1. Microbiology: *Tests Eligible for IQCP and *Tests That do NOT Need an IQCP March 8, 2016 Linda C. Bruno, M.A., MT(ASCP) Director, Microbiology and Molecular Labs ACL Laboratories, Rosemont, IL Linda.Bruno@advocatehealth.com

2. Where IQCP May Apply in Microbiology? 2

3. Microbiology – Test Systems where IQCP May Apply NON-WAIVED tests:  Rapid/Direct antigen kits with internal controls (eg Rotavirus, RSV, Strep A, Legionella Urinary Antigen, Strep pneumoniae Antigen, Flu)  Rapid molecular test with internal control (eg. Illumigene, BioFire, Cepheid)  Identification systems (if currently doing CLSI M50 Streamline QC), including Yeast ID systems  Sensitivity testing (eg Vitek, MicroScan, Disk diffusion testing)  Exempt Culture Media (as defined by CLSI M22) 3

4. Tests Eligible for IQCP 4

5. For these tests –labs may do ‘default’ QC listed on this slide or IQCP 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 5

6. For these tests –labs may do ‘default’ QC listed on this slide or IQCP 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 multiplex assays – examples Cepheid, BioFire, Illumigene, Nanosphere, and others) 6

7. For these tests –labs may do ‘default’ QC listed on this slide or IQCP 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… 7

8. For these tests –labs may do ‘default’ QC listed on this slide or IQCP TestQC Frequency CMS/CLIA – Subpart K: 493.1256 (e) (1) QC Frequency CAP MIC.21626 Identification SystemsEach 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) 8

9. For these tests –labs may do ‘default’ QC listed on this slide or IQCP TestQC Frequency CMS/CLIA – Subpart K 493.1261 (b) (1) QC Frequency CAP MIC.21910 Antimicrobial Susceptibility testing Each batch of media AND each lot # and shipment of antimicrobial agents before, or concurrent with initial use QC Frequency: Each day tests are performed, must use appropriate control organisms to check procedure 9

10. For these tests –labs may do ‘default’ QC listed on this slide or IQCP 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 10

11. CMS/CLIA Standards ‘default’ (and CAP requirements) Relating to Microbiology (Testing that does NOT need an IQCP) 11

12. Continue performing QC frequency as you are currently doing as outlined in the next few slides 12

13. 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 13

14. 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 14

15. 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 15

16. 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… 16

17. 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) 17

18. CMS and CAP QC Requirements – These do NOT need IQCP TestQC Frequency CMS/CLIA – Subpart K: 493.1263 (a) QC Frequency CAP MIC.41400 LactoPhenol Cotton Blue Each lot number (commercially prepared), and shipment 18

19. 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 19

20. 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 20

21. 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) 21

22. AGAIN Microbiology Tests That Do NOT Need An IQCP … 22

23. Summary of What Does NOT Need IQCP Gram Stain AFB Kinyoun Stain AFB Fluorescent stain Beta Lactamase other than Cefinase Bacitracin Catalase Cefinase Coagulase plasma Staph latex 23

24. Summary of What Does NOT Need IQCP Germ Tube test ONPG Oxidase Spot Indole X and V factor strips and disks Other reagents, disks (e.g. PYR, Mcat) Identification systems (if NOT using streamline QC) Salmonella and Shigella antisera Streptococcal serotyping systems 24

25. Summary of What Does NOT Need IQCP EIA testing in 96 well format, or break away wells (Manufacturers recommended positive and negative controls run with each batch) Non-exempt culture media (as defined in CLSI M22 -continue QC frequency as currently performing – no change) Antimycobacterial susceptibility test (continue QC frequency, each week tests are performed) Lactophenol Cotton Blue 25

26. Summary of What Does NOT Need IQCP Parasitology permanent stains (monthly) Special stains to detect parasites (e.g. acid fast, fluorescent) (Each time of use) 26

27. What is Eligible for IQCP in Microbiology - These 4 (That’s It) Tests that have an internal control (electronic/procedural/built-in) as it applies to direct antigen tests and rapid molecular tests Exempt culture media (as defined by CLSI M22) Antimicrobial susceptibility testing Identification Systems (for Streamline QC) 27

28. References – CLIA Brochures 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 CAP Microbiology Checklist, 7-28-2015 CAP All Common Checklist, 7-28-2015 28

29. References CMS/CLIA State Operations Manual Appendix C-Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, Rev. 147, 10-06-15 IQCP@cms.hhs.gov http://www.cms.gov/Medicare/Provider- Enrollment-and- Certification/SurveyCertificationGenInfo/Do wnloads/Survey-and-Cert-Letter-13-54.pdf 29