WEEK 3: Clinical Laboratory Act of 1966 [RA 4688]

Level 1

BIOSAFETY LEVEL:

• Personnel are expected to wear standard PPE such as masks, gloves, and laboratory gowns

Level 2

BIOSAFETY LEVEL:

• Moderate risk agent

• Normally process specimens such as blood, body fluids, tissues, and to some extent, human cell lines in which the organism causing the disease is unknown

Level 3

BIOSAFETY LEVEL:

• All procedures in processing samples should be done in a biosafety cabinet with a gas tight aerosol generation chamber.

• Access to laboratory is controlled.

Level 4

BIOSAFETY LEVEL:

• Provided with a specialized ventilation and waste management system.

Group 1

RISK GROUP:

• Bacillus subtilis

• Escherichia coli k12

• adeno-associated virus (AAV)

Group 2

RISK GROUP:

• Staphylococcus aureus

• Salmonella

• Herpes viruses

• Adenovirus

Group 3

RISK GROUP:

• Mycobacterium tuberculosis

• Bacillus anthracis

• HIV

Group 4

RISK GROUP:

• Ebola virus

• Marburg virus

• Lassa virus

June 18, 1966

When was Republic Act No. 4688 approved?

AO 2007-0027

The number of medical technologist staff in the laboratory depends on the workload and services provided by the establishment

RA 4688 (ClinLab Act 1966)

Regulate the operation and maintenance of clinical laboratories and to require their registration with DOH, providing the penalty for the violation thereof and other purposes

Dr. Clemente Gatmaitan

Who approved the Administrative Order No. 201, s. 1973

AO 201

Purpose of governing rules and regulations on registration, operation, and maintenance of clinical laboratories in the Philippines

AO 290, 1976

• Amended Subsection (a) of Section 11 of Administrative Order No. 201, s. 1973 that prescribes the requirements for clinical laboratories.

• It also includes certain provisions about a pathologist.

AO 59, 2001

Implements provisions regarding the rules and regulations on the operation, maintenance, and establishment of clinical laboratories in the Philippines

AO 48, 2003

Includes the third classification of clinical laboratories (institutional character).

AO 2007-0027

• Sets the revised rules and regulations regarding the establishment, operation, and maintenance of clinical laboratories.

• It prescribes provisions on the rationale, scope and coverage, and objectives

AO 2007-0027-A

• Amended certain provisions of AO 2007-0027

• (The Licensure and Regulation of Clinical Laboratories in the Philippines).

Department Memorandum 2009-0086

• Prescribes rules and regulations regarding the implementation of internal and external quality control programs as the requirements for the licensing of clinical laboratories in which a clinical laboratory is required to have a Quality Assurance Program.

Department Order 393, 2000

Designated the reference laboratories

• Research Institute for Tropical Medicine

• _{^{San Lazaro Hospital}}

• _{^{East Avenue Medical Center}}

• _{^{National Kidney and Transplant Institute}}

• _{^{Lung Center of the Philippines}}

REFERENCE LABORATORY:

• Dungue, Influenza, and all

• Confirmatory testing of blood units

• _{^{Research Institute for Tropical Medicine}}

• San Lazaro Hospital

• _{^{East Avenue Medical Center}}

• _{^{National Kidney and Transplant Institute}}

• _{^{Lung Center of the Philippines}}

REFERENCE LABORATORY:

• HIV, STDs, Hepatitis

• _{^{Research Institute for Tropical Medicine}}

• _{^{San Lazaro Hospital}}

• East Avenue Medical Center

• _{^{National Kidney and Transplant Institute}}

• _{^{Lung Center of the Philippines}}

REFERENCE LABORATORY:

• Environmental and Occupational Health

• Toxicology

• Micronutrient Assay

• _{^{Research Institute for Tropical Medicine}}

• _{^{San Lazaro Hospital}}

• _{^{East Avenue Medical Center}}

• National Kidney and Transplant Institute

• _{^{Lung Center of the Philippines}}

REFERENCE LABORATORY:

• Immunohematology

• Immunopathology

• Anatomic Pathology

• _{^{Research Institute for Tropical Medicine}}

• _{^{San Lazaro Hospital}}

• _{^{East Avenue Medical Center}}

• _{^{National Kidney and Transplant Institute}}

• Lung Center of the Philippines

REFERENCE LABORATORY:

• Biochemistry