Summary:
Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of new employee training records and interview with the histotechnologist, staff A, the technical supervisor did not document initial training for one of one new testing personnel. Finding include: 1. Review of new employee training records showed no documentation of initial training for staff A. 2. Interview with staff A on July 24, 2024, at 1:30 PM confirmed the technical supervisor did not document initial training for testing personnel. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of competency assessment records and interview with the histotechnologist, staff A, the technical supervisor did not document semiannual competency for one of one new testing personnel. Finding include: 1. Review of 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 -- competency assessment records showed no documentation of semiannual competency for staff A. 2. Interview with staff A on July 24, 2024, at 3:15 PM confirmed the technical supervisor did not document semiannual competency for testing personnel. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and patient logs and interview with the histotechnologist, staff A, testing personnel did not document cryostat temperatures and maintenance for seventeen of seventeen patient testing days between March 24, 2023, and June 25, 2023. Findings include: 1. Review of the cryostat temperature and maintenance log showed no documentation of temperatures or maintenance from March 24, 2023, through June 25, 2023. 2. Review of patient logs from March 24, 2023, and June 25, 2023, showed seventeen days of patient testing on one-hundred ten patients. 3. Interview with staff A on July 24, 2024, at 2:55 PM confirmed testing personnel did not document cryostat temperatures and maintenance on each day of patient testing. -- 2 of 2 --