so that the numbers would be - Just-in-time method
refreshed o Stocks are ordered the exact time
iv. **Products may be
refused/returned to the
supplier if they are defective,
expired, or not included in the
purchase order
Material Management System: Inventory
- Inventory – a complete list of items such as
properly, goods in stock, or the contents of a
company
- Inventory management – a continual
process of checking stock levels, rotating
stock to ensure freshness, ordering supplies in
sufficient quantities to meet current needs,
and minimizing the cost of carrying inventory
o checking stock levels – performing
an inventory to check the number of
supplies left
o rotating stock – FIFO (First in, first out);
making sure to use the supplies that
arrived first or would expire first to
avoid reagent spoilage
o ordering supplies in sufficient
quantities – ordering stocks that are
not too few that will be finished
immediately and not too many that
they will expire
o minimizing the cost – ensuring that
the supplies are ordered in sufficient
quantities
Important Concepts
Reorder Level
- the minimum quantity of an item that a
company can have in stock
- once the stock reaches the stated minimum
quantity, the item must then be reordered
o there are warning levels that is
assigned by the laboratory
- number of items that would prompt you to
reorder products
Stock Replenishment Methods:
- Minimum-maximum inventory ordering
method
o Minimum value – Stock level that
should prompt a reorder
o Maximum value – Target stock level
after reordering
they are needed
o E.g., we don’t order 10 dummy arms
every month, but they are purchased
when they are needed (i.e., there is
an increase of students)
LESSON 11: TECHNICAL INFRASTRUCTURE TO
SUPPORT HEALTHCARE
Information technology
- the study or use of systems (especially
computers and telecommunications) for
storing, retrieving, and sending information
Health Information Technology
- an area of information technology involving
the design, development, creation, use, and
maintenance of information systems for the
healthcare industry
- Basically the same with information
technology, difference is that the purpose of
this is for healthcare or clinical use
Electronic Health Record (EHR)
- Fundamental component of health
information technology
- Refers to the patient’s official health record
in digital form
- Easily shared across different health care
providers and agencies
- Patient record that is in softcopy or is
uploaded in the hospital information system
Benefits of EHR:
1. More efficient information sharing between
clinical staff
2. Decreased documentation time of staff, thus
allotting more time for direct patient care
a. It is easier to encode results than to
manually write them one by one
b. Filing and storing them in the storage
room takes more time
c. It is faster to process your data
through a computer or a system
3. Reduced documentation errors and
subsequent adverse events
a. Just like automation in the laboratory,
by using EHR, you can avoid manual
errors (e.g., wrong spelling)
36 | F O C
 4. Real-time checking
a. As the patient results are being
completed, the EHR is being updated
as well
5. Integration of clinical data with
computerized physician order entry,
electronic prescribing, and decision support
features
a. through the use of EHR, it would be
more accessible to physicians since
they don’t have to go to the nurse
station/laboratory to pick up the
results
b. It would help him create his test
orders, his prescriptions, and clinical
decisions
c. It is more convenient for physicians
d. at the same way, they can
computerize their test orders and
other documents
Challenges of EHR:
1. Limited opportunity for face-to-face
communication
a. If you will fully rely on online
communication, you might miss out
on important points
b. It can be difficult to seek
clarifications if everything is online
2. Fragmentation of Data
a. EHR would contain all of the data
related to a certain patient,
however, there is a possibility that
your EHR would not combine those
information
b. Correlation can be a bit difficult for
physicians
c. Data is separate from each other
3. Data overload
a. Since all of the information are there,
it can be overwhelming for the
physician; he has to filter the
information before getting to what
he really needs
4. Limited access
a. Only applicable if EHR is not
integrated with devices that are
outside the hospital
5. Lack of knowledge and efficacy
a. Focuses on the capability of the
medical staff
b. It would be a waste if you have a
very good EHR and HIS if your staff
does not know how to operate them
Clinical Data Repository
- Systematically structured and gathered
“storehouse” of patient-specific data, which
is usually mirrored from a clinical application,
or supplemented with data from other
systems
- Regarded as an important tool for decision
making of various stakeholders in healthcare
- Also known as clinical data warehouse
- Electronic Health Record is one type of a
CDR.
- is a storehouse/storage of patient data that
can be used for different purposes
Types of Clinical Data Repositories
REPOSITORY TYPE DEFINITION
Electronic Health A database of observations made as a
Record result of direct health care.
Study A database that collects observations for
a specific clinical research study.
Registry Observations collected and organized for
the purpose of studying or guiding
particular outcomes on a defined
population. Associated studies are either
multiple or long-term and evolving over
time. Storehouse for data that is used for
statistics or surveillance reports.
Warehouse A repository that adds levels of integration
and quality to the primary (research or
clinical) data of a single institution, to
support flexible queries for multiple uses. Is
broader in application that registry.
Collection A library of heterogenous data sets from
more organizations than a warehouse or
more sources than a registry. Organized to
help users find a particular data set, but
not to query for data combined across
data sets.
Federation A repository distributed across multiple
locations, where each location retains
control over access to its own data, and is
responsible for making the data
comparable with the data of other
locations.
Functions of CDR
1. It transfers clinical information
2. It consolidates clinical information
3. It analyzes clinical information
4. It queries/retrieves clinical information
5. It presents clinical information
37 | F O C
 a. access is given only to the
platform that develops that
Benefits of CDR:
specific software
1. Basis for reporting, studying, planning, and b. no access to the servers
supporting clinical research anymore
2. Simplified data processing and analysis c. mas mababaw yung control
3. Improved clinical decision making na meron ka
d. you will be given access to
Challenges of CDR: the platform that can be used
to develop the software
1. Difficult set up/programming
3. Software as a service (SaaS)
a. If you don’t have the suited personal
a. access is given to that
(i.e., IT), you can experience difficulty
specific software only
in setting up/programming your CDR
b. no access to platforms and
2. Privacy issues
servers that powers and runs
a. In cases where clinical data is
the software
obtained then you will use them for a
c. access given is only superficial
different purpose, it could
compromise the privacy /
confidentiality of data
b. Key: to employ a good protocol for
your data; make sure to get the
consent of the people involved if
you’re going to use the data for a
different purpose

Cloud Computing

- Defined as the delivery of computing

servicesꟷincluding servers, storage,
databases, networking, software, analytics,
and intelligenceꟷ over the Internet (“the
cloud”) to offer faster innovation, flexible
resources, and economies of scale
• According to Deployment (Deployment
(Microsoft)
Models)
- Management of data over the internet
- We use the internet to store and process
clinical data (e.g., laboratory results, EHR)
Models of Cloud Computing
• According to Service (Service Models)
1. Infrastructure as a service (IaaS)
a. You are giving the
organization the access to a
server network/foundation of
the platforms online
b. You are not just giving access
to the applications itself but to
the foundation that they can
use to program/configure
their own platform
2. Platform as a service (PaaS)
1. Private Cloud
a. Only one organization has
access to that particular
cloud
b. It is the company/medical
institution that sets up its own
cloud
2. Public Cloud
a. Owned by a third-party
company
b. Can be used by a lot of clients
c. Ex.: Google drive
3. Hybrid Cloud
a. A private cloud that is
connected to a public cloud
b. Mixture of private and public
cloud

38 | F O C
 c. The company is operating its
own cloud but at the same
time that cloud is part of a
bigger cloud/system
4. Community cloud
a. Similar to public cloud
wherein there are different
clients utilizing that
platform/software
b. There is a common ground
between those clients
c. Ex.: TLC drive, LMI drive, clients
are all educational institutions
Benefits of Cloud Computing:
1. Reduction in healthcare expenses through
reduced IT infrastructure and maintenance
a. because you are only available
services on the internet, you don’t
need to create your own machines
2. Increased access and flexibility of data
regardless of differences in systems/platforms
a. because it is access through the
internet, it is more possible for
healthcare professionals to access
the data they need
3. Reduced carbon emissions compared to
traditional ICT systems = better environmental
impact
a. since different institutions are just
relying on one server, it will reduce
the electricity consumed, etc.
Challenges of Cloud Computing:
1. Lack of reliable service cloud service
providers
2. Security and privacy issues
a. prone to hacking
b. information can be leaked
3. Legal issues on property and privacy
LESSON 12: MOBILE HEALTH
Mobile health
- medical and public health practices
supported by mobile devices such as: (WHO)
o Mobile phones,
o Patient monitoring devices,
o Personal digital assistants (PDAs), and
o Other wireless devices
- simply the delivery of public health or
medical services through devices that are
portable/mobile
Goal of Mobile Health
- To share information between the mobile
device and a patient’s electronic medical
record (EMR)
Examples of mHealth Apps
1. Kardia Mobile
a. Type of app: remote monitoring app
b. Origin country: the USA
c. Availability: iOS and Android
➢ app that can be used to monitor your
laboratory results and health records
while you are away from your
physician
2. BlueStar Diabetes
a. Type of app: chronic disease
management
b. Origin country: the USA
c. Availability: iOS and Android
➢ goal is to monitor the progress of your
disease (e.g., sugar levels, insulin
dosage)
3. Calm
a. Type of app: mental health app
b. Origin country: the USA
c. Availability: iOS and Android
➢ this app would recommend music
according to your current mental
state
4. Shopwell: Better Food Choices
a. Type of app: healthy living apps
b. Origin country: the USA
c. Availability: iOS and Android
➢ utilizes your health record to make
recommendations about your diet or
exercise in order to attain a certain
goal (e.g., weight)
5. WebMD Symptom Checker
a. Type of app: symptom checking app
b. Origin country: the USA
c. Availability: iOS and Android
➢ very good for individuals who are
curious about the symptoms they are
experiencing
6. PEPID
a. Type of app: clinical and diagnostic
apps
39 | F O C
 b. Origin country: the USA the app because that is
c. Availability: iOS and Android where the data is encoded
➢ used as a reference tool for ii. Clinical data may be used
healthcare professionals; quick both clinically and
search/google for doctors commercially
7. Appointik iii. Patients would feel the
a. Type of app: practice management benefit of this app because
app the clinical data is now made
b. Origin country: India available and is easier to refer
c. Availability: Android to a physician
➢ equivalent to konsultaMD, apps for iv. The app developers may use
telemedicine, used by doctors and your data to improve their
healthcare professionals to help them software
in their practice through b. Challenge
scheduling/storage for their patients i. Patients are not
compensated for the usage
Benefits and Challenges
of their data
1. Patient access ii. Third-parties are now using
2. Data ownership your data to improve their
3. Privacy and security business
4. Bystanders 3. Privacy and Security
a. Benefit
Benefits and Challenges i. Collection of health is
weaved into the everyday
1. Patient access
routine of the user
a. Benefit
ii. There are some apps that
i. Patients have the opportunity
collect your data
to be active partners in their
automatically (e.g., vital
own health
statistics)
ii. You can see your laboratory
iii. Less hassle because you don’t
results through the mobile
have to manually input your
health app
data
iii. mHealth app would
b. Challenge
encourage patients to be
i. Data collected is only as
more aware of their health
secure as the device itself
status
ii. Data is vulnerable to hacks
iv. You become more conscious
of your health and diet
** Being exposed as someone
b. Challenge
diagnosed with an illness comes with
i. Access to results can provide
real risk. Having that information
opportunity for confusion and
revealed makes one vulnerable to
potential distress
shame and stigma at best,
ii. Patients are pushed to refer to
discrimination and legal
online sources and take
consequences at worst. Most
matters into their own hands
individuals do not wish to keep health
iii. Can cause panic
information private for privacy’s sake.
2. Data ownership
[They] wish to keep their health
a. Benefit
information private from the people
i. Clinical data is owned by the
who have an impact on their lives in
patient because it is his/her
some way, people who have the
own clinical data but at the
capacity to influence their social or
same time is also owned by
legal standing of the subject.
40 | F O C
 4. Bystanders LESSON 13: MOLECULAR LABORATORY
a. Bystanders – third-party individuals
who did not consent to having their Reverse Transcription Polymerase Chain Reaction
information collected or stored - reversing RNA to DNA before you perform
b. Challenge PCR
i. Bystanders are put at legal or - DNA = deoxyribonucleic acid
personal risk - RNA = ribonucleic acid
ii. Non-maleficence and - Thermocycler – machine used in RT-PCR
autonomy principles are
violated Physical Requirements and Workflow
iii. Being a bystander has no
- Main goal: To prevent contamination
benefit on their side
o E.g., mixture of DNA with the reagents
iv. Having bystanders in your
that may cause faulty results,
mobile health app can be
contamination between sample 1
difficult/challenging because
and sample 2, exposure to
these bystanders do not
environment where they will be easily
receive any benefit from the
degraded
app instead they are at risk for
- Polymerase chain reaction
disclosing their clinical
o (Most) common molecular technique
information to the public
performed
Current State of mHealth o Easily susceptible to contamination
o Examples:
Reasons for using mHealth applications: ▪ Sample to sample
1. Simplicity and low cost ▪ Previous to current cycle
2. User-friendly service ▪ Cross-contamination of
3. Enhanced speed and accuracy of different reactions
healthcare delivery ▪ Contamination of reagents
with DNA templates
Current uses of mHealth apps:
Main procedures performed in PCR
1. Medication adherence and compliance aid
2. Remote data collection 1. Pre-PCR
3. Access to patient record a. Sample preparation
4. Access to health information database b. PCR preparation
5. Census taking i. DNA extractions from swabs,
6. EHR creation and storage reagent preparation,
creating your PCR mix
Future Direction ** both performed in a clean area (there
are very little/no contaminants yet)
• Usage of 5G technology
2. Post-PCR
• Increase global usage
a. Performing PCR
• Rise of complex, voluminous and multi-
i. actual performing of PCR
dimensional mobile health data
b. Post-PCR analysis
Challenges related to the Future of mHealth: i. analysis of your amplicons or
products such as
1. Lack of ICT infrastructure – lack of coverage electrophoresis, putting dye
and quality of internet providers for visualization
2. Lack of financial resources – lack of resources ** both performed in a dirty area
to computerize the health system
3. Lack of education Recommended Rooms
4. Security and privacy issues
1. Reagent preparation
5. Neglect of technological problems
2. Sample preparation
41 | F O C
 3. PCR step / Amplification room ▪ Negative pressure: post-PCR
4. Post-PCR step rooms (the pressure is lower
inside the room compared to
Alternatives
outside; direction of air:
5. Separate benches/working areas outside  inside)
6. Separate processing time o UV irradiation
▪ Used to sterilize the pre-PCR
laboratory

Physical Requirements and Workflow cont.

• Workflow: Must be unidirectional

o Remember: Clean to dirty
o possible contamination of the clean
room
o you can be a vehicle for
contamination since you were ** there should be a compartmentalization of your
already exposed to the dirty room equipment/materials inside the biosafety cabinet
• Additional measures to prevent
contamination Equipment
o Ventilation
• Must also include routine pathology
▪ Positive pressure: pre-PCR
equipment and consumables
rooms (there is a higher
o E.g., pipettes, tissue paper, cleaning
pressure inside the pre-PCR
solution, refrigerator, centrifuge, etc.
room compared to outside;
• Placement must also follow the unidirectional
direction of air: inside 
flow
outside)
o thermocycler – Post-PCR/PCR room
▪ difference in pressure would
o centrifuge, etc. – sample preparation
limit the air flowing from
room
outside to inside
42 | F O C
 • Budget must include service contacts for
maintenance and repair
• Instructions for calibration and maintenance
should be kept in the laboratory as written
guidelines

Biosafety cabinet

Thermocycler

Quality Assessment

• Standard operating procedure manuals

• identification of errors through Quality
Control
• Prevention of errors through Quality
Electrophoresis
Assurance
machine
• Internal QA:
o where we use our control solutions to
ensure that the machines are
performing with accuracy and
precision (negative, positive/normal,
pathological)
o within the laboratory only
o testing the accuracy of our machines
and equipment using control
solutions, resembling actual samples
• External QA:
o Most critical stage of quality
management
o a reference laboratory will send out
samples to different laboratories and
then those laboratories will process
the sample
o the reference laboratory will check if
the samples submitted are the same
with the reference value and if they
are the same with each other (e.g.,
there are outliers)
o involves other laboratories as well
participating in the program/
interlaboratory
o NEQAS – National External Quality
Assessment Scheme

43 | F O C
 o Research Institute for Tropical iv. PCR
Medicine (RITM) – National reference v. Clerical activities
laboratory for COVID testing b. Must follow the unidirectional flow
3. Equipment and Instruments
DOH Local Guidelines
a. Proper placement of equipment in
• DOH AO 2020-0014 designated areas
o Specific Guidelines b. Documented inventory of
1. Personnel equipment, supplies, reagents, and
2. Physical Facilities control
3. Equipment and Instruments c. Periodic calibration and
4. Service Capability maintenance of equipment
5. Quality Improvement d. Daily cleaning and maintenance
Activities 4. Service Capability
6. Information Management a. Manual of Procedures, Work
7. Environmental Management Instructions, Standard Operating
8. Contingency Plan Procedures
9. Release of Results b. RITM Biosafety Guidelines
1. Personnel i. the laboratory should comply
a. Minimum number of personnel: Seven with these biosafety
(7) guidelines to protect the
i. 1 pathologist workers from infection
ii. 3 full-time analyst 5. Quality Improvement Activities
▪ 3 MTs or a. RITM proficiency testing
▪ 2 MTs and 1 allied b. RITM NEQAS
health graduate 6. Information Management
iii. 1 full-time laboratory aide a. Adherence to Data Privacy Act of
iv. 1 full-time receptionist 2012: RA 10173
v. 1 full-time encoder b. COVID: RA 11332 - Mandatory
b. Required trainings Reporting of Notifiable Diseases and
i. Biosafety and Biosecurity Health Events of Public Health
▪ Biosafety – protecting Concern Act
people from c. Proper documentation through
pathogenic organisms logbooks
▪ Biosecurity – 7. Environmental Management
protecting a. focuses on making sure that the
microorganisms from wastes generated by the laboratory
bad people / are disposed properly
malicious use b. proper management of hazardous
ii. Molecular Diagnostics and toxic waste
▪ RITM provides c. decontamination measures before
proficiency training for disposing them as regular wastes
molecular diagnostics 8. Contingency Plan
▪ you should have your a. focuses on a backup plan in case the
certification before machine is broken, or the laboratory
you can be hired in a cannot perform the services
molecular laboratory b. Memorandum of Agreement /
2. Physical Facilities partnership with other laboratories
a. Dedicated spaces 9. Release of Results
i. Specimen reception a. Signatories:
ii. Reagent storage and i. RMT
handling ii. Senior MT for verification
iii. Pre-PCR iii. Pathologist for approval
44 | F O C
10. Validity of DOH-LTO
a. Validity of the License to Operate of
a COVID-19 testing laboratory in the
Philippines: One year
11. Regulating/Monitoring Agencies
a. Health Facilities and Services and
Regulatory Bureau (HFSRB)
b. Center for Health Development
(CHD)
c. Research Institute of Tropical
Medicine
i. PH’s reference laboratory for
COVID-19 testing
d. Epidemiology Bureau
e. Regulating agencies that monitor
clinical laboratories

45 | F O C