Premier Brain And Spine Llc

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of Patient Test Report (PTR), Procedure Manual (PM), and interview with the General Supervisor (GS), the laboratory failed to have accurate Reference Intervals (RI) for Urine Quantitative Toxicology tests from 2/1/25 to 8/19 /25. The findings include: 1. The analyte Norbuprenorphine had a cutoff value of 10 in the PM. 2. Surveyor review of PTR revealed Norbuprenorphine had a cutoff value of 20 on five out of five PTR. 3. The GS confirmed on 8/19/25 at 10:20 am, the laboratory did not have accurate RI. 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 --

Summary Statement of Deficiencies D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the Laboratory Director failed to ensure that PS were adequate to perform Urine Toxicology tests on the Applied Biosystem Sciex Triple Quad 4500 system from 9/1/21 to the date of survey. The finding include: 1. Sample stability studies were not performed. 2. The TS confirmed on 9/21 /21 at 2:20 pm that the LD did not ensure the PS were adequate. 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 --

Summary Statement of Deficiencies D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on surveyor review of Toxicology Records, Final Reports and interview with the Testing Personnel (TP) and Technical Supervisor (TS), the laboratory referred Urine Toxicology confirmation testing to a non-CLIA-certified laboratory from March 2019 to the date of survey. The findings include. 1. The TP #2 listed on CMS form 209 reviewed, verified and resulted toxicology results from a non-CLIA- certified laboratory. 2. The TP #2 listed on the CMS form 209 stated "TP read Toxicology results from home". 3. The TS confirmed on 8/13/19 at 2 pm that toxicology tests were reviewed and resulted from a non-CLIA-certified laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)