MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO
What guides the laboratory operation?
THE COMPLEXITY OF LABORATORY SYSTEM
RA 4688
The Clinical Laboratory Act of 1966
An act regulating the operation and maintennace 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.
RA 4688
The Clinical Laboratory Law
Approved June 18, 1966
Promulgated for the purpose of preventing the
operation and maintenance of substandard,
improperly managed and poorly equipped clinical
laboratories.
Section 1.
 Any person, firm or corporation, operating and
maintaining a clinical laboratory in which body fluids,
tissues, secretions, excretions and radioactivity from
beings or animals are analyzed for the determination of
the presence of pathologic organisms, processes and/or
conditions in the persons or animals from which they
were obtained, shall register and secure a license annually
at the office of the Secretary of Health.
 Provided, that government hospital laboratories doing
routine or minimum laboratory examinations shall be
exempt from the provisions of this section if their
services are extensions of government regional or central
laboratories.
Section 2.
 It shall be unlawful for any person to be professionally in-
charge of a registered clinical laboratory unless he is a
licensed physician duly qualified in laboratory medicine
and authorized by the Secretary of Health, such
authorization to be renewed annually.
 No license shall be granted or renewed by the Secretary
of Health for the operation and maintenance of a clinical
laboratory unless such laboratory is under the
administration, direction and supervision of an authorized
physician.
Section 3.
 The Secretary of Health, through the Bureau of Research
and Laboratories shall be charged with the responsibility
of strictly enforcing the provisions of this Act and shall
be authorized to issue such rules and regulations as may
be necessary to carry out its provisions.
Section 4.
 Any person, firm or corporation who violates any
provisions of this Act or the rules and regulations issued
thereunder shall be punished with:
- Imprisonment for not less than 1 month but
not more than 1 year.
- Fine of not less than 1000 nor more than
5000 pesos.
- Both such fine and imprisonment, at the
discretion of the court.
Section 5.
 If any section or part of this Act shall be adjudged by any
court of competent jurisdiction to be invalid, the
judgment shall not affect, impair, or invalidate the
remainder thereof.
Section 6.
 The sum of 50,000 pesos, or so much thereof as may be
necessary, is hereby authorized to be appropriated, out of
any funds in the National Treasury not otherwise
appropriated, to carry into effect the provisions of this
Act.
Section 7.
 All acts or parts of Acts which are inconsistent with the
provisions of this Act are hereby repealed.
Section 8.
 This Act shall take effect upon its approval.
The ff. Administrative and Executive Orders were issued
in relation to RA 4688:
 AO 201 s. 1973
 AO 290 s. 1976
 AO 52 s. 1983
 AO 49-B s. 1988
 EO 102 s. 1999 - Redirecting the Functions &
Operations of the DOH
 AO 59 s. 2001 - Rules & Regulations Governing The
Establishment, Operation & Maintenance of Clinical
Laboratories in the Philippines.
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO
 AO 27 s. 2007 - Revised Rules & Regulations
Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines.
Administrative Order No. 2007 - 0027
I. Rationale
One of the main thrusts of current health sector
reforms under FOURmula One (F1) for health is
regulation. The main objective of regulatory reform
is to ensure access to quality and affordable health
products, devices, facilities and services, especially
those commonly used by the poor.
II. Objective
- This Order is promulgated to prescribe a revised
minimum standard for clinical laboratories.
- This shall also ensure accuracy and precision of
laboratory examinations in order to safeguard public
health and safety.
III. Scope & Coverage
- Apply to all individuals, agencies, partnerships or
corporations that operate clinical laboratories in the
Philippines performing examinations and analysis of
samples tissues, fluids, secretions, excretions, or
other materials from the human body that would
yield relevant laboratory information, which
physicians use for the prevention, diagnosis, and
treatment of diseases, and the management and
promotion of personal and public health.
- Except, Government clinical laboratories, doing
microscopy work only for specific DOH programs
such as but not limited to malaria screening, acid fast
bacilli microscopy, test for sexually transmitted
infections, and cervical cancer screening using Pap
smears.
IV. Definition of Terms
 Applicant
a natural or juridical person who intends to operate a
clinical laboratory.
 BHFS
Bureau of Health Facilities & Services
 CHD
Center for Health Development
 Clinical Laboratory
a facility where tests are done on specimens from the
human body to obtain information about the health
status of a patient for the prevention, diagnosis and
treatment of diseases.
A. Clinical chemistry, hematology,
immunohematology, microbiology, immunology,
clinical microscopy, histopathology, cytology,
toxicology, endocrinology, molecular biology, and
cytogenetics.
B. Other functions of the clinical laboratory are to
provide consultative advisory services covering all
aspects of laboratory investigations.
C. Facilities that are involved in the pre-analytical
processes, such as the collection, handling or
preparation of specimens, or act as a mailing or
distribution center, such as in a laboratory network or
system are also considered to be a part of a clinical
laboratory.
D. The total testing process includes pre-analytical,
analytical and post-analytical procedures.
 Critical values
Panic values originally described by Lundberg as
“life - threatening” unless something is done
promtply and for which some corrective action could
be undertaken.
 DOH
Department of Health
 EQAP (External Quality Assessment Program)
- it is a program where participating laboratories are
given unknown sample for analysis.
- these samples are to be treated as ordinary human
specimens for the usual processing and examination.
- the quality of performance of the laboratory shall be
assessed through the closeness of its results to be pre-
determined value or to the reference value generated
by the participating laboratories through peer group
analysis.
 Inspection Tool
The checklist used by the regulatory officers during
inspection visits to evaluate compliance of a clinical
laboratory to the minimum standards and technical
requirements.
 Institution
A corporate body or establishment organized for an
educational, medical, charitable or similar purpose.
 License
- The document is issued by the DOH to an
individual, agency, partnership or corporation
that operates a clinical laboratory upon
compliance with the requirements set forth in
this Order.
- the individual, agency, partnership or corporation to
whom the license is issued and upon who rests
compliance with this Order.
 LTO (License to Operate)
It also refers to the license.
 Mobile Clinical Laboratory
A laboratory testing unit that moves from testing site
to another testing tsite or has a temporary testing
location. It shall have a base laboratory.
 Monitoring Examinations.
Tests done in series on patients as a guide for
treatment or follow-up of their condition.
 NRL (Natinal Reference Laboratory)
- it is a laboratory in a government hospital which
has been designated by the DOH to provide special
functions and services for specific disease areas.
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO
- these functions include provision of referral
services such as confirmatory testing, surveillance,
resolution of conflicting results between or among
laboratories; training, research, implementation of
EQAS; evaluation of diagnostic kits and reagents.
- an NRL may or may not be part of a general
clinical laboratory.
- Hematology - NKTI
- Infectious diseases - RITM
- Sexually transmitted infection -
NRL/SLH/SACCL
- Clinical Chemistry - LCP
- Water microbiology and drugs of abuse -
EAMC
- TTI-NRL - RITM
 POL (Physician’s Office Laboratory)
It is an individual doctor’s office/clinic wherein
laboratory examinations are performed.
 POCT (Point of Care Testing)
It is a diagnostic testing at or near the site of patient
care rather than the clinical laboratory. It includes
bedside testing, outpatient and home care.
 Routine Test
The basic, commonly requested tests in the
laboratory, the results of which are not required to be
released immediately upon completion. It shall
follow the usual procedures and system in the
laboratory.
 Satellite Testing Site
Any testing site that performs laboratory
examinations under the administrative control of a
licensed laboratory, but performed outside the
physical confines of the laboratory.
 STAT Tests
- tests done on urgent cases, the results of which shall
be released immediately, within 1 hour after the
procedure.
- STAT is an abbreviation “sta’tim” which means
immediately.
V. Classification of Laboratories
- Classification by Function -
 Clinical Pathology
Includes Clinical Chemistry, Hematology,
Immunohematology, Microbiology, Immunology,
Clinical Microscopy, Endocrinology, Molecular
Biology, Cytogenetics, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines.
 Anatomic Pathology
Includes Surgical Pathology, Immunohistopathology,
Cytology, Autopsy, Forensic Pathology and
Molecular Pathology.
- Classification by Institutional Character
 Institution-based
A laboratory that operates within the premises and as
part of an institution, such as but not limited to
hospital, medical clinic, school, medical facility for
overseas and seafarers, birthing home, psychiatric
facility, drug rehabilitation center.
 Freestanding
A laboratory that does not form part of any other
institution.
- Classification by Service Capability -
1. General Clinical Laboratory
 Primary category
- Routine Hematology ( Complete Blood Count -
includes Hemoglobin, Mass concentration,
erythrocyte volume fraction (Hematocrit), leucocyte
number concentration (white blood cell or WBC
count) and leucocyte number fraction (differential
count)).
- Qualitative Platelet Determination
- routine Urinalysis
- Routine Fecalysis
- Blood Typing - for hospital based
VI.
Laboratory Director
 Actively participate in the design and planning stages of
new laboratory facilities;
 Assess all potential risks and apply basic concepts of
organization in order to provide a proper and safe
environment for conducting laboratory activities,
including services to patients;
 Consider the organization of the laboratory when
developing new activities or new diagnostic techniques in
the laboratory.
Quality Manager (Designated Safety Officer)
 Develop a complete and thorough description of basic
safety rules and organization, and ensure that personnel
are trained in their specific duties when new activities or
techniques are introduced into the laboratory;
 Know the basics of safety and biosafety management
issues when working with chemicals and pathogens of
moderate or low level of risk;
 Know how to perform an extensive risk assessment when
developing new activities in the laboratory;
 Conduct laboratory safety audits.
Laboratorian
 Be aware of basic safety rules and processes;
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO

 Understand the basics of safety and biosafety  Bed (pediatric collection)

management issues when working with toxic chemicals,  Washing area
biological samples and physical hazards, and when  Exhaust fan
interacting with patient.  High ceiling

“Negligence of laboratory safety is costly!” Flow of Patient:

“Everyone is responsible for quality and safety!”

All diagnostic and health care laboratories must be designed
and organized for Biosafety Level 2 or above.
Laboratory Design
When designing a laboratory or
organizing workflow, ensure that
patients and patient samples do
not have common pathways. Flow of Sample Collection:
Access

Access to rooms where

manipulation or analysis of
samples takes place, or where
hazardous chemicals or other materials are stored, must be
restricted to authorized persons, usually laboratory technical
staff and maintenance staff.

Circulation Pathways

To identify where improvements in laboratory design may be Segregated Areas

needed in order to prevent or reduce risks of cross-
contamination, follow the path of the sample as it moves
through the laboratory during the pre-examination,
examination, and post-examination phases of testing.

 Path followed by the sample

- Reception and registration of patients
- Sampling rooms
- Dispatch between different laboratories
- Analysis of samples
- Report delivery, filing
 Service rooms
Registration Desk
Stock Room
Place where patients are entertained (patient service).
A laboratory must have a partner facility that is the same level
Safety during service: or higher (ex. both level 3).
 No unauthorized persons  Good inventory – First in, first out (FIFO)
 No friends
Challenge:
 No children
 No animals  Surplus – expiration 
 Shortage – not enough reagent, income 
“Please close the door!”
Flow of Waste Materials:
Facilities / Sample Collection Room
Should have and be:

 Properly ventilated
 Extraction chair
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO

The safety officer should be assigned responsibility for

ensuring that there is an adequate supply of appropriate
equipment for safety and biosafety, such as:
 PPE
 Fire extinguishers and fire blankets
 Appropriate storage and cabinets for flammable and toxic
chemicals
 Eye washers and emergency shower
 Waste disposal supplies and equipment
 First aid equipment
Premises
Standard Safety Practices
 High ceiling with good ventilation
Walls and ceiling
- Use washable, glossy paint
- Easy to clean and disinfect
 Floor
- Easy to clean and disinfect

Benchtops
Non-porous covering, easy to clean, resistant to chemicals and
disinfectants.

 No wood, no steel
- Wood is not easy to clean or disinfect, and will
deteriorate over time when repeatedly exposed to
disinfectants and detergents. It also supports the
growth of contaminants when wet or damaged.
- The steel will rust when washed with chlorine.
Scheduled Cleaning

 Daily
- Benchtops
- Floors
 Weekly
- Ceiling and walls
 Other
- Refrigerators
- Freezers
- Storage areas
Record date and cleaning staff
Safety Management
 Responsible: Safety Officer
 Safety Manual: laboratory-specific
 Standard Operating Procedures
 Trained personnel
- Potential risks
- Safety procedures
 Waste Management - All potentially harmful and
dangerous materials (including liquids and radioactive
materials) must be treated in a specific way before
disposing.
General Safety Equipment
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO
Safety Signs
Why perform a Risk Assessment?
Laboratory workers encounter a
significant number of risks, which
vary with the types of activities
and analyses that are performed.
Risk Assessment
Compulsory in order for the laboratory director to manage and
reduce risks to laboratory employees.
- Develop safety procedures that describe what to do in
case of accidents, injuries or contamination.
- Keep a record of staff exposures to hazards, actions taken
when this occurs, and procedures put into place to prevent
future occurrences.
Research Employee Injuries (1993-1997)
Howard Hughes Medical Institute, Office of Laboratory Safety.
Laboratory Support Injuries (1993-1997)
Howard Hughes Medical Institute, Office of Laboratory Safety.
Laboratory Hazards
 Physical
 Chemical
 Biological
Physical Hazards
Examples of equipment in which safety training and
precautions are important include autoclaves, centrifuges,
compressed gas cylinders and fume hoods.
Many laboratory instruments pose a danger of electrical
shock, and some equipment can emit dangerous microwaves
or radiation if not properly used or maintained.
Needles, Broken Glass, and Sharps
- Do not recap needles
- Always use puncture-resistant, leakproof, sharps
container
- Always use specific waste disposal containers
- Never directly handle broken glass
Do you see anything wrong?
Never use boxes for the disposal of:
 Sharps
 Biohazardous materials that have not been autoclaved
 Liquid wastes
 Chemically contaminated laboratory glassware or
plasticware
 Chemical containers that cannot be disposed of as regular
solid waste
Chemical Hazards
Exposure to toxic chemicals poses a real threat to the health
and safety of laboratory staff.
3 main routes by which chemicals enter the body:
Inhalation
Major route of entry when working with solvents; there is
great rapidity of absorption when fumes are inhaled.
Skin Penetration
May produce systemic poisoning; the condition of the skin
determines the rate of absorption.
Examples of chemicals with these risks are organic lead,
solvents such as xylene and methylene chloride,
organophosphate, pesticides and cyanides.
Ingestion
Accidental ingestion is generally due to poor hygiene
practices, such as eating or smoking in the laboratory.
To prevent or reduce incidents caused by exposure to toxic
chemicals:
- All chemicals transferred from their original containers
should be labeled with their common names,
concentrations and hazards.
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO

- Additional information, such as the date received, date

opened and date of expiration, should also be recorded.

Biosafety Level 1 and 2 Laboratories Separate cabinets for

storage:

 Spill containment cabinet

 Hazardous waste storage
 Flammable liquids storage

Radiochemicals require special precautions, and dedicated

benches with specific bench covers for manipulation of radio-
labeled elements are needed. Aerosols and droplets are the main sources of contamination.
Material Safety Data Sheet Contamination Routes
A technical bulletin providing detailed hazard and  Percutaneous inoculation
precautionary information.  Contact between mucous membranes and contaminated
The MSDS provides: material
- product information;  Accidental ingestion
- fire and explosion
precautions;
- toxicology;
- health effects;
- recommended PPE;
- storage recommendations;
Personal Protective
- leaks and spills—recommended actions;
- waste disposal recommendations; BSL 1 and 2:
- first aid.
 Hand Protection
The MSDS should be: Gloves – should be worn in all instances, and should be
 available to all employees prior to use of hazardous available to laboratory staff on a routine basis.
materials; Effective use of gloves relies on two simple practices:
 kept close to where the hazardous material is used and
located. 1. Remove gloves when leaving the working area to prevent
contamination of other areas such as the telephone, door
Biological Hazards handles and pens.
2. Never reuse gloves. Do not attempt to wash or
The Risks for Laboratory Workers
decontaminate gloves—they will develop microcracks,
Most frequently reported infections in US, 1979-1999. become more porous and lose their protective properties.
After use, gloves must be disposed of in the contaminated
waste.
 Face Protection

Goggles or face shield – projection of droplets is a frequent

occurrence when opening patient sample containers.

Masks – serve as a barrier when splashes or sprays occur.

 Hearing protection
Ear muffs and earplugs – devices reduce the noise energy
reaching and causing damage to the inner ear.
Single-source, Multiple Laboratory Infections
Reitman and Wedum, 1956.  Body Protection
Laboratory coats – compulsory in all instances in the physical
containment level 2 laboratory. A disposable laboratory coat is
 MLS 105: MEDICAL TECHNOLOGY LAWS AND BIOETHICS
LESSON 1: CLINICAL LABORATORY LAW RA 4688 & IT’S IMPLEMENTING GUIDELINES (AO #2007-0027)
2nd SEMESTER / S.Y. 2022-2023
LECTURER: ARIEL MARTICIO
compulsory in physical containment level 3 laboratories or in
specific instances such as sample collection when highly
dangerous pathogens can be involved, such as H5N1 avian
influenza or SARS.
Be aware of the composition of fabrics, as some might be
highly flammable.
Chemical Spills
Minor Spill
The person who spilled it is familiar with the chemical, knows
the associated hazards and knows how to clean up the spill
safely.
Steps for dealing with a minor spill include:
- alert coworkers, then clean up spill;
- follow procedures for disposal of materials used to clean
up spill;
- absorb free liquids with an appropriate absorbent, as
follows:
 caustic liquids – use polypropylene pads or
diatomaceous earth
 oxidizing acids – use diatomaceous earth
 mineral acids – use baking soda or polypropylene pads
 flammable liquids – use polypropylene pads;
- neutralize residues and decontaminate the area.
Major Spill
Anything beyond a minor spill and requiring help from
outside of the laboratory group constitutes a major spill.
Biological Spills
When surfaces are contaminated by biological spills, the
appropriate actions to take are:
1. Define/isolate the contaminated area.
2. Alert coworkers.
3. Put on appropriate PPE.
4. Remove glass/lumps with forceps or scoop.
5. Apply absorbent towel(s) to the spill; remove bulk and
reapply if needed.
6. Apply disinfectant to towel surface.
7. Allow adequate contact time (20 minutes).
8. Remove towel, mop up, and clean the surface with
alcohol or soap and water.
9. Properly dispose of materials.
10. Notify the supervisor, safety officer, and other
appropriate authorities.
Disinfectant
For most spills, use a 1:50 solution (1 g/l chlorine) of
household bleach (sodium hypochlorite solution containing 50
g/l chlorine).
For spills containing large amounts of organic material, use a
1:10 solution (5 g/l chlorine) of household bleach, or an
approved mycobactericidal.
Alcohols are not recommended as surface decontaminating
agents because they evaporate quickly, thus decreasing
contact time.
If laboratory personnel become contaminated with
biological hazards due to splashes or spills:
1. Clean exposed skin or body surface with soap and water,
eyewash (for eye exposures) or saline (for mouth
exposures).
2. Apply first aid and treat as an emergency.
3. Notify supervisor, safety officer, or security desk (after
hours).
4. Follow appropriate reporting procedures.
5. Report to physician for treatment or counselling.
Laboratory Fire Safety
A small laboratory fire is considered to be one that is
extinguishable within 1–2 minutes. Cover the fire with an
inverted beaker or wet paper towels. If this fails, use a fire
extinguisher.
For large fires, call the appropriate local authorities, usually
the fire department and the police department.
All laboratory personnel must learn how to operate a portable
fire extinguisher.
Summary
When designing a laboratory or organizing workflow, ensure that
patients and patient samples do not have common pathways.
Safety is dependent on:
 A responsible supervisor
 A safety manual and SOPs
 Trained personnel
 Assessment of risks
 Laboratory design
Key Message
Neglecting laboratory safety is costly.
It jeopardizes the lives and health of employees and patients,
laboratory reputation, equipment, and facilities.