Gastro Health Llc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on February 15, 2022 for Gastro Health, LLC. The Gastro Health, LLC laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Refer to D 2130.. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on February 15, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential for two consecutive testing events in 2021. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On February 15, 2022, on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential, as shown below. Event #2, 2021 white blood cell differential-0% Event #3, 2021 white blood cell differential-67% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On February 15, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on February15, 2022 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events as shown below. Event #2, 2021 white blood cell differential-0% Event #3, 2021 white blood cell differential-67% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/15/2020 found that Boca Raton Gastroenterology Associates LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 1- Cited the following Conditions: - D5200 General Laboratory Systems -D5400 Analytic Systems -D6000 Moderate Complexity Laboratory Director -D6063 Laboratory Testing Personnel 2- The following Standards deficiencies are repeat cites from the previous recertification survey on 9/18/2018: -D2015 Testing of Proficiency Testing Samples -D2128 Hematology -D5209 Personnel Competency Assesment Policies -D5439 Calibration and Calibration Verification D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory did not maintain all the proficiency testing (PT) records and did not have the required signatures on all the documentation for the period reviewed (2019-2020). Findings Include: A review of the American Proficiency Institute (API) records for the Hematology specialty for the past 2 years revealed that: -The laboratory failed to have attestation signed by testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- personnel (TP) for 2nd event of 2019. -There was no copy of attestation for 2nd event of 2020. -The Laboratory Director or its designee failed to sign API PT performance review evaluation for 5 out of 5 events reviewed 2019 (1, 2 and 3) 2020 (1 and 2). During an interview on 10/15/2020 at 11:30 AM, TP A confirmed that the forms listed above were not signed as described. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) record by American Proficiency Institute (API) and staff interview, the laboratory failed to score at least 80 % on the following analytes: Red Blood Cell (RBC) and White Blood Cells Differential (WBC) analyte in 1 out of 5 events reviewed for Hematology specialty. Findings include: Review of PT records revealed a score of 60 % for RBC in the 1st event of 2019 and for WBC a score of 67 % in the 3rd event of 2019. During an interview on 10/15/2020 at 12:30 PM, testing personnel (TP) A, confirmed the proficiency testing failure. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) and staff interview, the laboratory received an unsatisfactory score for 1 (3rd event 2019) out of 5 events for Hematology reviewed (2019-2020). Findings include: Review of API PT records revealed a score of 67 % for White Blood Cells Differential (WBC) in the 3rd event of 2019 resulting in a failing score of 71 % for the Hematology specialty. During an interview on 10/15/2020 at 12:30 PM, the testing personnel (TP) A confirmed the proficiency testing failure. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document remedial action for unsatisfactory proficiency testing (PT) results for 1 out of 5 events -- 2 of 7 -- of Hematology specialty and for 2 out of 2 Hematology analyte unsatisfactory scores in 2019, Red Blood Cells (RBC) 1st event and White Blood Cells Differential (WBC) 3rd event of 2019. Findings include: -Review of American Proficiency Institute (API) proficiency testing results in 2019 and 2020, showed that the laboratory had unsatisfactory score of 71 % for the 3rd Event of Hematology of 2019 due to an unsatisfactory score on WBC of 67 % and had an analyte unsatisfactory score for RBC of 60 % for the 1st event of 2019. -No documentation of the review and

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the analyte, white blood cell differential in the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 14, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential for two out of three testing events in 2018 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the an analyte in the specialty of hematology. Findings include: On January 14, 2019, on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential, as shown below. Event #1, 2018 white blood cell differential-0% Event #3, 2018 white blood cell differential-0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing for an analyte in the specialty of hematology. Findings include: On January 14, 2019, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation for the analyte, white -- 2 of 3 -- blood cell differential, in proficiency testing in the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 14, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2018 white blood cell differential-0% Event #3, 2018 white blood cell differential-0% -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on two years (2016 -2018) record review of API (American Proficiency Institute) hematology proficiency testing results and interview with office manager, the laboratory failed to retain documents showing the completion of proficiency testing for two of six events. The findings include: On September 18, 2018 at 2:00pm API proficiency testing results record review (September 2016 - Sept, 2018) showed no documentation of the testing performed for 2nd event 2017 and 1st event, 2018. During an interview on September 18, 2018, at 3:15pm, the office manager confirmed that the laboratory did not retain documents showing the completion of proficiency testing performed for 2nd event 2017 and 1st event, 2018. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on two years (2016 -2018) record review of API (American Proficiency Institute) Hematology proficiency testing results and interview with office manager, the laboratory failed to submit the proficiency testing results in the specified timeframe for the 1st Hematology event in 2018 resulting in a score of 0% for hematology analytes. The findings include: On September 18, 2018 at 2:00pm API proficiency testing results record review (September 2016 - Sept, 2018) showed 0% score for Hematology, Cell I D or WBC Diff (cell identification or white blood cell differentiation), RBC (red blood cell), HCT (hematocrit), HGB (hemoglobin), WBC (white blood cell), and Platelets for 1st event, 2018. During an interview on September 18, 2018, at 3:15pm, the office manager confirmed that the laboratory submitted the test results after the required date for hematology 1st event 2018. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on two years record review (year 2016 -2018) and interview with office manager, the laboratory failed to review and to take and document remedial action for 1st event, 2018 API (American Proficiency Institute) unsatisfactory proficiency testing results for 6 out of 6 hematology analytes. The findings include: On September 18, 2018 at 2:00pm API proficiency testing results record review (September 2016 - Sept, 2018) showed that laboratory had unsatisfactory score of "0" for Cell I D or WBC Diff (cell identification or white blood cell differentiation), RBC (red blood cell), HCT (hematocrit), HGB (hemoglobin), WBC (white blood cell), and Platelets for 1st event, 2018. API performance evaluation 2018 Hematology/Coagulation -1st event form showed that laboratory did not review the performance summery, and did not take