Managing Laboratory Risk

Transcription

1 Managing Laboratory Risk

2 Quality learning objectives Be able to define risk Be able to list several sources of risk in the laboratory Understand how choice of control materials may contribute to laboratory risk List the sections of ISO that require input from risk assessment 2

3 References ISO Medical devices Application of risk management to medical devices ISO Medical laboratories Requirements for quality and competence EP23-A Laboratory Quality Control Based on Risk Management, Clinical and Laboratory Standards Institute, Wayne PA Risk Analysis A Quantitative Guide, Third Edition, David Vose, John Wiley & Sons, Ltd. 3

4 Why a presentation on risk? Risk assessment and management is a requirement of ISO

5 What is risk? A random event that has a negative impact Risk has two components Probability of occurrence of harm Severity of that harm 5

6 Definitions Harm Physical injury, damage to health Hazard Potential source of harm Severity Measure of the consequence of harm Unnecessary treatment Death 6

7 Why do laboratories need to be concerned? Professional duty Serious consequences Can weaken the public s confidence A requirement of ISO

8 The ISO requirements Risk management The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken. 8

9 The ISO requirements 4.12 Continual improvement Improvement activities shall be directed at areas of highest priority based on risk assessments. 9

10 The ISO requirements 4.13 Control of records Records shall include, at least, the following: n) risk management records 10

11 The ISO requirements Review input The input to management review shall include information from the results of evaluations of at least the following: e) risk management 11

12 Risk management process Risk analysis Risk estimation Risk evaluation Risk control Evaluation of residual risk Periodic review 12

13 Risk analysis Voyage of reasoned thinking leading to the best possible decision at the time David Vose 13

14 Risk assessment: Sources of information Product insert and operator manual Troubleshooting guide Manufacturer alerts and bulletins Verification of performance specifications Personnel qualifications, training, competency QC and PT data QA information including corrective action Scientific publications Other sources as appropriate 14

15 Sources of risk : Specimen Patient preparation Specimen collection, labeling, storage, preservation, stability, transportation Specimen accessioning and processing Specimen acceptability and rejection Specimen referral 15

16 Sources of risk : Environment Temperature, humidity, dust, utilities Airflow/ventilation Light intensity Noise and vibration Altitude Water quality Adequate space 16

17 Sources of risk : Reagent Shipping/receiving Storage conditions Expiration date Preparation 17

18 Sources of risk : Test system Sampling Clot detection Detection of interfering substances Calibration issues Mechanical failures Failure of system controls and function checks Software/hardware Transmission of test result 18

19 Sources of risk : Testing personnel Education Training Competency Staffing levels 19

20 Sources of risk : control materials Electronic controls Embedded controls Liquid external controls 20

21 Control material characteristics Electronic controls Black box function checks Often do not challenge the entire testing process Usually only check the electronic/electronic circuitry and software Usually do not check any mechanical/physical processes 21

22 Control material characteristics Embedded controls Some blood gas anlayzers have built-in on-board liquid controls Optimized to work on the device May not challenge the entire testing process 22

23 Control material characteristics First party control materials Dependent control materials Instrument/reagent manufacturer Optimized One analyte or multiple analytes/vial Same formulation as calibrators 23

24 Control material characteristics Second party control materials Semi-dependent controls Manufactured exclusively FOR a device manufacturer Specific formulation/recipe May mimic calibrators 24

25 Control material characteristics Third party control materials Independent controls Independent and without influence Absolutely independent of calibrator Can be used across multiple platforms Often a human based material 25

26 Risk associated with control materials : systematic error Type of Control Ability Estimated Risk Level Electronic Not always High Embedded Not always High Dependent Not always High Semi-dependent Not always High Independent Frequently Low 26

27 Risk associated with control materials : Subtle changes in the test system Type of Control Ability Estimated Risk Level Electronic Not always High Embedded Not always Moderate to High Dependent Not always Moderate to high Semi-dependent Not always Moderate to high Independent Frequently Low 27

28 Risk associated with control materials : signal the operator of possible effects on patient result Type of Control Ability Estimated Risk Level Electronic Not always High Embedded Sometimes Moderate Dependent Not always High Semi-dependent Sometimes Moderate Independent Frequently Low 28

29 Important to remember A pre or post analytical failure normally affects only one patient An analytical error can affect many patients at one time. 29

30 Risk estimation / evaluation Can take many forms Failure Mode and Effects Analysis (FMEA) Process mapping Fishbone Diagrams (more focused on a specific problem) 30

31 Three components of FMEA Detection Occurrence Severity RISK 31

32 Three components of FMEA Detection Score Occurrence Score Severity Score RISK PRIORITY NUMBER (RPN) 32

33 Occurrence Scoring Score Description Condition 10 Certain to Fail Fails more than once a day 9 Extremely High Fails at least daily 8 Very High 7 Moderately High 6 High 5 Moderate Fails several times per quarter 4 Moderately Low 3 Low 2 Minor 1 Rare: Failure unikely Hardly ever fails 33

34 Detection Scoring Score Description Condition 10 Absolutely no detection No process checks whatsoever 9 Very remote probability Controls tested every 500 patient samples 8 Remote probability 7 Very low probability 6 Low probability 5 Moderate probability Daily electronic controls + surrogate QC but QC rules not customized Controls tested every 100 patient samples 4 Moderately high probability 3 High probability Controls tested every 50 patient samples 2 Very high probability Controls tested every 25 patient samples 34

35 Severity Scoring Score Description Condition 10 Catastrophic Failure could cause serious injury to the patient 9 Extremely High 8 Very High 7 Moderately High 6 High 5 Moderate Failure could result in repeat of all test results 4 Moderately low 3 Low 2 Minor 1 None Failure has no effect on the patient 35

36 FMEA analysis: Serum XYZ Failure Mode Occurrence Severity Detection RPN Reagent deterioration Calibration Air bubbles in the sample probe line TOTAL RPN

37 Risk profile summary TEST/PROCESS Serum XYZ 488 Plasma ABC 270 Process TOTAL RPN 37

38 Fishbone diagram 38

39 Risk control Pre analytical measures Analytical measures Post analytical measures 39

40 Evaluation of residual risk Re-estimate risk potential after mitigation to evaluate effectiveness Is it acceptable? 40

41 Periodic review Consistent with QMS requirements Effectiveness and continued relevance 41

42 In Summary: Risk Management Process Source: CLSI EP23-P Laboratory Quality Control Based on Risk Management Life Cycle Risk Management Process Risk Assessment Additional Risk Prevention/Control Measures Risk Analysis Severity of Harm Hazard Identification Probability of Harm Risk Estimation Risk Evaluation Risk Control Risk Monitoring Failure Investigation New hazard? Greater severity? Increased frequency?

43 Summary Risk analysis, assessment, management is not new to the lab FORMAL risk analysis, assessment, management is new It does not need to be complicated It is a professional obligation to the patient It is a regulatory requirement Keep in mind that risk mitigation can sometimes reduce risk substantially. 43

44 Questions and Discussion 45