Summary:
Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) records and interview with the Consultant, the laboratory failed to document positive and negative reactivity of Immunochemical Stains and the reaction of the Special and Hematoxylin Eosin stains used in Histopathology for the calendar year 2017. The consultant stated on 5/22/18 at 10:00 am that the laboratory could not locate QC records. 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 surveyor review of the Accession Log (AL) and interview with the with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Consultant, the laboratory failed to maintain an AL for all patients slides read in the calendar year 2017. The consultant stated on 5/22/18 at 10:20 am that the laboratory could not locate AL for 2017. -- 2 of 2 --