(Microsoft PowerPoint - 09.RECENT ACTIVITIES IN CLINICAL ...
RECENT ACTIVITIES IN
PRACTICE IN THEPRACTICE IN THE
DR. ARIEL M. VERGEL DE DIOS
PHILIPPINE COUNCIL FOR QUALITY
ASSURANCE IN CLINICAL LABORATORIES
• 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.
• FIVE HOSPITAL LABORATORIES WERE
DESIGNATED AS NATIONAL REFERENCE
• Designated November 1, 2000• Designated November 1, 2000
– NATIONAL KIDNEY AND TRANSPLANT
– RESEARCH INSTITUTE FOR TROPICAL
– LUNG CENTER OF THE PHILIPPINES
– EAST AVENUE MEDICAL CENTER
– SAN LAZARO HOSPITAL-STD-AIDS CENTRAL
• To provide laboratory referral functions: for
confirmatory and resolving conflicting
results between or among laboratoriesresults between or among laboratories
• To train laboratory personnel
• To provide a NEQAS program
• To evaluate test kits and reagents.
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
• 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.
NRL - NEQAS
• National Kidney and Transplant Institute
– Hematology – Provided presently
• EQAS – samples were tested for Hb, Hct, WBC, RBC, and
– Coagulation and Immunohematology – part of future
• 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
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
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
• 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
• 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
Issues on Accreditation of
Clinical Laboratories in the
Philippines• A consensus meeting attended by stakeholders of
clinical laboratories was held last February 05,
• 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
Issues on Accreditation of
• 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
• 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
• It is proposed that the body be named “The
National Board of Accreditation of Clinical
• When the Accreditation is in place, the Board will
seek recognition from international bodies like the
ILAC or the APLAC.
• 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
• Corporate members are being considered in the
• It has conducted National External Quality
– 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
• 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.