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. FOR BLOOD BANKS/ BLOOD CENTRES & TRANSFUSION SERVICES
NABH STANDARDS
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 step is 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. QA program - 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 labeling and 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: C for not more than 8 hours

10. Factors Affecting the Quality of Blood Components (2)
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

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 hrs
x 9 min at 22oC)
Red cells Platelet 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
Whole Blood Derived
Apheresis Derived
Packed Red Cells
Volume (450ml) - 280±40ml
(350ml) - 220±30ml
Hct %±5
Hb content g/unit
Leucocyte – 109
360ml
65% to 75%
≥51g/unit
<5x106
Platelets (PC)
Volume – 70 ml
Platelet count ≥ 5.5 x 1010
Leucocyte content x107 to 5.0x108
Red cell contamination ml
200 – 300 ml
≥3.0 – 7x1011
< 5.0x106
Traces to 0.5ml
Plasma
Volume – 230 ml
Fibrinogen – 400mgm/unit
Factor VIII U/ml
450 – 800ml
400 mg/unit
≥ 0.7 IU/ml

21. Process control is imperative
Objectives:
reduce lot to lot variation in BC manufacture
reduce risks 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. MOST COMMON LABORATORY ERROR
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
Summarize the presentation, emphasizing the importance of error reporting and management and the concept of ‘improvement opportunity’
Emphasize the importance of all staff and users being fully aware of error reporting policies and systems
Emphasize the importance of not punishing people for errors
It is essential that errors are reported and, in a culture of fear, they will not be reported
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