Bhg Reference Lab, Llc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedure, final patient test reports, and staff interviews, the laboratory included comments regarding the specimen condition for result interpretation on patient test reports that were not applicable in 2023 and 2024. The findings include: 1. Observation of the laboratory on 09/25/2024 at 10:00 a.m. revealed urine specimen bags grouped by date of receipt in a double door refrigerator. During the observation, the laboratory accession personnel described the procedure for specimen receipt and processing for testing. She stated that specimens were received Monday through Friday from the overnight delivery service that transported at room temperature. The personnel placed all overnight packages in a large plastic bag and wrote the date of receipt on the bag. The laboratory would pull the large bags out chronologically, and specimens were accessioned, aliquoted, and given to the testing personnel. The personnel placed the original urine specimen cups in bins in another double-door laboratory refrigerator and housed them until all confirmations were complete. 2. A review of the laboratory ' s procedure titled "Specimen Stability and Transport Requirements" revealed the following: Specimen Storage temperatures: Room Temperature 20-25C for four days Refrigerator 2-8C for seven days 3. A review of final patient test reports (five of nine 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 -- reviewed) revealed the following patient test reports with the comment "Specimen exceeds established laboratory stability": Patient B6312739 collected 10/26/2023, received 10/27/2023, tested 11/01/2023 Patient B552769 collected 04/03/2024, received 04/04/2024, tested 04/10/2024 Patient B1213783 collected 10/26/2023, received 10/27/2023, tested 11/01/2023 Patient B42A2212 collected 05/11/2023, received 05/15/2023, tested 05/16/2023 Patient B554470 collected 04/03/2024, received 04/04/2024, tested 04/10/2024 The specimens did not exceed the laboratory ' s established stability requirements. 4. An electronic interview with the laboratory technical supervisor three on 09/30/2024 at 7:50 a.m. confirmed the laboratory included comments regarding specimen condition for interpretation on patient test reports that did not apply in 2023 and 2024. Word Key: C- degrees Celsius -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 03/30/23. The facility was found to be NOT in compliance with the following 42 CFR Part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.1240 Pre-Analytic Systems D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of testing personnel records, proficiency testing records and interview with the general supervisor, the laboratory failed to ensure proficiency testing (PT) was performed by all testing persons in 2021, 2022, and 2023. The findings include: 1. Review of testing personnel records revealed two testing personnel performed urine drug screen testing in the laboratory in 2021, 2022, and 2023. 2. Review of the laboratory's proficiency testing records revealed that five of seven PT events were performed by the previous general supervisor (2021 events one, two, and three; 2022 events one and three). 3. Interview with the current general supervisor on 03/30/23 at 3:45 p.m. confirmed that there were two testing personnel who performed urine drug screen testing in the laboratory in 2021, 2022 and 2023 and that the previous general supervisor performed five of seven PT events during that period. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 review of the laboratory's alternative quality assessment records, and interview with the quality manager, the laboratory failed to ensure results for three of six quantitative urine ethanol test events from 2021 and 2022 had been reviewed or evaluated to determine the laboratory's accuracy. The findings include: 1. Review of the laboratory's alternative quality assessment records for the quantitative urine ethanol analyte revealed no review of the results for 2021 event two, 2022 event one, and 2022 event two. 2. Interview with the quality manager on 04/03/23 at 2:45 p.m. confirmed the laboratory failed to ensure the results of the alternative quality assessments used for verifying the accuracy of the quantitative urine ethanol analyte had been reviewed for three of six test events in 2021 and 2022. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, review of the laboratory's initial performance establishment studies for specimen stability, randomly selected final patient test reports and staff interviews, the laboratory failed to establish policies and procedures for specimen storage, preservation, and conditions for transportation (Refer to D5311) and failed to have an effective assurance process in place to prevent errors in test performance outside the laboratory's established specimen stability ranges (Refer to D5393). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, and staff interviews, the laboratory failed to establish policies and procedures for specimen storage, preservation, or conditions for transportation on the date of the survey (03/30/23). The findings include: 1. Observation of the laboratory on 03/30/23 at 10:15 a.m. revealed three instruments (Synermed IR 500 (x2) and Synermed IR 1200) in use for performing patient testing on urine for the following analytes: qualitative assays for amphetamine, barbiturate, benzodiazepine, buprenorphine, -- 2 of 3 -- cocaine, fentanyl, methadone, methadone metabolite, opiates, oxycodone, phencyclidine, cannabinoids, quantitative urine ethanol, urine creatinine, and urine pH. 2. Review of the laboratory's procedure manuals revealed the laboratory did not have specific procedures for specimen storage, preservation, or conditions for transportation. 3. Interview with the laboratory supervisor on 03/30/23 at 3:45 p.m. and virtual interview with the quality manager on 04/03/23 at 2:45 p.m. confirmed the laboratory did not have procedures for storage, preservation or transportation in 2023. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of