Republic of the Philippines Department of Health OFFICE OF THE SECRETARY i September 8, 2014 DEPARTMENT MEMORANDUM No._2009- 0086-6 To: BUREAU DIRECTORS, REGIONAL DIRECTORS, HEAD OF NRLs, HOSPITAL CHIEFS, HEAD OF LABORATORIES, REGULATORY OFFICERS AND OTHER CONCERNED OFFICIALS SUBJECT: 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 VLB.1.fii.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 BHES.and.respective Regional-Offices, I. The guidelines stated below shall be imposed as one of the requirements: 1, ANEQAS Certificate of Participation’ Proficiency Testing of previous year shall be considered for all clinical laboratories performing the following services: ial a, Hematology for all categories of Clinical Laboratories issued by Nati Kidney & Transplant Institute (NKTD) b. HIV, HBV, HCY, Syphilis and other STIs for clinical laboratories performing such services issued by STD-AIDS Cooperative Central Laboratory (SACCL), San Lazaro Hospital (SL) ©. Drug and Drinking Water issued by East Avenue Medical Center (EAMC) 4. 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 & Sensitivity for capable tertiary clinical laboratories by Research Institute for Tropical Medicine (RITM) ine 6517800 Dect Line THU9801 “Fox 743 3829; 45-1786» URL ip eh gh ealf Transfusion Transmissible Infections tests for blood donation samples and blood units Institute for Tropical Medicine (RITM) (HIV Test, HBV, HCV, Syphilis, Malaria) issued by Research By the year 2015, the certificate of participation in Antimicrobial Resistance Surveillance Program (ARSP) for Philhealth accreditation shall not be recognized as NEOAS for Bacteriology component . Schedule of fees per participation with corresponding services (parameter! analyte), frequency of NEQAS provision and deadline of application to National Reference Laboratories as follows: NRLs EQAS PROVIDER NEQAS PARAMETERS/ ANALYTES FREQUENCY OF NEQAS: PROVISION APPLICATION FEES DEADLINE OF APPLICATION National Kidney & Transplant Institute (KT!) Hematology CBC (Hgb, Het RBC, WBC and Platelet Once a Year 3,500 February Lung Center of the Philippines (LCP) Clinical Cheiistry Glucose, Urea Nitrogen, Uric Acid, Creatinine, Cholesterol, Albumin, " Total Protein, Sodium, Potassium, Chloride Per year cycle 8,000 (package) May ‘STD-AIDS Cooperative Central Laboratory (SACCL), San Lazaro Hospital (StH) HIV, HBV, HCV, sy One test event/ year 2,500 Cone analyte) 4,500 ( two or more analytes ) East Avenue Medical Center (EAMC) (Environmental, Occupational Health, Toxicology and Micronutrient Assay) Drug Test Screening (Methamphitamine and THC) Once a year 1,000 Water Bacteriology Once a year 3,000 December Research Institute for Tropical Medicine (ITM) a. Bacteriology, Parasitology & Mycobacteriology (Bacteriology, Parasitology, AFB Microscopy and or = TB Culture) ‘Once a year 7,500 (Parasitology, AFB Microscopy) ‘Once a year 4,200 First batch (February) ‘Second batch (May) ‘Third batch. (August) b. Transfusion, ‘Transmissible Infections HBV,HCV,HIV, SY, Malaria Once a year 6,500 MayI Issuance of Certificate of Participation/ Proficiency Testing by designated National Reference Laboratories National Reference Laboratories Services Schedule of Issuance National Kidney & Transplant Institute || Hematology September kT Lung Center of the Philippines (LCP) _| Clinical Chemistry October STD-AIDS Central Cooperative | HIV,HBV,HCV, | 3" week of December to Laboratory (SACCL), San Lazaro sy January Hospital (SLH) ‘© Certificate of Drug Test Participation - once East Avenue Medical Center (EAMC) the participants received their samples Water Bacteriology | + Certificate of Proficiency - October of the following year Bacteriology, Parasitology & | Two (2) months after sending Research Institute for Tropical |_Mycobacteriology_| of results Medicine (RITM) © Certificate of Transfusion Participation - after a ‘Transmissible week of submission of Infections 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 RLS. This is for strict compliance, By Authogty of the Secretary of Health: : a ATTY/NICOLAS B. LUPERO Ill, CESO 11 Assistantecretary