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 observation, record review and interview with laboratory director, determined that the laboratory did not ensure that expired controls labeled as such, removed from premises or not used from March 15 2018 till April 30th 2018. The findings are: Observation of quality controls showed that quality controls lot 73390710, 73390711 and 73390712 expired on 3/14/2018 Review of quality controls records and patient records showed that the laboratory used the set of controls of reference for testing patient number 1367 on 3/15/2018 and patient reference number 1368 on 3/19/2018 During an interview with laboratory director on 4/30/2018 at 10:30 am, he confirmed that the laboratory used expired controls for the days of reference. 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 --