Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as 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 result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: .Review of personnel records of six testing personnel performing moderately complex laboratory assays, lack of documentation and interviews with laboratory staff, determined the laboratory director failed to give written authorization for six of six testing personnel to perform moderately complex procedures without direct supervision. Survey findings follow: A) A review of personnel records of six testing peronnel, who have completed training for performing moderately complex procedures, revealed that six (#4, #5, #6, #7, #8, #9, as listed on the form CMS-209) failed to have the laboratory director's written authorization to perform moderately complex testing without supervision. B) Upon request, the laboratory was unable to provide documentation of the authorization to perform moderately complex testing for the personnel identified above. C) In an interview, at 10:40 a.m. on 4/11/24, laboratory employee (#2 as listed on the form CMS-209) confirmed the lack of written authorizations for the six personnel identified above and that they performed moderately complex testing.. 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 --