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: Based on record review and staff interview, the laboratory used expired Eosin-Y reagent (used for staining patient tissue pathology slides) for 5 of 6 months reviewed in 2018. Findings included: Record review of the "H & E Permanent Stain Line" log for 2018 showed the reagent name "Eosin-Y" with lot number 162104 had an expiration date of 8/3/2018. MOHs testing of 17 patients was performed on 8/21/18, 9 /18/18, and 10/16/18. MOHs testing was performed on 18 patients on 11/20/18 and 12 /18/18. The documentation showed the expired Eosin-Y was used on all five dates. An interview was done on 5/23/19 at 8:30am with the Histotechnologist. They confirmed the Eosin-Y was expired when used to stain patient slides. 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 --