Summary:
Summary Statement of Deficiencies D0000 The initial survey was performed on 06/16/2026. Standard-level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policy, and interview with the clinical coordinator, the laboratory failed to follow their policy for ensuring laboratory temperature and relative humidity had been documented daily for 3 of fifty-three days reviewed from 02/02/2026 through 06/16/2026; and failed to ensure the maintenance policy was followed for performing maintenance procedures on the Roundfin Cryostat (RD- 2288) during the review period of February through June 2026. Findings include: I. ROOM TEMPERATURE (1) On 06/16/2026 at 10:20 am the clinical coordinator stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using the Roundfin (RD-2280) cryostat; (2) A review of the policy titled "Roundfin Cryostat (RD-2280) QC & Maintenance Policy" required the room temperature be checked daily when the lab was in use; (3) A review of the "Room Temperature Humidity Logs" from 02/02/2026 through the current date identified the temperatures had not been recorded for 3 of fifty-three days reviewed; (4) The records were reviewed with the clinical consultant who stated on 06 /16/2026 at 1:11 pm, the room temperature readings had not been documented as stated above. II. RELATIVE HUMIDITY (1) On 06/16/2026 at 10:20 am the clinical coordinator stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using the Roundfin (RD-2280) 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 -- cryostat; (2) A review of the policy titled "Roundfin Cryostat (RD-2280) QC & Maintenance Policy" required relative humidity be checked daily when the lab was in use; (3) A review of the "Room Temperature Humidity Logs" from 02/02/2026 through the current date identified relative humidity readings had not been recorded for 3 of fifty-three days reviewed; (4) The records were reviewed with the clinical consultant who stated on 06/16/2026 at 01:11 pm, the relative humidity readings had not been documented as stated above. III. CRYOSTAT MAINTENANCE (1) On 06 /16/2026 at 10:20 am the clinical coordinator stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using the Roundfin (RD-2280) cryostat; (2) A review of the policy titled "Roundfin Cryostat (RD2280) QC & Maintenance Policy" required the microtome/chamber be decontaminated every month using Cavicide/Caviwipe, absolute alcohol, or equivalent; (3) A review of maintenance logs from February through June 2026 identified the microtome/chamber monthly decontamination had not been documented as performed as follows: (a) Prior to 03/05/2026; (b) Between 03/17/2026 and 06/02 /2026. (4) The records were reviewed with the clinical coordinator who stated on 06 /12/2026 at 01:11 pm, the monthly decontamination procedure had not been documented as stated above. -- 2 of 2 --