Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/07/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the histology supervisor 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 the histology supervisor, the laboratory failed to perform the manufacturers required maintenance procedures on the cryostat for 1 of 2 days of patient testing. Findings include: (1) On 01/07/2021 at 09:45 am, the histology supervisor stated to the surveyor the laboratory prepared frozen sections using the Leica CM 1860 UV Cryostat. The sections were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by a pathologist; (2) The surveyor reviewed the operators manual for the cryostat. Section 9.3 titled "Maintenance" on page 64, required daily cleaning and weekly oiling of the plastic coupling (the manufacturer provided an exception to the weekly oiling requirement with low volume labs, in an emailed document dated 10/04 /2016, which allowed laboratories with low volume use to oil the micrometer and coupling before use); (3) The surveyor reviewed records of patient testing and identified 2 patients had been tested during the review period of January 2019 through December 2020. The dates of service were 05/20/2019 and 03/18/2020; (4) The surveyor reviewed maintenance records for 2019 and 2020, which showed the cleaning and oiling had not been documented as performed on 05/20/2019; (5) The 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 -- surveyor reviewed the records with the histology supervisor, who stated on 01/07 /2021 at 10:30 am, the maintenance procedures had not been performed as stated above. -- 2 of 2 --