Summary:
Summary Statement of Deficiencies 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 the lack of verification of accuracy documentation and interviews with both technical supervisors, the laboratory failed to verify the accuracy of their toxicology tests (screening and confirmation testing) for the last two years. Findings include: a. From 2/17/2016 to 5/1/2018, the laboratory did not have documentation that they verified the accuracy of their screening and confirmation toxicology tests. b. Both technical supervisors/technical consultants affirmed (5/1/2018, 10:00 A.M.) that the laboratory had not verified the accuracy of their screening and confirmatory toxicology tests for the last two years. c. For the period of 2/17/2016 to 5/1/2018, the laboratory tested approximately 15 patient sample for toxicology: screening, confirmatory, or both, while having failed to verify the accuracy of these test systems. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on the review of a patient accession information and interviews with the laboratory's two technical supervisor/technical consultants, the laboratory failed to document the time a specimen was received. Findings include: a. For specimen 1804240001 (toxicology tests), the laboratory only recorded receipt date as 4/24/2018. No documentation of time of receipt was recorded. b. The two technical supervisors 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 -- /technical consultants affirmed that the laboratory did not record the time of receipt for the above specimen. c. The laboratory have tested approximately 15 patient samples (toxicology tests), even though the laboratory failed to record the time of receipt for one patient sample that the surveyor reviewed. -- 2 of 2 --