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1 ARCs Journey Toward EP23 Compliance David Martin BS MT(HEW)

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1 1 ARCs Journey Toward EP23 Compliance David Martin BS MT(HEW)

2 Austin Regional Clinic (ARC) 2 1,000,000 patient visits 380,000 active patients 1,500 employees 320 physicians 18 locations 16 specialties 6 cities 3 counties 1,000 square miles

3 TQMP Development 3 ARCs journey toward an EP23 IQCP from my perspective as a Lab Director Patient Safety is my #1 priority My Patient Safety Plan is the TQMP In the late 90s I found a promising Total Quality Management Plan Key to Quality from CLSI in 1998 Lucia Berte 3 rd party QC material Bio-Rads Unity RealTime & Westgard Advisor Lean Standardized policies, processes, & procedures Document Management System Balanced Scorecard EP23P – 2010 Discussion with Lab Support Group Quality Control Designs using data from Unity Real Time

4 Bio-Rads Quality Group to the Rescue 4 The Bio-Rad Discovery Group had been working with us on quality control design strategies. During one of our meetings I expressed an interest in the newly released EP23-A guideline. Dr. Parvin asked us if we would be interested in trying to tackle an EP23 effort and share the experience – we agreed. This is our story to date.

5 Project Participants 5 ARC David Martin, Administrative Director for Laboratory Services Jane Morgan, Clinical Laboratory Supervisor Leah Murphy, Laboratory Quality Technologist Tina Lam, Project Specialist Mary Tsourmas, Medical Director Clinical Risk Assessment Bio-Rad Curtis Parvin, Manager of Advanced Statistical Research John Yundt-Pacheco, Scientific Fellow Lakshmi Kuchipudi, Senior Scientist

6 What is EP23? 6 Laboratory Quality Control Based on Risk Management EP23-A; Approved Oct 2011 Clinical and Laboratory Standards Institute (CLSI) Consensus produced guideline Laboratory Professionals, Govt, & Industry

7 Project: Risk Assessment for a Vista Start with the EP23-A document & workbook Where necessary fill in gaps or modify to fit need Divide analytes by methodology Photometric Integrated Multisensor Technology (IMT) LOCI-chemiluminessence Nephelometric Begin with one analyte from each methodology Calcium Sodium TSH C-Reactive Protein

8 EP23-A: Risk Assessment (Figure 5) Hazard Identification Create a process map Identify potential failures in each process step Determine mechanisms in place to prevent or detect a failure 7.2 Risk Estimation Assess the likelihood or probability of harm for each failure Assess the severity of harm to a patient from each failure 7.3 Risk Estimation Is the residual risk of harm clinically acceptable 7.5 The Laboratorys QCP Compile set of QC process into QCP Review QCP for conformance to regulatory and accreditation requirements Document and implement the set of control processes as the laboratorys QCP No Yes 7.4 Risk Control Determine what control processes are needed to lower the risk to an acceptable level

9 9

10 Identify Potential Failures 10 Identify potential stages in the process where failures could occur (fishbone diagram) List all potential failure modes at each stage Characterize the consequences of each failure mode

11 11

12 Consequences of a Failure 12 The consequences of a failure which lead to a hazardous situation for a patient Incorrect result Delayed result What is an incorrect result? Define an allowable total error for each analyte, TE a If the difference between the correct result for a patients specimen and what the lab measures exceeds TE a then the result is incorrect. What is the extent of a failure? A failure that adversely effects only a single patient specimen A failure that can adversely effect many patient specimens No result Other

13 EP23-A: Probability of Harm (Figure 6) 13 Sequence of Events Creating Risk of Harm for a Patient (Example) Initiating cause Testing process failure Incorrect result generated Incorrect result reported Misdiagnosis Hazardous medical action Patient harmed P1P2P3P4P5P6 Hazardous Situation Probability of harm given a delayed or incorrect patient result Probability of a failure Lab prevention/detection of failure Number of delayed patient results, incorrect patient results not detected

14 Frequent = once per week Probable = once per month Occasional = once per year Remote = once every few years Improbable = once in the lifetime of the measuring system EP23-A: Probability of Harm (Figure 6) 14 Sequence of Events Creating Risk of Harm for a Patient (Example) Initiating cause Patient harmed Probability of harm given a delayed or incorrect patient result Probability of a failure Lab prevention/detection of failure Number of delayed patient results, incorrect patient results not detected

15 Severity of Harm 15 Severity of harm is described in terms of the severity of the consequence to a patient Severity of harm will differ for different analytes For a given analyte, severity of harm could differ for An incorrect result A delayed result No result For a given analyte, severity of harm could differ for different patient care situations Consider the most common patient care situation for the patient population served by the laboratory For a given analyte, can the severity of harm from an incorrect result differ based on the failure mode that produced the incorrect result?

16 EP23-A: Severity of Harm Categories 16 Negligible = inconvenience or temporary discomfort Minor = temporary injury or impairment not requiring professional medical intervention Serious = injury or impairment requiring professional medical intervention Critical = permanent impairment or life-threatening injury Catastrophic = patient death

17 EP23-A Risk Acceptability Matrix 17

18 EP23-A Risk Assessment Table 18 Probability of harm and severity of harm are assessed for each targeted failure mode Acceptability of residual risk based on risk acceptability matrix

19 ARC Experience 19 Struggled to make effective use of the EP23-A risk assessment table in its original form Replaced 4 columns Measuring system feature or recommended action Known limitations of feature or recommended action Control process effective? QCP actions required to address known limitations With 2 columns Engineering controls/Internal QC – manufacturer Lab implemented monitors/External QC – ARC TQMP Added 3 additional columns Causes of failure Methodology effected Extent of failure

20 EP23 Workshop in Houston, TX 20 Tools for Tackling EP23 TM : Laboratory Quality Control Based on Risk Management; Approved Guideline September 29, 2012 Presented by the Clinical and Laboratory Standards Institute

21 ARC Progress 21 Decided to include additional columns in our risk assessment worksheet for Frequency Severity Detectability Criticality Easier to think in terms of probability of occurrence of a failure and the ability to detect the failure Rather than probability of occurrence of patient harm

22 EP23 Workshop Risk Assessment Worksheet 22 New columns added to the worksheet Frequency Severity Detectability Criticality New Columns

23 Risk Assessment Worksheet: Frequency 23 Frequency (or probability) of occurrence of a failure Note, probability of occurrence of harm (EP23-A) is not the same as probability of occurrence of a failure (above)

24 24 Severity of patient harm Risk Assessment Worksheet: Severity

25 Risk Assessment Worksheet: Detection 25 Probability of detecting a failure mode that has occurred Not explicitly addressed in EP23-A

26 Risk Assessment Worksheet: Criticality Criticality = Frequency X Severity X Detectability 26

27 ARC Final Worksheet Design 27

28 ARC Final Worksheet Design: Left Columns 28

29 ARC Final Worksheet Design: Right Columns 29 Shipping Storage

30 Quality Control Plan for Siemens Vista Chemistry Analyzer External QC: Liquid Unassayed QC: a. Multiqual QC is run at the beginning and end of each shift (3x/day) b. Immunoassay, Cardiac, and Immunology QC are run at the beginning of each shift only due to lower patient volume for those tests c. TDM and Direct LDL QC is run once per day that patient is run due to extremely low volumes d. QC is run following each assay calibration, or when recommended by service e. Refer to QC - 2 level procedures for interpretation of results including Westgard rules 2. Proficiency/Competency testing: a. Participate in API proficiency testing 3x per year. PT is rotated among personnel b. Annual competency reviewed and documented by technical supervisor c. Techs are required to complete 10 hours of Continuing Education credits per year, 2-3 hours mandatory specific to ARC d. Lab Assistants are required to complete 2-3 hours of Continuing Education per year depending upon position 3. Training a. Lab Assistants: all laboratory assistants must complete phlebotomy and specimen process training. Refer to specimen collection procedures/manuals b. Techs: Operators must complete online training for Vista chemistry analyzer combined with hands on training before operating instrument without supervision c. Materials Manager: Follows all procedures for receipt and storage of reagents

31 Quality Control Plan for Siemens Vista Chemistry Analyzer Environmental Control a. Reagent storage refrigerators/freezers monitored 2x per day b. Room temperature and humidity monitored and recorded daily 5. Instrument Maintenance/Verification a. Instrument maintenance is performed as required by manufacturer b. Calibration/Verification of all assays with less than 3 point calibration is performed every 6 months. c. Instrument to instrument correlations are run on all Vista assays every 6 months 6. Monitor the IQCP on an ongoing basis for effectiveness a. NCEs are submitted and monitored by Lab Supervisor to document failures b. Review any complaints the laboratory may receive from providers c. LJ graphs are reviewed at least weekly to detect possible trends and shifts d. Balanced Scorecard prepared quarterly to monitor quality indicators

32 Laboratory Environment 32 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory-Implemented Monitor Frequency (F)Severity (S)Detectability (D)Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probablility to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2- Minor 3- Serious 4- Critical 5- Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Laboratory Environment Temperature Temperature out of range (too high or too low) A temperature failure can affect multiple patients. Whether it be in a freezer, refrigerator, ambient air, or if the analyzer's temperature goes out of range. The techs are trained to monitor the temperatures of ambient air as well as the refrigerators and freezers around the lab. There is a 24 hour temperature monitor in the walk-in regrigerator. The Vista is programmed to alarm if the temperature falls out of acceptable range. 24 hour monitoring system for walk-in refrigerator and each zone of the Laboratory. Techs record the temperatures for the freezers/refrigerators and ambient air at the beginning and end of work day. Velcro closures placed on the freezer doors. Installed a monitor in the walk-in refrigerator which records the temperature every 15 minutes, this information will be reviewed every Monday. OccasionalNegligible2<10 LowYes HumidityHumidity (too high or too low) A humidity failure can affect multiple tests and therefore multiple patients. Techs are trained to record humidity on a daily basis NoProcedures/logsRemoteNegligible2<10 LowYes Power SourcePower Failure A power failure can affect multiple patients. Multiple specimens can be lost due to a power failure changing the temperature in the refrigerators, freezers, incubators. Tests can also be lost due to the power source of the analyzer being compromised. No There is a power source backup on the vista that will last for 20 minutes. Possibly a back up generator.OcassionalNegligible2<10 LowYes * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

33 Specimen Ordering 33 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory- Implemented Monitor Frequency (F)Severity (S) Detectability (D) Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probablility to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2-Minor 3- Serious 4- Critical 5-Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Specimen Ordering Ordered by provider Test entered incorrectly Single Yes, training the providers to correctly order lab tests. No Training not done with laboratory procedures. NCEs are written up and discussed with the center managers and providers FrequentNegligible1<10 Low Yes, but this can result in a delay in testing. Dx code incorrect or missing SingleNoFrequentNegligible1<10 Low No ordersSingleNoFrequentNegligible1<10 Low Ordered by lab staff Transcription errorsSingle Yes, training the providers to correctly order lab tests. No Refer to procedures: Processing Lab Orders in Copia, Processing Add-on Lab Tests, Processing CPL Specimens and Reports, DSHS Specimen Processing ProbableNegligible1<10 Low Epic Copia SingleNoProbableNegligible1<10 Low paper orders Copia SingleNoProbableNegligible1<10 Low * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

34 Specimen Collection 34 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory- Implemented Monitor Frequency (F) Severity (S) Detectability (D) Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probablility to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2-Minor 3-Serious 4- Critical 5-Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Specimen Collection Patient IDIncorrect Patient ID Can affect two patients Yes, training all staff collecting specimens with proper specimen processing criteria. No Refer to Blood Specimen Collection procedure and NCE Management Program. Occasional Serious or Critical 2Mid to High Collection Technique Wrong TubeSingleNo Probable Negligible1<10 Low Yes, all of these can result in a delay in testing. Contamination: Incorrect Order of Draw, Improper cleansing of draw site SingleNo Occasional Negligible1<10 Low Site SelectionSingleNo Occasional Negligible1<10 Low Improper use of tourniquetSingleNo Occasional Negligible1<10 Low Improperly labeling specimen (provider) SingleNo Occasional Negligible1<10 Low Improperly labeling specimen (lab) SingleNo Occasional Negligible1<10 Low Improperly mixing the specimen Single Yes, training all lab staff with proper specimen processing criteria. No Refer to procedures: Blood Specimen Collection, Criteria for Specimen Rejection, Centrifuge Instructions, and NCE Probable Negligible1<10 Low Specimen Processing Not allowing SST to clot completely SingleNo Probable Negligible1<10 Low Not centrifuging specimen within allotted 2 hour period or not centrifuging at the correct RPM for the correct amount of time SingleNo Probable Negligible1<10 Low Pouring over specimen into the incorrect container SingleNo Probable Negligible1<10 Low Improper storage of the specimen. SingleNo Occasional Negligible1<10 Low * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

35 Specimen Transport and Receiving 35 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory- Implemented Monitor Frequency (F) Severity (S) Detectability (D) Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probablility to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2-Minor 3- Serious 4- Critical 5-Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Specimen Transport Incorrect Temperature Specimen shipped under incorrect conditions ex. No ice pack in cooler Potential for multiple since samples are shipped in batches Training staff to properly prepare coolers for transport. Some analytes can give clues as to whether tubes were centrifuged within 2 hours. Ex. Glucose No Currently there are procedures for Criteria for Specimen Rejection, Centrifuge Instructions, and Processing Specimens in Copia LIS. OccasionalNegligible1<10 LowYes Centrifuging Tubes Specimens not centrifuged w/in 2 hours can yield incorrect results Potential for multiple if samples are batched before centrifuging NoOccasionalNegligible1<10 LowYes Specimen Receiving ManifestIncomplete/IncorrectSingle Properly training staff to check-in coolers that arriving at the FW lab. NoProbableNegligible1<10 LowYes RSO (Release Stored Orders) Orders released in RSO but no sample received in lab SingleNoProbableNegligible1<10 LowYes Specimen received in lab but orders not released in RSO Single Vistas will give a "No Test Ordered" alarm for specimens that have not been released in the RSO. ProbableNegligible1<10 LowYes Sample Integrity LipemiaSingle Staff are instructed to let the Vista determine whether the sample can(not) be run based on it's measurements of the severity of HIL Vista will measure HIL and reject specimens not suitable to run. ProbableNegligible1<10 LowYes HemolysisSingleFrequentNegligible1<10 LowYes IctericSingleProbableNegligible1<10 LowYes * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

36 Operator Training and Competency 36 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory- Implemented Monitor Frequency (F)Severity (S)Detectability (D) Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probability to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2- Minor 3- Serious 4- Critical 5- Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Operator Training and Competency Capacity Training A tech has the potential to affect many patients if they are not properly trained. Training by staff/supervisors, staff must be signed off before operating the Vista on their own.They are not given a log-in to approve results until they are signed off by a supervisor. Making sure maintenance is completed on the Vista at the appropriate times. Competencies are given on a yearly basis. Controls can also detect correct preparation of controls/reagents. No, there is an option to enter individual user IDs on the Vista. ARC does not utilize this because results are approved in the LIS and tech ID can be tracked through the LIS system. The controls are approved in Unity Real Time which also requires a unique log-in for each user. Ensure that only staff that have been adequately trained and signed off are the sole operators of the Analyzer. If API surveys come back unsatisfactory, council the staff and figure out why the test was inaccurate, whether it be machine failure or staff incompetency. RemoteSerious1<10 LowYes Competency A tech has the potential to affect many patients if they do not have the knoweledge/competency to perform testing and interpret the results. RemoteSerious1<10 LowYes API Proficiency Since API testing mimics patient testing in the laboratory, any false results reported to API can mirror false results that are being reported on patients, and could affect multiple patients API Samples are run 3x per year and rotated among all Vista operators and between both analyzers to test the competency of laboratory personnel and the proficiency of the Vista Analyzer NoRemoteNegligible1<10 LowYes StaffingShort Staffing A tech who is overly stressed out has a greater chance of making a mistake and reporting inaccurate results which can affect multiple patients. Even the best trained staff can make mistakes when under stress or when rushed. Limited, the vista will detect a QNS control, but only review of the QC values will determine if a control/reagent was prepared improperly. Ensure that there is as much staffing as is required for the lab to run efficiently. Understand the limitations of staff, different staff members have different work capacities. ProbableSerious MidYes * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

37 Specimen Storage and Archiving 37 StepsFailure ModeCausesExtent Operator Training/External Control Engineering Control General Comments of other Laboratory- Implemented Monitor Frequency (F)Severity (S) Detectability (D) Criticality (FxSxD) Residual Risk Acceptable? Yes/No List the stage or aspect of the test systems process under investigation. List all manners in which failure could occur in this step. List all causes of the failure mode that have the potential to produce incorrect test results. Does the failure affect a single patient or have the potential to affect multiple patients? Can external controls and/or operator training increase the probability to detect failure? Are there manufacturer checks to reduce the probability of failure? What other processes can the laboratory implement to detect failure? 1- Improbable 2- Remote 3- Occasional 4- Probable 5-Frequent 1-Negligible 2-Minor 3-Serious 4-Critical 5-Catastrophic What is the likelihood that the control process detects or prevents the failure? (1-5)* 20 High If no, how will QCP address? Storage and Archiving Specimen Storage Specimen stored improperly after testing Multiple Yes, training of techs to properly store specimens that have already been tested and to adhere to a disposal schedule for specimens that are stored in the clinical laboratory refrigerator No Write a procedure pertaining to the storage and disposal of chemistry specimens. RemoteNegligible1<10 LowYes Specimen disposed of too soon MultipleNoRemoteNegligible1<10 LowYes Archiving Archiving too soonMultiple Yes, lab staff are trained to properly archive documents. No Refer to "Archiving Laboratory Reports" procedure RemoteNegligible1<10 LowYes Archiving the wrong reports MultipleNoRemoteNegligible1<10 LowYes * Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

38 What Did We Change/Learn 38 QC Frequency From 2x/day to 3x/day – added QC at end of day run Type and number of QC samples 2 levels of 3 rd party QC unassayed Statistical QC limits used to evaluate the result – added the 10x rule Compared our QC results with target results weekly Frequency of periodic review for trending shifts and trends Weekly or more often if we have a failure

39 What Did We Change/Learn (contd) 39 Actions taken when results exceed acceptable limits Education of operators Stop repeating QC – perform RCA Controls built into the measuring system IMT self calibrates every 2 hours Photometer check Checks reagent specs before adding sample Performs HIL interference TEa needs scrutiny and should be easier to find for each analyte

40 Lessons Learned 40 Challenges in performing a risk assessment for QC Daunting and Tedious – make templates Resources – internal, e.g. HR and external, e.g. vendors and seminars Support Staff – motivation & knowledge Front Line Staff – how to push down the info – educate and train Establish Allowable total error (TEa) for each analyte – CLIA, API, CAP, etc. Methods to minimize the challenges Staff Education and Training Start before you begin the journey CLSI EP23 workbook - imperative Bio-Rad Quality series - Dr. Westgards web site - CLSI Docs on quality GP26-A4 Utilize Industry periodicals, gurus, manufacturers, Involve front line staff in development Attend seminars Read instrument manuals

41 Lessons Learned cont. 41 Which test methods might be prioritized for risk assessment High volume quantitative tests Chemistry tests with high probability of harm Tests with most problematic history Sodium, Potassium, Glucose, Calcium, TSH EP23 IQCP can be modified or scaled for quantitative, semi- quantitative and qualitative tests Does risk assessment approach align with institutional quality goals ARC has a mature Patient Centered Medical Home and is part of a Pioneer Accountable Care Organization Quality & Value and demonstrating Quality & Value are priorities

42 The Journey Continues 42 ARC implemented their new EMR in July at the first clinic. The labs resources are supporting this endeavor I know the new Lab director will continue to refine and implement the IQCP


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