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 proficiency testing procedure and interview with technical consultant #1 (listed on the CMS-209), the laboratory failed to have written in their proficiency testing (PT) procedures a section stating not to refer their PT to another laboratory and notification of Centers for Medicare & Medicaid Services (CMS) of the receipt of any PT samples from another laboratory as evidenced by: 1. In review of the laboratory's procedure Standing Rock Health Centers Laboratory Proficiency Policy, the laboratory did not have in their procedure the following: a. Not to refer their PT to another laboratory b. To notify CMS of the receipt of any PT samples from another laboratory. 2. In interview with Technical consultant #1 at 1158, he stated that they did not have a CMS PT reporting paragraph or any type of PT referral section. 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 --