Summary:
Summary Statement of Deficiencies D0000 The findings were reviewed with Mohs technician #1 at the conclusion of the survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with Mohs technician #1, the laboratory failed to perform a maintenance procedure as required by the manufacturer. Findings include: (1) At the beginning of the survey, Mohs technician #1 stated to the surveyor Mohs surgical specimens and skin biopsy specimens were processed using two Avantik QS 11 Cryostats (designated as #1 and #2); (2) The surveyor reviewed the manufacturer's maintenance instructions for the Avantik QS11 Cryostats which required the following procedure: (a) Shutting-off for cleaning (i) "Cleaning, care and decontamination of the cryostat depends on how frequently the instrument is used. However, it is recommended to shut the instrument off every 6 - 8 weeks." (3) Maintenance records were then reviewed by the surveyor for 24 months (01/01/16 through 12/31/17). There was no documentation the laboratory had performed the shut down procedure as required during 24 of the 24 months reviewed; (4) The surveyor reviewed the findings with Mohs technician #1 who agreed the maintenance procedure listed above, had not been performed as required. 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 --