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: I. Based on observation and interview with the technical supervisor (TS), the laboratory failed to ensure the eyewash station solution was not expired. Findings: 1. The laboratory had an eyewash station affixed to the wall containing a bottle of solution to aid in flushing out the eyes of testing personnel should they be splashed with patient specimens, cleaning solutions, or testing reagents. 2. The expiration date listed on the bottle was 12/2022. 3. During the survey on 04/05/2023 at 12:45 PM, the TS confirmed that the eyewash solution was expired. II. Based on review of the procedure manual and personnel training records and interview with the technical supervisor (TS), the laboratory failed to ensure safety training for laboratory staff was documented as stated in the safety procedures. Findings: 1. The laboratory's "Fire Manual and Plan" (LAB.GEN.002) stated that all employees should be trained in fire safety and included a "Fire Safety Training Checklist" that recorded the name of the employee, the name of the trainer, the hire date, the training date, and a checklist of 11 fire safety knowledge items. 2. The laboratory's "Laboratory Bloodborne Pathogens Exposure Control Plan" (LAB.GEN.004) stated "The lab director shall ensure that training is provided at the time of initial assignment to tasks where occupational exposure to blood or other potentially infectious materials may occur. Training shall be repeated every 12 months, or when there are any changes or tasks or procedures affecting an employee's occupational exposure." The procedure included a "Employee Bloodborne Pathogens Training Checklist" that recorded the name of the employee, the name of the trainer, the hire date, the training date, and a checklist of 13 bloodborne pathogens knowledge items. 3. The completed "Fire Safety Training Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Checklist" and "Employee Bloodborne Pathogens Training Checklist" were missing from the training files of the testing person. 4. During the survey on 04/05/2023 at 12: 45 PM, the TS confirmed that the "Fire Safety Training Checklist" and "Employee Bloodborne Pathogens Training Checklist" were not completed for the testing person. 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)