Summary:
Summary Statement of Deficiencies D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the written procedure manual, interview with the technical consultant (TS), and the laboratory director (LD), the laboratory did not have a client service manual with written instructions for referring laboratory's to follow when submitting urine for toxicology testing. Findings: 1. The laboratory performs urine toxicology testing for 4 collection sites. 2. The collection sites submit urine specimens for (LCMS) Liquid Chromatography Mass Spectrometry confirmation testing. 3. The laboratory did not have written instructions to provide clients outlining the submission of specimens for testing that included the ordering, collection, preservation, storage, transport, and the quantitative methodology of the test performed. 4. The laboratory did not have written instructions to provide clients describing each drug included in a panel that is chosen by the ordering physician. 5. The laboratory did not have written instructions to provide clients describing the levels of testing performed depending when the patient is a low, moderate or high risk for certain drugs. 6. The TS and the LD confirmed that the laboratory did not have a client service manual to provide referring laboratory's with written instructions for submitting urine specimens for confirmation toxicology testing. 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 --