Endoscopy Center Of The North Shore, Llc

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the regulatory affairs manager (RM), the laboratory failed to ensure 5 of 14 elements of procedure were documented in the "GOPATH Laboratories" procedure manual for histopathology slide interpretations from 10/05/2022 to 10/30/2024, affecting 7,591 tests (Refer to D5403). The laboratory failed to document quality control (QC) reviews for immunohistochemical stain Helicobactor pylori, special (Alcian blue /periodic acid-Schiff (PAS)) and differential staining Hematoxylin and Eosin (H & E) by the testing personnel (TP) performing histopathology slide interpretations for five of five patients from 10/05/2022 to 10/30/2024, affecting 7,591 patient tests (Refer to D5601). 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) 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 -- 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 D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Allegation of Compliance submitted on 05/17/2021 and lack of communication, the laboratory director (LD) failed to provide overall management and direction in accordance with 493.1445 of this subpart in the specialty of Histopathology. Findings Include: 1. The LD failed to be accessible to provide onsite, telephone, or electronic consultation when needed (See D6080). D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on direct observation, review of the Allegation of Compliance (AOC) submitted on 05/17/2021 and lack of communication, the laboratory director (LD) failed to be accessible to provide onsite, telephone, or electronic consultation as needed affecting the laboratory's recertification survey on 04/16/2021. Findings: 1. The AOC submitted on 05/17/2021 and the laboratory personnel report (CMS 209) were reviewed. 2. The CMS 209 listed the pathologist, Dr Jim Lu as the sole laboratory personnel. Dr Lu functioned as the LD, technical supervisor (TS), clinical consultant (CC), general supervisor (GS) and testing personnel (TP) for 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 -- Histopathology slide interpretations. 3. The AOC received on 05/17/2021 stated the following: *GoPath (a different laboratory) was responsible for quality control documentation of slides read at Endoscopy Center of the North Shore. *GoPath was responsible for access to Endoscopy Center of the North Shore patient records when a Center of Medicare & Medicaid Services (CMS) representative conducted surveys. *GoPath was responsible for slide storage and retrieval during surveys. 4. Further review showed the GoPath representative submitted the 05/17/2021 AOC. 5. During the laboratory's recertification survey on 04/16/2021 at 12:30 PM, the surveyor communicated with a representative from GoPath laboratory. The LD was not present or consulted electronically or via telephone during the survey process and all email correspondences dated 04/15/2021; 04/16/2021; 04/21/2021; 05/18/2021; and 05/19 /2021 were not copied (cc:) to Dr Lu (the LD). 6. The LD failed to be available to perform the responsibilities of the LD, TS, GS, and/or TP during the laboratory's recertification process. 7. On a Desk Follow-Up survey conducted on 05/21/2021 at 11:30 AM, the LD was notified of the above findings via certified mail. -- 2 of 2 --

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 record review and an interview with the GoPath representative, the laboratory failed to document all control procedures performed, as specified in the specialty of Histopathology for 7 out 7 patients. Findings Include: 1. The laboratory's manual, Endoscopy Center of The North Shore patients' specimen submissions lists, and GoPath quality control (QC) log sheets were reviewed. 2. The procedures manual revealed the following: *The laboratory performed Histopathology slide interpretations only. *Patients' specimens were sent to GoPath laboratory for tissue processing and Histopathology slide production. 3. The 7 (seven) patients selected from the specimen lists and QC logs revealed the laboratory failed to document the following: *the QC of the Hematoxylin and eosin (H&E) stains for 6 out of 7 patients' slides; and *the QC from the special stains performed for 3 out of 3 patients' slides. 4. Further review of the QC log sheets showed it failed to provide space to include the recording of special stain quality controls. 5. The laboratory failed to document all tissue staining quality controls and failed to establish procedures which ensure the tissue stain quality of all processed tissue are assessed and documented from GoPath, prior to reading patients' Histopathology slides. 6. On a Recertification survey conducted on 04/16/2021 at 2:10 PM, the GoPath representative confirmed the above findings. 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 -- D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: Based on record review, lack of documentation, and an interview with the GoPath representative, the laboratory failed to meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. Findings Include: 1. The laboratory failed to meet the following inspection requirements: *To provide CMS agent with copies or exact duplicates of all records and data it requires. *To have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. *To provide, upon request, all information and data needed by CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. See D8103. D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and an interview with the GoPath representative, the laboratory failed to MEET the general requirements of the inspection process when it failed to *provide CMS agent with copies or exact duplicates of all records and data it requires. *have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. *provide, upon request, all information and data needed by CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. Findings Include: 1. The laboratory manual, Endoscopy Center of The North Shore patients' specimen submissions lists, GoPath quality control (QC) log sheets, and Clinical Laboratory Improvement Amendments (CLIA) survey packet were reviewed. 2. The procedures manual revealed the following: *The laboratory -- 2 of 3 -- performed Histopathology slide interpretations only. *Patients' specimens were sent to GoPath laboratory for tissue processing and Histopathology slide production. *Patients' slide were stored at GoPath Laboratory (14D2037930), located on 1351 Barclay Blvd in Buffalo Grove, Illinois. 3. The surveyor selected 7 patients (PT1, PT2, PT3,....PT7) from the submissions' lists for requisition, slides, quality control (QC), and final report review. The laboratory failed to be able to print the requisitions and final reports; failed to present the selected patients' slides, and failed to provide the QC records for 7 out of 7 patients, during the survey. 4. The surveyor extended the submission of the requested documents listed in Findings #3 and the completion of CLIA forms (the "Disclosure of Ownership" & Laboratory Personnel Report (CMS 209) form) to 04/20/2021. The documents received on 04/21/2021 at 4:33 PM revealed the following: *The laboratory failed to provide the requisitions for 3 (PT2, PT4 & PT7) out of 7 patients; *The laboratory failed to provide the final reports for 2 (PT2 & PT4) out of 7 patients; *A photo of Hematoxylin and eosin (H&E) and special stains slides for all 7 patients were included, however the laboratory failed to include the QC records of these slides. *The laboratory failed to submit a completed "Disclosure of Ownership" and CMS 209 form. 5. On a Recertification survey conducted on 04/16/2021 at 2:10 PM, the GoPath representative confirmed the above findings. -- 3 of 3 --