Gastroenterology Consultants Of Boca Raton

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Gastroenterology Consultants of Boca Raton on July 29, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the laboratory failed to store 100% Reagent Alcohol containers, Xylene, and Eosin Y Solution 1% weight to volume (w/v) in Alcohol and two reagent waste jug in a flammable cabinet. Findings Included: 1. On 7/29 /26 at 1:36 PM, 100% Reagent Alcohol containers, Xylene , and Eosin Y Solution 1% w/v in Alcohol containers were stored in a cabinet under the sink. Two reagent waste jugs were stored on the floor. 2. Review of Xylene sticker read, " Flammable liquid and vapor. Store locked up in a well-ventilated place." 3. Review of Eosin Y Solution ,1% w/v in Alcohol read, "Highly flammable liquid and vapor. Storage: Store locked up. Store in a well-ventilated place." 4. Review of 100% Reagent Alcohol sticker read "Highly Flammable liquid and vapor. Store in well- ventilated place. Use explosion-proof electrical/ventilating / light equipment" 5. Review of Quality Assurance Manual signed by the Laboratory Director on 6/20/2026 read, "All reagents shall be stored according to manufacturer's instructions." 6. On 7 /29/26 at 4:00 PM, the Administrator of Operations confirmed Reagent Alcohol containers, Xylene, and Eosin Y Solution 1% w/v in Alcohol containers and two reagent waste jug were not stored properly. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document open dates for reagents in use from 1/01/2025 to 7/29/2026. Findings Included: 1. Review of Manufactured Stains Reagents, Paraffin and Chemical Lot Log revealed no documented open dates for reagents in use listed from 1/01/2025 to 7/29/2026. 2. Review of the Quality Assurance manual signed by the Laboratory Director read, "All reagents will be marked with date opened." 3. On 7/29/26 at 4:00 PM, the Administrator of Operations confirmed no documented open dates for reagents from 1 /01/2025 to 7/29/2026. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to have a policy for onsite visits and documented two onsite visits for 2025. Findings Included: 1. Review of the Quality Assurance Manual signed by the Laboratory Director on 6/20 /2026 revealed a policy for onsite visits for Laboratory Director. 2. Review of Onsite Laboratory Director Visits revealed no documentation of two Laboratory Director onsite visits for 2025. 3. On 7/29/26 at 4:00 PM, the Administrator of Operations confirmed Laboratory Director did not have a policy for onsite visits and documentation of two onsite visits for 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/11/2022 found the GASTROENTEROLOGY CONSULTANTS OF BOCA RATON clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish a Quality Assessment (QA) procedure for monitoring, assessing, and correcting identified problems from 11/01/2020 to 05/11/2022. Findings include: Review of laboratory procedure manual revealed that there was no procedure for QA to monitor, asses or correct problems with specimen accessioning, processing, complaint investigations, personnel competency and proficiency testing performance. During an interview on 05 /11/2022 at 12:30 PM, the office manager confirmed that the procedure manual did not include a QA policy. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)

Summary Statement of Deficiencies D0000 An initial survey conducted on 10/12/2020 found that the Gastroenterology Consultants of Boca Raton clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for 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 record review and staff interview, the laboratory failed to document the positive and negative control reactivity verification for the immunohistochemical (IHC) stain that the laboratory performed for 3 (BG20-022, BG20-119, BG20-198) out of 3 patients reviewed since 6/18/2020. The findings include: -The laboratory started testing since 6/18/2020. -Test menu for Immunohistochemical (IHC) stains revealed that the laboratory used 3 different IHC: Cluster Differentiation 3 (CD3), Helicobacter Pylori (HP) and Homeobox Protein CDX-2 (CDX-2). - Review of patient reports: BG20-022, BG20-119 and BG20-198, revealed that 3 out of 3 had immunohistochemical stains (CD3, CD-X3 or HP), no documentation of the evaluation of the reactivity of the positive and negative control was found in the laboratory logs or patient reports. The laboratory performed the interpretation of 127 cases using IHC from 6/18/2020 to 10/12/2020. During an Interview on 10/12/2020 at 11.30 am, the office manager confirmed that the laboratory failed to document the positive and negative control reactivity for the immunohistochemistry stains for the cases of reference. 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 --