Minnie Hamilton Health Care Center Inc

Summary Statement of Deficiencies D0000 A routine recertification survey was completed for Minnie Hamilton Health Care Center Inc. on December 17, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(g) (d)(3)(v) 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 molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the verification records for the BCID2 PCR test panel on the Biofire Torch analyzer, BCID2 PCR test panel manufacturer instructions for use (IFU), BCID2 patient test results from the Biofire Torch analyzer, external quality control (QC) records, and interview with the general supervisor (GS), the laboratory failed to perform two levels of QC for the BCID2 PCR test panel on 10 of 12 days of patient testing from June 18, 2025 thru date of survey. Findings: 1. Review of the 2025 Biofire Torch BCID2 verification records revealed the laboratory director reviewed and approved the performance specifications for the BCID2 PCR test panel on the analyzer on 4/17/2025. 2. Review of the manufacturer IFU for the BCID2 test panel on the Biofire Torch analyzer revealed no specific frequency for the performance of external quality control (QC) for the moderate complex BCID2 PCR test panel. 3. Review of QC records (June 2025 thru November 2025) identified two 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 -- levels of external QC performed on two days of patient testing (6/18 and 7/2). 4. Review of 16 BCID2 PCR test panel patient results (June 2025 thru November 2025) identified 13 results released on 10 testing days with no performance of two levels of external QC: 6/21: patient 25034088, patient 25034087 6/23: patient 25034351 7/11: patient 25037918 7/15: patient 25038687, patient 25038359 7/19: patient 25039587 9 /29: patient 25051371 9/30: patient 25051526 11/12: patient 25058800, patient 25058828 11/18: patient 25059850 11/21: patient 63447 5. The GS could not locate an Individualized Quality Control Plan (IQCP) for the performance of external QC for the BCID2 PCR test panel less often than each day of patient testing. 6. An interview with the GS, 12/17/25 at 8:30AM, verified the lack of performance of two levels of external QC materials each day of patient testing for 10 of 12 days in time period reviewed for the BCID2 PCR test panel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey as conducted at Minnie Hamilton Health Care Center Inc., by the West Virginia Office of Laboratory Services on January 23-24, 2024. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of written policies and procedures (P&P), laboratory personnel competency records, lack of documentation, and interview the laboratory failed to ensure that the established process to assess employee competency was followed for one of two years reviewed. Findings: 1. Review of P&P identified an established process of assessing testing personnel competency for all methodologies used for patient testing in the laboratory. 2. Review of the laboratory current test menu identified direct antigobulin testing (DAT) and gram staining as methods utilized by laboratory testing personnel in 2022 and 2023. 3. Review of testing personnel (TP) competency records for 2022 and 2023 revealed a lack of documentation for the assessment of competency in the gram staining process (4 of 4 TP) and DAT (7 of 8 TP) in 2023. 4. An interview with the general supervisor, 1/23/24 at 9:15 AM, confirmed the lack of TP competency doumented for gram staining and DAT in 2023. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- 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 record review, observation, lack of documentation, and interview the laboratory failed to determine the mean normal patient prothrombin time (MNPT) for one of two lots (lot 564624) of Innovin prothrombin time (PT) reagent and verify the accuracy of the INR calculation before putting the lot into use for patient testing. Findings: 1. Review of the records for lot 564624 (expiry 6/2/25) of Dade Innovin revealed no documentation of the laboratory determined MNPT and no manual verification of the INR calculation. 2. Observation of the coagulation analyzer (Sysmex CA 620) set up menu, 1/24/24 at 10:30 AM, identified the current ISI in use for lot 564624 expiry 6/2/25 to be accurate per Dade Innovin product insert. 3. An interview with the technical consultant and laboratory administartion director, 1/24/24 at 10:35 AM, confirmed the lack of documentation for the verification of the required performance specifications for lot 564624 of Dade Innovin PT reagent. 4. An exit interview with laboratory and executive administration, 1/24/24 at 3:30 PM, confirmed the findings. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of written policies and procedures (P&P), lack of documentation, and interview the laboratory failed to establish a process for the validation of statistical parameters for new lots of unassayed quality control (QC) materials in Chemistry for analytes tested on the Vitros 7600. Findings: 1. Review of P&P revealed no established process for the validation of new lots of unassayed QC material used in Chemistry. 2. The technical consultant (TC) stated during an interview 1/23/24 at 1:00 PM that no documentation of the criteria for evaluating the validation of new lots of unassayed QC could be located. 3. An exit interview with the laboratory administration, 1/24/24 at 3:00 PM, confirmed the findings. 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 review of written policies and procedures (P&P), quality assurance (QA) -- 2 of 3 -- records, and interview the laboratory failed to establish a process for the step by step performance that evaluates and defines the correlation of test results between the Hematology automatic differential and manual differential testing methodologies twice a year. Findings: 1. Review of P&P revealed no established criteria for the performance and evaluation of the intra-laboratory comparison of testing personnel (TP) who perform manual differential testing. 2. Review of P&P revealed no defined criteria for the comparison of test results between the automatic differential and manual differential methodologies. 3. An exit interview with the laboratory technical supervisor (TS) and laboratory administration, 1/24/24 at 3:00 PM, confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Minnie Hamilton Health Care Center Inc. on November 3, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory received an unsatisfactory performance score for 3 of 23 analytes in the 3rd Chemistry Core proficiency testing event 2020. Findings: 1. Review of American Proficiency Institute (API) records identified the following scores: 2020 Chemistry Core 3rd event pCO2= 60% pH= 60% pO2= 60% 2. An interview with the geberal supervisor, 11/2/21 at approximately 10:30 AM, confirmed the findings. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to return results within 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 4 -- specified time frame for 1 of 3 Hematology proficiency testing (PT) events in 2020. Findings: 1. Review of College of American Pathologist (CAP) PT records identified the following: FH9-A 2020 Hematology Auto Differentials 0% Unsatisfactory score for event, results not returned 2. An interview with the general supervisor, 11/2/21 at approximately 10:30 AM, confirmed the findings. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve an overall testing score of 100% for Compatibility Testing in 1 of 3 proficiency testing (PT) events in 2020. Findings: 1. Review of College of American Pathologist (CAP) PT records identified the following: J-C 2020 Compatibility Testing= 80% 2. An interview with the general supervisor, 11/2/21 at approximately 10:20 AM, confirmed the findings. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on record review, policies and procedures (P&P), lack of documentation, and interview the facility failed to establish the specific criteria and parameters to promptly identify a blood or blood product transfusion reaction. Findings: 1. Review of laboratory blood bank records identified no transfusion reactions documented for 2020 or 2021. 2. Review of laboratory blood bank P&P identified "Suspected Transfusion Reaction Workup" which states "Detection of the reaction is the responsibility of persons performing the transfusion." 3. Review of nursing P&P identified "Blood Transfusion" which states to monitor the patient for "adverse effects of blood transfusion since IV products have a more rapid effect. This would include but not limited to: circulatory overload, hemolytic reaction." 4. No facility P&P that outlines the specific signs and symptoms of a transfusion reaction or patient monitoring parameters before, during, and after a transfusion could be located. 5. An interview with the general supervisor and the nursing supervisor, 11/3/21 at approximately 1:10 PM, confirmed the findings. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to retain the required transfusion records for 1 of 1 incident of emergency release of blood and blood products reviewed for 2021. Findings: 1. Review of emergency release blood bank forms identified patient 67976 as receiving 2 units of uncrossmatched, O Negative packed red blood cells on 6/2/21. The emergency release forms were complete and signed by the attending physician. No transfusion forms could be located for either unit. 2. An interview with the general supervisor, 11/3/21 at approximately 9:30 AM, confirmed the findings. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to (f) document quality control (QC) performed for 1 of 7 days of patient testing reviewed (5/26/21 thru 6/10/21). Findings: 1. Review of Transfusion Service Testing Record identified 7 days of patient testing- 5/26/21, 5/28/21, 5/31/21, 6/2/21, 6/4/21, 6 /7/21, 6/10/21. No documentation of which method testing personnel utilized for patient testing (manual gel method or automated Vision method) could be located. 2. Review of specified days of patiient testing identified QC for the automated Vision method 7 of 7 days. 2. The general supervisor stated on 11/3/21 at approximately 10: 00 AM that manual gel patient testing was performed 6/2/21. No documentation of that quality control could be located. 3. An interview with the general supervisor, 11/3 /21 at approximately 10:45 AM, confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of policies and procedures (P&P), blood bank transfusion records, and interview the laboratory failed to establish written P&P to monitor, assess, and when indicated, correct problems identified in transfusion medicine. Specifically: a) Ensuring all blood bank documentation is accurate and complete for transfusions of -- 3 of 4 -- blood and blood products b) Ensuring the facility has established P&P that define necessary vital signs to be obtained before, during, and after transfusion and the specific parameters for those vital signs to identify possible transfusion reactions c) Ensuring the retention of blood and blood product transfusion records d) Ensuring documentation of quality control for each method utilized for patient testing Findings: (a) Review of blood bank transfusion forms and emergency release forms identified that patient 67976 received multiple units of blood and blood products on 6/2/21: i) 2 units of O Negative packed red cells and 3 units of O Positive packed red cells -2 of 2 transfusion forms for the 0 Negative units could not be located -3 of 3 transfusion forms for O Positive units were not complete as they had no documentation if units were released crosssmatched or uncrossmatched as established in the laboratory P&P ii) 2 units of fresh frozen plasma (FFP); documentation of the unit numbers were found to be inaccurate, incomplete, and sometimes illegible: -Unit 1 was inaccurately and incompletely recorded as ending in 9553000J with expiration date of 10/30/21 in the Transfusion Service Testing Record, 953000J with expiration date of 10/30/21 in Blood Bank Log, and 95300J with no expiration date documented on the transfusion form. -Unit 2 product number was inaccurately and illegibly recorded in Transfusion Service Testing Record and transfusion form. The Transfusion Service Testing Record had no expiration date documented. iii) No documentation of the transfusion of either unit of FFP for patient 67976 could be located in the EHR. (b) No facility P&P could be located that included vital signs to be monitored for specific changes to identify potential transfusion reactions. Refer to D3025. (c) Transfusion records for patient blood and blood product transfusions were not retained. Refer to D3035. (d) Quality control not documented accurately. Refer to D5559. An exit interview with the general supervisor, 11/3/21 at approximately 1:10 PM, confirmed the findings. -- 4 of 4 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based upon a review of the laboratory Proficiency Testing (PT) records, current test menu, and interview with the General Supervisor (GS), the laboratory failed to verify accuracy at least twice per year for the Direct Antiglobulin Test (DAT), an analyte that is not included in Subpart I. Findings: 1. A review of PT records from 2018 and 2019 established that the laboratory had not performed commercial PT, or utilized other methods, to verify accuracy on the DAT testing in Immunohematology twice a year. 2. An interview with the GS, on 9/3/19 at approximately 1:30 PM, confirmed the findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the written laboratory policies and procedures and an interview with the General Supervisor (GS), the laboratory failed to establish and follow a written policy and procedure for monitoring, assessing, and correcting problems of 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 3 -- general laboratory systems. Findings: 1. No written policy or procedure for the Quality Assessment (QA) of the general laboratory systems could be located. This includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. An interview with GS, on 9/4/19 at approximately 12:30 PM, confirmed the findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a review of laboratory written policies and procedures and an interview with the General Supervisor (GS), the laboratory failed to establish and follow a written policy/ procedure for the Quality Assessment (QA) of preanalytic systems. Findings: 1. No written policy or procedure for the QA of preanalytic could be located. This includes the following: test request and specimen submission, handling, and referral. 2. An interview with the GS. on 9/4/19 at approximately 12:30 PM, the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based upon a review of the laboratory written policies and procedures and an interview with the General Supervisor (GS), the laboratory failed to establish a written policy/procedure for the Quality Assessment (QA) of analytic systems. Findings: 1. No written policy or procedure for the QA of analytic systems could be located. This included the following: procedure manual, test systems/equipment/supplies, establishment and verification of performance specifications, maintenance and function checks, calibration and calibration verification procedures, control procedures, comparison of test results,

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --