3/14/2016. The Joint Commission and IQCP. Objectives. Before Getting Started

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1 The Joint Commission and IQCP Stacy Olea, MBA, MT(ASCP), FACHE Executive Director Laboratory Accreditation The Joint Commission AACC 2015 Objectives Identify the three components of IQCP Determine a starting point for you own IQCP programs Use The Joint Commission standards to develop your IQCP programs Before Getting Started Check with your state for eligibility and restrictions State IQCP Acceptance Chart on Joint Commission Connect TM Check with your accreditor: The Joint Commission QSA EPs 1 8 Appendix C: IQCP: Eligible Requirements All specialties/subspecialties except tests that are only listed within pathology Update your e-app with your IQCP information 1

2 Ask Yourself Is the test moderate or high complexity? Does the test fall within an eligible specialty/subspecialty? Take into account those tests with multiple specialties. Does the manufacturer allow a QC frequency that is less than CLIA requirements AND you want to base your QC program on your individualized risk? Does the manufacturer allow a QC frequency that is less than Joint Commission standards requirements AND you want to base your QC program on your individualized risk? Not eligible for IQCP Waived Testing Testing within the specialty/subspecialty of pathology except those tests with a multiple specialty outside of pathology Will perform QC at a frequency that MEETS or EXCEEDS CLIA requirements Will perform QC at a frequency that MEETS or EXCEEDS Joint Commission standards requirements Start Here Instruments that used EQC i-stat, Alere Meter, TLI IQ System Moderate complexity kit tests Microbiology Media QC Streamlined QC for organism identification Weekly QC for antimicrobial susceptibility Blood Gases ACTs Where manufacturer QC protocol is less stringent than CLIA or Joint Commission requirements 2

3 What CAN be Delegated Establishing IQCP as part of the laboratory s overall QC program to the Technical Consultants or Technical Supervisors Specific portions of IQCP tasks to other qualified laboratory employees Delegation must be in writing! CLIA Laboratory Director Responsibilities Accurate and reliable test results that are appropriate for patient care no matter what QC method they use who is delegated QC responsibilities Signing and dating the QCPs before implementation and after changes QSA The laboratory develops an individualized quality control plan (IQCP) in an eligible specialty or subspecialty. 3

4 Eligible Specialties or Subspecialty All CLIA specialties/subspecialties will be included in IQCP, except... Pathology Histopathology Oral Pathology Cytology IQCP is an option for Laboratory Developed Tests (LDTS) See Appendix C in our CAMLAB for a list of standards that are eligible for IQCP Tests with Multiple Specialties If such a test is eligible for IQCP based on one of its specialties/subspecialties, then the lab may elect to use IQCP for that test regardless of the specialty/subspecialty listed on their CLIA certificate. Example: FISH testing may be classified as either histopathology or cytogenetics. The lab has histopathology on their CLIA certificate but not cytogenetics. Because this test may also be considered as cytogenetics, IQCP would be allowed even though it is listed as Histopathology on their CLIA certificate. Percentage IQCP by Specialties/Subspecialties Chemistry Microbiology Immunology Point-of-Care Hematology Other Immunohematology As of 02/26/16 4

5 Percentage of the number of Test Systems Implemented 5 or more As of 02/26/16 Percentage Expected to Expand Usage of IQCP Yes I'm not sure No As of 02/26/16 QSA IQCP EP 1 A complete IQCP that consists of the following three parts: Risk assessment, Quality control plan, Quality assessment 5

6 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 QSA Risk Assessment (RA) EP 2 A risk assessment that is established by the laboratory in its own environment by its own testing personnel. Note: The risk assessment may include test, method or instrument verification data; performance specifications; or historical quality control data. Published or manufacturer data may also be included, but cannot be the only data source for the risk assessment. EP 3 A risk assessment that contains the following five components: Specimen, Environment, Reagent, Test system, Testing personnel QSA Risk Assessment (RA) EP 4 A risk assessment that encompasses the following three phases of the entire testing process: Preanalytic, Analytic, Postanalytic Note: The risk assessment identifies the sources of potential failures and errors for a testing process, and evaluates the frequency and impact of those failures and sources of errors. EP 5 Laboratories that develop an individualized quality control plan (IQCP) include the following: a risk assessment that includes the manufacturer s instructions or other information needed to assess risk in all three phases of the testing process. Note: The risk assessment includes function and maintenance checks as required by, and not less than, manufacturers instructions. 6

7 Performing the Risk Assessment (RA) To conduct a Risk Assessment the lab must: Use their own staff (no manufacturer reps) Use their own data (historical or new) Use more than only published or manufacturer data Include all five components Identified the sources of potential failures and errors Evaluates the frequency and impact of those failures and errors Use the manufacturer s instructions or other information needed to assess all three phases of testing Includes function and maintenance checks as required by the manufacturer IQCP Risk Assessment (RA) Five Components: Specimen Environment Reagent Test system Testing personnel Three phases of the testing process: Pre analytic Analytic Post analytic RA: Specimen Patient preparation Specimen collection Specimen labeling Specimen storage, preservation, and stability Specimen transportation Specimen processing Specimen acceptability and rejection Specimen referral 7

8 RA: Environment Temperature Airflow/ventilation Lighting/intensity Noise and vibration Humidity Adequate Space Altitude Dust Water Static discharges Utilities (electrical failures, current variations, surges 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 8

9 RA: Test Systems Mechanical/electronic failure of test system optics Pipettes Barcode readers Software/hardware Data transmission RA: Testing Personnel Appropriate education and experience qualifications License requirements Orientation and Training Competency failure to follow instructions incorrect test interpretation Adequate staffing Vacancy rates and Turnover rates Tools for Conducting a RA Table or grids Fishbone diagrams Process flow diagrams Bullets or simple listing Paragraph format Highlighting/Underlining in the Manufacturer s Instructions 9

10 Example of RA Documentation Pre Analytic Analytic Post Analytic Specimen Environment Reagent Test Systems Testing Personnel Example of RA Documentation Example of RA Documentation 10

11 Example of RA Documentation QSA Quality Control Plan EP 6 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality control plan for devices at each location throughout a facility. EP 7 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality control plan (or changes in the plan) that the laboratory director signs and dates before implementation.. 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. 11

12 Quality Control Plan (QCP) Is required for each device location if you have different risks you want to mitigate If all risks are the same, 1 QCP can list all device locations 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 Quality Control Plan (QCP) Must be signed and dated by the Lab Director listed on the CLIA certificate before implementation and when changes are made Must use your own data to support the chosen QC rationale Must include: Number Type Frequency of testing Acceptability criteria of the quality control used Examples of Quality Controls 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 12

13 QSA Quality Assessment EP 8 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality assessment that includes documentation of corrective action and preventive action to monitor ongoing effectiveness. Quality Assessment (QA) 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 (QA) 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 13

14 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 Quality Control QC vs. QA 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 14

15 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 Reevaluating your QCP as part of your QA Not required by our standard 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 EP 1 Three Parts to IQCP EP 7 LD signature Percentage of IQCP Noncompliance EP 4 Three Testing Phases EP 6 QCP by locations EP 2 Lab specific data EP 8 QA EP 3 Five Components As of 02/26/

16 Watch Out! Still using EQC for blood gases performed outside the lab Forgetting about moderate complexity kit tests Not realizing you need IQCP for microbiology for: Media QC Streamlined QC for organism identification Weekly QC for antimicrobial susceptibility IQCP not implemented (completed but not signed by lab director) and performing QC at a frequency less than CLIA requirements IQCP did not take into consideration all testing locations Not understanding that the Risk Assessment is used to determine the type and frequency of quality control used Being part of a system and using the primary lab s Risk Assessment as their own Not setting aside time to work on IQCP Additional Findings Related to IQCP Standard LD EP 1 The laboratory director, technical consultant, and/or technical supervisor define the laboratory s criteria for the following: Quality control, Proficiency testing, Reporting of results QSA EP 3 The laboratory uses two quality control materials of different concentrations for each quantitative procedure on each day the procedure is performed. The quality control results are documented. QSA EP 4 The laboratory uses negative and positive control material for each qualitative procedure on each day the procedure is performed. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 21.49% 1.04% 5.08% 0.65% 7.56% Additional Findings Related to IQCP Standard QSA EP 2 The laboratory uses a positive and, as appropriate, a negative control material for each qualitative procedure in bacteriology, mycobacteriology, and mycology, at a frequency consistent with laboratory policy or the manufacturer s instructions, if more stringent. The quality control results are documented. QSA EP 2The laboratory performs antibacterial and antifungal susceptibility quality control testing each day the procedure is performed unless the laboratory demonstrates satisfactory performance that would qualify the laboratory to perform quality control testing on a weekly basis. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 10.84% 0.32% 12.5% 16

17 Additional Findings Related to IQCP Standard QSA EP 3 Either the laboratory or the preparer performs quality control testing on new batches of microbiological culture media, including sterility testing, using recommended organisms before or concurrently with the use of new batches of media. The quality control results are documented. QSA EP 1 The laboratory tests at least three levels of quality control materials (acid, normal, alkalosis) for blood gas testing each day the procedure is performed. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 15.66% 1.19% 16.38% Additional Findings Related to IQCP Standard QSA EP 2 The laboratory tests at least one level of quality control material for each eight hours of patient blood gas testing. The quality control results are documented. Note: The laboratory should attempt to perform quality control testing as close to 8-hour intervals as possible. A range may be specified in written policy, such as within 15 minutes before or after the 8- hour mark, providing a 30-minute window. Ranges in excess of +/- 30 minutes that produce a window of more than an hour do not meet the intent of this element of performance Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 18.10% i-stat IQCP Example This is only an example and may not include all risks a laboratory may identify. AACC

18 RA - Specimen RA Test System RA - Reagent 18

19 RA - Environment RA Testing Personnel NICU Based upon the specific location risks the Laboratory Director determined that the NICU staff must run two levels of external quality control once every day of testing AND one level of external quality control with every patient sample. Since this QC frequency exceeds the CLIA requirements: IQCP is not applicable QCP is not required 19

20 Quality Assurance Resources Joint Commission Connect TM Perspectives Articles (March 2014, July 2015) IQCP PowerPoint & Risk Assessment Template Leading Practice Library: IQCP examples Lab Focus publications (Aug/Sept 2015; February 2016) Submit a question to Standards Interpretation CMS Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.ht ml ASM website for microbiology examples 20

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