Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Biannual Assessment (BA) records and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopathology testing twice annually from 9/20/16. The findings include: 1. The name of the reviewing pathologist was not documented. 2. The OM confirmed on 9/27/18 at 10:00 am the laboratory did not verify the accuracy of Histopathology testing. 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 surveyor review of the Quality Control (QC) records, accession log and interview with the Office Manager (OM), the laboratory failed to record the reaction of a control slide for Hematoxylin and Eosin (HE) stains from 9/20/16 to the date of survey. The OM confirmed on 9/27/18 at 19:45 AM that QC was not documented. 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 --