Beckley Appalachian Regional Hospital

Summary Statement of Deficiencies D0000 An offsite, proficiency testing (PT) desk review was conducted for Beckley Appalachian Regional Hospital on July 24, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation is an initial occurrence and explained below. 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 CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from American Proficiency Institute (API), the laboratory failed to 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 -- achieve satisfactory performance for endocrinology analyte #0595 thyroxine in two consecutive testing events in 2025, resulting in an initial occurrence of unsuccessful participation in PT. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test 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 CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the analyte #0595 thyroxine in two consecutive events in 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0595 thyroxine: 20% 2025 event 1 60% 2025 event 2 2. Review of 2025 API Chemistry Core evaluation reports for PT events 1 and 2, confirmed the unsatisfactory scores for analyte #0595 thyroxine in two consecutive PT events and the resulting unsuccessful participation. -- 2 of 2 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, nongynecologic cytology slide preparations, and interviews the laboratory failed to establish and follow written policies and procedures for nongynecologic cytology specimen processing (refer to D5403); failed to accurately test staining materials for intended reactivity (refer to D5473); failed to establish and follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish and follow written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish and follow written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to establish and follow written policies and procedures to define the reporting system used for the descriptive nomenclature used to diagnose nongynecologic cytology specimens (refer to D5657). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, quality assessment records, nongynecologic cytology slide preparations, interview with Technical Supervisor B and the Administrative Director and laboratory documentation the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems. The laboratory failed to identify and correct problems with the Papanicolaou stain process used for nongynecologic cytology slide preparations in 19 of 153 days of use from June 2022 to December 2022 and January 2023 to the date of the survey in 2023. Cross refer to D5473 Findings include: 1. The laboratory failed to follow the procedure STAIN ASSESSMENT IN CYTOLOGY which stated: "Daily slides will be evaluated for the quality of each stain, bluing, clearing and coverslipping and noted on the documentation sheet." a. The laboratory failed to identify and correct poor stain quality with the Papanicolaou stain process used for nongynecologic cytology slide preparations in 19 of 153 days of use from June 2022 to December 2022 and January 2023 to the date of the survey in 2023. (Refer to D5473) 2. The laboratory failed to follow the procedure MODIFIED PAPANICOLAOU STAINING AND COVERSLIPPING PROCEDURE FOR CYTOLOGY SPECIMENS which stated: "A diagnosis is rendered on properly stained and cover slipped slides. The following procedure renders a reproducible stain and one that clearly delineates nuclei, cell borders, nucleoli and organisms." a. The laboratory failed to properly stain nongynecologic cytology slides prior to rendering a diagnosis in 19 of 153 days of use from June 2022 to December 2022 and January 2023 to the date of the survey in 2023. (Refer to D5473) 3. During an interview on October 12, 2023 at 12:10 PM these findings were confirmed by Technical Supervisor B and Administrative Director. 4. In documentation received via email from the laboratory on October 30, 2023 Laboratory Director/Technical Supervisor A confirmed the cases as "POOR SLIDE QUALITY" and stated "THANK YOU FOR THIS INSPECTION. WE HAVE CHANGED/MODIFIED OUR PROCESS AND THE RESULTS ARE VERY GOOD. SLIDES ARE OF MUCH BETTER QUALITY NOW AND STAINING IS ABSOLUTELY EXCELLENT." 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 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)

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Beckley Appalachian Regional Hospital on January 10 and January 11, 2023, 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 found are cited below. 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 record review and interview the laboratory failed to enroll in a commercial proficiency testing (PT) program for the molecular methodology utilized to detect potential pathogenic bacteria, viruses, and parasites on the Biofire FilmArray 2.0 analyzer for 2021 and 2022. Findings: 1. Review of American Proficiency Institute (API) PT records for 2021 and 2022 revealed no enrollment for the Biofire FilmArray Gastrointestinal, Meningitis, and Respiratory panels. No documentation of proficiency testing could be located. 2. An interview with the general supervisor and administrative laboratory director, on 1/10/23 at approximately 10:30 AM, confirmed the lack of PT enrollment for the Biofire Gastrointestinal, Meningitis, Parasite ID, and 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 -- Respiratory panels for 2021 and 2022. 3. An exit interview with the administrative team and the medical laboratory director, on 1/11/23 at approximately 4:00 PM, reiterated and confirmed the findings. D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: Based on written policies and procedures, observation, and interview the laboratory failed to follow the established policies and procedures (P&P) to ensure positive identification of patients receiving blood and blood products for 12 of 17 patient specimens examined. Findings: 1. Review of P&P identified "Patient Identification and Specimen Collection for Transfusion Services" stating blood bank specimens are required to have the collector's initials, initials of second staff member verifying that patient's identity, collection date, and collection time. 2. A tour of the blood bank laboratory, 1/10/23 at approximately 4:00 PM, identified the retained, previously tested patient specimens in the refrigerator. 3. An examination of 17 retained patient specimens revealed the following 12 unacceptable specimens: 3 specimens had no time of collection, 2 specimens did not have both sets of initials, 7 specimens had only a printed patient label with no documentation. 4. An interview with the general supervisor, 1/10/23 at approximately 4:00 PM, confirmed the lack of required elements on the blood bank specimens. 5. An exit interview with the administrative team and medical laboratory director, 1/11/23 at approximately 4:00 PM, reiterated and confirmed the 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 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)

Summary Statement of Deficiencies D0000 An announced, on site, initial certification survey was conducted at Beckley Appalachian Regional Hospital on June 9, 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 93. Specific deficiencies are explained below. 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 record review and interview the laboratory failed to assure all testing personnel performing proficiency testing (PT) signed the attestation statement for 3 of 3 2020 testing events in Respiratory Therapy (Blood Gas). Findings: 1. Review of American Proficiency Institute (API) PT records identified pCO2, PH, pO2, Oxyhemoglobin, Carboxyhemoglobin, Hg, and methemoglobin as the analytes tested by Respiratory Therapy personnel on the IL GEN Premier 5000 blood gas analyzer. 2. Review of 2020 and 2021 API PT records revealed that 3 of 3 2020 testing events for Respiratory Therapy (Blood Gas) had no testing personnel signatures on the attestation statements. 3. The laboratory director confirmed the findings during the exit interview 6/9/2021 at approximately 12:30 PM. D2121 HEMATOLOGY CFR(s): 493.851(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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve an acceptable score for all analytes in the American Proficiency Institute (API) Hematology 2020 2nd proficiency testing (PT) event. Findings: 1. Review of the API PT records for 2020 Hematology 2nd event identified the following unsatisfactory scores: WBC DIFF (analyte 0765) 48% PLATELETS (analyte 0815) 60% 2. The findings were confirmed by the laboratory director during the exit interview 6/9/2021 at approximately 12:30 PM. 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 record review and interview the laboratory failed to assess the competency of 2 of 2 laboratory personnel for 2020 in the Pathology department. Findings: 1. Review of employee files identified no documentation for the assessment of employee competency for 2 of 2 laboratory personnel in the Pathology department of the laboratory for 2020. 2. The findings were confirmed by the laboratory director during the exit interview 6/9/2021 at approximately 12:30 PM. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review, written policies and procedures, and interview the laboratory failed to perform and document the monthly environmental testing for the BioRad CFX96. Findings: 1. Review of laboratory P&P identified "Cleaning & Maintenance of BioRad CFX 96" which states a process for the monthly environmental testing involved in the BioRad CFX 96 testing. 2. Review of maintenance records for the BioRad CFX96 revealed a lack of documentation for 3 of 3 months in 2021 for the monthly environmental testing. 3. The findings were confirmed by the laboratory director during the exit interview 6/9/2021 at approximately 12:30 PM. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established -- 2 of 3 -- 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, written policies and procedures (P&P), and interview the laboratory failed to (e)(1) document the performance of all tests involved in the investigation of transfusion reactions in 1 of 3 reviewed. Findings: 1. Review of P&P identified "Transfusion Reactions Investigation and Records" which states "perform a direct antiglobulin test on pre- and post- transfusion samples". 2. Review of 3 2021 transfusion reaction investigation records revealed 1 investigation that had no direct antiglobulin testing performed and documented on pre- and post- transfusion samples (REQ 02441913) 3. The findings were confirmed by the laboratory director during the exit interview 6/9/2021 at approximately 12:30 PM. -- 3 of 3 --