Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, preventive maintenance (PM) documentation, five (5) patient records for Dermatopathology, and interviews with the office manager (OM) and regional director (RD), it was determined that the laboratory failed to ensure performed tests and function checks were documented or maintained prior to patient testing. The findings include: 1. The laboratory currently worked with two external Mohs technician companies to assist in procedures and document PM activities. 2. The surveyor's examination of the policy /procedure and PM documentation indicated that all PM performed on the cryostat and the reagents used on each Mohs patient testing day should be recorded. However, this protocol was not adhered to regarding the PM of the reagent stain. 3. All five Dermatopathology patient records reviewed lacked documentation of the reagent stain PM for the years 2022, 2023, and 2024. In addition, Patient 24-028 was found to be missing a record entry for the cryostat temperature on January 22, 2024. Thus, quality and reliability of patient tests reported cannot be assured. 4. The OM and RD affirmed by interview on June 6, 2025, at approximately 10:50 a.m. that the reagent stain used were overlooked to be recorded by the HT. 5. According to the testing declaration form submitted at the time of the survey, the laboratory performed and reported 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 -- approximately 750 Dermatopathology cases, which included the period when the HT failed to document information on the reagent stain PM and cryostat temperature mentioned in this deficiency. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, randomly selected patient test records, preventive maintenance documentation, and interviews with the office manager and reginal director on June 6, 2025, the laboratory director is herein cited due to failure to ensure that several aspects of the analytic and postanalytic phases of the laboratory testing were monitored. The findings include: 1. Missing preventive maintenance documentation. See D5435. -- 2 of 2 --