Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an interview with the previous Director and a review of the Federal Aspen Database and Physician Office Laboratory Evaluation Program (POLEP) records, the laboratory failed to notify POLEP of a change of Directorship required with 30 days of the previous Director's resignation as Director. Findings: 1. Under CLIA Regulation 493.51 Laboratories issued a Certficate of Compliance must notify POLEP within 30 day of a change of Director or Technical Supervisor. 2. During a phone discussion with POLEP on Directorships on October 25 at approximately 1:00 PM, the former Director indicated that she had resigned as Director as of September 9, 2018. 3. As of November 30, 2018, we have not received any documentation from the laboratory indicating a change in Directorship. 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 --