Summers County Arh Hospital Laboratory

Summary Statement of Deficiencies D0000 A routine recertification survey was performed at Summers County ARH Hospital Laboratory on June 9 & 10, 2026, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with 42 CFR 493, Requirements for Laboratories. Noncompliance was found and explained below. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 Prothrombin time (PT) reagent validation documents for the Sysmex CA-660, laboratory International Normalized Ratio (INR) calculation verification for 2025, direct observation of the Sysmex CA-660 analyzer, Dade Innovin reagent manufacturer instructions for use (IFU), laboratory policies and procedures, interview with the general supervisor (GS), and exit interview with the laboratory administration team, the laboratory failed to follow the manufacturer's instructions for use and ensure the normal patient Prothrombin time mean (MNPT) established for the new lot of Innovin PT reagent was implemented when put into use for patient testing (September 2025 thru date of survey). Findings: 1. A review of the Sysmex CA-660 Dade Innovin PT reagent validation records for lot number 564677 (expiry 12/16/27) revealed the laboratory established a normal patient Prothrombin time mean (MNPT) of 10.51 in the laboratory population PT study performed in September 2025. 2. A review of the INR calculation verification, performed 9/3/2025 to manually check the calculation used by the Sysmex CA-660 analyzer for the new PT reagent, identified the laboratory used an MNPT of 10.70 to manually calculate the INR for Innovin lot 564677 when put into use. 3. During a tour of the hematology 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, 6/9/26 at 3:30 PM, the state surveyor directly observed the normal patient Prothrombin time mean (MNPT) programmed as 10.7 and the ISI as 1.01 in the set parameters for Innovin lot 564677 on the Sysmex CA-660 analyzer. The IFU for the Dade Innovin reagent lot 564677 verified the ISI of 1.01 was correct. 4. A review of the Dade Innovin manufacturer IFU confirmed "the mean normal PT (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin (Innovin) lot using the method used to analyze patient samples." 5. The laboratory "CA 660 Reagent and Lot Conversion" standard operating procedure, in effect 3/11/2021, states "The calculation of the INR is appropriately adjusted for every new lot of PT reagent" with the established MNPT from the normal laboratory population and the manufacturer ISI from the new reagent lot IFU. 6. During an interview 6/9/26 at 3:40 PM, the GS verified that the incorrect MNPT of 10.7 was programmed into the Sysmex CA-660 analyzer and used for the INR calculation in patient PT testing since implementation of the new lot of Innovin in September 2025. 7. An exit interview with the laboratory administration team, 6/10/26 at 2:00 PM, confirmed the findings. D5781

Summary Statement of Deficiencies D0000 A routine recertification survey was performed at Summers County ARH Hospital Laboratory, April 30 and May 1, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) results to the American Proficiency Institute (API) program by the submission date for one of three routine chemistry events in 2023. Findings: 1. Review of API records revealed unsatisfactory scores for the Routine Chemistry 2nd event of 2023: 0% pH Blood Gas (#0315) 0% PO2 Blood gas (#0325) 0% PCO2 Blood Gas (#0335) 2. Review of the laboratory

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Summers County ARH Hospital Laboratory on April 19th and April 20th of 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to document the evaluation of results for 5 of 5 College of American Pathologists (CAP) proficiency testing (PT) events in Immunohematology for 2021. Findings: 1. Review of 2021 CAP Immunohematology PT records identified 5 of 5 event results had no documentation of review by the technical supervisor. 2. Review of the 2nd event 2021 identified a score of 80% for the analyte 0855 Antibody Detection. No

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with the laboratory manager, the laboratory failed to enroll in an approved program for Microbiology and Routine Chemistry for the 1st and 2nd testing events of 2020 and no other testing was performed to establish and maintain the accuracy of the testing procedures, in accordance with 493.1236 (c) (1). Findings: 1. A review of 2019 and 2020 API PT records identified no enrollment for Microbiology- Bacteriology PT of the Film Array BioFire GI panel, Respiratory panel, and Meningitis panel for testing events 1 and 2 of 2020. 2. A review of 2019 and 2020 API PT records identified no enrollment for Chemistry- Core Chemistry and Hematology PT of Respiratory Therapy testing pCO2, pH, pO2, Carboxyhemoglobin, Hemoglobin (Blood Oximetry), Methemoglobin, and Oxyhemoglobin for testing events 1 and 2 of 2020. 3. A review of the PT records for the API Microbiology and Core Chemistry 2020 testing events (1 and 2), identified an investigation and