Summary:
Summary Statement of Deficiencies 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 observation of retained slides in the laboratory and interview with the regional manager, staff A, the laboratory did not maintain slides in a manner that ensured their preservation; staff could not separate multiple stored slides in one of four cases performed in 2023 and 2024. Finding include: 1. Observation of retained slides on February 6, 2024, at 1:30 PM from four cases reviewed from 2023 and 2024 showed slides for two stages on patient 1 were stuck together and could not be separated to review individually. 2. Interview with staff A on February 6, 2024, at 1: 30 PM, confirmed the laboratory did not store the slides in a manner that ensure proper preservation to allow review of individual slides. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Mohs surgery log and patient records, observation of slides and interview with the regional manager, staff A, the laboratory did not correct problems identified when the patient's name was spelled incorrectly for one of four 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 -- cases reviewed. Findings include: 1. Review of the Mohs surgery log showed the last name of patient 2 was spelled with 'ei' in the middle. 2. Review of patient reports in the electronic health records (EHR) showed no patient with a name that matched patient 2 from the Mohs surgery log. Further review found patient 2 using their birthdate and the last name was spelled with 'ie' in the middle. 3. Observation of slides on February 6, 2024, at 1:35 PM showed the last name of patient 2 was spelled with 'ei' in the middle. 4. Interview with staff A on February 6, 2024, at 1:35 PM confirmed the laboratory did not correct problems identified with the mohs log and slide labeling. -- 2 of 2 --