Neighborhood Health Source Central Avenue Clinic

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate unacceptable Hematology proficiency testing (PT) results for 6 analytes in 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:05 a.m. on 03/16/22. 2. The laboratory performed PT using the College of American Pathologists (CAP) program. 3. The laboratory failed to submit PT results for the 2021 Hematology 1st event (FH1-A) to CAP within the specified timeline. A self-evaluation of the PT results was completed by the laboratory and indicated 9 of 30 PT results were unacceptable for the following analytes: Mean Corpuscular Hemoglobin Concentration (MCHC), Platelets (PLT), Red Cell Distribution Width (RDW), Neutrophil Percent (Neut%), Neutrophil Absolute (Neut Ab), and Lymphocyte Percent (Lymph%). See below. Analyte Results unacceptable MCHC 2 of 5 PLT 1 of 5 RDW 2 of 5 Neut% 1 of 5 Neut Ab 1 of 5 Lymph% 2 of 5 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing procedure located in the Procedure Manual. 5. Investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 11:00 a.m. on 03/16/22, the TC confirmed the above finding. 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 D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure hematology proficiency testing samples were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 08/28 /20 at 10:10 a.m. A Cell Dyn 1700 hematology analyzer was observed as present and available for use during the tour. 2. The laboratory performed proficiency testing (PT) for Hematology using the College of American Pathologists (CAP) proficiency provider. 3. The Proficiency Testing procedure located in the Central Avenue Clinic Laboratory Manual indicated PT samples would not be repeated unless results fell within repeat guidelines. In addition, PT samples would be handled, tested, and repeated in the same manner as patient samples. 4. Hematology PT samples FH1-06 through FH1-10 from the CAP 2020 FH1-B event were tested on 05/11/20 by former employee GE. Additional testing was performed on 05/12/20 by two other employees as indicated on test result documents generated by the Cell Dyn 1700 hematology analyzer. See below for testing personnel (TP) information and time of day testing was performed on 05/12/20. Sample TP Time FH1-09 AM* 8:14 FH1-10 TP1 8:19 5. In an interview at 11:55 a.m., the TC confirmed the above finding. *Former employee 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 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 a review of Center for Medicare and Medicaid Services reports, College of American Pathologists (CAP) and American Proficiency Institute (API) proficiency testing reports, and email communication with the Technical Consultant (TC), the laboratory failed to successfully participate in proficiency testing (PT) for White Blood Cell Differential testing under the specialty of Hematology. Findings include: 1. The CASPER Report 155, reviewed on December 4, 2019, indicated the unsatisfactory White Blood Cell Differential PT performance was a subsequent - not the first - failure that occurred in calendar year 2019. 2. Based on review of the CAP and API PT reports and email communication with Technical Consultant, 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 failed to achieve successful PT performance for White Blood Cell Differential testing in three of four consecutive PT events. See D2130. 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 review of proficiency testing (PT) reports from the College of American Pathologists (CAP) and the American Proficiency Institute (API) and email communication with the Technical Consultant (TC), the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two of three consecutive PT events in 2019. Findings include: 1. The CAP and API PT reports, reviewed on December 4, 2019 revealed that the unsatisfactory PT performance was a subsequent - not the first - failure which occurred under the specialty of hematology for White Blood Cell Differential during calendar year 2019 as listed below. 3rd quarter 2018 CAP 0% 1st quarter 2019 API 0% First failure 3rd quarter 2019 CAP 0% Subsequent failure 2. In an email communication on 12/04/2019 at 11:02 AM, the TC confirmed the laboratory lacked participation in the 3rd quarter 2019 hematology PT event because the laboratory missed the submission deadline date. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the College of American Pathologists (CAP) and email communication with the Technical Consultant (TC), the Laboratory Director failed to ensure PT results were returned to CAP within the established timeframe. Findings include: 1. The laboratory failed to return their Hematology PT results to CAP prior to the submission deadline for the events listed below. 2018 3rd event 2019 3rd event 2. In an email communication on 12/04/19 at 11:02 AM, the TC confirmed the above finding. -- 2 of 2 --

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 a review of Center for Medicare and Medicaid Services reports, College of American Pathologists and American Proficiency Institute proficiency testing reports, and email communication with the Technical Consultant, the laboratory failed to successfully participate in proficiency testing (PT) for White Blood Cell Differential testing under the specialty of Hematology. Findings are as follows: D2127 - the laboratory failed to submit PT results for the 2018 3rd Hematology testing event D2130 - the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two consecutive PT events 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 -- 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 score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the College of American Pathologists (CAP) and email communication with the Technical Consultant (TC), the laboratory failed to submit PT results for the 2018 3rd Hematology testing event which resulted in a score of 0 for all analytes. Findings are as follows: 1. The CAP PT report indicated the laboratory received a 0 score for all analytes included in the 3rd Hematology testing event of 2018. 2. In an email communication received at 1:41 p. m. on 05/21/19, the TC indicated the laboratory missed the PT result submission deadline for the 2018 3rd Hematology event. 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 review of proficiency testing (PT) reports from the College of American Pathologists (CAP) and the American Proficiency Institute (API), the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two consecutive PT events. Findings are as follows: The laboratory received unsatisfactory scores for White Blood Cell Differential testing in two consecutive PT events. Two consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from CAP and API listed the following unsatisfactory White Blood Cell Differential scores. -2018 3rd event CAP 0% -2019 1st event API 0% -- 2 of 2 --