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Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a lack of laboratory temperature logs, a review of the Sciex 4500 user manual and an interview with the technical supervisor on 11/20/2025, the laboratory failed to establish and monitor the testing temperature and humidity for the Sciex 4500. The findings include: 1. A lack of room temperature and humidity logs for the Sciex 4500 identified the laboratory failed to establish and monitor testing temperature and humidity per manufacturer requirements. 2. A review of the Sciex 4500 user manual identified an operating temperature of 5-40 C and an operating humidity of 20-80%. 3. An interview with the technical supervisor on 11/20/2025 at 3: 18 pm confirmed that the laboratory failed to monitor temperatures and humidity for the Sciex 4500. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on a review of Beckman Coulter AU480 maintenance logs and an interview with the technical supervisor on 11/20/2025, the laboratory failed to perform maintenance as required by the manufacturer. The findings include: 1. A review of the Beckman Coulter AU480 maintenance logs identified that the laboratory failed to document daily maintenance performance which included: inspecting the syringes for leaks; inspection the wash solution roller pump for leaks; inspect, clean and prime the sample probe, reagent probe and mix bars; inspect and replenish the wash solution from September 13, 2023 to November 3, 2025. 2. A review of the Beckman Coulter AU480 maintenance logs identified that the laboratory failed to document weekly maintenance performance which included: cleaning the sample probe and the mix bars; perform a W2; perform a photocal; clean the pre-dilution bottle from September 13, 2023 to September 1, 2025. 3. A review of the Beckman Coulter AU480 maintenance logs identified that the laboratory failed to document monthly maintenance performance which included: cleaning the sample probe and reagent probe wash wells; cleaning the mix bar wash wells; cleaning the wash nozzle unit and checking the tube mounting joints and cleaning the DI water tank, DI filter, and sample probe filter from September 2023 to January 2025. 4. An interview with the technical supervisor on 11/20/2025 at 2:43 pm confirmed that maintenance performance had not been documented. . -- 2 of 2 --

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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, CMS 116 application form, training and competency assessment records and an interview with the laboratory director on 9/13/2023, the laboratory failed to follow written policies and procedures to assess testing personnel training and competency in 2022 and 2023. The findings include: 1. A review of the CMS 209 identified two (2) testing personnel performing moderate and high complexity toxicology testing. 2. A review of the CMS 116 identified a new testing system (Beckman Coulter AU480) for performing moderate complexity toxicology testing. 3. A review of training and competency assessment records identified two (2) of two (2) testing personnel failed to have initial training for the for Beckman Coulter AU480 documented. 4. A review of competency assessment records identified one (1) of two (2) testing personnel failed to have a six month competency for the Beckman Coulter AU480 documented in 2022. 5. A review of competency assessment records identified one (1) of two (2) testing personnel failed to have an annual competency for the Beckman Coulter AU480 documented in 2023. 6. An interview with the laboratory director on 9/13/2023 at 1:30 pm confirmed the above findings. 7. The laboratory reports performing toxicology testing on 29,000 urine specimens annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- 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 a review of laboratory procedures, a lack of documentation and an interview with the technical supervisor (TS) on 9/13/2023, the laboratory failed to follow its procedure for centrifuge maintenance for 2022 and 2023. The findings include: 1. The laboratory procedure; "Laboratory Standard Operating Procedure, RTB SOP #3 Eppendorf 5430 Centrifuge" states to clean the centrifuge weekly and to calibrate every six months. 2. A lack of documentation for the Eppendorf 5430 Centrifuge identified that the laboratory failed to perform and document weekly cleaning and semiannual calibration. 3. An interview with the TS on 9/13/2023 at 3:50 pm confirmed that the laboratory failed to perform and document weekly cleaning and semiannual calibration of the centrifuge. 4. The laboratory reports performing toxicology testing on 29,000 urine specimens annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of laboratory maintenance logs and an interview with the technical supervisor (TS) on 9/13/2023, the laboratory failed to perform maintenance on the Beckman Coulter AU480 as defined by the manufacturer, with at least the minimum specified frequency. The findings include: 1. A record review of the Beckman Coulter AU480 maintenance logs identified that the laboratory failed to perform monthly maintenance as required by the manufacturer for 10 of 12 months in 2022 and 8 of 8 months in 2023. A review of the maintenance logs on the analyzer confirmed these findings. 2. An interview with the TS on 9/13/2023 at 3:32 pm confirmed the above findings. 3. The laboratory reports performing toxicology testing on 29,000 urine specimens annually. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the College of American Pathologists (CAP), the laboratory test menu and an interview with the technical supervisor (TS) on 12/9/2021, the laboratory failed to verify the accuracy for all confirmatory toxicology analytes listed on the test menu. The findings include: 1. A review of proficiency testing records from CAP and the laboratory test menu identified that the laboratory failed at least twice annually verify the accuracy for the analytes: Carfentanil, Mitragynine, Aminoclonazepam, Aminoflunitrazepam, Clonazepam, Diazepam, Flunitrazepam, Flurazepam, Hydroxyethylflurazepam, Norhydrocodone, Noroxycodone, Meperidine, Normeperidine, Sufentanil, Tramadol, Imipramine, Ketamine, Naloxone, Norketamine and Zolpidem for 2020 and 2021. 2. An interview with the TS on 12/9/2021 at 10:05 am confirmed that the laboratory failed to verify the accuracy for all confirmatory toxicology analytes for 2020 and 2021. 3. The laboratory reports performing 30,000 toxicology tests annually. 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 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 a record review and an interview with the laboratory technical supervisor, the laboratory failed to establish and assess the competency of one out of one testing person, the general supervisor, and the technical supervisor in toxicology since the last survey on December 20, 2017. Findings: 1. A review of competency documents for one out of one testing person revealed the laboratory technical supervisor failed to assess the competency for drug confirmation testing on the Sciex 4500 Mass Spectrophotometer since the last survey. 2. A review of competency documents and the procedure manual revealed the laboratory failed to establish a written procedure or policy to assess the competency for the position responsibilities of the technical supervisor and the general supervisor since the last survey. 3. An interview on September 4, 2019 at 11:35 AM, with the laboratory technical supervisor, confirmed the laboratory failed to establish and follow written policies and procedures to assess the competency of testing personnel. 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 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 -- 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)