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 surveyor review of the laboratory procedure manual and interviews with a technical consultant and the Risk and Quality Registered Nurse, the laboratory could not show the current laboratory director had approved, signed, and dated the current laboratory procedure manual. Findings include: 1. Review of the electronic procedure manual showed no evidence the director had approved, signed, and dated the procedures for Rh testing or vaginal wet mount exams. 2. Interview on May 19, 2021 with the technical consultant for immunohematology (Staff A) at 11:10 AM and the Risk and Quality Registered Nurse (Staff B) at 10:30 AM confirmed the manual did not show the director had approved, signed, and dated the testing procedures. 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 --