September 8, 2014
DEPARTMENT MEMORANDUM
No. 2009 – 0086–B
AMENDMENT
TO DEPARTMENT MEMORANDUM NO. 2009–0086–A 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,” section VI.B.1.f.ii. states that, “the clinical laboratory
shall participate in an EQAP administered by designated NRL or other local and
international EQAP approved by the DOH.” Hence, Certificate of Participation on
EQAP is required for the renewal of the license to operate of clinical
laboratories in the BHFS and representative Regional Offices.
A.The guidelines states below shall be imposed as one of
the requirements:
1. A NEQAS
Certificate of Participation/Proficiency Testing of previous year shall be
considered for all clinical laboratories performing the following services:
a. Hematology for all categories of Clinical Laboratories
issued by National Kidney and Transplant Institute (NKTI).
b. HIV, HBV, HCV, Syphilis and other STIs for clinical
laboratories performing such services issued by STD–AIDS Cooperative Central
Laboratory (SACCL), San Lazaro Hospital (SLH)
c. Drug and Drinking Water issued by East Avenue Medical
Center (EAMC)
d. Clinical Chemistry for all clinical laboratories
offering Chemistry services issued by Lung Center of the Philippines (LCP)
e. Parasitology for all categories and all clinical
laboratories offering AFB microscopy service; Bacteriology for all tertiary
clinical laboratories and TB Culture and Sensitivity for capable tertiary
clinical laboratories by Research Institute for Tropical Medicine (RITM)
f. Transfusion
Transmissible Infections tests for blood donation samples and blood units (HIV
Test, HBV, HCV, Syphillis, Malaria) issued by Research Institute or Tropical
Medicine (RITM)
By
the year 2015, the certificate of participation in Antimicrobial Resistance
Surveillance Program (ARSP) for PhilHealth accreditation shall not be
recognized as NEQAS for Bacteriology component.
2.
Schedule of Fees
xxxx
B.Issuance of Certificate of Participation/Proficiency
Testing by designated National Reference Laboratories
National Reference Laboratories
|
Services
|
Schedule of Issuance
|
National Kidney &
Transplant Institute (NKTI)
|
Hematology
|
September
|
Lung Center of the
Philippines (LCP)
|
Clinical Chemistry
|
October
|
STD – AIDS Central
Cooperative (SACCL), San Lazaro Hospital (SLH)
|
HIV, HBV, HCV, SY
|
3rd week of
December to January
|
East Avenue Medical
Center (EAMC)
|
Drug Test
|
· Certificate of
Participation
– once the participants received their samples
· Certificate of
Proficiency – October of the following year
|
Water Bacteriology
|
||
Research Institute for
Tropical Medicine (RITM)
|
Bacteriology,
Parasitology & Mycobacteriology
|
|
Transfusion
Transmissible Infections
|
· Certificate of
Participation – after a week of submission of results
· Certificate of
Proficiency – within the last quarter of the year
|
· Certificate of
Participation – certificate issued after submission of test results
· Certificate of
Proficiency – certificate issued after passing the prescribed rating set by
respective NRLs providers
EQAP Participation / Proficiency testing with 2 or more consecutive
failures, unsatisfactory, unacceptable results shall comply with the guidelines
of respective NRLs.
This is for strict
compliance.
By Authority of the
Secretary of Health:
ATTY. NICOLAS B. LUTERO
III, CESO III
Assistant Secretary
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