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 test procedure for Flow Cytometry testing and interview with the facility personnel, the laboratory failed to have the current laboratory director approve, sign and date the test procedure 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 listed as laboratory director on CLIA# 03D2240067 since 01/31/2023. 2. The test procedure, "CD4-CD8 Ratio for BAL Flow Panel" presented for review during the survey conducted on 8/28/2024 was not approved, signed and dated by the current laboratory director. 3. The facility personnel interviewed on August 28, 2024 at 11:10 AM confirmed the test procedure indicated above was not approved, signed and dated by the current laboratory director before use. 4. The laboratory began patient testing in the subspecialty of General Immunology on 2/15/2023, with an annual test volume of 16. 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 --