Virginia Gay Hospital

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 interview with the General Supervisor (GS), identifier #1, at 12:17 pm on 10/28/2024, the laboratory director failed to attest to the routine integration of PT samples into the patient workload for three out of six PT events from 01/01/2023 - 10/28/2024. The findings include: 1. For 2023 event 3, the laboratory director did not sign the Hematology /Coagulation PT attestation statement. 2. For 2024 event 1, the laboratory director did not sign the the Immunology/Immunohematology and Hematology/Coagulation PT attestation statements. 3. For 2024 event 2, the laboratory director did not sign the Microbiology verification attestation statement. 4. At the time of the survey, GS #1 confirmed the laboratory director did not sign the PT attestation statements listed above. 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 proficiency testing (PT) records and confirmed by interview with the General Supervisor (GS), identifier #1, at 12:17 pm on 10/28/2024, the laboratory failed to take and document

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of coagulation reagent studies and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1: 00 pm on 12/14/2022, the laboratory used expired prothormbin time (PT) reagent for 16 days of patient testing from 11/29/22 - 12/14/2022. The findings include: 1. The coagulation reagent lot studies stated that lot number 549763 of PT reagent expired on 11/28/2022. 2. Laboratory personnel identifier #1 confirmed in an interview that the laboratory used lot number 549763, expiration date 11/28/2022 of PT reagent from 11 /29/2022 - 12/14/2022 on patient specimens. 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: A. Based on lack of comparison testing records and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 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 -- 12/14/2022, the laboratory failed to perform comparison studies between two i-STAT analyzers and the AU 480 chemistry analyzer for 11 analytes from four out of four time periods from 1/1/2021 - 12/14/2022. The findings include: 1. On i-STAT analyzer, serial number 404936, the laboratory performed: potassium, sodium, chloride, ionized calcium, total carbon dioxide, glucose, urea nitrogen, creatinine, lactic acid, venous pH and troponin testing. 2. On i-STAT analyzer, serial number 414749, the laboratory performed: potassium, sodium, chloride, ionized calcium, total carbon dioxide, glucose, urea nitrogen, creatinine, lactic acid, venous pH and troponin testing. 3. On the AU 480 chemistry analyzer, the laboratory performed: potassium, sodium, chloride, total carbon dioxide, glucose, urea nitrogen and creatinine testing. 4. At the time of the survey, the laboratory had not performed comparison testing for those analytes that are performed on both i-STAT analyzers and the AU 480 chemistry analyzer. B. Based on lack of comparison testing records and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 1: 45 pm on 12/14/2022, the laboratory failed to perform comparison studies between two Biofire analyzers and the Cepheid GeneXpert for 42 pathogens from four out of four time periods from 1/1/2021 - 12/16/2022. The finding include: 1. On Biofire analyzer, serial number FA3465, the laboratory performed the GI Panel which consisted of 22 pathogens, including Clostridium difficile and the Respiratory Panel 2.1 which consisted of 20 pathogens, including influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2. 2. On Biofire analyzer, serial number FA3437 the laboratory the GI Panel which consisted of 22 pathogens, including Clostridium difficile and the Respiratory Panel 2.1 which consisted of 20 pathogens, including influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2. 3. On the Cepheid GeneXpert, the laboratory performed Clostridium difficile, influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2 testing. 4. At the time of the survey, the laboratory had not performed comparison testing for those analytes that are performed on both Biofire analyzers and the Cepheid GeneXpert. D5783