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 surveyor observation of testing reagents, review of testing logs, and interview with the laboratory director, the laboratory used potassium hydroxide (KOH) reagent past the expiration date on the bottle. Findings include: 1. Observation of the KOH reagent available for testing in the laboratory on September 24, 2020 at 9: 30 AM showed the expiration date printed on the label was October 9, 2019 (2019-10- 09). The lot number on the label was not readable. 2. Review of the KOH testing log from 2020 showed the laboratory performed three patient KOH tests in February. 3. Interview with the laboratory director on September 24, 2020 at 9:30 AM confirmed testing personnel used the observed bottle of KOH reagent for patient testing past the expiration date of the reagent. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved