2015 Focus on Compliance What You Really Need to Know About the Individualized Quality Control Plan (IQCP) and Ensuring Your Laboratory s Compliance

Transcription

1 The Individualized Quality Control Plan (IQCP): what you need to know to ensure compliance Deborah Perry, M.D. Objectives Describe changes to the quality control regulations Explain how the CAP has implemented IQCP Outline the steps to formulate an IQCP Review materials to prepare for a CAP inspection Review frequently asked questions on IQCP Identify additional resources for developing an IQCP 2 Historical Quality Control Options CLIA final regulations published in 1992 Two levels of QC per day (default QC) One-size fits all Equivalent Quality Control (EQC) option published in CMS Interpretive Guideline in 2004 First attempt at alternative QC Two levels of QC per day or EQC Disadvantages o Limited scope o Prescriptive o Analytical focus only CMS discontinued EQC on 1/1/

2 CMS Individualized Quality Control Plan (IQCP) CMS published new Interpretive Guideline with IQCP option in January 2014 An all inclusive approach which evaluates the entire testing process Pre-analytical, analytical, and post-analytical Voluntary quality control option based on risk management (concepts from CLSI s EP23-A Guideline) 4 CMS Individualized Quality Control Plan (IQCP) Option ONLY applies to non-waived testing IQCP will not necessarily reduce the QC testing practices QC may NOT be performed less frequently than printed in the manufacturer s instructions IQCP regulations contain some restrictions for eligibility of use IQCP WILL allow you to develop a customized quality control plan for your laboratory specific to specimens, test system, reagents, environment and testing personnel 5 CMS Timing for IQCP IQCP is optional, but there is no grandfathering of test systems already using EQC As of January 1, 2014 January 1, Default CLIA QC or 1. Default CLIA QC or 2. EQC or 2. Implement an IQCP 3. Implement an IQCP 6 2

3 CAP Implementation of IQCP CAP approved by CMS to implement IQCP option, April 2015 Updated IQCP checklist requirements published in July 2015 checklist edition All Common Checklist o New IQCP section with five new IQCP requirements Other Checklists (e.g. Chemistry, Hematology & POCT) o Revisions to existing QC requirements throughout checklists to allow for use of traditional QC or IQCP o Provisions for EQC removed 7 CAP Implementation of IQCP Laboratories may develop their own model for designing an IQCP CAP option requires all elements defined in CMS option CAP option for IQCP is more restrictive than the CMS and other accreditors in some areas NOTE: IQCPs in use that do not reduce the QC frequency below the minimum default QC requirement are not inspected with the IQCP checklist requirements 8 CAP Eligibility to use IQCP CMS IQCP eligibility criteria apply CAP defines additional criteria: Testing must employ an internal quality control system (electronic, procedural, or built-in control) o Exception: Microbiology media and reagents used for microbial identification and susceptibility testing 9 3

4 Eligibility Determination for Individualized Quality Control Plan (IQCP) Option Does your state/jurisdiction allow for use of an IQCP to reduce the frequency of daily external quality control? NO Ineligible for IQCP: Follow QC requirements in state regulations and default CAP QC requirements YES What is the complexity of the test? WAIVED Ineligible for IQCP: Follow manufacturer s QC instructions and CAP Checklist requirements for waived testing NONWAIVED Is the test under the CMS specialty of Anatomic Pathology (ANP) or Cytopathology (CYP), not including tests that can be assigned to other CMS specialties*? YES Ineligible for IQCP: Follow default CAP QC requirements NO Does the test, instrument or device have an internal control process (electronic, procedural, or built-in)? IQCPE4.0 FEBRUARY Eligibility Determination for Individualized Quality Control Plan (IQCP) Option (Continued) Does the test, instrument or device have an internal control process (electronic, procedural, or built-in)? NO Does the test involve the use of microbiology media or panels used for microbial identification (with 2 or more substrates) or susceptibility testing? YES YES Do the manufacturer s instructions allow for external quality materials to be run less frequently than the default** CLIA and CAP QC frequency? NO Ineligible for IQCP: Follow default CAP QC requirements NO Ineligible for IQCP: Follow default CAP QC requirements YES Eligible for IQCP: Follow Checklist requirements for IQCP ** The default CAP QC frequency for external quality control materials is as follows: 1) Quantitative tests - two controls at different concentrations each day of patient testing, except for Coagulation tests (two levels every eight hours) and Blood Gas testing (one level every eight hours) 2) Qualitative tests positive and negative controls each day of patient testing. IQCPE4.0 FEBRUARY CAP Eligibility to use IQCP (these do NOT need an IQCP) FISH, microarray, Next Generation Sequencing (NGS) CAP ealert for Molecular based testing Revisions to : o ANP (FISH/ISH controls) o CYG (FISH controls) o MOL (FISH controls) Blood Bank Antibody Identification Panels TRM addresses new lots & QC Flow cytometry for leukemia/lymphoma testing FLO defines flow QC. 12 4

5 CAP Eligibility to use IQCP (these do NOT need an IQCP) Tests where there is not external QC available & lab determines QC procedures Lab Gen & 42CFR (h) Examples: Platelet aggregation Cold agglutinins Manual platelet counts Manual microscopic testing PPM procedures 13 IQCP Option Risk Assessment (RA) Quality Control Plan (QCP) IQCP Quality Assessment (QA) 14 IQCP Overview Risk Assessment Identifies and evaluates potential failures & sources of errors in the testing process, includes: o Three phases of testing: pre-analytical, analytical & postanalytical o Five components: Reagent, Environment, Specimen, Test System, Testing Personnel (RESTT) Quality Control Plan (QCP) Written document describing the practices and procedures to reduce the chance of possible failures and errors in the test processes Ensures accurate, reliable test results Quality Assessment The continuous process of monitoring the effectiveness of the QCP QC reviews, PT performance, complaints 15 5

6 Risk Assessment - What could possibly go wrong? 16 IQCP Checklist Requirements Risk Assessment COM evaluate potential sources of errors including: Three phases of the testing process o Preanalytic, Analytic, and Postanalytic Five components o Reagents, Environment, Specimen, Testing Personnel, Test System Variations in the components based on use of test Data from the laboratory's own environment, instrument/equipment performance, and testing personnel Intended medical uses of the test and impact if inaccurate results are reported (clinical risk) Manufacturer s instructions and recommendations 17 Risk Assessment Where do I start? Put together a team Gather materials for risk assessment QC, device failures, intended use, operators, literature Evaluate and record potential sources of error and processes used to mitigate error Incorporate all three phases of testing process and the five components (RESTT) Determine if the level of risk is acceptable Retain records 18 6

7 CLSI Guideline - Risk Assessment Using a Fishbone Diagram Reagents Environment Specimen Potential Error Incorrect Test Result Test System Testing Personnel 19 Risk Acceptability Matrix Based on ISO Severity of Harm Probability of Harm Negligible Minor Serious Critical Catastrophic Frequent Unacceptable unacceptable unacceptable unacceptable unacceptable Probable acceptable unacceptable unacceptable unacceptable unacceptable Occasional acceptable acceptable acceptable unacceptable unacceptable Remote acceptable acceptable acceptable acceptable unacceptable Improbable acceptable acceptable acceptable acceptable acceptable 20 Risk Assessment Use probability or likelihood of a failure leading to harm combined with severity of that harm to evaluate risk to the patient 21 7

8 Arizona Rainbow IQCP Checklist Requirements Quality Control Plan COM defines all aspects monitored based on risk assessment The number, type (external and internal quality control systems), and frequency of quality control Personnel training and competency assessment Equipment and environment monitoring Provisions for multiple identical devices and variation for uses covered under one IQCP Define criteria for acceptable performance o Follow manufacturer s instructions and recommendations for QC at minimum o Include the use of external control materials at least every 31 days and with new lots and shipments of reagents 23 Example Quality Control Plan 24 8

9 Quality Control Plan Approval Quality Control Plan Approval - COM QCP signed and dated by the laboratory director prior to implementation No delegation allowed Separate approved quality control plan for each laboratory with a separate CAP/CLIA number IQCP Checklist Requirements Quality Assessment Monitoring - COM requires ongoing monitoring of the effectiveness of the IQCP Review of quality control and instrument/equipment maintenance and function check data at least monthly Evaluation of errors relating to all phases of the testing process Review of complaints from clinicians and other healthcare providers regarding the quality of testing Evaluation of corrective actions taken if problems are identified Reapproval of the quality control plan by the laboratory director or designee at least annually 27 9

10 Quality Assessment Process If errors are identified, adjust the quality control plan to prevent future failures. Patients potentially affected by the failure need to be identified and corrective actions taken. Investigate identified failures Continue to monitor the effectiveness of the QPC Adjust the QCP as needed 28 IQCP Components Risk Assessment (RA) Quality Control Plan (QCP) IQCP Quality Assessment (QA) 29 ALL COMMON Checklist Summary COM Risk Assessment COM Quality Control Plan (QCP) COM QCP approval COM Quality Assessment COM IQCP test list 30 10

11 Microbiology & CAP Checklist updates EQC option removed CMS interpretive guideline for alternative QC of microbiology media, susceptibility testing and identification systems based on the CLSI guidelines removed 31 Microbiology and Quality Control Since May 2004 Microbiology quality control obligations were met with CLSI references October 31, 2014 CMS memorandum: CLSI document references will be removed from the upcoming revision of survey procedures and interpretive guidelines (IGs) for laboratories Why did this happen? CMS removed mention of CLSI documents from its interpretive guidelines for QC because government agencies, cannot make private guidelines regulatory in effect unless those guidelines are available for free What now for laboratories? 2 options for CLIA QC compliance: Follow all applicable CLIA QC regulations OR Implement IQCP 32 Microbiology and IQCP eligible Molecular infectious disease testing Direct antigen testing Nonwaived tests Devices with internal control processes Testing performed using media, identification systems and susceptibility test systems 33 11

12 Microbiology testing for which an IQCP is NOT needed Gram stain weekly QC MIC Testing of new lots & shipments of certain tests MIC Monthly QC of typing antisera MIC Media QC MIC and MIC Media QC in Microbiology MIC.21240, MIC An appropriate sample of each medium prepared by the laboratory or each lot and shipment of purchased media is checked for each of the following... Key points The list includes sterility checks, ability to support growth, and biochemical reactivity The previous reference to M22-A3 is invalid after January 1, 2016 with the expiration of EQC An IQCP is required to continue to practice familiar quality checks 35 QC of ID Systems and AST in Microbiology QC of Identification Systems Appropriate positive and negative control organisms are tested and results recorded for each new lot and shipment of reagents used in bacterial identification systems. QC of Susceptibility Testing MIC For antimicrobial susceptibility testing by either disk or dilution methods, quality control organisms are tested with each new lot number or shipment of antimicrobials or media, and each day the test is performed thereafter. An IQCP is required after January 1, 2016 with the expiration of EQC. MIC Any use of CLSI documents M2, M7, M50 and M100 now depend upon the QCP that you develop 36 12

13 Our Experience with IQCP IQCP Team POCT coordinators Microbiology supervisors Quality manager Pathologists Support from service executives Separately met with nurses & other testing personnel

14 Risk Assessment 40 Risk Assessment

15 43 44 IQCP policy PURPOSE: The Individualized Quality Control Plan (IQCP) is an all-inclusive approach to assuring the quality of the entire non-waived testing process, including pre-analytic, analytic, and post-analytic phases of testing. An IQCP provides the framework for customizing a quality control (QC) program for test systems in each laboratory s unique environment. Each IQCP has three components: risk assessment, quality control plan and quality assessment. SCOPE: Pathology Center and Nebraska Collaborative Laboratory POLICY: Criteria for IQCP Development All new devices/analytes/test systems are to be evaluated to determine if an IQCP is needed (see attached flow chart). The Laboratory Director is responsible for deciding if the laboratory is to utilize IQCP, and ensuring that the quality control plan effectively meets the IQCP requirements. The Laboratory Director may assign specific duties for the IQCP to qualified personnel. No IQCP is required for the device/analyte if 2 levels of external QC is performed each day of patient testing. If no IQCP plan is required, the Quality Control policy, is to be followed. If the QC frequency of manufacturer s instructions is LESS than 2 levels of external QC each day of patient testing, the test may be evaluated for an IQCP. If NO quality control procedure requirements are defined by the manufacturer, or if laboratory developed tests and/or text book methods are utilized, then an IQCP may be developed if QC frequency is less than 2 levels of external QC each day of patient testing

16 46 47 Review 48 16

17 Risk Assessment 49 Risk Assessment 50 Risk Assessment 51 17

18 Risk Assessment QCP 54 18

19 QCP Review & Signature 57 19

20 IQCP tests at Children s General Laboratory Beta hcg Uni-Gold HIV ½ Osmo MONO test Urine Drug Screen PFA-100 EPOC ACT Avox Microbiology/Virology C. difficile Crypto/Giardia rapid Xpert CT/NG Xpert Enterovirus Xpert Flu/RSV Xpert Pertussis MRSA Disk Diffusion antimicrobial susceptibilty testing Strep A Vitek2 AST cards HSV 1/ CAP Inspection Preparation All laboratories inspected on or after January 1, 2016 must do the following: Discontinue EQC option AND Perform external quality following the frequency defined in the CAP inspection checklist (default CLIA QC) OR Implement an IQCP, if eligible 60 20

21 Inspection Preparation Provide CAP IQCP forms to inspection team upon request Have risk assessment records, quality control plan, and quality assessment records readily available Retain IQCP records for the length of time that the IQCP is in use, plus two years 61 IQCP Checklist Requirements IQCP Test List COM requires completion of two forms to be provided to the inspection team if IQCP is used List of Individualized Quality Control Plans o The laboratory has identified all tests using an IQCP Individualized Quality Control Plan Summary o The IQCP includes a written quality control plan approved by the laboratory director prior to implementation Forms available on CAP website 62 Case Examples using CAP IQCP Forms 63 21

22 Case Examples using CAP IQCP Forms Frequently Asked Questions Are any tests exempt from IQCP? Do I need an IQCP for my fill in the blank test? How do I complete the required forms? Are the materials that I am currently using for daily QC considered an internal control or an external control? Is it okay to use an IQCP provided by a manufacturer? Can I use an IQCP that has been developed by one of the other laboratories in my healthcare system if we are using the same instrument? 66 22

23 Frequently Asked Questions - Microbiology Can I continue to follow the CLSI protocols for media QC, stream line QC for ID systems, and susceptibility testing? For the risk assessment, do I need to do in-house studies for my exempt media? Do I need to implement an IQCP for gram stains, and for some of the reagents that I use when working up a culture, such as catalase, coagulase, and oxidase if I am not doing daily QC? 67 Frequently Asked Questions What will inspectors be focusing on? Will my laboratory be cited if our IQCP for a test defines different processes to mitigate risk than the IQCP used by the inspector s lab for the same instrument? 68 CAP Website Resources New IQCP Resources page available on CAP website ( gehierarchy/page671.jspx?_afrloop= #%40%3F_afrLoop%3D %26_adf.ctrlstate%3D1d513j5g9z_34) 1 st option when typing IQCP in the search field 69 23

24 CAP Website Resources Resources for Laboratories: o Frequently Asked Questions o IQCP Eligibility Determination Flow Chart o Microbiology IQCP Applicability Tool o IQCP Webinar o IQCP inspection forms and instructions (with completed example) Jointly Developed IQCP Resources - CAP/ASM/CLSI o Template and examples for antimicrobial susceptibility testing, ID systems, and media 70 Other IQCP Resources Clinical and Laboratory Standards Institute Guideline EP23-A and companion documents CDC/CMS Handbook: Developing an IQCP A Step-by- Step Guide ( f) CMS Guidances and Brochures ( Guidance/Legislation/CLIA/Individualized_Quality_Control _Plan_IQCP.html) Manufacturer tools, if available Questions: accred@cap.org 71 Summary IQCP is voluntary IQCP must be developed for each test system/device/instrument for each location Risk assessment must evaluate all phases of testing and the required five components Quality control plan must follow manufacturer s instructions at a minimum Errors identified through the quality assessment process require careful evaluation for risk The IQCP must be signed by the medical director 24

25 Questions 73 25