Summary:
Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: I. Based on review of the "Cryostat Cleaning & Temperature Maintenance Log" and interview with the histo tech (HT) and the laboratory director (LD), the LD failed to document monthly review of the worksheet to ensure that the HT was maintaining the quality of the cryostat. Findings: 1. The "Cryostat Cleaning & Temperature Maintenance Log" worksheets from January 2024 through August 2024 were reviewed. The upper left hand corner of the worksheet has a section for documenting the monthly review of the worksheet. There were no initials and dates showing that the worksheet had been reviewed each month of testing. 2. During the exit interview on 09/18/2024 at 10:15 AM, the HT and LD confirmed that there was no documentation on the worksheet showing that the data had been reviewed as required. II. Based on review of the final patient reports and interview with the HT and LD, the LD failed to ensure that the case number was on the final report as required. Findings: 1. Three final reports from 2024 were reviewed for accuracy. One of the three failed to include the case number along with the information transcribed from the Moh's surgical map. 2. During the exit interview on 09/18/2024 at 10:15 AM, the HT and LD confirmed that the case number was missing from one of the three final reports that were reviewed. 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 --