Summary:
Summary Statement of Deficiencies D0000 An onsite Validation Survey was performed on 07/28/26. Standard-level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on the laboratory's written procedure, record review, and interview with the technical supervisor, the laboratory failed to ensure specimen integrity for five of five urine drug screen specimens. Findings included: 1. During a laboratory tour on 07/28 /26 at 09:00 am, the technical supervisor confirmed the laboratory performed a 10- panel urine drug screen on the ImmTox benchtop chemistry analyzer. 2. In an interview on 07/28/26 at 11:30 am, the technical supervisor confirmed the following: a. Laboratory received outside specimens from four clients. b. Specimens were transported to the laboratory in a cooler. 3. Review of the laboratory's written procedure, "Toxicology Specimen Collections, Integrity and Rejection Guidelines" section stated the following: a. "Storage Temperatures" - Urine Drug Screen Panel "18-25C Room Temp" or "2-8C Refrigerated". b. "Established Sample Stability (Stability study approved by the laboratory director on 11/16/22) - Urine Drug Screen Panel "14 days Room Temp" or "14 days Refrigerated". 4. A review of five laboratory test requisitions revealed the laboratory failed to follow its own written procedure for specimen integrity for five of five patient specimens as follows: a. Requisition #68602695 -Collected on 04/16/26, received into the laboratory on 04/24/26, and 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 -- reported on 04/24/26. Revealed no documentation of the specimen disposition (e.g. temperature) upon receipt into the laboratory. b. Requisition #11727 - Collected on 06 /19/26, received into the laboratory on 06/23/26, and reported on 06/23/26. Revealed no documentation of the specimen disposition (e.g. temperature) upon receipt into the laboratory. c. Requisition #59102463 - No collected date on specimen, received into the laboratory on 06/23/26 and reported on 06/23/26. Revealed no documentation of the specimen disposition (e.g. temperature) upon receipt into the laboratory. d. Requisition #52694482 - Specimen collected on 07/13/26, received into the laboratory on 07/17/26, and reported on 07/28/26. Revealed no documentation of the specimen disposition (e.g. temperature) upon receipt into the laboratory. 5. In an interview on 07 /28/26 at 12:10 pm, the technical supervisor confirmed the findings above. 6. The laboratory performs approximately 50,100 toxicology tests annually. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (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 record review and interviews with the technical supervisor and chief operating officer, the laboratory failed to provide written client service instructions for collecting and referring urine drug screen specimens for four of four clients. Findings included: 1. During a laboratory tour on 07/28/26 at 09:00 am, the technical supervisor confirmed the laboratory performed a 10-panel urine drug screen on the ImmTox benchtop chemistry analyzer. 2. In an interview on 07/28/26 at 11:30 am, the technical supervisor confirmed the laboratory received outside specimens from four clients. 3. Review of the laboratory's written procedures revealed no evidence of a written client service manual to explain the laboratory's specimen handling policies (e. g., collection, preservation, storage, and transport). 4. In an interview on 07/28/26 at 12:30 pm, the chief operating officer, confirmed the findings above. 5. The laboratory performs approximately 50,100 toxicology tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the laboratory's written procedure, record review, and interview with the technical supervisor, the laboratory failed to follow its own written procedure for laboratory test requisitions for four of five patients. Findings included: 1. During a laboratory tour on 07/28/26 at 09:00 am, the technical supervisor confirmed the laboratory performed a 10-panel urine drug screen on the ImmTox benchtop chemistry analyzer. 2. In an interview on 07/28/26 at 11:30 am, the technical supervisor confirmed the laboratory received outside test requisitions and specimens from four clients. 3. A review of the laboratory's written procedure, "Patient Test -- 2 of 3 -- Management", section "A. Lab Test Orders" stated "The lab requisition will contain the following information ... Time, date of collection ...". 4. A review of five laboratory test requisitions revealed the laboratory failed to follow its own written procedure for four of five laboratory test requisitions as follows: a. Requisition #68602695 - no evidence of specimen collection time for the specimen collected on 04 /16/26, received into the laboratory on 04/24/26, and reported on 04/24/26. b. Requisition #11727 - no evidence of specimen collection time for the specimen collected on 06/19/26, received into the laboratory on 06/23/26, and reported on 06/23 /26. c. Requisition #59102463 - no evidence of specimen collection date and time for the specimen received into the laboratory on 06/23/26 and reported on 06/23/26. d. Requisition #52694482 - no evidence of specimen collection time for the specimen collected on 07/13/26, received into the laboratory on 07/17/26, and reported on 07/28 /26. 5. In an interview on 07/28/26 at 12:05 pm, the technical supervisor confirmed the findings above. 6. The laboratory performs approximately 50,100 toxicology tests annually. -- 3 of 3 --