Exploring the Medical Laboratory Quality ToolBox-A

1. Exploring the Medical Laboratory Quality ToolBox-A Michael A Noble MD FRCPC Clinical Microbiology Proficiency Testing program Program Office for Laboratory Quality Management University of British Columbia Vancouver BC

2. Managementby theMoment

3. Managementby theMoment You can try to fix them…

4. Managementby theMoment But they never go away!

5. So the better approach is… An systemic approach of organization, plan, review, and action gives you the best chance of success.

6. The Quality Toolbox Lean Surveys Six Sigma RISK FMEA Metrics Statistics The Quality Toolbox The Quality Toolbox

7. What are quality tools? LEAN Six Sigma ISO 9001: 2000 A quality tool is a supplement or component part of a quality program that usually will not stand alone but can enhance the total quality system

8. Mega-Tools Lean Six Sigma Priority Matrices and Risk Assessment Tools/Techniques Balanced Scorecards Brainstorming Control Charting Flow Charting Quality Indicators Surveys Tools in the Toolbox

9. Quality Indicators are Metrics(measured process information) Determine quality of services. Highlight potential quality concerns, Identify areas that need further study and investigation, and Track changes over time. 

10. Amazon.com $30.00 A really good, inexpensive reference book

11. Keeping ScoreUsing the Right Metrics to Drive World Class Performance1996 Many organizations spend thousands of hours collecting and interpreting data. However many of these hours are nothing more than wasted time because they analyze the wrong measurements, leading to inaccurate decision making. Mark Graham Brown.

12. Characteristics of Good Metrics

13. Seven Steps to Successful IndicatorsDo not start data collection until these are addressed Objective Methodology Limits Interpretation Limitations Presentation Action plan

15. Developing Indicators

16. Developing Indicators

17. Setting Relevant Limits and Ranges Set Objectively Validate by Study Clinical Relevancy Customer Expectation Matched Benchmarks Regulation 60 minutesRelevant or Easy?

18. Assessing Quality Indicators Importance Potential for Improvement Scientific Acceptability Reliability and Validity Feasibility Implementation and cost Usefulness Comprehensive Having QualityQuality Indicators

19. IQLM Indicator List • Diabetes monitoring (system) • Hyperlipidemia screening (system) • Test Order Accuracy and Appropriateness (pre-analytic) • Patient Identification (pre-analytic) • Adequacy and Accuracy of Specimen Information (pre-analytic) • Blood Culture Contamination (pre-analytic) • Accuracy of point-of-care testing (analytic) • Cervical cytology/biopsy correlation (analytic) • Critical Values Reporting (post-analytic) • Turnaround time (post-analytic) • Clinician satisfaction (post-analytic) • Clinician follow-up (post-analytic)

20. Ordered test is appropriate for patient care Patient consent appropriately collected Test utilization by clinician for best patient care Physician written order with every specimen Cost/benefit assessment for laboratory test menu Patient identification and its accuracy Preparation of patient for specimen collection Appropriate specimen container Timing of specimen collection Phlebotomy success Specimen integrity Specimen quantity Specimen transportation Accuracy of specimen identification Condition for specimen storage CLMA Survey Pre-examination Phase Indicator List

21. Quality Control EQA-external quality assessment Time to first result availability Specimen contamination Laboratory injuries or accidents Competency of testing personnel Vacancy of technical staff CLMA Survey Examination Phase Indicator List

22. Result reporting accuracy Adequacy of information for interpretation of laboratory tests Report delivery turnaround time Consistency of critical values reporting Result interpretation by physician Patient’s satisfaction with laboratory services Patient’s satisfaction specifically with phlebotomy services Physician’s satisfaction with laboratory services CLMA Survey Post-examination Phase Indicator List

24. Objective: to ensure that blood culture results reflect sepsis. Methodology: Count single bottle positives of common skin flora/ total sets Limits: Below 2% Interpretation: Meeting accepted limits all the time Limitations Definition may include some true infections and may miss others Presentation: Linear time graph Action plan: Identify and educate blood collector group. If stable for 2 years, then consider dropping from routine

25. Quality Indicators and Timing Use an indicator only as long as it providesyou with usefulinformation. Don’t get tied to your indicators

27. Objective: to ensure that blood culture are properly filled. Methodology: Count underfilled bottles / total bottles collected Limits: Below 2% (?) Interpretation: Wards with inexperienced collectors have problems Limitations Some frail and elder people have very weak veins and may be impossible to collect Presentation: Linear time graph Action plan: Identify and educate blood collector group.

28. Caution about patient outcome indicators Theoretically, outcomes best assess quality, but they are themost difficult to measure too many confusing variables Age, underlying conditions, therapy, circumstance requirehigh volumes of detailed data need long collection periods David Hsia Medicare Quality Improvement Bad Apples or Bad Systems? JAMA. 2003;289:354-356.

29. Quality Indicators, Done Well, Will Consume More Time Than You Have FACT: • Set Priority • Set Limits • Drop Non-Productive Activity • Target: 10-12 Don’t be an Indicators Glutton

30. Computer Nonsense Metrics [urine culture] * [glucose] * [INR] X100 [NUPA hr] * [Telephone minutes] Just because a computer can calculate a value, doesn’t mean that it should.

31. The BIG SECRET for Quality Indicator Team Engage the folks who do the work, because they know what they do!

32. Risk management is activity directed towards assessing, mitigating (to an acceptable level) and monitoring of risks to an enterprise. Risk Managementhelps definePRIORITIES and helpsPREVENT ERROR

33. Tough Decisions 1 • A group of 10 laboratories over 300 square miles considers centralizing all tests to a single facility. Improved cost efficiencies Simplified process control Closer oversight Improved utilization managementImproved Patient Care Reduced clinical-lab interface Extended pre-examination phase Test delaysImpeded Patient care

34. Tough Decision 2 • A laboratory considers laboratory redesign based on LEAN analysis. Improved workflow Improved time efficiencies Solve ergonomic challenges Improved cost efficiencies Improved Patient Care Expensive renovations Construction interruptions Staff retraining Equipment specificity Test menu specificity Impeded Patient care

35. Tough Decision 3 • Laboratory considers implementing a quality management team. Better information for better decisions Better process control Continual Improvement Process Improved Patient Care Staff Reallocation Increased immediate costs Quality Commitment Impeded Patient care

36. Tough Decision 4 • A laboratory proposes the need for an on-site level 3 (increased biosafety level) microbiology laboratory. Improved biosafetyReduced laboratory infectionsFaster diagnosisImproved Patient Care Construction costs Operating costs Potential Bioterror target Impeded Patient care

37. COMFORT PRIORITY ACTION Risk and Priority and Prevention are Relative Terms • Risk tolerance • Risk transfer • Risk reduction • Risk prevention • Risk avoidance • Risk aversion

38. Risk Management Documents for the Medical Laboratory • ISO 14971:2007 Medical devices -- Application of risk management to medical devices • ISO 20993:2006 Biological evaluation of medical devices -- Guidance on a risk-management process • ISO WD TS22367:2007 Medical laboratories -- Reduction of error through risk management and continual improvement

39. Linking Quality and Risk Managements

40. Introduction to ISO TS 22367 “Risk management framework has been described as being of steps, planning for risk, identifying risk and its impacts, developing risk-handling strategies, and monitoring for risk control. These steps are consistent with management requirements as described in ISO 15189:2003 including identification and control of non-conformities, establishment of preventive and corrective actions, performance of internal audit and management review and continual improvement. It is the objective of this technical report to link these in the context of the medical laboratory.”

41. Linking Prevention and RiskISO TS 22367 • Assessment of risk of deviations from standard • The quality manager should establish and maintain a process for identifying incidents associated with deviations from standards requirements, estimating and evaluating the associated risks to patient care, and controlling these risks and monitoring effectiveness of the control. • The process should include a prospective risk assessment method for processes considered as high risk. • Assessment of potentially high risk processes may be based upon previous audit, survey, experience, or evidence-based literature on procedures where a failure may lead to significant safety risk to patients.

42. Linking Prevention and RiskISO TS 22367 (Continued) • The quality manager should identify a team of people to study the selected process.Note 1: The team should have personal knowledge of the process.Note 2: The team should be comprised of people with different levels and types of knowledge. • The team should organize a thorough investigation of the process to include:a) each step of the processb) how each step of the process may failc) how each failure at each step of the process may affect patient safetyd) the rank of severity of each failure mode effecte) the most critical failure mode effects f) potential root causes of the most critical failure mode effectsg) procedures to address the potential root causes. • The analysis of this Failure Mode Effects Analysis should form the basis of a Prevention Action Plan.

43. Occurrence – Severity Grid(Qualitative) ACCEPTABLERISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK UNACCEPTABLE RISK ACCEPTABLERISK DEBATABLE RISK DEBATABLE RISK UNACCEPTABLE RISK DEBATABLE RISK UNACCEPTABLE RISK UNACCEPTABLE RISK UNACCEPTABLE RISK

44. Occurrence – Severity Grid(Semi-Qualitative) ACCEPTABLERISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK UNACCEPTABLE RISK ACCEPTABLERISK DEBATABLE RISK DEBATABLE RISK UNACCEPTABLE RISK DEBATABLE RISK UNACCEPTABLE RISK UNACCEPTABLE RISK UNACCEPTABLE RISK

45. Severity – Occurrence Grid • Numerical Values • Literature Benchmarks • Consensus • Experience • Regardless of source, values should be both verified, and validated to fit the FMEA being performed.

46. HIV Testing Risk EvaluationCanadian versus American Risk Analysis ACCEPTABLERISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK ACCEPTABLERISK ACCEPTABLERISK DEBATABLE RISK UNACCEPTABLE RISK ACCEPTABLERISK DEBATABLE RISK DEBATABLE RISK UNACCEPTABLE RISK ? UNACCEPTABLE RISK UNACCEPTABLE RISK UNACCEPTABLE RISK

47. Quality Approaches Look Alike

48. Failure Mode Effects Analysis • FMEA is a systematic method of studying failure. • 1940s US Armed Forces1960s Aerospace (Apollo Space program)1970s Ford Motor Company (post-Pinto)1990s semiconductors, food service, plastics, software, and diagnostics equipment. • Documented FMEA is a REQUIREMENT in the automotive, in-vitro diagnostics, and pharmaceutical industries.

49. FMEA: Failure Mode Effects Analysis In a process: • where are points that the process is likely to break down? • what is the probable occurrence of the different possible break-downs? • what are the likely severity and consequences of the different possible break-downs? • What is the priority list for addressing the different possible break-downs?

50. FMEA: Failure Mode Effects Analysis • FMEA • Failure Mode Effects Analysis • FMECA • Failure Modes Effects and Criticality Analysis • FTA • Fault Tree Analysis • HACCP • Hazards Analysis and Critical Control Points • PDPC • Process Design Program Chart