Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the current, approved policies and procedures, lack of personnel training records, as well as interview with the laboratory director (LD), the LD failed to perform and document clinical consultant (CC) competency assessment. Findings: 1. There was no documentation of CC competency evaluation. 2. Current, approved policies and procedures did not include written description of CC job duties, responsibilities, and written instructions for performing CC competency evaluation. 3. LD confirmed findings on February 15, 2024, at 1:00 P.M. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the current, approved standard operating procedures, fume hood Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- maintenance records, and interview with the Histotechnician (HT), and LD, the HT failed to perform the required weekly XVS fume hood maintenance. Findings: 1. The XVS fume hood maintenance log required weekly alarm performance test. 2. There was no documentation of weekly alarm test for 2023. 3. This is contrary to instructions indicated in the current, approved standard operating procedures. 4. TP and LD confirmed findings on February 15, 2024, at 1:00 P.M. D5781