Arkansas Dermatology

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Through a review of Laboratory test reports and interview with staff it was determined the laboratory test reports failed to include the name of the laboratory where the test was performed. Survey findings include: A. A review of laboratory test reports (seven of seven) revealed the laboratory results reports reviewed failed to include the name of the laboratory where testing was performed. B. In an interview at 9:12am on 6/25/24 the laboratory representative (#1 as listed on the form entrance/exit conference sheet) confirmed the laboratory test report did not include the laboratory name. 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 --

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the monthly Quality Control Log for stain quality, a review of patient test records for 2022 and interviews with laboratory staff, it was determined the laboratory failed to document stain quality on two of six days in which patient histopathology slides were stained and examined. Survey finding include: A. The Quality Control Log is used to document the daily stain quality and any