THE CLINICAL LABORATORY LAWS

ATTY. REY CRIS A. PANUGALING, MSPHA-HA, CHA

Lecturer

Content
DAY 1: BACKGROUND
1. REPUBLIC ACT 4688 s. 1966
2. ADMINISTRATIVE ORDER 201 s. 1973
3. ADMINISTRATIVE ORDER 2007 – 0027 s. 1994

DAY 2: developments
1. Pertinent laws and issuances
2. Changing Department of health landscape
3. Legal issues and concerns
4. Jurisprudence

REPUBLIC ACT NO. 4688

AN ACT REQUIRING 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.

SECTION 1
Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues,
secretions, excretions and radioactivity from human 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 the gov’t hospital laboratories are doing routine of minimum laboratory examinations shall be
excepted from the provisions of this section if their services are extensions of government regional or central
laboratories.

SECTION 2
It shall be unlawful to any person to be professionally in-charge of a registered clinical laboratory unless he is a
license 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 and supervision of an authorized
physician

SECTION 3
The Secretary of Health through the BRL 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 maybe necessary to carry
out its provisions.

SECTION 4
Any person, firm or corporation who violates any provision of this Act of 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 1 year, or by a fine not less than one thousand pesos nor more than five thousand pesos, or
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 fifty thousand pesos, or so much thereof as maybe necessary, is hereby authorized by the
appropriated, out of many funds in the National Treasury not otherwise appropriated, to carry into effect the
provisions of this act.

SECTION 7
All Acts or parts of this Acts which are inconsistent with the provisions of this Act are hereby repealed.

SECTION 8
This Act shall take effect upon its approval.
Approved: June 18, 1966.

ADMINISTRATIVE ORDER 201 S. 1973

REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION, OPERATION AND MAINTENANCE OF
CLINICAL LABORATORIES IN THE PHILIPPINES

SECTION 1. Purpose and Title

The rules and regulations published and enforced pursuant to Section 3 of RA 4688 approved on June 18,
1966 are hereby revised and shall be known as “REVISED RULES AND REGULATIONS GOVERNING THE
REGISTRATION, OPERATION AND MAINTENANCE OF CLINICAL LABORATORIES IN THE PHILIPPINES” and
promulgated for the purpose of preventing the operation and maintenance of substandard, improperly
managed and poorly equipped laboratories.

SECTION 2. Scope
The regulations embodied herein apply to any person, firm or corporation, operating and maintaining clinical
laboratories in which any or all of the following: body fluids, tissues, secretions, excretions, and radioactivity
from human beings are analyzed for the determination of pathogenic organisms, pathologic processes and/or
conditions of the person from which they are obtained, provided that government hospital laboratories doing
routine or minimum laboratory examinations are exempt if their services are declared as extensions of
government or regional or central laboratories being used solely for academic training and/or purely research
activities likewise not herein covered.

SECTION 3. Basic 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:

SECTION 3. Basic Requirements

- Name, Citizenship and domicile of the head of the laboratory
- The place, municipality and province where it is to be established
- Name of the establishment
- Name, citizenship and domicile of the owner
- Scope and nature of work to be undertaken
- Statement that applicant has complied with all business requirements under existing laws
- Tax clearance for the preceding year
SECTION 4. License Fees
A fee of Php 100.00 shall be charged for every license issued to operate a clinical laboratory, payable to BRL.
The license is subject to renewal within last (2) months of each year upon payment of a renewal fee of fifty
(50.00) pesos. A grace period of (2) months is allowed for renewal subject to a fine of (10.00). Thereafter the
license will be considered to have a lapsed and new license shall be applied for. All government laboratories
are exempted from paying these fees.

SECTION 5
No clinical laboratory is allowed to operate without the proper license from the Secretary of Health, thru the
BRL who are charged with the responsibility of strictly enforcing the provisions of RA 4688 and the rules and
regulations herein promulgated.

SECTION 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 stipulated in section 7 (b), and duly authorized by the Secretary of Health, such
authorization to be renewed annually. The authorization shall be exempted from any fees.

SECTION 7. Definition of Terms

A. CLINICAL LABORATORIES
 Clinical Pathology – CLINICAL CHEMISTRY, Hematology, Microbiology, CLINICAL MICROSCOPY,
serology, Immunohematology, Blood Banking, radioisotope laboratory, and laboratory endocrinology
 Anatomical Pathology – surgical pathology, cytology and post-mortem examination
 Forensic Pathology – medico-legal examinations

SECTION 7. Definition of Terms

B. HEAD, “CHIEF”, DIRECTOR or “IN-CHARGE”
Duly registered physician qualified in laboratory medicine, and having been certified by Philippine Board of
Pathology either Anatomical or Clinical or both.

SECTION 7. Definition of Terms

C. PERSONNEL
1. Associate Pathologist . Licensed physician certified by the Philippine Board of Pathology either anatomical,
clinical or both who is under the direct supervision of the Head of a clinical laboratory.
2. Pathology Assistant . duly licensed physician and registered by the Philippine Medical Board of Examiners,
with at least 1 year training in laboratory medicine, who shall under the direct supervision of the head or
associate pathologist
3. Medical Technologist. must be a licensed MT duly registered by the Board who shall be directly under the
supervision of a registered pathologist, or a licensed physician authorized by the Secretary of Health.
4. Laboratory Technicians. must have completed at least 2 years of college work with at least 12 units of
laboratory subjects, and one year training in an accredited laboratory; or without college work but at least 10
years training and experience in a duly approved clinical laboratory. LabTech shall be under the supervision of
RMT and Pathologist.
5. Laboratory aides. should be at least high school graduates and who shall assist the medical technologists or
laboratory technicians but whose activities should be limited to non-technician procedures.
Except as specifically authorized by The Secretary of Health in writing, interpretations of the meaning of the
regulations or its part by any office 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.
Application for license shall be filed by the owner or his duly authorized representatives in a form “PETITION
TO ESTABLISH, OPERATE AND MAINTAIN CLINICAL LABORATORY” together with the “INFORMATION SHEET”
to be filled by the physician in-charge, prepared for the purpose, with the BRL for the necessary screening and
approval. Each petition shall be signed by the applicant or a person duly authorized to act for and in his behalf.
Neither the license shall be assigned or otherwise transferred to an unauthorized party in violation of the
provisions of these regulations.

Any owner, administrator or manager of the clinical lab desiring to transfer the physical location of his
registered clinical lab to another should inform in writing the BRL 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 shall likewise be reported within 15 days in writing by the persons
concerned in BRL for notation and approval.

Failure to do so will automatically revoke the license of the laboratory

A. PERSONNEL
 1 RMT per 800 examinations per month
 In automated laboratory, the ratio will be determined by the director of BRL
 All MT and Labtech should be registered by the Board and should only perform duties of the position
for which they are hired
 1 RMT can supervise 2 lab technicians at one time
 In clinics and hospitals with less than 50 beds, the physician in charge may assume the responsibilities
covering the night duty of the laboratory
 No lab technician maybe assigned on duty at anytime without a MT or physician in-charge of the
laboratory

A pathologist maybe required to manage and supervise and/or be an associate pathologist in not more
than 4 clinical laboratories and/or blood banks continuously located in the particular area.

B. PHYSICAL PLANT
1. A clinical lab should be situated in a place separate from any commercial or non-medical establishment or
residential quarters. It should be housed in a permanent building constructed of strong materials, preferably
concrete or semi-concrete, tiled or linoleum finish.
2. The working space of the clinical lab of a hospital must correlate with the bed capacity and type of hospital
it serves as well as the services it offers to support the needs of the medical care of the confined and
outpatients of the hospital.
3. Adequate physical provisions; for the safety of the personnel must be provided for especially considering
exposure to contamination to infectious materials and obnoxious gases as well as dangers due to inflammable
reagents and fires or radioisotope substances.
4. If needed, provisions must be made for sleeping quarters separate from the laboratory area.
5. Laboratory space cannot be utilized as bleeding area or reception room for a blood bank.

C. MINIMUM EQUIPMENT REQUIREMENT

1. Basic equipment
a. for CLINICAL laboratories doing routine examinations of stool, urine, blood, sputum, and other body fluids,
blood grouping and matching:
  Microscope
 Urinalysis set
 Centrifuge
 Burner
 Hemocytometer
 Stop watch
 Hemoglobinometer
 Glasswares and other reagents

b. If chemistry examination is done:

 Spectrophotometer
 Water bath
 Sterilizer
 Small drying oven
 Refrigerator
 Interval timer
 Balances (analytical and rough)
 Glasswares, reagents and standards

c. If bacteriological examinations are done:

 Autoclave
 Incubator
 Hot air oven
 Centrifuge
 Microscope
 Waterbath
 Burner
 pH meter of color comparator
 Balance
 Glasswares

d. IF serological examinations are done:

 Waterbath
 Refrigerator
 Sterilizer
 Centrifuge
 Interval timer
 VDRL rotator
 Other supplies required

e. If pathological examinations are done:

 Microtome set
 Microscope
 Paraffin oven
 Staining dishes
 Waterbath
 Interval timer
 Supplies including glasswares, reagents and stains
EQUIPMENT SHOULD BE ADEQUATE TO PERFORM:
1. Routine tests including U/A, CBC, S/E, BT and matching
2. Routine blood chemistry which includes sugar, NPN, creatinine, BUN, uric acid, cholesterol, bilirubin, serum
protein (quanti) and special hematology
3. Special biochemistry and serology which include electrolytes, steroids, hormones, widal, VDRL
4. Mycology which includes smear and cultures from clinical materials for isolation and identification of
pathogenic fungi.
5. Parasitology which includes protozoal and zoological diagnosis – detection and determination of different
species, genus, family and habitat of parasites.
6. Anatomic pathology which includes gross and microscopic examination of pathologic specimens and
necropsies; preparation of paraffin and frozen sections and pathological specimens and cytology.
7. Radioisotope examinations including determination or RIA and other isotope compounds, tracing and
scanning of body organs, etc.

All laboratory requests shall be considered as consultation between the requesting physician and the
pathologist in 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 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 maybe released as authorized by the
pathologist.

Provisions for filing, storage, indexing, cross 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 in the patient’s medical records.

Records of anatomic and forensic pathology should be kept permanently in the laboratory.

The rate of laboratory fees to be charged by the clinical laboratory for examination shall be within the range
of usual fees prevailing at the time and particular place taking into consideration cost 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.

Publicity of approved laboratory should be within moral, ethical and professional concepts of acceptable
medical practice.

Only the name of the laboratory, address, telephone number of the laboratory, pathologist and pathology
assistants and field of work covered by the licensure shall appear on the letterhead and other information
media.

The license of the 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.
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 laboratory

Application for the renewal of license shall be filed in accordance with the preceding Section 3 and 4. The BRL
shall process applications for license renewal immediately upon receipt thereof, provided however such
clinical laboratories may continue operation during the pendency of the final action on their applications,
unless otherwise advised or ordered by the Secretary of Health to cease operation. Periodical inspection by
the Secretary of Health or his representative.
1. Each licensee shall give the Secretary of Health or his duly authorized representative/s the opportunity at all
reasonable time to inspect the premises and facilities of the clinical laboratory.
2. Each licensee shall make available all records kept by him pursuant to these regulations for inspection by
the Secretary of Health or his authorized representative/s.
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 BRL
The director of BRL or his representative is hereby authorized to conduct such quality control tests as he
deems appropriate or necessary for the administration of these regulations and for the control of the
operation.

License maybe revoked, suspended or modified in full or in part for any material false statement in the
application as revealed by the 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 a
violation of, or failure to observe any of the terms and provisions of these regulations.

The Secretary of Health or his duly authorized representative shall investigate the complaint or charge and
verify if the laboratory concerned or any of its personnel is guilty judicial authorities for criminal action.

Any person who violates the provisions of these rules and regulations shall be punished with an imprisonment
from not less than 1 month but not more than 1 year or a fine of not less than Php 1,000.00 or not more than
Php 5,000.00 or both shall fine an imprisonment 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.

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

ADMINISTRATIVE ORDER No. 2007 - 0027

REVISED RULES AND REGULATIONS GOVERNING THE LICENSURE AND REGULATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES

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 a public health and safety.
Shall apply to all individuals, agencies, partnerships and 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 public
health.
Applicant - a person who intends to operate a clinical lab
BHFS – Bureau of Health Facilities and Services
CHD – Center for Health and Development
Clinical Laboratory – a facility where the tests are done
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
DOH – Department of Health
EQAP – External Quality Assessment Team
Inspection Tool – checklist used by the regulatory officers during inspection
Institution – a corporate body or establishment organized for an educational, medical, charitable, or similar
purpose
License – document issued by the DOH upon compliance of clinical laboratory the requirement set forth in this
order.
Licensee – individual, agency, partnership or corporation to whom the license is issued
LTO – License to Operate
Mobile Clinical Laboratory – lab testing unit that moves from testing site to another testing site
Monitoring Examinations – test done in series to guide for treatment of follow-up conditions of patients
NRL – National Reference Laboratory (confirmatory)
POL – Physician’s Office Laboratory
POCT – Point of Care Testing
Routine Tests – basic, commonly requested tests in the laboratory
Satellite Testing Site – lab outside the testing site
STAT tests – tests done on urgent cases; abbreviation for “sta’tim” which means immediately

CLASSIFICATION
OF CLINICAL LABORATORIES
CLASSIFICATION OF CLINICAL LABORATORIES
1. Ownership
2. Function
3. Institutional Character
4. Service Capability

1. OWNERSHIP
Government. Operated and maintained partially or wholly by government
Private. Owned, established and operated by any individual, corporation, association or organization

2. FUNCTION
Clinical Pathology. cc, hema, immunohema, micro, immuno, cm, entoxi, molecular biology, cytogen, tdm, etc
Anatomic Pathology. surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology and
molecular pathology

3. INSTITUTIONAL CHARACTER
Institution Based. 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 workers and seafarers, birthing home,
psychiatric facility, drug rehabilitation center.
Freestanding. Laboratory that does not form part of any other institution.

4. SERVICE CAPABILITY
Primary category. Routine hematology, qualitative platelet determination, R/U, S/E, BT for hospital-based
Secondary Category. primary category + routine clinical chem, crossmatching, G/S, KOH for hospital based
Tertiary category. primary + secondary + special chemistry, special hema, immunology, Microbiology C/S

WHO CLASSIFICATION
Biosafety level 1. Risk group 1
Biosafety level 2. Risk group 2
Biosafety level 3. Risk group 3
Biosafety level 4. Risk group 4

ADMINISTRATIVE ORDER NO. 290, S. 1976

- AMENDED SUBSECTION (A) OF SECTION 11 OF AO 201. S. 1973 THAT PRESCRIBES THE REQUIREMENTS
FOR CLINICAL LABORATORIES.
- PATHOLOGIST: NOT MORE THAN 3 CLINICAL LABORATORIES
- LOCALITIES WITHOUT QUALIFIED PATHOLOGISTS: A QUALIFIED PHYSICIAN UNDER 7(B) MAY HEAD
ONLY 1 CLINICAL LABORATORY
-
ADMINISTRATIVE ORDER NO. 59, S. 2001
- Redirecting the functions and operations of the department of health.
- The DOH through the BUREAU OF HEALTH FACILITIES AND SERVICES (BHFS) in the health regulation
cluster shall exercise the regulatory functions under the rules and regulations issued to implement RA
4688.
-
ADMINISTRATIVE ORDER NO. 48, S. 2003
- THIRD CLASSIFICATION OF LABORATORIES (INSTITUTIONAL CHARACTER)
- HOSPITAL AND NON-HOSPITAL-BASED CLINICAL LABORATORIES BELONG TO THIS CLASSIFICATION
- DIFFERENTIATES INSTITUTIONAL CHARACTER LABORATORIES: INSTITUTION-BASED AND FREE
STANDING LABORATORIES

ADMINISTRATIVE ORDER NO. 2007-0027-A

- AMENDED AO 2007-0027 (THE LICENSURE AND REGULATION OF CLINICAL LABORATORIES IN THE
PHILIPPINES)
- EXEMPTED THE NATIONAL TUBERCULOSIS REFERENCE LABORATORIES (NTRL) AND REGIONAL TB
REFERENCE LABORATORIES PERFORMING TB CULTURE FROM SECURING A LICENSE, PROVIDED THAT
THEY ADHERED TO THE PROGRAM, POLICIES, AND INTERNATIONAL STANDARDS AND REQUIREMENTS
OF THE NATIONAL REFERENCE LABORATORIES.

DEPARTMENT MEMORANDUM ORDER NO. 2009 - 0086

- IMPLEMENTATION OF INTERNAL AND EXTERNAL QUALITY CONTROL PROGRAMS AS THE
REQUIREMENTS FOR LICENSING OF CLINICAL LABORATORIES IN WHICH A CLINICAL LABORATORY IS
REQUIRED TO HAVE A QUALITY ASSURANCE PROGRAM.
- INTERNAL QUALITY CONTROL – INPUTS, PROCESSES, AND OUTPUTS, INCLUDING CQI
- EXTERNAL QUALITY ASSESSMENT PROGRAM (EQAP) REQUIRES A CLINICAL LABORATORY TO
PARTICIPATE IN THE NATIONAL EXTERNAL ASSESSMENT PROGRAM (NEAP)

DEPARTMENT MEMORANDUM ORDER NO. 393, S. 2000

DESIGNATED NATIONAL REFERENCE LABORATORIES:
1. RESEARCH INSTITUTE OF TROPICAL MEDICINE (RITM) – DENGUE, INFLUENZA, TB, AND OTHER
MYCOBACTERIA, MALARIA, AND OTHER PARASITES, ANTIMICROBIAL RESISTANCE, AND EMERGING DISEASES
AND NRL FOR CONFIRMATORY TESTING OF BLOOD UNITS
2. SAN LAZARO HOSPITAL – HIV/AIDS, HEPATITIS, SYPHILIS, AND OTHER STI
3. EAST AVENUE MEDICAL CENTER – ENVIRONMENTAL AND OCCUPATIONAL HEALTH, TOXICOLOGY,
MICRONUTRIENT
4. NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI) – HEMATOLOGY, IMMUNOHEMATOLOGY,
IMMUNOPATHOLOGY, AND ANATOMIC PATHOLOGY
5. LUNG CENTER OF THE PHILIPPINES - BIOCHEMISTRY
DEPARTMENT MEMORANDUM ORDER NO. 2009-0086-A
- REQUIRES CLINICAL LABORATORY TO PARTICIPATE IN THE NATIONAL EXTERNAL QUALITY
ASSESSMENT SCHEME (NEQAS)
- NEQAS CERTIFICATE OF PARTICIPATION PROFICIENCY TESTING IS INCLUDED AS REQUIREMENT FOR
LICENSE TO OPERATE IN 2014

TERTIARY TYPE BEFORE CLINICAL LABORATORY BE CONSIDERED AN ACCREDITED TRAINING AND TEACHING
LABORATORY
- ADMINISTRATIVE ORDER NO. 274, S. 1976: UNIVERSITIES AND COLLEGES OFFERING THE SAME
PROGRAM MAY AFFILIATE WITH DESIGNATED LABORATORIES FOR THE PURPOSE OF TEACHING AND
TRAINING MEDICAL TECHNOLOGY INTERNS; SOLE AND JOINT RESPONSIBILITIES OF HOSPITAL-BASED
LABORATORIES AND THE AFFILIATING UNIVERSITIES AND COLLEGES OFFERING THE SAME PROGRAM.

- ADMINISTRATIVE ORDER NO. 118-B, S. 1992: PRESCRIBED THE RULES AND REGULATIONS ON THE
ACCREDITATION OF CLINICAL LABORATORIES AS TEACHING AND TRAINING GROUNDS;
ACCREDITATION REQUIREMENTS, PRESCRIBED TRAINING PROGRAMS FOR UNIV. AND COLLEGES
OFFERING BSMT.

- CHED MEMORANDUM ORDER NO. M6, 2008: TRANSFERRING THE ACCREDITATION PROGRAM OF
TEACHING AND TRAINING CLINICAL LABORATORIES FROM THE DEPARTMENT OF HEALTH TO THE
COMMISSION ON HIGHER EDUCATION.

CASE LAW: GARCIA VS. SALVADOR, GR NO. 168512, MARCH 20, 2007

FACTS:
RANIDA SALVADOR STARTED WORKING AS A TRAINEE IN LBHT. SHE UNDERWENT A MEDICAL EXAM AT CDC
WITH GARCIA (MEDTECH) CONDUCTING THE HBS AG TEST. HER RESULT WAS REACTIVE. THE COMPANY
PHYSICIAN (STO. DOMINGO) TOLD HER SHE IS SUFFERING FROM HEPAB, AND BASED ON THE MEDICAL
REPORT SD SUBMITTED, LBHT TERMINATED HER EMPLOYMENT. RANIDA TOLD HER FATHER RAMON ABOUT
HER CONDITION, THEN THE LATTER SUFFERED A HEART ATTACK AND WAS CONFINED AT BATAAN DOCTORS
HOSPITAL. RANIDA TOOK ANOTHER HBS AG TEST IN BDH, AND THE RESULT WAS NON-REACTIVE. SHE TOLD
DR. SD ABOUT IT BUT THE LATTER SAID THE CDC TEST WAS MORE RELIABLE, SO SHE TOOK ANOTHER TEST AT
CDC AGAIN, AND THE RESULT THIS TIME WAS NON-REACTIVE. SHE TOOK THE SAME TEST USED IN CDC AT
BDH AND THE RESULT WAS NON-REACTIVE. SHE SUBMITTED THE RESULTS TO THE LBHT EXECOM WHO
REQUESTED HER TO UNDERGO UNDER TEST - RESULT IS NEGATIVE, SO LBHT REHIRED HER.

A COMPLAINT FOR DAMAGES AGAINST MEDTECH GARCIA AND PATHOLOGIST CASTRO, CLAIMING THAT THE
ERRONEOUS INTERPRETATION LED HER TO LOSE HER JOB, SUFFER MENTAL ANXIETY, WHILE RAMON WAS
HOSPITALIZED AND LOST BUSINESS OPPORTUNITIES. GARCIA DENIED THE ALLEGATIONS OF GROSS
NEGLIGENCE AND INCOMPETENCE; EXPLAINED "FALSE POSITIVE." CASTRO SAID HE DID NOT EXAMINE
RANIDA, AND THAT THE RESULTS BORE ONLY HIS STAMPED SIGNATURE.
RTC DISMISSED THE SALVADOR’S COMPLAINT FOR FAILURE TO PRESENT SUFFICIENT EVIDENCE. CA REVERSED
THIS AND ORDERED GARCIA TO PAY MORAL DAMAGES (50K), EXEMPLARY DAMAGES (50K), AND ATTY'S
FEES (25K). CASTRO WAS EXONERATED.

ISSUE: WHETHER OR NOT (WON)CA CORRECTLY FOUND GARCIA LIABLE FOR DAMAGES.

RULING:
1. NEGLIGENCE - FAILURE TO OBSERVE FOR THE PROTECTION OF ANOTHER'S INTEREST THAT DEGREE OF
CARE, PRECAUTION AND VIGILANCE.
A. ALL ELEMENTS OF AN ACTIONABLE CONDUCT ARE PRESENT IN THIS CASE
DUTY
BREACH
INJURY
PROXIMATE CAUSATION

2. NEGLIGENCE IS A VIOLATION OF STATUTORY DUTY

A. CDC IS NOT ADMINISTERED, DIRECTED, SUPERVISED BY LICENSED PHYSICIAN BUT BY A LICENSED MEDTECH
B. CASTRO'S INFREQUENT VISIT BARELY QUALIFIES AS AN ADMIN SUPERVISION AND CONTROL
C. GARCIA CONDUCTED HBS AG TEST OF RANIDA WITHOUT CASTRO'S SUPERVISION
D. HBS AG TEST RESULT RELEASED TO RANIDA WITHOUT CASTRO'S AUTHORIZATION

3. GARCIA'S FAILURE TO COMPLY WITH LAWS, RULES PROMULGATED FOR THE PROTECTION OF PUBLIC
SAFETY AND INTEREST IS FAILURE TO OBSERVE THE CARE WHICH A REASONABLY PRUDENT HEALTH CARE
PROVIDER WOULD OBSERVE - BREACH OF DUTY.
4. INJURIES SUFFERED BY RANIDA COULD HAVE BEEN AVOIDED HAD PROPER SAFEGUARDS BEEN FOLLOWED
5. NCC 20 IS THE LEGAL BASIS FOR AWARD OF DAMAGES TO ONE WHO SUFFERS WHENEVER ANOTHER
COMMITS AN ACT IN VIOLATION OF SOME LEGAL PROVISION

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.

GARCIA MAY NOT HAVE INTENDED TO CAUSE THE CONSEQUENCES WHICH FOLLOWED AFTER THE RELEASE OF
THE HBSAG TEST RESULT. HOWEVER, HIS FAILURE TO COMPLY WITH THE LAWS AND RULES PROMULGATED
AND ISSUED FOR THE PROTECTION OF PUBLIC SAFETY AND INTEREST IS FAILURE TO OBSERVE THAT CARE
WHICH A REASONABLY PRUDENT HEALTH CARE PROVIDER WOULD OBSERVE. THUS, HIS ACT OR OMISSION
CONSTITUTES A BREACH OF DUTY.

DAMAGES, FEES UPHELD. GARCIA GUILTY OF GROSS NEGLIGENCE.

CASE LAW: GARCIA VS. SALVADOR, GR NO. 168512, MARCH 20, 2007

DOCTRINE:
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.