Accreditation in the Philippines

Transcription

1 2015/LSIF/FOR/014 Accreditation in the Philippines Submitted by: Philippines 2 nd APEC Blood Supply Chain Policy Forum Anaheim, United States 23 October 2015

2 3/11/2015 ACCREDITATION in THE PHILIPPINES ENSURING THE QUALITY of BLOOD SERVICES APEC AABB FORUM, ANAHEIM, CA 23 0CT0BER 2015 eyarcellananuquiapec eyarcellananuquimdwbdd2015 1

3 NVBSP: MANDATORY SCREENING HIV-1 and HIV-2: screening for both HIV antigen and antibody, or in combination Hepatitis B: screening for hepatitis B surface antigen (HBsAg) Hepatitis C: screening for either a combination of HCV antigen/antibody or HCV antibodies Syphilis (Treponema pallidum): screening for specific treponemal antibodies. eyarcellana-nuqui,mdapec NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM, DEPARTMENT OF HEALTH FIVE MANDATORY TTIs : MALARIA ADDED NUCLEIC ACID TESTING IN SELECTED BLOOD SERVICES NAT UNDER STUDY BY TECHNICAL COMMITTEE FOR INCLUSION IN TESTING ALGORITHM FOR ALL BLOOD CENTERS IN 2016 NAT IMMINENT IN PHILIPPINE RED CROSS BLOOD CENTERS eyarcellananuquiapec

4 QUALITY ASSURANCE FRAMEWORK UNIVERSITY OF THE PHILIPPINES - NATIONAL INSTITUTES OF HEALTH - HILTON LAM, PhD et.al QAF FOR NATIONAL BLOOD SERVICES EYARCELLANA-NUQUI,mdAPEC2015 Quality Assurance Framework (QAF) Objectivity, Impartiality Staff development and training Support from Central Office Sound Financial Management Respecting privacy, Confidentiality Objectivity, Impartiality Quality NVBSP Blood eyarcellananuquiapec

5 Strengthening the Quality assurance framework of the NVBSP eyarcellananuquiapec QAF TOOLS Documentation and monitoring A) Product definition B) Product standardization C) Process documentation D) Equipment maintenance E) Donor satisfaction F) Patient satisfaction G) Hospital satisfaction H) Staff development eyarcellananuquiapec

6 QAF TOOLS : EVALUATION A) Internal time series benchmarks B) External benchmarks C) Identification of good practices D) Adjustment policies (innovations) eyarcellananuquiapec QAF TOOLS: BRANDING OR CONFORMITY A) Centers of excellence B) ISO certification C) JCI Accreditation D) WHO Seal E) NVBSP Seal F) Excellence awards G) Leadership awards eyarcellananuquiapec

7 Philippine Data: HIV per region 1984 to present 16,516 cases reported 2% 2 3.4% 4 HIV CONFIRMED CASES FROM BLOOD DONATIONS DISTRIBUTION PER REGION 2013 STATISTICS. 54% 63 2%(4a) 2 23% 27 5% % % 12 eyarcellananuquimdapec2015 HIV GEOGRAPHIC DISTRIBUTION AS OF APRIL 2015 eyarcellananuquimdwbdd2015 6

8 900 DISTRIBUTION OF POSITIVE BLOOD UNITS BY TYPE OF DONOR Directed Replacement No Data HBV HCV HIV SYP EYARCELLANANUQUI,MDmay2015 NCBS TECHNICAL COMMITTEE REVIEW OF TESTING ALGORITHMS FOR TTIs IMPLEMENTATION OF TECHNICAL STANDARDS UPDATES ON PRODUCT CERTIFICATION STRENGTHENING NEQAS / EQAS CONTINUING PROFESSIONAL EDUCATION, TQM EYARCELLANA-NUQUI,MD2015 7

9 NCBS TECHNICAL COMMITTEE EVIDENCE-BASED EVALUATION AND ADVICE ACTIVE PARTICIPATION IN TECHNICAL WORKING GROUPS / GLOBAL FUND PROJECTS RESEARCH ON VALIDATION OF NON-REACTIVES EYARCELLANA-NUQUI,MD2015 VALIDATION OF NON-REACTIVES QUALITY STATUS SURVEY (WHO) QUALITY ASSURANCE FRAMEWORK STUDY (HILTON LAM et al) NEQAS BY NRL-TTI, RITM EYARCELLANANUQUI,mdAPEC2015 8

10 Validation using Nucleic Acid Testing (NAT) of results of blood donor samples found to be nonreactive to transfusion-transmissible viruses by Immunoassays (EIA/CLIA) RHODA T. YU, RMT Medical Technologist IV Supervisor Transfusion Transmissible Infections National Reference Laboratory (TTI-NRL) eyarcellananuquiapec TTI CONFIRMED POSITIVE BLOOD UNITS Donation Frequency , , New Donors Repeat Donors Total 356 eyarcellananuquiapec2015 HCV HBV HIV 18 9

11 RITM NRL TTI 2014 TTI CONFIRMED POSITIVE BLOOD UNITS 51% Repeat Donors Several Years Ago(2-34 yrs) After a Year Ago < a year ago (2-11 months) No Data HCV HBV HIV eyarcellananuquiapec RITM PRELIMINARY RESULTS FINAL STATUS FREQUENCY PERCENTAGE NEGATIVE % POSITIVE (NAT HBV and EIA HBV) % POSITIVE (EIA HBV only) % POSITIVE (NAT HBV only) % NOT TESTED* % TOTAL: % *Not Tested (Spilled QNS No Sample Old Sample) 10

12 ACCREDITATION in the PHILIPPINES PHILIPPINE ACCREDITATION OFFICE / BUREAU ISO JOINT COMMISSION ON ACCREDITATION (JCI) COLLEGE OF AMERICAN PATHOLOGISTS (CAP) AABB? eyarcellananuquiapec MAJOR CONSTRAINTS THE COSTS OF ACCREDITATION THE COSTS OF EXTERNAL QUALITY ASSURANCE PROGRAMS LIMITED FUNDING FOR NATIONAL REFERENCE LABORATORY UPHEAVALS IN ORGANIZATIONAL STRUCTURE CHANGES IN POLICY DIRECTION STRATEGIC PLANNING AND IMPLEMENTATION NETWORKING LIMITATIONS OF GEOGRAPHY, TOPOGRAPHY eyarcellananuquiapec

13 ISSUES /CHALLENGES ANNUAL BUDGET FOR NEQAS, ANNUAL BUDGET FOR NEGATIVE VALIDATION REGULAR PROFICIENCY TRAINING NATIONAL REFERENCE LABORATORY TTI REVIEW OF TESTING ALGORITHMS GOOD DATA, ACCURATE DATA (NBBNETS, IBBIS) EYARCELLANANUQUI,mdAPEC2015 APEC AABB FORUM 23 OCTOBER 2015 ANAHEIM, CALIFORNIA, USA THANK YOU! MARAMING SALAMAT! MUCHAS GRACIAS! Elizabeth Arcellana-Nuqui, MD National Council for Blood Services, Philippines eyarcellananuquiapec