Boca Raton Gastroenterology Center Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted from 11/16/2022 to 11/18/2022 found the BOCA RATON GASTROENTEROLOGY CENTER PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain histopathology slides for at least 10 years for 53 cases in 2021. Findings include: -Review of stored slides revealed that the laboratory was missing the slides for 53 cases that were processed from January to April in 2021. During an interview on 11/16/2022 at 2:30 PM, the Laboratory Director confirmed that the laboratory failed to have on site the stained slides for the cases of reference, he explained that he was going to contact the reading pathologist to check if he had the slides of reference. On 11/18/2022, the laboratory confirmed that could not located the slides and they were going to request that new slides were processed. 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 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 -- 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 staff interview, the laboratory failed to have and record the reactivity of negative control for immunohistochemical (IHC) stains for four (#1, #2, #3 and #4)) of four (#1-#4) patients' slides and Pathology Reports reviewed in 2021 and 2022. Findings include: -The laboratory performs only the microscopic examination of the slides. Four of four patients' slides and Pathology Reports reviewed had IHC stained slides. The laboratory evaluated the following IHC stains: (Cluster Differentiation 3 T cell Lymphocytic (CD 3), Helicobacter pylori (H. pylori) IHC stain and protein CDX 2 (CDX2) IHC stain. No documentation of the IHC controls reactivity in the reports -Review of Stain control log for 2021 and 2022 revealed that the laboratory failed to document the negative control reactivity for the IHC of reference and failed to have negative control slides. During an Interview on 11 /16/2022 at 02.30 PM, the laboratory director confirmed that the laboratory failed to have and document the negative control reactivity for the IHC stains for the cases of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 12/11/2020 found that the Boca Raton Gastroenterology Center Pa clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document the initial and 6 months competency assessment for 1 out of 1 Testing Personnel (TP) that started on year 2020. Findings include: 1)Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 12/07/2020 revealed that: -That the laboratory had 1 TP (A) 2) Review of employee folders revealed that TP A started on 2/2020. There was no documentation of the initial and 6 months evaluation performed by the Technical Supervisor. During an interview on 12/11/2020 at 10:30 AM, with office consultant, she confirmed that the laboratory failed to document the initial and 6 months competency assessment for the TP A. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced 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 -- Based on record review and office consultant interview, the laboratory failed to ensure the twice a year accuracy verification for histopathology testing during 2020. Findings include: -Review of peer review documents revealed that the laboratory failed to document the peer review for 2020 -During an interview on 12/11/20 at 10:30 a.m., the office consultant confirmed that there was no documentation of peer review for histopathology during 2020. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)