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2015/LSIF/FOR/014
Accreditation in the Philippines
Submitted by: Philippines
2nd APEC Blood Supply Chain Policy Forum Anaheim, United States
23 October 2015
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ACCREDITATION inTHE PHILIPPINESENSURING THE QUALITY of BLOOD SERVICES
APEC – AABB FORUM, ANAHEIM, CA
23 0CT0BER 2015
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• � 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 treponemalantibodies.
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NVBSP: MANDATORY SCREENING
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
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QUALITY ASSURANCE FRAMEWORK
• UNIVERSITY OF THE PHILIPPINES - NATIONAL INSTITUTES OF HEALTH - HILTON LAM, PhD et.al
• QAF FOR NATIONAL BLOOD SERVICES
Quality Assurance Framework (QAF)
Quality NVBSP Blood
Respecting privacy,
Confidentiality
Sound Financial
Management
Objectivity, Impartiality
Support from Central Office
Objectivity, Impartiality
Staff development and training
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Strengthening the Quality assurance framework of the NVBSP
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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 developmenteyarcellananuquiAPEC2015 8
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QAF TOOLS : EVALUATION
• A) Internal time series benchmarks
• B) External benchmarks
• C) Identification of good practices
• D) Adjustment policies (innovations)
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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 awardseyarcellananuquiAPEC2015 10
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Philippine Data: HIV per region
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2%2
2%(4a)2
54%63
5%6
10%12
1984 to present –16,516 cases reported
HIV CONFIRMED CASES FROM BLOOD DONATIONS DISTRIBUTION PER REGION2013 STATISTICS.
3.4%4
23%27
0.85%1
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HIV
• GEOGRAPHIC
• DISTRIBUTION
• AS OF APRIL 2015
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DISTRIBUTION OF POSITIVE BLOOD UNITS BY TYPE OF DONOR
0
225
450
675
900
Directed Replacement No Data
HBV HCV HIV SYP
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NCBS TECHNICAL COMMITTEE
• REVIEW OF TESTING ALGORITHMS FOR TTIs
• IMPLEMENTATION OF TECHNICAL STANDARDS
• UPDATES ON PRODUCT CERTIFICATION
• STRENGTHENING NEQAS / EQAS
• CONTINUING PROFESSIONAL EDUCATION, TQM
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NCBS TECHNICAL COMMITTEE• EVIDENCE-BASED EVALUATION AND
ADVICE
• ACTIVE PARTICIPATION IN TECHNICAL WORKING GROUPS / GLOBAL FUNDPROJECTS
• RESEARCH ON VALIDATION OF NON-REACTIVES
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VALIDATION OF NON-REACTIVES• QUALITY STATUS
SURVEY (WHO)
• QUALITY ASSURANCE FRAMEWORK STUDY (HILTON LAM et al)
• NEQAS BY NRL-TTI, RITM
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Validation using Nucleic Acid Testing (NAT) of results of blood donor samples found to be non-reactive to transfusion-transmissible viruses by Immunoassays (EIA/CLIA)
RHODA T. YU, RMTMedical Technologist IV
SupervisorTransfusion Transmissible Infections
National Reference Laboratory (TTI-NRL)
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0
500
1000
1500
2000
2500
3000
New Donors Repeat Donors Total
186 170356
9201,024
1,944
237201
438
2014TTICONFIRMEDPOSITIVEBLOODUNITSDonationFrequency
HCV HBV HIVeyarcellananuquiAPEC2015 18
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0
100
200
300
400
500
600
700
Several Years Ago(2-34 yrs) After a Year Ago < a year ago (2-11 months) No Data
8945 24 12
467
333
171
53
86
57
34
24
RITMNRL‐ TTI2014TTICONFIRMEDPOSITIVEBLOODUNITS‐
51% Repeat Donors
HCV HBV HIVeyarcellananuquiAPEC2015 19
RITM PRELIMINARY RESULTSFINAL STATUS FREQUENCY PERCENTAGE
NEGATIVE 3170 96.265%POSITIVE (NAT HBV and EIA HBV) 12 0.364%
POSITIVE (EIA HBV only) 3 0.091%
POSITIVE (NAT HBV only) 48 1.458%
NOT TESTED* 60 1.822%
TOTAL: 3293 100.00%
*Not Tested (Spilled | QNS | No Sample | Old Sample)
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ACCREDITATION in the PHILIPPINES
• PHILIPPINE ACCREDITATION OFFICE / BUREAU
• ISO 15189
• JOINT COMMISSION ON ACCREDITATION (JCI)
• COLLEGE OF AMERICAN PATHOLOGISTS (CAP)
• AABB?
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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, TOPOGRAPHYeyarcellananuquiAPEC2015 22
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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)
APEC AABB FORUM23 OCTOBER 2015
ANAHEIM, CALIFORNIA, USA• THANK YOU!
• MARAMING SALAMAT!
• MUCHAS GRACIAS!
• Elizabeth Arcellana-Nuqui, MD
• National Council for Blood Services, Philippines
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