Summary:
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 Surveyor review of laboratory policy and procedure, quality control and patient testing records, and interview with the laboratory director and testing personnel, the laboratory failed to document the results of the special staining reactions of the control slides in 1 case out of 3 cases reviewed. The findings include: a. The laboratory performed a professional component on a patient slides # S2019- 005663G that was stained with Congo red, and # S19-05663 which was stained with Giemsa special stains. However, the laboratory did not have any documentation showing that it had reviewed and interpreted the results of the appropriate special stain quality control slides. b. On September 26, 2019 at 12:25 pm the laboratory director affirmed that the laboratory did not have any record of quality control documentation for the special staining. c. The laboratory testing declaration form, signed by the laboratory Director on September 26, 2019, indicates that the laboratory performs approximately 2,100 tests, annually. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a 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 -- manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory quality control and patient testing records, and interview with the laboratory Director, the laboratory failed to retain the quality control slides for the special stains Congo red and Giemsa that was used to interpret the results of patient slides # S2019-005663G and # S19-05663. The findings include: a. The laboratory performed a professional component on a patient slides # S2019- 005663G that was stained with Congo red, and # S19-05663 which was stained with Giemsa special stains. The laboratory did not have stored the corresponding quality control slides. b. On September 26, 2019 at 12:35 pm the laboratory director confirmed that the laboratory did not have the quality control slides. c. The laboratory testing declaration form, signed by the laboratory Director on September 26, 2019, indicates that the laboratory performs approximately 2,100 tests, annually. -- 2 of 2 --