Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Observations and interview of facility personnel found that the laboratory failed to ensure that expired materials were used in patient testing. The findings included: 1. Observations made during the tour of the facility found the following expired materials available for use in the laboratory: Platinum Line I Optic Mount Xylene lot 2168 expiration 09/2017 Ferric Subsulfate lot 6147 expiration 2018/05/26 Jessner's solution-(Caprock Discount Drug) dated 02/12/15 - no date of expiration. 2. Interview of the histotechnician conducted on 06/18/2018 at 3:48 PM confirmed that the Platinum Line I Optic Mount Xylene and the Jessner's solution were currently being used by the laboratory. She went on to say that the Ferric Subsulfate was no longer used by the laboratory. 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 --