Summary:
Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of test requisitions for review and interview with the facility personnel, the laboratory failed to retain test requisitions and test authorizations for at least two years. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Toxicology, with an approximate annual test volume of 176,400. 2. No records of test requistions were presented for review during the survey conducted on August 21, 2019 for testing that was performed prior to August 1, 2019. 3. The facility personnel acknowledged that the laboratory was only keeping the test requisitions for about a month and then shredding them. 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 proficiency testing (PT) results for Urine Drug Testing for the first event of 2019 and interview with the technical supervisor, the laboratory failed to provide an adequate explanation of the unacceptable results received for urine creatinine for each of three PT specimens tested. Findings include: 1. The laboratory performs PT for urine drug analysis as a form of accuracy check to satisfy the 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 -- requirements under the CLIA regulations. 2. The