Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manuals and interview with the Technical Consultant (TC-1), the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS-209, Laboratory Personnel Form presented for review during the survey has been serving as laboratory director since 4/23/2025. 2. The policy and procedure manual presented for review during the survey conducted on 6/11/25 was not approved, signed and dated by the current laboratory director. 3. The TC-1 interviewed on 6/11/25 at 12:30 PM confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 4. The laboratory performs patient testing under the specialties of Chemistry and Hematology with an annual test volume of 2,400. 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 --