Total Quality Management in blood transfusion services

1. Total Quality Managementin blood transfusion services Prof. NeelamMarwahaM.D; F.A.M.S; F.I.S.H.T.M. Head, Department of Transfusion MedicinePostgraduate Institute of Medical Education and Research, Chandigarh

2. Quality – A Challenge in BTS • Blood is covered under the definition of ‘Drug’ under Sec. 3(b) of Drugs & Cosmetics Act • Quality of the end product cannot be tested as each unit is a batch in itself • Blood Banks need Quality management system to ensure that blood and blood products are safe for transfusion

3. Why Quality in BTS Quality is about consistently producing products that are fit for their purpose Safe • Free from infection risk • Free from other contamination • Correctly labelled • “In date” Effective • Contain required bioactive substances • Give clinical benefit • Lower risk of transfusion-associated morbidity or mortality • Fewer adverse transfusion reactions • Fewer transfusion-transmitted infections • Increased confidence in the BTS

4. Impossible to ignore when Bad Invisible when Good

5. Factors Affecting Quality OUTPUT Equipment, reagents Personnel PROCESS INPUT Environment Methods

6. Total Quality Management TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization. In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations

7. Key Elements of TQM

8. Why TQM • Blood transfusions today are safer than ever before, yet there are increasing number of complaints and controversies. • This is likely due to the general public and governments having a low tolerance for risk in this area. • Transfusion Medicine is an evolving field with continuous questions on risks and benefits; management is thus becoming more complex.

9. Objective of TQM “Do the right things right the first time and everytime” or “ Achieve total client satisfaction through quality products and services and Endeavour towards continuous improvements”

10. Principles of TQM • Choice must be made by the top management, only then it will be translated to the whole organization • Inspection of the process is as important as the inspection of the product • Preventing variability is the key to producing high quality • Quality is a journey of continuous improvements, it is not a destination

11. National Standards for Quality in BTS

12. Level 1 Policy Level 2 Process Level 3 Procedure (SOP) Level 4 Forms, records, labels Document pyramid What will be done How it happens How to do it What was done

13. Quality Policy

14. Quality Planning • Mission Statement should be clear • Establish quality goals • Identify all activities required to meet regulations and accreditation standards • Develop operational processes for blood product preparation and issue • Develop process controls • Develop validation protocols

15. Organogram • The blood bank should have a written dated and signed organogram(organisational structure), clearly defining the reporting structures and hierarchies of the management and staff • The organogram should be displayed at a place where it can be viewed by the staff

16. Process Management • A process approach is important because a desired result is achieved more efficiently when activities and related resources are managed as a process • A process flow chart should be prepared with inputs, outputs and control points • Identify process owners,i.e. persons who actually perform the job • Communicate effectively and rapidly • Validate the process.In BTS this is essential since it is not feasible to inspect each product

17. Generic Flow – blood collection Donor recruitment Post donation care Donor selection Phlebotomy • Motivation • Education • Counselling • Retention • Medical • Physical • Hb testing • Interview • Consent • Identification • Labelling • Arm disinfection • Proper mixing/volume • Refreshment • Reactions • Observation • Gratitude MOIC Nurse MOIC / Nurse Motivator

18. Donor selection Yes No Fit Deferral Phlebotomy Successful No Yes Post donation counseling Adverse effects donation Actual process flow in blood collection • Donor Identification • Labeling of bag / tubes • Arm disinfection • Proper mixing / volume Deferral registry Thank the donor Management

19. Quality Indicators • Important tool of quality Management • Assess efficiency of key points in the process

20. Document Control System A document control system to ensure that documents are • written in a standardized format • approved prior to implementation • available at point of use • reviewed at least once every two years • identified with current revision status • indexed, filed , stored and disposed in a controlled manner • obsolete documents are destroyed

21. Quality Control and quality assurance • Operational techniques and activities used to monitor and eliminate causes of unsatisfactory performance • Internal QC (for precision) indicates reproducibility of results Control Charts, Run Charts • External QC (for accuracy) is also equivalent to Proficiency Testing ( Interlaboratory comparisons) • Proficiency testing is meaningful if handling and testing of PT samples is same as those for patient and donor specimens • Quality Assurance - defined as overall program that ensures that the final results reported by the laboratory are correct

22. Accuracy and precision • Accuracy: is the degree of closeness of measurements of quantity to actual (true) value. • Precision: also called reproducibility or repeatability, is the degree to which repeated measurements under unchanged conditions show the same results. • Two types of precision: intra-assay precision and inter-assay precision • Accuracy: is the degree of closeness of measurements of quantity to actual (true) value. • Precision: also called reproducibility or repeatability, is the degree to which repeated measurements under unchanged conditions show the same results. • Two types of precision: intra-assay precision and inter-assay precision

23. QA at All Levels from Vein-Vein Recruitment Hemovigilance Administration Selection Collection Issue Pre Tx Testing Processing Requesting for Tx Gp & TTI Testing Labelling & Storage QUALITY IN BLOOD SUPPLY QUALITY IN Tx PRACTICE Through ensuring quality at each CCP

24. Human resource management Choose right people for the right place Encourage teamwork • Improves communication • Makes workplace more enjoyable • Improves productivity • Helps in problem solving Define responsibility

25. Training • Orientation; processes,procedures,documents • In service refresher training • Workshops, CMEs, seminars • Higher courses; PG degree, diploma • Periodic review of training curriculum • National and international fellowships and conferences

26. Competency Assessment

27. Materials, supplies and services used as inputs to a process are considered “critical” as they affect the quality of products and services being produced Ref: AABB Technical Manual, 15th Edition

28. Examples

29. Non conforming supply • Initiate corrective action • Contact supplier • Withold payment • Request for replacement • Demonstrate evaluation if necessary • Repeat quality test on new supply • If acceptable release payment

30. Continuous Improvement Nonconforming products and services Customer complaints QC records Proficiency testing Audits Identification of problems Analysis of causes • Process flow charting may help to identify problem-prone areas • The cause-and-effect diagram or fish-bone diagram to arrive at a root cause • Pareto chart where causes are arranged in decreasing order of frequency

31. Root Cause Analysis of Failed Test Run

32. Corrective Action Eliminate detected nonconformity CAPA • Preventive Action • Prevent nonconformity occurrence

33. Example of CAPA • Remedial action • Discard unit, decontaminate centrifuge • Corrective action • Find out the cause if unit was over collected • Calibrate the centrifuge (speed) / biomixer (vol) • Preventive action • AMC of equipment • Checking volume before centrifugation Event: Rupture of whole blood unit during centrifugation

34. Poor Quality has High Costs Errors Repeat tests Equipment failures Wastage Delays Serious adverse events Litigations Tangible Costs Intangible Costs • Breach of trust with treating clinicians and the patients • Low morale of staff • Low market value

35. Assessment of bts Audit • A systematic independent examination and review to determine whether actual activities and results comply with planned arrangements. Internal Audit • Audits are formally planned and organized and are carried out by Quality Manager or designated personnel • Audits are not done by sections for their own activities. External Audit • Performed by a licensing/ accrediting agency or inspections by those not affiliated with that BTS

36. Evolution of the Concept of Quality Total Quality Management Quality Assurance Quality Management Quality Control

37. Appreciation • Words of praise for a task well done • Recording good performance in review reports • Letter of appreciation • Generous in giving grading in ACRs • Recommending for awards • Giving positions of responsibility • Creating special awards at CMEs,conference

38. To conclude TQM is the art of managing the whole to achieve excellence

39. Your Attitude determines your Altitude Stephen Covey Thank You