1. A partnership of the Advocate and Aurora Health Care System IQCP – Where Are We Now? May 11, 2016 Linda C. Bruno, M.A., MT(ASCP) Director, Microbiology and Molecular Labs ACL Laboratories, Rosemont, IL Linda.Bruno@advocatehealth.com

2. A partnership of the Advocate and Aurora Health Care System OBJECTIVES  Explain current QC options for labs  Name tests that are eligible for IQCP  Discuss Microbiology tests that do NOT require IQCP  List components of IQCP  Cite additional CAP required components of IQCP  Discuss where are we now 2

3. A partnership of the Advocate and Aurora Health Care System DISCLOSURES Accelerate ThermoFisher 3

4. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan aka ‘IQCP’ Where Are We Now? 4

5. A partnership of the Advocate and Aurora Health Care System WHAT CHANGED IN CMS/CLIA and CAP STANDARDS? TWO THINGS WENT AWAY 1/1/2016 1.Equivalent Quality Control (EQC) (Ex. QC performed once every 30 days as in kits/cartridges with internal controls) 2.All references to CLSI documents in CMS CLIA standards pertaining to Microbiology: QC susceptibility testing – weekly (M100) QC exempt media- not required by end user (M22) for each new lot #/shipment Streamline QC on Identification Systems (M50) – allows reduced # of QC organisms – each lot #/shipment 5

6. A partnership of the Advocate and Aurora Health Care System So what exactly does this mean? 6

7. A partnership of the Advocate and Aurora Health Care System CHANGES in EXTERNAL QC – TESTS WITH INTERNAL CONTROLS Prior to 1/1/2016 - Equivalent QC (EQC): 2 external QC performed once/30 days 7 Effective 1/1/2016 - CMS / CAP ‘Default’ External QC: 2 external QC performed each day of patient testing x 30 days

8. A partnership of the Advocate and Aurora Health Care System CHANGES in QC TESTING FOR AST Prior to 1/1/2016 CLSI M100 QC - Antimicrobial Susceptibility Testing (AST): QC frequency was once per week 8 Example: 2 organisms/panel x 3 panels x 52 wks/yr = 312 panels /year Effective 1/1/2016 CMS/CAP ‘Default’ QC - Antimicrobial Susceptibility Testing (AST): Control organisms must be tested each day of patient testing Example: 2 organisms/panel x 3 panel x 365 days/yr = 2,190 panels/year

9. A partnership of the Advocate and Aurora Health Care System CHANGES in QC TESTING FOR EXEMPT MEDIA Prior to 1/1/2016 – End users not required to perform QC with each lot # / shipment Effective 1/1/2016 - CMS / CAP ‘Default’ – End users MUST perform QC with each lot # /shipment and - Sterility - Ability to support growth - Select or inhibit specific organisms - Produce biochemical response - Document…when compromised…deterioration… - In addition to required documentation of visual checks 9

10. A partnership of the Advocate and Aurora Health Care System CHANGES in QC TESTING FOR IDENTIFICATION SYSTEMS Prior to 1/1/2016 – Labs allowed to use Streamline QC as defined in CLSI M50 Effective 1/1/2016 - CMS / CAP ‘Default’ – End users MUST perform QC - all organisms listed by manufacturer with each lot # /shipment 10

11. A partnership of the Advocate and Aurora Health Care System LABORATORY OPTIONS: EITHER …. CMS / CAP ‘DEFAULT’ OR…. YOU CAN DO AN IQCP 11

12. A partnership of the Advocate and Aurora Health Care System Tests Eligible for IQCP 12

13. A partnership of the Advocate and Aurora Health Care System Per CAP: Eligibility for IQCP is Limited to These: internal (electronic/procedural/built-in) quality control system* Nonwaived tests that employ an internal (electronic/procedural/built-in) quality control system* Exception: Microbiology media and reagents used for microbial identification and susceptibility testing may implement an IQCP as defined in the checklist” * *CAP All Common Checklist, IQCP section 7-28-2015 *CAP Microbiology Checklist, 7-28-2015 13

14. A partnership of the Advocate and Aurora Health Care System Where IQCP May Apply in the Lab? 14

15. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR External QC/Each Day Patient Testing Rapid/Direct antigen kits - built-in internal control Examples: 15 Test Name Sure Vue Mono TestQiagen AMNSURE Alere Leuko EZ VueHemachrom ACT Quidel Quick Vue + HCG/SerumBinax Now Rotavirus Hologic Fetal FibronectinOSOM Strep A Binax Now Legionella Urinary AntigenAlere BNP Alere HIV AG/AB ComboAbbott iSTAT International PTINRFlu A & B Antigen Kits Binax Now Strep pneumoniae AntigenBinax Now RSV

16. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR External QC/Each Day of Patient Testing Rapid Molecular tests – built-in internal control Examples: 16 Test Name BioFire multiplex testing:Cepheid: GastroPathogen PanelMRSA Meningitis/EncephalitisClostridium difficile Positive Blood CultureInfluenza Illumigene:Nanosphere: Strep AGN panel Clostridium difficileGP panel Strep B

17. A partnership of the Advocate and Aurora Health Care System Test Systems where IQCP May Apply Microbiology:  Exempt Culture Media (as defined by CLSI M22)  Identification systems (CLSI M50 Streamline QC), including Yeast ID systems  Sensitivity testing (CLSI M100- eg Vitek, MicroScan, Disk diffusion testing) 17

18. A partnership of the Advocate and Aurora Health Care System 18 Where IQCP May Apply in the Microbiology?

19. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR External QC/Each Day of Patient Testing TestQC Frequency CMS/CLIA – Subpart K: 493.1261 (a) QC Frequency CAP MIC.14583 Direct Antigen Test (External positive and negative QC) Each day of patient testing NOTE: If an internal quality control process (e.g. electronical/ procedural/built-in) is used instead of external control material to meet daily QC requirements, the lab MUST have an IQCP in place 19

20. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR External QC/Each Day of Patient Testing TestQC Frequency CMS/CLIA – Subpart K: 493.1261 (a) QC Frequency CAP: MIC.63262 Molecular-based Testing (External positive and negative QC) Each day of patient testing NOTE: If an internal quality control process (e.g. electronical/ procedural/ built-in) is used instead of external control material to meet daily QC requirements, the lab MUST have an IQCP in place (this includes rapid Molecular assays – examples Cepheid, BioFire, Illumigene, Nanosphere, and others) 20

21. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR CMS / CAP “Default” QC TestQC Frequency CMS/CLIA – Subpart K: 493.1256 (e) (4) QC Frequency CAP: MIC.21240 MIC.31380 MIC.41200 Media (IQCP may be done on exempt media as defined in CLSI M22) Each new batch, lot #, and shipment – check before or concurrent with initial use -Sterility -Ability to support growth -Select or inhibit specific organisms -Produce biochemical response -Document…when compromised…deterioration… 21

22. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR CMS / CAP “Default” QC TestQC Frequency CMS/CLIA – Subpart K: 493.1256 (e) (1) QC Frequency CAP MIC.21626 Identification Systems Each new lot # and shipment Check (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity of each substrate (includes mycology ID systems) 22

23. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR CMS / CAP “Default” QC TestQC Frequency CMS/CLIA – Subpart K 493.1261 (b) (1) QC Frequency CAP MIC.21910 Antimicrobial Susceptibility testing Each day tests are performed, must use appropriate control organisms to check procedure Each batch of media AND each lot # and shipment of antimicrobial agents before, or concurrent with initial use 23

24. A partnership of the Advocate and Aurora Health Care System EITHER IQCP OR CMS / CAP “Default” QC TestQC Frequency CMS/CLIA – Subpart K: 493.1263 (b) (2) QC Frequency CAP MIC.42620 Antifungal susceptibility tests (Disk, strip, or MIC method) Each day tests are performed, laboratory must use the appropriate control organism(s) to check the procedure Each batch of media and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s) CMS: 493.1263 (b) (1) CAP: MIC.42600 24

25. A partnership of the Advocate and Aurora Health Care System CMS/CLIA Standards ‘default’ (and CAP requirements) Relating to Microbiology (The following do NOT need an IQCP) 25

26. A partnership of the Advocate and Aurora Health Care System Continue performing QC frequency as you are currently doing as outlined in the next few slides 26

27. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA Subpart K: QC Frequency CAP Gram stainWeekly 493.1261 (a)(2) Weekly MIC.21540 AFB Stain (eg Kinyoun) Each day of use 493.1256 Each day of use MIC.31640 Fluorescent stain (includes fluorochrome) Each time of use 493.1256 Each time of use MIC.21570 MIC.31650 Beta Lactamase other than Cefinase Each day of use 493.1261 Each day of use MIC.21632 27

28. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA- Subpart K: 493.1256 (e) (1) QC Frequency CAP MIC.21624 BacitracinEach new batch, lot # and shipment CatalaseEach new batch, lot # and shipment CefinaseEach new batch, lot # and shipment Coagulase PlasmaEach new batch, lot # and shipment Staph latexEach new batch, lot # and shipment 28

29. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA Subpart K: 493.1256 (e) (1) QC Frequency CAP MIC.21624 Germ TubeEach new batch, lot # and shipment ONPGEach new batch, lot # and shipment OptochinEach new batch, lot # and shipment OxidaseEach new batch, lot # and shipment Spot indoleEach new batch, lot # and shipment X & V factor strips/diskEach new batch, lot # and shipment Other reagents, disks / strips/stains (e.g. PYR, Mcat disk and others) Each new batch, lot # and shipment 29

30. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA – Subpart K: 493.1256 (e) (4) QC Frequency CAP: MIC.21240 MIC.31380 MIC.41200 Media (Non- exempt media as defined in CLSI M22) Each new batch, lot #, and shipment – check before or concurrent with initial use -Sterility -Ability to support growth -Select or inhibit specific organisms -Produce biochemical response -Document…when compromised…deterioration… 30

31. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA – Subpart K: 493.1261 (a) (3) QC Frequency CAP MIC.21628 Salmonella and Shigella antisera, streptococcal serotyping systems Each lot # and shipment, and once every 6 months (NOTE: CAP for streptococcal grouping reagents MIC.21624) 31

32. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA – Subpart K: QC Frequency CAP LactoPhenol Cotton Blue Each lot number (commercially prepared), and shipment CMS: 493.1263 (a) CAP: MIC.41400 32

33. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA – Subpart K: QC Frequency CAP Special Stains used to detect Parasites (e.g. acid fast, fluorescent) Each time of use CMS: 493.1256 (e)(3) CAP: MIC:51170 Parasitology permanent stain(s) Each month of use, the laboratory must check permanent stains using a fecal sample control material that will demonstrate staining characteristics CMS: 493.1264 (c) CAP: MIC.51160 33

34. A partnership of the Advocate and Aurora Health Care System CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA –Subpart K: 493.1262 (b) (1) QC Frequency CAP MIC.31680 Antimycobacterial susceptibility test Each week tests are performed, laboratory must use the appropriate control organism(s) to check the procedure Each batch of media and each lot number and shipment of antimycobacterial agent(s) before, or concurrent with, initial use, using an appropriate control organism(s) CMS: 493.1262 (b) CAP: MIC.31380 34

35. A partnership of the Advocate and Aurora Health Care System These do NOT need IQCP Continuous Monitoring Instruments do NOT need IQCP What does need an IQCP related to the instrument IQCP it may be included in Blood culture (ie BD FX, bioMerieux BacTAlert) Blood culture bottles (meeting criteria in CLSI M22) Exempt media (as defined in CLSI M22) AFB (ie BD MGIT, bioMerieux BacTAlert) AFB tube or bottle (meeting criteria in CLSI M22) Exempt media (as defined in CLSI M22) 35

36. A partnership of the Advocate and Aurora Health Care System Manufacturer’s Instructions Labs must follow all manufacturers instructions If mfg instructions for QC are absent or less stringent than CMS/CLIA ‘default” lab must choose to either:  follow CMS/CLIA ‘default’ QC regulations  or develop an CMS/CLIA IQCP 36

37. A partnership of the Advocate and Aurora Health Care System WHAT IS AN INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP)? 37

38. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan (IQCP) 38 IQCP 3 Quality Assessment 2 Quality Control Plan 1 Risk Assessment

39. A partnership of the Advocate and Aurora Health Care System CMS IQCP – WHAT IS IT? IQCP consists of three key parts: 1.Risk Assessment (RA) identifies areas where errors or failures could occur in entire workflow path pre-analytical, analytical, post-analytical assesses risk for harm to the patient if an error would occur and be reported 2.Quality Control Plan (QCP) Defines the control mechanisms in place for detecting or preventing errors 3.Quality Assessment (QA) Continually monitors effectiveness of QCP 39

40. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan (IQCP) 40 IQCP 3 Quality Assessment 2 Quality Control Plan 1 Risk Assessment

41. A partnership of the Advocate and Aurora Health Care System IQCP – Risk Assessment (RA) 1. Risk Assessment:  Five components that MUST be covered: Specimen (patient ID, collection, transport, integrity, receiving, processing) Lab Environment (temperature, humidity, power failure …) Testing personnel (training, competency, proficiency testing, staffing) Reagent/QC (shipping, storage, preparation, expiration date) Test system (sample failure, reagent failure, software failure, hardware failure, test results) 41

42. A partnership of the Advocate and Aurora Health Care System Risk Assessment Reference: See page 3 of this link for CMS information on areas to include for potential sources of error for 5 risk assessment components http://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/Downloads/CLIAbrochure13.pdf http://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/Downloads/CLIAbrochure13.pdf 42

43. A partnership of the Advocate and Aurora Health Care System RISK ASSESSMENT Fishbone Diagram Tool you may use (however, not required) 43

44. 1 Specimen 2 Testing Personnel 3 Environment 4 Reagents 5 Test System Identify Potential Hazards Incorrect Test Results Instrument /Assay -Software -Hardware -Contamination -Instrument maintenance -Proper sampling -Calibration -QC Testing Personnel -Training -Competency Assessment -Proficiency Testing -Staffing Specimen -Patient ID -Collection container -Volume -Transport -Storage -Proper specimen Reagent Integrity -Shipping / storage -Expirations date -Preparation -QC Factors -Temperature -Humidity -Ventilation -Electrical -Space -Noise/Vibrations -Water quality Fishbone Diagram of Identification of Potential Failures /Errors Pre-analytical Analytical Post-analytical 44

45. A partnership of the Advocate and Aurora Health Care System RISK ASSESSMENT- HISTORICAL REVIEW Gather pertinent information and data Review areas of risk/error Document the review Write a summary Identify - potential areas of risk that may cause failure or be sources of error within the entire testing system/ process Evaluate - frequency of those failures/errors Weigh - severity those failures/errors could have on causing harm to patients 45

46. A partnership of the Advocate and Aurora Health Care System RA – What Determines Frequency of Occurrence and Severity of Harm? Review all failure/error data, how many times in a week, month, year did a particular failure or error occur? Did it cause harm to the patient? Corrective action reports Proficiency Testing corrective action Retraining of personnel Temperature out-of-control records QC failures Corrected reports Etc… 46

47. A partnership of the Advocate and Aurora Health Care System IQCP – Risk Assessment Review Checklist Manufacturer package insert Manufacturer QC requirements/recommendations Certificate of QC (exempt media) SOPs (Policies and Procedures) Historical QC data Proficiency survey results Training / Competency Records Instrument maintenance logs Temperature charts/records Specimen rejection Manufacturer Alerts 47

48. A partnership of the Advocate and Aurora Health Care System IQCP – Risk Assessment Review Checklist (Example -Helpful Tool) Review VITEKCEPHEIDBINAX NOW ID AST MRSA C DIFF FLU RSV Manufacturer Pkg inserts Manufacturer QC frequency Procedure / SOP Verification / Validation Data Historical QC Data Proficiency Survey results Competency Records Temp charts/Maintnce logs 48

49. A partnership of the Advocate and Aurora Health Care System Determining Risk “Frequency of occurrence” How often does this error occur? Review all data to determine frequency “Severity of harm” When error occurred, what was the harm to the patient or possible harm that could be to the patient? 49

50. A partnership of the Advocate and Aurora Health Care System Determining Risk – Example 4 levels Frequency of Occurrence Severity of Harm Unlikely (once /2-3 yrs)Negligible (temporary discomfort) Occasional (1/yr)Minor (temporary injury; not requiring medical intervention) Probable (1/mo)Serious (impairment requiring medical intervention) Frequent (1/wk)Critical (permanent impairment requiring medical intervention) 50

51. A partnership of the Advocate and Aurora Health Care System Determining Risk – Example 5 levels Frequency of OccurrenceSeverity of Harm Rare (once /2-3 yrs)Negligible (temporary discomfort) Unlikely (1/yr)Minor (temporary injury; not requiring medical intervention) Possible (1/mo)Moderate (may require medical intervention) Likely (2/mo)Serious (impairment requiring medical intervention) Almost certain (1/wk)Critical (permanent impairment requiring medical intervention) 51

52. Severity of harm (Impact) Probability of harm (Frequency) NegligibleMinorSeriousCriticalCatastrophic Frequent UUUUU Probable AUUUU Occasional AAAUU Remote AAAUU Improbable AAAAA A = Acceptable risk U = Unacceptable risk CLSI EP-23 document: Risk Matrix 52

53. A partnership of the Advocate and Aurora Health Care System Risk Assessment After identifying all potential sources of risk/error for 5 components: Build table(s) or grid(s):  List each component with all risks identified from fishbone diagram or other format used  Based on your review of documented records of failure or error determine:  “Frequency of occurrence” and  “Possible severity of harm”  Determine if risk is ‘Unacceptable’ or ‘Acceptable’ 53

54. 1 Specimen 2 Testing Personnel 3 Environment 4 Reagents 5 Test System Identify Potential Hazards Incorrect Test Results Instrument /Assay -Software -Hardware -Contamination -Instrument maintenance -Proper sampling -Calibration -QC Testing Personnel -Training -Competency Assessment -Proficiency Testing -Staffing Specimen -Patient ID -Collection container -volume -Transport -Storage -Proper specimen Reagent Integrity -Shipping / storage -Expirations date -Preparation -QC Factors -Temperature -Humidity -Ventilation -Electrical -Space -Noise/Vibrations -Water quality Fishbone Diagram of Identification of Potential Failures /Errors Pre-analytical Analytical Post-analytical 54

55. A partnership of the Advocate and Aurora Health Care System Risk Assessment – Specimen EXAMPLE of TABLE FORMAT 1 Specimen Frequency of Occurrence Severity of Harm Risk Measures to control risk Relevant SOP Patient identification OccasionalSeriousA Patient identification criteria defined; acceptability defined; competency assessment performed SOP# Collection/ Container/ Volume OccasionalMinorACollection/ container criteria defined per source; acceptability defined; competency assessment performed SOP# 55

56. A partnership of the Advocate and Aurora Health Care System Risk Assessment (and then what?) Resulting “Risk Assessment” is then used to develop Quality Control Plan (QCP) How will these risks be controlled? How often does QC need to be performed based on potential risks identified? What QC material needs to be used? What is criteria for QC acceptability? 56

57. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan (IQCP) 57 IQCP 3 Quality Assessment 2 Quality Control Plan 1 Risk Assessment

58. A partnership of the Advocate and Aurora Health Care System Quality Control Plan (QCP) - Overview What is QCP? Document (or chart/table) that describes practices, resources, and procedures used to control quality of test system Must monitor accuracy and precision of test performance MUST include number of QC, type of QC, frequency of QC and define criteria for acceptability of QC MUST have Lab Director’s review, approval, signature (this cannot be delegated) NOTE: Lab Director is the name on the lab CLIA license 58

59. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan (IQCP) 59 IQCP 3 Quality Assessment 2 Quality Control Plan 1 Risk Assessment

60. A partnership of the Advocate and Aurora Health Care System Quality Assessment - Overview Laboratory must establish a review system for on-going monitoring of effectiveness of their QCP Monitoring must include at least the following: testing personnel testing environment specimens test reagents test system 60

61. A partnership of the Advocate and Aurora Health Care System IQCP – QA Monthly Review Checklist (Example – helpful tool) Vitek AST Review JanFebMarAprMayJunJul Specimen rejection logs Temperature logs Training / Competency Weekly QC: GN Panel: Note exceptions GP Panel: Note exceptions Corrected reports Proficiency Survey results Physician complaints 61

62. A partnership of the Advocate and Aurora Health Care System Quality Assessment – Overview (cont) Continually monitoring IQCP and ask:  Was there a failure?  Was it investigated?  Was there impact on patient care  How could it be avoided?  Does QCP need to be modified?  Modifications approved by Lab Director 62

63. A partnership of the Advocate and Aurora Health Care System Individualized Quality Control Plan (IQCP) 63 IQCP 3 Quality Assessment 2 Quality Control Plan 1 Risk Assessment

64. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP 64

65. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50200IQCP Test List/ Summary II “The laboratory has identified all tests using an IQCP and completed the CAP’s forms for laboratories using an individualized quality control plan.”  List of Individualized Quality Control Plans (Listing of all IQCP laboratory performs)  Individualized Quality Control Plan Summary (Must be completed for each IQCP in use) 65

66. A partnership of the Advocate and Aurora Health Care System 66 (For CAP inspection and inspector use only – not for use as an IQCP development tool)

67. A partnership of the Advocate and Aurora Health Care System 67 (For CAP inspection and inspector use only – not for use as an IQCP development tool)

68. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50300IQCP Risk Assessment II “The IQCP for a test/device/instrument includes a risk assessment to evaluate potential sources of error to include the following….” NOTE: Lab must involve representative sample of testing personnel in the process of conducting the risk assessment. 68

69. A partnership of the Advocate and Aurora Health Care System Requirement #CategoryPhase COM. 50400Quality Control Plan Approval II “The IQCP includes a written quality control plan approved by the laboratory director prior to implementation.” NOTE: Suggest having an implementation date in addition to approval date. Implementation date is on CAP IQCP Summary 69 CAP Requirements for IQCP

70. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50500Quality Control Plan Elements II “The individualized quality control plan must define all aspects monitored based on the potential errors identified during the risk assessment, including the following parameters….”  Number, type (external and internal QC system), and frequency of QC  Criteria for acceptable performance  Monitoring of testing environment and reagents  Specimen quality  Instrument calibration, maintenance, and function checks  Training and competency of testing personnel  Provisions for multiple identical devices and variation for uses covered under one IQCP 70

71. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50500Quality Control Plan Elements II (continued) “NOTE: The components of the quality control plan must meet regulatory and CAP accreditation requirements and be in compliance with the manufacturer instructions and recommendations, at minimum. The quality control plan must control quality of the test process and ensure accurate and reliable test results. External control material samples must be analyzed at least every 31 days and with new lots and shipments of reagents or more frequently if indicated in the manufacturer’s instructions External control material samples must be analyzed at least every 31 days and with new lots and shipments of reagents or more frequently if indicated in the manufacturer’s instructions. 71

72. A partnership of the Advocate and Aurora Health Care System NOTE: (per CAP) IQCP provision in COM.50500 requiring external QC every 31 days does NOT apply to:  Exempt media  Identification systems  Antimicrobial susceptibility testing (AST) – weekly QC 72

73. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50600Quality Assessment Monitoring II “Ongoing quality assessment monitoring is performed by the laboratory to ensure that the quality control plan is effective in mitigating the identified risks for the IQCP and includes the following:”  Review of QC and instrument/equipment maintenance and function check data at least monthly  Evaluation of errors relating to pre-analytic, analytic and post analytic phases of the testing process  Review of complaints from clinicians and other healthcare providers regarding the quality of testing to confirm the clinical efficacy of testing, and 73

74. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase COM. 50600Quality Assessment Monitoring II (Continued)  Evaluation of corrective action taken if problems are identified  Re-approval of the QC plan by the laboratory director or designee at least annually 74

75. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase MIC.11018 HEM.20143 CHM.14600 IMM.34250 MOL.34393 QC Corrective Action II “There are records of corrective action when control results exceed defined acceptability limits” “…The corrective action for tests that have an IQCP approved by the lab director must include an assessment of whether further evaluation of the risk assessment and quality control plan is needed based on the problems identified (e.g. trending for repeat failure, etc.).” 75

76. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase MIC.11020 HEM.20146 CHM.14916 IMM.34362 MOL.34495 Monthly QC Review II “Quality control data are reviewed and assessed at least monthly by the laboratory director or designee” “The review of quality control data for tests that have an IQCP approved by the laboratory director must include an assessment of whether further evaluation of the risk assessment and quality control plan is needed based on problems identified (e.g. trending for repeat failures, etc.)” 76

77. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase MIC.14583Direct Antigen Test QC II “For nonwaived direct antigen tests on patient specimens, positive and negative controls are tests and recorded at least daily, or more frequently if specified in the manufacturer’s instruments, laboratory procedure or CAP Checklist” NOTE 1 of 2 NEW with 7/28/15 checklist: “If an internal quality control process (e.g. electronic/ procedural/built-in) is used instead of an external control material to meet daily quality control requirements, the laboratory must have an IQCP…” (Running external QC for 20 days to validate is removed) 77

78. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement #CategoryPhase MIC.14583Direct Antigen Test QC II “For nonwaived direct antigen tests on patient specimens, positive and negative controls are tests and recorded at least daily, or more frequently if specified in the manufacturer’s instruments, laboratory procedure or CAP Checklist” NOTE 2 of 2 NEW with 7/28/15 checklist: For each test system that requires an antigen extraction phase….system must be checked with appropriate positive control that will detect problems in extraction process. If an IQCP is implemented…quality control plan must define how extraction phase will be monitored….” “For each test system that requires an antigen extraction phase….system must be checked with appropriate positive control that will detect problems in extraction process. If an IQCP is implemented…quality control plan must define how extraction phase will be monitored….” 78

79. A partnership of the Advocate and Aurora Health Care System CAP Requirements for IQCP Requirement # CategoryPhase MIC.21910Susceptibility Test QC Frequency II “For antimicrobial susceptibility testing by either disk or gradient diffusion strips or broth dilution (MIC) methods, quality control organisms are tests with each new lot number or shipment of antimicrobials or media, and each day the test is performed thereafter.” NOTE: The frequency of QC testing may be reduced to weekly….. If the laboratory director approves the use of an individualized quality control plan (IQCP)….. 79

80. A partnership of the Advocate and Aurora Health Care System What If a Lab Chooses to Do Nothing - Not performing the ‘default’ AND still performing EQC….EXPECT 80

81. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase COM.50200IQCP Test List and Summary formsII COM.50300Risk AssessmentII COM.50400Quality Control PlanII COM.50500Quality Control Plan ElementsII COM.50600Quality Assessment MonitoringII

82. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase MIC.14583Direct Antigen TestingII MIC.63262Molecular infectious disease testing -w/ internal control II MIC.21240Exempt media – bacteriologyII MIC.31380Exempt media – mycobacteriologyII MIC.41200Exempt media – mycologyII MIC.21626Identification systemsII

83. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase MIC.21910Antimicrobial susceptibility testingII MIC.42620Antimicrobial susceptibility testing (mycology) II MIC.11018QC Corrective ActionII MIC.11020Monthly QC ReviewII

84. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase CHM.13900Daily QC – Nonwaived TestsII CHM.14600QC Corrective ActionII CHM.14916Monthly QC ReviewII HEM.19360Daily QC – Nonwaived TestsII HEM.20143QC Corrective ActionII HEM.20146Monthly QC ReviewII

85. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase IMM.34120Daily QC – Nonwaived TestsII IMM.34170Weakly Reactive ControlsII IMM.34250QC Corrective ActionII IMM.34362Monthly QC ReviewII IMM.41850Direct Antigen Test QCII

86. CAP Checklist Questions Relating to IQCP Requirement #CategoryPhase MOL.34229Controls – Qualitative AssaysII MOL.34270Controls – Quantitative AssaysII MOL.34393QC Corrective ActionII MOL.34495Monthly QC ReviewII

87. A partnership of the Advocate and Aurora Health Care System What Does IQCP Need to Include? 87 Clinical Laboratory Improvement Amendments (CLIA)

88. A partnership of the Advocate and Aurora Health Care System So What Did We Learn? 88

89. A partnership of the Advocate and Aurora Health Care System Review of Historical Data When Historical Data Was Reviewed:  What did we find?  What did we learn?  What changes are being made?  How are we continually monitoring the QCP in the QA? 89

90. A partnership of the Advocate and Aurora Health Care System Organization of Data  How is your data being stored?  Is it organized?  Can it be easily retrieved for review?  Suggestion – scan documents and keep on secure network drive 90

91. A partnership of the Advocate and Aurora Health Care System Organization of Data 91  Corrected reports?  Rejected specimens?  QC records  Instrument maintenance logs  Temperature records  Training and competency assessments  How long is it kept? Is that long enough? Is it too long?

92. A partnership of the Advocate and Aurora Health Care System Has IQCP improved the quality and process of quality control and patient testing? 92

93. A partnership of the Advocate and Aurora Health Care System What are your thoughts? 93

94. A partnership of the Advocate and Aurora Health Care System QUESTIONS? 94

95. A partnership of the Advocate and Aurora Health Care System References 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? Brochure #4 - Equivalent Quality Control Procedures College of American Pathologists, Checklists, July 28, 2015 95

96. A partnership of the Advocate and Aurora Health Care System References NCCLS M22-A3 “Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard” – Third Edition CLSI M50-A “Quality Control for Commercial Microbial Identification Systems; Approved Guideline” CLSI M100–S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Sixth Informational Supplement” 96

97. A partnership of the Advocate and Aurora Health Care System References CLIA Advance copy-revised Appendix C- Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, Oct, 2015 IQCP@cms.hhs.gov http://www.cms.gov/Medicare/Provider- Enrollment-and- Certification/SurveyCertificationGenInfo/Do wnloads/Survey-and-Cert-Letter-13-54.pdf 97

98. A partnership of the Advocate and Aurora Health Care System THANK YOU 98