Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2, the laboratory failed to follow policies and procedures for performing and documenting daily preventative maintenance for the two Avantik QS-12 (Serial Number: 519010200 and 518122741) cryostats used for frozen sections during Mohs micrographic surgery for two of five dates reviewed. Findings include: 1. Review of laboratory policies and procedures revealed the policy, "Cryostat Sectioning", which stated, under "Quality Assurance ", "Maintain Daily temperature logs and maintenance logs." 2. Review of laboratory records revealed no documentation of daily temperature/humidity monitoring and daily preventative maintenance on the two Avantik QS-12 (Serial Number: 519010200 and 51812274) cryostats on two of five days reviewed. Date of missed documentation 06-03-25 12-22-25 3. Interview with TP #2 on 01/21/2026, at 12:23 pm, confirmed the laboratory failed to follow policies and procedures regarding daily temperature/humidity monitoring and preventative maintenance for the two Avantik QS-12 (Serial Number: 519010200 and 518122741) cryostats for two of five dates reviewed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --