Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through observation, review of manfacturer's package insert and interview it was determined that the laboratory failed to amend the expiration date of three of three vials of Boule Con Diff hematology control material after opening and and placing the vials in use. Findings follow: A) Review of the Boule Con Diff hematology control material package insert revealed that the vials had "14 consecutive day open tube stability". B) During a tour of the laboratory on May 27, 2022 at 1:45 pm , three vials of Boule Con Diff hematology control vials lot numbers 2220131, 2220132, and 2220133 were observed in a plastic cup in the laboratory refrigerator with no date of opening or amended expiration date on the vials or the container the vials were in. C) When asked at the time, the testing personnel, identified as number three on the CMS 209 form stated that the vials were currently the hematology controls in use and the date of opening or amended expiration date was not on the vials or the container the vials were in. D5783