Gastroenterology Institute Of Orlando Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 4, 2022. Gastroenterology Institute of Orlando clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 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 record review and interview, the laboratory failed to include name and address of the laboratory where the professional component was performed for five (#1, #2, #3, #4, #5) of six patients' gastrointestinal (GI) pathology reports, (#1, #2, #3, #4, #5, #6). Findings: Review of patients' "GI Histology Report" showed the name and address of the laboratory where the professional component was performed was not listed on five ((#1, #2, #3, #4, #5) of six patients' reports (#1, #2, #3, #4, #5, #6) reviewed. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 08/04 /2022, the laboratory had an annual test volume of 810 tests. On 08/04/2022 at 12:00 PM, Laboratory Director confirmed that five of the reports did not have the name and address of the laboratory where the professional component was performed. 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 D0000 An initial certification survey was conducted on August 11, 2020. Gastroenterology Institute of Orlando clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, record review and interview, the laboratory failed to have negative control slides for recording the negative reactivity for 3 (#1, 2, 4) out of 4 (#1, 2, 3, 4) patients with Immunohistochemical (IHC) stained slides. Findings: The laboratory evaluated the following IHC stains: CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), and H. pylori (Helicobacter pylori, bacteria IHC stain). Review of the "Technical Quality Assurance Form and Slide Delivery Log" indicated that a CD3 IHC slide was performed on patient #1. Observation of the slides for patient #1 showed that the patient had a CD3 IHC stain slide and no negative control slide was available for review. Review of the "Technical Quality Assurance Form and Slide Delivery Log" indicated that a CD3 and H. pylori IHC slide was performed on patient #2 and #4. Observation of the slides for patient #2 and 4 showed that the patients had a CD3 and H. pylori IHC stain slides and no negative control slides were available for review. During an interview on 8/11/20 at 1:45 PM, the Laboratory Consultant stated she was unable to locate the negative control slides for IHC stained slides. 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 -- 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 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 record review, observation, and interview, the laboratory's pathology reports failed to provide the test results of the special stains in 2 (#3, 4) out of 4 (#1, 2, 3, 4) patient pathology reports examined. Findings: Review of the "Technical Quality Assurance Form and Slide Delivery Log" indicated that an Alcain Blue stained slide was performed on patient #3. Observation of the slides for patient #3 showed an Alcain Blue slide for biopsy "A: Stomach, Body, Biopsy" was included with the other slides for the patients. Review of the "GI Pathology Report" for patient #3 showed that the test results of the Alcain Blue slide were not included in the "GI Pathology Report." report. Review of the "Technical Quality Assurance Form and Slide Delivery Log" indicated that a Periodic Acid - Schiff (PAS) - Hematoxylin stained slide was performed on patient #4. Observation of the slides for patient #4 showed a PAS - Hematoxylin slide for biopsy "D: Duodenum, Bulb, Distal, Biopsy" was included with the other slides for the patients. Review of the "GI Pathology Report" for patient #4 showed that the test results of the PAS - Hematoxylin slide were not included in the "GI Pathology Report." During an interview on 8/11/20 at 2:05 PM, the Laboratory Director stated the test result for the Alcain Blue and PAS stains were not mentioned on the pathology reports. -- 2 of 2 --