Feedback, Incident Reporting

and Root Cause Analysis

 Patient Feedback Mechanism

Patient
Feedbacks

Appreciations Complaints Suggestions

2
Complaint Management Process
Risk Management in Health Care

Incident Reporting Sentinel Event

Root Cause Analysis

(RCA)

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 Incident
An incident may be Root Cause Analysis
defined as ‘any event that Sentinel event (RCA)
has caused harm, or has
the potential to harm a It is an unexpected
Process for identifying the
patient, visitor or staff occurrence involving death
basic or causal factor(s)
member, or any event or serious physical or
that underlies variation in
which involves psychological injury, loss of
performance, including the
malfunction, damage or limb or function, or the
occurrence or possible
loss of equipment or risk thereof.
occurrence of a sentinel
property, and any event event.
which might lead to a
complaint.

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 Event Classification
Adverse Events
Adverse events are untoward incidents, therapeutic misadventures, iatrogenic
injuries, or other adverse occurrences directly associated with care or services
provided within jurisdiction of health care services.

Near miss
It is an event or situation that could have resulted in an adverse event, but did
not, either by chance or through timely intervention.

Incident
An incident is defined as ‘any event that has caused harm, or has the potential to
harm a patient, visitor or staff member, or any event which involves malfunction,
damage or loss of equipment or property, or an event which might lead to a
complaint or any unexpected, unintended response to a drug or treatment.
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 Who Can Report An Incident??

Any person, who is an employee of an organization, who

directly identifies that incident, or his / her Manager/ HOD
or designee, is responsible for reporting it.

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Major Categories
Adverse Drug Event ID/Documentation/Consent
Against Medical Advice Infection Control
Airway Management IV/Line/Tube device
Blood/Blood Product Lab Specimen/Test
Care Coordination Maternal/Childbirth
Diagnosis/Treatment Medication/Fluid
Diagnostic Imaging Professional Conduct
Employee Event Safety/Security
Equipment/Medical Device Restraint/Supportive Devices
Facilities Skin/Tissue
Fall event Surgery/Procedure
Healthcare IT
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 Risk Assessment Matrix

CONSEQUENCE

Life
Serious Injury threatening
No Minor Injury or causing injury or Death or
PEOPLE injury/harm First Aid hospitalization multiple multiple life
or Treatment Care or multiple serious threatening
NO treatment medical injuries injuries
required treatment causing
cases hospitalization

Insignificant Minor Moderate Major Catastrophic

1 2 3 4 5

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 Criteria for Sentinel Event
1. Death
2. Permanent harm
3. Severe temporary harm
4. The suicide of any patient receiving care, treatment, and services in an around-the-
clock care setting or within 72 hours of discharge, including from the hospital’s
emergency department (ED)
5. Unanticipated death of a full-term infant
6. Discharge of an infant to the wrong family
7. Abduction of any patient receiving care, treatment, and services.
8. Any elopement (that is, unauthorized departure) of a patient from a staffed
around-the-clock care setting (including the ED), leading to death, permanent
harm, or severe temporary harm to the patient.
9. Administration of blood or blood products having unintended ABO and non-ABO
(clinically important blood groups) incompatibilities, hemolytic transfusion
reactions, or transfusions resulting in severe temporary harm, permanent harm, or
death.
10. Rape, assault (leading to death, permanent harm, or severe temporary harm), or
homicide of any patient receiving care, treatment, and services while the on-site at
the hospital. 10
 Case Scenario 1
A middle-aged man was admitted to the medical service of a teaching hospital with suspected
vasculitis. When the initial diagnostic studies failed to provide a definitive diagnosis, the team decided
to treat the patient empirically with high-dose steroids.

When discussing the patient on morning rounds, the senior resident instructed the intern quite clearly
to “give the patient one gram of steroids.” After rounds (and some quick math), the intern ordered:

“Prednisone 20 mg tabs 50 pills PO x 1 now”

After receiving the written order, the pharmacist contacted the intern to clarify the order. She
suggested to the intern that the one gram of steroids probably was supposed to be given in an
intravenous form. The busy and harried intern stated firmly that he wished to give the patient fifty 20-
mg pills. When the pharmacist persisted in questioning the order and gently suggested the intern may
want to contact his senior resident for clarification, the intern refused and replied, “You can give it with
a tablespoon of Maalox.”

The patient was brought fifty 20-mg pills of prednisone and became angry and frustrated as he
swallowed pill after pill. He developed mild nausea and heartburn while taking the prednisone.

The following day, upon review of the medication record, the senior resident found the error. The oral
prednisone was stopped, and the patient was correctly given a gram of intravenous
methylprednisolone (Solu-Medrol). He eventually recovered from his vasculitis and was discharged in a
stable condition
 Case Scenario 2
56 year old female, Laurel Johnson was admitted after having a new
onset seizure. She was pleasant but worried about the seizure and
what it could mean. She had never been on medication before and
now was to be started on a medication, Klonipin 1mg. The
medication was not up from pharmacy yet, but her nurse had just
spent time with her providing education about the medication. The
nurse took telephone order from a physician for another patient,
Lara Johnstone. The order was for Clonidine 0.1mg. The medication
was then ordered. After giving the medication, the nurse returned
to the medication room to set up the medications for another
patient. When she arrived at the medication room, she found
another nurse searching through the medication bins.
 Case Scenario 2 (cont)
When asked what she was doing, the nurse said she was looking for
her patient’s dose of Clonidine. It was a new dose and she knew it
came up from pharmacy as she put it in the patient’s bin herself. The
nurse for Laurel Johnson had a sick feeling in her stomach and checked
the medication wrapper in her hand from the dose she just gave Laurel
Johnson. She saw that it was the Clonidine with the name Lara
Johnstone and birth date November 18, 1952 clearly stamped on it.
The physician for Laurel Johnson was called and informed of the error.
The patient’s vital signs were ordered to be monitored q hour for 2
hours then every 2 hours for 4 hours. She had a slight drop in her
blood pressure, however she recovered well
 Case Scenario 3
An 80-year-old man with a history of coronary artery disease, hypertension,
and schizophrenia was admitted to an inpatient psychiatry service for
hallucinations and anxiety. On hospital day 2, he had sudden onset of
confusion, bradycardia, and hypotension. He lost consciousness, and a "code
blue" was called.
The inpatient psychiatry facility is adjacent to a major academic medical
center. Thus, the "code team" (comprising a senior medical resident, medical
intern, anesthesia resident, anesthesia attending, and critical care nurse)
within the main hospital was activated. The message blared through the
overhead speaker system, "Code blue, fourth floor psychiatry. Code blue,
fourth floor psychiatry."
The senior resident and intern had never been to the psychiatry facility. "How
do we get to psych?" the senior resident asked a few other residents in a
panic. "I don't know how to get there except to go outside and through the
front door," a colleague answered. So the senior resident and intern ran down
numerous flights of stairs, outside the front of the hospital, down the block,
into the psychiatry facility, and up four flights of stairs (the two buildings are
actually connected on the fourth floor).
 Case Scenario 3 (cont)
Upon arrival minutes later, they found the patient apneic and pulseless. The
nurses on the inpatient psychiatry ward had placed an oxygen mask on the
patient, but the patient was not receiving ventilatory support or chest
compressions. The resident and intern began basic life support (CPR with chest
compressions) with the bag-valve-mask. When the critical care nurse and the
rest of the code team arrived, they attempted to hook the patient up to their
portable monitor. Unfortunately, the leads on the monitor were incompatible
with the stickers on the patient, which were from the psychiatry floor (the
stickers were more than 10 years old). The team did not have appropriate leads
to connect the monitor and sent a nurse back to the main hospital to obtain
compatible stickers. In the meantime, the patient remained pulseless with an
uncertain rhythm. Moreover, despite ventilation with the bag-valve-mask, the
patient's saturations remained less than 80%. After minutes of trying to
determine the cause, it was discovered that the mask had been attached to the
oxygen nozzle on the wall, but the oxygen had not initially been turned on by the
nursing staff. The oxygen was turned on, the patient's saturations started to rise,
and the anesthesiologist prepared to intubate the patient. Chest compressions
continued. Patient was not revived.
 Case Scenario 4
A 55-year old female was transported to the floor after recovering
from a surgical procedure. An epidural catheter with morphine was
placed for post-operative pain control. Upon arrival, the patient
complained of nausea and a headache prompting the on-call physician
to prescribe, “Demerol 75mg every three hours for pain.” The
preprinted medication orders from anesthesia stated “No narcotics,
sedatives, or other respiratory depressants to be given during infusion
of epidural medication and for 12 hours after epidural is discontinued
except by order of anesthesia.” The nurse had not reviewed this order
prior to obtaining and administering the new order for Demerol, a
narcotic.
Twenty minutes later, the patient was found unresponsive and
aggressive resuscitation efforts were implemented, resulting in
intubation and mechanical ventilation of the patient. When brain
activity was not found, the family made the decision to take the
patient off of life support and the patient died shortly thereafter.
 RCA process
• Start the investigation
• Gather data (e.g. staff involved, create a timeline)
• Analyze the data
• Identify root causes
– A determination of the human and other factors most
directly associated with the sentinel event and the
process(es) and systems related to its occurrence;
– Analysis of the underlying systems and processes through a
series of “WHY?” questions to determine where redesign
might reduce risk;
– Identification of risk points and their potential contributions
to this type of event
• Create recommendations
• Complete investigation and follow up on results
ROOT CAUSE ANALYSIS