Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 03/28/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's temperature/humidity logs, policies/procedures and staff interview, the laboratory failed to define and monitor Mohs slides' storage conditions for one of two rooms with slide storage. Findings included: 1. Surveyor's observations on 03/28/2024 at 1355 hours in the facility revealed Mohs slides were stored in two separate rooms, the designated laboratory, and a separate office. 2. Review of laboratory's temperature/humidity logs revealed the laboratory did not have documentation of monitoring slide storage conditions in the office. 3. Review of laboratory's policies/procedures revealed the laboratory did not have a protocol in place defining the storage conditions (temperature/humidity) for Mohs slides. 4. In an interview on 03/28/2024 at 1355 hours in the laboratory, the facility's Regional Manager (as indicated on submitted Survey Entrance/Exit document) confirmed the findings. 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 --