Clinical Gastrointestinal Associates

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's temperature records, and interview with the laboratory director (LD), the laboratory failed to monitor and document room temperature (RT) to ensure operating conditions were met to ensure reliable test system operation and test result reporting of histopathology microscopic slide examinations from 11/23/2022 to the day of survey. Findings Include: 1. The instruction manual for the Micronix Leica stated, "The Leica DM100 can be used at +10C to +40C." 2. On the day of the survey, 10/02/2024 at 10:00 am, the laboratory failed to provide RT monitoring records to ensure reliable test system operation for 1 of 1 Micronix Leica microscope prior to reporting microscopic histopathology slide examinations from 11/23/2022 to 10/02/2024. 3. The LD confirmed the findings above on 10/02/2024 at 10:00 am. 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 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 -- 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 review of the laboratory's quality control (QC) staining records and interview with the laboratory director (LD), the laboratory failed to check for negative staining reactivity each time of use for 1 of 1 immunohistochemical (IHC) stain used for microscopic histopathology slide examinations performed from 11/23/2022 to the day of the survey. Findings Include: 1. On the day of the survey, 10/02/2024 at 09:50 am, review of the laboratory's QC records revealed the laboratory failed to check for negative staining reactivity each time of use for 1 of 1 IHC stain (Helicobacter Pylori) used for microscopic histopathology slide examinations performed from 11/23/2022 to 10/02/2024. 2. The LD confirmed the finding above on 10/02/2024 at 09:50 am. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on peer review records and interview with the Laboratory Director (LD) and Laboratory Manager (LM), the laboratory failed to asses at least biannually verification accuracy of histology slides read on site in 2019. Findings include: 1. Reviewed of Quality Control and Performance Improvement Procedure, 2nd opinion /peer review policy (page 14) states"Peer review will be conducted a minimum of 2 times per year in each calendar year. At that time, 2-3 cases will be reviewed for QA /QC purposes". 2. On the day of survey, 09/15/2020 the peer review records indicated that only one peer review event was conducted during 2019 on 7/29/2019. 3. The LD and LM confirmed the findings above on 9/15/2020 at 09:00 am. *** Repeat Deficiency *** 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 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: Based on peer review records and interview with the Laboratory Director (LD) and Laboratory Manager (LM), the laboratory failed to assess at least twice annually verification accuracy of histology slides read on site in 2017. Findings include: 1. Review of Quality Control & Performance Improvement Procedure, 2nd Opinion Peer Review Policy, Bullet number 5 states: "Peer review will be conducted a minimum of 2 times per year in each colander year. At the time, 2-3 cases will be reviewed for QA /QC purposes." 2. On the day of survey, 04/24/2018, the Clinical Gastroeneterology Quality Assurance check sheet used to document peer review lists: a. 2 cases reviewed in 2016 b. 1 case reviewed in 2017 c. 1 case reviewed so far for 2018. 3. The LD and LM confirmed that the laboratory failed to perform at least twice annually verification accuracy of histology slides read on site in 2017 on 04/24/2018 around 01:30 PM. 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 review of the laboratory's procedure manuals and interview with the 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 -- Laboratory Director (LD) and Laboratory Manager (LM) the laboratory failed to establish and follow written policies and procedures for ongoing mechanism to monitor and assess Laboratories Quality Assessment. Findings include: 1. On the day of survey, 04/24/2018, a review of the laboratory's manuals revealed that the laboratory failed to have a written policy to assess the quality of the laboratories, pre analytical, analytical and post analytical laboratory systems. 2. The LD and LM confirmed the findings above on 04/24/2018 around 02:00 PM. -- 2 of 2 --