Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2018 Mohs surgery logs, lack of cryostat temperature records, and confirmed by nursing staff at approximately 2:00 pm on 06/11/2019, the laboratory failed to retain daily cryostat temperature records for at least two years for 2018. The findings include: 1. Each day of patient testing, the laboratory records the cryostat temperature on the corresponding date of a calendar kept in the same room as the cryostat. 2. During the survey, the 2018 calendar with cryostat temperature records could not be located. 3. At the time of the survey, additional cryostat temperature records were not available. 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 --