Process Control i n a Component Laboratory

1. Process Control in a Component Laboratory Dr.S.B.Rajadhyaksha, MD,DTM,PGDMLS Professor & Head Dept. of Transfusion Medicine Tata Memorial Hospital, Mumbai

2. Blood Components (BC) processing • Biological variations between blood donors influence the component production/ quality • BC are highly concentrated, not completely free of other blood elements • BC processing cannot completely optimize product quality

3. QUALITY SYSTEM ESSENTIALS (AABB Standards) 1. Organization 2. Resources 3. Equipment 4. Supplier and Customer Issues 5. Process Control 6. Documents and Records 7. Deviations, Non-conformances, and Adverse Events 8. Assessments: Internal and External 9. Process Improvement -Corrective and Preventative Action 10. Facilities and Safety

4. NABHSTANDARDS FOR BLOOD BANKS/ BLOOD CENTRES &TRANSFUSION SERVICES • PROCESS CONTROL Note: Some of the following might not be applicable to the scope of all blood banks/ blood centres. 6.1 Policies and validation of processes and procedures The blood bank/ blood centre shall have policies and validated processes and procedures that ensure the quality of the blood, components and services. The blood bank/ blood centre shall ensure that these policies, processes and procedures are carried out under controlled conditions. Process or procedure steps For each critical step in collection, processing, compatibility testing and transportation of blood and components issued, there shall be a mechanism to identify who performed the step and when it was performed.

5. PROCESS CONTROL Defn.: Sum of actions that assures processes are operating within acceptable parameters and established practices Ensures each stepis performed in a consistent manner (SOPs) Each critical step in a process should be traceable. Each staff member involved in each process along the way should be documented. 3. QAprogram - verify reagents and equipment functioning as intended 4. Measures to reduce chances of bacterial contamination 5. There must be a well defined process for product labelingand review. 6. Proficiency testing (e.g. EQAS) - to compare the accuracy & reliability of test methods

6. Process Variation Process can be out of control due to • Malfunctioning equipment • Defective reagents or supplies • Untrained staff • Incorrect procedure

7. Process Control Steps Produce Goods Start Provide Service No Take Sample Problem? Yes Inspect Sample Stop Process Create Find Out Why Control Chart

8. Collection and Processing of Components (WB and Apheresis) by Component extractor Particular component is collected

9. Factors Affecting the Quality of Blood Components (1) • Selection of donor: Antiplatelet drug therapy, defer for 72 hours • Quality of blood bag and anticoagulant used • Techniques of phlebotomy • Clean venipuncture - minimal tissue trauma • Flow- uninterrupted, should be completed in 8-10 min • Frequent gentle mixing • Time period: separation within 6-8 hrs of collection • Transit temperature: 20-240C for not more than 8 hours

10. 6. Precentrifugation: Allow for 2 hours of resting time 7. Centrifugation: calibration Critical variables – speed, temp, duration, rotor size Accurate balancing, Bag position Gentle handling, Resuspension of platelets 8. Storage temperature 4±20C = WB, PRBC 200C-240C = platelets ≤ -300C = FFP, Cryoppt 9. Uninterrupted, gentle flat bedded platelet agitator 60-70 cycles /min Factors Affecting the Quality of Blood Components (2)

11. Component Preparation protocol Weighing Counter balancing Expression Centrifugation

12. Collection and processing method of Platelet Concentrates (PC)

13. PRP method for preparation of platelets Whole blood Soft spin within (1800 rpm 6 hrs x 9 min at 22oC) Red cellsPlatelet rich plasma (PRP) Hard spin (3000 rpm x 7 min at 2 Plasma Platelet Conc. (RDP)

14. Platelet Preparation Buffy Coat Method

15. Separation of component using Automatic component extraction Conventional Quadruple Bag (TAT) Top and Bottom Bag (TAB)

16. Quality Control of Blood Components • Should be performed on • >/= 1% of all components produced per month • (if fewer than 100 per month, at least 4) • >/= 75% components tested must meet specifications

17. Sampling • Mixing of product and stripping of lines Should be standardised • For platelet count Samples in dry EDTA tube, to induce disaggregation • Sampling methods must be validated - consistent samples, regardless of operator

18. Sampling …contd. • NOT to be taken from the last part of the tube • This section is difficult to strip properly and the last 2 cm should be cut off after stripping the rest of the line

19. When to Perform Quality Control • For platelet products it should be done on expiry date (end of storage period) of the component • On installation and after repair of equipments (refrigerator, centrifuges, deep freezers etc.) • Modification in procedure for components preparation • Recruitment of new personnel

20. Comparison of QC Parameters of Blood Components

21. Process control is imperative Objectives: • reduce lot to lot variation in BC manufacture • reducerisks of Tx to as low as reasonably achievable Based on principles Continuous Statistical Process Improvement process control Innovation

22. Process Improvement Continuous Improvement is the Goal • Data collection & analysis of performance • Identification & evaluation of problems & solutions • Changes to improve performance • Corrective action reduces or eliminates recurrence • Preventive action eliminates potential non-conformance to prevent occurrence

23. Statistical process control • Problem solving tool in attaining process stability and improving capability by decreasing variability e.g. Control charts to identify non conforming lots or individual components and to detect trends • Centered on error management - redesigning processes to prevent error from recurring

24. Process innovation • Employs information technology to control manufacturing processes • Next opportunity to improve significantly the safety and quality of blood supply

25. Error Management • Systems need to be in place to report & investigate quality incidents or errors • Systems of correction, CAPA need to be in place of which all staff and users need to be aware of • Incidents must be used to improve processes / procedures, not to punish staff MOST COMMON LABORATORY ERROR Transcription

26. To summarise… • Process control necessary to ensure a process is stable, predictable and with minimum variability • Validation of SOPs and QC: Evaluation of performance of process • Proficiency testing (EQAS): Comparison of performance to a goal • Error Management/Audit: Control of non-conformances • Regular monitoring and control of production /process will ensure safer and consistency of quality of Blood components