The ABCs of IQCP 3/20/2017. Williamsport. UPMC Susquehanna. Katheryn Inglis, MS, MT(ASCP) B102: 3/27/2017

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1 The ABCs of IQCP Katheryn Inglis, MS, MT(ASCP) B02: 3/27/207 Williamsport UPMC Susquehanna Located in Williamsport, Pennsylvania Home of Little League World Series Located in central Pennsylvania, UPMC Susquehanna is made up of these 4 hospitals: total of 332 licensed acute and 259 long-term care beds, Our Mission To extend God s healing love by providing outstanding patient care and shaping tomorrow s health care through clinical and technological innovation and education. Divine Providence Hospital: Outpatient Hospital 7 Room PSC Cancer Treatment Center & Infusion Same Day Surgery Behavioral Health

2 Objectives Understand IQCP why complete one? Perform a risk assessment on a test system. Develop a Quality Control Plan from your risk assessment. Assess the effectiveness of your IQCP. Resources Worksheets for each of the 5 risk components A guide to develop and perform your own risk assessment Resources EP23-A: Laboratory Quality Control Based on Risk Management; Approved Guideline Provides guidance based on risk management For laboratories to develop quality control plans tailored to Measuring system(s) Laboratory setting Clinical application of the test. 2

3 Resources CAP.org Frequently Asked Questions (PDF, 636 KB) IQCP Eligibility Determination (PDF, 78 KB) Microbiology IQCP Applicability Tool (PDF, 40 KB) What You Really Need to Know About the IQCP and Ensuring Your Laboratory's Compliance (Webinar) IQCP What Your Lab Needs to Know (CAPcast) Annual Assessment of IQCP Example Form (Word, 626 KB) Prepare your Laboratory for Inspection Instructions for Completing the Individualized Quality Control Plan Forms (PDF, 279 KB) List of Individualized Quality Control Plans Form (Word, 627 KB) Individualized Quality Control Plan Summary Form (Word, 63 KB) Resources - ASM Clinical Microbiology Portal ASM together with CAP and CLSI have coordinated preparation of materials to help you address the CMS requirement for implementation of IQCP Examples of IQCPs for several clinical microbiology test systems. IQCP Labs must develop an IQCP if they wish to perform QC less stringent than the regulatory requirements (minimum 2 levels each day of testing) CMS new CLIA IQCP option incorporates RM concepts IQCP cannot be less stringent than manufacturer s recommendations It is a documented strategy using risk management techniques 3

4 Why? Prevents failures and detects non-conformities before reporting incorrect results: Describes practices, resources & specified activities Builds on current policies and procedures Builds on testing device quality and risk reduction features Appropriate for the testing device and situation Environment Operators Patient population Individualized Quality Control Plan (IQCP) Provides a framework for customizing a quality control program for your test systems and environment Requires planning for all 3 phases of testing: Pre-analytical Analytical Post-analytical 46-48% 8-47% 7-3% And includes (3 steps) Risk Assessment Quality Control Plan Quality Assessment Risk Assessment Quality Assessment Quality Control Plan IQCP 3 phases Pre-analytical Analytical Post-analytical Right test Right test Right patient Right patientresult record Right time Right specimen Right clinical Right sample handling interpretation 4

5 IQCP Input Information for Each Device Medical Requirements for Test Results Regulatory Requirements Test System Information: from Manufacturer & Laboratory Information about Test-Site Setting Process Risk Assessment Output Quality Control Plan Post Implementation Monitoring Quality Assurance Adapted from EP23-A Workbook IQCP May or may not reduce QC the right QC It allows you to develop customized QC for your lab Specific to specimens, test system, reagents, environment, personnel Evaluate potential sources of failure in your testing system and reduce/eliminate them. Equivalent Quality Control (EQC) IQCP replaced EQC effective January, 206 Labs can elect to perform the minimum instead of IQCP (2 levels QC each day) 5

6 EQC Vs IQCP EQC IQCP Standardized Rigid Narrow Scope, Limited regulations Analytical Phase Only Requires internal QC Decreases external QC Customizable Flexible Broader Scope, More regulations Adapts testing practices for technology Excludes Pathology Pre-analytical, Analytical, and Post-analytical phases Does not require internal QC Optimizes the use of electronic/integrated controls May/May not decrease QC CMS QC Recommendations Two levels of external QC for each day of testing OR Laboratory develops an IQCP: Balance instrument/test control processes with liquid QC Reduce frequency of liquid QC to minimum recommended by manufacturer Maximize clinical outcome, available staff resources, and cost effectiveness. When to consider IQCP? Manufacturer s instructions recommend QC frequency less than CLIA requirements You have two choices:.perform 2 levels external QC each day of testing OR 2.Perform an IQCP * 6

7 Considerations for IQCP For Current or New Test Systems Yes Are there Manufacturer s instructions? No Frequency less than 2 levels/day? Yes Select option No QC requirements No Follow manufacturer s instructions Perform 2 levels QC / day Perform an IQCP: RA QCP QA * CAP EligibilityDetermination for IQCP Option Where to start POCT non waived Areas where we feel we may be performing too much QC Where the manufacturer QC protocol is less stringent than regulatory requirements Make a list of every test offered, how often QC d, is there EQC with no external QC 7

8 Where to start Non-waived Where to start with POCT Where the manufacturer QC protocol is less stringent than regulatory requirements you will need to do the IQCP in order to follow the manufacturer QC protocol Make a list of every non-waived test offered, how often QC is performed, is there EQC with no external QC? Many sites Many devices Many operators POCT Challenges The number of sites, devices and operators plus volume creates situations where rare events can happen in every day operations 8

9 Some POCT to consider for IQCP Blood Gas (75% testing errors are pre-analytic) istat HIV Pregnancy Troponin Drugs of Abuse Hb AC Urinalysis ACT PT/INR AVOX IQCP Applications in Microbiology Test systems (non-waived) where all QC not performed each day of testing ID systems Sensitivity testing Rapid/Direct antigen kits (RSV, Flu, etc) Exempt Culture Media (CLSI M22-A3) Rapid Molecular Tests Some reagent tests (refer to CMS standards) Testing CMS Standards Microbiology Tests that do NOT need IQCP AFB Stains Beta-lactamase other than Cefinase Fluorescent and immunohistochemical stains Bacitracin, Catalase, Cefinase, Coagulase plasma Germ tube test ONPG, Optochin, Oxidase, Spot indole Gram Stain Salmonella & Shigella antisera, streptococcal serotyping systems QC Required Pos/Neg each day of use Pos/Neg each day of use Pos/Neg each time of use Pos/Neg Each new batch, lot #, & shipment Pos each new batch, lot #, and shipment Pos/Neg Each new batch, lot #, & shipment Pos/Neg each week of use Pos/Neg Each lot #, shipment, and once every 6 months 9

10 Before you begin All CLIA, CAP (if applicable), DOH and other applicable regulations remain and must be followed Any IQCP eligible regulation that the lab chooses to replace with IQCP must be supported in the Risk Assessment * List of Individualized Quality Control Plans Complete the fields below for each IQCP in use and present to the inspector during the on-site inspection. Fill out a separate Individualized Quality Control Plan Summary form for each IQCP listed. Laboratory Name: CAP Number: ) Laboratory Section/Department ) Instrument/Device Include name, manufacturer, and model ) Tests List all tests included under the IQCP Laboratory Name: Laboratory Section/Depart ment: Individualized Quality Control Plan Summary Complete a separate form for each IQCP in use and present to the inspector during the on-site inspection. ) Instrument/ Device Include name, manufacturer, and model ) Tests List all tests included under the IQCP ) Num ber of Devices In Use ) List of Test Sites* If used in more than one area Date of Director Approval CAP Number: Date Impleme nted. Date Retired Instrument/Device: Reagents Environment Specimen Test System Testing Personnel Other 0

11 Objectives Understand IQCP Perform a Risk Assessment Develop an IQCP Assess the effectiveness of your IQCP Team Formation 4 6 Members Include users for all process steps: Operator Clerical Staff Person collecting specimen Supervisor Director End user

12 Risk Assessment (RA) Must encompass the entire testing process: Preanalytic Analytic Postanalytic Risk Assessment Quality Control Plan Quality Assessment RA Must evaluate these 5 components Specimen Collection Transport Integrity Receiving Processing Environment Temperature Humidity Power failure Reagent/QC Shipping Storage Preparation Expiration Date Test System Sample or reagent failure Software failure Hardware failure Transmission of results Testing Personnel Education Training & Competency Risk Assessment: Must Include Specimen/Samples Operator/ testing personnel Environment Sample Integrity Operator Atmospheric Environment Capacity -Temperature -Lipemia -Training -Humidity -Hemolysis -Competency -Interfering substances Operator Staffing -Short staffing Utility Environment Sample Presentation -Correct staffing -Electrical -Inadequate volume -Wireless Reagent Degradation -Shipping -Storage -Used past expiration Instrument Failure -Software failure -Optics drift Incorrect Test Result Quality Control Material Degradation -Shipping -Storage -Used past expiration Reagents Inadequate Instrument Maintenance -Dirty optics -Contamination -Scratches Test/Measuring System 2

13 Risk Assessment Some risks may fit under more than one of the 5 components. Identify under the component that is most appropriate for your lab. Any device can and will fail under the right conditions. Risk Assessment (RA) Similar to FMEA Identify sources of potential failures Evaluate frequency and impact of the potential failures In-house data must be included Demonstrates stability of test system in its own environment by its own personnel Supports number and frequency of QC May be historical and/or new data Risk Assessment Process. Collect Facts: a) Regulatory & organizational requirements b) Test method requirements c) Test site information d) Device s risk/error reduction features e) Historical data 2. Investigate testing process: a. Utilize operators to identify risks that could impact quality in each phase b. Investigate specimen, operator, environment, reagents, test system 3. Review current procedures: a. Gap analysis: identify what additional steps are needed to reduce risks 3

14 RA Collect Facts/Data Regulatory requirements (DOH, CLIA, CAP, etc) Manufacturer s package insert Operator manual Troubleshooting guide Alerts and bulletins Journals, Scientific Groups, List serves, etc. Test site information Device error reduction features Validation data Testing personnel records QC/PT data Corrected reports Instrument maintenance records, including environment QA information Multiple identical test systems Single risk assessment may be performed You must take in consideration: Differences in testing personnel Differences in environment Must show evaluation these differences Customize QCP as needed Manufacturers Information Intended use Off-label use requires extensive validation (eg. Glucose) Specimen requirements Patient preparation Limitations Environment Risk reduction features Type of QC & frequency Troubleshooting Alerts & Bulletins 4

15 Sources of Test System Information Test Site: Validation studies, including accuracy, precision, reportable range QC and PT performance data Simulator results QC check code reports QA findings Testing personnel: Qualifications, training, competency Clinician input Risk Reduction Sources Journal articles Technical reports List serves POC groups Manufacturer Risk Assessment Investigation Risk Assessment must include: Specimen Operator Environment Reagents Test System Use experts to identify risks Break down each phase into steps Ask What are our possible sources of error? Ask What can go wrong? Review current policies/procedures for significant risks Can our identified sources of error be reduced? 5

16 RA Specimen Patient preparation is fasting required? Are specimens collected in the correct container? Proper preservatives? Correct order of draw? Current version of manufacturer s instructions used? Are manufacturer s instructions followed for proper centrifugation (speed, time)? Specimen storage? Are there written procedures for specimen referral to other laboratories? Is the specimen properly labeled? Is the specimen accurately identified throughout testing process? Criteria for specimen rejection established and followed? RA - Environment What are manufacturer s instructions for: Temperature Humidity Airflow/ventilation Lighting Noise & Vibration Altitude Dust Water requirements Utilities: Electric Space RA Reagent & QC Shipping/Receiving/Storage are lot numbers recorded? Is there a procedure for evaluating new lot numbers before beginning use for patient testing? Expiration dates clearly identified? All used within the designated dates? Preparation Appropriate use Adequate mixing 6

17 RA- Test System Test System means instructions & all of the Instrumentation Equipment Reagents Supplies needed to perform an assay or examination and generate test results. RA- Test System Used for intended use? Does the lab have an established range for an acceptable calibration that verifies lab s reportable range? Are you able to detect mechanical or electronic errors on the test system? Does the lab define and document mechanisms to detect optical, pipette, or barcode reader errors? Does the lab perform system controls & function checks following manufacturer s instructions: Internal controls (built in procedural & electronic) External or internal liquid QC Temperature monitors? RA- Test System Is hardware/software current and appropriate? Is evaluation of instrument & reagent stability performed after relocation of instrument? Are there established corrective action SOPs for out of range controls & calibrations Are Corrective actions & resolutions documented, reviewed and shared with testing personnel? 7

18 RA- Test System Are there multiple locations? Has a risk assessment been performed for each? Do procedures follow manufacturer s instructions? Does the system recognize when QC, calibrations, reagents are expired? Does the lab have an adequate manual or electronic system in place to accurately transmit results? RA Testing Personnel Do all testing personnel meet educational & training requirements (CLIA, state)? Do all perform QC & PT? Do all follow manufacturer s instructions? Do personnel have license or certification if required? Is there an ongoing & documented competency assessment (with all 6 elements)? Does the lab have adequate staffing? RA - Scoring Look at Frequency, Severity, and Detectability for each identified risk. CMS mandates the laboratory must identify the sources of potential failures and errors for a testing process, and evaluate the frequency and impact of those failures and sources of error 8

19 Frequency (-5) Score Chance of Occurrence How Often 5 Once per week Frequent 4 Once per month Probable 3 Once per year Occasional 2 Once every few years Once in life of system Remote Inconceivable 9

20 Risk Assessment Risk Acceptability Look at severity and probability of harm to determine if risks are acceptable. CLSI s Risk Acceptability Matrix: Probability of Harm Negligible Minor Serious Critical Catastrophic Frequent Unacceptable Unacceptable Unacceptable Unaccept Unaccept Probable Acceptable Unaccept Unaccept Unaccept Unaccept Occasional Acceptable Acceptable Acceptable Unaccept Unaccept Remote Acceptable Acceptable Acceptable Acceptabl e Improbable Acceptable Acceptable Acceptable Acceptabl e Unaccept Acceptable Risk Assessment - Summary Include all three phases of the testing process Include the five components Break down procedure into steps Review information about the testing process Review historical data Look at each step to identify potential failures Do current practices/processes detect sources of error? 20

21 End Result of RA Potential Risks Gap Analysis: Review current procedures, training, device features for reduction of potential risks identified Modify practices as necessary Potential Potential Currently Goal: Eliminate all significant risk failure Cause Example of RA Grid: Step where failure could happen steps in place to reduce risk? Added steps for significant risk Examples of Possible Changes in Procedure based on RA Sample: Patient ID: use 2 identifiers; patient ID scanning Test System: Customize result restrictions when to repeat Reagents: Electronic temperature monitoring New expiration date label when moved to room temperature Operator: Education/training Competency assessments Environment: Temperature monitoring Objectives Overview of CMS/CLIA requirements Understand IQCP Perform a Risk Assessment Develop an IQCP Assess the effectiveness of your IQCP 2

22 Quality Control Plan (QCP) Describes practices, resources, and procedures to control quality of a test process. Includes measures to assure accuracy and reliability of results. Provide for immediate detection of errors that occur Monitor over time accuracy & precision that may be affected by changes in test system, environment, or operator. * Quality Control Plan (QCP) Create a plan that includes activities to reduce likelihood of errors identified from your risk assessment. Consider the amount of QC necessary based on frequency and volume of patient testing. Note: must meet QC procedures specified by the manufacturer Risk Assessment Quality Control Plan Quality Assessment Quality Control Plan Must include: Number Type Frequency of testing (must be no less than that specified in manufacturer s instructions) Criteria for acceptable result(s) of the QC * 22

23 Quality Control Plan May include: Electronic / internal controls Procedural controls Training & competency assessment Calibration Maintenance Other specified QC activities Quality Control Plan Type of Quality Control Frequency Criteria for Acceptability Temperature checks Room Refrigerator Verify specimen for acceptability Internal QC External QC Normal Abnormal Training Record daily on temperature log sheets With each specimen Performed with each reagent cartridge Performed with each lot number Each shipment Each week With each new testing personnel and when indicated Room C Refrigerator 2-8 C Refer to specimen rejection policy. Document as acceptable prior to reporting results Acceptable range printed on manufacturer s package insert Successful demonstration of test performance. Competency Assessment Initial, 6 months, annually Meet all 6 elements Types of Quality Control Built in device controls or system checks Electronic QC simulates signals electronically Internal QC lab analyzed sample controls External QC blind proficiency survey Control processes engineered by manufacturer or enacted by laboratory Example - barcoding * 23

24 Staff Train to the QCP Competency Assessment initial, 6 months, annually * IQCP Laboratory Director responsibilities: Development and implementation - may be delegated in writing Must be documented evidence that Director has approved, signed and dated the QCP. * Getting Started: BD Veritor INTENDED USE The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal wash, aspirate and swab in transport media samples from symptomatic patients. 24

25 Getting Started: BD Veritor QUALITY CONTROL: Each BD Veritor System Flu A+B device contains both positive and negative internal/procedural controls:. The internal positive control validates the immunological integrity of the device, proper reagent function, and assures correct test procedure. 2. The membrane area surrounding test lines functions as a background check on the assay device. NOTE: The internal controls do not assess proper sample collection technique. Getting Started: BD Veritor External Positive and Negative Controls: Flu A positive/b negative and Flu B positive/a negative control swabs are supplied with each kit. These controls provide additional quality control material to assess that the test reagents and the BD Veritor System Instrument perform as expected. Prepare kit control swabs and test using the same procedure (either Analyze Now or Walk Away mode) as used for patient specimen swabs. When using the barcode scanning feature to document QC procedures, scan the barcode on the control swab packaging when prompted for a specimen ID. Getting Started: BD Veritor Your laboratory s standard Quality Control procedures applicable local, state and/or federal regulations or accreditation requirements dictate the performance of external quality control procedures. BD recommends external controls be run once for: each new kit lot, each new operator, each new shipment of test kits, as required by internal quality control procedures and in accordance with local, state and federal regulations or accreditation requirements. 25

26 Example getting started BD Veritor Influenza Gather supporting data for your lab and record findings: PT performance reports Test performance validation studies Specimen (recollect data, issues) Instrument maintenance (Test System) review logs Review of patient test results & external QC results Review of troubleshooting logs Review of lot to lot logs Environment temperature logs Testing personnel training and competency records For each risk assessment component Ask what could go wrong? Are there actions the lab could take to reduce sources of error? Consider your testing process in its entirety (order placed thru to reporting) Example BD Veritor Risk Factor Possible Error Fr eq Specimen. Improper patient. Patient ID identification 2. Nasopharyngeal 2. Improper labeling hard to get specimen 4 3. VTM media needs 3. Improper to be at room procurement/handling/ temp/ within processing expiration 4. Freshly collected 4. Swab taken out specimens should be of VTM processed and tested immediately, within hour. If necessary, specimens may be stored at 2-8 C for up to 72 hours. D S et e v Sc or e Thought Process reducing error Adhere to procedures in SOP that addresses patient identification and specimen collection, labeling, and transport. Review of RL-6 = 0 errors. Make CDC Video on nasopharyngeal collections available Procedure with pictures of specimen collection: annually distribute Link video to Lab Page Annually review representative specimen processing errors 26

27 RA - BD Veritor Operator Incompletely trained. Competency 2. Proficiency testing 3. Turnaround times walk away from timer 4. Patient ID/ specimen labeling 5. Results reading and reporting Review training and competency records, which include direct observations. All testing personnel have had appropriate training before performing this assay. Review turnaround times: adequate staffing to support this test and turnaround times is available on all shifts. Proficiency Testing WRMC error last year; MVH good. All staff involved in PT and review all final critiques. Audit weekly, resolve issues, report quarterly: Supervisor review work sheets to data entry in computer Reagents. Shipping 2. QC 3. Storage 4. Electronic Device reader verification cartridge good for 3000 tests 5. Reader expiration date RA - BD Veritor Received frozen Back orders Improper temperature Expired reagents Room temperature logs are reviewed. QC new lot, new shipments, every 3 days: review demonstrates no problems or indications of problems for past year. Wrong temperature would cause QC failures and so would detect All specimen-specific QC parameters are controlled within the cartridge, If the test is invalid, the BD Veritor System Reader will display a Control Invalid result and the test is repeated. All reagents are used within expiration dates. Reader notifies/alerts expiration. Parallel testing lot to lot: Review of lot-to-lot reagent logs demonstrates no problems or indications of problems for past year. RA - BD Veritor Environment. Reader 5-30 C 2. Testing 5-30 C 3. Lighting dropper visible 4. Battery operated Room temperature out of range. Inadequate lighting. Battery failure 2 2 Review of Room temperature logs demonstrates no problems with temperature for past year Laboratory lighting on emergency generator 2 extra AA batteries kept on hand. 27

28 RA - BD Veritor Measuring system. 5 second self test Self test failure before use. Internal QC failure 2. Internal QC with each assay Doesn t apply sample properly or 3. Flat, dry stable surface not in direct sunlight required fails to vortex 4. Applying Sample 5. Vortexing Sample 6. Results Reporting a. Log worksheet & label set b. LIS drop down error q 3 yrs c. Call all positives and document Flat, dry stable surface away from sunlight available for use. Review of reader verifications show no problems with test system for the past year. Review of patient test results and two levels of external QC results for the past year demonstrates no problems with the test system. Competency/training: if interrupted during testing, can vortex again Positives to DOH until confirmed, then IP and SNU only Review Review your Risk Assessment Does it include all 3 phases of testing process? Does it include the 5 components? Determine if your current practices are sufficient to detect sources of error in your test system. Determine whether your identified risks need to be monitored or controlled regularly. Quality Assessment Monitor and Assess Include review of effectiveness of corrective actions taken to resolve problems Update RA and modify the QCP as necessary based on information obtained from the QA Risk Assessment Quality Assessment Quality Control Plan 28

29 Example of QA activity: Review room temperature log sheet for problems and evidence of corrective action Review control documents for out of range values and corrective action Review personnel training records for completion of required training and assessments Quality Assessment - Failures If a test process failure is detected, you must Identify cause Identify impact on patients Make appropriate modifications to the QCP Lab Director review & approval of modifications Revised QCP signed and dated Documents to Consider for QA QC data sheets review Delta check logs PT records Complaint reports Patient results review Specimen recollection logs/ rejection logs Critical value call logs Turnaround time reports Temperature logs PMs, maintenance, troubleshooting logs, follow-up Competency records & training logs FDA alerts 29

30 IQCP MONITORING QC Acceptable (External & Internal) Specimen Rejection Issues (Mislabeling, Hemolysis, QNS, etc.) Incidents and Physician Complaints (RL6) Reagent Lot to Lot Acceptable Temperatures Acceptable Periodic Maintenance Procedures Acceptable Proficiency Testing Acceptable Technical Competency Complete Corrected Reports Reviewed/Date JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No / / / / / / / / / / / / # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No # # # # # # # # # # # # Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No / / / / / / / / / / / / # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total # Total Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No % % % % % % % % % % % % Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No # # # # # # # # # # # # Comments IQCP The three parts of IQCP may be viewed as a continuous cycle of improvement Risk Assessment: What can go wrong? Quality Assessment: Is it working? Quality Control Plan: How do we prevent or detect? IQCP: A Possible Outline. Reference the Laboratory s SOP & Where Located 2. Summary of Historical In-house QC Data 3. QCP and Changes Based on the Risk Assessment a. Reagents (for tests performed; QC with # levels, type, frequency, acceptability) b. Specimen/Sample requirements (Suitable samples, mixing, exposure to air, etc) c. Testing Personnel/Operators (Competency, Training) d. Test System (Components, Features to prevent errors) e. Testing Environment (Testing surface, Temperature, Features to prevent errors, etc) 4. Post-analytic Phase (Result Reporting and Interpretation) 5. Quality Assurance (Ongoing review of IQCP) 6. Authorization (Lab Director s Name/Signature, Date) 30

31 Quality Control Plan for the BD Veritor System. Follow the Laboratory s SOPs: BD Veritor Flu A/B and BD Veritor RSV 2. Summary of Historical In-house QC Data Review of RL-6 reports for the past year identified zero errors. Review of training and competency records identified no issues, all complete. Review of proficiency testing results: error last year at WRMC; no errors at MVH. All staff involved in proficiency testing and review final critiques. Review of reader verifications show no problems with the test system for the past year. Review of patient test results and two levels of external QC results for the past year demonstrated no problems with the test system. The external QC was run with each new lot, each shipment, and every 3 days. Review of lot-to-lot parallel testing demonstrated no problems or indications of problems for the past year. Review of room temperature logs for the past year did not identify temperature issues. QCP BD Veritor System 3. QCP and Changes Based on the Risk Assessment a. 2 levels of external quality control material (positive and negative) will be tested: With each lot of reagents With each shipment of reagent If storage and/or testing temperature falls out of range (5-30 C) Every 3 days. Parallel Testing: Lot to lot test validation will be performed with each new reagent lot received. b. Specimen/Sample requirements : Nasopharyngeal swabs in Viral Transport Media. Freshly collected specimens should be processed and tested within hour. If necessary, specimens may be stored at 2-8 C for up to 72 hours. QCP BD Veritor System c. Testing Personnel/Operators (Competency, Training): A competency checklist will be utilized to document training and competency for the employee. Direct observations, review of QC and patient results, and proficiency testing or blind unknowns are included in the assessment. Problem solving will be included in the competency assessment. Competency assessment will be completed before the employee performs testing, and 6 months after initial training, and annually thereafter. d. Test System: All specimen-specific QC parameters are controlled within the cartridge. If the test is invalid, the BD Veritor System Reader will display a Control Invalid result and the test is repeated. e. Testing Environment : Temperature logs are maintained, and reviewed by the technical supervisor. Temperature required 5-30 C. 3

32 QCP BD Veritor System 4. Post-analytic Phase: Positive results are called, and the call documented. 5. Quality Assurance: The RL-6 reporting system will be monitored for errors and complaints. Employee competency assessments and training will be monitored quarterly for a) issues identified with corrective actions and b) % completed on time. Proficiency testing participation and results reviewed will be monitored. Room temperature logs are reviewed monthly by the technical supervisor. Quality control results are reviewed monthly by the technical supervisor. 6. Authorization: Date: Summary Risk Management is something we already do IQCP is voluntary, you can elect to perform a minimum of 2 levels external QC on every test. Each IQCP is unique it considers your testing environment and testing staff, this may vary between laboratories Once implemented, the IQCP is monitored for effectiveness and modified as needed. QUESTIONS? kringlis@yahoo.com 32

33 Take Home Templates The following pages are templates you may use in your laboratory Your IQCP is individualized for your laboratory these templates may be modified for you. NYSDOH Checklist Test System/Device: Fill in required info Date Task Completed Manufacturer: Package insert or product manual Number & type QC analyzed QC Frequency (actual) QC recommendations by manufacturer Regulatory requirements for this test system NYSDOH Checklist Fill in required info Date Task Completed Validation Calibration data (if required for test method) Review of historical QC data QC Acceptability Criteria Any product recalls? Review of previous PT evaluation & QA: Any problems identified? 33

34 NYSDOH Checklist Testing Process Review Risk Assessment SOP -. Specimen 2. Testing Personnel 3. Reagents 4. Environment 5. Test System 6. Test Results Fill in required info What are the risks identified? SOP# List Potential Hazards found during RA What is the occurrence & Severity at each phase above? Define steps/actions to lessen or prevent the error from happening. Develop QC Plan Date Task Completed NYSDOH Checklist Fill in required information Date task completed Define Quality Assessment monitors for test system Frequency of monitors Assessment of QA monitors (was there any variations from established policy/procedure?) Define corrective action plan if QC or system fails. IQCP Facility: Test System: Test System Primary SOPs include: Historical Quality Review: Regulatory and Accreditation Requirements: Method verification: Instrument received and test system verification completed in year. Subsequent verifications performed when were added (dates ). Documentation filed in. Training of personnel: Completion of training documented in. Competency Assessment: New employees 6 months after initial training and annually thereafter. Documentation filed in. Proficiency Testing: Rotate personnel, all personnel review results. Records filed in. Quality Control: 34

35 IQCP Continued Test System Information: Manufacturer: Package insert contains system performance data and describes testing principle & procedure, QC recommendations, and limitations. Insert is located. Manufacturer alerts and bulletins are located. Operator s manual including troubleshooting guide is located. Scientific Publications used during collection of information for RA: Summary of in-house data from routine QC testing: QC testing was performed according to SOP. Review of QC records for the past months demonstrated: Summary of in-house data from routine instrument performance checks: Instrument checks were done according to SOP. Review of instrument QC records and checks of instrument revealed no instrument performance problems that would impact patient results. Summary of corrected reports and physician complaints: Documentation located. Review of reporting errors identified prior to report release, corrected reports & physician complaints for the past 2 months revealed: Final QCP for System XYZ IQCP Continued Based on our risk assessment and Quality Assessment, the QCP consists of following the instructions that are provided in detail in QC Section II of SOP # are summarized here: 2 levels of external quality control material (positive and negative) will be tested: With each lot of reagents With each shipment of reagent If storage and/or testing temperature falls out of range (5-30 C) Every 3 days. Parallel Testing: Lot to lot test validation will be performed with each new reagent lot received. Recording and evaluating QC results according to QC acceptability criteria as defined in SOP # for performance of. Any out-of-range result is immediately investigated and corrective action performed prior to releasing any patient results. IQCP Continued Quality Assessment: Ongoing Monitoring for QCP Effectiveness (Performed by supervisor) Monthly review of QC results. The RL-6 reporting system will be monitored for errors and complaints. Proficiency testing participation and results will be monitored monthly. Room temperature and refrigerator temperature logs will be reviewed monthly. Employee training and competency records will be monitored quarterly for issues identified with corrective actions and completeness of records. Authorization: Date: 35

36 RA Example of Table Format Specimen List each risk identified Testing Personnel Reagents Environment Test System Freq Severity Detection Score Measures to Control Risk Relevant SOP Risk Assessment Table Risk Factor Possible Error How can error be reduced? Specimen Testing Personnel Reagents Environment Test System: Transmission of results to LIS Incorrect transmission Delay in transmission Annual check of test system LIS interface QA monitor for TATs RA Template Risk Factor Possible Error Freq Det Sev Score Thought Process reducing error Specimen. Are criteria for specimen rejection established and followed? 2. Are specimens collected in the correct container, with proper preservatives? 3. Are specimens properly labeled? 4. Is the specimen accurately identified throughout the testing process? 5. Are the manufacturer s instructions followed for proper centrifugation (time and speed) to ensure proper and adequate separation of cells from serum or plasma? 6. Are the manufacturer s instructions followed for proper specimen collection and use of specimen collection containers? 7. Are there written procedures for specimen referral to other laboratories? 8. Are criteria established and followed for specimen transportation and storage? 36

37 Risk Factor Possible Error Freq Det Sev Score Thought Process reducing error Operator/ Testing Personnel Do all personnel who collect specimens and perform testing follow manufacturer s instructions? Do all testing personnel perform QC and PT? Do all lab personnel meet education/training specified by CLIA? Is there adequate staffing to perform testing in a safe and timely manner? Does the lab have an ongoing and documented competency assessment program that includes the 6 elements required? Reagents. Expiration dates clearly identified and properly labeled? 2. Are all reagents, QC, calibrators within the manufacturer s designated expiration date? 3. Are lot numbers recorded when new lots rec d and when beginning new lots? 4. Is there a procedure for evaluating new lot numbers before beginning use for patient testing? 5. Are storage requirements for reagents followed? 6. Is integrity of reagents checked when received? 7. Are manufacturer s instructions for reagent preparation followed? 8. IS there specified water required by the test system? Environment Is ventilation adequate for conducting all phases of testing? Do manufacturer s instructions specify requirements for ventilation and airflow? Do manufacturer s instructions specify type of water required for testing process? Does the lab have adequate space to perform testing, prevent cross contamination, and/or injury? Is lighting adequate? Are surge protectors used to prevent fluctuations of power source in testing Environment Is ventilation adequate for conducting all phases of testing? Do manufacturer s instructions specify requirements for ventilation and airflow? Do manufacturer s instructions specify type of water required for testing process? Does the lab have adequate space to perform testing, prevent cross contamination, and/or injury? Is lighting adequate? Are surge protectors used to prevent fluctuations of power source in testing areas? Is testing area kept clean and clear of clutter and debris that could interfere with the testing process? 37

38 Test system Is the laboratory able to detect mechanical or electronic errors on this test system? Does the lab have an established range for acceptable calibration that includes a minimum, midpoint, and maximum value to verify reportable range? Does the lab define and document mechanisms to detect test system optical, pipette, or barcode reader errors? Does the lab perform system controls and function checks according to manufacturer s instructions, to include checks for: Built-in procedural and electronic controls (internal controls)? External or internal liquid QC? Temperature monitors and systems? Are there interfering substances to consider? Are maintenance procedures performed within manufacturer s isntructions? Software/hardware current and appropriate? Evaluation of instrument and reagent stability following relocation of instruments? Established corrective action policies and procedures for out of range controls and calibrations? Adequate manual or electronic systems to accurately transmit patient results in timely manner? Final results reviewed by supervisor within 24 hours? Procedure to monitor accuracy and completeness of information transmitted to the LIS? If multiple locations assessment for each location? Procedures written according to manufacturer s instructions? 38