final 10 sept skills and knowledge required for accreditation with focus on competency assessment.pptx

Accreditation is an essential step in providing quality lab services. Competency testing is also required to make sure that staff is well trained and competent to carry out the activity.

1. Skills & Knowledge required by Laboratory personnel for Accreditation of their laboratories focus on competency assessment Prof. Ashok Rattan, MD, MAMS, Common Wealth Fellow, INSA DFG Fellow, SEARO Temporary Advisor, WHO Lab Director (CAREC/PAHO) Advisor: Pathkind Labs Knowledge Forum, R & D and Quality

2. Laboratory Medicine Plays an important role in management of patients Laboratory tests influence 70% of all medical decisions Laboratory spend is 3% of total healthcare cost

3. Laboratory test results help decide A. Clinical medicine : 1. Diagnosis, prognosis & predictive assessment of patients 2. Prevention or monitoring of disease 3. Management of treatment B. Public health: 1. Aggregate of test results are used for disease surveillance 2. Healthcare performance measurement 3. Quality improvement C. Clinical Research data also provide: 1. New knowledge for innovation 2. Evidence based medicine 3. Improve clinical practice guidelines

4. Optimal Laboratory System

5. Test selection Test ordering Sample collection Transportation Sample Accessioning Analysis Reporting Interpretation ACTION 1. Has the right test been ordered ? 2. Errors between result receipt & action Preanalytical Preanalytical Preanalytical Pre Preanalytical Pre Preanalytical analytical Post analytical Post analytical Post post analytical Post post analytical Diagnostic Cycle Pre Examination Examination Post examination Pre Pre Examination Pre Examination Examination Post Examination Post Post Examination

6. 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

7. Change in understanding about how to fix the problem Identify bad apple Name, blame & shame Deming Red Bead Experiment with Sampling Paddle

8. 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 Process Input Output Patient sample Laboratory Processes Test Report

9. Quality Documents

10. Document Creation, Review & Approval Process

11. Requirements for QSE Customer Focus

12. Laboratory Medicine curriculum Is packed with updated & relevant topics But requirements for accreditation is not part of the curriculum

13. What is the definition of Quality ? Deming:  "Quality is defined from the customer’s point of view as anything that enhances their satisfaction ". Juran :  "Fitness for use. Those product features which meet the needs of customers and thereby provide product satisfaction. Freedom from deficiencies". ASQC:  "The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs ". COPC:  "Quality is defined as knowledge of agents that would enable them to provide accurate and consistent solution to the customer at the very first attempt”. ISO:  "Degree to which a set of inherent characteristics, of a product or service, fulfill requirements ”.

14. What do the customers want ? B  B B  C 1. Reliable & Reproducible or Accurate & Precise 2. In clinically relevant TAT 3. At reasonable price If the laboratory is not producing results that are accurate, reliable, interpretable and timely That laboratory is a liability in the healthcare system and can do much harm

15. Reliable & Reproducible or Accurate & Precise

16. Benefits of Accreditation 1. Assurance of technical competence 2. Risk reduction 3. Staff confidence 4. Improve communication 5. International recognition 6. Peer review of laboratory operations 7. Demonstrates a commitment to quality and accountability 8. Continuous improvement 9. Different perspective 10. Volunteering as assessor

17. ISO 15189 accreditation in Medical Laboratories is accorded in 1. Clinical Biochemistry 2. Clinical Pathology 3. Haematology 4. Microbiology & Infectious disease serology 5. Histopathology 6. Cytopathology 7. Flow Cytometry 8. Cytogenetics 9. Molecular Testing

18. ISO 15189 Standard: Medical Laboratories- Requirements for Quality and Competence Clause 4: Management Requirements 1.Organization & Management responsibilities 2. Quality Management system 3. Document control 4. Service Agreements 5. Evaluation of referral laboratories 6. External services & supplies 7. Advisory services 8. Resolution of complaints 9. Identification & control of non- conformaties 10. Corrective action 4.11 Preventive action 4.12. continual improvements 4.13 control of records 4.14 Evaluation & audits 4.15 Management review Clause 5: Technical Requirements 1 Personnel. 2. Accommodation & Environmental conditions 3. Laboratory equipment, Reagents & consumables 4. Pre examination processes 5. Examination processes 6. Ensuring quality of examination 7. Post examination processes 8. Reporting of results 9. Release of results 10. Laboratory Information Management

19. QMS includes both QC & QA as well as management activities to make a lab’s best contribution to patient care Process approach & risk based thinking Quality Planning defines all process components & elements of pre examination, examination & post examination including QC & QA for each test Measures & assesses the effects of all activities in the diagnostic pathway (clause 4.12 – 4.15) Findings from clause 5.6 requirements & EQAS results (5.6.3) Monitors the performance of measurement systems (5.6.2) Consists of both statical & nonstatistical controls Quality Control Quality Assurance Quality Management

20. Correlation between CLSI GP 26-A3 & ISO 15189:2012 CLSI GP 26- A3 ISO 15189 : 2012 Documents & Records 4.3. Document control 4.13 Control of records (quality & technical records) Organization 4.1 Organization & management responsibilities 4.1.1.3 Ethical conduct 4.2 Quality management system 4.15 Management review Personnel 5.1 Personnel Equipment 5.3.1 Laboratory equipment 5.10 Laboratory information management Purchasing & inventory 4.4 Service agreements 4.5 Examination by referral laboratories 4.6 External services & supplies

21. CLSI GP 26- A3 ISO 15189 : 2012 Process Control 5.4 Pre examination processes 5.5 Examination processes 5.6 Ensuring quality of examination results 5.7 Post examination processes 5.8 Reporting of results Information Management 5.10 Laboratory information Management Occurrence Management 4.10 corrective action 4.11 Preventive action 4.14 Risk management Assessment: External & Internal 5.6.2 Quality control (IQC) 5.6.3 Inter laboratory comparisons; 5.6.3.2 Alternative approaches 5.6.4 Comparability of examination results Process Improvement 4.12 Continual improvement; 4.14 Evaluation and audits 4.14.7 Quality indicators; 4.15 Management review Customer Service 4.1,2,2 Needs of the users; 4.7 Advisory services; 4.8 Resolution of complaints; 4.14.3 Assessment of user feedback 4.14.4 Staff suggestions; 4.14.8 Reviews by external organizations Facilities & Safety 5.2 Accommodation & environmental conditions

22. ISO Quality Principles Customer focus Leadership Involvement of people Competency assessment Process approach Systems approach to management Continual improvement Factual approach to decision making (evidence based) Mutually beneficial supplier relationship

23. Involvement of people People at all levels are the essence of an organization & their full involvement enables their abilities to be used for the organizations benefits Involvement of people typically leads to Understanding the importance of their contribution & role in the organization Identifying constrains in their performance Accepting ownership of problem & their responsibility for solving them Evaluating their performance against their personal goals & objectives Actively seeking opportunities to enhance their competence, knowledge & experience Freely sharing knowledge & experience Openly discussing problems & issues

24. 5.1. Personnel 5.1.1. General 5.1.2. Personal qualifications 5.1.3. Job Description 5.1.4. Personal introduction to the organizational environment 5.1.5. Training 5.1.6. Competency assessment 5.1.7. Review of staff performance 5.1.8. Continuing education & professional development 5.1.9. Personal records

25. Major Requirements for QSE Personnel

26. Competency assessment 5.1.6. Following appropriate training, the laboratory shall assess the competence of each person to perform assigned management or technical tasks according to established criteria How & By whom Two direct observations Two review of documents Two assessments

27. What is Competency ? Competency is the ability of personnel to apply their skills, knowledge & experience to perform their laboratory duties correctly Who is required to have a competency assessment undertaken ? Clinical consultants Technical consultant Technical supervisors General supervisors Testing personnel Lab Director is responsible to ensure that all testing personnel are competent & maintain their competency Who is responsible for performing competency assessment ? Technical consultant

28. ISO defines Competency : demonstrate ability to apply knowledge & skill Education Training Experience

29. Technical Competence Examination Process Professional Competence Advice on test selection Interpretation of results Management of quality & risk Organizational competence

30. Competency assessment Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observations of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills

31. From CAHO Webinar by Dr Venkatesh Thupill

32. From CAHO Webinar by Dr Venkatesh Thupill

33. From CAHO Webinar by Dr Venkatesh Thupill

34. From CAHO Webinar by Dr Venkatesh Thupill

35. From CAHO Webinar by Dr Venkatesh Thupill

36. From CAHO Webinar by Dr Venkatesh Thupill

37. From CAHO Webinar by Dr Venkatesh Thupill

38. From CAHO Webinar by Dr Venkatesh Thupill

39. From CAHO Webinar by Dr Venkatesh Thupill

40. From CAHO Webinar by Dr Venkatesh Thupill

41. From CAHO Webinar by Dr Venkatesh Thupill

42. From CAHO Webinar by Dr Venkatesh Thupill

43. From CAHO Webinar by Dr Venkatesh Thupill

44. From CAHO Webinar by Dr Venkatesh Thupill

45. From CAHO Webinar by Dr Venkatesh Thupill

46. From CAHO Webinar by Dr Venkatesh Thupill

47. From CAHO Webinar by Dr Venkatesh Thupill

48. From CAHO Webinar by Dr Venkatesh Thupill

49. From CAHO Webinar by Dr Venkatesh Thupill

50. From CAHO Webinar by Dr Venkatesh Thupill

51. From CAHO Webinar by Dr Venkatesh Thupill

52. From CAHO Webinar by Dr Venkatesh Thupill

53. From CAHO Webinar by Dr Venkatesh Thupill

54. From CAHO Webinar by Dr Venkatesh Thupill

55. Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives, Quality also marks the search for an ideal after necessity has been satisfied and mere usefulness achieved. Will A. Foster Doing the Right thing Right, the First time & Every time “ The bitterness of poor quality remains long after the sweetness of low price is forgotten ” Benjamin Franklin

56. I Thank You for your attention