Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to label in-use Complete Blood Count (CBC) controls with open and expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on January 21, 2026 at 10:04 am revealed the following Coulter 6 Cell controls loaded in an instrument rack in the Isotemp refrigerator located in the room with the i-Stat analyzers were not labeled with open and expiration dates: Level 1 lot 123176280, Level 2 lot 133186280 and Level 3 lot 143196280. The master box of controls had a handwritten received date of January 6, 2026. 2. Review of the manufacturer's package insert for the Coulter 6 Cell controls revealed the controls open vial stability as sixteen days not to exceed eighteen events. 3. In interview on January 21, 2026 at 10:04 am, the Technical Consultant confirmed the identified controls were not labeled with open and expiration dates. 4. Review of the laboratory's test menu revealed the laboratory performs 127,750 CBC tests annually. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: An on-site follow-up of the Validation survey was performed at Baton Rouge Specialty Hospital, CLIA ID 19D1018867, on January 20, 2026 through January 21, 2026. Based on review of the laboratory's