CLINICAL LABORATORY AND ITS LAWS

CLASSIFICATION OF CLINICAL LABORATORIES IN THE PHILIPPINES

(ADMINISTRATIVE ORDER 2007-0027)

A. CLASSIFICATION BASED ON OWNERSHIP

1. GOVERNMENT-OWNED
- Maintained, partially or wholly, by either the national or local government
2. PRIVATE
- Established, operated and maintained by an individual, corporation, or association without
any affinity with the government

B. CLASSIFICATION BASED ON FUNCTION

1. LABORATORY WITH A CLINICAL PATHOLOGY FUNCTION
- A laboratory that provides diagnosis through tests involving clinical chemistry, hematology,
immunohematology, clinical microscopy, serology, endocrinology, molecular biology,
cytogenetics, toxicology, and therapeutic drug monitoring
2. LABORATORY WITH AN ANATOMIC PATHOLOGY FUNCTION
- A laboratory that provides diagnosis through surgical, immunology, histopathologic,
cytologic, autopsy procedure, forensic, and molecular pathologic techniques

IV. CLASSIFICATION BASED ON INSTITUTIONAL CHARACTER

1. INSTITUTION-BASED CLINICAL LABORATORY
- A laboratory that operates within the premises and as part of an institution such as hospital,
clinic, school or a medical facility
Ex. Department of Pathology of the National Kidney and Transplant Institute
2. FREE STANDING
- Has no affinity with any other institution
Ex. Hi-Precision Diagnostics Laboratory

V. CLASSIFICATION BASED ON SERVICE CAPACITY

1. PRIMARY CLINICAL LABORATORIES
- Offer standard laboratory procedures such as routine hematology, urinalysis, fecalysis and
blood typing
2. SECONDARY CLINICAL LABORATORIES
- Those that provide the minimum service capabilities laboratory with added services such as
routine chemistry matching, Gram staining, and KOH preparations of a primary analysis, cross-
3. TERTIARY CLINICAL LABORATORIES
- Provide the service capabilities of a secondary laboratory in addition to the following services:
special chemistry procedures, special hematology including coagulation procedures,
immunology and culture, and sensitivity procedures

WORLDHEALTH ORGANIZATION CLASSIFICATION OF LABORATIES BASED ON BIOSAFETY LEVEL

1. BIOSAFETY LEVEL 1 LABORATORIES

- those that handle organisms which are considered by the WHO as Risk Group 1, i.e. those that
are unlikely to cause human diseases.
- Personnel who work in this type of laboratory are expected to wear the standard personal
protective equipment (PPE) such as masks, gloves and laboratory gowns.
- Special containment systems are not required
- The personnel are supervised by a scientist with previous training in microbiology or a related
field

2. BIOSAFETY LEVEL 2 LABORATORIES

- Handle a spectrum of moderate-risk agents or Risk Group 2 organisms associated with human
diseases with different degrees of severity.
- Personnel working in this type of laboratory normally process human-derived specimens such
as blood, body fluids, tissues and to some extent, human cell lines in which the organism
causing the disease is unknown.
 - Aside from wearing PPE, the personnel have secondary barriers such as a sink, waste
decontamination facilities (autoclave) to reduce the transmission of biohazard waste, and a
biosafety cabinet

3. BIOSAFETY LEVEL 3 LABORATORIES

- Handle Risk Group 3 organisms that are considered indigenous or exotic agents with the
potential to be transmitted via respiratory routs and that can cause severe or sometimes fatal
infection.
- All procedures in processing samples should be done in a biosafety cabinet with a gas-tight
aerosol generation chamber.
- Access to laboratory is controlled to prevent potentially infectious aerosols from escaping to
the environment.

4. BIOSAFETY LEVEL 4 LABORATORIES

- Handle extremely dangerous and exotic agents that can be transmitted through the air, have
no available vaccine or therapeutic cure, and are under Risk Group 4 classification.
- The personnel working under BSL 4 laboratories are required to wear full-body, air-supplied
positive-pressure suits.
- This kind of laboratory is provided with a specialized ventilation and waste management
system.
- Most of the time, such a facility operates in a separate building.

RISK GROUPS AND DESRCRIPTIONS

Risk Group Agent Risk Description Examples

(RG)

RG-1 Agents that are not associated with diseases
in healthy adult humans
RG-2 Agents that are associated with human
diseases that are rarely serious and for which
preventive or therapeutic interventions are
often available
RG-3 Agents that are associated with serious or
lethal human diseases for which preventive or
therapeutic interventions may be available
RG-4 Agents that are likely to cause serious or
lethal human diseases for which preventive or
therapeutic interventions are not usually
available
Bacillus subtilis, Escherichia coli
K12, adeno-associated virus (AAV)
Staphylococcus aureus, Salmonella
sp, Herpes simplex viruses,
Adenovirus
Mycobacterium tuberculosis,
Bacillus anthracis, HIV
Ebola virus, Marbug virus, Lassa
virus
 PERTINENT LAWS
I. ADMINISTRATIVE ORDER (AO) 2007-0027 (CLINICAL LABORATORY STAFF)
- Governs the licensing and regulation of clinical laboratories in the Philippines
- A clinical laboratory should be headed by a registered medical technologist and managed by a
pathologist (clinical/anatomical) who is duly certified by the Philippine Board of Pathology

II. REPUBLIC ACT NO. 4688 (CLINICAL LABORATORY ACT OF 1966)

- Approved on June 18, 1966
- Was put into effect to regulate the operation and maintenance of clinical laboratories and to
require their registration with the DOH, providing penalty for the violation thereof and other
purposes.

SEC. 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.

and provided further that laboratories being used solely for academic training and/or for purely
research activities are likewise not herein covered. (AO 201 s. 1973)

SEC. 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, as provided for in the preceding paragraph.

SEC. 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.

SEC. 4
Any person, firm or corporation who violates any provisions of this Act or the rules and regulations
issued thereunder by the Secretary of Health shall be punished with imprisonment for not less
than one month but not more than one year, or by a fine of not less than one thousand pesos nor
more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.

SEC. 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.

SEC. 6
The sum of fifty thousand pesos, or so mush 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.

SEC. 7

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

SEC. 8
This Act shall take effect upon its approval.
III. ADMINISTRATIVE ORDER (AO) 201 S. 1973

SEC. 3 BASIC LICENSING REQUIREMENTS

Any person, firm, or corporation desiring to establish or operate and maintain a clinical laboratory
shall submit to the Secretary of Health, thru the Bureau of Research and Laboratories, a sworn
petition/application, said form prepared and adopted therefore, and containing among others the
following data:
(1) The name, citizenship and domicile of the head of the laboratory;
(2) The place, municipality and province where it is to be established;
(3) The name of establishment
(4) The name, citizenship and domicile of the owner
(5) Scope and nature of work to be undertaken (see Section 11-c)
(6) Statement that applicant has complied with all business requirements under other existing
laws or ordinances that are necessary in pursuance of the activity for which a license is herein
applied for
(7) A tax clearance for the preceding year

If the applicant is a partnership or corporation it must be duly registered under existing laws, and
that a copy of its registration papers to be attached to the corresponding petition. An inspector of
the Bureau of Research and Laboratories shall, upon receipt of said application inspect within 60
days the establishment and verify if the applicant has complied with the requirements prescribed
in these regulations. The license will henceforth be issued, signed and approved by the Secretary
of Health, if the application is found to be meritorious; otherwise the same shall be returned
without action.

SEC. 4 LICENSE FEES

SEC. 5
No Clinical Laboratory is allowed to operate without the proper license from the Secretary of
Health thru the Bureau of Research and Laboratories who are charged with the responsibility of
strictly enforcing the provisions of Republic Act No. 4688 and the Rules herein promulgated.

SEC. 6
No person is permitted to manage, administer or supervise a clinical laboratory unless he is a
physician, licensed and duly registered with the Board of Medical Examiners of the Republic of the
Philippines, qualified in laboratory medicine as stipulated in Section 7 (b) and duly authorized by
the Secretary of Health, such authorization to be renewed annually. This authorization shall be
exempted of any fees.

SEC. 7 DEFINITION OF TERMS

Clinical Laboratories:
1. Clinical Pathology
2. Anatomical Pathology
3. Forensic Pathology

SEC. 8 INTERPRETATIONS
Except as specifically authorized by the Secretary of Health in writing, no interpretation of the
meaning of the regulations or its part by any officer or employee of the Office of the Secretary of
Health other than a written interpretation by the Secretary of Justice will be recognized to be
binding upon the Secretary of Health.

SEC. 9 APPLICATION FOR LICENSE

Application for license shall be filed by the owner of his duly authorized representatives in a form
"Petition to Establish, Operate and Maintain a Clinical Laboratory" together with the "Information
Sheet" to be filled by the Physician-In-Charge, prepared for the purpose, with the Bureau of
Research and Laboratories for the necessary screening and approval. Each petition shall be signed
under oath on affirmation by the applicant or a person duly authorized to act for and in his behalf.

SEC 10. TERMS AND CONDITIONS OF LICENSE

Neither the license shall be assigned or otherwise transferred to an authorize party in violation of
the provisions of these regulations. Any owner, administration or any clinical laboratory desiring
to transfer the physical location of his registered clinical laboratory to another place should inform
in writing the Bureau of Research and Laboratories within 15 days after transfer has been
completed. His laboratory in its new location shall be subject to reinspection and should comply
with these rules. Any change in ownership or change in head of the laboratory shall likewise be
reported within 15 days in writing by the persons concerned to the Bureau of Research and
Laboratories for notation and approval, failure to do so automatically revoke the license of the
clinical laboratory.

SEC. 11 REQUIREMENTS FOR A CLINICAL LABORATORY

a) Personnel
b) Physical Plant
c) Minimum Equipment and Apparatuses

SEC. 12 REPORTING
All laboratory requests shall be considered as consultations between the requesting physician and
the pathologist of the laboratory. As such all laboratory reports on various examinations of human
specimens shall be construed as consultations. No person working in an approved clinical
laboratory shall issue a report, orally or in writing or portions thereof without the actual signature
of the Pathologist or his authorized associate or assistants, to the requesting physician or his
authorized representative except in emergencies when the results may be released as authorized
by the Pathologist.

SEC. 13 RECORDING
An adequate and effective system of recording all requests and reports of all human specimens
submitted to and examined in the laboratory should be maintained to include provisions for filing,
storage, indexing and accession number in addition to patient's personal and clinical information
to prevent erroneous reporting and permit ready identification and retrieving. All requests and
reports in clinical laboratory shall be kept on file for at least one year provided a duplicate copy is
on file for the patient's medical records. Records of anatomic and forensic pathology should be
kept permanently in the laboratory.

SEC. 14. LABORATORY FEES

The rate of laboratory fees to be charges by clinical laboratory for examination shall be within the
range of the usual fees prevailing at the time and particular place taking into consideration costs
of production and quality control of various laboratory procedures. Professional services rendered
to the patient in the performance of special procedure of examination shall be treated separately
and not included in the laboratory fee.

SEC. 15 PUBLICITY
Publicity of approved laboratory should be within the normal, ethical and professional concepts
of acceptable medical practice. Only the name of the laboratory, address, telephone number of
the laboratory, pathologists and assistants and field of work covered by the licensure shall appear
on the letterhead and other information media. Advertising matter should be directed exclusively
to physician through recognized professional bulletins or medical journals. No laboratory shall
make advertisement on medical pad, fictitious and unproven claim misleading statements and to
advocate directly or by any means of subterfuge unreliable and inconclusive laboratory
procedures which may prove detriment to patient care.

SEC. 16 Exhibition of Certificate of Approval and license and rules and regulations
The license of the clinical laboratory must be placed in a conspicuous place within the laboratory.
The physician-in-charge must likewise place his or her license and authority together with his
certificate of proficiency in the specialty in a prominent place in the laboratory. A copy of the rules
and regulations should be readily available for guidance of all staff and personnel in the laboratory.

SEC. 17 EXPIRATION
Each specific license shall expire on the last day of December of the year stated therein, including
the authorization given to the Head, Director or Physician-in-charge of the clinical laboratory.

SEC. 18 RENEWAL
 Application for renewal of license shall be filed in accordance with the preceding Section 3 & 4.
The Bureau of Research and Laboratories shall process applications for license or renewal
immediately upon receipt thereof, provided, however, that such clinical laboratory may continue
operation during the pendency of the final action of their applications unless otherwise or ordered
or advised by the Secretary of Health to cease operation.

SEC. 19 INSPECTION
It shall be the duty of the Secretary of Health or his representative to conduct periodical inspection
of clinical laboratories
(1) Each license shall give the Secretary of Health or his duly authorized representatives the
opportunity at all reasonable time to inspect the premises and facilities of the clinical
laboratory.
(2) Each license shall make available all records kept him pursuant to those regulations for
inspection by the Secretary of Health of his authorized representatives.
(3) Directors of Regional Health Office, Provincial, city or municipal Health Officers are required
to report the existence of unlicensed clinical laboratories, and/or violations of these rules to
the Bureau of Research and Laboratories.

SEC. 20 QUALITY CONTROL TEST

The Director of the Bureau of Research and Laboratories or his representative is hereby authorized
to conduct such quality control tests as he deems appropriate or necessary for the administration
of these regulations for the control of operation.

SEC. 21 MODIFICATION AND REVOCATION OF LICENSE

The terms and conditions of each license shall be subject to amendment for modification by means
of amendments to these regulations as the Secretary of Health may deem fit to suit. Any license
may be revoked, suspended or modified in full or in part from any material false statement of the
applicant, or as shown by the record of inspection which will serve as basis for the Secretary of
Health to refuse issuance of license on an original application or for violation of, or failure to
observe any of the terms and provisions of these regulation. Except in cases of willful or repeated
violation hereof or where public health interest or safety requires otherwise, no license shall be
modified, suspended, or revoked unless prior notice has been made and the corresponding
investigation conducted.

SEC. 22 INVESTIGTION OF CHARGES AND COMPLAINTS

Upon the filling of a complaint or charges duly sworn by any person interested party or
corporation, against a clinical laboratory or any of its personnel to the effect that one or more of
such personnel of an approved laboratory have violated or are violating R.A. no. 4688 or the
provisions of these regulations, the Secretary of Health or his duly authorized representatives shall
investigate the complaint or charge and verify if the laboratory concerned or any of its personnel
is guilty of the charges. If upon investigations, a person or persons are found violating the provision
of R.A. No. 4688 or any of these regulations, the Secretary of Health shall cancel or revoke for a
definite or indefinite period of time the license of the laboratory and the authority of the offending
person or persons, without prejudice to taking the case to judicial authorities for criminal action.

SEC. 23 VIOLATIONS
Any person who violated any provisions of these rules and regulations shall be punished with
imprisonment for not less than one month but not more than one year or a fine of not less than
one month but not more than one year or a fine of not less than one thousand pesos (P 1,000.00)
but not more than five thousand (P5,000.00) pesos, or both such fine and imprisonment at the
discretion of the court. Provided, however, that if the offender is a firm or corporation, the
managing head and/or owner thereof shall be liable to the penalty imposed herein.

SEC. 24 EFFECTIVITY
These rules and regulations shall take effect upon approval and publication as required.

IV. AO NO. 290 S. 1976

- Amended Subsection (a) of Sec. 11 of AO No. 201 s. 1973 that prescribes the requirements for
clinical laboratories.
 **In the employment of associate pathologists, pathology assistants, medical technologists,
medical laboratory technicians and laboratory aides, the head of the laboratory must observe
the following:
1. Any clinical laboratory whether attached or unattached to a hospital or clinic performing not
more than 800 examinations a month should have at least one medical technologist and for
every additional 800 or fraction thereof, another medical technologist should be hired.
2. In an automated laboratory the ration between the number of examinations performed per
month and the required number of medical technologist to be hired shall be determined on
a case to case basis by the Director of Bureau of Research and Laboratories.
3. All medical technologists and medical laboratory technicians hired in the laboratory should
be registered with the Board of Medical Technology and should perform only duties of the
position for which they are hired. A medical technologist hired as a medical technician must
perform the duties of said position only. A medical laboratory technician, may, however,
perform the laboratory examinations within the specified workload mentioned above
provided that he or she should be under the direct supervision of a medical technologist hired
as such, or a pathologist or physician-in-charge as authorized by the Department of Health.
4. A medical technologist can supervise the work of two medical laboratory technician at one
time.
5. In clinics, with in-patients and hospitals with less than 50 beds, the physician-in - charge of
the laboratory may assume the responsibilities for covering the night duty in the laboratory.
6. No medical laboratory technician may be assigned on duty at any time without a medical
technologist or physician- in-charge of the laboratory or pathologist to supervise the work
rendered.
A pathologist may be authorized to manage and supervise and/or be an associate pathologist
in not more than (3) clinical laboratories and/or blood banks contiguously located in the
particular area. In localities without qualified pathologist, a licensed physician is authorized
under Section 7 (b) may head only one (1) clinical laboratory.

V. AO NO. 59 S. 2001
- Implements provisions regarding the rules and regulations on the operation, maintenance
and establishment of clinical laboratories in the Philippines

SEC. 2 AUTHORITY
These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law
consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the
Department of Health. The Department of Health (DOH), through the Bureau of Health Facilities
and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions
under these rules and regulations.

SEC. 3 PURPOSE
These rules and regulations are promulgated to protect and promote the health of the people
by ensuring availability of clinical laboratories that are properly managed with adequate
resources, with effective and efficient performance through compliance with quality standards.

SEC. 4 SCOPE
1. These regulations shall apply to all entities performing the activities and functions of clinical
laboratories which shall include the examination and analysis of any or all samples of human
and other related tissues, fluids, secretions, radioactive, or other materials from the human
body for the determination of the existence of pathogenic organisms, pathologic processes
or conditions in the person from whom such samples are obtained.
2. These regulations do not include government laboratories doing laboratory examinations
limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening,
provided their services are declared as extension of a licensed government clinical
laboratory.

SEC. 5 CLASSIFICATION OF LABORATORIES

1) CLASSIFICATION BY FUNCTION
a) Clinical Pathology
b) Anatomic Pathology
2) CLASSIFICATION BY INSTITUTIONAL CHARACTER
a) Hospital-based laboratory
 b) Non-Hospital-based laboratory
3) CLASSIFICATION BY SERVICE CAPABILITY
a) Primary
b) Secondary
c) Tertiary

SEC. 6 POLICIES
1. An approved permit to construct and design lay-out of a clinical laboratory shall be secured
form the BHFS prior to submission of an application for a Petition to Operate.
2. No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the BHFS.
3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on
compliance with the minimum licensing requirements (Annex A).
4. The clinical laboratory shall be organized and managed to provide effective and efficient
laboratory services.
5. The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clientele.

SEC. 7 REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCTION

AND PERMIT TO OPERATE
1. Application for Permit to Construct
2. Application for New License
3. Application for Renewal of License
a) Renewal of License
Application for renewal of license shall be filed within 90 days before the expiry date of
the license
4. Permit and License Fees
5. Penalties
a) A penalty of one thousand pesos (P1,000.00) for late renewal shall be charged in addition
to the renewal fee for all categories if the application is filed during the next two (2)
months after expiry date.
b) An application received more than two (2) months after expiry date shall be fined one
hundred pesos (P100.00 for each month thereafter in addition to the P1,000.00 penalty.
6. Inspection
7. Monitoring
8. Issuance of License
9. Terms and Conditions of License
a. The license is granted upon compliance with the licensing requirements.
b. The license is non-transferable.
c. The owner or authorized representative of any clinical laboratory desiring to transfer a
licensed clinical laboratory to another location shall inform the CHD in writing at least 15
days before actual transfer.
d. The laboratory in its new location shall be subject to re-inspection and shall comply with
the licensing requirements.
e. An extension laboratory shall have a separate license.
f. Any change affecting the substantial conditions of the license to operate a laboratory
shall be reported within 15 days in writing by the person(s) concerned, to the BHFS/CHD
for notation and approval. Failure to do so will cause the revocation of the license of the
clinical laboratory.
g. The clinical laboratory license must be placed in a conspicuous location/area within the
laboratory.

SEC. 8 VIOLATIONS
1. The license to operate a clinical laboratory shall be suspended or revoked by the Secretary
of Health upon violation of R.A. 4688 or the Rules and Regulations issued in pursuance
thereto.
2. The following acts committed by the Owner, President, Managers, Board of
Trustees/Director, Pathologist or its personnel are considered violations.
a. Operation of a clinical laboratory without a certified pathologist or without a
registered medical technologist.
 b. Change of ownership, location, head of laboratory or personnel without informing
the BHFS and/or the CHD.
c. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by
the BHFS during reasonable hours.
d. Gross negligence.
e. Any act or omission detrimental to the public.
3. The Provincial, City and Municipal Health Officers are authorized to report to the CHD and
BHFS the existence of unlicensed clinical laboratories or any private party performing
laboratory examinations without proper license and/or violations to these rules and
regulations.

SEC. 9 INVESTIGATION OF CHARGES OR COMPLAINTS

1. The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and
verify if the laboratory concerned or any of its personnel is guilty of the charges.

If upon investigation, any person is found violating the provision of R.A. 4688, or any of these
rules and regulations, the BHFS/CHD or his duly authorized representative(s) shall suspend,
cancel or revoke for a determined period of time the license, as well as the authority of the
offending person(s), without prejudice to taking the case to judicial authority for criminal
action.

2. Any person who operated a clinical laboratory without the proper license from the
Department of Health shall upon conviction be subject to imprisonment for not less than 1
month but not more 1 year or a fine of not less than P1,000.00 and not more than P5,000.00
and not more than P5,000.00 or both at the discretion of the court. Provided, however, that
if the offender is a firm or corporation, the Managing Head and/or owner/s thereof shall be
liable to the penalty imposed herein.

3. Any Clinical Laboratory operating without a valid license or whose license has been
revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his duly
authorized representative. The BHFS/CHD may seek the assistance of the law enforcement
agency to enforce the closure of any clinical laboratory.

4. The closure order issued by the DOH shall not be rendered ineffective by any restraining
order and injunction order issued by any court, tribunal or agency or instrumentalities.

SEC. 10 MODIFICATION AND REVOCATION OF LICENSE

1. A license maybe revoked, suspended or modified in full or in part for any material false
statement by the applicant, or as shown by the record of inspection or for a violation of, or
failure to comply any of the terms and conditions and provisions of these rules and
regulations.
2. No license shall be modified, suspended or revoked unless prior notice has been made and
the corresponding investigation conducted except in cases of willful, or repeated violations
hereof, or where public health interest or safety requires otherwise.

VI. AO NO. 48 S. 2003 o

- Amended Sec. 5(2) of AO No. 59 s. 2001

CLASSIFICATION BY INSTITUTIONAL CHARACTER:

1) Institution-based laboratory
a laboratory that operates within the premises and operates as part of an institution
(e.g. hospital, multi-specialty clinics, schools, medical facilities for overseas workers
and seafarers).

2) Freestanding laboratory
a laboratory that operates outside the premises of an institution and operates
independently.

VII. ADMINISTRATIVE ORDER NO. 2007 - 0027

REVISED RULES AND REGULATION GOVERNING THE LICENSURE AND REGULATION OF
CLINICAL LABORATORIES IN THE PHILIPPINES
I. RATIONALE
- Physicians utilize laboratory work-ups in aid of diagnosis and management of patients.
- Accuracy of laboratory results is important in assuring and improving the quality of
patient care.
- Republic Act No. 4688 s. 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", mandated
the DOH to look after public welfare by effectively enforcing and updating the current
regulations to improve laboratory performance.
- Advances in technology necessitate the need to update the minimum standards and
technical requirements for clinical laboratories.
- AO No. 59 s. 2001 - no longer relevant in order to ensure the quality of services of clinical
laboratories nationwide.

II. OBJECTIVE
- To prescribe a revised minimum standard for clinical laboratories
- To ensure accuracy and precision of laboratory examinations in order to safeguard public
health and safety

III. SCOPE AND COVERAGE

- applies to all individuals, agencies, partnerships, or corporations that operate clinical
laboratories in the Philippines performing examination and analysis of samples of 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.
- Government clinical laboratories, doing microscopy work only for specific DOH programs
such as but not limited to malaria screening, acid fast bacilli microscopy, tests for sexually
transmitted infections, and cervical cancer screening using Pap smears, shall be
exempted from the provisions of this Order.

IV. DEFINITION OF TERMS

§ 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.

§ Critical Values- panic values originally described by Lundberg as "life-threatening" unless

something is done promptly and for which some corrective action could be undertaken.

§ EQAP (External Quality Assessment Program) - a program where participating

laboratories are given unknown samples 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
the pre -determined value or to the reference value generated by the participating
laboratories through peer group analysis.

§ STAT Tests- tests done on urgent cases, the results of which shall be released
immediately, within one (1) hour after the procedure. STAT is an abbreviation for sta'tim
which means immediately.

V. CLASSIFICATION OF CLINICAL LABORATORIES

a) Classification based on Ownership
b) Classification based on Function
c) Classification based on Institutional Character d) Classification based on Service Capacity

VI. GUIDELINES
A. GENERAL GUIDELINES
1. The LTO shall be issued only to clinical laboratories that comply with the standards and
technical requirements formulated by the BHFS.
2. Clinical laboratories that are operated and maintained exclusively for research and teaching
purposes shall be exempted from the licensing requirement of this Order but shall be
required to register with the BHFS.
3. Special clinical laboratories that are not subject to the provisions of other administrative
orders, such as but not limited to, Assisted Reproduction Technology Laboratories,
Molecular and Cellular Technology, Molecular Biology, Molecular Pathology, Forensic
Pathology, Anatomic Pathology laboratories operating independent of a clinical laboratory
are required to register with the BHFS without being licensed under the provisions of this
Order. Such procedure shall subsist until the appropriate regulation for such purpose is
subsequently promulgated. A pathologist or a licensed physician who is trained in the
management, principles and methodology of the specialized services that are being
provided shall head this type of laboratory.
4. The NRL designated by the DOH shall be covered by the license of the clinical laboratory of
the hospital where they are respectively assigned. The NRL that is physically independent
from the clinical laboratory of the hospital where they are respectively assigned shall be
allowed to register only with the BHFS, provided that, they are duly accredited or certified
by an international accrediting or certifying body, such as but not limited to, the Center for
Disease Control of the U.S.A. and the World Health Organization and/or local accrediting or
certifying body recognized by the DOH.

B. SPECIFIC GUIDELINES
I. Standards
Every clinical laboratory shall be organized to provide quality, effective and efficient
laboratory services.
(a) Human Resource
(b) Equipment
(c) Glassware, Reagents and Supplies
(d) Administrative Policies and Procedures
(e) Technical Procedures
(f) Quality Assurance Program
(g) Communication and Records
(h) Physical Facilities/Work Environment
(i) Referral of Examinations outside of the Clinical Laboratory
II. LTO (License to Operate)

VII. PROCEDURAL GUIDELINES

A. Registration for Special Clinical Laboratories, National Reference Laboratories, Research and
Teaching Laboratories
B. Procedures for Application for Initial/Renewal of LTO
C. Renewal of LTO
D. Inspection E. Monitoring

VIII. SCHEDULE OF FEES

A. A non-refundable fee shall be charged for the initial application /renewal of license to
operate a clinical laboratory, either government or private.
B. All fees/checks shall be paid to the order of DOH in person or through postal money order.
C. All fees, surcharges and discounts shall follow the current DOH prescribed schedule of fees.

IX. VIOLATIONS
Violation of Republic Act 4688 or these rules and regulations and/or commission of the following
acts by personnel operating the clinical laboratory under this authority shall be penalized.

X. INVESTIGATION OF COMPLAINTS
A. The BHFS or the CHD Director or his authorized representative(s) shall investigate the
complaint and verify if the laboratory concerned or any of its personnel is accountable for
an alleged violation.
B. The CHD Director or his authorized representative(s), after investigation, shall suspend,
cancel or revoke for a determined period of time the LTO of licensees who are found
violating the provision of R.A. 4688 or this Order, without prejudice to taking the case to
judicial authority for criminal action. The CHD shall seek the assistance of any law
enforcement agency to execute the closure of any erring clinical laboratory, when necessary.
 XI. PENALTY
Any person who operates a clinical laboratory without the proper license from the DOH shall
upon conviction be subject to imprisonment for not less than one (1) month or a fine of not less
than Php 1,000.00 and not more than Php 5,000.00 or both at the discretion of the court.
Provided, however, that if the offender is a firm or corporation, the managing head and/or
owner(s) thereof shall be liable to the penalty imposed herein.

XII. APPEAL
The decision of the BHFS/CHD may be appealed to the Office of the Health Secretary within ten
(10) days after receipt of the notice of the decision. Thereupon, the BHFS shall promptly certify
and file a copy of the decision, including all documents and transcripts of hearings on which the
decision is based, with the Office of the Health Secretary for review. The decision of the Office
of the Health Secretary is final and executory.

VIII. ADMINISTRATIVE ORDER NO. 2007 - 0027-A

AMENDMENT TO ADMINISTRATIVE ORDER NO. 2007 - 0027 "REVISED RULES AND REGULATIONS
GOVERNING THE LICENSURE AND REGULATION OF CLINICAL LABORATORIES IN THE
PHILIPPINES"

Section III of Administrative Order No. 2007 - 0027 "Revised Rules and Regulation Governing
Licensure and Regulation of Clinical Laboratories in the Philippines" is hereby amended to
exempt the NTRL and its regional TB Reference Laboratories performing TB culture from securing
a license to operate a clinical laboratory provided they adhere to program policies and
international standards and requirements as a National Reference Laboratory.

IX. DEPARTMENT MEMORANDUM NO. 2009 - 0086

IMPLEMENTATION OF EXTERNAL QUALITY ASSESSMENT PROGRAM AS A REGULATORY
REQUIREMENT FOR LICENSING OF CLINICAL LABORATORIES

Five institutions were designated as the National Reference laboratories namely:

1. Research Institute for Tropical Medicine
National Reference Laboratory for Dengue, Influenza, Tuberculosis and other Mycobacteria,
Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems,
Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases; NRL for
confirmatory testing of blood donors and blood units.

2. San Lazaro Hospital

National Reference Laboratory for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases

3. East Avenue Medical Center

National Reference Laboratory or Environmental and Occupational Health; Toxicology and
Micronutrient Assay.

4. National Kidney and Transplant Institute

National Reference Laboratory for Hematology including immunohematology (consistent
with previously issued D.O. 301-I series 1999)

5. Lung Center of the Philippines

National Reference Laboratory for Anatomic Pathology and Biochemistry

X. DEPARTMENT MEMORANDUM NO. 2009 - 0086-A

AMENDMENT TO DEPARTMENT MEMORANDUM NO. 2009 - 0086 ENTITLED,
"IMPLEMENTATION OF EXTERNAL QUALITY ASSESSMENT PROGRAM AS REGULATORY
REQUIREMENT FOR LICENSING OF CLINICAL LABORATORIES"

The following guidelines shall be enforced as requirement for renewal of license to operate (LTO)
of clinical laboratories nationwide:
Starting 2013, upon filing for renewal of License to Operate (LTO) for 2014 and thereafter, a
NEQAS Certificate of Participation/Proficiency Testing Certificate of the previous year or the
current year if available shall be included as documentary requirement in the following areas:
 a) Hematology for Primary, Secondary and Tertiary Clinical Laboratories issued by the
National Kidney and Transplant Institute.
b) Clinical Chemistry for Secondary and Tertiary Clinical Laboratories issued by the Lung
Center of the Philippines.
c) HIV/AIDS, hepatitis, Syphilis and other STIs for all HIV Accredited Testing Laboratories,
Secondary and Tertiary Clinical Laboratories performing the tests issued by STD - AIDS
Central Clinical Laboratory (SACCL), San Lazaro Hospital.
d) Drug and Drinking Water Testing Laboratories issued by East Avenue Medical Center.
e) Bacteriology, TB, and Parasitology for all Tertiary Clinical Laboratories issued by Research
Institute for Tropical Medicine (RITM). By 2014, the certificate of participation in
Antimicrobial Resistance Surveillance Program (ARSP) for PhilHealth accreditation shall not
be recognized as NEQAS for bacteriology component.

TEACHING AND TRAINING IN CLINICAL LABORATORIES

Any clinical laboratory (hospital-based, non-hospital based, or free-standing) should first be
recognized as a tertiary type before it can be considered an accredited training and teaching
laboratory. One a clinical laboratory becomes a tertiary type, it has to meet the requirements
prescribed by law.

XI. ADMINISTRATIVE ORDER NO. 274 SERIES OF 1976

RULES AND REGULATIONS GOVERNING AFFILIATION OF MEDICAL TECHNOLOGY SCHOOLS,
COLLEGES AND UNIVERSITIES IN GOVERNMENT HOSPITALS UNDER THE DEPARTMENT OF
HEALTH

Health laboratory services of the Department of Health have been established primarily to give
the adequate laboratory support to the clinicians in the diagnosis and therapy of patients and to
help detect pathologic changes prior to its manifest signs and symptoms. However, it has been
long been aware that while accomplishing this primary objective, it plays an important role in
the training of medical technology interns. A balance must be had at all times so that service and
training can go hand in hand effectively. In line thereof with the policies of fully maximizing the
effectivity of laboratory services, of upgrading the training of medical technology interns and of
properly utilizing the medical technology during training, the Department of Health promulgated
rules and regulations to be strictly observed and complied with in the affiliation of medical
technology interns in the Department of Health laboratories

I. RESPONSIBILITIES OF THE DEPARTMENT OF HEALTH LABORATORIES

1. The laboratory should be duly licensed as specified by the law on Clinical Laboratories, R.A.
4688
2. The position of medical technologist should be provided for each of the section of Clinical
Chemistry, Clinical Microscopy (Urinalysis and Parasitology), Microbiology (Bacteriology),
Hematology, Blood Banking and Serology and Histopathology
3. There should be an adequate laboratory space to accommodate both the staff and the
medical technology interns
4. There should be sufficient equipment and supplies necessary depending on the volume and
type of examinations as well as the number of interns to be trained by the laboratory
5. Each section of the laboratory can be utilized for training only if it can accommodate at least
two interns at any one time.
6. The laboratory should have a training program for medical technology interns.
7. The minimum number of examinations or samples of each section to accommodate interns
are as follows:
a) Clinical Chemistry - 3000 examinations/annum
b) Clinical Microscopy
1. Urinalysis - 1500 samples / annum
2. Parasitology (direct fecal smear and concentration test or Kato thick smear) - 1500
samples/annum
c) Microbiology
1. Gram Staining, Acid fast staining - 800 samples/annum
2. Isolation and identification of organisms - 1000 samples/annum
 d) Hematology
1. Peripheral blood study to include hemoglobin white cell count, Schilling hemogram
and red cell morphology or CBC - 1200 samples/annum
2. Sedimentation rate, platelet count, bleeding and clotting time, malarial smears and
other tests - 800 samples / annum
e) Blood Banking and Serology
1. Typing - 900 test/annum
2. Complete cross matching - 600 tests/annum
3. Serology
VDRL - 300 tests/annum
Widal test - 300 test/annum
f) Histopathology - 500 tissues/annum Cytology - 500 tissues/annum
For each additional intern, another half of the requirement shall be added.
8. At least one member of the professional staff of the laboratory to every group of interns not
exceeding ten (10) in each section should be provided.
9. The staff and personnel of the laboratory will be assisted by a laboratory instructor
experienced in actual laboratory work from the sending University or College to assist
especially to monitor individual attendance, behavior, performance or the students
including guidance in reading and application of the theoretical knowledge taken up in
school to actual practice.
10. No more than 10 medical technology interns shall be allowed to train during the night shift
in understaffed hospitals and so certified by the director of the same, such interns should
have a medical technologists to work with them. No intern is to be assigned without the
regular professional staff of the laboratory on duty at the same time.
11. The allotment derived from the intern's affiliation fee for the laboratory must be spend for
the laboratory needs utilized exclusively for training and not payment of furniture or
appliances of the laboratory.
12. The Director of the hospital is responsible for the admission of the number of interns
approved by the Committee. He should not enter into any contract of affiliation with any
College, university or school for medical technology if any of the conditions set forth in this
Administrative Order are not complied with.
13. Quarterly reports on the affiliation fees received showing the percentage of each category
or personnel and the budgetary outlay showing the proposed amount for each personnel
participating in the affiliation program must be submitted to the Secretary of Health thru
the Accreditation Committee together with the narrative report on the status and/or
problems of the Affiliation Program.

II. RESPONSIBILITIES OF THE AFFILIATING UNIVERSITIES/SCHOOLS/COLLEGES OF MEDICAL

TECHNOLOGY
All universities, schools, colleges or Medical Technology must have met the following
requirements before applying for affiliation to any clinical laboratory of the Department of
Health
1. Approval from the Department of Education and the Board of Medical Technology
2. Compliance with the provision of R.A. 5527 and Presidential Decree No. 498

III. JOINT RESPONSIBILITIES OF AFFILIATION UNIVERSITIES, SCHOOLS AND COLLEGES OF

MEDICAL TECHNOLOGY AND THE LABORATORIES
1. The training program shall be prepared by the Pathologist-in-charge of the laboratory in
coordination with the training officer of the hospital. Its implementation shall be the joint
responsibility of the Pathologist, staff and personnel of the laboratory and the laboratory
instructor of each university, school or college assigned to the laboratory for the duration of
the internship of their respective students
2. The internship schedule shall be properly apportioned to the different section of the
laboratory service as follows:
(a) Clinical Chemistry - 2.5 months
(b) Microbiology - 2.5 months
(c) Clinical Microscopy - 3 months
(d) Hematology - 2 months
(e) Blood Banking & Serology - 1 month
(f) Histopathology - 1 month
Under no circumstances is the duration of internship in any section be prolonged or shortened
 3. A monthly conference should be held to evaluate the implementation of the program and
institution of the program and institution of changes by the Pathologist, laboratory
instructor and staff of the laboratory and for problems that might arise during the
implementation.
4. Maintenance of cooperation and harmonious working relations at all times among the
students and staff of the hospital.

XII. ADMINISTRATIVE ORDER NO. 118 - B SERIES 1992

RULES AND REGULATIONS GOVERNING THE ACCREDITATION OF CLINICAL LABORATORIES FOR
TRAINING OF MEDICAL TECHNOLOGY INTERNS

Sec. 2 Authority
These rules and regulations are issued in accordance to Section 13 of Republic Act 5527 (Medical
Technology Act of 1969) and consistent with Executive Order 119 (Reorganization Act of the
Ministry of Health) and R.A. 4688 (Clinical Laboratory Law), R.A. 1517 (Blood Bank Law).

Sec. 3 Purpose
These rules and regulations are promulgated to upgrade the training of medical technology
interns to maintain the quality of laboratory services, and to properly utilize the medical
technology interns during their training. Only those laboratories which are accredited for training
shall be utilized for the affiliation of medical technology interns.

Sec. 4 Scope
The rules and regulations embodied herein shall apply to all clinical laboratories performing
examinations for the diagnosis of diseases or for public health purposes as defined in R.A. 4688
and utilized as training laboratories for medical technology interns from universities and colleges
offering medical technology courses.

Sec. 5 Regulatory Authority

The accreditation of training laboratories for medical technology interns under these rules and
regulations shall be exercised by the Department of Health, through the Bureau of Research and
Laboratories in the office for Standards and Regulation.

Sec. 6 Accreditation Requirements for a Training Laboratory for Medical Technology Interns
1. All clinical laboratories must be required to demonstrate compliance with the following
technical standards as requirements for accreditation.
a. The Clinical Laboratory shall be duly licensed by the Bureau of Research and
Laboratories (BRL).
b. The laboratory shall be headed by and under the supervision of a duly licensed physician
who is certified by the Philippine Board of Pathology.
c. The laboratory shall be staffed by at least one (1) medical technologist, duly registered
with the Board of Medical Technology for each of the sections of Clinical Chemistry,
Clinical Microscopy, Microbiology, Hematology, Blood Banking and Serology and
Histopathology
d. The physical plant shall have adequate laboratory space to accommodate both
laboratory staff and medical technology interns.
e. There should be sufficient equipment and supplies necessary depending on the volume
and type of examinations as well as the number of interns to be trained by the
laboratory.
f. A section of the laboratory can be utilized for training only if it has a sufficient volume
of laboratory examination adequate for training of at least one Medical Technology
Intern.
g. The laboratory should have a written training program for the Medical Technology
interns.
2. The BRL shall evaluate compliance to the technical standards in accordance with the
requirements including the minimum number of examination of samples required of each
section as the BRL may promulgate.

Sec. 7 Training Program

The training program for Medical Technology interns should include the following:
 1. The person responsible for the training program must be a duly licensed physician
certified by the Philippine Board of Pathology. He shall be assisted by a registered medical
technologist with previous experience in training medical technology interns.
2. The program shall provide for an objective measure or evaluation of the baseline skills
and knowledge prior to allowing or utilizing interns to handle actual specimens from
patients.
3. The program shall include the (1) objective of training, (2) laboratory methods or
procedures to be taught, (3) principles and clinical applications of the laboratory
procedures, (4) right work attitudes and ethical values, (5) required quota of tests to be
performed to develop accuracy and precision (6) objective evaluation of performance in
each section (7) time schedule (8) lecture seminars and conferences and (9) methodology
of training.
4. Not more than 20% of the number of Medical Technology interns but not to exceed (10)
interns shall be allowed to train during the night shift. Provided further that no intern
shall be allowed to train without a registered Medical Technologist on duty to supervise
them.
5. There should be at least one (1) registered Medical Technologist with adequate skills and
expertise in training for every group of interns not exceeding five (5) in each section.
6. The staff and personnel of the laboratory shall be assisted by a laboratory instructor who
must be a registered Medical Technologist from the sending university or school
especially tasked to monitor individual attendance, behavior and performance of
students.
7. A monthly conference by the Pathologist, laboratory staff and laboratory instructor of
the school shall be held to evaluate the implementation of the program, the problem that
have been encountered and changes that have been instituted.

Sec 8. Reporting
Each accredited clinical laboratories shall render an annual report of the number of Medical
Technology interns training, the number of examinations performed and other activities in
accordance with the format prescribed of the BRL.

Sec 9. Affiliation of Medical Technology Interns from Universities, Colleges and School of
Medical Technology
Accredited clinical laboratories shall be allowed to accept for affiliation Medical Technology
interns from universities, schools or colleges of Medical Technology who have met the
requirements specified in the Department of Health Administrative Order No. 70-A series 1989.

Sec. 10. Basic accreditation requirements

Any clinical laboratory desiring to train Medical Technology interns shall submit to BRL a sworn
petition/application on the prescribed form containing /attaching among others:
1. Name of establishment
2. Place, municipality and province where it is to be established
3. Name, citizenship and domicile of the head of the Clinical Laboratory 4. Name, citizenship
and domicile of owner
5. Copy of a valid permit to operate a clinical laboratory or blood bank from the Department
of Health
6. The training program for Medical Technology interns
7. Volume of examination performed in the previous year for each section

Sec. 11 Application for Accreditation

1. An application for accreditation shall be filed in a form "Application for Accreditation of
Laboratories for Training Medical Technology Interns" with the Office of the Bureau of
Research and Laboratories for screening and approval.
2. Each application shall be signed under oath or affirmation by the owner or a person duly
authorized to act for and of his behalf.
3. Within sixty (60) days after receipt of said application together with the accreditation fee,
an inspector from the Bureau of Research and Laboratories shall inspect the establishment
and verify if the applicant has complied with the requirements prescribed in these
regulations.
4. Any material false statement in the application or failure to comply with the requirements
may serve as basis of the Director of the Bureau of Research and Laboratories to refuse
recommending the issuance of a certificate of accreditation.

Sec. 12 Accreditation Fees

1. A non-refundable fee shall be charged for every application for accreditation for the training
of Medical Technology interns for government and private laboratories.
2. A non-refundable fee is charged on application of renewal of accreditation if filed at least
sixty (60) days before the accreditation expires.
3. All fees shall be payable to the Bureau of Research and Laboratories in accordance with the
following schedule:
For initial application 500
For renewal of accreditation 250
4. A penalty of P200.00 for late renewal shall be charged in addition to the renewal fee when
filed within ninety (90) days after expiration of accreditation
5. Ninety (90) days after expiration of accreditation, un-renewed certificates shall be
considered lapsed, and a new certificate shall be applied for (initial application).

Sec. 13 Inspection
Clinical Laboratory for training of Medical Technology intern's facilities and records shall be
subject to regular inspection to determine compliance with the above regulations.
1. The Director of Bureau of Research and Laboratories or his duly authorized representative(s)
shall be given reasonable time and opportunity to inspect the premises and facilities wherein
the training of Medical Technology interns is being performed.
2. Each laboratory shall make available to the Director of the Bureau of Research and
Laboratories or his duly authorized representative all records kept pursuant to these
regulations for inspection.
3. The Director of the Bureau of Research and Laboratories or his representative may be
assisted by duly designated experts from professional associations in such inspections.
4. Directors of Regional Health Offices, Provincial, City and Municipal Health Officers are
hereby directed to report to the Bureau of Research and Laboratories the existence of
unaccredited clinical laboratories training Medical Technology interns or any private party
performing such training without a proper accreditation certificate.

Sec. 14 Issuance and Exhibition of Certificate of Accreditation

1. The certificate shall be issued and signed by the Undersecretary of Health for Standards and
Regulation upon compliance with the requirements prescribed herein and provided the
corresponding fees are duly paid.
2. The accreditation certificate should be placed in a conspicuous place within the laboratory.
A copy of the rules and regulations shall be readily available for the guidance of the staff in
the laboratory.

Sec. 15 Terms and Conditions of Accreditation

1. The certificate as herein granted or any right under the certificate shall not be assigned or
otherwise transferred directly or indirectly to an unauthorized party.
2. The owner or manager of any clinical laboratory training Medical Technology interns desiring
to transfer to another place shall inform the Bureau of Research and Laboratories in writing,
stating the new place and site of establishment within fifteen (15) days after such transfer.
The new facilities shall be subject to re-inspection before it can resume operation.
3. Any laboratory desiring to cease training Medical Technology interns should notify the
Bureau of Research and Laboratories stating the said date of termination.
4. Any Pathologist who decides to terminate his services or transfer supervision should inform
the Bureau of Research and Laboratories within fifteen (15) days after such termination or
transfer.
5. Failure to report in writing within fifteen (15) days any change in conditions of Accreditation
will be cause for suspension or revocation of the certificate of accreditation of the
laboratory.

Sec. 16 Expiration of Accreditation Certificate

Each accreditation certificate shall expire two years after the date of approval which is indicated
in the upper right hand corner of the certificate.
Sec. 17 Renewal
Application for renewal of certificate shall be filed at least sixty (60) days before its expiration.
The Bureau of Research and Laboratories shall process applications for renewal immediately
upon receipt thereof subject to inspection upon the discretion of the Director; provided,
however, that such clinical laboratory may continue operation pending action on their
application, unless otherwise advised or ordered by the Director, of the Bureau of Research and
Laboratories or his duly authorized representative to cease operation.

Sec. 18 Publication of List of Accredited Laboratories

1. A list of laboratories and blood banks accredited for training Medical Technology interns under
these rules and regulations shall be published periodically and be made available to any person,
agency or organization for legitimate purposes.

Sec. 19 Modification and Revocation of Certificate

The terms and conditions of each certificate shall be subject to amendment or modification as
may be provided by any amendments to these regulations as the Secretary of Health may deem
necessary. Except in cases of willful or repeated violations hereof, or where public health interest
or safety requires otherwise, no certificate shall be modified, suspended or revoked unless prior
notice has been made and the corresponding investigation conducted.

Sec. 20 Violations
1. The certificate of accreditation of a laboratory to train Medical Technology interns shall be
suspended or revoked by the Undersecretary of Health for Standards and Regulation for any
violation of these Rules and Regulations, including the following acts:
a. Training Medical Technology interns without a qualified Pathologist or Medical
Technologist.
b. Any material false statement in the application.
c. Failure to correct deficiencies within a reasonable time after due notice from the Bureau
of Research and Laboratories.
d. Refusal to allow inspection of the laboratory by persons authorized by the Bureau of
Research and Laboratories during reasonable hours.
e. Repeated failure to submit an annual report to the Bureau of Research and Laboratories.
2. Any clinical laboratory that violates these rules and regulations shall be liable under the
Medical Technology Act (R.A. 5527) and Clinical Laboratory Law (R.A. 4688), and shall suffer
penalties provided for in these laws and the Revised Rules and Regulations issued pursuant to
such laws. Such violations shall be the basis for sanctions including suspension or revocation of
the license to operate the Clinical Laboratory.

Section 21
Upon the filing of a complaint or charge duly sworn to by any person or interested party against
a clinical laboratory or of any of its personnel for violating any provisions of this regulations, the
Undersecretary of Health for Standards and Regulation or his duly authorized representative(s)
shall investigate the complaint or charges and verify if the laboratory concerned or any of its
personnel is guilty of the charges. If upon investigation, a person or persons are found violating
any of the provision of this rules and regulations, the Undersecretary of Health for Standards and
Regulations shall suspend for a definite or indefinite period of time or cancel or revoke the
accreditation of the laboratory without prejudice to taking the case to judicial authorities for
criminal action.
CASE

G.R. NO. 168512

MARCH 20, 2007

ORLANDO D. GARCIA, JR., doing business under the name and style COMMUNITY
DIAGNOSTIC CENTER and BU CASTRO
vs.
RANIDA D. SALVADOR and RAMON SALVADOR

FACTS

Respondent, Ranida D. Salvador, started working as a trainee in the Accounting Department of

Limay Bulk Handling Terminal, Inc. As a prerequisite for regular employment, she underwent a
medical examination at the Community Diagnostic Center (CDC). Garcia who is a medical
technologist, conducted the HBs Ag (Hepatitis B Surface Antigen) test and issued the test result
indicating that Ranida was "HBs Ag: Reactive." The result bore the name and signature of Garcia
as examiner and the rubber stamp signature of Castro as pathologist.

When Ranida submitted the test result to Dr. Sto. Domingo, the Company physician, the latter
apprised her that the findings indicated that she is suffering from Hepatitis B, a liver disease.
Thus, based on the medical report submitted by Sto. Domingo, the Company terminated Ranida's
employment for failing the physical examination.

When Ranida informed her father, Ramon, about her ailment, the latter suffered a heart attack
and was confined at the Bataan Doctors Hospital. During Ramon's confinement, Ranida
underwent another HBs Ag test at the said hospital and the result indicated that she is non-
reactive. She informed Sto. Domingo of this development but was told that the test conducted
by CDC was more reliable because it used the Micro-Elisa Method.

Thus, Ranida went back to CDC for confirmatory testing, and this time, the Anti-HBs test
conducted on her indicated a "Negative" result. Ranida also underwent another HBs Ag test at
the Bataan Doctors Hospital using the Micro-Elisa Method. The result indicated that she was non-
reactive.

Ranida submitted the test results from Bataan Doctors Hospital and CDC to the Executive Officer
of the Company who requested her to undergo another similar test before her re-employment
would be considered. Thus, CDC conducted another HBs Ag test on Ranida which indicated a
"Negative" result. Ma. Ruby G. Calderon, Med-Tech Officer-in-Charge of CDC, issued a
Certification correcting the initial result and explaining that the examining medical technologist
(Garcia) interpreted the delayed reaction as positive or reactive. Thereafter, the Company
rehired Ranida.

Ranida and Ramon filed a complaint for damages against petitioner Garcia and a purportedly
unknown pathologist of CDC, claiming that, by reason of the erroneous interpretation of the
results of Ranida's examination, she lost her job and suffered serious mental anxiety, trauma and
sleepless nights, while Ramon was hospitalized and lost business opportunities.

Garcia denied the allegations of gross negligence and incompetence and reiterated the scientific
explanation for the "false positive" result of the first HBs Ag test. On the other hand, Castro
claimed that as pathologist, he rarely went to CDC and only when a case was referred to him;
that he did not examine Ranida; and that the test results bore only his rubber-stamp signature.

ISSUE

Whether or not Garcia should be held liable liable for damages to the respondents for issuing an
incorrect HBsAG test result.
RULING

YES. Owners and operators of clinical laboratories have the duty to comply with statutes, as well
as rules and regulations, purposely promulgated to protect and promote the health of the people
by preventing the operation of substandard, improperly managed and inadequately supported
clinical laboratories and by improving the quality of performance of clinical laboratory
examinations. Their business is impressed with public interest, as such, high standards of
performance are expected from them.

In fine, violation of a statutory duty is negligence. Where the law imposes upon a person the
duty to do something, his omission or non-performance will render him liable to whoever may
be injured thereby.

A clinical laboratory must be administered, directed and supervised by a licensed physician

authorized by the Secretary of Health, like a pathologist who is specially trained in methods of
laboratory medicine; that the medical technologist must be under the supervision of the
pathologist or a licensed physician; and that the results of any examination may be released only
to the requesting physician or his authorized representative upon the direction of the laboratory
pathologist. These rules are intended for the protection of the public by preventing performance
of substandard clinical examinations by laboratories whose personnel are not properly
supervised. The public demands no less than an effective and efficient performance of clinical
laboratory examinations through compliance with the quality standards set by laws and
regulations.

The Supreme Court ruled that petitioner Garcia failed to comply with these standards. First, CDC
is not administered, directed and supervised by a licensed physician as required by law, but by
Ma. Ruby C. Calderon, a licensed Medical Technologist. Second, Garcia conducted the HBsAG
test of respondent Ranida without the supervision of defendant-appellee Castro. Last, the
disputed HBsAG test result was released to respondent Ranida without the authorization of
defendant-appellee Castro.