Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 10/21/2022 and concluded on 10/21/2022. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493.801(b)(1) with a deficiency cited. 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 proficiency testing record review, procedure manual review, competency evaluation review, and personnel interview, the laboratory failed to ensure proficiency testing (PT) was rotated among testing personnel who routinely performed urine sediment testing for five (5) of five (5) PT events reviewed from 2021 and 2022. The findings include: The laboratory's procedure manual, revised 01/14/2019, included a policy titled, "Rules for Proficiency Test Participation;" however, the policy did not include instructions to rotate proficiency testing among all personnel who routinely performed testing. Review of competency evaluations performed in 2021 revealed that Testing Personnel 1 and Testing Personnel 2 were evaluated and determined to be competent to perform urine sediment testing. A review of signed PT attestation statements from Medical Laboratory Evaluation (MLE) revealed Testing Personnel (TP) #2 performed all urine sediment proficiency testing for 2021, MLE-M2 (testing event 2); 2021, MLE-M3 (testing event 3); 2022, MLE-M1 (testing event 1); 2022, MLE-M2 (testing event 2); and 2022, MLE-M3 (testing event 3). Interview with TP #2, on 10/21/2022 at 10:55 AM, revealed that TP #1 and TP #2 routinely performed urine sediment testing in the laboratory. According to TP #2, TP #1 had not participated in any of the PT events reviewed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --