Levy Dermatology, Pc

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory procedure manual, a review of the laboratory's alternative proficiency testing records, lack of documentation, a review of the Centers for Medicaid and Medicare Services Laboratory Personnel Report (CLIA) (FORM CMS-209), and a staff interview, the laboratory policy failed to specify

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 of the laboratory, review of patient number test report, and interview with the histotech, the laboratory failed ensure reagents were not used past their expiratin date in 2019. The findings include: 1) Observation of the laboratory on August 21, 2019 at 8:45 am revealed red and blue dyes in use for marking patient tissue for histopathology procedures. The expiration date for the red dye was 09/18; the expiration date for the blue dye was 06/19. 2) Review of patient number six MOHS micrographic surgery report dated August 12, 2019 revealed tissue marking performed using both red and blue dyes. 3) Interview with the histotech on August 21, 2019 at 11:45 am confirmed the laboratory used the expired dyes used for marking patient tissue for histopathology procedures in 2019. 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 --