2015/LSIF/FOR/012 Using Accreditation As an Indicator of Progress Submitted by: Fortis Memorial Research Institute 2 nd APEC Blood Supply Chain Policy Forum Anaheim, United States 23 October 2015
Using Accreditation as an Indicator of Progress Dr. N. Choudhury Additional Director & Head, Fortis Memorial Research Institute Delhi (Gurgaon), India What is Safe Blood? Safe blood is the blood which is negative for transfusion associated infections which has been taken from a healthy donor (VNRBD) and has appropriately undergone compatibility & other serological procedures with respect to the recipients 1
What is quality? (1) # It is not easy to define # Quality in health care: Efficiency and optimality Efficacy and effectiveness Acceptability and legitimacy Equity What is quality? (2) Efficacy and Effectiveness describes the best possible care and outcome under optimum condition Efficiency and optimality related to absolute and relative cost of improving or maintaining health 2
What is quality? (3) Acceptability and legitimacy are concerned with the wishes, acceptation and value of the patient and community Equity looks after social needs and distribution of health care. Quality Assurance can be seen as tripod Quality Assurance Assessment and Monitoring Program Development Quality improvement 3
Basic BB Quality in AATM Member Countries AATM members from 18 countries and 13 countries has country chapters Country chapters: Afghanistan, Bangladesh, Bhutan, India, Iran, Maldives, Mongolia, Laos Nepal, Pakistan, Sri Lanka, Turkey, Timor Les Few countries maintain good quality standard (Iran, SL, Turkey) others need to improve Only India has a formal accreditation program AATM initiatives for Quality AATM Quality initiatives: EQAS program (NABH in IN; MoH Thailand for BH, BD, MD, NP, SL & IBTO for AF, PK) Wet-workshops: 14 WW organized in 2014; Quality main topic (& IH+ TTI) AATM-AABB joint accreditation (one step) program in Asia 4
Management of National BTS (AATM member countries) Nationally coordinated & centralized: # Afghanistan, Bhutan, Maldives, Iran, Mongolia, Sri Lanka, Iran, Timor Leste Nationally coordinated (under Red Cross) # Nepal, Nationally Coordinated but fragmented # Bangladesh, India, Pakistan Basic about Indian BTS Governed by Drug & Cosmetics Act of 1940, modified through multiple Notifications (2001) Constrains of blood banking sector in India Highly fragmented BTS Accessibility and affordability of safe blood Absence of a nation-wide network of blood banks. Different levels of Quality standards. Absence of a system for the continuous monitoring and evaluation of the service 5
Introduction: Status Indian BTS is highly fragmented. There are >2600 blood banks at present. Blood banks are in four sectors (appox): # 40% are in government sector # 35% from Corporate sector # 20% are from NGO sector # 5% under Red Cross Society Introduction: Regulations Indian BTS regulated by Drugs & Cosmetics (D&C) Act through federal & provincial Govt. agencies Quality management system (QMS) varied in between cities even BB in same city. Utmost important to implement uniform QMS Efforts were made to bring uniform QMS through common Accreditation Program under federal Govt. 6
Need for Quality Imperative for meeting country s demand-supply gap Business imperative Fundamental to profession s ethics Need for Accreditation Wide variance in quality standards among BB Inadequate: # Resources: Personnel/ equipment/ consumable # Monitoring system Need to Improve services to donor & patients To ensure safety of blood 7
Accreditation Agencies (1) In India, NABL for Laboratories # Under Ministry of Science & Tech # Traceable with APLAC & ILAC NABH for other medical services # Under Ministry of commerce # Traceable to ISQUA Accreditation Agencies (3) NABL: Previously: ISO 17025 Presently: ISO 15189 Accreditation for testing & calibrating lab Blood Centre: does not cover donation & component sections 8
NABH Accreditation Programs Accreditation of Hospitals Accreditation of Blood Banks Accreditation of SHCO/ Nursing Homes Accreditation of OST Centers Accreditation of PHC/CHCs Accreditation of AYUSH hospitals Accreditation of Wellness Centers Accreditation of Medical Imaging Services Accreditation of Dental Centers Allopathic Clinics Benefits of accreditation (1) Accreditation results in high quality of care and safety of donor / patient Donor/ patient gets services by credible medical staff. Donor/patient safety regularly evaluated Confidence of donor/patient increases 9
Benefits of accreditation (2) Blood bank is stimulated for continuous & demonstrates commitment to quality care Improved credibility of blood centre Unbiased assessment by an external agency Benefits of accreditation (3) Staff: # more satisfied # continuous learning/ good working environment Promotes intra and inter-institutional interactions. Achieve a benchmark in blood banking 10
Methods: Preparing Standard NABH BB Standard prepared in 2006 by Technical Committee (TC) on following platform: # ISO-15189 # D&C Act-1940 (Govt. regulation, updated-2001) # Technical Manual (NACO- Govt. of India) # Technical Manual DGHS (MoH, Govt. of India) # Technical Manual-AABB; Standard- NATA. NABH BB Standard released : January 2008 Accreditation Prog. rolled out in same year. Methods: the process Started with 4 principal assessors Four assessors courses (5 days) in a year: 92 successful assessors Three days implementation program (preparatory) across India= 24 no. One day sensitization prog. for prospective BB province wise across India= 45 no. 11
Methods: Monitoring program Regular evaluation of assessment processes: NABH secretariat/ Surveillance/ Surprise visit/ Public feedback/ Regular TC & AC meet Assessors performance feed back= 360 o Assessors meeting (3 days) = self appraisal & homogenization of accreditation NABH BB audit by ISQUA Results: Sensitization Program One day prog to inform about basics & process Out of 32 provinces, 45 sensitization programs Program well known to Indian BB community/ Administrator/ Regulators/ Government Competition felt among NGO & corporate BB 12
Results: Implementation Program Max: 30 participants & it is paid program Total 24 program across the country in four yrs NABH program started with pre & post feedback; follow-up by TC members Very high impact program for quality improvement Results: Assessors Program Hugely successful & high demand for BB doctors Assessors meet regularly for harmonization of assessment process. All assessors are rotated under two senior TC members Assessors are Ambassadors of accreditation # Self improvement # Encourage/ assist others 13
Results: Prog Internal Audit Average time from application to award: # Range: 4-11 mths (mean= 5 mth) Time taken by NABH Secretariat: # Range: 2-6 weeks (mean=2.5 wks) Time taken for pre-assessment (after QM receipt) # Range: 4-12 weeks (mean= 7 weeks) Time taken for final assessment (after pre assesmt) # Range: 4-28 weeks (mean= 2.5 mths) Results: Look Back-Success Why only 85/2600 BB coming forward? Quality of all BB not at accreditation level Many small economically unviable BB BB not familiar with non technical clauses Apprehension (Q Manual, internal audit etc.) Fees to be paid (~US$2000 for 20K collection) 14
Result: Accreditation status Status of BB 2009 2010 2011 2012 2013 2014 Total New BB 9 10 19 14 10 12 74 Surveillance 0 0 11 13 13 22 59 Renewal assessment 0 0 0 5 8 14 27 BB drop out 0 0 0 0 0 0 0 Total 9 10 30 27 23 34 160 Result: Accreditation 85/2600 BB enrolment show apathy/ apprehension/ inequality in quality in BTS Majority BB (38) from corporate & NGO (31) sector; IRCS=3; Govt=13 Competitiveness in NGO & Corporate BB 15
Conclusions: Program First BB accreditation program in South Asia based on a defined Standard Sense of competition started among BB; indirectly elevating QMS in BB Sensitization excellent in blood bankers mind Fear factors are in mind; more implementation program & follow up needed to remove fear. Conclusions: Progress Indicator Brings quality commitments through 45 sensitization programs amongst BB Brings quality to door-step through 24 Implementation program Prepare an army of 94 Assessors for NABH assessment helps & spread Quality Massage Brings competitions amongst BB It is a mandate for many in corporate sector 16
Conclusions: Consistency There was no drop out from accredited blood banks shows satisfaction of customers with the process. Brining QMS parity in a fragmented BTS has started in India and intervention needed for covering government sector BBs where enrolment is low. WHO & GoI joint initiatives for more BB: 2015 Accreditation as part of System (AATM countries) India is a successful model (own program) Accreditation Prog should be available for others Advocacy to National governments Country level program (sensitization & implementation) Developing local assessors (core group) International coordination 17
What International support needed? Credible, customized accreditation program Advocacy at MoH level Involvement of other regional stake holders (WHO, IFRC, AABB, APBN, AATM etc) Multiple sensitization and hand holding programs a country levels EQAS program to be made available Time bound action plan Thank you for your kind attention Any Questions? 18