Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review Accession Log (AL), Work Records (WR), Observation of slides and interview with the Testing Personnel (TP), the laboratory failed to maintain an accurate AL for Mohs testing from 1/3/18 to the date of the survey. The findings include: 1. The Mohs work record for slides 18-004 did not match the AL a) The AL stated there were three stages. The WR stated there were two stages. b) The WR stated there were four slides the laboratory had two slides. 2. The TP confirmed on 6 /20/19 at 1:30 pm that the laboratory failed to maintain an accurate AL. 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 --