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 failed discontinue the use of expired potassium hydroxide (KOH) reagent in 2018 and 2019. Findings include: 1) Observation on 6/26/2019 at 10:40 a.m. of the microscopy work station revealed 1 bottle of KOH reagent. Review of the bottle revealed the KOH reagent expired on 11 /27/2018. 2) Review of patient records from 11/28/2018 through 6/26/2019 revealed 53 KOH results had been performed. 3) Interview on 6/26/2019 at 10:40 a.m. with Staff A confirmed the bottle of KOH reagent expired on 11/27/2018 and had been used for the 53 patient KOH tests after the expiration date. 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 --