Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial certification survey was conducted at Wall Dermatology LLC on 06/03/2025 - 06/06/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) 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; This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual and staff interview, the Laboratory Director failed to establish a comprehensive quality assessment program to encompass all aspects of laboratory services from 02/17/2025 to 06/06/2025. Findings include: 1. The lab policy titled "Quality Assurance Program", approved by the Laboratory Director 02/17/2025 was reviewed. It failed to include monitoring of pre-analytic, analytic, and post-analytic systems. 2. Electronic communication with the Laboratory Director on 06/06/2025 at 12:54 p.m. confirmed the above. 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 --