Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the Viva-E toxicology maintenance records, the Maintenance Requirements Viva-E policy and confirmed by interview with the Laboratory Director at 1:13 pm on 10/30/2025, the laboratory failed to perform and document daily maintenance for three out of four days of patient testing from 6/1/2025 - 6/30/2025. 1. The Maintenance Requirements Viva-E policy states, "Do the daily maintenance before you start to test samples or controls" 2. The Viva-E Daily Maintenance Checklist indicated the following needed to be performed each day of patient testing: *Fill water container with 10 liters of DI water and 25 mL of System Solution *Empty waste containers *Check rotor blank results for SD errors. Change cuvette rotor if necessary *Set onboard Reagent expiration dates to four weeks. Discard reagent bottle and their contents at the expiation date or when a new lot of reagent will be used. *Fill HCl bottle on the reagent rotor with 0.1 N HCl *Fill tube in W position on sample rotor with Needle rinse (Sodium Hypochlorite Solution) *Remove measurement disk cover and inspect wash arm, mixer belt and measurement rotor *Check that the reagent rotor compartment is being cooled. *Archive Results *Perform an instrument Fill System 3. The laboratory used the Viva-E toxicology analyzer to perform patient testing on 6/13/2025, 6/20/2023, and 6/27/2025. 4. At the time of the survey, the laboratory director confirmed the laboratory did not perform daily maintenance on the above dates of patient testing. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, the Quality Control Policy, and confirmed by interview with the Laboratory Director (LD) at 1:13 pm on 10/30/2025, the laboratory failed to perform a negative and positive control at least once each day of patient testing for one out of four days from 06/01/25 - 6/30/2025 for the analytes: amphetamines, barbiturate, benzodiazepine, cocaine metabolite, opiate, oxycodone and cannabinoids (THC). The findings include: 1. The laboratory used the Viva-E chemistry analyzer to perform: amphetamines, barbiturate, benzodiazepine, cocaine metabolite, opiate, oxycodone and THC testing. 2. The Quality Control policy stated, "Both positive and negative controls must be run each day of testing for each analyte assayed." 3. On 6/27/2025 the laboratory performed amphetamines, barbiturate, benzodiazepine, cocaine metabolite, opiate, oxycodone and THC testing on 23 patients.. 4. At the time of the survey, the LD confirmed that the laboratory did not perform negative and positive controls for amphetamines, barbiturate, benzodiazepine, cocaine metabolite, opiate, oxycodone and THC testing on 6/27 /2025. -- 2 of 2 --