Administrative Order No. 55-A, series 1989, Republic of the Philippines

Administrative Order No. 55-A, series 1989

Date:    January 2, 1989

Source:    Department of Health

Subject:    Rules and Regulations Governing the Accreditation of Laboratories Performing HIV Testing

Text:

These rules and regulations are promulgated to protect and promote the health of the people by regulating the performance and assuring the quality of HIV testing in laboratories and blood banks licensed according to the Implementing Rules and Regulations of R.A. 4688 and R.A. 1517.

SCOPE:

The regulations embodied herein shall apply to any person, firms, corporation, laboratory or blood bank performing or seeking to perform HIV testing in the Philippines for the public, for diagnostic or public health purposes. HIV testing shall include the determination of the presence of antibody, antigen/protein, viral particles in a clinical specimen indicating infection by Human Immunodeficiency Virus (HIV).

The accreditation of an HIV Testing Laboratories/Blood Banks 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.

Accreditation requirements for a HIV Testing Laboratory: (Technical Standards)

All clinical laboratories or blood banks shall be required to demonstrate compliance with the following Technical Standards as a requirement to accreditation:

1.1. The clinical laboratory or blood bank shall be duly licensed by the Bureau of Research and Laboratories.

1.2. The laboratory shall be headed by and under the direction and supervision of a duly licensed physician who is certified by the Philippine Board of Pathology or Philippine Board of Hematology and Blood Transfusion.

1.3. The laboratory shall be staffed by medical technologists duly registered with the Board of Medical Technology, who have undergone acceptable training in HIV testing duly certified by a training laboratory.

1.4. The physical plant shall be housed in well-lighted and ventilated, dust-free areas with an adequate supply of water. The space appropriately furnished, should be sufficient to accommodate the activities needed for HIV testing.

The HIV Testing Laboratory shall have the appropriate equipment, glassware and other supplies needed for HIV testing.
The laboratory shall utilize reagents, such as HIV kits, which have been registered with the Bureau of Food and Drugs (BFAD) and evaluated and recommended by RITM.
Report Forms - The report forms should be clear, objective and indicate the type of HIV.