Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(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 test procedure for the Chem8+ test performed on the I-Stat analyzer and interview with the facility personnel, the laboratory failed to have the current laboratory director approve and sign the test procedure before use. Findings include: 1. The laboratory began patient testing using the Chem8+ test cartridge on the I-Stat analyzer in June 2020. 2. The Chem8+ policy and test procedure presented for review during the survey conducted on January 12, 2022 was not approved, signed and dated by the current laboratory director before use. The policy was signed by the laboratory director on 1/12/2021. 3. The facility personnel confirmed that the test procedure indicated above was not approved, signed and dated by the current laboratory director before use. 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 --