Gastroenterology Associates Ltd

Summary Statement of Deficiencies 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 review of laboratory procedure manuals and interview with the Histology Technician (HT), the laboratory failed to provide a competency assessment (CA) procedure to assess 1 of 1 Technical Supervisor (TS) for their supervisory responsibilities from 03/01/2024 to the day of survey. Findings Include: 1. The laboratory's Personnel Competency policy states: " The Medical Director will attest to the competency of senior technical personnel." 2. On the day of survey, 01/27/2025 at 01:00 pm, the laboratory could not provide CA records for 1 of 1 TS (CMS 209 Personnel #2) for the assessment performed for the supervisory responsibilities from 03/01/2024 to 01/27/2025. 3. The HT confirmed the findings above on 01/27/2025 at 01:00 pm. 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 record review, lack of documentation and interview with the Histology Technician (HT), the laboratory failed to ensure that the verification of accuracy for macroscopic histopathology examinations were performed at least twice annually, as 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 -- required for tests not included in subpart I from 03/01/2024 to the date of the survey. Findings include: 1. On the day of the survey, 01/27/2025 at 1:00 pm the laboratory failed to provide documentation for the verification of accuracy for macroscopic (grossing) histopathology examinations performed at least twice annually from 03/01 /2024 to 01/27/2025. 2. The laboratory could not provide a procedure for performing verification of accuracy for required tests not included in subpart I. 3. The HT confirmed the finding above on 01/25/2025 at 1:00 pm. 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. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, lack of documentation and interview with the Histology Technician (HT), the laboratory failed to document positive and negative stain reactivity each time of use for 22 of 22 immunohistochemical stains (IHC) used for microscopic histopathology examinations from 03/03/2024 to 01/27 /2025. Findings include: 1. On the day of survey 01/27/2025 at 12:00 pm, the laboratory failed to provide documentation for positive and negative reactivity each time of use for the following 22 of 22 immunohistochemical stains (IHC) used for microscopic histopathology examinations performed from 03/1/2024 to 01/27/2025: Actin-Smooth Muscle (SMA) BCL-1 (Cyclin D1) BCL-2 BCL-6 CD3 CD5 CD10 CD20 CD34 CD43 CD117 (c-KIT) CK-5/6 CMV (Cytomegalovirus) EMA (Epithelial Membrane Antigen) Gastrin H, pylori (HBP) HSV I/HSV II (Herpes Simplex Virus I&II) p16 p53 S100 Synaptophysin (Monoclonal) Vimentin (VIM) 2. The HT confirmed the findings above on 01/27/2025 at 1:00 pm D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview with Histology Technician (HT), the laboratory failed to ensure authorized ordering personnel were notified and issued corrected reports for 1 of 1 histopathology patient report when errors were detected from 10/15/2024 to 01/27/2025. Findings include: 1. The laboratory's Send Out Consult policy states: " If the original and send out diagnosis show a difference of major clinical significance, then the original signing out pathologist will review the case and if necessary, a third outside consultation should be obtained. All such consults should be communicated to the submitting physician -- 2 of 3 -- and any discrepancies of major clinical significance will be reported as an addendum to the original case report. A log of any discrepancies and actions taken will be kept." 2. On the day of the survey, 01/27/2025 the laboratory failed to provide documentation for the addendum to the original case report and the notification to the submitting physician when 1 of 1 patient histopathology report (S24.881) had discrepancies of major clinical significance from 10/15/2024 to 01/27/2025. 3. The HT confirmed on 01/27/2025 at 01:00 pm that the laboratory does not create an addendum, the send out diagnosis is just scanned into the patient report. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with the Histology Technician (HT), the Technical Supervisor (TS) failed to assess the competency for 1 of 1 testing personnel (TP) (CMS 209 personnel #2) through testing previously analyzed specimens, internal blind testing, or external proficiency testing samples for macroscopic histopathology examinations performed in 2024. Findings include: 1. On the day of survey, 01/27/2025 at 11:00 a.m., review of laboratory competency assessment records revealed the TS did not include assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 1 of 2 TP (CMS 209 personnel #2) who performed macroscopic histopathology examinations (grossing) in 2024. 2. The HT confirmed the finding above on 01/27/2025 around 12:00 pm. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of competency assessment (CA) records, and interview with the Histology Technician (HT), the Technical Supervisor (TS) failed to assess the annual competency for 1 of 1 testing personnel (TP) for microscopic histopathology examinations and 2 of 2 TP for macroscopic histopathology examinations performed in 2024. Findings Include: 1. On the day of survey 01/27/2025 at 11:00 am, review of competency assessment records revealed TS failed to assess the annual competency assessment for the following TP in 2024: - 1 of 1 TP for microscopic histopathology examinations (CMS 209 personnel #2) - 2 of 2 TP for macroscopic (grossing) histopathology examinations (CMS 209 TP personnel #3 and #4) 2. The HT confirmed the findings above on 01/27/2025 at 01:00 pm. -- 3 of 3 --