Reducing Risk in the Laboratory: IQCP In Action! 9/24/2015

2015 APHL ASCLS Webinar Series Reducing Risk in the Laboratory: IQCP In Action! 9/24/2015 Speaker James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology, and Immunology, Medical Director, Clinical Chemistry, Associate Medical Director, Clinical Operations, Vanderbilt University School of Medicine, Nashville, TN James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry, and Associate Medical Director for Clinical Operations at Vanderbilt University School of Medicine.Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Pointof-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology. Objectives At the conclusion of this program, participants will be able to: Recognize common sources of error in the laboratory Identify CLSI EP23 guideline as a resource for risk management Build an Individualized Quality Control Plan (IQCP) for a simple lab test Continuing Education Credit The American Society for Clinical Laboratory Science (ASCLS) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program. Participants who successfully complete each program will be awarded 1.0 contact hours. ASCLS P.A.C.E. is accepted by the ASCP Board of Certification and all states including Florida and California as an approved provider of continuing education. ASCLS will submit attendance to CE Broker for Florida licensees. Continuing education credits are available to individuals who successfully complete the program and evaluation by 9/24/2016. CPH-recertification credit is not available for this program. Evaluation/Printing Certificate A. Evaluation (complete first) Go to http://ascls.webedcafe.com/registration/1200/5/r/iqcp and complete the evaluation by 9/24/2016, Upon completion of the evaluation, you will be sent to a page with a unique session code and instructions on how to use CE Organizer. Print out that page. Record the session code number. You will need this number in CE Organizer to get credit for attending the session. B. Certificate a. If you have not used CE Organizer before, I suggest you take a moment to view the tutorial on the ASCLS web site at http://ceorganizer.ascls.org/. After you have used the program once or twice, you will be quite comfortable with it. If you do have questions or comments, please call 571-748-3770 or email ascls@ascls.org. b. Here is a brief summary describing how to use the ASCLS CE Organizer: 1. Go to http://ceorganizer.ascls.org/. 2. If you already have a CE Organizer account, log in with your email address and password. If you have not used CE Organizer before, scroll down the page to the Log In instructions. ASCLS members will log in using the same username and password used to enter the Members Section of the ASCLS website. ASCLS members without a username and password should click on the link to register. If you are not an ASCLS member, click the Register Here link to create a username and password. If you cannot remember your username or password, send an email request to ascls@ascls.org. Do not create another username and password. 3. Once logged in, click on Certificates. 4. In the list of ASCLS P.A.C.E. approved events, click on APHL-ASCLS Webinar Series. 5. On the next screen, check the box(es) of the/every webinar you attended and click Next at the bottom of the page. If you cannot see the checkboxes, you may need to use the scroll bar at the bottom of the page. The Association of Public Health Laboratories (APHL) sponsors educational programs on critical issues in laboratory science. For more information, visit www.aphl.org/courses

Archived Program The archived streaming video will be available within one day after the live program. Anyone from your site can view the Web archived program and/or complete the evaluation and print the certificate for free. Registration is not necessary for the archive program. For Live or archived site registrations, the URL will be sent to the site representative who is responsible for distributing the URL. Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL/ASCLS. The APHL/ASCLS does not authorize any program faculty to express personal opinion or evaluation as the position of APHL/ASCLS. The use of trade names and commercial sources is for identification only and does not imply endorsement by the program sponsors. This program is copyright protected by the speaker(s), ASCLS and APHL. The material is to be used for this APHL/ASCLS program only. It is strictly forbidden to record the program or use any part of the material without permission from the author, ASCLS or APHL. Any unauthorized use of the written material or broadcasting, public performance, copying or re-recording constitutes an infringement of copyright laws. The Association of Public Health Laboratories (APHL) sponsors educational programs on critical issues in laboratory science. For more information, visit www.aphl.org/courses

Reducing Risk in the Laboratory: IQCP in Action! James H. Nichols, PhD, DABCC, FACB Professor of Clinical Pathology, Microbiology and Immunology Medical Director of Clinical Chemistry and Point of Care Testing Vanderbilt University School of Medicine Medical Director, Clinical Chemistry Nashville, Tennessee, USA james.h.nichols@vanderbilt.edu Faculty Disclosure The Association of Public Health Laboratories and the American Society for Clinical Laboratory Science adhere to established standards regarding industry support of continuing education for healthcare professionals. The following disclosures of personal financial relationships with commercial interests within the last 12 months as relative to this presentation have been made by the speaker(s): James H Nichols Nothing to disclose. 1 2 Objectives What is Risk? 1. Recognize common sources of laboratory error 2. Identify CLSI EP23 guideline as a resource for risk management 3. Build an Individualized Quality Control Plan for a simple test to meet the new CLIA interpretive guidelines 3 4 History CLIA 88 requires 2 levels of QC each day of testing! Newer lab devices offer internal and engineered control processes that make daily liquid QC duplicative and redundant. IQCP allows laboratories to develop a plan that optimizes the use of engineered, internal control processes on a device and balances the performance of external liquid QC without impacting safety! CLSI EP23 introduces industrial and ISO risk management principles to the clinical laboratory CMS adopted key risk management concepts to develop the IQCP option for quality control IQCP replaces 2003 EQC options currently in place. New IQCP Two levels of liquid QC required each day of testing OR Laboratory develops an IQCP: Balance internal control processes with external controls Reduce frequency of liquid QC to minimum recommended by manufacturer Maximize clinical outcome, available staff resources and cost effectiveness in the lab 5 6

Individualized Quality Control Plan Risk Assessment Quality Control Plan Quality Assessment Risk in the Laboratory There is no perfect laboratory device, otherwise we would all be using it! Any device can and will fail under the right conditions A discussion of risk must start with what can go wrong with a test (errors or nonconformities) Lab tests are not fool proof! Individualized Quality Control Plan 7 CLIA 8 What Could Go Wrong? Risk Mitigation Liquid quality control is historic means of detecting and preventing errors (nonconformities or incidents)! Liquid controls detect systematic errors that affect every sample the same way (calibration errors, pipette errors, reagent degradation) Liquid controls do a poor job at detecting random errors that affect a single sample uniquely (hemolysis, lipemia, clots, drug interferences) For unit use tests, liquid controls consume entire test and do not ensure performance of next test Newer devices have built in electronic controls, and onboard chemical and biological controls. 9 10 Types of Quality Control On Board or Analyzer QC built in device controls or system checks Internal QC laboratory analyzed surrogate sample controls External QC blind proficiency survey Laboratory Manufacturer Partnership No single QC procedure can cover all devices, because the devices may differ. Newer devices have built in electronic controls, and on board chemical and biological controls. Developing a quality plan surrounding a laboratory device requires a partnership between the manufacturer and the laboratory. Some sources of error may be detected automatically by the device and prevented, while others may require the laboratory to take action, such as analyzing surrogate sample QC on receipt of new lots of reagents. Other types of QC control processes either engineered by a manufacturer or enacted by a laboratory to ensure result reliability 11 Clear communication of potential sources of error and delineation of laboratory and manufacturer roles for how to detect and prevent those risks is necessary. ISO. Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer. ISO 15198. Geneva, Switzerland: International Organization for Standardization; 2004. 12

CLSI Document EP23 EP23 Laboratory QC Based on Risk Management Laboratory Quality Control Based on Risk Management; Approved Guideline (EP23 A ) James H. Nichols, PhD, DABCC, FACB, Chairholder of the document development committee Medical Requirements for Test Results Regulatory and Accreditation Requirements Input Information Test System Information: Provided by the manufacturer Obtained by the Laboratory Process Risk Assessment Information about Health Care and Test-Site Setting EP23 describes good laboratory practice for developing a QCP based on the manufacturer s risk mitigation information, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting. Continuous Improvement Output Laboratory Director s QC Plan Post Implementation Monitoring CLSI EP23 Table 13 14 EP23 Laboratory QC Based on Risk Management Create a Process Map (Preanalytic Analytic Postanalytic) Identify Weaknesses in the Process Gather the Information Define a Process that will Mitigate Risk Summarize Processes and Actions in a QC Plan 15 16 Laboratory Example ffn is a low volume test (<2 samples/day) Need for daily liquid QC uses 2 cassettes ($100 ea) and adds 40 mins TAT. Adoption of nontraditional TLi IQ would improve cost, test and labor efficiency. TLi IQ Control Processes Automatic calibration with lot specific code Three types of control processes: QCette daily functional control cassette verifies analyzer performs within specification Internal controls with each patient test verify the integrity of sample, cassette flow by measuring the intensity of control line Liquid controls with each shipment of cassettes qualifies performance upon receipt 17 18

QCette More complex than an electronic control Comprised of a replica cassette containing preprinted test and control lines. Goes through full read cycle by instrument Checks electronics, optics and functionality of software algorithms to generate a value within predetermined specifications Procedural Control line in high positive range, must be above a minimum threshold Test Line in the low range, must be within 5% of a value established at instrument setup Negative the white space between lines meets specs to pass. 19 20 Internal Control Checks Performed with each test automatically Instrument checks LEDs, photosensor and motor immediately before and after each test. Chemistry checks: Minimal procedural control threshold Adequate flow of conjugate Adequate specimen volume. Cassette Pass or Fail with Invalid result 21 22 TLi IQ Control Processes QCette Daily Verifies analyzer performance within specs Internal Controls Automatic with each test Verifies analyzer and cassette performance during patient testing Liquid Controls Each shipment Qualifies cassette and lot performance on arrival Evaluation of TLi IQ Two levels of QC daily for 1 month (N=20) QCette daily Minimum manufacturer s recommendations followed for assessing TLi IQ acceptability Two levels of QC and QCette passed One exception, liquid Neg control was invalid due to an internal cassette failure (sample did not migrate). Repeated successfully on new cassette. 23 24

Process Map: Finding the Weak Steps in the ffn Process Create a Process Map Identify Weak Steps for Hazards or Risk of Error Test Order Electronic or hardcopy Test collection False + (bleeding, advanced dilation, sexual intercourse previous 24 hrs, ROM, etc.) Wrong swab/collection kit Sample degradation delay/temp exposure Analysis Incorrect calibration Failure of reagent during storage Wrong sample volume applied to cassette Device failure during analysis Reporting Results transcription errors 25 26 Conduct a Risk Assessment Identify Control Processes for Each Hazard that Maintain Risk to a Clinically Acceptable Level 27 28 Risk Assessment Specimen Improper sample collection Physician education Wrong tube, clotting NA special collect kit Specimen delay monitor transport conditions Operator Too much or too little sample application TLi IQ onboard controls, also use dedicated pipette Incorrect timing/interpret NA automatic device Training/competency Minimal MT staff in lab Transcription error double check results Incorrect operation NA automatic device 29 30 CLSI QMS Communities website http://community.clsi.org/qms/wpcontent/uploads/sites/13/2013/07/qms_community_piece_042214_hologic_iqcp_guidance_-ffn_on_the_tliiq_system.pdf

Risk Assessment Reagent Test exposure outside specs (temp, humidity, etc) analyze QC samples with each shipment Wrong calibration NA auto calibration lot # Expired reagents operator must check for reagent exp date Environment Core Lab no other errors noted in past for similar methods/readers Analysis Electronic/System failure NA TLi IQ checks Result drift monthly liquid QC reagent viability Risk Assessment Clinical Application Immediate medical decisions internal TLi IQ controls with each test, inhouse 30 day comparison to external QC verifies process stability Stability of sample sample stable for retest if result is questioned! 31 32 The QC Plan Summarize the QC Plan Analyze QC Each new shipment* Start of a new lot* Monthly Whenever uncertainty about cassettes* Utilize QCette each day* Internal controls with each test* Physician education on collection, false positive sources Courier refrigerate samples and monitor transport times Use dedicated 200 microliter pipette for sample application Use checklist to document training/comp/maintenance (* Manufacturer recommendations) 33 34 IQCP Quality Assessment Implement the QC Plan CMS Quality Assessment! Monitor for Failure/Errors and Modify QC Plan as Needed Number complaints: false positives/retests Frequency test cancellation specimen received using wrong swab/collection kit Liquid QC failure rates Frequency device error codes Any other unexpected error 35 36

EP23 Laboratory QC Based on Risk Management Create a Process Map (Preanalytic Analytic Postanalytic) Where is the Risk in Our Process? Baseball Coach Loans Ferraris to Teenagers. What Could Possibly Go Wrong? April 1, 2009 Identify Weaknesses in the Process Define a Process that will Mitigate Risk Summarize Processes and Actions in a QC Plan 37 38 Falsely Decreased Glucose Results Complaint from an ICU of sporadic falsely decreased glucose results Immediate repeat test on same meter, gave significantly higher clinically sensible values Inspection of unit found nurses taking procedural shortcuts to save time Bottles of test strips dumped on counter in spare utility room Some strips not making it into trash, falling back on counter and being REUSED 39 Risk of Error from Open Reagents Glucose test strips exposed to air for as little as 2 hours have been shown to cause 26% bias. 1 Strips left on counters pose risk of reuse, leading to falsely low results. Some meters catch reuse and error preventing a result. Other meters do not! 2 1. Keffer P, Kampa IS. Diabetes 1998; 47; abs 0170. 2. Silverman BC, Humbertson SK, Stem JE, Nichols JH. Operational errors cause inaccurate glucose results. Diabetes Care 2000;23:429-30. 40 Sample Errors: Specimen Volume Some glucose meters recommend that operators visually inspect strips for uniform color development after each test (detects underfilling and bubbles) Other meters have automate sample detection. (Fill trigger is designed to prevent short sampling.) Test starts only when enough blood has been applied. Operator Errors: Training/Competency Operator lockout Functions through number code, name or barcoded ID List of operators and training/competency dates maintained in data manager system Devices can warn operators of impending certification due dates (in advance of lockout) 41 42

Operator Errors: Performing QC Devices require periodic QC QC lockout shuts off patient testing if QC not performed or fails target ranges. Prevents patient testing unless QC documented Operators workaround QC lockout by performing patient testing in QC mode! Newer devices distinguish QC samples, prevent patient testing in QC Coagulation Devices Meter has a number of built in QC functions Two level on board QC test and patient result determination in single test strip chamber Electronic component and function check at meter on Test strip temperature check during test progress Test strip expiration date and lot check through code chip 43 44 Operator Errors: Patient Identification Incorrect entry of patient identification can Chart results to the wrong patient s medical record Lead to inappropriate medical decisions and treatment Improper billing and compliance Barcoded patient wristbands reduce the chance of misidentification, but patients can be banded with: Another institution s identification Outdated account numbers A wrong patient s wristband Residual risk of error even with barcoded ID bands Barcoded ID entry alone doesn t satisfy requirement for patient safety 2 unique identifiers National Patient Safety Goals Joint Commission: Use at least two ways to identify patients. For example, use the patient s name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment. College of American Pathologists: Personnel must confirm the patient s identity by checking at least two identifiers before collecting a specimen. For example, an inpatient s wristband may be checked for name and unique hospital number; an outpatient s name and birth date may be used. 45 46 Operator Errors: Patient Identification Some devices have positive patient ID ADT feed to device Two identifiers plus active confirmation (also satisfies Joint Commission time out) Positive patient ID reduced errors from 61.5 errors/month to 3 errors/month. 1 (unregistered patients; 2 ED and 1 non ED) conducted over 2 months 38,127 bedside glucose tests. Operator Errors: Data Transfer POCT results may not get recorded in patient s medical record, particular problem for manual tests POCT data management ensures capture of data in device (QC and Patient results), but doesn t guarantee transfer until operators dock device Wireless ensures data transmitted to patient record. (Need continuous wireless or operators may forget to push send button) 1. Alreja G, Setia N, Nichols J, Pantanowitz L. Reducing patient identification errors related to glucose point- of-care testing. J Pathol Inform 2011; 2: 22 [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc3097526/] 47 48

Benefits of Wireless Real time data transmission to EMR Physicians can immediately access results remotely Glucose results can transpose insulin dosage for individualized patient management INR results can populate dosage software and algorithms Reagent Errors: Expired Reagents Centers for Disease Control Check and record expiration dates of reagents/kits, and discard any reagents or tests that have expired. 1 U.S. Food and Drug Administration Check the expiration date on the test strips. As a test strip ages, its chemical coating breaks down. If the strip is used after this time, it may give inaccurate results. 2 1. Ready? Set? Test! Centers for Disease Control booklet http://wwwn.cdc.gov/dls/waivedtests/readysettestbooklet.pdf 2. Useful Tips to Increase Accuracy and Reduce Errors in Test Results from Glucose Meters, U.S. Food and Drug Administration http://www.fda.gov/medicaldevices/safety/alertsandnotices/tipsandarticlesondevicesafety/ucm109519.htm 49 50 Strip Wastage When Outdated Operator must check manufacturer s expiration date prior to testing. Vials/strips and controls must be manually dated when opened by operator (prematurely expires once opened) Undated, opened vials must be discarded. (? expiration) Reagent Errors: Expired Reagents Serialized vials/strips and controls barcoded for lot number and expiration date (good to stamped expiration date) can recognize individual vials on opening (30, 60 or 90 day open expiration) Automatic lockout for expired test strips and controls Some devices can also recognize exposure to humidity (few hours), wet or reused strips as additional control measure Discarded strips due to no date 1 1. Undated vials between September, 2010 and May, 2011, Willis- Knighton Medical Center, Shreveport, Louisiana 51 52 Resource for Reducing Errors Clinical Chemistry book recently released! Focus on errors in the Chemistry Laboratory including POCT Discussion of real world errors and what can be done to detect and prevent errors. The Right QC is IQCP CMS will incorporate key EP 23 concepts into CLIA Interpretive Guidelines (IG) as an alternative QC policy called IQCP (Individualized QC Plans) Effective Jan 1, 2014, IQCP will be implemented Existing CLIA QC & quality system concepts won t change No regulations will change! CMS survey process won t change 2 year phase in and educational process Accreditation agencies, CAP and Joint Commisstion will release more information in 2014. CLIA 53 54

The Right QC is IQCP Permits labs to develop an IQCP using many of their existing quality practices/information Is based on labs patient population, environment, test system, clinical uses, etc. Applies to CMS certified non waived labs IQCP is a choice & default is 2 external QC/day Labs must follow mfr s. instructions if > CLIA Includes existing & new analytes/test systems Individualized Quality Control Plan Risk Assessment Quality Control Plan Individualized Quality Control Plan Quality Assessment CLIA 55 56 CLIA Benefits of IQCP to Lab Single use cartridge based methods use engineered controls in lieu of 2 levels QC/day POCT analyzers perform QC by lot of cartridge (using subset of devices) rather than every lot and each device. Core lab analyzers moderate and high complexity tests helps labs identify weaknesses and appropriate actions to reduce risk of error (may need >2 levels QC/day) Don t Be Discouraged Risk Management Is Documenting Much of What We Already Do! 57 58 Summary Risk management is something laboratories are already doing. EP23 simply formalizes this. An IQCP assesses the medical need for test, performance requirements, and weaknesses in the testing process as well as actions to address those risks. Each IQCP is unique because the combination of device, setting, medical requirements and operators may differ between laboratories. An IQCP is the industry standard. It depends upon the extent to which the device s features achieve their intended purpose in union with the laboratory s expectation for ensuring quality results. Once implemented, the IQCP is monitored for effectiveness and modified as needed to maintain risk at a clinically acceptable level. Questions? 59 60 Comments/concerns about this program? Email: webinar@aphl.org