Hrmc Physicians Clinic

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 7/9/25. HRMC Physicians Clinic laboratory was found not in compliance with the following requirements: D5775 and D6053. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and monitor criteria for acceptable differences between one analyte (human chorionic gonadotropin) hCG performed by two different test methods (qualitative vs quantitative). Those test methods had not been evaluated twice a year in 2024 and to date in 2025 to determine if their differences had been acceptable. Findings include: 1. Review of the laboratory's test menu revealed: * hCG qualitative patient specimen tests had been performed using Cardinal Health hCG combo kits. * hCG quantitative patient specimen tests had been performed on the Siemens EXL 200 analyzer. Review of the laboratory's annual test volume form revealed 7 patient serum qualitative hCG specimen tests and 185 patient serum quantitative hCG specimen tests were performed in 2025. Review of the laboratory's quality assessment records revealed there was no documentation that indicated a comparison of qualitative and quantitative hCG test methods had been completed in 2024 or to date in 2025. Interview on 7/9/25 at 1:00 p.m. with laboratory director C revealed: *The laboratory had performed hcG qualitative patient specimen testing with Cardinal Health serum test kits. *The laboratory had performed hCG quantitative patient specimen testing on the Siemens EXL 200 analyzer. *She confirmed comparison testing between the hCG Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- qualitative and quantitative test methods had not been performed in 2024, nor to date in 2025. *She had been aware that, twice a year, comparison testing was required for analytes processed with two different test methods. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to ensure one of five laboratory personnel (testing personnel B) had received two competency assessments during their first year of patient testing for the test methods they had been performing. Competency assessment helps ensure staff can process and accurately report patient test specimens. Findings include: 1. Review on 7/9/25 at 11:25 a.m. of the laboratory's Centers for Medicare's Services 209 Laboratory Personnel Form signed by laboratory director C On 7/2/25, revealed laboratory staff B was listed as testing personnel. 2. Review on 7/9/25 at 11:30 a.m. of the laboratory's employee competency assessments for testing personnel B revealed: *He had started testing patient samples in May 2023. *He had his initial training orientation on 5/15/23. *His first competency assessment had been completed by technical consultant A on 3/12 /24. *His next competency assessment had been completed by technical consultant A on 4/17/25. Review on 7/9/25 at 12:00 p.m. of the laboratory's competency assessment procedure, last revised 12/24 revealed: *New employees would be evaluated after their initial orientation. *New employees would then be evaluated biannually during their first year of employment and annually after. Interview on 7/9 /25 at 12:15 with laboratory director C revealed: *She and technical consultant A had been cross-training staff between the clinic and the hospital. *Testing personnel B had previously only worked at the hospital. *She was aware that new staff needed to have two competency assessments, even if they were cross-training. *She confirmed a second competency had not been completed within testing personnel A's first year of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 2/11/19. The Tschetter & Hohm Clinic PC laboratory was found not in compliance with the following requirements: D5447 and D5471. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the creatinine kinase MB (CKMB), myoglobin and troponin (nonwaived test method) quality control (QC) records and interview with the laboratory manager, the laboratory failed to perform two levels of controls or establish an equivalent quality control method to verify the accuracy of CKMB, myoglobin, and troponin test results for 13 of 14 dates (11/13/18, 11/16/18, 11/19/18, 11/23/18, 11 /26/18, 11/30/18, 12/10/18, 12/11/18, 12/14/18, 12/15/18, 12/17/18, 12/19/18, and 12 /21/18 ) of patient testing reviewed. Findings include: 1. Review of the CKMB, myoglobin, and troponin QC records revealed QC results had not been documented on the 13 days identified above. Patient test results had been reported to the provider on those days. Interview on 2/11/19 at 0910 with the laboratory manager revealed: *The laboratory runs QC once per month or upon receipt of a new shipment of reagents per the manufacturers requirements in the package insert. *She did not know that CLIA required QC to be performed on each day of patient testing. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the potassium hydroxide (KOH) reagent, review of the annual test volume form, and interview with the laboratory manager, the laboratory failed to verify each lot number or shipment of the KOH reagent for its positive reactivity prior to testing 67 of 67 patient specimens tested during 2018. Findings include: 1. Observation on 2/11/2019 at 9:30 a.m. revealed a bottle of KOH reagent (lot # 1824011, expiration date 8/28/19) was available for use on patient specimens. The bottle of KOH reagent was approximately three quarters full. Review of available records revealed KOH QC had not been documented in 2017, 2018, or 2019 for any lot number, different shipments of the same lot number, or when a different lot number had been received. Review of the annual testing volume survey form indicated sixty-seven KOH patient tests had been performed during 2018. Interview at the above time with the laboratory manager revealed she was unaware QC was required of a new lot number or shipment before use on patient samples. They had not perfomed QC on the KOH reagent as long as she had worked there. -- 2 of 2 --