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 procedure manual presented for review during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director before use. Findings include: 1. The laboratory began patient testing in the sub-specialty of histopathology in December 2018, with an approximate annual test volume of 9,500. 2. The laboratory's procedure manual presented for review during the survey conducted on November 8, 2019 was approved, signed and dated by the laboratory director on November 1, 2019. 3. The facility personnel acknowledged that the procedure manual was not approved, signed and dated by the laboratory director until after patient testing began. 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 --