Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Morgan DermPath labs Inc on 08/28/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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. This STANDARD is not met as evidenced by: Based on interview, and record review, the laboratory failed to perform positive and negative controls for 28 out of 28 patients reviewed for Immunohistochemistry (IHC) staining in 2024. Findings Include: Review of the Quality Assurance policy signed by the Laboratory Director on 3/26/25 read, "Quality Control Standards: will maintain daily Quality Control logs of routine and special stain adequacy, section adequacy and appropriate labeling." A statement regarding Immunohistochemistry controls for positive and negative was missing from the policy. Review of the Patient Log revealed 28 patients were tested for IHC in 2024. Review of Quality Control log revealed no documentation of positive and negative controls for IHC in 2024. On 8/28 /25 at 3:19 PM, the Laboratory Director confirmed that IHC positive and negative controls were not documented for the 28 patients in 2024. 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 --