audits, the NABH also conducts surprise checks to ensure that these facilities are obeying
the set guidelines. Currently, the NABH accredits hospitals, medical laboratories, small
healthcare organizations, primary and community healthcare centers, blood banks, dental
facilities, as well as imaging facilities.
The Clinical Establishment (Registration and Regulation) Act was enacted by the Central
Government in 2012. Since Health is a State subject, the States have been told to adopt the
law through a resolution in their Assemblies, and Uttar Pradesh, Rajasthan and Jharkhand
have done so. This Act aims to bring about the enforcement of uniform minimum standards
across clinical establishments in the country.
The All India Institute of Medical Sciences (AIIMS) in Delhi launched the National Initiative
on Patient Safety (NIPS) in 2009. NIPS resources have started to train and sensitize clinical
professionals across the country on adverse events, reporting systems and patient safety
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practices. Several tertiary care hospitals in both the private and public sector have taken part
in workshops that are held in Delhi, on a regular basis.
Meanwhile, the Directorate General of Health Services in collaboration with WHO conducts
national-level workshops on patient safety concerns and strategies dealing with safer systems,
documenting case studies and recording other innovative practices. However, a lot remains
to be done, and this is both a challenge and an opportunity!
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How medical fraud and corruption harm
27
patients- And why it is rampant in India
I can pardon everybody’s mistakes except my own. Marcus Cato
Many patients have experienced the seamy side of commercial medical practice today.
** Surgeons demanding large cash payments before they will operate in an emergency
** Pediatricians peddling unnecessary vaccines by playing on the fears of parents
** Doctors writing prescriptions for unnecessary, expensive medicines because of the
incentives that drug companies lure them with
** Specialists ordering expensive tests in order to get kickbacks from diagnostic centers
With the privatization of medical colleges, we have reached a deplorable state of affairs in
which medical education is seen to be a business expenditure, and the doctor’s professional
fees are regarded as his return on this investment in his training. This is why patients no
longer have any faith in the profession’s ability to regulate itself – or in an external authority
doing it either.
Corruption is rampant
However, the roots of medical corruption and fraud run much deeper than this, and cause
far more extensive harm. Forms of corruption in healthcare and medicine include:
** Bribes and kickbacks

** Theft and embezzlement
** Absenteeism (where doctors and healthcare workers do not attend work , but claim their
salary)
** Informal payments or “speed money” which the patient has to give the medical staff to
expedite their care
** Institutionalized corruption (in some for-profit hospitals, revenue targets are set by the
management, and physicians are obliged to admit at least a minimum number of patients
every month , even if the hospitalization is unnecessary, if they don’t want to be sacked)
While the damage a crooked doctor does is limited to his patients, the elephant in the room
is the far more extensive damage wrought by a corrupt pubic healthcare system. The Govt of
India pumps money to try to provide safe and affordable healthcare for the poor, but most
of this gets wasted and diverted. This has been extensively documented many times, but
nothing seems to have changed over the years.
For example, in 2012, India’s Comptroller and Auditor General (CAG) reported that
the UP State Health Mission failed to fulfill its mandate and was responsible for an
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unaccounted loss of Rs 5754 crores out of the total amount of Rs 8657 crores. They described
this as “organized looting of) government funds.”
According to the Central Bureau of Investigation (CBI), “Large-scale bungling took place
in the implementation of NRHM ( National Rural Health Mission).” The modus operandi
for siphoning off state wealth included overpricing, fake supply of medicines and hospital
equipment by fictitious firms as well as huge kickbacks in construction activity to improve
health services in government-run primary health centers in rural areas.
The cover-up
The truth is that what is visible is only the tip of the iceberg; the bottom of the “iceberg” of
corruption is almost untraceable. Sadly, the art of healing has turned into a science of stealing
and the conspiracy to cover up has introduced criminality into medicine. No public health
program can succeed in a setting in which scarce resources are siphoned off, depriving the
disadvantaged and poor of essential healthcare. Safe care cannot be provided by a healthcare
delivery system in which kickbacks and bribery are a part of life.
It’s high time we stopped turning a blind eye to the cancer of corruption that has corroded
the heart of our healthcare system. As individuals, we often feel that we are powerless to
make a difference in a system that seems so set in its ways. However, if we work together,
as doctors, patients and concerned citizens, we can help to fix the problem by speaking up
against it. By keeping quiet (which is what most of us do) and because of our lackadaisical
attitude, we become part of the problem.
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How health insurers can keep patients
28
safe- Creating a financial safety net
Mistakes are lessons of wisdom. The past cannot be changed. The future is
yet in your power. Hugh White
More than a million Indians die each year due to lack of access to healthcare because over
700 million of us live in remote villages where basic healthcare facilities do not exist. Around
350 million of Indians live below the poverty line and survive on less than Rs 100/- per day,
which puts almost all medicines out of their reach.
It’s true that many government hospitals are supposed to provide medical care free of cost
to the underserved, but the poor do not even have the means to travel to the nearest Primary
Health Centre (PHC) to use these services. The numbers are mind-boggling, and the biggest
tragedy is that many of these deaths are preventable.
Unaffordable medical care

A large percentage of patients are unable to seek timely medical care because they cannot
afford it. In such cases, health insurance for the needy can ensure better access to healthcare.
Since most Indians are poor, it’s important that insurance companies float attractive,
affordable health insurance products.
These wheels have already been set into motion and health insurers now provide cover with
premiums as low as Re 1/- per day, which cater to the needs of the underserved in our
society. These can make a significant difference in making safe medical care more accessible
to the poor.
The first hurdle that has to be navigated is to create a demand for low-cost health insurance
products because the target audience is still unaware of the benefits of these products. India
has a very limited number of insurance companies and penetrating rural India is an uphill
task for them.
They need to learn from leading FMCG and telecom companies that have managed to create
a market where none existed before. The Insurance Regulatory and Development Authority
(IRDA) (https://www.irda.gov.in/) has taken a lot of initiatives to help simplify health insurance.
These protect the patient’s interests, by ensuring efficient and transparent claims settlements,
and this will help to encourage more citizens to buy health insurance.
The role of the government

The government needs to build a robust national network so we can provide safe healthcare to
Indians at affordable prices. The Rashtriya Swasthya Bima Yojana (RSBY, literally “National
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Health Insurance Programme”) is an innovative government-run health insurance scheme

for the Indian poor.
It provides for cashless insurance for hospitalization in public as well as private hospitals,
and has won plaudits from the World Bank, the UN and the ILO as one of the world’s best
health insurance schemes. Under RSBY, smart cards are issued to BPL ( below poverty line)
families; according to official figures, there were over 37 million active smart cards in June
2015.
Beneficiaries pay only Rs 30 as registration fee and the central and state governments pay
the premium. RSBY, which was launched in 2008 was earlier with the Labor Ministry, and
was shifted to the Health Ministry from April 1 2015, with plans to roll out a National Health
Assurance Mission to provide universal healthcare. The Arogyasri scheme in Andhra Pradesh
and the Yeshasvini programme in Karnataka are self-funded initiatives , which are run by
the respective state governments.
Creating innovative products and business models

Health insurers need not limit themselves only to providing a financial safety net for patients
– they can play a far more active role in developing the entire healthcare industry. Rural
India is highly medically underserved right now, because patients don’t have the requisite
paying capacity. However, if doctors know that patients living in small towns will be able to
pay for their medical care because they are insured, they are very likely to settle down and
start hospitals in these areas!
A health insurance cushion also allows individuals to seek care in better equipped hospitals
that are likely to be safer, because they are accredited and have newer technology. These are
more expensive, and would have been out of their reach had they not been insured, and were
forced to foot the entire bill themselves.
Progressive insurers have also implemented safety measures such as a free mandatory
second opinion whenever surgery is advised, to ensure that the care being advised is correct.
They can also reduce over-testing and overtreatment by investing in patient education, thus
helping to protect patients from unnecessary medical intervention.
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Drug safety: A huge challenge and
29 an even bigger opportunity- How to
mitigate the risks
From the errors of others, a wise man corrects his own. Publilius Syrus
In this day and age, when we pop pills so casually, we often tend to forget that medicines
contain powerful chemicals which should be consumed with caution. Not only should drugs
be of good quality, safe, and effective, they also must be used sparingly and rationally.
How pharmacists can help

A pharmacist (chemist) can play a vital role in ensuring the safe use of medicines by educating
patients and their families. We need to remember that he is not just a shop-keeper who sells
drugs; he is a trained professional, who can provide vital information on the prescribed drug,
such as the correct dosage; when it should be taken (morning, afternoon, evening or night);
and how ( on an empty stomach/before meals/after meals).
Ideally, he should educate patients and their relatives, both orally , and in writing. Generally,
a physician who is preoccupied with his daily case load may not have the time to advise
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patients on the safe use of various drugs. In a country like ours, where the doctor-patient
ratio is so skewed, most patients do not get enough time to spend with the doctor.
The wait list can be so long that doctors usually rely on their receptionists to hand over the
prescription, and answer the patients’ queries Such a dangerous practice can cost both the
doctor and the patient dearly when the instructions gets garbled during transmission!
However, a pharmacist is an independent professional . He is a specialist on drugs, and he

should remain vigilant about the irrationality of any drug combination. He can alert the doctor
and the patient, if he detects anything amiss in the doctor’s prescription. He can prevent
harmful drug interactions, because he has a complete list of all the medicines the patient takes
on a daily basis. To reduce the risk of drug toxicity, a number of drug information centers
(DICs) have been established. Pharmacists can access these for unbiased drug information.
The information provided by DICs is reliable, evidence-based and current, and this can help
to reduce the harm which medicines can cause.
When the right patient takes the right medicine at the right time in the right dose at the right
price, we can say that drug use has been rational. The pharmacist can play a key role in
ensuring this. Common types of irrational use of drugs which can harm the patient include:
** Self-medication
** Drug overuse, because of easy availability of drugs without a medical prescription
** Misuse or improper use of antibiotics
** Polypharmacy – prescribing too many drugs at one time
** Drug interactions- when the drugs react with each other
Side effects and adverse drug reactions
How often have you asked your doctor about the possible “side-effects” of a medicine he has
prescribed? The truth is hardly ever, because we are scared to ask too many questions, as a
result of which our concerns get suppressed. Patients today play an inconsequential role in
monitoring and reporting “adverse drug reactions” (ADRs).
This is a lost opportunity, as monitoring by patients can help identify drug reactions quickly
and efficiently. We need to engage with patients, so they can play an active role in drug
safety. Pill-popping is a habit that can become difficult to control, especially for patients with
chronic illnesses, who are seeking quick relief. As laypersons, they are not aware of the side
effects of most medicines, some of which can cause harm.
Pharmacists can play a crucial role in making patients aware of the dangers they are subjecting
their bodies to, especially with the overuse of over the counter (OTC) drugs. This is especially
necessary in a country like India, where many medications can be obtained from a chemist
store, even without a physician’s prescription.
Sadly, many chemist shops today still do not have a qualified pharmacist. The FDA has now
cracked the whip, and hopefully the new rules will help to improve drug safety in India.
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Drug safety: A huge challenge and an even bigger opportunity
How can we combat the menace of spurious drugs?

Fake drugs form 20% of the Rs 40,000 crore pharma market in India. Counterfeiting can
happen with both generic and branded products. Pharmaceutical companies have launched
many initiatives to help curb the menace of spurious drugs. These include: holograms on
their packaging, which are hard to duplicate; and the use of barcodes on medicines that can
be photographed using smartphones, and the image messaged to a number, to check that the
batch is authentic.
Clever companies such as PharmaSecure also offer a “track and trace” SMS verification
system which is aimed at giving every consumer the power to check her drug. The user
just needs to SMS the code, and not only does she receive confirmation that the product is
genuine, she also receives information about the drug she is taking.
Are generic medicines safe?
About three-quarters of prescription medication are generics, but

many patients still have a concern about their efficacy. The truth
is that generics contain the same active ingredients in the same
quantity as the branded drug. They are “tried and tested” and
many reputed manufacturers now produce high quality generics,
which cost a fraction of the branded products.
Ayurvedic medicines are extremely popular in India. However, many of these are
manufactured in sub-standard facilities, and are often contaminated with toxic heavy metals
and steroids. Just as allopathic medicines go through rigorous clinical testing procedures,
herbal drugs too should be subject to similar testing, to confirm they are safe and effective.
Because there is a shortage of qualified doctors in India, many AYUSH (Ayurveda, Unani,
Siddha and Homeopathy) doctors will also prescribe allopathic medicines. This can be
harmful, because they are not taught how to use these medicines properly. For example,
many will use powerful injectible steroids to treat a fever, because patients demand instant
relief.
However, these can have harmful effects, and patients need to understand that a good doctor
trained in a particular system of medicine will only prescribe medicines developed by that
system.
Preventing harmful drug interactions

Some medicines can interact adversely with other medicines, foods and dietary supplements.
To prevent drug interactions, the patient be treated with as few medicines as possible. Many
good doctors follow the rule that if they need to start a new medicine, they will think about
which old medicine they can stop. Sadly, it’s common to see many elderly patients taking
dozens of drugs daily.
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They often don’t have a clue why they are taking the medicine or why it was started in the
first place. Doctors rarely bother to review all the medicines the patient is taking, because
most specialists focus only on the particular organ which they are treating, and are unaware
of what the other specialists have prescribed.
A good chemist can do a “brown bag” review, where he asks the patient to bring all the
medicines he is taking, so he can advise him as to which ones are essential, and which can be
safely stopped, after discussion with the doctor.
Illegible medical prescriptions – Disasters waiting to happen

Messy and illegible handwriting can result in many errors, such as the wrong drug, incorrect
dose, and/or incorrect route. The situation is more complex in India because of the availability
of multiple brands of the same medicine with similar-sounding trade names that can confuse
doctors, nurses and the dispensing pharmacists.
Sadly, doctors seem to take a perverse pride in how poor their handwriting is. An ideal
prescription should be printed, or legibly written in ink in capitals; it must include the
following:
** Name, address, telephone number of the prescriber

** Date of prescription
** Generic name of the drug and brand name
** Dosage form, strength and total amount
** Any special instructions and warnings
** Name, address, age, sex of patient
** Signature or initials of prescriber
The Medical Council of India has prescribed a standard prescription format, and hopefully
all doctors will start using this soon. The use of computers to print out prescriptions can
also help to reduce the chances of errors. E-prescribing or electronic prescribing is a viable
solution to counter the shortcomings of the current paper based prescribing processes.
However, accessibility and cost barriers have slowed adoption. There are lots of successful
pilots, and the beauty is that the prescription reaches the pharmacy even before the patient
does. It also allows for home delivery of the medications, thus adding to the patient’s
convenience.
How can medication errors be reduced?

Here are some simple tips which doctors and chemists can follow, to help ensure patients
take their medicines properly:
** Indicate the dosage in clear terms

** Use words instead of numbers, for example “Take one tablet every day” instead of “Take
1 tablet every day.”
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Drug safety: A huge challenge and an even bigger opportunity
** Use units which are familiar to the patient, and for which they are likely to have suitable
measuring devices.
e.g. “Take two teaspoonfuls every six hours.” instead of “Take 10 ml. ...”
** In some instances it may be critical that an exact volume, such as 2.0 ml, be administered.
In such a case, a properly calibrated measuring device should be provided along with the
medication.
** Specify the route of administration if the medication is not intended for oral use.
E.g. insert one suppository vaginally every night at bedtime.
** Do not use abbreviations.
e.g. “Take two capsules twice a day.” not “Take two caps twice a day.”
** For illiterate patients, it is a good idea to include photos of what the medicine bottle/
capsule/ tablet looks like, so the patient can visually check he is taking the right medicine.
** Provide clear and legible printed labels on the dispensed medications, so that patients
know exactly what they are taking
** Encourage patients to use pill organizers and dispensers, so they remember to take the
right medicines at the right time. This is especially helpful for older patients, who are
often on many drugs, and may suffer from poor eye-sight or a failing memory
** The visual “Universal Medication Schedule”, a health literacy-based tool to improve
medication adherence, can also help to reduce errors.
The visual “Universal Medication Schedule”
Making patient information leaflets more patient-friendly

One way to prevent medication errors is to educate the patient. Pharmaceutical companies
are required by law to provide patients with medication information in the package, and
chemists and doctors should encourage patients to read these leaflets. These are supposed
to help patients take their medications properly, but most leaflets come with the following
problems:
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** Small text, crammed together

** Poorly printed, small, and hard-to-decipher warning labels’ symbols
** Unclear, non-standardised instructions
** Complex language that can be hard to understand
I wonder how many patients bother to even read these leaflets, leave alone understanding
what they convey. The information doesn’t seem to be designed with the patient in mind at
all. It appears that pharmaceutical companies print leaflets just to comply with the regulations
and to protect themselves from lawsuits should the patient suffer a complication as a result
of the drug.
Not only does this represent a missed opportunity to educate patients; unintelligible leaflets
are actually a potentially grave risk to the health of patients, who are often clueless about
the side effects and complications of the medicines they are taking because the leaflets are
unreadable.
There are some great examples of well-designed patient information leaflets @

http://www.choiceandmedication.org/cnwl/. These serve as a very good model for how
pharmaceutical companies can teach patients the information they need to know about their
medicines. The pharmaceutical industry needs to adopt the motto: “Educate before you medicate!
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also issued
guidelines to help improve package inserts:
** Use plain language, simple punctuation, short paragraphs, and bullet points
** Use an easy-to-read font
** Use headings and colour to help patients navigate the text
** Consider the use of simple, easy to understand symbols and pictographs
The full guidelines can be accessed at
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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Pharmaceutical companies as
30 partners in patient safety – Time to
learn from the West
Confidence turns into pride only when you are in denial of your mistakes.
Criss Jami
Modern medicines can have adverse effects, and these need to be tracked and monitored,
so that we do not see a repeat of the dreaded thalidomide tragedy, which caused thousands
of children to be born with birth defects. A study published in 2012 found that out of every
1000 prescriptions, approximately 80 are likely to result in adverse drug events (ADEs) in the
general hospitals and clinics in New Delhi.
About Pharmacovigilance
Pharmacovigilance is the pharmacological practice used to detect, assess, understand and
prevent adverse effects of medicines. The National Pharmacovigilance Program established
in January 2005 is based in the Central Drugs Standard Control Organization, New Delhi. At
present, there are 19 monitoring centers across the country, with AIIMS as the nodal centre
for monitoring adverse drug reactions in the country.
Recently, the Indian Pharmacopoeia Commission (IPC) in association with the Indian
Medical Association (IMA) launched Continuing Medical Education (CME) programs on
pharmacovigilance for doctors. The CMEs underline the need for doctors to take responsibility
for monitoring and reporting drug side effects.
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Learning from the US FDA

The US FDA (Food and Drug Administration) is a world leader in taking action to improve
drug safety. Since 80 percent of active ingredients in US medicines come from overseas
sources, the Food and Drug Administration Safety and Innovation Act, or FDASIA empowers
the FDA to inspect pharmaceutical factories all over the world.
They now even have the clout to shut down factories in India which don’t meet their safety
standards! This is the extent to which the FDA goes to in order to protect the global drug
supply chain , and making sure that US patients have access to safe drugs . Some countries in
the EU have made it compulsory that all AEs (Adverse Events) in the initial post-marketing
period are reported.
The FDA MedWatch program at http://www.fda.gov/Safety/MedWatch/ also provides a gateway

for clinically important safety information. It sends regular safety alerts and encourages
patients and doctors to report problems with drugs. Medication safety studies can be
expanded beyond reporting only adverse drug reactions to encompass a broader range of
patient injuries , so that the surveillance system becomes more robust in reducing errors.
US-headquartered, ISMP (https:/www.ismp.org/) is known and respected worldwide as the

premier resource for disseminating accurate medication safety information. It has compiled
a huge database of system-based causes of medication errors, based largely on review of
thousands of reports in its national Medication Error Reporting Program (MERP).
ISMP uses this knowledge base to spread global awareness about practical, proven, error-
free strategies of patient care.
For example, the ISMP Medication Safety Self-Assessment® for Community/Ambulatory

Pharmacy is one of the online tools designed to heighten awareness about safe pharmacy
systems. We need to make a concerted effort to get the key stakeholders to work together to
reduce errors related to drug names, packages, and labeling.
Clinical trials– keeping subjects safe by protecting the poor and illiterate
Clinical trials are scientific research experiments conducted on human volunteers in order to
find new ways to treat diseases. Medical science has grown by leaps and bounds on the back
of such biomedical research. When done properly, such studies are very useful in improving
our medical knowledge base. Pharmaceutical companies carry these out routinely, to establish
the safety and superiority of the new molecules their R&D department discovers.
However, clinical trials can be risky business. The fact that it is a trial means that we do not
know if the intervention will help the patient. The truth is that it may also harm them, and
the only way of finding out is by doing the trial. However, this exposes the trial participants
to increased risk. Now, if the subjects provide informed consent to participate as human
guinea pigs in the trial, that’s fine.
However, the problem is that not all clinical trials are conducted ethically. This is especially
true in India, which is fast becoming an attractive destination for carrying out clinical trials,
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Pharmaceutical companies as partners in patient safety
primarily because we have a huge and diverse pool of poor patients on whom these trials can
be conducted fairly inexpensively.
To a certain degree, the threat that the clinical trials’ industry poses to patient safety stems
from the fact that these are largely conducted by contract research organizations (CROs)
which are hired by the pharmaceutical companies. These CROs are commercial enterprises
that may cloak their financial motivations under the garb of doing benevolent medical
research to advance science.
The bad ones indulge in unethical practices, such as providing lucrative financial incentives
to healthcare workers, for the recruitment of poor illiterate “volunteers” , who are then
arm-twisted into signing “informed-but-not-understood-consent” forms. The Supreme
Court expressed reservations about the unethical way in which most clinical trials are being
conducted in the country, and has directed the Ministry of Health to formulate proper
guidelines on this, to protect patients’ interests.
While it is important that clinical trials need to be allowed in India, these have to be fair
and transparent. Although every hospital is supposed to have its own ethical committee to
oversee research carried out in that hospital, in our country most are defunct bodies.
The National Human Rights Commission (NHRC) guidelines propose that a research
group must provide participants with printed literature, explaining in simple, non-technical
language:
** The purpose of the study

** Details of the procedure
** Risks involved
** Financial or other interests of the researcher
** Commitment to treat (completely and free-of-cost), any complication that may arise
during the course of the trial
The research subject too has to certify in writing that she has understood the document and is
volunteering to participate in the research, without the promise of any monetary inducement
that is not permitted under the Indian law.
The desired outcome of clinical research is clear- to facilitate the conduct of responsible research
in such a way that no one is harmed. Prevention of harm - the protection of human subjects, is
a critical element of an effective and trustworthy research system. Without trust, the supply of
volunteers for clinical trials will dry up, and progress in biomedical research will grind to a halt.
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How pharma can leverage technology
31 to make care safer- A wide range of
solutions
Salil Kallianpur
More people would learn from their mistakes if they weren’t so busy denying
that they made them . Anonymous
Since pharmaceutical companies are the ones that manufacture the drugs, they can play a key
role in improving medication safety. They have multiple opportunities to do so including:
** Pre-market testing of brand names to reduce the risk of “sound-alike” drugs

** Using clearer labeling to prevent the problem of “look-alike” drugs
** Developing safer tamper-proof packaging
** Creating effective post-marketing surveillance measures to proactively identify and deal
with potentially harmful situations
Sadly, most companies today squander these opportunities. This is because patient safety
is not a priority for many of them, and they see the need to fix problems as a drain on their
resources, because of the costs it imposes.
Poor implementation of safety measures

Today, when notified of errors, many pharmaceutical companies assume that merely
sending a “Dear Doctor” letter to increase awareness of the problem suffices. If changes in
the product name, label, or package need to be implemented, the time lag (given the intricate
and complicated regulatory mechanisms), may be long, and the older product often remains
in inventory until it is exhausted, instead of being immediately recalled.
Post-marketing medication safety studies have largely relied on spontaneous, passive

reporting systems. These are limited by the fact that clinicians may fail to identify and report
side effects and complications that they suspect are caused by a drug. In order to plug these
gaps, developed countries (mainly in the EU) have developed robust systems where all drug-
related AEs (Adverse Events) have to be routinely reported in the initial post-marketing
period.
We should make a concerted effort to get key stakeholders to work together so that we
can reduce errors related to drug names, packages, and labeling. The use of technology in
managing health data has made this easier. In fact, governments in the developed world are
working to build an information infrastructure that will eventually lead to:
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How pharma can leverage technology to make care safer
** Elimination of most handwritten clinical data and their gradual replacement with
electronic health records (EHRs)
** Mobile prescribing (mRx)
** Automated pharmacies for prescription filling and dispensing
What pharmaceutical companies can do
Pharmaceutical companies can integrate with this digital ecosystem by partnering with
technology providers to ensure patient safety. For example, companies which make drugs for
treating asthma can also provide inexpensive sensors on their inhalers , along with intelligent
smartphone apps, so that asthmatic patients can be reminded to take their medicines at the
right time; and their intake of medications can be logged and recorded.
We need to remember that patients are much more likely to use apps if they are prescribed
by their physicians. Doctors will be happy to use digital solutions created by pharma, if it
aids in diagnosis ; improves the efficiency of their care; or enhances the physician–patient
relationship.
Patients can share information (either by providing active inputs or through the passive
collection of digital data via their smart phone). This data can provide valuable insights for
everyone - the patient, the doctor , the caregiver, as well as the pharma company. Automated
intelligent analysis of the data may allow us to predict that an individual patient’s risk of
getting an asthmatic attack is increased at a specific time of the day, or in one particular
location (perhaps because of pollution).
Armed with these relevant insights, the patient will be able to prevent the attack more
intelligently, and reduce her chances of hospitalization. This delivery of customized insights,
personalized coaching and medication reminders is very valuable for patients, so they
can manage their own illness with greater safety. These tools can help the pharmaceutical
industry to start thinking “beyond the pill “, so they can engage directly with patients , and
produce intelligent products which add more value to the life of their patients.
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Medical device safety-
32
The current state of affairs
Mistakes are proof that you are trying. Anonymous
It is an uncomfortable fact of life that patients can get injured , and even die , due to the
incorrect use of medical devices that are supposed to help them get well. Some of the new
medical technologies that pose the most challenges are implants and materials that are placed
in the body permanently. A major limitation is that problems and failures might become
evident only after several years of clinical use; but safety data prior to introduction of these
devices in the market, tends to be gathered only for a short period of time.
For example, the long-term problems with hip-replacement prostheses, where the fixation
materials failed, only occurred after several years of use. Similarly, even though drug-eluting
stents for treating diseased coronary arteries have been in widespread use for many years,
it is only now that we are realizing that they are associated with an increased risk of late
thrombotic complications.
The pressures and risks

There are many pressures to introduce new medical technology without adequate assessment.
Manufacturers have a strong financial incentive to promote and sell their products as soon as
possible, to maximize their profits. Pressure is also created by cowboy doctors who want to
use the newest state-of-the-art technology, even though its safety is still unproven. Between
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Medical device safety- The current state of affairs
the vested interests of manufacturers and the allure of “shiny-object-syndrome” for doctors,
there is often a dearth of information on the safety of the newest medical technology.
New technology introduces risks that are often unforeseen. Regulation, health technology
assessment , clinical engineering, together with staff training, all have a vital role in ensuring
the safety of new devices. Because safety information is often imperfect, we need ongoing
systems of surveillance, to pick up problems in a timely fashion.
Donated second hand technology is often ineffective

The problem is worse in developing countries like India because of poor infrastructure.
Untested technology is either acquired, or thrust upon the system, without an understanding
of the need or capacity to absorb this. This can cause harm if it is used incorrectly, installed
incorrectly, serviced incorrectly, or used by untrained individuals. Capacity development
and education are key to ensuring safe use of technologies
New technology in the developing world often meant the use of old, obsolete or ineffective
technology from the developed world. This was introduced without any evaluation process,
and was often completely inappropriate for use in poor countries. Most of this was donated
equipment, which was refurbished, and had a limited shelf-life. This often ended up being
discarded, because it never worked, and can even now be found gathering dust in dark and
dingy hospital storerooms .
In Colombia, it was estimated that up to 96% of foreign-donated medical technology stopped

functioning within 5 years of being donated, and that 39% never worked at all. Even when
new modern technology is introduced, careful thought should be given to exactly how it is to
be introduced; and the extent to which it is appropriate for the local setting. It may otherwise
end up causing harm.
The Indian landscape

Currently, India has in excess of 1000 medical device manufacturers who cover consumables,
instruments, disposables, electronics as well as diagnostics. The market is dominated by local
manufacturers for low value products, while multi-national companies manufacture the high
end equipment.
The need for regulation is underscored by the fact that almost 60% of India’s requirement
for medical devices and equipments is met by imports. However, many of these are of poor
quality, because they are distributed by fly-by-night agents, whose focus is on saving money.
These expose patients to needless risk.
Testing the quality of these imported devices is therefore extremely important to ensure
patient safety. The potential for harm to the poor in the fragile, underfunded, corrupt Indian
public health system is huge. This is because of:
** The poor state of infrastructure and equipment

** Unreliable supply and quality of drugs
** Insufficient staff
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** Lack of accountability
** Shortcomings in waste management and infection control
** Severe under financing of essential operating costs because of the illegal diversion of
funds
Incidents such as the J.J hospital tragedy involving the use of unapproved and untested stents
on 60 patients paved the way for the Mashelkar Committee Recommendations of 2004. The
central tenet is that the import of critical medical devices such as stents, catheters, implants,
intra-ocular lenses should be regulated.
Importers needed to submit US-FDA clearance , or similar approvals from other countries
, as proof of adherence to global quality standards, before they are granted permission to
import these devices. A recent initiative by the Indian government is the introduction of the
Drugs and Cosmetics (Amendment) Bill, 2013 that recognizes medical devices as distinct
from drugs, requiring separate regulation.
Technology or toys ?
Even though the medical devices industry is regulated, new and untested innovations can
still cause harm to patients. A good example of this is the introduction of robotic surgery.
While this is a great “gee-whiz” toy for macho surgeons to play with, and hospitals are
happy to advertise their million dollar purchase to show how “cutting –edge and state of the
art” their facilities are, the fact is that there is a learning curve associated with all these new
devices, and patients can be harmed while the surgical team is struggling to master the use
of the unfamiliar device.
A common example in India is the use of lasers or endoscopic equipment for complicated
surgery. Just attending a two-day workshop and acquiring a certificate does not make a
doctor sufficiently expert in using this technology; and a number of mishaps have been
reported because of operator inexperience.
Many medical devices today are designed to be disposable ( single use only) , which means
they are supposed to be discarded after they have been used once. However, because many
of these are so expensive (such as guide-wires and balloon catheters used in cardiology and
equipment used for laparoscopic surgery), many hospitals routinely reuse these devices after
reprocessing, to help reduce the financial burden on patients.
However, there is a risk that inadequately decontaminated products might cause infections;
and that cleaning and sterilization might erode their less durable components, leading to
malfunction. This is why manufacturers warn that it is unsafe to recycle devices which were
designed to be used only once.
Hospitals which take short-cuts while reusing disposable devices end up compromising
patient safety. This is why the US Food and Drug Administration ( FDA) has taken steps
to ensure that reprocessing companies adhere to the same stringent regulations for their
products that original-device makers do. If these are followed, then the risk to patients is not
increased.
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Medical device safety- The current state of affairs
Injection safety in India

During the 20th century, injection use has increased tremendously, and injections are now
probably the commonest healthcare procedure. Many injections given to provide treatment
in developing countries are in fact unnecessary, as oral drugs would be equally effective.
However, the belief in the curative power of injections, as opposed to pills, is one reason for
the continuation of this illogical practice.
The dangers come from the reuse of syringes without sterilization, with syringes often just
being rinsed in boiling water in between injections. In a poor country everything is reused,
simply because there is no alternative. Although lack of knowledge and poor standards play
a part, the danger is hugely compounded by the basic lack of resources. Medical staff is often
forced to take shortcuts because they don’t have any alternative. In a medical emergency,
for example, when the patient needs a life-saving antibiotic injection, even an unsterilized
syringe is better than nothing.
A huge proportion of injections are still given unsafely , and the numbers of people affected
are staggering. In some areas, as many as 75% of injections are unsafe, as a result of which
many poor unsuspecting patients get infected with hepatitis, HIV infection and other blood
borne pathogens.
We might think that aiming for safety in healthcare is the prerogative of rich countries and
that safety is a luxury poor people cannot afford. In fact, the reverse maybe true. When you
have few resources, it is all the more important that you do not cause harm or waste those
resources on poor quality care. Those living in poverty with little healthcare available can
least afford unsafe care.
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Digital health can make medical
33
care safer- all about EHRs and apps
Making mistakes is human . Repeating ‘em is too. Malcolm Forbes
EMRs
Medical records can be very valuable in preventing errors. However, old-fashioned paper-
based records are no longer viable, not only because they are highly prone to human errors
themselves, but because it is so hard to collate and analyze the data which is locked up inside
them. This is why EMRs or electronic medical records (also called EHRs or electronic health
records) have become so popular.
Improved digital communication reduces errors by making key medical data (such as the
medical history and lab reports) available to the doctor at his fingertips, 24/7. EMRs tend to
record and expose patient safety problems when they occur, while paper-based care buries
them.
EMRs can help reduce medical errors by using artificial intelligence . For example, automatic
alerts can be triggered when there is a possible toxic drug interaction, and the doctor is
“reminded” about these risks, thus reducing the potential for errors. While these alerts can be
life-saving, one of the great challenges of these clinical decision support systems (CDSS) has
been alert fatigue, as clinicians tire of being repeatedly bombarded by electronic warnings,
and start to ignore the important ones, thus allowing errors to creep in.
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Digital health can make medical care safer
One of the problems which plague EMRs is that of GIGO (garbage in = garbage out). In order
to make sure that errors do not creep into the EMR, it’s helpful to share this with the patient,
so she can check them and make sure they are accurate. Many EMRs now offer a patient
portal through which the patient can access her records. Patients should be encouraged to
contribute to their EMR, so that these provide a holistic picture of her illness.
One huge advantage of electronic records is that they allow us to analyze the data from millions
of patients after it has been anonymized and collated. Big data analytics can then be used to
track trends and this can help to improve safer medical care. For example, epidemiologists
have been able to track the spread of infectious diseases such as influenza, using Twitter to
track health trends in real time, and this can help safeguard the public’s health.
However, it is naïve to assume that adopting EMRs will be a bed of roses. The successful
implementation of health IT “is not a technical project, it’s a social change project.” It is the
environmental and organizational factors, rather than the digital wizardry itself, that will
determine the success and impact of digital health tools. This phenomenon is known as the
“productivity paradox” of information technology.
Some crucial issues:
** Clinicians need to become familiar with new EMR systems and this will take time. The
older senior physicians are still digital dinosaurs and because they are computer-phobic,
they will often resist this change .
** EMR systems themselves need to evolve and improve, so that they don’t interfere with
clinical workflow. Doctors should be able to customize the screens to suit their clinical
style, otherwise they will resist using software which is not designed around their
personal preferences.
** One major problem is that EMRs may cause care to become impersonal. The doctor is so
focused on making sense of the data on the computer screen that he is not able to establish
eye contact and rapport with the patient.
** Many EMRs still function in silos, and their data is locked up inside them. They need to
be made interoperable, so that they can exchange data and “talk” to other EMRs.
The Govt of India, Ministry of Health and Family Welfare (GOI MoH & FW) has published
the ‘Electronic Health Records & Healthcare IT’ (EHR and HIT) standards for Healthcare
Providers in September 2013. It has also announced the formation of a Regulatory Body –
NeHA (National eHealth Authority for India), which will make these standards mandatory.
The website at http://www.nhp.gov.in/electronic-health-record-standards provides updated
information about this dynamic area.
Digital technology as a safety net

Today, it has become possible to remotely monitor in real time a patient’s health using a
network of sensors and actuators , many of which can be used with her smartphone. This is
called the Internet of Things for Medical Devices (IoT-MD), and provides an environment
where a patient’s vital parameters are transmitted onto a secure cloud based platform, where
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it can be stored, aggregated and analyzed. Armed with this data, we can now come up with
a number of clever ways to help keep people safer. For example, it’s possible to use webcams
to monitor the elderly, so that if they trip and fall at home after hip surgery, they can receive
medical assistance promptly.
A number of diabetes apps now help diabetics to control their blood sugar levels much
more effectively. Other smartphone apps help to improve patient compliance, by reminding
patients to take their medicines on time, thus improving medication adherence. This creates
a safety net which reduces chances of medication errors.
Digital technology is being used in other clever ways to help improve patient safety.
Thus, a range of software tools have been developed to help radiologists recognize subtle
abnormalities in mammograms, and this helps in the early detection of breast cancer.
Similarly, the ThinPrep Imaging System combines the power of computer-assisted screening
with human diagnostic experience, to study Pap smears. This helps in picking up cervical
cancer early.
Telemedicine is also contributing in a big way to help keep patients safe. For example, patients
can take dialysis treatment at home , and a medical team remotely manages the procedure.
Not only are the chances of acquiring a hospital-borne infection fewer, but the costs are also
markedly reduced , and patients enjoy a better quality of life because they are in control.
Cutting-edge telemedicine has been used to make care in Intensive Care Units ( ICUs) safer
in the USA. Because of a critical shortage of critical care physicians or intensivists, many
ICUs don’t have a full-time intensivist on staff. This is why hospitals are now using virtual
intensivists to keep 24 hours vigil over the critically ill patients in the ICU using remote ICU
monitoring programs. These “eye in the sky” doctors can reduce mortality rates for ICU
patients as well as their length of stay, while also providing significant cost savings.
The new generation of smart computers (such as IBM’s Watson) apply artificial intelligence (
AI) based on deep machine learning , and can serve as a peripheral medical brain for doctors.
They can help to reduce diagnostic errors by generating a comprehensive list of possible
diagnoses, thus reminding doctors of conditions they may have overlooked.
On a much more basic level, an increasing number of physicians are now using smart
phones in their professional activities to communicate with their colleagues to get a
“digital curbside consultation”- for example, by sharing Whatsapp images of an unusual
X-ray image or a puzzling ECG tracing, to get a second opinion.
The danger
While digital health has tremendous theoretical appeal, its history has been characterized
by a surprising number of failures and unanticipated consequences. For example, like all
IT systems, digital health can become a very efficient error propagator if incorrect data is
entered. Whenever one introduces a technology to reduce one kind of error, one is likely to
introduce the possibility of new kinds of error.
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Digital health can make medical care safer
While computers help to prevent medical errors, they are also causing new kinds of mistakes,
some of which are whoppers. Sensors and monitors generate mountains of data, often leading
to more confusion than clarity. Overload causes the brain to tire, and that’s when medical
staff start cutting corners.
The term multitasking is a misnomer, and performance degrades rapidly when clinicians try
to do several things simultaneously, because of the cognitive trap of inattentional blindness
(focusing so much on one thing that they miss another). This becomes a fertile breeding
ground for error. One of the ironies of automation is that over reliance on technology can
paradoxically increase the possibility of error through reduced vigilance.
Because of the false sense of security which electronic monitoring engenders, the medical
staff starts allowing the machine to overrule the evidence of their own eyes, and this can
endanger patient safety. Extensive testing in real settings is the only way to tackle these
vulnerabilities.
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How media can bridge the doctor-
34 patient gap- Patient education is
the holy grail
Dr Reshma P Nayak
It is only an error in judgment to make a mistake , but it shows infirmity of

character to adhere to it when discovered. Christian Bovee
The problem with the press

Press accounts of medical errors are usually sensationalized and exaggerated because
mainstream media reporting today is largely about grabbing eyeballs. Attention-seeking
Headlines such as -“Medical error or murder?” “Doctor on Trial for Baby’s Death”, “Injection
Leaves Baby with Brain Damage”, and “Fatal Goof Jolts Famous Cancer Institute” have
become routine. Journalism today is all about TRPs, readership, and page views. These
parameters determine how well a newspaper, a TV channel or a website does in the market,
which is why the media is no longer bothered about providing an honest and truthful news
service.
Journalists, the underpaid slaves of this system , work under immense pressures of their own.
They have to turn in their “stories” in time before the edition can be put to bed. This pressure
to meet the deadline combined with the human tendency to unnecessarily sensationalize
even the most serious issue causes a lot of damage . Truth becomes a casualty, because the
reports fail to provide the right context or the proper perspective.
This is why doctors have become very disillusioned with the press. They feel that they blow
matters out of proportion and that the media today is indulging in an orgy of doctor-bashing.
When a patient dies, his family members seek out a reporter, who then writes up a very one-
sided human interest story which paints the doctor and hospital as a villain. The doctor is
often not allowed to present his perspective, because his lawyers tell him to clam up. As a
consequence, the reporting is very biased and unbalanced.
Rather than try to explain that errors can occur because of systemic defects, editors are out to
fix blame and look for a scapegoat. They suffer from The Owl Syndrome, aptly named after
a bird that is notoriously short-sighted. Their emphasis is on -Who? Their goal is to nail the
person who they feel was responsible for committing the mistake, because this makes for a
much juicier story, rather than take the more responsible approach of determining how the
tragedy came to pass. These are the remnants of our blame and shame culture.
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How media can bridge the doctor-patient gap
Passing the buck

An excellent example of poor quality reporting is the media coverage of the death of 13
women who died in a mass tubal sterilization camp in Chhattisgarh in Nov 2014. The
operating surgeon, Dr R K Gupta, who had done hundreds of similar camps safely in the
past, and had even been awarded a state honor 10 years ago for his sterilization work, was
held solely responsible for the deaths by the press.
He was promptly arrested and put behind bars. The public health department officials,
who were supposed to be responsible for ensuring patient safety in the camp that they
had organized, went scot-free, even though it was they who failed to provide the basic
infrastructural support services the doctor needed to carry out the surgery safely.
More than 4 million people (a large percentage of which are women), undergo sterilization
operations in India very year, often in unhygienic conditions and without proper care. This
camp was held in an abandoned hospital with no running water, and the sterilization of rusty
equipment was inadequate. Rules were flouted at several levels. These dangerous conditions
are not uncommon in sterilization camps throughout India, which means this is a disaster
waiting to happen again – and again.
However, rather than take responsibility for the disaster, public health officials started playing
their standard game of passing the buck. Dr KC Urao, deputy director of the Chhattisgarh
health and family welfare department, said the camp had not been authorized. He blamed
the tragedy on adulterated or contaminated drugs – and held the officials of the local health
department who had purchased them responsible for the deaths.
The saving grace

The good news is that digital media is giving niche players a golden opportunity to reach out
to patients. This sector is growing exponentially and online media will soon come to play a
big role, not just in reporting on health issues , but also in educating patients. Today, thanks
to clever digital entrepreneurs, you can search for the best doctor for your ailment, seek an
appointment, take a second opinion, order blood tests, read doctor reviews, as well as seek
support groups for your particular illness .
We need to create a trusted digital health platform in India to bridge the doctor-patient chasm
, where doctors would be able to connect with their patients , and patients could become
more empowered to make the right decisions.
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The Patient Safety Alliance -
35
Keeping patients in India safe
Dr Nikhil Datar
It’s not a person’s mistakes which define them - it’s the way they make
amends. Freya North
Increasing tension between doctors and patients

The relationship between patients and doctors has changed significantly in the last few years.
Patients now think of themselves as being healthcare consumers , and because they are better
informed, they expect more accountability, transparency and professionalism from their
doctors, replacing the earlier paternalistic approach, based on blind faith.
Increased awareness, rising expectations, escalating costs, medical advances and medical
laws have made it more challenging for doctors to meet their patient’s expectations.
Consequently, we have been seeing a steep increase in medico-legal litigation because of the
rising discontent over the manner in which health care services are currently being delivered.
As a practicing gynecologist and medical teacher, I have myself witnessed the tragic
consequences of unintended medical errors. International data reveals that one out of ten
patients seeking health care services is likely to be harmed by his doctor. It can safely be
assumed that the burden of harm may be higher in developing countries like India.
Often, when things go wrong, some doctors sulk, some curse their luck, but a few, more
responsible ones, try to figure out what went wrong and how to prevent the problem from
recurring. In India, many doctors expect that their patients should accept the error as part of
their fate, but this is not the right approach.
An error can cause death, disability, loss of income, and untold suffering to the patient and
his family. Some patients may take legal recourse and drag their doctors and hospitals to the
court of law. But nothing can adequately compensate for the patient’s personal loss, which
can be immense.
Doctors, who have been trained to be healers, find it hard to accept the fact that they were
instrumental in causing someone’s death or disability. I know of a few cases where a remorseful
doctor committed suicide after making a grievous error. Even where a doctor is sincere and
competent, errors can occur. However instead of passing the buck, it is worthwhile to explore
productive ways of eliminating such errors.
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The Patient Safety Alliance -
The Patient Safety Alliance

After receiving advanced training in Patient Safety through the Commonwealth Professional
Fellowship, with the help of few like-minded people , I founded an organization called “Patient
Safety Alliance” (www.patientsafetyalliance.in) that aims to empower patients and support
doctors in preventing medical errors in a blame-free environment. We have produced an
educational film in Hindi on preventing medication error that is available free on YouTube.
We have created simple low-cost paper tools to assist patients. For example, our medication
card helps to reduce errors by allowing patients to maintain accurate and up-to-date
information on the various medicines that different doctors have prescribed to them in a
single place. We have also designed a simple checklist which patients can use before getting
admitted to a hospital to protect themselves from harm. All these tools are available on our
website for free download.
At Patient Safety Alliance, we believe that any attempt to improve health care delivery can
be successful only when it makes things easier, simpler, faster and more efficient for all
stakeholders. One of the exciting projects that we are currently working on is “Safe Rx”, a
software application that assists doctors in prescribing medicines in an error-free manner. It
allows doctors to prescribe safely, without making any changes in their writing style!
We conduct a seminar called “Be Alert” for communities and consumers, aimed at sensitizing
them about sources of medical errors. We discuss subjects such as “How to communicate
effectively with your doctor” ,“How to ask the right questions of your doctor”, and “How to
search the internet for authentic and evidence-based information”. Anyone can request us to
present our seminar at their workplace, club house or housing society.
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Final Thoughts
While there’s lots of scope to reduce medical errors, we will never be

able to eradicate them. This section describes what needs to be done
when errors occur – and why saying sorry works so well.
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The aftermath: The need for open
36
disclosure to allow healing
I claim to be a simple individual liable to err like any other fellow mortal.
I own, however, that I have humility enough to confess my errors and to
retrace my steps. Mahatma Gandhi
What patients look for

Patients and relatives may suffer in two distinct ways from a medically induced injury. First
from the injury itself; and second from the insensitive manner in which the incident may be
handled afterwards by the medical staff. This emotional impact is particularly difficult to
deal with because the harm was caused by the very people in whom they had placed their
trust. On the other hand, when medical staff come forward, acknowledge the damage, and
take positive action, the support offered can ameliorate the impact.
The term “adverse medical event” or “unintended outcome” is useful, but has been
deliberately sanitized to make it neutral and bland. It conceals the gut-wrenching trauma
which it can induce.
Appreciating and understanding the experiences of injured patients is essential if one is

going to provide individually appropriate and practical help. Patient-centered care does not
cease just because a medical error occurs, and we need to continue to honor and respect the
needs of the patients and their families who have been harmed.
Imagine that you or your husband, mother or child has suffered a medical injury. What
would you want? Well, I imagine you would want to know what happened; you would want
an apology; you would want to be looked after ; and, later on, you might want steps to be
taken to prevent such things happening again to anyone else. If the injury led to you being
unemployed or unable to care for your children, you would want financial support to help
you during the recovery period.
These are reasonable expectations, but most healthcare organizations have proved (in the
past at least) to be extraordinarily bad at dealing with injured patients; resorting at times,
particularly during litigation, to deeply unpleasant tactics of delay and manipulation which
seriously compounded the initial problem. Dr Vincent coined the term, ‘second trauma’, to
describe what some patients experience when they are abandoned by their healthcare team.
When things go wrong

When a patient is harmed, possibly because of an error, the natural tendency of the medical
staff is to clam up. This is the natural human response to a mistake. Even when a child
goofs up, the instinctive reaction is to hide the mistake and try to bury it. The medical team
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feel guilty and ashamed , and believe that they have let the patient down because of their
incompetence. The emotional impact on them is disproportionately hard, because they feel
they have betrayed their patient’s trust.
While one would expect an apology to the patient to be the natural response, the truth
is that it’s especially hard for doctors to say – “I am sorry”. Traditionally, there’s always
been a culture of secrecy around professional failings, because of the fear of medico-legal
consequences which can damage their professional reputation. This is especially true when
the patient is poor, because the doctor knows he can get away with “passing the buck”.
Often the doctor doesn’t know what to do, because he has not been trained in how to talk
to the patient or her family about the error. He takes refuge in silence and hopes that the
problem will go away. Doctors are very busy, and one way of coping with the error is to
divert their attention to other patients who need their help.
Sadly, there is very little organizational support for the doctor who has committed an error.
Most hospitals in India still don’t have adverse incident reporting and learning systems; and
they have not bothered to set up organizational protocols of how to deal with a patient who
has suffered medical harm.
How patients get bullied

Sometimes, patients also inadvertently contribute to this conspiracy of silence because
they find it hard to ‘speak up,’ ask questions and have their needs for answers met. This
is especially true when patients are poor and illiterate, because they still treat the doctor as
God. They feel that it would be ungrateful on their part to cross-question the doctor, and
because they are vulnerable, they allow themselves to get bullied because they don’t know
any better. However, the resentment and anger can build up and come to a boil later on.
Sadly, doctors have been given bad advice by their insurance indemnity lawyers, who tell
them to clam up, because they are more concerned about the doctor’s liability than their
humanity. The good news is that insurers are realizing that encouraging doctors to be open
actually helps to reduce the costs of fighting malpractice suits.
The new trend is to encourage disclosure. For example, the COPIC Insurance Company that
provides insurance cover to physicians in Colorado, USA, uses a voluntary early intervention
program. The 3Rs program, applicable to cases that do not involve death or clear negligence,
involves “recognizing” a complication, “responding promptly” and “resolving issues”.
Practice versus theory

While the principle of being honest and open is hard to disagree with, in practice a host of
questions immediately arise:
** Should everything be disclosed - even minor errors of no consequence ?

** Should all serious injuries be disclosed, even though knowledge about the damage will
make no material difference to the patient or family? How will this help the patient?
** Will patients become unduly anxious once they know how frequently errors occur?
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The aftermath: The need for open disclosure to allow healing
These are all reasonable questions that are beginning to be systematically explored. Whether
barriers to disclosure and apology are legal, organizational, financial or psychological, the
ethical imperative remains the same- to tell patients the truth and apologize when called for.
Taking a proactive approach, including apologizing when appropriate, could actually help
avoid lawsuits. Preventive law can be as effective as preventive medicine. You can address
issues before they mushroom into something much bigger.
Physicians can’t just be told to do better at disclosing medical errors. They need help to do
this well. It’s a very difficult thing to do, because the instinct is to deny and avoid. It’s a real
skill and like every single skill in medicine and in life, you need training to get better at it.
Effective communication requires practice, repetition and feedback. Some hospitals have set
up error disclosure teams, which are taught to show the 3Cs - Concern, Compassion and
Commitment.
It’s about feelings, not just words

Sorry Works at www.sorryworks.net has numerous training tools and resources that help
doctors and nurses learn how to say sorry. Communication after a medical error is fraught
with hazard, and doctors need to remember that, how something is said can have as much
impact as what is said. When navigating the critical yet exceptionally difficult conversations
that follow a medical error, doctors need to remember that it is more about feelings than just
words, more about heart than just methods.
A poorly planned apology can be as bad as or worse than no apology at all, and Dr. Michael
Woods , in his book, Healing Words: The Power of Apology in Medicine, suggests using five
“R’s” to ensure the apology is authentic. The key is distinguishing between expression of
empathy and admission of fault.
** Recognition = A perceptive response by a doctor or nurse that acknowledges her own

feelings and those of the patient and family. If the patient is reluctant to talk, this may be an
indicator that the medical team is not meeting their needs adequately.
** Regret = An empathetic response by the provider to let the patient know the provider
understands their experience and feels badly about it. “I am so sorry. I know this outcome is
not what you expected. It is not what I expected either.”
** Responsibility = A statement of transparency that attempts to answer the patient’s questions
about their unexpected outcome. What happened? Why did it happen ? What steps will be
taken to prevent reoccurrence?
** Remedy = What is being done to correct the problem? Who is going to be responsible for the
cost of fixing it?
** Remain Engaged = Be there for the patient. Reassure the patient that you will not abandon
her. Focus on and provide for your patient’s continuing care needs. Follow up, even after you
hand off to someone else.
Clinicians can use the TRACK process to rebuild the trust that has been disrupted by the
medical error. TRACK is an acronym coined by Dr Robert Truog which reminds them about
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the five key values they need to embody at this time: Transparency, Respect, Accountability,
Continuity and Kindness.
Hospitals are coaching physicians how to deal with families after an error, and doctors are
asked to “role-play” during case scenarios to help them prepare for errors in real life. Saying
sorry is not an apology – it’s an expression of caring. It can be a crucial part of an empathetic
and compassionate response to patients who have gone through a traumatic medical event.
This helps doctors reclaim their natural capacity for caring and kindness when emotions
are running high, rather than thinking of the relatives of the injured patient as potential
adversaries.
In 2006, the Harvard Medical School developed this approach for talking about adverse
events.
Immediately after the event:
** Acknowledge the event

** Express regret
** Take steps to minimize further harm
** Explain what happens next
** Commit to investigate to find out why the adverse event occurred
Later follow-up
** Disclose the results of the internal investigation

** Apologize if there is an error or systems failure
** Make changes to prevent the failure from recurring
** Provide continuing emotional support to the patients and health professionals involved
The disclosure process - a senior doctor’s responsibility
Communication with the patient and family after an adverse outcome is a delicate task, and
should not be delegated to a junior doctor. It must be done by a senior doctor. This can be
reassuring for the family, who needs to see that experts are now engaged in trying to resolve
the matter efficiently. This helps them feel they are in safe hands.
Dr James Pichert and Dr Gerald Hickson offer the following useful guidelines for doctors.
** Give bad news in a private place, where you can respond appropriately to the patient
and/or family’s reactions.
** Deliver the message clearly. The adverse outcome must be spelled out. ‘I’m sorry to report
that the procedure resulted in . . . ’
** Wait silently for a reaction. Give the patient/family time to consider what has happened
, so they can formulate their questions.
** Acknowledge and accept the initial reaction. The usual reaction to bad news is a mixture
of denial, anger, resignation, shock and so on.
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The aftermath: The need for open disclosure to allow healing
** Listen to what the family has to say.

** Resist the urge to blame or appear to blame other health professionals for the outcome.
** Discuss transition support. Tell the patient/family what steps will be taken to provide
medical, social or other forms of support.
** Finish by reassuring them about your continued willingness to answer any questions
they might have
** Discuss the next steps.
** Schedule a follow-up meeting. Some patients will want to talk only after the crisis has
subsided.
** Afterwards, document a summary of the discussion. Ideally, this should be shared with
the patient and family.
A healthy disclosure process must:
** Allow staff to show respect to the patient (and/or family members) by offering an
immediate and sincere apology
** Be conducted as much as possible by those originally involved in the patient’s care
** Allow patients to appoint a support person
** Allow patients to indicate the matters they want to see action taken on
** Allow staff to give carefully structured feedback as matters come to light, rather than
delaying feedback until the end of a closed-door investigation
** Prevent different staff members from expressing conflicting perspectives on the causes of
the unexpected outcome
** Be deployed as a formal process for all high-severity adverse events.
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37 The night I nearly killed my patient—redux
You make mistakes, mistakes don’t make you. Maxwell Maltz
Let’s go back to where we started - the night I nearly killed my patient.
Time is a teacher and a healer

I was never given the opportunity to discuss this case in a non-critical forum, and the other
residents were not given a chance to learn from my mistakes either. The only silver lining
was that I read and learned everything I could about the management of severe PIH, and
became so well-versed on this topic, that the other residents would ask me for help when
they had to treat a patient with PIH.
All doctors have had a similar experience during their training, but this was the elephant
in the room which no one was willing to discuss at that time. In fact, Dr Albert Wu has
described the doctors and nurses who harm their patients as a result of their mistakes as
being “the second victim”. The truth is that all doctors make terrible mistakes, and this is part
of learning to become a doctor. Some are so scarred by these errors that they lose confidence
in their abilities, and quit medicine.
With the passage of time, I have now learned to be kinder to myself. The truth is that medical
errors will keep happening until we bring them out in the open and talk about them. However,
because making an error is so shameful for a doctor, all we want to do is hide it. As doctors,
if we make a mistake, this failure to take care of our patients is something we internalize; it
is us - we are the error, and this can be hard to live with. The shame is so powerful that most
doctors will never come forward and discuss their errors.
When only perfection will do

It’s partly the socialization of doctors which makes it so hard for us to admit a mistake. We
tend to pick perfectionists as medical students, knowing that the medical system is not for the
faint of heart. Then they’re trained to become perfect. There’s no place for a “good enough”
doctor – you are either excellent or terrible, which means there is no margin for error. Being
perfect is tough, and you can’t spoil your image by discussing your errors.
Doctors are not alone in harboring expectations of perfection, and patients too expect their
doctors to be flawless . As doctors, we are trained to take charge – to be the captain of the
ship. That means you take personal responsibility for every single thing that happens to the
patient in your care , whether or not it was your fault. You are responsible, and the buck
stops with you.
When a complication occurs, the first feeling that envelops you is one of sadness, because
you’re a healer and seeing people suffer makes you feel sad. This is compounded by the
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The night I nearly killed my patient—redux
shame that you actually caused that suffering, followed by the fear that you are going to
somehow be ostracized, sued, and humiliated publicly. Then comes the anger because you
feel very alone and wonder why the system isn’t supporting you in this difficult time for you
as a professional. Soon the panic sets in , as a result of all these emotions.
A ray of hope
The good news is that hospitals are now realizing that they need to do a better job of
supporting physicians when things go wrong. Dr Jo Shapiro, MD, helped start the Center for
Professionalism & Peer Support at Boston’s Brigham and Women’s Hospital in October 2008,
to offer emotional support to peers involved in cases of patient harm.
“When there’s any kind of adverse event that we hear about, one of us will make an outreach
call to the physician involved,” says Dr Shapiro. This simple gesture gives doctors a chance to
speak confidentially with a colleague, about the guilt, fear and shame that often accompany
adverse events. “We also validate what they are feeling. We tell them that the suffering
they’re feeling means that they care. We wouldn’t want people not to care.”
After an error, we need to support everyone post the event. Not only do we need to
treat patients and families in a more humane fashion, we need to be equally kind to the
doctors and nurses involved as well. Medically Induced Trauma Support Services
(MITSS, www.mitss.org) was founded to assist in healing the relationship between clinicians
and patients who have experienced an error together. MITSS also provides insights to the
public to prevent errors from happening.
Strategies for helping the “”second victim” cope with error and
harm
** Be open about error and its frequency. Senior doctors should

talk openly about their personal mistakes.
** Stories can be a very effective teaching tool.
** Accept that a need for support is not a sign of weakness.
** Clinicians have to be resilient but almost all are grateful for the
support of colleagues when disaster strikes.
** For a particularly profound reaction, perhaps to the death of a
child, formal psychological intervention may be valuable.
** Teaching hospitals have to continue to teach junior doctors, but
they should be supervised properly. Particularly in surgery,
the use of simulation and models will help trainees learn new
procedures with fewer risks to patients.
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A new beginning-
38
Challenges and opportunities
Errors in judgment must occur in the practice of an Art which consists

largely in balancing probabilities. Sir William Osler
Trust is the bedrock of medical practice , but when medical errors are made (and even
worse, when an attempt is made to cover them up) this trust gets eroded, which means that
the cover-up is worse than the crime. On the other hand, trust breeds trust; and if patients
know that doctors can be relied on to admit their errors, they will reward this candor with
their trust. To create trust, we need to promise and deliver three things – a valuable service;
transparency and accountability.
Doctors are very interested in creating a safer healthcare system. Not only do we want to work
in a system that will help us to avoid mistakes in order to protect ourselves professionally ,
we want this for personal reasons as well. We know that we too will become patients some
day, and because we are so aware of the scope for medical errors, we’d like to be able to
ensure we get safe medical care ourselves when we fall sick!
Preventing medical errors is a topic which is both important and urgent. Even if you are
healthy now, since all of us are future patients, all of us can be potential victims of medical
error, and we need to learn to protect ourselves. I can guarantee you know at least one person
who has been harmed by a medical mistake. However, in spite of the enormous harm they
can cause, we rarely talk about them because we feel they will never happen to us. This
ostrich in the sand attitude is dangerous .
The point of this book is not to scare you – it’s to arm you with tools you can use to protect
yourself proactively! Sadly, even though the scope for errors in India is far greater than in
the USA, (given our overloaded healthcare system), this problem is not given the attention
it deserves. Many errors go unrecognized and unreported, and in some cases, are even
deliberately covered up to avoid litigation
We have the expertise to protect patients (and doctors as well) from medical error, and we
have discussed lots of tools we can use to do so. However, this is not something doctors can
do by themselves – this needs a systemic change, in which everyone needs to participate,
starting from the health minister to the hospital CEO to the ward assistant as well as the
patient.
You can contribute to the conversation at the website for this book, www.safetyforpatients.in.
The change needs to start with each one of us. If we don’t learn to protect ourselves from
medical errors, then who will?
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If you’d like to find out more
If you’d like to find out more
The Patient’s Perspective

The Patient’s Checklist: 10 Simple Hospital Checklists to Keep You Safe, Sane & Organized.
Elizabeth Bailey, 2012
Patients can experience serious communication and safety issues that can put them at risk.
The Patient’s Checklist is an important practical tool to keep you safe.
The Patient Survival Handbook: Avoid Being the Next Victim of Medical Error. Stephen M.
Powell, Richard D. Stone, 2015
This handbook gives patients and their loved ones ways to prevent medical errors. It
empowers the reader to become a more informed and active partner in preventing errors and
in making better healthcare decisions.
Speak Up and Stay Alive - the patient advocate hospital survival guide. Patricia J. Rullo,
2012
Medical errors are the fourth leading cause of death in the United States, making the hospital
a dangerous place to be. Why do they happen? What can you do about them? How can you
keep yourself safe?
What Did the Doctor Just Say? How to Understand What Your Doctor Is Saying and Prevent
Medical Errors from Happening to You and Your Loved Ones. Lynn R Parker , 2009
This book will help you avoid falling victim to medical error by teaching you how to
understand what the doctor says and how to ensure he understands you too.
Did the Doctor Make A Mistake? Doug Wojcieszak, 2013
This quick read is a valuable practical guide . It will help you keep your cool when something
goes wrong and you are worried that the doctor may have made a mistake.
The Doctor’s Perspective

Communication for Nurses: How to Prevent Harmful Events and Promote Patient Safety.
Dr Pamela Schuster, 2010
This book for nurses guides the development of comprehensive, professional communication
skills to prevent errors that result in patient injuries and death.
Adverse Events, Stress, and Litigation: A Physician’s Guide: A Physicians’s Guide. Sara
Charles and Paul R. Frisch, 2005
Bad medical outcomes traumatize patients but they also traumatize physicians. It gives
doctors an understanding of how lawyers think and work to help defendants.
151
Error Reduction in Health Care: A Systems Approach to Improving Patient Safety.

Patrice L. Spath , 2011
Offers a step-by-step guide for implementing the recommendations of the Institute of

Medicine to reduce the frequency of errors in health care services; and to mitigate the impact
of errors when they do occur.
Patient Safety and Healthcare Improvement at a Glance. Sukhmeet Panesar (Editor), 2014
This is thorough overview of healthcare quality and safety, written specifically for nursing
students , junior doctors and healthcare professionals. It bridges the gap between the practical
and the theoretical to ensure the safety and wellbeing of patients.
Understanding Patient Safety. Robert Wachter, 2012
This classic text book has been authored by one of the leaders in the US hospital safety
movement. It describes complex concepts very clearly.
Patient Safety: A Case-Based Comprehensive Guide. Abha Agrawal, 2014.
Uses an engaging format to teach doctors about patient safety, by describing the case histories
of patients whose care has been marred by medical errors. Comprehensive and well-written.
Patient Safety , 2nd edition. Charles Vincent, 2010.
Excellent text book which covers all aspects of patient safety, written by one of the leaders in
the field. Provides a perspective from the UK, and is a pleasure to read.
Sorry Works! 2.0 : Disclosure, Apology, and Relationships Prevent Medical Malpractice
Claims. 2nd Edition. Doug Wojcieszac, 2010
This book explains why saying sorry is one of the first things which doctors should do when
a medical error occurs.
Talking with Patients and Families about Medical Error: A Guide for Education and Practice.
1st Edition. Robert D. Truog, 2010
A very useful and practical guide which teaches doctors the nitty-gritty of how to talk to
patients after a medical error occurs.
152

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Whos houldr eadthisbook?I t'

HELP – Health Education Library for People

Tel. No: 65952393/65952394

Helping patients to talk to doctors!

The website for this book is www.safetyforpatients.in

Cartoon by Sidney Harris – ScienceCartoonsPlus.com

Dinesh Chindarkar holds a degree in Life Sciences & Pharmacy. He specializes in marketing

Salil Kallianpur is a senior executive in the pharmaceutical industry. He is an avid observer

Dr Nikhil Datar is a senior Gynaecologist practicing in Mumbai. He is also a renowned health

The night I nearly killed my patient 9

Background – Setting the Stage

Patient Safety from the Patient’s Perspective

Patient Safety from the Professional and Clinical Perspective

Patient Safety from the System Perspective

Making matters worse

Medical errors are the diseases of the healthcare delivery system.

** Harm-Any physical or psychological injury or damage to the health of a person, either

Learning from our mistakes

What is the difference between patient safety and quality?

Medical errors from the doctor’s perspective

Amid many possibilities of error, it would be strange indeed to be always

** Skills (e.g. asking an inexperienced doctor to perform a laparotomy without supervision);

James Reason’s Swiss cheese model for medical error

The “Swiss cheese’ model

Types of Medical Errors

How can we make the system safer?

The key to patient safety lies in patient empowerment, and there’s

The empowered patient

Do your homework – become an expert patient!

It is important to determine beforehand how much information you actually need to

Form a partnership with your doctor

An empowered patient is the CEO of her health team

** I feel comfortable with each of my doctors

S: Speak up if you have questions, or if you don’t understand something;

Experience is making mistakes and learning from them. Bill Ackman

When do diagnostic errors occur?

Why does misdiagnosis occur?

Poor quality labs

What can patients do to reduce diagnostic error and harm?

1. What else could it be?

** Step back and take a second look

The medical establishment has become a major threat to health.

The “defensive medicine” trend

How can you protect yourself from over-testing?

Medical Test checklist

Unnecessary screening tests

Technology to the rescue

Internationally, websites of well-known pharmaceutical brands such as Lipitor and Allegra

Online support groups

The greatest mistake is to imagine that we never err. Thomas Carlyle

** What time should I take the first pill?

** My doctor said to call if I notice problems. What kinds of problems?

What can you do?

to understand your explanations. Our book, Decoding Medical Gobbledygook – Health

A patient advocate should have the negotiation skills of a diplomat, the

The poor patient’s plight

The patient advocate comes to the rescue

‘To err is human, to blame … even more so’ (unknown).

** A retained instrument in the abdomen after an operation

Here are some useful suggestions.

Your medical records

Patient complaints can improve patient safety