PMLS FINALS

THE CLINICAL LABORATORY

Its main task is to provide accurate and reliable
information to medical doctors for the diagnosis,
prognosis, treatment, and management of diseases.

Place where specimens (e.g. blood and other body
fluids, tissues, feces, hair and nails) collected are
processed, analyzed, preserved and properly disposed

ACCORDING TO FUNCTION

CLINICAL PATHOLOGY & ANATOMIC PATHOLOGY:

CLINICAL PATHOLOGY

Diagnosis and treatment of diseases performed through
laboratory testing of blood and other body fluids

ANATOMIC PATHOLOGY

Diagnosis of diseases through microscopic examination
of tissues and organs

ACCORDING TO INSTITUTIONAL
CHARACTERISTICS

INSTITUTION-BASED & FREE-STANDING:

INSTITUTION-BASED

Is a clinical laboratory that operates within premises or
part of an institution or part of an institution

FREE-STANDING

Clinical laboratory is not part of an established institution.

ACCORDING TO OWNERSHIP

GOVERNMENT-OWNED & PRIVATELY-OWNED:

GOVERNMENT-OWNED

clinical laboratories are owned, wholly or partially, by
national or local government units

PRIVATELY-OWNED

clinical laboratories are owned, established and operated
by an Individual, corporation, institution, association or
organization

ACCORDING TO SERVICE CAPABILITY

PRIMARY CATEGORY, SECONDARY CATEGORY, TERTIARY CATEGORY, & NATIONAL REFERENCE LABORATORY

PRIMARY CATEGORY

Clinical laboratories under primary category are licensed
to perform basic, routine laboratory testing, namely.

SECONDARY CATEGORY

Clinical laboratories secondary category (Hospital and
non-hospital-based) are licensed to perform laboratory
tests being done by the primary category clinical
laboratories with routine clinical chemistry tests.

TERTIARY CATEGORY

ALL laboratory tests in the secondary category plus

NATIONAL REFERENCE LABORATORY

Is a laboratory in a government hospital designated by the
DOH to provide special diagnostic functions and services
for certain diseases.

LAWS ON THE OPERATION , MAINTENANCE,
AND REGISTRATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES

R.A. 4688- Clinical Laboratory Act of 1966 & A.O. 59 s. 2001

R.A. 4688- Clinical Laboratory Act of 1966

An act regulating the operation and maintenance of
clinical laboratories and requiring the registration of
the same with the department of health, providing
penalty for the violation thereof, and for other
purposes

A.O. 59 s. 2001

“Rules and Regulation Governing the Establishment,
Operation and Maintenance of Clinical Laboratories
in the Philippines”

SECTIONS OF THE CLINICAL LABORATORY

CLINICAL CHEMISTRY, MICROBIOLOGY, HEMATOLOGY AND COAGULATION STUDIES, CLINICAL MICROSCOPY, BLOOD BANK/ IMMUNOHEMATOLOGY, IMMUNOLOGY AND SEROLOGY

SECTIONS OF ANATOMIC PATHOLOGY

HISTOPATHOLOGY/CYTOLOGY

SPECIALIZED SECTIONS OF THE LABORATORY

IMMUNOHISTOCHEMISTRY, MOLECULAR BIOLOGY AND BIOTECHNOLOGY

CLINICAL CHEMISTRY

- Is intended for the testing of blood and other body fluids
• To quantify essential soluble chemicals including waste
products useful for diagnosis
o Blood and urine are the most common body fluids in
this section

MICROBIOLOGY

- Identification of bacteria and fungi on specimens received
• Blood and other body fluids, stool, tissues, and swabs
from different sites in the body
• Microscopic visualization of microorganisms after
staining, isolation, and identification of bacteria (aerobes
and anaerobes) and fungi using varied culture media and
different biochemical tests antigen typing and
antibacterial susceptibility testing.

HEMATOLOGY AND COAGULATION STUDIES

- Enumeration of cells in the blood and other body fluids
(e.g. CSF, pleural fluid)
- blood testing for the determination of various
coagulation factors

CLINICAL MICROSCOPY

• Macroscopic exam to det. Color, transparency, specific
gravity and pH level and microscopic examinations
• To detect presence of abnormal cells and/or parasites as
well as to quantify red cells and WBC and other chemicals
fund in urine.
• detection and identification of parasitic worms and ova
are the primary activities in this area.

BLOOD BANK/ IMMUNOHEMATOLOGY

• Blood typing and Compatibility testing are the two
main activities performed in this section.
• Antibody screening and blood components used for
transfusion
• Most critical in the clinical lab
• Hospital-based: blood donation activities prompt other
activities such as donor recruitment and screening,
bleeding of donor, and post-donation care

IMMUNOLOGY AND SEROLOGY

• Analyses of serum antibodies in certain infectious
agents (viral agents)

HISTOPATHOLOGY/CYTOLOGY

• Tissue processing, cutting into sections, staining,
preparation for microscopic examination by a pathologist

IMMUNOHISTOCHEMISTRY

• Combines anatomical, clinical and biochemical
techniques where antibodies (monoclonal and plyclonal)
bounded to enzymes and fluorescent dyes are used to
detect presence of antigen in tissue.
• Useful in the diagnosis of some types of cancers by
detecting the presence of tumor-specific antigens,
oncogenes, and tumor suppressor genes.
• It can be used to assess the responses of patients to
cancer therapy as well as diagnosis of certain
neurodegenerative disorders

MOLECULAR BIOLOGY AND BIOTECHNOLOGY

• primarily using different enzymes and other reagents,
DNA and RNA are identified and sequenced to detect any
pathologic conditions/ disease processes.
• The most common technique: polymerase chain
reaction (PCR).
• This technique has contributed to scientific
advancements in lab research and is useful for a number
of clinical techniques such as screening genetic
indicators and diagnosis of cancer and infectious
diseases

LABORATORY TESTING CYCLE

• Laboratory testing cycle encompasses all activities
starting from a medical doctor writing a laboratory request
up to the time ( called the turnaround time [TAT])
• The results are generated and become useful information
for the treatment and management of the patients.

LABORATORY TESTING CYCLE THREE PHASES:

1. PRE-ANALYTIC
2. ANALYTIC
3. POST-ANALYTIC

PRE-ANALYTIC PHASE

• Receipt of laboratory request
• Patient preparation
• Specimen collection
• Proper transport of specimen
• Processing of specimen

Sources of error:
o Diet
o Medications
o Alcohol and caffeine intake
o Exercise
o Underlying disease conditions
o Patient ID and labeling of specimens
o Anticoagulant used
o Volume of specimen collected with regards to
volume of anticoagulant

ANALYTIC PHASE

• Actual testing of the submitted/ collected specimen
• Important considerations: equipment and instruments
used, reagents, and internal quality control

Sources of error:
o Equipment and instruments
o Quality of reagents
o Internal quality control program

POST-ANALYTIC PHASE

• Transmission of test results to the medical doctor for
intepretation
• TAT
• Application of doctors’ recommendation

Sources of error:
o Control of the variables of TAT
o Transcription errors (e.g. wrong value used, results
given to the wrong patient)

QUALITY ASSURANCE

Quality Assurance encompasses all activities performed
by lab personnel to ensure reliability of test results

Organized, systematic, well-planned and regularly
done with the results properly documented and
consistently reviewed

TWO MAJOR COMPONENTS:

INTERNAL QUALITY ASSURANCE SYSTEM
(IQAS) & EXTERNAL QUALITY ASSURANCE SYSTEM
(EQAS)

INTERNAL QUALITY ASSURANCE SYSTEM
(IQAS)

day to day activities that are undertaken in order to control
factors or variables that may affect test results

EXTERNAL QUALITY ASSURANCE SYSTEM
(EQAS)

checking performance among clinical laboratories

DEFINING HEALTH CARE WASTE

The disposal of wastes generated by health care facilities
has become a growing concern in the country and around
the world.

refer to all solid or liquid wastes
generated by any of the following activities:
(1) diagnosis, treatment, and immunization of humans;
(2) research pertaining to diagnosis, treatment, and
immunization of humans;
(3) research using laboratory animals geared towards
improvement of human health;
(4) production and testing of biological products; and
(5) other activities performed by a health care facility that
generates wastes.

CATEGORIES OF HEALTH CARE WASTES

INFECTIOUS WASTE, PATHOLOGICAL AND ANATOMICAL WASTE, SHARPS, CHEMICAL WASTE, PHARMACEUTICAL WASTE, RADIOACTIVE WASTE, & NON-HAZARDOUS OR GENERAL WASTE

INFECTIOUS WASTE

- refers to all wastes suspected to
contain pathogens or toxins in sufficient concentration
that may cause disease to a susceptible host.

- It includes discarded materials or equipment used for
diagnosis, treatment, and management of patients with
infectious diseases.

PATHOLOGICAL AND ANATOMICAL WASTE

- refers to tissue
sections and body fluids or organs derived from biopsies,
autopsies, or surgical procedures sent to the laboratory
for examination.

SHARPS

- refer to waste items that can cause cuts, pricks,
or puncture wounds.

- They are considered the most dangerous health care
waste because of their potential to cause both injury and
infection.

CHEMICAL WASTE

- refers to discarded chemicals (solid,
liquid, or gaseous) generated during disinfection and
sterilization procedures.

- It also includes wastes with high content of heavy metals
and their derivatives.

PHARMACEUTICAL WASTE

- refers to expired, split, and
contaminated pharmaceutical products, drugs, and
vaccines including discarded items used in handling
pharmaceuticals.

- It includes antineoplastic, cytotoxic and genotoxic wastes
such as drugs used in oncology or radiotherapy, and
biological fluids from patients treated with the said drugs.

RADIOACTIVE WASTE

- refers to wastes exposed to
radionuclides including radioactive diagnostic materials
or radiotherapeutic materials.

- Residues from shipment of radioactive materials and
unwanted solutions of radionuclides intended for
diagnostic or therapeutic use are examples of radioactive
wastes as well as liquids, gases, and solids contaminated
with radionuclides whose ionizing radiations have
genotoxic effects.

NON-HAZARDOUS OR GENERAL WASTE

- refers to wastes that
have not been in contact with communicable or infectious
agents, hazardous chemicals, or radioactive substances,
and do not pose a hazard.

GENERAL WASTE CLASSIFICATION:

Recyclable wastes, Biodegradable health care wastes, & Non-recyclable/non-biodegradable health care
wastes

Recyclable wastes

in health care facilities such as:
§ Paper products such as used office paper,
computer printouts, and corrugated cardboard
boxes
- Aluminum from beverage cans and other
aluminum containers
- Pressurized gas containers such as oxygen
tanks
- Plastic products including polyethylene
terephthalate (PET) plastic water bottles, plastic
milk containers, and polypropylene plastic
bottles for saline solutions and irrigation fluids
- Glass such as used vials for sterile solutions

- Wood such as scrap wood and used wood
shipping pallets
- Durable goods such as furniture and furnishings
- Electronic devices such as used computer
equipment and print cartridges

Biodegradable health care wastes

such as left-
over food from non-infectious patients and garden

wastes such as grass trimmings and tree cuttings

Non-recyclable/non-biodegradable health care wastes

that cannot be classified into either of the first
two categories.

chronic exposure

(for prolonged periods in minute
quantities)

acute exposure

(for short periods in large
quantities)

INTERNATIONAL AGREEMENTS PERTAINING TO
HEALTH CARE WASTE MANAGEMENT

- THE MONTREAL PROTOCOL ON SUBSTANCES
THAT DEPLETE THE OZONE LAYER (1987)

- THE BASEL CONVENTION ON THE CONTROL
OF THE TRASBOUNDARY MOVEMENTS OF
HAZARDOUS WASTES AND THEIR DISPOSAL (1989)

- UNITED NATIONS FRAMEWORK CONVENTION
ON CLIMATE CHANGE (1992)

- STOCKHOLM CONVENTION ON PERSISTENT
ORGANIC POLLUTANTS (2001)

- ASEAN FRAMEWORK AGREEMENT ON THE
FACILITATION OF GOODS IN TRANSIT (1998)

THE MONTREAL PROTOCOL ON SUBSTANCES THAT DEPLETE THE OZONE LAYER (1987)

- The Montreal Protocol on Substances that Deplete
the Ozone Layer (1987) was adopted in Montreal,
Canada on September 16, 1987 and came into force, as
agreed upon, on January 1, 1989.
- It sets the final objective of the Protocol to eliminate
ozone depleting substances in the environment.

THE BASEL CONVENTION ON THE CONTROL OF THE TRASBOUNDARY MOVEMENTS OF HAZARDOUS WASTES AND THEIR DISPOSAL (1989)

- is concerned with the transboundary movements of hazardous waste.
- The countries that signed the Convention accepted the
principle that only legitimate transboundary shipments of
hazardous waste are exported from countries that lack
the facilities or expertise to safely dispose certain wastes
to other countries that have both facilities and expertise.

UNITED NATIONS FRAMEWORK CONVENTION ON CLIMATE CHANGE (1992)

includes a legally non-binding
pledge that by the year 2000, major industrialized nations
would voluntarily reduce their greenhouse gas emissions
to 1990 levels.

STOCKHOLM CONVENTION ON PERSISTENT ORGANIC POLLUTANTS (2001)

The Stockholm Convention on Persistent Organic
Pollutants (2001) is a global treaty to protect human
health and the environment from persistent organic
pollutants (POPs).

ASEAN FRAMEWORK AGREEMENT ON THE FACILITATION OF GOODS IN TRANSIT (1998)

is a core instrument that
provides nine high level protocols that set out generic
standards to be put into place for the implementation of
an international transit system.

NATIONAL LAWS AND POLICIES ON HEALTH CARE WASTE MANAGEMENT

- REPUBLIC ACT NO. 4226 “HOSPITAL
LICENSURE ACT” (1965)
- REPUBLIC ACT NO. 6969 (1990)
- PRESIDENTIAL DECREE 813 (1975) AND
EXECUTIVE ORDER 927 (1983)
- PRESIDENTIAL DECREE 856
- PRESIDENTIAL DECREE NO. 984
- PRESIDENTIAL DECREE NO. 1586
- EXECUTIVE ORDER NO. 301
- DOH ADMINISTRATIVE ORDER NO. 2008-0021
- DOH ADMINISTRATIVE ORDER NO. 2008-0023
- DOH “MANUAL ON HEALTH CARE WASTE
MANAGEMENT” IN 2011
- PHILHEALTH BENCHBOOK FOR QUALITY
ASSURANCE IN HEALTH CARE (2006)
- BFAD MEMORANDUM CIRCULAR NO. 22,
SERIES OF 1994

REPUBLIC ACT NO. 4226 REPUBLIC ACT NO. 4226 “HOSPITAL
LICENSURE ACT” (1965)

is an act that requires the registration and
licensure of all hospitals in the country and mandates the
DOH to provide guidelines for hospital technical
standards as to personnel, equipment, and physical
facilities.

DOH Administrative Order No. 70-A series of 2002
“Revised Rules and Regulations Governing the
Registration, Licensure, and Operation of Hospital
and Other Health Facilities in the Philippines”

includes the application or renewal of license,
submission of plans, and other design requirements
under the Code of Sanitation of the Philippines,
National Plumbing Code of the Philippines, Revised
Fire Code of the Philippines, and National Building
Code of the Philippines. The Manuals on Hospital
Waste Management and Health Facilities
Maintenance are also required for submission for
verification by the DOH – Bureau of Health Facilities
and Services (BHFS).

DOH Administrative Order No. 2005-0029

dated December 12, 2005 “Amendment to Administrative
Order No. 70-A series of 2002 re: Revised Rules and
Regulations Governing the Registration, Licensure,
and Operation of Hospitals and Other Health
Facilities in the Philippines” – requires the HCF to
submit a health care waste management Plan to
BHFS as one of its requirements for the issuance of
license to operate.

DOH Administrative Order No. 2007-0027

dated August 22, 2007 “Revised Rules and regulations
Governing the Licensure and Regulations of Clinical
Laboratories in the Philippines” – requires written
procedures for the proper disposal of health care
waste and other hazardous substances and required
written policy guidelines on biosafety and
biosecurity.

REPUBLIC ACT NO. 6969 (1990)

requires the registration of waste generators, waste transporters, and operators of toxic and hazardous waste treatment facilities with the EMB.

DENR Administrative Order No. 36, Series of 2004

“Revising DENR Administrative Order No. 29,
Series of 1992, to Further Strengthen the
Implementation of Republic Act 6969 and
Prescribing the Use of the Procedural Manual” – the
Procedural Manual requires a comprehensive
documentation on the legal and technical
requirements of hazardous waste management.

DOH-DENR Joint Administrative Order No. 02 series of 2005

dated August 24, 2005 entitled
“Policies and Guidelines on Effective and Proper
Handling, Collection, Transport, Treatment, Storage,
and Disposal of HCW” – aims to:
(a) provide guidelines to generators, transporters,
and disposal of health care waste (HCW);
(b) clarify the jurisdiction, authority, and responsibility
of DENR and DOH with regard to health care waste
management (HCWM); and
(c) harmonize the efforts of DENR and DOH on
HCWM.

DOH Administrative Order 2007-0014

2007-0014 “Guidelines
on the Issuance of Certificate of Product Registration
for Equipment or Devices Used for Treating Sharps,
Pathological and Infectious Waste” – requires the
manufacturers, importers, and distributors, including
generators of HCW that sell and/or use equipment
and devices in treating sharps, pathological, and
infectious waste to secure a Certificate of Product
Registration (CPR) from DOH through the Bureau
of Health Devices and Technology.

REPUBLIC ACT NO. 8749 “THE PHILIPPINE
CLEAN AIR ACT OF 1999”

prohibits the incineration of bio-medical wastes
effective July 17, 2003.

• It promotes the use of state-of-the-art, environmentally-
sound, and safe non-burn technologies for the handling,

treatment, thermal destruction, utilization, and disposal of
sorted, unrecycled, biomedical, and hazardous wastes.

REPUBLIC ACT NO. 9003 “ECOLOGICAL SOLID
WASTES MANAGEMENT ACT OF 2000”

Republic Act No. 9003 “Ecological Solid Wastes
Management Act of 2000” mandates the segregation of
solid wastes at the sources including households and
institutions like hospitals by using a separate container for
each type of waste.

REPUBLIC ACT 9275 “THE PHILIPPINE CLEAN
WATER ACT OF 2004”

Republic Act 9275 “The Philippine Clean Water Act of
2004” pursues a policy of economic growth in a manner
consistent with the protection, preservation, and revival of

the quality of the country’s fresh, brackish, and marine
waters.

PRESIDENTIAL DECREE 813 (1975)

“Strengthening the Functions of Laguna
Lake Development Authority (LLDA)” which further
strengthens the powers and function of the LLDA to
include environmental protection and jurisdiction over
surface waters of the Laguna Lake basin.

EXECUTIVE ORDER 927 (1983)

the LLDA is empowered to issue permits for the use of surface waters within Laguna de Bay.

PRESIDENTIAL DECREE 856

requires the approval of
DOH in terms of the following:
(1) constructions of any approved type of toilet in every
house and community which may be allowed for a
group of small houses of light material or temporary
in nature;
(2) plans of individual sewage or sewage system and the
sub-surface absorption system or other treatment
device;
(3) location of any toilet or sewage disposal system in
relation to a source of water supply;
(4) the discharge of untreated effluent from septic tanks
and/or sewage treatment plants to bodies of water;
(5) manufacture of septic tanks; and
(6) method of disposal of sludge from septic tanks or
other treatment plants.

PRESIDENTIAL DECREE NO. 1586

requires projects, like
the construction of new hospital buildings or expansion of
existing hospitals, to secure an Environmental
Compliance Commitment (formerly Environmental
Compliance) Certificate (ECC) prior to the construction
and operation of the facility.
• An ECC is required for the installation and operation of
HCW treatment systems like pyrolysis, autoclave,
microwave, and other treatment technology including
landfills.

EXECUTIVE ORDER NO. 301

aims to:
(1) promote the culture of making environmentally
informed decisions in the government, especially in
the purchase and use of different products;
(2) Include environmental criteria in public tenders,
whenever possible and practicable;
(3) establish the specifications and requirements for
products or services to be considered
environmentally advantageous; and
(4) develop incentive programs for suppliers of
environmentally advantageous products or services.

DOH ADMINISTRATIVE ORDER NO. 2008-0021

requires all health care facilities (HCF) to gradually
phaseout the use of mercury-containing devices and
equipment.
• The initial targets of the phaseout are mercury
thermometers and sphygmomanometers in the health
care facility.

DOH ADMINISTRATIVE ORDER NO. 2008-0023

requires
the establishment and maintenance of a culture of patient
safety in the HCF as the responsibility of its leaders.
• As such, HCF shall ensure that an enabling
mechanism/strategy is in place to ensure patient safety.

DOH “MANUAL ON HEALTH CARE WASTE MANAGEMENT” IN 2011

serves as a reference for HCF
administrators in the implementation of an effective and
efficient waste management program.
• The requirements for doing such are provided in the
manual by listing the standards of performance, defining
the mandatory requirements, providing new concepts,
and citing examples and tools.
• The Manual is designed to be used by all workers within
the HCF.

PHILHEALTH BENCHBOOK FOR QUALITY ASSURANCE IN HEALTH CARE (2006)

includes health care waste
management as one of its parameters in the quality
assurance of healthcare.

BFAD MEMORANDUM CIRCULAR NO. 22, SERIES OF 1994

these circulars are released to prevent the
proliferation of adulterated, misbranded, and counterfeit drugs brought about by the recycling of used
pharmaceutical bottles and vials.

HEALTH CARE WASTE MANAGEMENT SYSTEM

Health care waste generated by health care facilities
generally follows a well-defined flow from the point of
generation down to their treatment and disposal.

In the health care waste management hierarchy

(More Preferable)
- Prevent
- Reduce
- Reuse
- Recycle
- Recover
- Treat
- Dispose
(Least Preferable)

RESOURCE DEVELOPMENT

Safely reusing, recycling, and recovering wastes are
collectively termed as resource development.

Reusing

refers to either finding a new application for
a used material or using the same product for the same
application repeatedly.

Recycling

refers to the processing of used material
into new products.

END OF PIPE APPROACH

For wastes that cannot be safely reused, recycled, or
recovered, the end of pipe approach is implemented.

(END OF PIPE APPROACH)
This approach to health care waste management involves two aspects:

treatment and disposal

(Green Procurement Policy)
This approach to health care waste management involves two aspects:

waste prevention and waste reduction

Waste treatment

is the process of changing the
biological and chemical characteristics of waste to
minimize its potential to cause harm.

Waste disposal

on the other hand, refers to
discharging, depositing, placing, or releasing any health
care waste into air, land, or water.

Segregation

is the process of separating different
types of waste at the point of generation until their final
disposal.

Sterilization

kills all microorganisms

Disinfection

reduces the level of microorganisms
present in the material.

PYROLYSIS

is the thermal decomposition of health care
wastes in the absence of supplied molecular oxygen in
the destruction chamber where the said waste is
converted into gaseous, liquid, or solid form.

AUTOCLAVE

is the use of steam sterilization to render
waste harmless and is an efficient wet thermal
disinfection process.

MICROWAVE

is a technology that typically incorporates
some type of size reduction device.

CHEMICAL DISINFECTION

chemicals like sodium
hypochlorite, hydrogen peroxide, peroxyacetic acid, and
heated alkali are added to health care wastes to kill or
inactivate present pathogens.

BIOLOGICAL PROCESS

uses an enzyme mixture to
decontaminate health care wastes.