Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 record review and staff interview, the laboratory failed to follow their established policies and procedure for instrument relocation and sample comparison in the subspecialty of toxicology. Findings include: 1. Record review on 07/08/2025 of the laboratory's 'Instrument Relocation Sample Comparison' validation study for the 'ImmTox 270 Benchtop Analyzer' revealed the following samples with result comparison and acceptance criteria discrepancy: a. Pre instrument relocation: i. Sample ID: CAP 15 1. Results: benzodiazepine (positive), cocaine (negative), opiate (negative), oxycodone (negative) and tramadol (negative). b. Post instrument relocation: i. Sample ID: CAP 15 1. Results: benzodiazepine (positive), cocaine (negative), opiate (positive), oxycodone (negative) and tramadol (positive). c. 'Acceptance Criteria: a minimum of 95% of the lab comparisons for each analyte tested should have 100% concordance'. d. 'Results: the clinical comparison study exhibited 100% concordance across all samples and all analytes'. 2. Staff interview on 07/08/2025 at 10:30 AM with the laboratory's technical consultant (TC) confirmed the above findings. The TC further commented that he/she might suspect sample swapping that resulted in the above discrepancy listed in 1(a) and (b). 3. The laboratory performs approximately 2,600 drug screening tests annually in the subspecialty of toxicology. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to use in date chemical consumables for the 'ImmTox 270 Benchtop Analyzer' in the subspecialty of toxicology. Findings include: 1. Surveyor observation on 07/08 /2025 at 9:15 AM of the laboratory work bench area revealed 2 of 2 'Acid Washing Solution' bottles with a lot number of 230512 and a receive date of 08/28/2024 that are in use and had exceeded the expiration date of 11/2024. 2. Record review on 07/08 /2025 of the laboratory's 'Reagent Handling' standard operating procedure revealed 'Expired reagents are not to be used in patient testing and each lab section is required to regularly review inventories to locate and discard expired reagents'. 3. Staff interview on 07/08/2025 at 9:20 AM with the laboratory's technical consultant confirmed the above findings. 4. The laboratory performs approximately 2,600 drug screening tests annually in the subspecialty of toxicology. D5781