Summary:
Summary Statement of Deficiencies D0000 . On March 19, 2026, a desk review of the allegation of compliance submitted for the MI155220 complaint survey was performed. The Michigan Department of Licensing and Regulatory Affairs, Bureau of Survey and Certification has determined the laboratory to be in substantial compliance with federal CLIA requirements (42 CFR Part 493, Laboratory Requirements). D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the laboratory owner (LO) and the laboratory's contracted quality technical supervisor (QTS), the laboratory failed to ensure that high complexity toxicology testing was performed under the direction of a qualified laboratory director for two (December 2025 and January 2026) of two months since the laboratory director vacated the position. Findings include: 1. During a tour of the laboratory on 2/19/2026 at 11:45 am, the surveyor observed two analyzers in the laboratory: a. An Agilent 6420 Triple Quad LC/MS Analyzer used for confirmatory drug testing. The analyzer was powered on. b. An Indiko Plus DRI Analyzer used for Enzyme Immuno Assay (EIA) drug screen testing. The analyzer was powered off and cold to the touch. 2. An interview with the LO on 2/19/2026 at 12:00 pm revealed that the last working day of the laboratory director (LD) was 12/19 /2025. 3. An interview with the LO on 2/19/2026 at 12:15 pm revealed patient drug screens were being sent to a referral laboratory under a contract beginning on 12/13 /2025. 4. A request was made for patient requisitions for the referral laboratory for all patients since the departure of the LD. A review of the requisition documentation revealed that 31 patient samples collected from 12/11/2025 to 12/24/2025 were sent to 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 -- the referral laboratory for testing on 12/30/2025. 5. An interview was conducted on 2 /19/2026 at 12:29 pm with the QTS. The QTS stated the last day the laboratory performed testing was 12/20/2025 and 13 patient test results were reported on 1/15 /2026. 6. A request was made to the QTS on 2/19/2026 at 12:45 pm for documentation of any patient testing performed after 12/20/2025. 7. An interview with the QTS was conducted on 02/19/2026 at 12:50 pm. The QTS stated there were 422 total tests performed from 12/20/2025 to 1/28/2026: a. 268 EIA screens were performed. b. 154 confirmation tests were performed. -- 2 of 2 --