Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 22-23, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of laboratory policy, "Proficiency Testing Policy,"review of laboratory records, review of the College of American Pathologists (CAP) proficiency testing (PT) evaluations and interview with the chemistry and microbiology supervisors, the laboratory failed to verify the accuracy of their results with no test scores due to educational challenges and no referee consensus. Findings include: 1. Laboratory policy, "Proficiency Testing Policy," states, "Educational challenges or ungraded challenges must be manually evaluated and graded by the laboratory." 2. Review of the laboratory's PT records revealed that there was no documentation of review for DAI-A 2021, Urine Drug Adulterant, with no test scores due to an educational challenge as noted on the CAP PT evaluation for that event. 3. Review of the laboratory's PT records revealed that there was no documentation of review for D2-C 2020, Urine Culture Antibiotic Susceptibility Testing, with no test scores due to a lack of referee consensus as noted on the CAP PT evaluation for that event. 4. 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 -- Review of the laboratory's PT records revealed that there was no documentation of review for MVP-B 2020 and MVP-C 2020, Molecular Vaginal Panel, with no test scores due to an educational challenge as noted on the CAP PT evaluation for those events. 5. Review of the laboratory's PT records revealed that there was no documentation of review for IDPN-A 2020 and IDPN-B 2020, ID Pneumonia Panel, with no test scores due to an educational challenge as noted on the CAP PT evaluation for those events. 6. The chemistry and microbiology supervisors confirmed the findings during the on-site survey on 3/22/2022 at approximately 2:00 PM. The laboratory performs approximately 271,885 chemistry and 35,624 microbiology tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory test records and interview with the chemistry supervisor, the laboratory failed to verify the accuracy of the oral fluid and urine drugs not on the list of analytes tested with the proficiency testing programs enrolled by the laboratory, at least twice annually in 2021. Findings include: 1. Review of laboratory records for twice a year accuracy checks for oral fluid drugs revealed that samples were tested on 7/21/2021 and no other dates in 2021. 2. Review of laboratory records for twice a year accuracy checks for urine drugs revealed that the comparison testing with a reference laboratory was conducted on 6/15/2021 and no other dates in 2021. 3. The chemistry supervisor interviewed on 3/22/2022 at approximately 1:00 PM confirmed the findings. The laboratory performs approximately 271,885 chemistry tests annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, review of quality control records, review of laboratory instrument maintenance records, review of laboratory temperature records, and interview with the chemistry and microbiology supervisors, the laboratory failed to meet the analytic systems requirements in CFR 493.1251 through 493.1283. The laboratory did not require the testing personnel to read and follow the director approved procedures (refer to D5401); the laboratory failed to define storage conditions for laboratory reagents and store them appropriately (refer to D5413); the laboratory failed to ensure expired standards were not used (refer to D5417); the laboratory failed to ensure that instrument maintenance and function checks were conducted according to manufacturer's requirements (refer to D5429); the laboratory -- 2 of 10 -- failed to ensure that twice annual comparison of test results were conducted (refer to D5775); and the laboratory failed to ensure that