Clinical Laboratory Act

RA 4688

RA 4688

Clinical Laboratory Act is also known as what RA?

June 18, 1966

RA 4688 was approved on

Bureau of Health Facilities and Services

BHFS

Center for Health Development

CHD

Department of Health

DOH

External Quality Assurance Program

EQAP

License to Operate

LTO

National Reference Laboratory

NRL

• Classification by Ownership

• Classification by Functions

• Classification by Institutional Character

• Classification by Service Capability

Classification of Laboratory

1. Clinical Pathology

2. Anatomic Pathology

Classification by Function

Clinical Pathology

Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Blood banking, Endocrinology and Toxicology

Anatomic Pathology

Surgical Pathology, Immunopathology, Cytology, Autopsy and Forensic Pathology

1. Hospital Based Laboratory

2. Non-Hospital Based Laboratory

Classification by Institutional Character

Hospital Based Laboratory

A laboratory that operates within a hospital.

Non-Hospital Laboratory

A laboratory that operates on its own

1. Primary Laboratory

2. Secondary Laboratory

3. Tertiary Laboratory

Classification by Service Capability

Primary Laboratory

• Routine Hematology, Routine urinalysis and Fecalysis,

• Qualitative platelet determination

• Blood typing can be done in a hospital based laboratory.

• Centrifuge, Hemacytometer, Microhematorit centrifuge, Microscope, Hemoglobinometer, Diff count counter

Special Clinical Laboratory

a lab that offers highly specialized lab services that are usually not provided by gen clin lab. Molecular.

Secondary Laboratory

• Provides the minimum service capabilities or primary with addition of the following:

1. Quantitative Platelet determination

2. Routine Clinical Chemistry

3. Gram staining & KOH (Hospital based Lab)

4. Cross matching (hospital based laboratory)

• Refrigerator, spectrophotometer, water bath, timer

Tertiary Laboratory

• Provides the Secondary capabilities with the following laboratory test

1. Special Chemistry

2. Special Hematology

3. Immunology and serology

4. Microbiology

• Incubator, Analytical balance, Rotator, Serofuge, Autoclave, Drying oven, Biosafety cabinet

two (2) years

Clinical laboratory shall be inspected every ___ or as necessary

Notice of Violation

___ for non compliant shall be issued immediately after monitoring by CHD, forwarded to BHFS

NO LTO

If the reason is due to ___ has been issued, the provincial, city and municipal health officers are enjoined by BHFS to explain for the existence of colorum as part of their duties and responbility

licensed physician certified by the Philippine Board of Pathology

The clinical laboratory shall be managed by a ___

three months

In areas where pathologist is not available a physician with ___ training on clinical laboratory medicine, quality control and laboratory management may manage a primary or secondary category clinical laboratory.

one

There should be at least ___ Medical Technologist.

AO 201, 4

Based on ___, pathologist are authorized to supervise of how many clinical lab/BB.

2

1 MT can only supervise ___ MLT at one time

800 tests/ per month / MT

Manual method

10 square meter

Minimum working space requirement for Primary Laboratory

20 square meter

Minimum working space requirement for Secondary Laboratory

60 square meter

Minimum working space requirement for Tertiary Laboratory

• Internal Quality Control

• External Quality Control

Quality Control Program

Pathologist

No person in clinical laboratory shall issue a report orally or in writing, whole or portions, thereof without a directive from ___

1 year

All requests and results in duplicate original copy will be filed as part of patients medical record) shall be kept in file for at least ___

permanently

Records on anatomic and forensic pathology shall be kept ___ in laboratory.