Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiency was cited. 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 review of the laboratory's policies and procedures, test reports, quality control (QC) records, pre-survey paperwork, and interview, the laboratory failed to document the reactivity of the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics for their quality control used in diagnostic interpretations of histopathology specimens for one out of 10 test reports reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled "Microscopic Examination of Anatomic Pathology Specimens." revised 06/25/2024, under Testing Accuracy and Quality Assurance stated, "The pathologist will review the staining and slide quality each day as well as the quality of the gross. The results of this review are recorded on the CPA Daily Histology QC Log. A rating of 'Good Quality' indicates the following respectively: 1. Histology H&E stained slides a. H& E stain: i. Nuclei and basophilic structures stain blue ii. Cytoplasm and acidophilic structures stain pink b. Gross quality is acceptable i. Specimen was submitted with correct measurements ii. Specimen number of pieces is acceptable iii. No cross contamination of specimens c. Slide quality is acceptable i. Slide demonstrates tissue as expected ii. No cutting artifact that impacts rendering of a diagnosis as defined by 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 -- the pathologist iii. Cover slipped appropriately." B. Random review of patient test reports against the Daily Histology Quality Control revealed one out of 10 test reports without QC for the H&E stain as listed by date reported and accession number: Date Reported Accession Number 1. 11/04/2024 LG24-002661 C. Review of the CMS Form 116 showed an estimated annual test volume of 178 in histopathology. D. Interview with the Client Services Manager on December 4, 2024 at 1605 hours in the office confirmed there was no documentation of QC for the test report after a review of the records. -- 2 of 2 --