The document discusses the importance of laboratory quality management amidst fiscal and human resource constraints, highlighting the need for accreditation, quality assurance, and total quality management. It emphasizes that medical errors often stem from systemic issues rather than individual mistakes and advocates for better data management and actionable processes to enhance laboratory services. Recommendations include improved test selection, interpretative services for complex results, and continuous monitoring to optimize performance and reduce errors.

1. Laboratory reorganization in view of fiscal & human resource constrains Dr. Ashok Rattan, Chief Executive, Fortis Clinical research Ltd., Adviser, Religare SRL Diagnostics labs in Fortis / Escorts Hospitals, Delhi & NCR

2. Optimal Laboratory System

4. Quality in Laboratory Services

5. What is Quality ? Quality is difficult to define, Invisible when GOOD, impossible to ignore when BAD Doing the right thing, right (the first time) Dr. James Hospedales, PAHO Meeting and exceeding expectations (STANDARDS)

6. International Standards Organization Quality : The totality of features & characteristics of an entity that bears its ability to satisfy a stated or implied need Quality control : Determines to what extent a product or service complies with a set standard Quality assurance : Is a more comprehensive approach to quality. Based on structure – process – outcome framework Total quality management : an organization wide approach aiming at continuously improving overall performance.

7. International standards for Diagnostic Labs: ISO 15189 Importance of accreditation Recognises competence Facilitates exchange of services Provides a valuable management tool Ensures the needs & requirements of all users

8. Principles of accreditation Adherence to high professional standards Timeliness of test results Laboratory accuracy & precision Clinical relevance Qualification of laboratory professionals Training of personnel Prevention of error

11. Use of 12 QSE would ensure Reduction or elimination of medical error Likelihood to meet customer satisfaction Potential for successfully meet accreditation assessment Sustained attainment of quality objectives

12. We never make any mistakes in our Laboratory , Mr. Sharma My name is Sunil Verma Recognize that we ALL make mistakes

13. To err is human 1999 (IOM report) 44,000 to 98,000 Americans die each year from medical error >8 th leading cause of death >motor vehicle deaths, breast cancer or AIDS Laboratory tests errors: 50 % : failure to use indicated tests 32% : failure to act on results of test or findings 55% : involved delay in diagnosis

14. Deaths in USA due to medical error are Equivalent to ONE Jumbo jet crashing every day of the year

15. Old Paradigm Errors because of bad apple Name, Blame and Shame

16. Deficiencies in design, organization, maintenance, training and management create conditions in which persons are more likely to make mistakes. Deming Red beads experiment

17. Medical error is a failure of process The concept that errors result largely from the failure of systems, not from individual carelessness or inadequacy, is fundamental to the new efforts to address safety and runs counter to the traditional focus of medical training on individual performance

18. Blunt and Sharp end model

19. Swiss cheese model of error prevention

20. Optimal Laboratory System

21. 9+2 Establish NETWORK Set up Rapid response labs Supported by Reference Lab

22. Pre analytical Sample Collection & Transportation

23. SRL Clinical Reference Laboratory: The lab that never sleeps Infrastructure & Trained Manpower

24. Analytical Automation

25. IT enabled bidirectional interphase Post Analytical

26. Processes & Accreditation

28. Which tests are available Which can be ordered as STAT How to complete lab request form Pt preparation & precollection assessment Collection instruction Transport, temperature, storage Feedback on specimen quality Tracking mechanism Roles & Responsibilities

29. Performing the tests as per SOP Use ICQ Participate in EQA Verify validity of test results Interpreting the findings Reconcile significant disparity

30. Preliminary reports Final report Report TAT Corrected reports Specimen management Report & material archiving

32. Data, data, data, My dear Watson, I can not do anything without data Whatever gets measured, gets done Why measure ? To take action to ensure success of reaching goals What ? Key actionable process elements that will help monitor the process Where ? As close as possible to the variation When ? As often as necessary How ? As unobtrusively as possible Monitoring

33. constantly review quality of results

38. frequently review output

39. review workload & optomise (wo)manpower

40. Provide Regular Feedback & Monitor Corrective Action

41. Effect on Workload in NCR Total Accessioning TOTAL 49,915 65,724 89,536 973 771 729 423 279 219 - - - ROT 6294 6303 4485 3333 3264 3267 3459 2871 2843 DLF 5945 3938 3658 3471 3474 3321 3028 2951 2656 SUN 3719 3160 3269 2696 2843 2601 2926 1271 2287 FHJR 6902 5012 4883 4129 4232 3471 3887 3299 2736 PV 7148 6084 5350 4804 5083 4911 5569 5222 4949 FHVK 11783 11351 10405 8552 8589 9001 9667 8278 7875 FHN 46772 44281 44859 42634 44388 38933 42108 30818 26569 GGN Sep Aus Jul Jun May Apr Mar Feb Jan Labs

42. A decade back Diagnosis known & tests available Clinicians experience In test selection & interpretation No difference

43. Situation now Diagnosis known & tests available Clinicians’ experience In test selection & interpretation No expert advice provided unless asked

44. Potential solutions Use Reflex testing as much as possible to increase appropriateness of test selection Provide patient specific narrative interpretation of test results for complex evaluation of many areas of laboratory medicine (obtain relevant clinical information whenever necessary)

45. Potential solutions (Go the extra “mile”) Results only Canned comments with results (IR) Patient specific interpretation of results (often requires detailed clinical data)

46. Answer questions on lab Related issues Necessary to get Visibility in patient care Provide interpretative services For complex tests Necessary to gain indispensability in patient care

47. Secret of Quality Juran: Reduce variation ( Variation is evil ) Imprecise Precise Precise Inaccurate Inaccurate Accurate

48. Even if we are on the right track we risk being run over, if we just sit there ACT

49. Pre-Analytic Analytic Post-Analytic Data and Lab Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing Quality is not a trivial thing, but attention to trivial detail leads to quality even in these times of fiscal & human resources constrains