Summary:
Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for sixteen testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize two of sixteen testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for sixteen testing personnel (TP), TP- 3 (as listed on the form CMS- 209) failed to have written authorization from the laboratory director, to perform high complexity testing without direct supervision. B) In an interview on 3/27/2025 at 1:04 pm, the testing personnel (TP-3 on form CMS 209) confirmed the lack of written authorization for two TP on form CMS 209. 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 --