Summary:
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 review of laboratory policies and procedures, stain quality control records, and confirmed in interview, the laboratory failed to verify the staining materials for the Hematoxylin and Eosin (H&E) stain were acceptable for negative and positive reactivity at least once each day of use. Findings included: 1. Review of the laboratory's H&E Quality of Stain and Monthly review is documented with the initials of the Histotech. There is no documentation of H& E quality documented on this form by the Testing personnel interpreting the stained tissue results. 2. Review of 6 patient test records found no documentation of the H&E stain reactivity in six of six patient reports. 3. Interview of the Office staff conducted on September 20, 2019 at 9:33 AM confirmed that the laboratory testing personnel reading patient specimen slides did not document the acceptability of H&E stains each day of use. The histotechnician stated that the individual performing the processing and staining of the tissue specimens signed off as assessing the quality of the stain. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where 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 test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test records and confirmed in interview, the laboratory failed to ensure that the name and address of the laboratory where the test was performed appeared on the final report for six of six reports reviewed. Findings included: 1. . Review of 6 patient test records found no documentation of the address of the facility where testing was performed for six of six patient reports reviewed. 3. Interview of the Office staff conducted on September 20, 2019 at 9:55 AM confirmed that the laboratory address did not appear on the final reports for the six patients reviewed. -- 2 of 2 --