Murray County Medical Center

Summary Statement of Deficiencies D0000 The Murray County Medical Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on January 16, 2026. The following condition-level deficiencies were cited: 493.803 Successful Participation 493.1441 Laboratories performing high complexity testing; laboratory director The following standard-level deficiencies were cited: 493.861 Unexpected antibody detection. 493.1445 Laboratory director responsibilities . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION 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 3 -- . Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and 2025 American Proficiency Institute (API) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Immunohematology and for the analytes Unexpected Antibody Detection. Refer to D2172. . D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of CASPER 0155 report and 2025 American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (100%) for the same analyte in two of three consecutive testing events in the specialty of Immunohematology for the analyte Unexpected Antibody Detection. Findings are as follows: 1. Review of the CASPER 0155 report revealed the following results: 2025 Immunology/Immunohematology - 2nd Event: The laboratory received an unsatisfactory score of 0% for Unexpected Antibody Detection 2025 Immunology/Immunohematology - 3rd Event: The laboratory received an unsatisfactory score of 80% for Unexpected Antibody Detection 2. A review of the 2025 American Proficiency Institute (API) proficiency testing records (2nd and 3rd Immunology/Immunohematology Events) confirmed the laboratory received the above results. . D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on a proficiency testing desk review of CASPER 0155 report and 2025 American Proficiency Institute (API) records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D2172. . D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: . Based on a proficiency testing desk review of CASPER 0155 report and 2025 -- 2 of 3 -- American Proficiency Institute (API) records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2172. . -- 3 of 3 --

Summary Statement of Deficiencies D0000 The Murray County Medical Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on June 12, 2025. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiencies were cited: 493.863 Compatibility testing . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Compatibility Testing PT under specialty of Immunohematology in 2024 and 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2024 Immunohematology/Immunology - 2nd Event Performance Summary and Comparative Evaluation and the API 2025 Immunohematology/Immunology - 1st Event Performance Summary and Comparative Evaluation were reviewed on June 12, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for Compatibility Testing in two of three consecutive testing events from 2024 and 2025, resulting in unsuccessful performance of the analyte (see D2181). . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2024 and 2025, constituting unsuccessful participation for the analyte. Findings are as follows: 1. API Performance Summary and Comparative Evaluation PT reports from the 2024 Immunohematology/Immunology 2nd Event and the 2025 Immunohematology /Immunology 1st Event were reviewed on June 16, 2025. 2. The reports indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. See below. Unsatisfactory Compatibility Testing PT Events: Event Score 2024 2nd Event 40% 2025 1st Event 60% . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Murray County Medical Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey completed on November 7, 2024. The following standard-level deficiencies were cited: 493.1256 Control procedures 493.1451 Technical supervisor responsibilities . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform minimum quality control activities required for a Chemistry test system in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 1:10 p.m. on 11/06/24. 2. A Profile-V MedtoxScan Drugs of Abuse Test System was observed as present and available for use during the tour. 3. The manufacturer required Quality Control (QC) testing with positive and negative control materials for new lots and shipments of Profile-V cartridge devices and weekly as defined in the manufacturer's Profile-V MedtoxScan Reader System Quick Reference Instructions proved by the laboratory. 4. QC testing using positive and negative control materials was required for new lots and shipments of test 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 -- cartridges as established in the Medtox Individualized Quality Control Plan and the Drug Screening Procedure (Medtox) found in PolicyStat, the laboratory's policy management software. A requirement for weekly QC testing was not found in procedures reviewed on date of survey. 5. The laboratory performed QC testing with positive and negative control materials for new lots and shipments of Medtox test cartridges as indicated in laboratory QC records. Weekly QC testing documentation was not found. The laboratory was unable to provide weekly QC documentation for the time period under review, November 2022 through November 2024, upon request. 6. In an interview at 10:08 a.m. on 11/07/24, the GS confirmed the above finding and indicated Medtox system QC testing was only performed for new test cartridge lots and shipments. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to ensure comprehensive competency assessments for four of four tenured testing personnel were performed and documented in 2023. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 1:10 p.m. on 11/06/24. 2. The following non-waived test systems, analyzers, tests, and test kits were in use in 2023 as indicated by the GS during the tour: Quidel Solana molecular testing platform Ortho Vitros 5600 chemistry analyzer Radiometer ABL Flex blood gas analyzer Alere Triage Meter chemistry analyzer Alere Afinion2 chemistry analyzer Profile-V Medtoxscan chemistry analyzer Sysmex XN-550 hematology analyzer Sysmex CA- 660 coagulation analyzer Alcor miniiSED ESR analyzer Grifols Immunohematology (IH) test system Microscopes and stains for microscopic examinations Manual differential Urine sediment KOH fungal exam Vaginal wet preparation Post vasectomy Serum hCG test kit 3. A competency assessment including all current laboratory tests was required annually for tenured testing personnel as established in the Competency Assessment procedure found in PolicyStat, the laboratory's policy management software. 4. Competency assessment forms implemented in 2023 did not include the following tests systems or tests as indicated below: Direct observation of test performance: Solana, ABL 90 Flex, Triage,Afinion2, Medtox, miniiSED, Grifols IH system Direct observation of equipment maintenance: Solana, ABL 90 Flex, Triage,Afinion2, Medtox, miniiSED, Grifols IH system Blind sample assessment or proficiency testing: ABL 90 Flex, Triage, Afinion2, Medtox, Grifols IH system Problem solving: Solana, ABL 90 Flex, Triage,Afinion2, Medtox, CA-660, miniiSED, Grifols IH system, Microscopic examinations 5. The laboratory was unable to provide additional competency assessment documentation upon request. 6. In an interview at 4: 08 p.m. on 11/06/24, the GS confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Murray County Medical Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the proficiency testing desk review survey performed on October 9, 2024. The following condition-level deficiencies were cited: 493.303 Successful Participation The following standard-level deficiencies were cited: 493.859(f) and (g) ABO Group and D(Rho) Type . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in D(Rho) Type PT under the subspecialty of ABO/RHO in 2023 and 2024. Finding are as follows: The CMS CASPER Report 0155D and the API 2023 Immunohematology - 3rd Event Performance Summary and Comparative Evaluation and the API 2024 Immunohematology - 2nd Event Performance Summary and Comparative Evaluation were reviewed on October 9, 2024. The reports indicated the laboratory failed to achieve satisfactory performance for D(Rho) in two out of three consecutive testing events from 2023 and 2024 resulting in unsuccessful performance of the analyte (see D2162) and the subspecialty (see D2163). . D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory analyte PT performance of 100% for D(Rho) Type testing in two out of three consecutive testing events which led to unsuccessful performance for the analyte. Findings are as follows: 1. API results indicated the laboratory had unsatisfactory performance for D(Rho) Type testing in two out of three consecutive events leading to unsuccessful performance for the analyte. Unsatisfactory PT performance of D(Rho) Type testing was obtained in the following events. - 2023 3rd event 80% - 2024 2nd event 80% . D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance of 100% for the ABO/RHO Subspecialty in two out of three consecutive testing events which led to unsuccessful PT performance in the Subspecialty. Findings are as follows: 1. API reports indicated the laboratory had unsatisfactory performance for D(Rho) Type PT in two out of three consecutive events leading to unsuccessful PT performance for the analyte. See D2162 2. CMS reports indicated the laboratory had unsatisfactory performance for the ABO/RHO Subspecialty in two out of three consecutive events leading to unsuccessful PT performance for Subspecialty. Unsatisfactory PT performance for the ABO/RHO Subspecialty was obtained in the following API events. - 2023 3rd event 90% - 2024 2nd event 90% . -- 2 of 2 --

Summary Statement of Deficiencies 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to evaluate the relationship between test results obtained from the Hematology analyzer and a manual testing method at least twice annually. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/08/22, at 12:05 p.m. 2. A Horiba ABX XL80 hematology analyzer was observed as present and available for use during the tour. The GS indicated the laboratory performed and reported automated and manual White Blood Cell differential testing. 3. The following procedures located in the Murray County Medical Center Policy & Procedures manual: - Hematology Pentra XL80 CBC with 5 Part Automated Differential - Manual Differential - Back-up Method Comparison did not include a requirement to compare automated and manual differential testing twice annually. Twice annual comparisons of these test methods was not found in laboratory records. The laboratory was unable to provide comparison records upon request. 4. In an interview on 11/09 /22, at 10:30 a.m., the GS confirmed twice annual comparisons of the automated and manual White Blood Cell differential testing had not been performed. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of all tests performed at least twice annually. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/30/18 at 8:05 a.m. 2. A Beckman Coulter AU680 chemistry analyzer was observed as present and available for use during the tour. 3. The laboratory performed Transferrin testing as confirmed by the GS. 4. The laboratory utilized American Association of Bioanalysts (AAB) as the Proficiency Testing (PT) provider. Twice annual verification of accuracy documents for Transferrin were not found during review of PT records from 2016, 2017, and 2018. The laboratory was unable to provide these documents upon request. 5. In an interview on 10/30/18 at 10:15 a.m., the GS confirmed the above findings. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)