Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Steven P. Smith, M.D. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 and record review, the laboratory failed to ensure laboratory reagents were not used when they had exceeded their expiration date as evidenced by the following: During a tour of the laboratory on 8/15/18 at 9:40 a.m. the surveyor observed the following expired item: Eosin stain solution lot number 1615806 expired 6/9/18. Review of patient record revealed that the stain had been used for MOHS skin slide exams on 7/24/18. The laboratory performs approximately 1,365 MOHS cases annually. 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 --