THE CLINICAL LABORATORY LAW OF 1966

1958

BRL (Bureau of Research and Laboratories) was created

June 18, 1966

RA 4688 was enacted

1971

Licensure Section was created within the BRL

1986 E.O. 119 s. 1986

Reorganizing the Ministry of Health, its attached Agencies and for Other Purposes”, regulatory functions were performed by BRL

1999 E.O 102 s. 1999

Redirecting the Functions and Operations of the DOH”

2001

BRL was renamed to BHFS (Bureau of Health Facilities and Services)

2014

BHFS was changed to HFSRB (Health Facilities and Services Regulatory Bureau)

R.A. NO. 4688?

It is the law regulating the opeartion and maintenance of clinical laboratories in the Philippines and requiring the registrationofthesamewithDOH,throughtheHFSRB(Health Facilities and Services Regulatory Bureau)

A.O. 2012-0021

National Framework of the National Health Laboratory Network

Dept. Memo 2009-0086

Implementation of External Quality Assessment (EQAS) Program as a Regulatory Requirement for Licensing of Clinical Laboratories

Dept. Order 2009-5148

Philippine Heart Center as the National Reference Laboratory in anatomic pathology for cardiac diseases

Dept. Order 393-E s. 2000

Designation of Five (NRL) National Reference Laboratories to undertake the functions of the (BRL) Bureau of Research and Laboratories

clinical laboratory

is a facility where tests are done on specimens taken from the human body to obtain information about the health status of a patient.

Clinical Pathology

includes clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, histopathology, cytology, toxicology, endocrinology, molecular biology, cytogenetics, toxicology, and therapeutic drug monitoring etc.

Anatomic Pathology

includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology and molecular pathology.

Primary Category Laboratory

• Routine Hematology

• Qualitative Platelet Determination

• Routine Urinalysis

• Routine Fecalysis

• Blood Typing-Hospital Based

Secondary Category Laboratory

• Primary laboratory examination +

• Routine Clinical Chemistry

• Quantitative Platelet Determination

• Crossmatching-Hospital based

• Gram Staining-Hospital based

• KOH-Hospital based

Tertiary Category Laboratory

• Secondary laboratory examination +

• Special Chemistry

• Special Hematology

• Immunology/ Serology

• Microbiology - aerobic/non-aerobic - hospital based

Limited-Service Capability (Institution-based)

• Dialysis centers

• Social hygience clinics

Special Clinical Laboratory

• Assisted reproduction technology

• Molecular and cellular technology

• Molecular biology

• Molecular pathology

• Forensic pathology

• Anatomic pathology

PRE-ANALY TICAL

• Specimen collection and handling

ANALYTICAL

• Tests, procedures, instrumentation, equipment, reagents,
  QG, personnel, facilities

POST-ANALYTICAL

• Reporting of results and proper waste disposal

Physician's Office Laboratory?

• an individual doctor's office or clinic wherein laboratory examinations are performed.

Mobile Clinical Laboratory?

• Is a specialized facility that moves from one testing site to another.

POCT (Point of CARE Testing)

• diagnostic test that is performed near the site of the patient rather than the clinical laboratory.

Pathologist

• Who heads and manages a clinical laboratory?

National Reference Laboratories i the Philippines?

1. PNHC (Philippine National Heart Center)

2. NKTI (National Kidney and Transplant Institute)

3. LCP (Lung Cancer of the Philippines)

4. SLH (San Lazaro Hospital)

5. RITM (Rsearch Institute for Tropical Medicine)

6. EAMC (East Avenue Medical Center

PNHC

Anatomic pathology for cardiac disease

NKTI

Hematology, coagulation tests, Immunohematology, Immunopathology, Anatomic pathology for renal disease, Automated Urinalysis

LCP

Clinical chemistry, Anatomic pathology for pulmonary diseases

SLH/SACCL

Screening and Confirmatory tests for HIV, Syphilis, Hepatitis B and Hepatitis C

RITM

Dengue, influenza, TB and other mycobacteria, malaria and other parasites, bacterial enteric diseases, measles and other exanthems, enterovirus,...

EAMC

Screening and confirmatory drug tests, water testing potability, analytical toxicology, methemoglobin, hemoglobin, and sulfhemoglobin.

Registered Medical Technologist Pathologist

Who are the people authorized to sign an official laboratory result?

Secretary of Health (SOH) through the HFSRB

Who is tasked to enforce the provisions of the clinical laboratory law and its implementing rules?

Top 10 Violations of R.A. 4688

1. Refusal to participate in EQAS

2. Issuance of a report which is NOT in accordance with the documented procedure approved by the head of the laboratory

3. Permitting unauthorized person to perform technical procedures

4. Incompetence: consistent errors in laboratory examinations

5. Substandard test procedures: using of expired reagents

6. Erroneous results: tampered result, untested specimen

7. Lending or using the name of the licensed clinical laboratory or licensed personnel to an unlicensed clinical laboratory

8. Unauthorized use of the name and signature of the pathologist and or medical technologist to secure an LTO

9. Transferring of results done in an outside laboratory to a result form of the referring laboratory.

10. Performing and reporting tests in a specialty or subspecialty in which the laboratory is not licensed.

HFSRB or the CHD Director

Who will investigate the complaint lodged against a clinical laboratory?