Summary:
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: Based on lack of quality control records, review of patient test reports, and confirmed by the laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 3/26/2021, the laboratory failed to document the Hematoxylin and Eosin stain quality each day of patient testing for one out of one day (2/23/2021). The findings include: 1. Patient identifier #1 had a frozen section performed on 2/23/2021. 2. At the time of the survey, the laboratory did not document the Hematoxylin and Eosin stain quality for 2/23/2021. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, Form-116 and patient test reports and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personal Report) at approximately 11:00 am on 3/26/2021, the laboratory failed to include the name and address of the testing facility on 1 out of 1 test report from February 2021. The findings include: 1. The CLIA Application for Certification, Form-116 stated the name and address of the testing facility as: Lakeview Surgery Center, LC 1750 60th Street West Des Moines, IA 50266 2. Patient identifier #1 had a frozen section performed on 2/23/2021. 3. The test report for patient identifier #1 did not have the name and address of the testing facility. -- 2 of 2 --