Learning Objectives State when an IQCP is required Individualized Quality Control Plans Andy Quintenz Scientific / Professional Affairs Compare / Contrast Traditional QC approach with Risk Based QC List the mandatory components of an IQCP Agenda Risk Management & QC IQCP Requirements Breaking down the IQCP Project Another Way To Determine QC Hooray!!!! What is QC QC = Warm Fuzzies The set of mechanisms, processes, and procedures designed to monitor the measuring system to ensure the results are reliable for the intended clinical use. In clinical laboratory testing, QC includes the procedures intended to monitor the performance of a test procedure to ensure reliable results. ISO 9000 Bio-Rad Laboratories QCNet.com / IQCP 1
Why Risk Why Now Why Risk Why Now Batch Testing Batch Testing Continuous Testing.. Continuous Testing.. QC forthe Instrument or the Patient Technology in the 21 st Century Instrument-focus Forward looking Is the instrument okay to use After QC failure Recovery & Continue Patient-focus Backward looking Were the results okay After failure Recovery & Assessment [E]venthe most sophisticated instruments cannot be expected to monitor all aspects of testing and warn us of every possible problem. Sharon Ehrmeyer, PhD Clinical Lab Products Mar 2013 Technology in the 21 st Century How Prevalent Are Errors Detecting errors means QC is working; if you aren t seeing out-of-control QC, it is likely you are missing something. NicholaBaumann, PhD, CAP Today: Mar 2014 Mayo Clinic -more than 15 separate events affecting 20 patients or more over a 1 year period. "Robust error detection can be achieved in high-volume, massproduction settings by designing and implementing multiple and redundant QC and QA methods and matching the frequency of these activities to the lab s volume and throughput." Nichola Baumann, PhD, CLN: October 2012 Vanderbilt University drew a similar conclusion with real-time reporting and automation: QC frequency becomes a function of test volume. James Nichols, PhD CLN: November 2011 Bio-Rad Laboratories QCNet.com / IQCP 2
Where Do Failures Occur All Failures Are Not Created Equal Ross& Boone CDC 1989 Plebani & Carraro Clin Chem 1997 Carraro& Plebani Clin Chem 2007 Pre-Analytic Analytic Post-Analytic 46% 7% 47% 68% 13% 19% 62% 15% 23% One or Many If the particular failure occurs, Is one patient affected or are many affected Where Do Failures Occur Where Do Failures Occur Pre-Analytic Analytic Post-Analytic Ross& Boone 46% 7% 47% CDC 1989 Plebani & 68% 13% 19% Carraro Clin Chem 1997 Carraro& 62% 15% 23% Plebani Clin Chem 2007 52,000 tests >50% of tests that lead to inappropriate patient care were incorrect results due to instrument errors Pre-Analytic Analytic Post-Analytic Ross& Boone 46% 7% 47% CDC 1989 Plebani & 68% 13% 19% Carraro Clin Chem 1997 Carraro& Plebani Clin Chem 2007 62% 15% 23% 52,000 tests Current >50% QC of practices tests that lead are to inappropriate not adequate patient to care detect medically were incorrect important results due errors to instrument Plebani- errors 2013 Global Movement Towards Risk ISO 15189: 2012 References to Risk Assessment & Risk Management ISO 22870: POCT: Personnel & Quality Directs user to follow ISO 15189 CLIA Individualized Quality Control Plans based on EP23 EP23 (CLSI) Laboratory QC Based on Risk Management Bio-Rad Laboratories QCNet.com / IQCP 3
Regulatory References What is EP23 ISO 15189 5.6.6.2 Quality control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result. CLIA QC Frequency may be reduced to below CLIA minimums if a Risk Based QC Plan is created CLSI Consensus Guideline Government, Laboratorians, Industry Lab-identified sources of error What the level of risk is for each error If that risk is acceptable If not, what control measures are put in place What monitoring activity will take place to determine if errors How much QC is appropriate The Right QC The clinical use of the test result, the impact of errors on patient care, test stability, number of patients between QC events, and frequency of calibration influences the maximum interval between control events. Based on instrument / test method quality Test volume Might be more QC Might be less QC Balanced approach EP23A 5.1.1 CLSI, Wayne PA What is Risk Management What is Risk Management Use of policies / procedures designed to minimize the occurrence of patient harm due to an incorrect test result Example: Run QC material to ensure the instrument is performing properly Monitoring refrigerator temp where reagents are stored Bio-Rad Laboratories QCNet.com / IQCP 4
Key Concepts for Risk Management QC Based on Risk Management Know your risks (hazards) Remove, minimize, or monitor risks Monitor process to ensure risk remains acceptable Goal Appropriate use of QC material and activities that deliver quality patient results Activities Identify, Assess, Treat / Mitigate / Control, Monitor Process Mapping, Fishbone Analysis, FMEA, etc. Deliverable QC Plan What is in a QC Plan Control Steps and Frequency They are Performed Example: Electronic controls auto -every 24 hrs Liquid QC 2 levels before & after Calibration or Maintenance 2 levels every 200 patient tests New lot of reagents.etc. Proficiency Testing Calibration Maintenance Introducing IQCP IQCP I Quit Caring Plan Individualized QC Placebo Individualized Quality Control Plan Individualized Quality Control Plan Understanding Sources of Error What is the level of risk for each error Is that risk acceptable If not, how will it be mitigated Bio-Rad Laboratories QCNet.com / IQCP 5
Timeline Voluntary and Mandatory Equivalent QC or IQCP is acceptable in 2015 Educational Phase IQCP is voluntary Current CLIA control default regulations continue to be in effect EQC ends Jan 1, 2016. Period. Still have 9 months! Is an IQCP Required Accrediting Bodies NO! Waived Tests or Running CLIA min YES! Want to run less QC and Mfr QC req < CLIA COLA same as CLIA A2LA same as CLIA Joint Commission - summer CAP summer So what does it involve 3-5-3 Bio-Rad Laboratories QCNet.com / IQCP 6
3 5 3 Phases of Testing 5 Areas to Assess Pre-Analytic Analytic Post-Analytic S P I R E 5 3 5 Areas to Assess 3 Mandatory Parts of the IQCP Specimen People Instrument Reagent Environment Risk Assessment QC Actions Monitoring Effectivity side notes How to get started 1 IQCP for each location of testing Cannot go below Mfr s recommendation NING Can t use Mfr sdata or IQCP must be custom Must have data to support frequency Bio-Rad Laboratories QCNet.com / IQCP 7
Enlightenment Planning Phase Learn, learn, learn Gain an understanding of EP23 Webinars on EP23 and IQCP Whitehatcom.com (FREE webinars) CLSI.org COLA.org QCNet.com CLSI EP23 and workbook Instrument manufacturer NING Planning Before starting Which instruments POCT only Hard to control instruments Unsure about Frequency Put together an exploratory team Should you implement a Risk Based QC Plan What is the scope All POCT All non-waived All A test A device A group of activities Assign responsibilities Establish criteria for quality in the lab Planning Risk Assessment Phase Who needs to be involved Must include those who run the tests Medical Technicians, Nurses, Medical Assistants, etc Consider those involved in steps from Receiving supplies Receiving patient samples To the receipt of results by the clinician NING Create teams and timeline Identify a template QC Plan Bio-Rad Laboratories QCNet.com / IQCP 8
Some Advice Before Starting Risk Assessment Don t panic Start small Pick a test or a device Document, document is the identification and evaluation of potential failures and sources of errors in a testing process. Risks are potential failures and sources of error that can impact the accuracy and precision of test results Every Lab is Unique Risk Assessment in QC Plan The risk assessment for any given test system may look very different in different labs For example, The same risk may be assessed higher or lower by neighboring labs Different procedures, training, environments NICU is different from ED Both need their own QC Plan Test System Environment Entire Testing Process Pre, Analytic, Post Specimen Reagents Testing Personnel Let s Get Started What Mfr Documents Can I Use Gather information and data for all three phases of testing and all five areas of required focus Sources of information and data Review and analyze Look for signs of poor performance or potential hazards Process mapping is helpful Shouldn t use manufacturer data only Must be unique to testing site Example / Template of QC Plan from manufacturer may be used as a source document to build own QC Plan Data MUST be from the lab / testing site Laboratory s own data required Can be new data or historical Bio-Rad Laboratories QCNet.com / IQCP 9
Risk Assessment Tools Fishbone Diagram Process mapping Potential hazards Control points Fishbone diagrams Identifies possible causes of failure modes and their effects Man, Materials, Methods, Measurement, Machine Samples, Operator, Environment, Reagents, Measuring System Next Step: Risk Evaluation Risk Evaluation IF a certain failure occurs, how does that affect the patient and is that okay The laboratory evaluates the risks There are many methods to evaluate risks IQCP does not mandate any specific method of risk evaluation The laboratory must provide documented evidence of the risk assessment EP23-A CLSI Severity Rating Occurrence Rating Common Terms Possible Description Catastrophic Critical Serious Minor Negligible Results in patient death Results in permanent impairment or lifethreatening injury Results in injury or impairmentrequiring professional medical intervention Results in temporary injury or impairment not requiring professional medical intervention Inconvenience or temporary discomfort Common Terms Possible Description Frequent More than 1 in 1000 tests Probable Between1 / 1000 and 1 / 10,000 tests Occasional Between 1/10,000 and 1 / 100,000 tests Remote Between 1 /100,000 and 1 / 1,000,000 tests Improbable Less than 1 in a million tests ISO 14971:2012 Application of Risk Management to Medical Devices ISO 14971:2012 Application of Risk Management to Medical Devices Bio-Rad Laboratories QCNet.com / IQCP 10
Detection Rating Laboratory Risk Evaluation Common Terms Possible Description Absolute Uncertainty High Uncertainty Unknown certainty High Certainty Absolute Certainty Failure would never be caught before test result is released. Incorrectresult may or may not becaught before being released Failure wouldresult in no test result or obviously incorrect value. Ultimately, the laboratory director is guaranteeing that the risk assessment considers both CLIA requirements for accurate test results test result quality is adequate for patient care. QC Plan Writing Phase Linking Risk Assessment to QC Plan NING After the lab has identified the sources of potential failures and errors for a testing process and evaluated the frequency and impact of those failures and errors, the resulting RA is used to develop the Quality Control Plan (QCP). Requirements for the QC Plan Residual Risks Frequency, type and number of controls Good faith effort Some tests may be more QC Some tests may be less QC Should be about doing the right QC. At minimum the Plan should do three things Ensure accuracy and reliability of testing Detect error immediately Monitor over time, accuracy and precision Any Risk that is determined to be unacceptable should be identified in the QC Plan with a control mechanism to catch the potential issue Examples: Storage Temperature Log Procedure Step to verify expiration dating Running of QC material Bio-Rad Laboratories QCNet.com / IQCP 11
Other Controls to Consider Example of Simple QC Plan If indicated by the evaluation of the risk assessment, the QCP may also include electronic controls, procedural controls, training and competency assessment, other specified quality control activities The Plan Simple and straightforward. This example shows : steps the lab was doing already 3 new steps the lab added after doing risk assessment Excerpt from EP23A Workbook CLSI Implementing the Plan Training & Implementation NING Plan adequate time to: Route procedure for approvals Train all staff Put new controls in place Logsheets, temp monitors, software, etc. Follow-up to ensure new procedures are being followed and questions are answered Verify Effectiveness Phase Quality Assurance NING Establish a review system for monitoring effectiveness Monitoring includes: personnel, environment, specimens, reagents, and test system. The review system (elements, criteria, frequency) are identified in the QCP Bio-Rad Laboratories QCNet.com / IQCP 12
Quality Assurance Quality Assurance Responding to effectiveness review What adjustments to the IQCP (if any) are needed Is there need for further risk assessment Does the IQCP provide sufficient data for review and comparison When the laboratory discovers a testing process failure, the laboratory must conduct and document an investigation to identify the cause of the failure, its impact on patient care, and make appropriate modifications to their QCP. Don t Panic There s plenty of Time NING Thank You QCNet.com/IQCP Bio-Rad Laboratories QCNet.com / IQCP 13