Urology Associates/Minnesota Urology

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 document review and interview with laboratory personnel, the laboratory failed to document Histopathology quality control (QC) procedures performed to test Hematoxylin and Eosin (H&E) stain for intended reactivity each day of use in 2022. The laboratory performed approximately 9,311 Histopathology tests on patient samples annually. Findings are as follows: 1. The laboratory performed Histopathology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on February 22, 2023 at 10:05 a.m. 2. The QC Evaluation of Pathology Slides procedure and the H&E Staining procedure found in the Histology SOP (Standard Operating Procedure) white binder included procedures for reviewing the stain quality of the H&E slides daily for acceptability and documenting it on the appropriate log by the Pathologist. 3. A patient's prostate biopsy (ID # xxx550), performed on 06/08/2022, documents were reviewed on the day of survey. It was found that the patient had 18 slides evaluated on 06/08/2022, each stained with H&E. Review of the H&E QC log, found that the daily QC evaluation and documentation was not performed on the day of patient testing. The documentation of the assessment of the staining characteristics were documented weekly, when the reagents were changed, not each day of use. 4. In an interview on 12:05 p.m. on February 22, 2023, the LD confirmed the above findings. *H&E = Hematoxylin and Eosin 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 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 observation, document review and interview with laboratory personnel, the testing personnel (Pathologist) failed to document the acceptability of the Immunohistochemical Stain Quality Control (QC) slides on each day of patient specimen testing. Findings are as follows: 1. The laboratory performed Pathology testing under the subspecialty of Histopathology as confirmed by the Histology Technologist (HT) during a tour of the laboratory on 06/25/18 at 9:35 a.m. 2. A BioCare Medical Intellipath Automated Slide Staining System was observed as present and available for use during the tour of the laboratory. 3. A requirement for the review of accuracy and quality of Immunohistochemical Stain QC slides by the Pathologist was established in the PIN-4 Cocktail (CK5 + CK14 + p63 + p504S) Immunohistochemical Stain procedure located in the Procedure manual. 4. In an interview on 6/25/18 at 10:15 a.m., HT stated that surgical prostrate tissue was sourced from a local hospital for use for positive staining QC slides. 5. Documentation of inclusion of Immunohistochemical Stain QC slide processing was not found during review of the following laboratory record (Immuno Daily Run Log): Date Range: 01/03/18 to 6/22/18 # of Staining Batches Performed: 99 # of Patient Cases Evaluated: 345 # of Patient Slides Stained: 696 6. Documentation of processing 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 -- of Immunohistochemical Stain QC slides was not found during review of the BioCare Medical Intellipath IHC Batch Reports obtained for the same time period and testing dates. 7. In an interview on 07/2/18 at 9:35 a.m.., the HT confirmed the above finding. -- 2 of 2 --