September 26, 2013
DEPARTMENT MEMORANDUM
AMENDMENT
TO DEPARTMENT MEMORANDUM NO. 2009 – 0086 ENTITLED, “IMPLEMENTATION OF
EXTERNAL QUALITY ASSESSMENT PROGRAM AS REGULATORY REQUIREMENT
FOR LICENSING OF CLINICAL LABORATORIES”
Pursuant to Administrative
Order No. 2007 – 0027 entitled “Revised Rules and Regulations
Governing the Licensure and Regulation of Clinical Laboratories in the
Philippines,” a clinical laboratory is required to participate in the National
External Quality Assessment Scheme (NEQAS) administered by the designated
National Reference Laboratories (NRLs). Initial implementation stated in the
year 2009 in which NEQAS participation was required for the renewal of the
license to operate of clinical laboratories in selected Center for Health
Development (CHDs).
The following guidelines
shall be enforced as requirement for renewal of license to operate (LTO) of
clinical laboratories nationwide:
1. Starting 2013,
upon filing for renewal of License to Operate (LTO) for 2014 and thereafter, a
NEQAS Certificate of Participation/Proficiency Testing Certificate of the
previous year or the current year if available shall be included as documentary
requirement in the following areas:
a. Hematology for Primary, Secondary and Tertiary
Clinical Laboratories issued by the National Kidney and Transplant Institute.
b. Clinical Chemistry for Secondary and Tertiary Clinical
Laboratories issued by the Lung Center of the Philippines.
c. HIV/AIDS, hepatitis, Syphilis and other STIs for all
HIV Accredited Testing Laboratories, Secondary and Tertiary Clinical
Laboratories performing the tests issued by STD – AIDS Central Clinical
Laboratory (SACCL), San Lazaro Hospital.
d. Drug and Drinking Water Testing Laboratories issued by
East Avenue Medical Center.
e. Bacteriology, TB, and Parasitology for all Tertiary
Clinical Laboratories issued by Research Institute for Tropical Medicine
(RITM). By 2014, the certificate of participation in Antimicrobial Resistance
Surveillance Program (ARSP) for PhilHealth accreditation shall not be
recognized as NEQAS for bacteriology component.
For strict compliance.
ENRIQUE T. ONA, M.D.,
FPCS, FACS
Secretary of Health
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