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 maintenance records review, lack of documentation, and interview with staff, the laboratory failed to ensure reagents were not used beyond their expiration dates for 4 of 5 reagents used for staining Mohs histopathology specimens. The laboratory performs approximately 150 Mohs surgeries annually. Findings include: 1. The last record of histopathology reagents in use was listed on the laboratory maintenance chart covering maintenance done from 05/18/2017-08/02/2017. The chart listed Alcohol lot 0484409 expired on 08/2018, Hematoxylin lot 048354 opened on 04/2017 with an unreadable expiration date, Eosin lot 050476 expired on 06/2018, Clear rite lot 300243 expired 01/2018, and Mounting media lot 289360 expired 02 /2016. 2. The laboratory maintenance records reviewed lacked documentation of any reagents put in use since 08/02/2017. 3. Staff stated on 09/24/2018 at approximately 12:00 p.m. they replaced reagents multiple times since 08/02/2017 but failed to record reagent lot numbers and expiration dates. 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 --