Mississippi Sports Medicine & Orthopaedic Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: A. Based on review of toxicology drug testing proficiency testing records since the last survey and interview with the General Supervisor/Testing Personnel (GS/TP), listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of the drugs of abuse testing performed on the Dimension EXL 200 chemistry analyzer. Findings include: 1. Review of proficiency testing records since the last survey on 3/12/2024, revealed no documentation of performance of proficiency testing for the drugs of abuse testing (amphetamine, barbiturate, benzodiazapine, cocaine, methamphetamine, Oxycodone, THC, PCP) performed on the Dimension EXL 200 chemistry analyzer for the 1st or 2nd proficiency events of 2024 and 2025, to verify accuracy twice a year. 2. In an interview on 3/2/2026 at 3:30 p.m., the GS/TP confirmed there was no verification of accuracy twice a year or proficiency testing documented as performed since September of 2023 for the drugs of abuse test performed on the Dimension EXL 200 chemistry analyzer. Only the dry challenge was performed on the proficiency testing events. 3. There was no documentation of verification of accuracy for the drugs of abuse testing performed on the Dimension EXL 200 for 24 months of patient testing, from March 2024 through March 3, 2026. Even though the laboratory was enrolled in proficiency testing, four of four proficiency events were not performed to verify accuracy of the drugs of abuse testing. B. Based on review of toxicology drug testing proficiency testing records since the last survey and interview with the General Supervisor/Testing Personnel (GS/TP), listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of the drugs of abuse confirmatory testing performed on the Shimadzu 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 -- LCMS 8045 analyzer since the installation in March 2025. Findings include: 1. Review of proficiency testing records since the installation of the Shimadzu LCMS 8045, revealed no documentation of performance of proficiency testing for the drugs of abuse confirmatory drug test (52 tests) performed on the Shimadzu LCMS 8045 analyzer for the 1st or 2nd proficiency events of 2025, to verify accuracy twice a year. 2. In an interview on 3/2/2026 at 3:30 p.m., the GS/TP confirmed there was no verification of accuracy twice a year or proficiency testing performed for the drugs of abuse confirmatory tests performed on the Shimadzu LCMS 8045 analyzer. Only the dry challenge was performed on the proficiency testing events. 3. There was no documentation of verification of accuracy for the drugs of abuse confirmatory testing performed on the Shimadzu LCMS 8045 for 12 months of patient testing, from March 2025 through March 3, 2026. Even though the laboratory was enrolled in proficiency testing, two of two proficiency events were not performed to verify accuracy of the confirmatory drugs of abuse testing. D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of toxicology drug testing proficiency testing records, and interview with the General Supervisor/ Testing Personnel (GS/TP) listed on the CMS 209 Personnel Form, the Technical Supervisor failed to ensure the laboratory participated in the proficiency testing events for 2024 and 2025 to verify accuracy of the unregulated testing. Findings include: 1. Review of proficiency testing records since 3 /12/2024, revealed no documentation of performance of proficiency testing for the drugs of abuse screening drug test performed on the Dimension EXL 200 chemistry analyzer or the confirmatory testing performed on the Shimadzu LCMS 8045 analyzer. 2. In an interview on 3/2/2026 at 3:30 p.m., the GS/TP confirmed there was no verification of accuracy twice a year or proficiency testing documented as performed since September of 2023 on the Dimension EXL 200 chemistry analyzer. No verification of accuracy had been performed on the Shimadzu LCM'S since the installation in March of 2025. 3. The Technical Supervisor did not ensure the laboratory participate in the HHS approved proficiency program in which they were enrolled in for 2024 and 2025 to satisfy the verification of accuracy for the Drugs of Abuse screening testing performed on the Dimension EXL 200, for four of four events (2024 and 2025) or the confirmatory drug testing performed on the Shimadzu LCMS 8045 for two of two events (year 2025). -- 2 of 2 --

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and review of personnel records on the day of survey, the laboratory director failed to ensure that prior to testing patient specimens Testing Personnel #2 - 16 received the appropriate training for high complexity testing and demonstrated that they could perform all testing operations reliably to provide and report accurate results. Findings include: Review of personnel records since testing began on 1/28 /2022 revealed no documentation of training verified by the Laboratory Director for Testing Personnel #2 - #16 listed on the CMS 209 personnel form prior to performing high complexity testing on patient specimens. The lab has tested 2,588 patient samples since testing began. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of the CMS 209 Laboratory personnel form and personnel records from 1/28/2022 when testing began through 9/28/2022, the technical supervisor failed to evaluate and document the performance of Laboratory Testing Personnel #2 - 16 semiannually during the first year these individuals performed high complexity testing. Findings include: Review of the CMS 209 Laboratory personnel form and personnel records revealed no semiannual evaluations by the technical supervisor documenting the performance of Laboratory Testing Personnel #2 - 16 since 7/28 /2022 when all interpretive testing personnel working remotely would have been due for semiannual evaluations. -- 2 of 2 --