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: Based on interview of the Histo Technician and review of the laboratory records, the Laboratory Director failed to maintain the laboratory's Quality Assessment program, for 2 of 2 years, from 09/20/2017 through 03/15/2019. Findings include: 1. The laboratory Quality Assessment policy in use at the time of the survey (09:45 03/15 /2019), requires the Quality Assessment to be reviewed at the end of each month by the Laboratory Director and staff. 2. The laboratory failed to provide documentation of the daily Quality Assessment per the laboratory Quality Assessment policy in use at the time of the survey, (09:45 03/15/2019). 3. During the survey at approximately (11:30 03/15/2019), the histotechnologist confirmed the above 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 --