Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant, the laboratory did not retain quality control assay sheets or instructions for use of the Drugs of Abuse Total (DOAT) control materials, manufacturer's instructions for the eight toxicology assays performed in the laboratory, or lot number and expiration date records of reagents used in the laboratory. Findings include: 1. Review of laboratory records showed no evidence of DOAT quality control assay value sheets or instructions for use, manufacturer instructions for toxicology assays, or records documenting the reagent lot numbers used in the laboratory and their expiration dates. 2. Interview with the technical consultant on January 25, 2021 at 11: 45 AM confirmed the laboratory had not retained control instructions or assay sheets, toxicology reagent instructions, or reagent records. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory procedures, records, and reports, observation 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 -- of the facility, and interview with the facility and laboratory staff, the laboratory had not met the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. Written instructions for specimen collection and handling were not available for referring clients. See D5317. 2. Individual procedures or instructions were not available for the toxicology assays performed in the laboratory. See D5401. 3. Storage temperatures were not documented. See D5413. 4. Expired reagents were available for use. See D5417. 5. Required maintenance was not documented. See D5429. 6. Calibration records were not available. See D5437. 7.