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 two years record review (July 2016 to July 12, 2018) and the interview with the testing person, the laboratory failed to perform and record the daily hematoxylin and eosin stain quality control slide for histopathology subspecialty on the day of testing. The findings include: Daily QC (quality control) worksheet record review from 7/2016 to 7/12/2018 on July 12, 2018 at 12:30pm revealed that the laboratory did not perform hematoxylin and eosin quality control slide before the patient-test slide on 4/16/18. Patient test logs for 4/16/18 had two cases (18-028 and 18-029) for hematoxylin and eosin stain for MOHS procedure with no stain quality control slide records for that date. During an interview on July 12, 2018 at 2:00pm, the testing person confirmed that laboratory did not perform the hematoxylin and eosin stain quality control slide before patients (18-028 and 18-029) on 4/16/18 and there were no records for H&E QC stain for that date.. 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 --