Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 12/01/2022 and the facility was found not to be in substantial compliance with the laboratory requirements of 42 CFR Part 493, with a deficiency cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and review of the facility's procedures, it was determined that the facility failed to document the hematoxylin and eosin (H&E) stain quality for seven (7) of seven (7) micrographically oriented histographic surgery (Mohs) cases reviewed. The findings include: Review of the facility's procedure manual, dated 02/2022, revealed that the slide stain quality "will be addressed in each and every case". Interview with the Laboratory Director, on 12/01/2022 at 11:15 AM, revealed the stain quality was documented in the patient's record on every case. The following patient records were reviewed for Mohs testing, and the slide stain quality was not documented in the record: a. Patient #1, date of service 10/21/2022 b. Patient #2, date of service 07/15/2022 c. Patient #3, date of service 04/25/2022 d. Patient #4, date of service 03/03/2022 e. Patient #5, date of service 07/08/2021 f. Patient #6, date of service 09/17/2021 g. Patient #7, date of service 06/09/2022 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 --