Summary:
Summary Statement of Deficiencies D0000 . An onsite survey conducted found the laboratory in compliance with 42 CFR Part 493. Requirements for Laboratories. . 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: . Based on review of laboratory records, the Centers for Medicare and Medicaid Services (CMS) form 209, and confirmed in interview, the laboratory director failed to specify in writing, the responsibilities and duties for two of two testing personnel (TP), TP-3 and TP-4, performing moderate complexity testing. The findings include: 1. During review of laboratory records, the surveyor failed to find a written delegation of duties for testing personnel performing moderate complexity testing. 2. Review of the CMS-209 listed the following two personnel performing moderate complexity testing: TP-3 TP-4 3. In an interview on 1/12/2022 at 1445 hours, in the laboratory, the office manager confirmed that there was no written delegation of responsibilities and duties for the testing personnel performing moderate complexity 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 --