Cunningham Pathology

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records, a review of the CAP attestation statement, and an interview with Testing Personnel #7, the laboratory failed to ensure the previous Laboratory Director signed the attestation statements for one of eighteen events reviewed from 2020 to 2022. The findings include: 1. A review of the CAP PT records revealed no signature by the previous Laboratory Director (or designee) on the attestation statement for 2020 (third event) S-C HcG Serum (Human Chorionic Gonadotropin-Serum). 2. A further review of the CAP attestation statement revealed, "...the laboratory director or designee... must sign..." 3. During an interview on October 6, 2022, at 11:18 AM, Testing Personnel #7 confirmed the above findings. 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: Based on a review of quality control (QC) for Hematoxylin and Eosin (H&E) stain and an interview with Testing Personnel #3, the laboratory failed to retain documentation of H&E QC each day of patient testing. The findings include: 1. A review of quality control revealed that in 2019 and 2020 the quality of the stain was documented on the "Remote Frozen Section QA [Quality Assurance] Form" for each patient. 2. A review of the 2019 QA records revealed a total of 42 frozen cases were performed, however only 18 forms were retained in the laboratory. The laboratory was unable to specify the dates of the 24 other frozen cases in 2019, or whether H&E QC was performed and acceptable. 3. A review of the 2020 QA records revealed a total of 26 frozen cases (January - August), however only 22 forms were retained in the laboratory. The laboratory was unable to specify the dates of the other four frozen cases in 2020, or whether H&E QC was performed and acceptable. 4. During an interview on 11/05/2020 at 1:40 PM, Testing Personnel #3 confirmed the "Remote Frozen Section QA Form" should be retained in the laboratory to provide documentation of the daily quality control for the H&E stain. SURVEYOR ID #32558 Licensure and Certification Surveyor 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 --