Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with the Laboratory Director (LD) , the Testing Personnel (TP) failed to sign 2 of 14 CAP PT attestation statements for Chemistry testing performed from 06/10/2024 to 06/10/2026. Findings include: 1. The CAP PT attestation forms stated, "The laboratory director or designee and the testing personnel must sign this form." 2. On the day of the survey, 06/10/2026 at 10:45 am, the laboratory failed to provide attestation statements signed by the TP for the following 2 of 14 CAP PT events performed from 06/10/2024 to 06/10/2026: - Drug Monitoring Pain Managment: (DMPM-B 2024) - Urine Toxicology: (UT-C 2024) 3. The LD confirmed the findings above on 06/10/2026 at 12:45 pm. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Laboratory Director (LD), 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 3 -- laboratory failed to retain analytic systems records for 21 of 24 months as required from 06/10/2024 to 06/10/2026. Findings include: 1. On the day of survey, 06/10 /2026 at 11:45 am, the laboratory failed to provide documentation of the following analytic system records for 21 of 24 months as required from 06/10/2024 to 06/10 /2026: -Refrigerator, freezer, room temperature and room humidity logs - Maintenance logs for ABSciex Triple Quad 4500 and Indiko instruments - Quality Control logs 2. The laboratory performed 476,659 Chemistry tests in 2025 (CMS 116 estimated annual volume, dated 06/10/2026 ). 3. The LD confirmed the above findings on 06/10/2026 at 12:45 pm. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) policy, College of American Pathologist (CAP) PT records and interview with the Lab Director (LD), the laboratory failed to verify the accuracy of the PT results obtained for 4 of 4 CAP Toxicology PT testing events performed that were not scored by the PT agency from 06/10/2024 to 06/10/2026. Findings Include: 1. The laboratory's Proficiency Testing Procedure stated, "All results that are not graded or given 100% due to non-consensus or lack of peer group will be evaluated." 2. The CAP's actions laboratories should take when a PT result is not graded document stated, "the laboratory is required to review participant summary for comparative results and document performance accordingly. Evaluation criteria is not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self- evaluation." 3. On the day of survey, 06/10/2026 at 10:25 am review of the laboratory's CAP PT records revealed the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency for 4 of 4 CAP Toxicology PT testing events performed from June 2024 to June 2026: - 2nd event 2024 DAI B - DAI 04, DAI 05, and DAI 06 (Creatinine qual, pH qual, Specific Gravity qual) - 1st event 2025 DAI A - DAI 01, DAI 02, and DAI 03 (Creatinine qual, pH qual, Specific Gravity qual) - 2nd event 2025 DAI B - DAI 04, DAI 05, and DAI 06 (Creatinine qual, pH qual, Specific Gravity qual) - 1st event 2026 DAI A - DAI 01, DAI 02, and DAI 03 (Creatinine qual, pH qual, Specific Gravity qual) 4. The LD confirmed the findings above on 06/10/2026 at 12:45 pm. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor room and refrigerator temperatures to ensure proper storage of reagents on weekends and holidays for 252 of 730 days from 06/10/2024 to 06/10/2026. Findings include: 1. On the day of survey, 06/10/2026 at 11:20 am, review of the laboratory's temperature records revealed the laboratory failed to monitor and document room and refrigerator temperatures to ensure proper storage of the following reagents was maintained for 252 of 730 days from 06/10/2024 to 06/10 /2026: - ThermoFisher DRI Multi-Drug calibrators (manufacturer's recommended storage, 2 to 8 degrees Celsius) - ThermoFisher Amphetamine reagent (manufacturer's recommended storage, 2 to 8 degrees Celsius) - ThermoFisher Buprenorphine calibrators (manufacturer's recommended storage, 2 to 8 degrees Celsius) - ThermoFisher Benzodiazapine reagent (manufacturer's recommended storage, 2 to 8 degrees Celsius) - ThermoFisher Specific Gravity calibrators (manufacturer's recommended storage, 20 to 25 degrees Celsius) - ThermoFisher Creatinine reagent (manufacturer's recommended storage, 20 to 25 degrees Celsius) - ThermoFisher Specific Gravity reagent (manufacturer's recommended storage, 20 to 25 degrees Celsius) 2. The laboratory performed 476,659 Chemistry tests in 2025 (CMS 116 estimated annual volume, dated 06/10/2026 ). 3. The LD confirmed the findings above on 06/10/2026 at 12:45 pm. -- 3 of 3 --