February 3, 2009
DEPARTMENT MEMORANDUM
No. 2009 – 0086
IMPLEMENTATION
OF EXTERNAL QUALITY ASSESSMENT PROGRAM AS A REGULATORY REQUIREMENT FOR
LICENSING OF CLINICAL LABORATORIES
Pursuant to Administrative
Order No. 2007 – 0027 entitled “Revised Rules and Regulation
Governing the Licensure and Regulation of Clinical Laboratories in the
Philippines,” a clinical laboratory is required to have a Quality
Assurance Program (QAP). The QAP shall include an Internal and External Quality
Control Program. The Internal QAP covers inputs, processes and outputs
as well as practice of continuous Quality Improvement Program covering all
aspects of laboratory performance. On the other hand, for External Quality
Assessment Program (EQAP), a clinical laboratory is required to participate
in the National External Quality Assessment Scheme (NEQAS) administered by the
designated National Reference Laboratories (NRLs) or in other local or
international EQAP recognized by the Department of Health. The NEQAS shall be
conducted to ensure that laboratory procedures are done in accordance with
standards and laboratory results are accurate and within the standard range for
quality health care.
As provided in Department
Order No. 393–E series 2000, five institutions were designated as the
National Reference laboratories namely:
1. Research
Institute for Tropical Medicine
National
Reference Laboratory for Dengue, Influenza, Tuberculosis and other
Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, measles
and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance
and Emerging Diseases; NRL for confirmatory testing of blood donors and blood
units.
2. San Lazaro
Hospital
National
Reference Laboratory for HIV/AIDS, Hepatitis and Sexually Transmitted Diseases
3. East
Avenue Medical Center
National
Reference Laboratory or Environmental and Occupational Health; Toxicology and
Micronutrient Assay.
4. National
Kidney and Transplant Institute
National
Reference Laboratory for Hematology including immunohematology (consistent with
previously issued D.O. 301–I series 1999)
5. Lung
Center of the Philippines
National
Reference Laboratory for Anatomic Pathology and Biochemistry
The following guidelines
shall be enforced as requirement for renewal of license to operate (LTO) of
clinical laboratories nationwide:
1. Certificate of
Participation/Registration for NEQAS shall be a requirement for the renewal of
license to operate of clinical laboratories in the following areas:
a. Hematology – Primary, Secondary and Tertiary Clinical
Laboratories in National Capital Region (NCR).
b. Clinical Chemistry – Tertiary Clinical Laboratories in
the National Capital Region (NCR) and Center for Health Development IV–A
CALABARZON
c. HIV/AIDS, Hepatitis B & C Proficiency Testing –
All HIV Accredited Testing Laboratories and Secondary and Tertiary Clinical
Laboratories performing Hepatitis B and C tests.
d. Drug and Water Proficiency Testing – all Water and
Drug Testing Laboratories.
2. A Certificate of
Participation shall be issued by the NRLs to the participating clinical
laboratory every time NEQAS is conducted. For the initial implementation of
NEQAS, only one (1) certificate is required for the renewal of license to
operate.
3. NEQAS
/Proficiency Testing for Drug and Water Testing Laboratories require
participation and a satisfactory rating on the survey. For Microbiology, TB and
Parasitology, participation in the three components is required and a
certificate of participation in Antimicrobial Resistance Surveillance Program
(ARSP) is recognized as NEQAS for Microbiology component only and participation
in the TB and Parasitology component is still required.
a. Hematology xxx
b. Clinical Chemistry xxx
c. HIV/AIDS, Hepa B & C xxx
d. Drug Proficiency Testing xxx
e. Water Proficiency Testing xxx
f.
Microbiology xxx
For strict compliance.
FRANCISCO T. DUQUE III,
MD, MSc
Secretary of Health
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