1. Validation, Verification and Qualification plans – for all things in the Blood Bank
Theresa Dunning, MT(ASCP)SBB, MSQA, CMQ/OE(ASQ)
CBBS QSE, Regional Seminar

2. Disclosures
No conflicts of interest.

3. Learning Objectives
Describe the difference between a validation, verification and qualification plan.
List one process or equipment example to illustrate what would need a validation, verification or qualification test plan.
List 1 – 2 references or resources that can assist with developing an appropriate test plan.

4. Validation versus Verification
AABB Definitions
Validation versus Verification
Validation: Establishing recorded evidence that provides a high degree of assurance that a specific process will consistently produce an outcome meeting its predetermined specifications and quality attributes. (IQ, OQ and PQ)
Verification: Confirmation by examination and provision of objective evidence that specified requirements have been met. (IQ and OQ)

5. Agencies Requiring Validation/Verification
AABB
CAP
FDA
CMS(CLIA)
Guidance / Reference Documents
FDA – Guidance
CLSI – Clinical Laboratory Standards Institute

6. AABB Standards 3. Equipment 3.2 Qualification of Equipment
All equipment shall be qualified for its intended use. Equipment repairs and
upgrades shall be evaluated and equipment re-qualified, as appropriate, based
on the facility’s policies and manufacturer recommendations.
3.2.1 Installation Qualification
Equipment shall be installed per manufacturer’s specifications.

7. AABB Standards 3.2.2 Operational Qualification
The functionality of each piece of equipment and each component of a
computer system shall be verified before actual use, and shall meet the
manufacturer’s operational specifications.*
*FDA Guidance for Industry: Blood Establishment Computer System Validation in the User’s
Facility (April 2013)
3.2.3 Performance Qualification
The BB/TS shall demonstrate that equipment performs as expected for its
intended use. Performance specifications established by the manufacturer shall
be met.

8. AABB Standards 3.9 Information Systems
The BB/TS shall have processes to support the implementation and
modification of software, hardware, and databases relating to the
requirements of these BB/TS Standards….These processes shall
include:
1) Risk analysis, training, validation, implementation, and evaluation
of post-implementation performance.

9. CAP Standards COM.30550 Instrument/Equipment Performance Verification
The performance of all instruments and equipment is verified prior to initial use,
after major maintenance or service, and after relocation to ensure that they run
according to expectations.
Instrument/equipment performance verification…includes processes to verify
that the instruments and equipment perform according to expectations for the
intended use and within defined tolerance limits.

10. CAP Standards TRM.22000 LIS Transfusion Validation
The laboratory information systems are validated for blood
banking/transfusion medicine activities.
NOTE: The LIS must be validated at initial installation, and when a change is made to the
system.

11. FDA Regulation cGMP regulations: 21CFR parts 210 and 211
– In summary, these regulations require that manufacturing
processes be designed and controlled to assure that in-process
materials and the finished product meet predetermined quality
requirements and do so consistently and reliably.
– § (a) states “there shall be written procedures for
production and process control designed to assure that the drug
products have the identity, strength, quality, and purity they
purport or are represented to possess...”

12. FDA Guidance
Process Validation: General Principles and Practices (January 2011)
Blood Establishment Computer System Validation in the User’s Facility (April 2013) - (BECS)
Risk Assessment

13. CMS – Clinical Laboratory Improvement Amendments (CLIA)
Verification of Performance Specifications – Brochure #2
Accuracy
Precision
Reportable Range
Reference Intervals
Apples to Patient Test Performance

14. CLSI – Clinical Laboratory Standards Institute
CLSI ILA33-A:2009 Validation of Automated Systems for Immunohematological Testing Before Implementation, 1st Edition
CLSI EP18-A2:2009 Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition
Laboratory Best Practice guidelines

15. Validation, Verification, Requalify
New Equipment /Software IQ OQ PQ
FDA Risk Assessment
BECS
CLIA Test Specifications
Requalify after moving, repair, post implementation monitoring
Ortho Vision Analyzer X
Blood Irradiator
BB Plasma Thawer
Blood Storage Cooler
BB Refrigerator
Electronic XM
Digitrax Label printer
BB Cell Washer
Validation
Verification

16. Validation, Verification, Requalify
New Equipment /Software IQ OQ PQ
FDA Risk Assessment
BECS
CLIA Test Specifications
Requalify after moving, repair, post implementation monitoring
Blood Warmers X
Bellmont Rapid Infuser
Haemonetics 5+
Pneumatic tube transport system
Validation
Verification

17. Required Documentation for Validation
Written Plan
People, roles and responsibilities
Biomedical, Field Service Engineer, CLS, Project Managers, Project Sponsors
IT support staff, BECS interface – Software change control
Laboratory Medical Director as a final approver
Equipment documentation from the vendor
Operating instructions, environmental requirements, performance specifications
Equipment / Analyzer customer configuration
Risk assessment
Sequence of testing – IQ, OQ, PQ

18. Required Documentation – cont’d
Written Procedures for assessing and/or testing each element (IQ, OQ, PQ)
Includes vendor performance specifications and customer quality attributes
Training for those individuals that will conduct the test cases
Data collection evaluation and final summary with approvals
Problem resolution process defined
Post approval
Operational SOPs developed based on final analysis – Lessons learned
Staff Training and Competency
Implementation of the new equipment / analyzer
Monitoring for any potential unforeseen issues

19. Ortho Vision Validation Plan

20. Risk Assessment

21. Scope Roles & Responsibilities

22. IQ based on manufacturer’s specifications

23. OQ & PQ

24. Acceptance Criteria

25. Validation Summary

26. Laboratory Pneumatic Tube for Specimens and Blood Product transport
Uses formal validation plan with IQ, OQ and PQ
IQ – assessment of the pneumatic tube installation specifications, mapped routes
OQ – assessment of the basic functions, programming, longest route, routes exposed to exterior temperatures
PQ – Use paired patient test samples 1st ) sent to the lab 2nd) sent though the tube
PQ – Blood product visual assessment before and after tube transport, pRBCs evaluated for increased hemolysis (pre and post transport plasma hemoglobin measured)

27. Blood Bank Equipment IQ & OQ

28. Qualification / Requalification
Examples:
Small table top equipment such serofuge for manual tube testing:
Verification
Upon initial installation & calibrate manual test tube method performance
Measure rpm/timer at 6 month intervals
Daily QC
Requalify:
If moving from one bench top to another perform basic maintenance, daily QC

29. Requalify - Blood Transport Coolers
Initially new coolers are validated
Use expired blood products and pack in various configuration
Measure time and temperature, using a NIST thermometer
Define policy on remote blood storage use based on data
Yearly Requalify each cooler based on:
Visual integrity of the contain, lid closure

30. Questions?