Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures, review of laboratory records and absence of documentation 2/24/22, the laboratory failed to maintain all PT (proficiency testing) records and failed to ensure the laboratory director and testing personnel signed the attestation statements for 4 of 4 testing events in 2020 and 2021. Findings: Review of the laboratory's Proficiency Testing Policy revealed, "Proficiency Testing Procedure and Guidelines"...2.. The individual testing or examining the samples and the Laboratory Director must attest to the routine integration of samples into the patients' workload using the laboratory's routine methods....5. The laboratory personnel will document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory will maintain a copy of all records for a minimum of two years from the date of the proficiency testing event..." Review of laboratory records revealed no documentation on file for the 2020 and 2021 API (American Proficiency Testing) PT events. The laboratory was able to contact API during the survey to obtain a copy of the graded PT results. The laboratory failed to maintain the PT report forms used by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the laboratory to record PT results, copies of the instrument printouts, the confirmation of the electronic submission of the PT results to the PT vendor, and the review of the graded results by the laboratory director and testing personnel, and failed to ensure the laboratory director and testing personnel signed the attestation statements for the following: a. 2020 API Chemistry Miscellaneous 1st and 2nd events; b. 2021 API Chemistry Miscellaneous 1st and 2nd events. 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 policies and procedures, review of 2020, 2021, and 2022 laboratory records, observation, and interviews with the laboratory director 2/24/22, the laboratory failed to monitor and evaluate the overall quality of the urine toxicology testing performed on the Siemens Viva-E analyzer and failed to identify problems and implement