Summary:
Summary Statement of Deficiencies D0000 Federal Jurisdictional Complaint Survey An onsite unannounced complaint survey was conducted on 7/24/2024, with a standard level deficiency cited. The allegations were unsubstantiated. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, interview with testing personnel # 3 (listed on CMS-209) and the Laboratory Director, the laboratory failed to establish a proficiency testing procedure as evidenced by: 1. In review of the laboratory's procedure manual, the laboratory did not have a procedure for proficiency testing. 2. In interview with testing personnel #3 and the Laboratory Director at 1251 both stated, the facility did not have a proficiency testing procedure for the facility. 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 --