Alere Toxicology Services, Inc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Alere Toxicology Services, Inc on January 29-31, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on the review of policy and procedures (P&P), method comparison records, lack of documentation, and interviews, the lab failed to follow the established P&P for performing a method comparison of the methodologies used for specific gravity and pH analysis twice annually from 01/01/22 up to dates of survey on 01/29/24-1/31/24 (22 months). Findings include: 1. Review of the P&P revealed the following statements, "4.3 Instrument Comparison/Donor Comparison", "Donor Comparison is completed every 6 months for all NON-SAMHSA SVT assays with more than one validated instrument/method by the comparison of a minimum of 5 donor specimens or controls within the specified ranges." The P&P provided step-by-step instructions for performing method comparison for the specific gravity, pH, creatinine, and oxidants analytes. 2. Review of the method comparison records on the dates of the survey (01/29/24-1/31/24) revealed a lack of documentation of the method comparisons as defined in the P&P from January 2022 up to December 2023 as follows: Specific gravity- method comparisons performed in December 2023 between three Beckman Coulter AU 5400 (#21, 22 and 23), two Beckman Coulter AU 5800 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 -- (#24 and 26) analyzers and the two 3-place hand-held Atoago Palette, five 4-place hand-held Atoago Palette refractometers and one Reicherts refractometer. No further documentation of method comparisons was observed. pH- method comparisons performed in December 2023 between three Beckman Coulter AU 5400 (#21, 22 and 23), three Beckman Coulter AU 5800 (#24, 25 and 26) analyzers and the four Mettler Toledos and one Orian pH meters. No further documentation of method comparisons was observed. 3. In an interview with technical supervisor #1 on 01/30/24 at 10:20 AM, the inspector requested to review method comparisons for the above-specified analytes. They stated, "we were not performing the comparisons every six months. We opened a QI [Quality Indicator] in December 2023 and will perform the comparisons every six months going forward." 4. An exit interview with the technical supervisors #1, #2 and #3, the lab director and quality assurance director on 01/31/24 at 10:15 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Alere Toxicology Services on April 27 & 28, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 -42 C.F.R. 493-1250 Condition: Analytic Systems *Repeat Deficiencies*. D6108- 42 C.F. R. 493-1447 Condition: Laboratory Technical Supervisor *Repeat Deficiencies*. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of policies, maintenance/temperature records, lack of documentation, and interviews, the laboratory failed to: 1. follow their established water quality policy of monthly microbial content checks during seventeen of twenty- six (26) months reviewed (timeframe January 2020 to the date of the inspection April 27-28, 2022); 2. document the monitoring for acceptable storage temperature of negative urine specimens for 26 of 26 months reviewed; 3. follow established policies for required maintenance protocols for two (2) of 2 toxicology micro-plate enzyme immunoassay platforms, thirteen of seventeen liquid chromatography mass spectrometry toxicology instruments and five of eight gas chromatography mass spectrometry toxicology instrument platforms during the 26 month review timeframe. See D5401(*repeat deficiency), D5413 (*repeat deficiency), and D5429. 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 tour, review of policies and maintenance records, lack of documentation, and interviews, the laboratory failed to follow their established water quality policy of monthly microbial content checks during seventeen (17) of twenty-six (26) months reviewed (timeframe January 2020 to the date of the inspection April 27-28, 2022). **REPEAT DEFICIENCY Findings include: 1. During a tour of the laboratory on 4 /27/22 at approximately 2:00 PM, the inspectors noted a Siemens Vantage PTC Water System (Serial Number 0162125187, service installer Evoqua Water Technologies) in use to provide Type 1 deionized water for all laboratory applications. 2. Review of the laboratory's Standard Operating Procedure Manual revealed an "Ancillary Equipment" section policy (titled: Water Quality) that stated "water quality is monitored with microbial content checked monthly, and both 1 and 10 mOhm resistivity lights to be recorded on a daily basis. If the count is greater than 10 cfu/mL notify your supervisor immediately. If either daily reading is unacceptable, the Evoqua vendor will be notified immediately for remedial action.