Laboratory Management With Constrains Iamm 2010


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Clinical laboratory services are a critical yet much neglected component of health systems in resource poor countries. They are crucial for public health, disease control and surveillance, and guide patient diagnosis and care, but their key role is often not recognized by governments or donors. Laboratory tests should be used to improve the outcome for individual patients or to provide public health information. However, if the quality of laboratory tests is poor, resources will be wasted on repeat tests or inappropriate management and the laboratory service will be inefficient.

The primary goal of Laboratory Medicine is to provide information that is useful to assist medical decision-making, allowing optimal health care. This can only be obtained by generating reliable analytical results on patient samples. Meaningful measurements are indeed essential for the diagnosis, monitoring, treatment, and risk assessment of patients. Inadequate laboratory performance may have extensive consequences for practical medicine, healthcare system, and, in conclusion, for the patient. Poor quality results may actually lead to incorrect interpretation by the clinician, impairing the patient’s

Accreditation authorities have identified twelve quality system essentials that need to be in place for a laboratory to perform clinical tests adequately and in a quality assured manner. Along with each laboratory performing tests that are in its scope, it is essential that duplication and excess capacity is addressed by forging and operating a network of laboratories leading to consolidation and integration of clinical testing. A network would have collection centers at places convenient to the patients, supported by frequent transfer of samples in appropriate conditions to the laboratory. In the laboratory there is a need for increased automation and relevant training of personnel and the setting up of centralized accessioning, pneumontic chutes for transport of samples to the work bench and for bidirectional interphased equipment to transfer results to desk top of laboratory physicians and after validation of results for the results to be electronically transferred by SMS and/or PDF files via email and/or becoming available online for clients, supplemented by delivery of hard copies of the results.

The challenge in the next decade for laboratory medicine is to accomplish these major changes in organization to meet fiscal restraint and shortage of adequately trained laboratory personnel. Collaborative networks, constructive use of point of care devices, and the development of rapport between laboratories and their clients leading to cost effective utilization of limited resources, are some of the strategies that will maximize patient benefit

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Laboratory Management With Constrains Iamm 2010

  1. 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. 2. Optimal Laboratory System
  3. 4. Quality in Laboratory Services
  4. 5. What is Quality ? <ul><li>Quality is difficult to define, </li></ul><ul><li>Invisible when GOOD, </li></ul><ul><li>impossible to ignore when BAD </li></ul><ul><li>Doing the right thing, right (the first time) </li></ul><ul><ul><ul><ul><ul><li>Dr. James Hospedales, PAHO </li></ul></ul></ul></ul></ul><ul><li>Meeting and exceeding expectations (STANDARDS) </li></ul>
  5. 6. International Standards Organization <ul><li>Quality : </li></ul><ul><ul><li>The totality of features & characteristics of an entity that bears its ability to satisfy a stated or implied need </li></ul></ul><ul><li>Quality control : </li></ul><ul><ul><li>Determines to what extent a product or service complies with a set standard </li></ul></ul><ul><li>Quality assurance : </li></ul><ul><ul><li>Is a more comprehensive approach to quality. Based on structure – process – outcome framework </li></ul></ul><ul><li>Total quality management : </li></ul><ul><ul><li>an organization wide approach aiming at continuously improving overall performance. </li></ul></ul>
  6. 7. International standards for Diagnostic Labs: ISO 15189 <ul><li>Importance of accreditation </li></ul><ul><ul><li>Recognises competence </li></ul></ul><ul><ul><li>Facilitates exchange of services </li></ul></ul><ul><ul><li>Provides a valuable management tool </li></ul></ul><ul><ul><li>Ensures the needs & requirements of all users </li></ul></ul>
  7. 8. Principles of accreditation <ul><li>Adherence to high professional standards </li></ul><ul><ul><li>Timeliness of test results </li></ul></ul><ul><ul><li>Laboratory accuracy & precision </li></ul></ul><ul><ul><li>Clinical relevance </li></ul></ul><ul><ul><li>Qualification of laboratory professionals </li></ul></ul><ul><ul><li>Training of personnel </li></ul></ul><ul><ul><li>Prevention of error </li></ul></ul>
  8. 11. <ul><li>Use of 12 QSE would ensure </li></ul><ul><li>Reduction or elimination of medical error </li></ul><ul><li>Likelihood to meet customer satisfaction </li></ul><ul><li>Potential for successfully meet accreditation assessment </li></ul><ul><li>Sustained attainment of quality objectives </li></ul>
  9. 12. We never make any mistakes in our Laboratory , Mr. Sharma My name is Sunil Verma Recognize that we ALL make mistakes
  10. 13. To err is human 1999 (IOM report) <ul><li>44,000 to 98,000 Americans die each year from medical error </li></ul><ul><ul><li>>8 th leading cause of death </li></ul></ul><ul><ul><li>>motor vehicle deaths, breast cancer or AIDS </li></ul></ul><ul><li>Laboratory tests errors: </li></ul><ul><ul><li>50 % : failure to use indicated tests </li></ul></ul><ul><ul><li>32% : failure to act on results of test or findings </li></ul></ul><ul><ul><li>55% : involved delay in diagnosis </li></ul></ul>
  11. 14. Deaths in USA due to medical error are Equivalent to ONE Jumbo jet crashing every day of the year
  12. 15. Old Paradigm Errors because of bad apple Name, Blame and Shame
  13. 16. <ul><li>Deficiencies in design, organization, maintenance, training and management create conditions in which persons are more likely to make mistakes. </li></ul><ul><li>Deming Red beads </li></ul><ul><li>experiment </li></ul>
  14. 17. Medical error is a failure of process <ul><li>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 </li></ul>
  15. 18. Blunt and Sharp end model
  16. 19. Swiss cheese model of error prevention
  17. 20. Optimal Laboratory System
  18. 21. 9+2 Establish NETWORK Set up Rapid response labs Supported by Reference Lab
  19. 22. Pre analytical Sample Collection & Transportation
  20. 23. SRL Clinical Reference Laboratory: The lab that never sleeps Infrastructure & Trained Manpower
  21. 24. Analytical Automation
  22. 25. IT enabled bidirectional interphase Post Analytical
  23. 26. Processes & Accreditation
  24. 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
  25. 29. Performing the tests as per SOP Use ICQ Participate in EQA Verify validity of test results Interpreting the findings Reconcile significant disparity
  26. 30. Preliminary reports Final report Report TAT Corrected reports Specimen management Report & material archiving
  27. 32. Data, data, data, My dear Watson, I can not do anything without data Whatever gets measured, gets done <ul><li>Why measure ? </li></ul><ul><ul><li>To take action to ensure success of reaching goals </li></ul></ul><ul><li>What ? </li></ul><ul><ul><li>Key actionable process elements that will help monitor the process </li></ul></ul><ul><li>Where ? </li></ul><ul><ul><li>As close as possible to the variation </li></ul></ul><ul><li>When ? </li></ul><ul><ul><li>As often as necessary </li></ul></ul><ul><li>How ? </li></ul><ul><ul><li>As unobtrusively as possible </li></ul></ul>Monitoring
  28. 33. constantly review quality of results
  29. 38. frequently review output
  30. 39. review workload & optomise (wo)manpower
  31. 40. Provide Regular Feedback & Monitor Corrective Action
  32. 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
  33. 42. A decade back Diagnosis known & tests available Clinicians experience In test selection & interpretation No difference
  34. 43. Situation now Diagnosis known & tests available Clinicians’ experience In test selection & interpretation No expert advice provided unless asked
  35. 44. Potential solutions <ul><li>Use Reflex testing as much as possible to increase appropriateness of test selection </li></ul><ul><li>Provide patient specific narrative interpretation of test results for complex evaluation of many areas of laboratory medicine (obtain relevant clinical information whenever necessary) </li></ul>
  36. 45. Potential solutions (Go the extra “mile”) <ul><ul><ul><li>Results only </li></ul></ul></ul><ul><ul><ul><li>Canned comments with results (IR) </li></ul></ul></ul><ul><ul><ul><li>Patient specific interpretation of </li></ul></ul></ul><ul><ul><ul><li>results (often requires detailed clinical data) </li></ul></ul></ul>
  37. 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
  38. 47. Secret of Quality <ul><li>Juran: Reduce variation ( Variation is evil ) </li></ul>Imprecise Precise Precise Inaccurate Inaccurate Accurate
  39. 48. Even if we are on the right track we risk being run over, if we just sit there ACT
  40. 49. Pre-Analytic Analytic Post-Analytic <ul><li>Data and Lab Management </li></ul><ul><li>Safety </li></ul><ul><li>Customer Service </li></ul>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