IQCP : Where Do I Start? Developing a Successful IQCP: Let s Keep it Simple. Objectives 7/4/2015

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1 Developing a Successful IQCP: Let s Keep it Simple Elia Mears, MHA MT(ASCP)SM Field Surveyor The Joint Commission Stacy Olea, MBA, MT(ASCP), FACHE Executive Director Laboratory Accreditation The Joint Commission AACC July 2015 ME3 Objectives Explain how the Plan meets regulatory requirements Be able to identify the three components of IQCP Define and conduct a Risk Assessment (RA) and list the required components Define and design a Quality Control Plan (QCP) and list the required components Explain how Quality Assurance (QA) is integral to IQCP IQCP : Where Do I Start? Elia Mears MHA, MT(ASCP)SM Field Surveyor The Joint Commission 1

2 Slide 2 ME3 Mears, Elia, 5/25/2015

3 DISCLOSURE Elia Mears Financial Disclosures Employed by The Joint Commission Grant/Research Support: None Consultant Fees: None Advisory Boards/Committees: None Stocks/Bonds: None Honorarium/Expenses: None Intellectual Property/Royalties: None Westgard IQCP Survey Results IQCP readiness: less than 10% of labs have implemented a single IQCP at this point; over 17% of labs currently developing their IQCP; a majority of US labs still in research and review stage looking at what to do, but not done anything yet Use of IQCP: 30%of labs not sure if IQCP applies to them; 45% will only apply IQCP to tests with current EQC Budget for IQCP: 73% of labs have no money to devote to development of IQCP, many dedicating only one person to the project IQCP implementation January 1, 2016 NOT MUCH TIME LEFT!! Labs Share Opinions/Frustration Grrrrr!!!!! Just wish I could understand better Just tell me what I need to do! I don t understand how small rural hospital labs can perform studies to implement IQCP Very confusing with very little training; difficult for labs with limited staff While the intent is good, the amount of work to implement is daunting Guidance is vague and abstract Frustrating with something so important, little defined expectations available; also how do I monitor? 2

4 CMS Information Bulletin on Quality Control Changes Individualized Quality Control Plan (IQCP) : A New QC Option Dated August 16, 2013 Two levels of external QC each day of testing OR laboratory develops an IQCP Foundation of IQCP Includes key concepts from CLSI EP- 23, Laboratory Quality Control Based on Risk Management Labs are not required to incorporate EP-23 IQCP is not EP-23, but can be used as reference Quality Control Quality Control in the laboratory has traditionally focused on the ANALYTICAL phase of testing This may not be sufficient to ensure ROBUST process control for ALL test systems, in ALL environments, throughout the ENTIRE process An IQCP is tailored to the laboratory s unique environment and is a tool intended to identify and mitigate and manage risks that could lead to an erroneous result 3

5 Development of IQCP Customized QC plan based on individual environment, test systems, personnel, and patient population Requires labs to consider QC in a broader context IQCP is not intended to necessarily reduce QC requirements, but it is intended to ensure effective QC for each laboratory and the tests it performs IQCP is voluntary EQC vs. IQCP EQC Standardized/Transitional Rigid/Government Created Narrow Regulatory Scope Limited Specialties IQCP Customizable/Updated Flexible/Consensus Developed Broad Regulatory Scope All but Pathology Analytic Requires Internal QC Decreases External QC Pre Post Analy c Doesn t Require Internal QC May/May not Decrease External QC Specialties and Subspecialties All CLIA specialties/subspecialties will be included in IQCP, except... Pathology Histopathology Oral Pathology Cytology Laboratory Developed Tests (LDTs) are subject to same IQCP requirements as any other laboratory test - no special guidelines 4

6 Microbiology QC cannot be exclusively based on CLSI documents, it affects: streamlined QC for Organism Identification weekly QC for Antimicrobial Susceptibility Media QC You can use CLSI documents as reference in your IQCP development Choice: IQCP or CLIA regulations Tests with Multiple Specialties Under CLIA, certain tests may be assigned to one of several specialties/subspecialties If such a test can be eligible for IQCP based on any specialty/subspecialty, then the laboratory may elect to use IQCP for that test regardless of the specialty/subspecialty they have assigned it to in their laboratory For example, FISH testing may be classified as either histopathology or cytogenetics. The lab has it as histopathology on their CLIA certificate So if the lab assigns a test to histopathology, it would appear to be excluded from IQCP However, because this test may also be considered as cytogenetics, IQCP would be allowed even though it is listed as Histopathology on their CLIA certificate CLIA Laboratory Director Responsibilities Accurate and reliable test results that are appropriate for patient care no matter what QC method they use Ensuring that IQCP meets the requirements as set forth in IQCP Interpretive Guidelines (S&C CLIA, Attachment 1) Signing and dating the QCPs (THIS CANNOT BE DELEGATED!!!!) 5

7 What CAN be Delegated Establishing IQCP as part of the laboratory s overall QC program to the TC/TS Specific portions of IQCP tasks to other qualified laboratory employees Delegation must be in writing! When to Consider IQCP? If manufacturer instructions state to perform 2 levels of external QC each day of testingyou meet minimum CLIA QC requirements and IQCP is not required If manufacturer s instructions recommend QC frequency less than CLIA, you have to: perform 2 levels of external QC each day of testing OR perform an IQCP Look at your test systems, QC protocols and what would cost the most if CLIA QC would be performed and PRIORITIZE the development of an IQCP How to Decide Where to Start POCT Currently using EQC Example: i-stat, Alere Meter, TLI IQ System Microbiology Blood Gases Moderate complexity kit testing ACTs Where manufacturer QC protocol is less stringent than regulatory, or poor guidance Make a list of all tests offered, locations, QC frequency (presently using EQC?) 6

8 Same Device, Multiple Locations RA performed for the test system QCP applies to individual device location Performance specifications must be established or verified for each device and analyte Each device must be monitored, as well as each location Individualized Quality Control Plan Risk Assessment Quality Control Plan Quality Assurance The Three Components of IQCP Risk Assessment (RA) Identify & evaluate potential failures and sources of errors in a testing process Quality Control Plan (QCP) Policies/procedures to prevent or reduce the risk and control test quality Quality Assurance (QA) Continuous quality monitoring to evaluate the effectiveness of the IQCP 7

9 What is Risk? A future event which may result in process failure. In the laboratory, it is those instances that may lead to errors that would harm patients. These must be identified and mitigated. Risk Assessment Risk Assessment - the identification and evaluation of potential failures and sources of errors in a testing process. (S&C CLIA, Risk Assessment Section) IQCP Risk Assessment 5 Required Components: Specimen Environment Reagent Test system Testing personnel MUST include the entire testing process: Pre analytic Analytic Post analytic 8

10 IQCP Risk Assessment RA: Specimen Patient preparation Specimen collection Specimen labeling Specimen storage, preservation, and stability Specimen transportation Specimen processing Specimen acceptability and rejection Specimen referral RA: Environment Temperature Airflow/ventilation Lighting/intensity Noise and vibration Humidity Adequate Space Altitude Dust Water Static discharges Utilities (electrical failures, current variations, surges 9

11 RA: Reagent Shipping/receiving conditions Storage conditions Expiration Date (may differ based on storage requirements) Preparation instructions/require ments RA: Test Systems Inadequate sampling Clot detection capabilities Capabilities for detection of interfering substances (e.g., hemolysis, lipemia, icterus, turbidity) Calibration associated issues Failure of system controls and function checks Built-in procedural and electronic controls (internal controls) External or internal liquid quality control (assayed vs. unassayed) Temperature monitors and controllers RA: Test Systems Mechanical/electronic failure of test system optics - pipettes/pipettors - barcode readers Software/hardware Data transmission 10

12 RA: Testing Personnel Appropriate education and experience qualifications License required? Training Competency -failure to follow instructions -incorrect test interpretation Adequate staffing? Performing the Risk Assessment Make a team: 4-6 laboratory members, include supervisors, bench techs, phlebotomists (they are collecting the specimen!), specimen receiving assistants Resources for potential error: regulatory requirements (CLIA/ State/ Lab Accrediting Agency), operator/training manual, manufacturer package insert, troubleshooting guide, alerts/bulletins, validation data, testing personnel records, QC data, PT reports, corrected reports, complaints, QA/PI information, journals Performing the Risk Assessment To conduct a RA the lab must: Identify sources of potential failure/errors for a testing process, evaluate frequency/impact of those failures, document all the RA activities Data requirements: laboratory s own data, new or historical The risk assessment for any given test system may look very different in different laboratories 11

13 Tools for Conducting an RA Table or grids Fishbone diagrams Process flow diagrams Bullets or simple listing Paragraph format Highlighting/Underlining in the Manufacturer s Instructions Example of RA Documentation Pre Analytic Analytic Post Analytic Specimen Environment Reagent Test Systems Testing Personnel Example of RA Documentation 12

14 Sample of RA Documentation Determining Risk Process Maps 13

15 QCP & QA: Completing the IQCP circle Stacy Olea, MBA, MT(ASCP), FACHE Executive Director Laboratory Accreditation The Joint Commission DISCLOSURE Stacy Olea Financial Disclosures Employed by The Joint Commission Grant/Research Support: None Consultant Fees: None Advisory Boards/Committees: None Stocks/Bonds: None Honorarium/Expenses: None Intellectual Property/Royalties: None From RA to QCP After the lab has identified/evaluated 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). (S&C CLIA, Risk Assessment Section) 14

16 Quality Control Plan (QCP) A laboratory s standard operating procedure that describes the practice, resources, and procedures to control the quality of a particular test. Minimum QC Frequency No set minimum QC frequency However Not performing any QC is unacceptable QC frequency cannot be less than the manufacturer s instructions The QC frequency must be supported by your Risk Assessment Quality Control Plan Laboratory Director (named on CLIA certificate) Responsible for ensuring the QCP developed effectively meets IQCP requirements Delegate in writing to qualified personnel the development and implementation of the QCPs Review, sign and date the QCPs before patient testing begins and results are reported (This cannot be delegated) May want to consider the lab s clinical and legal responsibilities for providing accurate and reliable test results 15

17 Quality Control Plan Your own data must support the rationale used Must include: Number Type Frequency of testing Acceptability criteria of the quality control used May incorporate: Electronic controls Equipment maintenance Internal controls Personnel training and competency assessment Equipment calibration Other specified quality control activities Examples of Data External controls Electronic controls Internal controls Procedural controls Verification Data or establishment of performance specification Data Maintenance records Calibrations Temperature records Proficiency Testing results Training and competency assessments Corrective Actions taken Quality Control Plan Must provide for the immediate detection of errors Must monitor overtime the accuracy and precision of the test performance Must not be less stringent than the manufacturer s guidelines Required for each device location if RA identifies specific risks per location If all risks are the same, 1 QCP can list all device locations 16

18 Quality Control Plan Ask yourself, does the QCP Provide for immediate detection of errors for each phase of the testing process? Specify the number, type and frequency of testing QC material? Contain criteria to determine acceptable QC results? Require the lab perform QC as specified by the manufacturer instructions? Indicate that your Laboratory Director has reviewed, signed, and dated the QCP document before implementation? Quality Assessment An ongoing review process that encompasses all facets of the laboratory s technical and nontechnical functions and all locations/sites where testing is performed. Quality Assessment helps you Make sure that your QCP is working as expected Monitor errors and QC failures Identify errors and failures so you can take the appropriate corrective action Investigate the cause of the error and reassess your risk assessment if needed Evaluate whether any changes need to be made in the QCP 17

19 QC vs. QA Quality Control Recording the refrigerator temperature Documenting control results Documenting personnel training Documenting maintenance Documenting personnel competency Quality Assessment Reviewing the temperature records Reviewing the control results Reviewing the personnel training records Reviewing maintenance records Reviewing personnel competency records Examples of Documents to Review QC results PT performance review (scores, failures, and trends) Temperature logs Specimen rejection/qns log TAT reports Complaint reports Specimen recollection logs Communication logs Review of preventive measures, corrective actions, and follow-up Maintenance log Patient results review Training and competency documents FDA alerts Delta check logs Panic value/critical results log Quality Assessment Closes the loop to your RA and QCP Activities you are already doing Should have a QA activity for each QC activity 1 QA may be sufficient for all testing locations QA is used to determine if the quality activities you have put in place are working 18

20 Reevaluating your QCP as part of your QA When changes occur in the specimen, test system, reagent, environment, and testing personnel When the Quality Assessment identifies a problem Consider within the first 6 months of a new or updated QCP Consider an annual review Corrective Actions for Testing Process Failures Must conduct an investigation that identifies the cause and impact The investigation must include: Documentation of all corrections Corresponding corrective actions for all affected patient results Evaluation of the effectiveness of the corrective action Must implement corrections and corresponding corrective actions If necessary, must update the RA and modify the QCP Quality Assessment Ask yourself, does your QA do the following Outline the QA practices for your laboratory? Monitor continuously for effectiveness? Revise policies and procedures necessary to prevent recurrence of the problem? Discuss QA reviews with appropriate staff? Document all QA activities? 19

21 Resources Joint Commission Perspectives Articles IQCP PowerPoint on Joint Commission Connect Lab Focus publication CMS Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html Brochure #11 - CLIA Individualized Quality Control Plan Introduction (IQCP) Brochure #12 - CLIA IQCP, Considerations When Deciding to Develop an IQCP Brochure #13 - CLIA IQCP, What is an IQCP? FAQs IQCP IQCP benefits IQCP workbook: Developing an IQCP, A Step-by-Step Guide i-stat IQCP Example Before Getting Started Check with your state New York Washington California New Jersey Check with your accreditor The Joint Commission QSA EPs 1 8 Appendix C: IQCP Eligible Requirements All specialties/subspecialties except Pathology All locations, test systems, and tests except Pathology 20

22 RA - Specimen RA Test System RA - Reagent 21

23 RA - Environment RA Testing Personnel 22

24 Quality Assurance Questions 23