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 record review and interview with the Histotechnician, the Laboratory Director failed to ensure quality assessment programs were established for post analytic systems for 11 (January 2021 to December 2021) of 11 months reviewed. Findings include: 1. A review of the laboratory's "Director- High Complexity- Job Description" revealed a section stating, "Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur." 2. The surveyor requested the laboratory's post analytic quality assessment on 12/29/21 at 11: 20 am and it was not made available. 3. An interview on 12/29/21 at 11:20 am with the Histotechnician confirmed the laboratory did not have a post analytic quality assessment. 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 --