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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 Regulations 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 s. 2000, five institutions were designated as the National Reference laboratories namely:


  • 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 units.
  • San Lazaro Hospital - National Reference Laboratory for HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls).
  • East Avenue Medical Center- National Reference Laboratory for Environmental and Occupational Health; Toxicology and Micronutrient Assay
  • National Kidney and Transplant Institute - National Reference Laboratory for Hematology including Immunohematology, Immunopathology and Anatomic Pathology (consistent with previously issued D.O. 301-1 s. 1999)
  • Lung Center of the Philippines- National Reference Laboratory for Biochemistry.

The following specific guidelines shall be enforced to initially implement the NEQAS:

1. A certificate of participation/registration in NEQAS shall be a licensing
requirement for the renewal of license to operate a clinical laboratory for 2009
in the following areas:

      a. Hematology - Primary, Secondary and Tertiary Clinical Laboratories in the
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 Band 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 requires participation and a satisfactory rating on the survey. For Microbiology, TB and Parasitology, participation in the three component is required and a certificate of participation is issued by the Microbiology Department of RITM. 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.

4. The schedule of fees per participation is as follows:
      a. Hematology P 2,000.00
      b. Clinical Chemistry P 2,000.00
      c. HIV/AIDS, Hepa B & C P 2,500.00
      d. Drug Proficiency Testing P 1,000.00
      e. Water Proficiency Testing P 2,500.00
      f. Microbiology P 5,000.00


Republic of the Philippines Department of Health, DEPARTMENT MEMORANDUM No. 2009 - 0086"

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Activities and Guidelines in the Performance of External Quality Assessment Program (EQAP) of the National Reference Laboratory for HIV/AIDS, Hepatitis B & C and STIs

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10 comments:

  1. ask ko lang po kng san po pwd dwnload ung application neqas s hema.tnx!

    ReplyDelete
  2. here's the link http://www.nktilab.com/NRL/NRL.aspx
    It can be downloaded under Quality Assurance Survey of that page.

    ReplyDelete
  3. where can i download the neqas application for clinical chemistry? thanks

    ReplyDelete
  4. im not yet sure if it can be downloaded from the internet. il get back to you as soon as i got the info. in the mean time you can contact the lung center of the philippines which was designated as the NRL for biochemistry. The hospital's trunk line number is (632)924-6101 to 20. local number for chemistry section is 397.

    ReplyDelete
  5. thanks for the information. hopefully the form is available for download.

    ReplyDelete
  6. for initial registration in chem neqas you must contact lung center reference lab for details. application form will be sent thru email. the number is (632) 924-6101 local 388

    ReplyDelete
  7. thanks for posting this info.. it helps a lot..god bless!!

    ReplyDelete
  8. Stated in this order were the initial schedule of fees per participation. This was released on 2009. These fees are subject to change depending on the designated NRL. Please contact the NRL concerned for a copy of their new schedule of fees.

    ReplyDelete
  9. Can i ask the reasons why RA 4688 (Clinical Laboratory Law)/ AO no.59 s.2001 was revised/changed? what's the purpose of revising it to AO no27 s.2007? and what's it all about?

    please contact me 09082298928/ kazic_26@yahoo.com
    thanks! or you can post it here.

    ReplyDelete
  10. can i ask where can i download the EQAS registration form for HEMATOLOGY? I FOLLOWED THE LINK but the page was not found

    ReplyDelete

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