Greene County Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on January 9, 2026. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, high complexity 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute, the laboratory failed to successfully participate in two out of three consecutive testing 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 -- events for the analytes: cell identification, partial thromboplastin time, and prothrombin time . The laboratory had unsatisfactory scores for 2025 event 1, 2025 event 2 and 2025 event 3. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two out of three consecutive testing events for the analytes: cell identification, partial thromboplastin time, and prothrombin time. The findings include: 1. For 2025 event 2, the laboratory received an unsatisfactory performance score of 40% for the analyte, cell identification.. For 2025 event 3, the laboratory received an unsatisfactory performance score of zero for the analyte, cell identification. 2. For 2025 event 1, the laboratory received an unsatisfactory performance score of 40% for the analyte, partial thromboplastin time. For 2025 event 3, the laboratory received an unsatisfactory performance score of zero for the analyte, partial thromboplastin time. 3. For 2025 event 1, the laboratory received an unsatisfactory performance score of 40% for the analyte, prothrombin time. For 2025 event 3, the laboratory received an unsatisfactory performance score of zero for the analyte, prothrombin time. 4. The CASPER 155 report and graded results from API confirm the findings listed above. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2025 event 1, 2025 event 2, and 2025 event 3), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. 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 review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Sysmex CA-660 coagulation reagent verification records, observation of the coagulation instrument, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 12:44 pm on 06/19/2024, the laboratory failed to program the correct normal patient mean into the coagulation instrument for one out of one lot number of prothrombin time reagent (lot number 564610, expiration 01/20/2025). The findings include: 1. The laboratory began using prothrombin time reagent lot number 564610 (expiration 01/20/2025) for patient testing on 09/27/2023. 2. Review of the coagulation reagent verification records for prothrombin time reagent lot number 564610 indicated that the laboratory established a normal patient mean of 10.1 seconds. 3. Observation of the coagulation instrument showed that the laboratory programmed a normal patient mean of 10.4 seconds in for prothrombin time reagent lot number 564610. 4. At the time of the survey, personnel identifier #1 confirmed that the laboratory programmed the incorrect normal patient mean into the coagulation instrument for prothrombin time reagent lot number 564610 (expiration 01/20/2025). 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), at approximately 10:30 am on 9/13/2022; the laboratory director and/or testing personnel failed to attest to the routine integration of PT samples into the patient workload for three out of five PT events from 1/1/2021 - 9/13/2022. The findings include: 1. For 2021 PT event 3, the laboratory director did not sign the PT attestation statement for hematology and coagulation. 2. For 2022 PT event 1, the laboratory director did not sign the PT attestation statement for core chemistry, hematology and coagulation, immunology and immunohematology, and chemistry - miscellaneous. Additionally, the test personnel did not sign the PT attestation statement for core chemistry. 3. For 2022 PT event 2, the laboratory director did not sign the PT attestation statement for core chemistry, hematology and coagulation, and immunology and immunohematology. 4. At the time of the survey, the laboratory director and/or testing personnel did not sign the PT attestation statements for the above PT events. 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 D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of immunohematology quality control records, Micro Typing Systems (MTS) instructions for use and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:50 am on 10/29/20, the laboratory failed to perform a negative control material each day of patient testing as specified in D5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of immunohematology quality control records, Micro Typing Systems (MTS) instructions for use and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:50 am on 10/29/20, the laboratory failed to perform a negative control material each day of patient testing for one patient who had ABO group, D (Rho) typing and unexpected antibody 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 -- detection testing performed on 3/7/2020. The findings include: 1. Patient identifier A had ABO group, D (Rho) typing and unexpected antibody detection testing performed on 3/7/2020. The laboratory used the MTS A/B/D Monoclonal and Reverse Grouping Card to perform the ABO group and D (Rho) typing, and the MTS Anti-IgG card to perform the unexpected antibody detection testing. 2. The MTS A/B/D Monoclonal and Reverse Grouping Card instructions for use state, "To confirm the reactivity and specificity of the microtubes containing Anti-A and Anti-B, it is recommended that each lot of cards be tested each day of use with antigen positive and antigen negative red blood cells. 3. The MTS Anti-IgG Card instructions for use state, "To confirm the specificity and reactivity of the MTS Anti-IgG card, it is recommended that each lot be tested each day of use with known positive and negative antibody samples with the appropriate red blood cells." 4. Laboratory personnel identifier #1 confirmed the laboratory routinely performed a positive control on the the MTS A/B/D Monoclonal and Reverse Grouping card and on the MTS Anti-IgG card each day of patient testing, but not a negative control. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of 2017-2018 chemistry proficiency testing (PT) records and confirmed by the laboratory personal identifier #1 (refer to Laboratory Personal Report) at approximately 12:00 PM on 07/26/2018, the laboratory failed to take and document