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 upon review of personnel files for testing personnel listed on the form CMS- 209, lack of documentation, and interviews with laboratory staff, the laboratory director failed to authorize two of two testing personnel reviewed to perform testing without direct supervision. Survey findings include: A) Review of personnel files for two testing personnel listed on form CMS-209 revealed written authorization from the laboratory director to perform moderately complex testing without direct supervision was not present for testing personnel (#'s 4 and 5 on the form CMS 209). B) Upon request, the laboratory could not provide written authorization to perform moderately complex testing signed by the laboratory director for the personnel identified above. C) In an interview, at 10:05 a.m. on 6/23/26 laboratory staff member #3 (as listed on the form CMS 209) confirmed the lack of written authorizations to perform tests for employees identified 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 --