CONCLUSION

1
CONCLUSION

• Accreditation is a process wherein standards are
  set and compliance with them is measured
• Helps in the grading of Facility BTCin
  accordance to the parameters

2
Quality Blood Banking

• 2063 Licensed Blood banks in India.
• 45 are in public sector and 23 in private while
  the rest are run by NGOs.
• Basic criteria set by the drug Controller are met
  by all licensed blood banks
• But now there is a growing need to focus on
  Quality rather than on attaining quantitative
  benchmarks.

3
Accreditation

• Is a process wherein standards are developed for
  voluntary compliance in blood collection,
  processing, component preparation,storage and
  transfusion.
• Accreditation is voluntary
• Blood banks follow guidelines and standards
  prescribed by accreditation agency

4
Accreditation stands for C C C

• The setting up standards is always done through
  a consultative process among the facility and
  accreditation team.
• Reaching to a consensus regarding the
  appropriate level of the standards to be
  followed.
• And then finally judging the compliance of the
  facility by the Accreditation team.

5
Purpose of Accreditation Survey

• It is a step essential for healthy blood
  transfusion services.
• Enable Transfusion Medicine Deptt.(B.T.C)
  to attain self sufficiency
• Improve Quality standards manifold, bring them at
  par with BEST INTERNATIONAL PRACTICES

6
Broad Goals of Accreditation

• Attaining self-sufficiency of highest quality
• Appropriate and Rationale use of blood
• Ensuring economical processing of safe blood
• Continued regulatory influence in improving the
  quality of blood.

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Eligibility For Accreditation of Blood Banks
(B.B.)

• B.B. has to be operational licensed
• B.B. assumes or is willing to assume
• responsibility for improving its quality of
• its care services
• The B.B. provides services as addressed
• by the accreditation body

8
Accreditation Team

• To be carried out by a team of assessors
  having sound technical expertise and training in
  quality assessment programme technical
  expertise in the activities performed in the
  facility.
• Teams should comprise of
• Lead assessor having primary responsibility
• General assessors

9
Preassessment Materials

• B.T.C intending to have Accreditation should
  submit a copy of the following before the actual
  on site assessment.
• Organizational structure
• Quality program
• Table of contents for the standard operating
  procedure (SOP) manual
• SOP for SOPs including change control
• Error management SOPs
• Summary of internal and external assessment
  findings since the last assessment

10
Quality Systems Essentials (QSE) which are the
starting points for Accreditation

• Organization
• Personnel
• Equipment
• Supplier issues
• Process control, final inspection and handling
• Documents and records
• Incidents,errors and accidents
• Assessments internal and external
• Process improvement
• Facilities and safety

11
Organization

• Has the organization defined Quality policy?
• Has the organization (BTC) set definite goals
  objectives, which is under control of designated
  officer?
• Is there an organization tree or chart framed for
  effective implementation of work flow?
• Does the organization (BTC) have adequate
  infrastructure space,manpower equipment, and
  disposables

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Procedure performed on-site by the facility

• Cross match
• Saline cross match
• AHG
• Using Gel cards
• Antibody screening
• Antibody investigation
• Prenatal postnatal screening
• Blood product preparation modification
• Infectious marker screening
• Testing for bacterial contamination of platelets
  (By the ACP, Dec 2002)

13
Personnel

• Does the facility have qualified personnel with
  appropriate education, training and
  experience-competent performance of assigned
  duties
• Effective job description

14
Personnel
Well defined program
Regular scheduled competency evaluation of
staff To ensure that their skills are
maintained
Orientation of new employees
15
Orientation Programs

• Facility-specific requirements for safety,
  blood-borne pathogens, facility security,cGMP
  training e.t.c.
• Job related aspects should
• - Cover all technical aspects of
  training
• - Documentation to identify all areas
  covered
• - Joint approval of training by facility
  trainer and employee
• -

16
Competency Evaluation Program

• Does the facility have regular scheduled
  competence evaluation compatible with the FDA
  requirements (e.g.employee must be assessed 6
  months after recruitment annually thereafter.)
• Does the Competency program include
• written evaluation
• direct evaluation of test procedures
• review of work records or reports/computer
  records
• testing of unknown samples
• testing of employees problem solving skills
• Documentation of all aspects of
• employee training and competence is
• mandatory

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Equipment Validation Calibration Preventive
maintenance

• Does the facility maintenance the schedule for
  validation, calibration and preventive
  maintenance of all essential equipments.
• Are the policies for installation of new
  equipment clearly defined,with documentation of
  any problems and follow up action.
• Is the facility having the List of essential
  equipment
• ( stand by ) for schedule preventive
  maintenance, calibration planning quality
  control.
• Are the records of maintenance, repairs or
  calibration kept reviewed periodically.

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Equipment Validation Calibration Preventive
maintenance

• Records will assist the facility -
• Reviewing the functionality of the
• equipment
• Allow better control to manage defective
  equipment
• Serve as a gauge to judge when the
• equipment needs to be replaced

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Supplier/Client issues

• Suppliers clients can be classified broadly
  into
• Blood Donors
• Patient
• Hospital
• Disposables and Equipment Suppliers
• Another Blood Bank

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Supplier Issues
Blood Donors can be classified into
Blood Donor
Autologous
Voluntary
Apheresis
Replacement
Directed
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Supplier issues

• Supplier Qualification Contract review Receipt,
  inspection, and testing of incoming supplies.
• List of suppliers and their respective products
  or
• services
• Records of receipt, inspection, testing (where
  
• required), and segregation/quarantine of
  materials
• and blood components not meeting acceptance
• criteria.
• Tracking the suppliers ability to meet
  expectation over time gives valuable information
  about stability and commitment of supplier

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Documentation Hierarchy- representing the level
of documentation in a blood bank
Level IPolicies What to do
Policies
Level IIProcesses How it happens
Processes
Level IIIProcedures How to do it
Procedures (SOPs)
Forms/Records/Supporting documents/Data/QC
Records/Templates
Level IV
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DOCUMENTATION

• If you have not documented it,You have NOT done
  it.

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Records Management

• Proper documentation of all samples processed
• All forms required in trace back or look back
  process
• Transfusion requests kept for 1 month
• Transfusion reaction forms indefinitely
• Records( employee signature,ID,initials) 5 years
  or as per national guidelines
• Non transfusion serological tests results for 5
  years

27
Records Management

• Quality controls records (reagents/serological
  test controls/external proficiency testing) 5
  years
• Quality assurance 5 years
• Antibody identification reports indefinitely
• Method revision sheet indefinitely
• Donor segments/serum/plasma,clotted and or EDTA
  sample for 7 days post-transfusion
• Computer QA records 3 years
• Patient data files indefinitely
• Policy for Product Recall/Retrival/Lookback-Trac
  eback

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Documentation

• Are the records of incidents, errors, and
  accidents maintained ?

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ERRORS ARE USEFUL INFORMATION

• WE LEARN MORE FROM OUR FAILURES THAN WE MAY FROM
  SUCCESS

Give me a fruitful error anytime, full of seeds,
bursting with its own corrections. You can keep
your sterile truth for yourself VILFRED PARETO

• CAN IMPROVE OUR PROCESS WHEN STUDIED
• BENIGN ERROR MAY PREDICT DISASTERS OR BAD OUTCOMES

31
Mainstay of Accreditation is Quality Control

• To check whether Internal and External Controls
  in place for
• Donor selection
• Phlebotomy
• Preparing blood components
• Infectious marker screening
• Storage of blood and blood components
• Documentation and issue of blood
• Blood transfusion reactions

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Does the Facility have Bio-safety programme?

• Safety instructions
• Reporting of accidents
• Education
• BTS environment-practice and procedures
• Shipment of specimens
• Disposal and disinfections of contaminated
  material
• Emergency procedure for accidents
• Immunization of BTC personnel

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Does the facility have periodical Internal Audit ?

• It is a way to establish whether all activities
  that affect quality are being carried out
• Performed by trained auditors
• It is the quality system that is audited and not
  the staff
• Does the facility maintain records of internal
  audits
• Is HTC in place?

34
Does the Facility have External Quality
Assessment Scheme ( EQAS)

• Objectives being
• To evaluate IQC
• To influence reliability of future activities
• To ensure credibility of BTC
• To stimulate performance improvements
• To identify common errors and encourage use of
  standard reagents

35
CONCLUSION
Continued Improvement
Commitment Policy
Management Review
Planning
Implementation Improvement
Checking Corrective Action
36
CONCLUSION

• Accreditation is a process wherein standards are
  set and compliance with them is measured
• Helps in the grading of Facility BTCin
  accordance to the parameters

37
CONCLUSION

• Decision of accreditation are based on finding of
  the survey. Blood banks can receive one of the
  two Accreditation decisions
• Accreditated When the service demonstrates
  acceptable compliance with all standards and
  achieves a minimal numerical score. The numerical
  scores will indicate overall achievements and
  standard levels(Accreditation Awards)
• Accreditation denied When the B.B. is
  consistently not in compliance with standards

38
CONCLUSION

• Accreditation is a process wherein standards are
  set and compliance with them is measured
• Helps in the grading of Facility BTCin
  accordance to the parameters