Brain And Spine Medical Services Pllc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of SOPs (Standard Operating Procedures), personnel competency assessment records, as well as interview with the TS (Technical Supervisor), the laboratory failed to follow written policies and procedures to assess employee and consultant competency. FINDINGS: 1. There was no documentation of competency assessment performance for the Clinical Consultant (CC), TS, and General Supervisor (GS). 2. The current SOPs did not include instructions for performing CC, TS, and GS competency assessments. 3. There was no documentation of initial training and six- month competency assessment for the Testing Person (TP) #1 hired November 10, 2023. 4. This is contrary to instructions indicated in the current, approved SOPs. 5. It was noted that a TP #1 annual competency assessment was performed and documented on September 23, 2024. 6. The TS confirmed the findings October 21, 2025, at approximately 1:00 P.M. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's liquid chromatography mass spectrometry (LCMS) analysis records, lack of Agilent quality control (QC) and calibration records, as well as confirmed by interview with the testing person (TP), the laboratory failed to save the Agilent 1260/6460 LCMS system final results analysis from August 25, 2022, through September 26, 2023. FINDINGS: 1. The TP confirmed on September 27, 2023, at approximately 3:30 P.M. that final results analysis documentation was not saved after completion of analysis and integration. Surveyor was informed that final result analysis data regeneration from the archived files was not likely to be successful. 2. Due to lack of documented pending logs, it was not possible to determine the approximate number of patients affected. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's standard operating procedures (SOP); Agilent LC /MS/MS and Thermo Scientific Indiko Plus control and calibration records; direct Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- observation of reagent, control and calibration, and stock solution inventory; as well as interview with the TP, the laboratory failed to ensure that control results were within acceptable ranges; that expired reagents, control materials, and stock solutions were removed from inventory; errors were identified,