05 August 2017

Department Memorandum 2009-0086-B


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

Two (2) months after sending of results
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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