Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on procedure manual and record review and interview with the office manager (OM), the laboratory failed to ensure that the laboratory's eyewash station was maintained in order to ensure protection from physical, chemical, and biochemical hazards, and biohazardous materials. Findings: 1. The procedure, "Eyewash Inspection" states, "Eyewash bottle will be inspected monthly to ensure seal has not been broken and the eyewash bottle is not expired." 2. A review of "Eyewash Inspection Logs" from September 2023 through June 2024 showed that eyewash bottle checks were not performed four out of ten months. 3. During an interview on 09 /25/2024 at 3:45 PM, the OM confirmed that monthly eyewash bottle checks were not performed. 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 laboratory record review and interview with the office manager (OM), the laboratory failed to retain all analytic systems records for at least 2 years. Findings: 1. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- "Laboratory Temperatures & Humidity Logs" were reviewed from September 2023 through June 2024. The log includes space to document room and refrigerator temperatures, humidity, and the "Reaction Temp" and "Wash Temp" of the chemistry analyzer. 2. Temperature log record review showed that the "Laboratory Temperatures & Humidity Log" for April 2024 was missing. 3. During an interview on 09/25/2024 at 3:45 PM, the OM confirmed that the laboratory did not maintain all analytic systems records for at least 2 years. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on record review and interview with the office manager (OM), the laboratory failed to maintain a copy of the Clinical Laboratory Improvement Amendments (CLIA) license for each reference laboratory used in order to vet the laboratory's certification in CLIA. Findings: 1. The laboratory performs qualitative toxicology screening on urine specimens. During an interview on 09/25/2024 at 10:00 AM, the OM stated that the laboratory sends out specimens which require confirmatory testing to two outside laboratories. 2. Record review showed that the laboratory did not have a copy of the CLIA license for either of the two referral laboratories, showing that the laboratories were CLIA-certified or met equivalent requirements as determined by the Centers for Medicare and Medicaid Services. This was confirmed by the OM during an interview at 3:45 PM. 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: I. Based on procedure manual review and interview with the office manager (OM), the laboratory failed to ensure that all of the procedures in the written procedure manual were complete and included all of the information required. Findings: 1. Procedure manual review showed that three of the procedures were incomplete. The procedure, "Fire and Electrical Precautions" included a page which stated, "This page is intentionally blank. Insert emergency exit floor plan" but did not include the emergency exit floor plan; 2. The procedure, "Contingency Plan" included a page which stated, "This page is intentionally blank to insert a copy of the specimen storage /handling requirements for the Reference Lab" but did not include the specimen storage/handling requirements; and 3. The procedure, "Reference Laboratory" included a page which stated, "This page is intentionally blank to insert a copy of the CLIA certificate for the Reference Lab" but did not include a copy of the CLIA licenses for the laboratory's two reference laboratories. Cross-refer to D5315. 4. During an interview on 09/25/2024 at 3:45 PM, the OM confirmed that the laboratory's written procedure manual was not complete. II. Based on procedure -- 2 of 7 -- manual review and interview with the office manager (OM), the laboratory failed to follow procedures for saving data from the Laboratory Information System (LIS) to an external data storage device. Findings: 1. The procedure, "LIS Back Up Protocol" states that "All the data in the laboratory information system will be saved to an external data storage device on a weekly basis." 2. During an interview on 09/25/2024 at 4:15 PM, the OM stated that the laboratory was not backing up the data from the LIS onto an external storage device, to ensure that patient information was maintained. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)