Activity 1

Compare and differentiate

Subject: Clinical Pathology

Date: April 4, 2023

Prepared by: Team Compassionate 3A

Ca-at, Julieen Rose
Caballes, Adrian Joe
Demegillo, Kathleen Faith
Salipoden, Samera

Introduction
Clinical laboratories serve an essential role in the diagnosis, treatment, prevention, and control of disease. This
requires rules and regulations that would ensure accurate, precise, and reliable laboratory test from the
laboratories. Moreover, time is gold in health and medicine. Thus, it is important for these test results to be
delivered in a timely manner.

In this paper, we will know about two rules and regulations that are used as basis for guidelines for Clinical
Laboratories

AO 037 DOH RLED

Administrative Oder No. 2021-0037 - New Rules and Regulations Governing the Regulation of Clinical
Laboratories in the Philippines
Mandated by: Department of Health (DOH) through the Bureau of Medical Services, now known as the Health
Facilities and Services Regulatory Bureau (HFSRB)

ISO 15189:2012
 ISO 15189:2012 - Medical Laboratories - Requirements for quality and competence
Prepared by: the International Organization for Standardization (ISO) through ISO technical committee,
specifically the ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

General Comparison
AO 037 DOH RLED ISO 15189:2012

Objective To serve as the new guidelines in
the licensing of diagnostic clinical
laboratories in the Philippines
which shall ensure accountability
of the laboratory on generation of
accurate, precise, and reliable
laboratory results in a timely
manner through continuous
compliance
intended for use throughout the
currently recognized disciplines of
medical laboratory services, those
working in other services and
disciplines such clinical
physiology, medical imaging, and
medical physics
basis for activities of bodies
engaged in the recognition of the
competence of medical
laboratories

Structure/Components Rationale Introduction

*Parts or sections that are
unique (or does not have
similarity) to each standards
are highlighted in red
Objective Scope
Scope of application Normative References
Definition of terms Terms and Definitions
General guidelines Management Requirements
Specific guidelines Organization and
Procedural guidelines Management Responsibility
Roles and Responsibilities Quality Management System
Violations, Sanctions and Appeal Document Control
Transitory Provisions Service agreements
Annex A Examination by referral
Licensing Standards for laboratories
Clinical Laboratory External services and supplies
Physical Plant Advisory services
Personnel Resolution of complaints
Equipment/Instrument/Re Identification and control of
agent/Glassware/Supplies nonconformities
Service delivery Corrective action
Information management Preventive action
Continual improvement
 Administrative
Policies and
Procedures
Communication and
Records Management
Quality Improvement
Referral of Laboratory
Examinations
Environmental
Management
Assessment Tool for Licensing
a General Clinical Laboratory
Prohibited Acts in the
Operations of Clinical
Laboratories
Planning and Design
Guidelines for General Clinical
Laboratory
Checklist for Review of Floor
Plans - General Clinical
Laboratory
General Guidelines for Remote
Collection Permit for Clinical
Scope of Application Local (Philippines)
All individuals , agencies,
partnerships or corporations,
whether private or government-
owned, involved in the application
for DOH license to operate
those in the operation of
diagnostic clinical laboratories
Bangsamoro Autonomous Region
in Muslim Mindanao (BARMM)
subject to the provisions of RA
11054
General Guidelines All Clinical Laboratories (CL) shall
secure DOH-LTO prior to its
Control of records
Evaluation and audits
Management review
Technical Requirements
Personnel
Accommodation and
environmental conditions
Laboratory equipment,
reagents, and consumables
Pre-examination process
Examination process
Ensuring quality of
examination results
Post-examination processes
Reporting of results
Release of results
Laboratory information
management
International
not intended to be used in the
purposes of certification
specifies requirements for quality
and competence in medical
laboratories
medical laboratories
can be used in developing
their quality management
systems and assessing their
own competence
laboratory customers, regulating
authorities and accreditation
bodies
can be used in confirming or
recognizing the competence of
medical laboratories
not intended to be used for
certification purposes
 operation and must comply with
Document to
the minimum regulatory standards
Secure
and requirements at all times.
From where shall
The DOH-LTO shall be secured
the document be from the DOH regulatory office in
secured? accordance with DOH guideline.
Services allowed

Comments
ISO 15189:2012 has a more proper outline of its inclusions and components. Requirements were clearly
subdivided into Management Requirements and Technical Requirements
AO No. 2021-0037 has clearer and more defined scope. It is maybe because it is specifically intended for
local use. ISO on the other hand could not mandate specific requirements or scope since it is intended as a
guideline for global use. There are rules and regulations that may or may not be applied to a country.

Comparison of Requirements
This comparison table aims to put the details of the two standards side-by-side in order to have a clear picture of
how they are outlined and to determine differences and resemblances in their mandates/requirements.

Management Requirements AO 037 DOH RLED ISO 15189:2012

Legal Entity Regulations included on General 4.1.1.2

Guidelines
The laboratory or the organization of
which the laboratory is a part shall be
an entity that can be held legally
responsible for its activities.

Ethical Conduct No specific section intended for this. 4.1.1.3

Ethical conduct is touched in various
sections. Laboratory management shall have
arrangements in place to ensure the
following:

there is no involvement in any

activities that would diminish
confidence in the laboratory’s
competence, impartiality,

Laboratory director/Head of the shall be a pathologist (V.
Laboratory General guidelines - G)
competent and experienced
Qualifications
professional, with a specialized
Responsibilities skill set related to and
proportionate to the laboratory
category
responsible for the operation of
the entire laboratory, its
personnel, functions, and data,
all pf which shall meet the
quality assurance criteria and
regulatory requirements
Management responsibility There is no specific section intended
for Management responsibility alone.
Requirements concerning
management are distributed in many
sections including:
V. General Guidelines
VIII. Roles and Responsibilities
Annex A - II Personnel
judgement or operational
integrity
person or persons with
competence and delegated
responsibility for the services
provided
responsible for the
professional, scientific,
consultative or advisory,
organizational, administrative
and educational matters
relevant to the services offered
by the laboratory
4.1.2 Management responsibility
Management commitment
provide evidence of its
commitment to the
development and
implementation of the
quality management
system and continually
improve its effectiveness
Needs of users
ensure that laboratory
services, including
appropriate advisory and
interpretative services,
meet the needs of patients
and those using the
laboratory services
Quality policy
define the intent of its
quality management
system in a quality policy
Quality objectives and planning
establish quality objectives,
including those needed to
meet the needs and
requirements of the users,

Quality Management System No specific section for Quality
Management System. A separate
manual serves as basis (as indicated
in the references):
Manual of Standards on
Quality Management System in
the Clinical Laboratory , Health
Facility Development Bureau,
at relevant functions and
levels within the
organization. The quality
objectives shall be
measurable and consistent
with the quality policy.
Responsibility, authority and
interrelationships
ensure that responsibilities,
authorities and
interrelationships are
defined, documented and
communicated within the
laboratory organization.
This shall include the
appointment of person(s)
responsible for each
laboratory function and
appointment of deputies
for key managerial and
technical personnel.
Communication
effective means for
communicating with staff
Records shall be kept of
items discussed in
communications and
meetings.
Quality manager
appoint a quality manager
who shall have, irrespective
of other responsibilities,
delegated responsibility
and authority
4.2 Quality Management System
establish, document,
implement and maintain a
quality management system
and continually improve its
effectiveness in accordance
with the requirements of this
International Standard
Includes requirements on:
 Department of Health. Manila.
2019.
Document Control No specific section for Document
Control. It is included in the Annex A-
V B Information Management -
Communication and Records
Management which can be read in
the technical requirements below
Referral of Laboratory Annex A - VII Referral of Laboratory
Examinations Examinations
ensure the quality of services
provided through an
agreement, or its equivalent, to
a DOH licensed CL performing
the laboratory services needed
referral laboratory must be a
DOH-licensed CL
Memorandum of
Agreement (MOA) with the
referring CL and shall be
responsible for the
collection, transport and
processing of specimens,
and releasing of results
separate MOA is required when
referred tests, which are not
within the service capability of
the CL, unless the referral is
part of the contingency plan
A MOA prescribing the
accountabilities of each party,
shall be secured when
laboratory examinations are
referred to and provided by
another DOH-licensed CL.
Referral of examinations to
other DOH-licensed CL are only
permitted in the following
circumstances:
General requirements
Documentation
requirements
Quality Manual
4.3 Document Control
control documents required by
the quality management system
and shall ensure that
unintended use of any obsolete
document is prevented
4.5 Examination by Referral
Laboratories
Selecting and evaluating
referral laboratories and
consultants
documented procedure for
selecting and evaluating
referral laboratories and
consultants who provide
opinions as well as
interpretation for complex
testing in any discipline
Provision of examination
results
referring laboratory (and
not the referral laboratory)
shall be responsible for
ensuring that examination
results of the referral
laboratory are provided to
the person making the
request
 If the laboratory test to be
sent out is not part of the
service capability expected
for the particular category
of the referring laboratory
If referral of laboratory
testis part of the
contingency plan, in cases
of equipment breakdown,
of the referring CL, this
shall be for a certain limited
period of time only, which
shall not last for more than
3 months. This shall be
properly documented.

Technical Requirements AO 037 DOH RLED ISO 15189:2012

Personnel Annex A II - Licensing Standards - 5.1.1 to 5.1.9 Personnel

Personnel
General
Qualifications
Job descriptions
Personnel introduction to the
organizational environment
Training
Competence assessment
Reviews of staff performance
Continuing education and
professional development
Personnel records
adequate number of trained
personnel, depending on the
workload, to provide safe,
effective and efficient services
to the clients
Registered Medical
Technologists (RMT)
adequate # of full-time
RMTs
shall undergo staff
development and
continuing education
program at all levels of
organization to upgrade
knowledge, attitude and
skills
1 should be designated
Biosafety and Biosecurity
Officer in-charge
Support staff
The laboratory shall have a
documented procedure for
personnel management and
maintain records for all
personnel
Laboratory management shall
document personnel
qualifications for each position.
The qualifications shall reflect
the appropriate education,
training, experience and
demonstrated skills needed,
and be appropriate to the tasks
performed. The personnel
making judgments with
reference to examinations shall
have the applicable theoretical
and practical background and
experience.
The laboratory shall have job
descriptions that describe
 adequate # of laboratory
technician, laboratory aide,
encoders, and receptionists
when applicable
POCT Coordinator - if
applicable
senior staff to recommend
procedures that will ensure
the quality of results of
POCT in consultation with
the pathologist; ensure
POCT machines/device and
kits are properly
maintained
POCT Operator — if applicable
designated operator of the
POCT device/machine and
testing kits
MCL Personnel
responsibilities, authorities and
tasks
The laboratory shall have a
program to introduce new staff
to the organization
The laboratory shall provide
training for all personnel
the quality management
system
assigned work processes
and procedures
the applicable laboratory
information system
health and safety, including
the prevention or
containment of the effects
of adverse incidents;
ethics;
confidentiality of patient
information
Following appropriate training,
the laboratory shall assess the
competence of each person to
perform assigned managerial or
technical tasks according to
established criteria.
Reassessment shall take place
at regular intervals. Retraining
shall occur when necessary.
the laboratory shall ensure that
reviews of staff performance
consider the needs of the
laboratory and of the individual
in order to maintain or improve
the quality of service
A continuing education program
shall be available to personnel
who participate in managerial
and technical processes.
Records of the relevant
educational and professional
qualifications, training and
experience, and assessments of
Equipment and Instruments Annex A III - Licensing Standards -
Equipment/Instruments/Reagents/Gl
asswares/Supplies
Selection, Purchasing, Management
No concrete/separate
requirement stating this
Provision
Every CL shall have an
adequate equipment,
instruments, reagents,
glassware and supplies which
are all in good working
condition and sufficient for the
operations.
available and operational
equipment/machines/devices to
provide the laboratory
examination that the laboratory
is licensed for
adequate available reagents,
glassware and supplies
Equipment acceptance testing
No concrete/separate
requirement stating this
Equipment instructions for use
No concrete/separate
requirement stating this
reagents, glassware and
supplies shall be properly
stored
5.3 Laboratory equipment, reagents,
and consumables
Selection, Purchasing, Management
The laboratory shall have a
documented procedure for the
selection, purchasing and
management of equipment.
Provision
The laboratory shall be
furnished with all equipment
needed for the provision of
services
In those cases where the
laboratory needs to use
equipment outside its
permanent control, laboratory
management shall ensure that
the requirements of this
International Standard are met.
The laboratory shall replace
equipment as needed to ensure
the quality of examination
results.
Equipment acceptance testing
laboratory shall verify upon
installation and before use that
the equipment is capable of
achieving the necessary
performance and that it
complies with requirements
Equipment instructions for use
Equipment shall be operated at
all times by trained and
authorized personnel
Current instructions on the use,
safety and maintenance of
equipment, including any
relevant manuals and directions
for use provided by the

Equipment calibration and
metrological traceability
calibration, preventive
maintenance and repair
program
No concrete/separate
requirement related to
metrological traceability
Equipment maintenance and repair
contingency plan in case of
equipment/machines/devices
breakdown and malfunction
Equipment adverse incident
reporting
No concrete/separate
requirement stating this
Equipment records
inventory control of the
reagents, glassware and
manufacturer of the
equipment, shall be readily
available.
procedures for safe handling,
transport, storage and use of
equipment to prevent its
contamination or deterioration
Equipment calibration and
metrological traceability
shall have a documented
procedure for the calibration of
equipment that directly or
indirectly affects examination
results
Equipment maintenance and repair
shall have a documented
program of preventive
maintenance which, at a
minimum, follows the
manufacturer’s instructions
Equipment shall be
maintained in a safe
working condition and in
working order
Whenever equipment is
found to be defective, it
shall be taken out of service
and clearly labelled
Equipment adverse incident
reporting
Adverse incidents and
accidents that can be
attributed directly to specific
equipment shall be investigated
and reported to the
manufacturer and appropriate
authorities
Equipment records
 supplies
Others
machines/devices, reagents and
test kits shall be approved by
the Philippine Food and Drug
Administration and validated by
the proper government
institutions (e.g. National
Reference Laboratory)
MCL shall have its own set of
functional, and operational
equipment, as well as its own
set of supplies
Service Delivery Annex A IV - Licensing Standards -
Service Delivery
services provided shall ensure
quality and safety to clients, to
its personnel and to the general
public
shall ensure that the service
being delivered to patients
must comply with the
standards and other related
relevant issuances
MCL
collection site/area shall be
located within the same
region, at a maximum of
one hundred (100)
kilometer radius, from the
address
Aside from specimen
collection for different
tests within the service
capability of the main CL,
the MCL shall be allowed to
perform the following on-
site tests
Records shall be maintained for
each item of equipment that
contributes to the performance
of examinations
5.4 - Pre-examination processes
5.5 - Examination Process
5.6 - Ensuring quality examination
results
5.7 - Post examination processes
5.8 - Reporting of results
5.9 - Release of results
Pre-examination:
laboratory shall have
documented procedures
and information for pre-
examination activities to
ensure the validity of the
results of examinations
Includes requirements on:
information for
patients and users
Request form
information
Primary sample
collection and handling
Instructions for pre-
collection activities
Instructions for
collection activities
 Urinalysis
Fecalysis
Pregnancy Test (lateral
flow)
Basis Serologic Test
using Rapid Test Kits — Examination process:
Dengue, Screening of
Hepatitis
B, RPR/Syphilis Test,
and HIV
Specimen collected for
other test, not mentioned
above, should be properly
handled and transported.
Serum blood samples
for chemistry testing
must be separated
within four (4) hours
from the time of
collection
Note: This is basically all that is
written in the requirements under
Service delivery.
Ensuring quality of examination
results:
Post-examination processes:
Sample transportation
Sample reception
Pre-examination
handling, preparation
and storage
laboratory shall select
examination procedures
which have been validated
for their intended use
Includes requirements on:
Verification of
examination
procedures
Validation of
examination
procedures
Measurement
uncertainty of
measured quantity
values
Biological reference
intervals or clinical
decision values
Documentation of
examination
procedures
laboratory shall ensure the
quality of examinations by
performing them under
defined conditions
includes requirements on:
Quality control
materials and data
Interlaboratory
comparisons
Comparability of
examination results
Includes requirements on:
Review of results
 Storage, retention and
disposal of clinical
samples
Reporting of results:
results of each examination
shall be reported
accurately, clearly,
unambiguously and in
accordance with any
specific instructions in the
examination procedures
shall define the format and
medium of the report (i.e.
electronic or paper) and the
manner in which it is to be
communicated from the
laboratory
shall have a procedure to
ensure the correctness of
transcription of laboratory
results
include the information
necessary for the
interpretation of the
examination results
process for notifying the
requester when an
examination is delayed that
could compromise patient
care
Includes requirements on:
Report attributes
Report content
Release of results:
shall establish documented
procedures for the release
of examination results
Includes requirements on:
Automated selection

Laboratory Information Annex A V - Information 5.10 Laboratory information

Management Management management

Every CL shall maintain a laboratory shall have access to

system of communication, the data and information
recording, reporting and
releasing of results.
Administrative Policies and
Procedures
CL shall have written
policies and procedures for
the provision of laboratory
services, the operation and
maintenance of the CL,
which includes satellite
laboratories, MCL and
POCT, and shall include the
accountabilities of every
personnel working in the
laboratory.
There shall be documented
technical procedures for
services provided in each
section of the laboratory
There shall be a risk
assessment for every
section
Communication and Records
Management
CL shall maintain and
ensure the confidentiality
of all records
procedures for the receipt
and performance of routine
and STAT requests
procedures for the
reporting of results of
routine and STAT laboratory
examinations, including
critical values that would
impact on patient care
All results shall be released
in accordance with DOH
guidelines.
All laboratory reports on
various examinations of
specimens shall bear the
name, PRC registration
number, and original
needed to provide a service
which meets the needs and
requirements of the user
documented procedure to
ensure that the confidentiality
of patient information is
maintained at all times
Authorities and responsibilities
ensure that the authorities
and responsibilities for the
management of the
information system are
defined
define the authorities and
responsibilities of all
personnel who use the
system
Information system
management
system(s) used for the
collection, processing,
recording, reporting,
storage or retrieval of
examination data and
information shall be
validated by the supplier
and verified for functioning
by the laboratory,
documented, protected
from unauthorized access,
safeguarded against
tampering or loss, operated
in an environment that
complies with supplier
specifications, maintained
in a manner that ensures
the integrity of the data and
information, and in
compliance with national or
international requirements
regarding data protection
verify that the results of
examinations, associated
information and comments are
 signature of the registered accurately reproduced,
medical technologist(s) who electronically and in hard copy
performed the laboratory where relevant, by the
examinations, and the information systems external to
pathologist who shall be the laboratory intended to
accountable for the directly receive the information
reliability of the results. documented contingency plans
policy guideline on the use to maintain services in the
of digital signature event of failure or downtime in
procedures for the information systems
reporting of workload,
quality control, inventory
control, work schedule and
assignments
procedures for the
reporting of workload,
quality control, inventory
control, work schedule and
assignments
retention of laboratory
documents, records, slides
and specimens shall be in
accordance to the
standards promulgated by
the DOH or by competent
authorities
operating hours of the CL

Comments
PERSONNEL: The personnel requirements were differently presented or organized compared to ISO. ISO's
presentation is according to the details enumerated in the left column. In AO 037, the types of personnel
are enumerated and each has its own list of requirements.
EQUIPMENT AND REAGENTS: ISO 15189:2012 have separate and detailed requirements for equipment and
reagents/consumables. AO 037 have a somewhat generalized requirements. Also, there are requirements
that are specified in AO but are not specified in ISO, and vice versa.
SERVICE DELIVERY: As what can be clearly seen on the comparison table above, the completeness and
details of the requirements for service delivery based on ISO 15189:2012 is really comparable to that of AO
037. A0:037 provided requirements that are general and vague while ISO 15189:2012 provided specific
guidelines from Pre-examination until the Release of Results.
LABORATORY INFORMATION MANAGEMENT: A0:037 has detailed requirements regarding this. Some
requirements are not stipulated in the information management part for ISO 15189:2012 but are already
included in other sections of the standards.
Conclusion:
ISO 15189:2012 and AO No. 2021-0037 are two rules and regulations that aims to provide guidelines for Clinical
Laboratories to achieve the best and quality services. Though they have some differences, specific items that are
lacking in each other, they still are both important. Each rules and regulations have its own strengths which if used
together, would be very helpful in achieving an excellent clinical laboratory in the service of the people.