CLS 3311 Advanced Immunohematology

1. CLS 3311Advanced Immunohematology Quality Assurance Chapter 15 Modern Blood Banking and Transfusion Medicine

2. Regulatory Agencies • Health Care Financing Administration (HCFA) • CLIA ’88 regulation requires QA program • Food and Drug Administration (FDA) • 21 CFR 606 and 21 CFR 211.22 Accrediting Agencies • American Association of Blood Banks (AABB) • Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) • College of American Pathologists (CAP)

3. Regulatory Agencies Clinical Laboratories are accountable to the following agencies and need to adhere to and have copies of regulations and standards on site: Health Care Financing Administration(HCFA) Clinical Laboratory Improvement Amendments 1988 - (CLIA ’88) regulations require a Quality Assurance program be established in Clinical Laboratories. There is much more to these amendments but this is the most significant. I have added a link to each agency to enable you to go to their website and review what each expects of a blood bank or transfusion center.

4. Regulatory Agencies Food and Drug Administration(FDA) • Federal codes under which Blood centers and Transfusion services are regulated include: 21 CFR 606 and 21 CFR 211.22 (CFR stands for Code of Federal Regulations). These must be onsite and followed. • FDA defines blood as a “Drug” thus it regulates it under those standards.

5. Accrediting Agencies • Represent Voluntary Compliance: Transfusion services and Blood Banks can voluntarily apply for and receive accreditation from the following agencies. Accrediting Agencies • American Association of Blood Banks(AABB) • Inspections and accreditation as a reference lab • College of American Pathologists(CAP) • Periodic Inspections • CAP Surveys: Specimens with histories to be performed in the lab by current personnel

6. Quality Systems • “Quality programs encompass quality control (QC), quality assurance (QA), and quality improvement into a broad-based program that ensures application of quality principles throughout the operational areas of an organization.” AABB Technical Manual

7. Quality Assurance A set of planned actions to provide confidence that SYSTEMSand ELEMENTS that influence the quality of the product or service are working as expected individually and collectively.

8. What is Quality Assurance What is Quality Control What is Current Good Manufacturing Practices (cGMP) The overall process of quality improvement and maintenance in the entire blood bank. Routine testing of Blood Bank Reagents to insure potency, calibration of serofuges, taking temps on fridges and freezers, testing blood components, etc. Following guidelines found in Standard Operating Procedures (SOP).

9. Comparison of Two QA Systems • AABB Quality System Essentials • Developed to be consistent with ISO Standards and FDA Guidelines. • International Organization of Standardization (ISO) • Business and Industry are responsible to ISO standards to maintain quality and performance. • Following Table: Left column is AABB system and right column is corresponding ISO standard.

11. AABB Quality System Essentials • Number 5 under the AABB system is:Process control, final inspection and handling. • Under the heading of Process Control alone, there are approximately 9 parameters, which are outlined in the next two slides.

12. Total Process Control 1. Development, maintenance and use of SOP’s 2. Processes to control change to policies, processes, or procedures 3. Process for acceptance testing for new/revised software involved in blood bank procedures 4. Process validation of new policies, processes, or procedures 5. Monitoring and control of production processes

13. Total Process Control 6.Participation in proficiency testing appropriate for each system in place. 7. Establishment of QC schedules and monitoring of QC policies, processes, and procedures 8. Processes to determine that supplier qualifications and product specifications are maintained 9. Processes to control nonconforming blood and blood components and products

14. Project #1 • The student and their Blood Bank Manager or QA Officer (or whoever!) need to review the preceding list and select a topic under which the student can perform a project that would serve the Blood Bank and make the Faculty happy. • For example: #2 on the list would involve any changes in the SOP manual. The student could go through the SOP and revise and/or update any necessary changes or write a new SOP.

15. Why we do this!?! Sources of error in Blood Administration • Outside Transfusion Service – 58% • Inside Transfusion Service – 25% • Both – 17% Is 99.9% performance good enough? • 16,000 pieces of mail lost every hour • 500 incorrect surgeries each week • 2 unsafe landings at O’Hare airport/week • 1 hour of unsafe drinking water each week • Remember the list of Agencies?

16. Out of 3000 ABO Groupings… Out of 5000 Cross- matches Result in 30 Incorrect ABO’s groupings Result in 50 incorrect crossmatches 99% Performance in the Blood Bank: Good Enough?

17. Examples of Errors Patient sample labeling error Blood issued to wrong patient Incorrect grouping/typing due to technical error Incorrect grouping/typing due to clerical error Incomplete quality control of reagents 99% Performance in the Blood Bank

18. How do we reduce errors? • CLIA ‘88 states that clinical laboratories must have a Quality Assurance Plan in place. • Does a Quality Assurance Plan guarantee no technical errors or the production of blood components that will not transmit disease, etcetera? NO!! • But, it does provide a mechanism to improve the quality of work performed and components produced.

19. Validation • Establishing documented evidence that provides a high degree of assurance that a specific process consistently produces a product that meets the predetermined specifications and quality attributes.

20. ValidationPlan • Suggested Elements of a Validation Plan • System description • Purpose / objectives • Risk Assessment • Responsibilities • Validations procedures • Acceptance Criteria • Approval signatures • Required supporting documentation • Implementations time line

21. Validation of Equipment Installation qualification • Operates within manufacturers specifications Operational qualification • In all cases the process will produce the desired result or defines the process limitations Product qualification • Assurance that the process results in acceptable measurable or quantifiable specifications attributed to the product

22. Documents and Records • To be in compliance facilities must have a process to insure that documents (policies, process descriptions and procedures) are identified, approved, implemented and retained. • The next slide represents the levels of documents in an organization.

23. Policies Level 1: Policies “What to do” Processes Level II: Processes“How it happens” Procedures Level III: Procedures “How to do it” Forms/Records/Supporting Documents/Data/ QC Records/Templates Level IV: Forms, etc.

24. Changes to SOP • Effective Dates: When process was instituted • Retired documents: must be stored according to regulations • Appropriate demonstrable control of SOPsare required by regulatory agencies: 21 CFR 211.100 requires SOPs to be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit

25. Quality Control • QC results are used to determine if specific critical practices are performed within the established range of acceptability. ESSENTIAL: QC of equipment and methods used for collecting, testing, modifying, or otherwise affecting blood or transfusion.

26. Question? • Post on the discussion board quality control measures that you participate in every day and every week. • List as many as you can. • Consider, also, the consequences of NOT performing quality control on these systems! What would be the outcome? Why?