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(Microsoft PowerPoint - 09.RECENT ACTIVITIES IN CLINICAL ...

  1. 1. RECENT ACTIVITIES IN CLINICAL LABORATORY PRACTICE IN THEPRACTICE IN THE PHILIPPINES DR. ARIEL M. VERGEL DE DIOS PAST PRESIDENT PHILIPPINE COUNCIL FOR QUALITY ASSURANCE IN CLINICAL LABORATORIES
  2. 2. • THE DEPARTMENT (MINISTRY) OF HEALTH WAS REORGANIZED IN 2000 • BUREAU OF RESEARCH AND• BUREAU OF RESEARCH AND LABORATORIES WAS ABOLISHED • LICENSING OF LABORATORIES WAS TRANSFERRED TO THE BUREAU OF HEALTH FACILITIES AND SERVICES.
  3. 3. • FIVE HOSPITAL LABORATORIES WERE DESIGNATED AS NATIONAL REFERENCE LABORATORIES • Designated November 1, 2000• Designated November 1, 2000 – NATIONAL KIDNEY AND TRANSPLANT INSTITUTE – RESEARCH INSTITUTE FOR TROPICAL MEDICINE – LUNG CENTER OF THE PHILIPPINES – EAST AVENUE MEDICAL CENTER – SAN LAZARO HOSPITAL-STD-AIDS CENTRAL COOPERATIVE CENTER
  4. 4. NRL Functions • To provide laboratory referral functions: for confirmatory and resolving conflicting results between or among laboratoriesresults between or among laboratories • Research • To train laboratory personnel • To provide a NEQAS program • To evaluate test kits and reagents.
  5. 5. DOH – NRL - NEQAS • Department of Health issued an Administrative Order No. 2007-0027 known as “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines” which states: The clinical laboratory shall participate in an External Qualitylaboratory shall participate in an External Quality Assurance Program (EQAP) administered by designated NRL or other local and international EQAP approved by the DOH • A certificate of participation/registration in an EQAS shall be a licensing requirement for the renewal of license to operate a clinical laboratory in 2009.
  6. 6. NRL - NEQAS • National Kidney and Transplant Institute – Hematology – Provided presently • EQAS – samples were tested for Hb, Hct, WBC, RBC, and platelets. – Coagulation and Immunohematology – part of future plans • Lung Center of the Philippines – Clinical Chemistry – presently provided. Only 10 analytes are tested. Glucose, BUN, creatinine, Total protein, albumin, uric acid, cholesterol, sodium, potassium and chloride
  7. 7. NRL - NEQAS • San Lazaro Hospital – EQAS on Infectious Immunology – HBsAg, HIV and HCVHIV and HCV • East Avenue Medical Center – EQAS on Drugs of Abuse – metamphetamine and cannabinoids
  8. 8. NRL - NEQAS • Research Institute for Tropical Medicine – EQAS on Microbiology and Parasitology – Laboratories were asked to identify– Laboratories were asked to identify microorganisms and do antibiotic sensitivity testing of bacterial unknowns, do Gram stains, AFB stains, and identify several parasitic ova including speciation and quantitation of malaria
  9. 9. QUALITY MANAGEMENT STANDARD • Developed by a Taskforce composed of representatives from the DOH, the NRLs, PCQACL, PSP, PAMET and PSQua.PCQACL, PSP, PAMET and PSQua. • The DOH-Quality Management Standards in the Clinical Laboratory are being developed as a Local or National Accreditation Standard for Clinical Laboratories
  10. 10. QUALITY MANAGEMENT STANDARD • The QMS were initially based on Dr. David Browning’s “Standards for Medical Laboratories” and in consultation with otherLaboratories” and in consultation with other national and international standards like the PCAHO, JCI, ISO, CAP, and CLSI. ISO 15189 and its predecessors were also reviewed.
  11. 11. QUALITY MANAGEMENT STANDARDS • COMPONENTS: – MANAGEMENT RESPONSIBILITY – RESOURCE MANAGEMENT – SERVICE DELIVERY – MONITORING PERFORMANCE – QUALITY IMPROVEMENT ACTIVITIES – INFORMATION MANAGEMENT – ENVIRONMENTAL MANAGEMENT
  12. 12. Issues on Accreditation of Clinical Laboratories in the Philippines• A consensus meeting attended by stakeholders of clinical laboratories was held last February 05, 2009 • It was agreed that accreditation is needed to• It was agreed that accreditation is needed to improve the quality of laboratory services. • The consensus was to use the QMS as the National Standard for Accreditation. • The National Accreditation System will be voluntary and will be offered to clinical laboratories that desire to improve the quality of their services.
  13. 13. Issues on Accreditation of Clinical Laboratories • The DOH – QMS are adapted to local condition. • It has been adopted by the DOH as one of the 8 Hospital Operating Manuals. These guide all government hospitals in upgrading their services.government hospitals in upgrading their services. • Clinical laboratories who have been accredited using QMS will find it easy to attain ISO 15189 or JCI accreditation
  14. 14. QMS Implementation • The consensus was the PCQACL shall take the lead in the implementation in collaboration with PSP, PAMET, PSHBT, NRLs, PSQua, PCAHO and other stakeholders who may desire to join inand other stakeholders who may desire to join in the future. • It is proposed that the body be named “The National Board of Accreditation of Clinical Laboratories.” • When the Accreditation is in place, the Board will seek recognition from international bodies like the ILAC or the APLAC.
  15. 15. PCQACL • The Philippine Council for Quality Assurance in Clinical Laboratories is an organization whose main objective is to promote quality assurance / improvement in clinical laboratories.improvement in clinical laboratories. • Chartered members are the PSP, PAMET, PSHBT, PCHA and PSQua. • Laboratories could join now as institutional members. • Corporate members are being considered in the future.
  16. 16. PCQACL • It has conducted National External Quality Assurance Surveys – 10 in hematology – 8 in clinical chemistry– 8 in clinical chemistry – 3 in coagulation – 2 in blood banking • There were plans to expand the scope of the NEQAS to include parasitology, bacteriology and immunology.
  17. 17. PCQACL • STANDARDIZATION WORKSHOPS – Goal is to achieve consensus and standardize laboratory testing in these areas. – Workshops conducted on:– Workshops conducted on: • Point of care • Hematology – complete blood count • Urine analysis • Stool analysis – Plans are to produce manuals based on the workshops. Future workshops are to be scheduled.
  18. 18. • THANK YOU• THANK YOU

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