Quality control, quality assessment, TQM.pptx

QUALITY CONTROL, QUALITY ASSESSMENT, TQM

1. Quality Control in IVF Lab Dr. Deepthi Repalle Ph.D. IVF LAB DIRECTOR MOHAK IVF SRI AUROBINDO INSTITUTE OF MEDICAL SCIENCES INDORE

2. Quality Subjective/Imaginary Good quality does not necessarily mean high quality- predictable degree of uniformity and dependability suited to the market

3. Quality An expression of superiority of product Conformance to specification Conformance to customer opinions & expectations

4. Quality in IVF Services that meet patient expectations. Services that are efficient, safe & protect rights and dignity of all parties.

5. Terminologies Quality Quality control (QC) Quality assurance (QA) Total quality management (TQM)

6. Quality control Making sure each task is done correctly Involves monitoring & functional Within limits previously determined to tolerable References are used to verify results

7. Quality Assurance Focuses on procedures & systems Relates to the way work is done Quality is designed into the process. Thus increasing likelihood that the process will go exactly as planned. It includes QC

8. Quality Assurance vs. Quality control

9. Total Quality Management Achievement of total quality through everyone ’ s commitment & involvement. Management approach Central focus on quality Participation of all members

10. Total Quality Management .Know patient need .Improve processes .Training the staff .Communicate .Identify goals .Identify risk .Achieving KPIs .Collective responsibility

11. QC in IVF LAB Temperature CO2 & pH Microbial Contamination Media Disposables Air Quality Personnel training & evaluation

12. Temperature Spindle is temperature sensitive Gametes/Embryo temp-important determinant- success Daily temp check Display as well as thermocouple/thermometer Never relay on displays Traceability

13. Temperature Standard practice- qc monitoring should be the first event in the morning. Brief exposure/Prolonged exposure

14. CO 2 & pH Aim is to provide a stable & physiological pH Daily incubator check for CO 2 levels IR based device pH measurements at regular interval Humidity – 90-100% RH in the incubators Room humidity- <50% Gases –medical grade

15. Microbial contamination Incubator shelves Incubator water pan Air All surfaces Monthly once UV with AHU Disinfectants- embryo safety

16. Media & Disposables Quality tissue culture grade plastics Preferably IVF certified Media from reliable manufacturer & distributor Temperature maintenance of media Maintain material logs that can track the batch, shelf life, date of first use

17. Air Quality Clean room Particle count VOC’s AHU - Positive pressure, -HEPA filters,

18. Personnel Training and Evaluation Adhere to SOPS/ competence/timing Post wash survival rates Total motile fraction Monitor fertilization rate, oocyte degeneration rate Monitor clinician & embryologist combinations Monitor thaw survival rate

19. QC of Procedures Uniformity of the procedures Consistency of performance Written protocol at the performing site Materials and equipment –clearly listed Calculations required- simply and directly Protocols- reviewed annually

20. QC of Equipments Equipments operate- tolerable limits Periodic testing to confirm proper operation Biologically optimal conditions set- gametes Incubators, microscopes, refrigerators, storage Dewar's, heating blocks, heating surfaces etc., Corrective actions –out-of-tolerance Microscopes-clarity of the images daily

21. External Validation Andrology QC schemes Andrology reference CD ROMs Online resources ( QAP Online ) Yearly twice Air quality, lab culture conditions. Lab equipments maintenance

22. Validation validation is “confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.” Guidelines that outline the general principles for process validation. Quality, risks, safety, and efficacy should be considered from the design phase of a process.

23. Validation Certainly in IVF, the quality of the “end product” cannot be measured, so each contributing factor (infrastructure, equipment, and utilities) and all the steps of the process need to be known and controlled.

24. Process testing

25. QC in the clouds Cloud computing allows data to be accessed anywhere and creates a remote way of monitoring the periodic quality control data. Quality control reporting has its very core the monitoring of periodic drift. Drift may seriously influence the outcome and can signal a decline in equipment performance and well being if left unchecked.

26. QC in the clouds Six basic types of drifts and if not electronically recorded they can be difficult to recognize, subtle changes may be overlooked, and abrupt changes may be either missed or fleetingly disregarded. Using electronic means allows a way to precisely classify the data, reflect, and adapt to such changes quicker, whether these are sudden, incremental, or gradual deviations, recurring, sudden, or simply “noise”.

27. QC in the clouds

28. QC in the clouds

29. THE SMART LAB As processes in the ART laboratory have constantly been improved and refined with the implementation of quality management, it is time to realize that data can now be processed with minimal effort and inconvenience with the maximum computational power using existing cloud services. Quality control in the IVF laboratory can surely only benefit from a more digital integration and a more active uptake around the world by embryologists; it only remains to be seen if this forecast of new technologies can give a brighter outlook into the way we perform quality control giving this cloud a silver lining.

30. THE SMART LAB

31. There is only one thing that is truly important in an IVF laboratory Everything!

32. Thanks