Jose A Monteiro Md, Pc

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted on 9/29/22 for the Jose A. Monteiro, MD, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of a second occurrence of unsuccessful proficiency testing performance for the subspecialty area of Routine Chemistry and the White Blood Count differential and Hemoglobin analytes, the following Condition level deficiencies were deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. Condition 42 CFR 493.1403 - Laboratory Director. Refer to D2016, D2089, D2097, D2123, D2130, and D6000. . 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This CONDITION is not met as evidenced by: Based on record review on 9/29/22 of calendar years 2019, 2020, 2021 and 2022 proficiency testing results (four testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the Medical Laboratory evaluation (MLE) proficiency testing program for the subspecialty of Routine Chemistry and the specialty of Hematology as evidenced by the following Routine Chemistry: First Unsuccessful Occurrence: The laboratory failed to participate in the third testing event of 2021 and first event of 2022 for the subspecialty area of Routine Chemistry. This resulted in the first occurrence of unsuccessful performance for the subspecialty area. Refer to D2089. Second unsuccessful occurrence: The laboratory failed to participate in the third event of 2021 and the first and second events of 2022 in the subspecialty of Routine Chemistry. This resulted in the second occurrence of unsuccessful performance for the subspecialty area. Refer to D2089 and D2097. Hematology First Unsuccessful Occurrence: The laboratory obtained a score of zero (0) percent for the first and third testing events of 2019 for the White Blood Count differential analyte. The laboratory obtained a score of sixty (60) percent for the first and third testing events of 2019 for the Hemoglobin analyte. This resulted in the first occurrence of unsuccessful performance for the two analytes. Second Unsuccessful Occurrence: The laboratory obtained a score of twenty (20) percent for the third testing event of 2021 and a score of zero (0) percent (failure to participate - refer to D2123) for the second testing event of 2022 resulting in the second occurrence of unsuccessful performance for the White Blood Count differential analyte. The laboratory obtained a score of sixty (60) percent for the third event of 2020, forty (40) percent for the first testing event of 2022 and a score of zero (0) percent (failure to participate - refer to D2123) for the second testing event of 2022 resulting in the second occurrence of unsuccessful performance for the Hemoglobin analyte. Based on this evidence the laboratory failed to undertake the appropriate training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the subspecialty area of Routine Chemistry and the White Blood Count differential and Hemoglobin analytes. . D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review of 2021 and 2022 proficiency testing results (four testing events), the laboratory failed to return proficiency testing results resulting in two unsuccessful occurrences of unsuccessful proficiency testing in the subspecialty area of Routine Chemistry as evidenced by the following: a) First unsuccessful occurrence: A review of the the Medical Laboratory Evaluation (MLE)) proficiency testing results for 2021 revealed that the laboratory had received excused nonparticipation from the proficiency testing company for testing events two and three of 2021 as well as the -- 2 of 4 -- first testing event of 2022. However, the laboratory failed to meet the criteria of nonparticipation in the proficiency testing by: 1) failing to notify the State agency of the suspension of patient testing; and, 2) failed to participate in the previous two proficiency testing events (2021 testing event 3) resulting in a score of zero for each of the analytes as well as the subspecialty of Routine Chemistry. This resulted in the first occurrence of unsuccessful performance for the subspecialty area. b) Second unsuccessful occurrence: A review of the the Medical Laboratory Evaluation (MLE)) proficiency testing results for 2022 revealed that the laboratory had received excused nonparticipation from the proficiency testing company for the first testing event of 2022 and failed to participate in the second testing event of 2022. The laboratory failed to meet the criteria of nonparticipation in the proficiency testing by: 1) failing to notify the State agency of the suspension of patient testing; and, 2) failed to participate in the previous two proficiency testing events (2021 testing event 3) resulting in a score of zero for each of the analytes as well as the subspecialty of Routine Chemistry. This resulted in the second occurrence of unsuccessful performance for the subspecialty area. c) The laboratory's failure to notify the State agency or participate in the second testing event of 2022 was confirmed through a letter sent by the laboratory director via email on 9/12/22. . D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review of calendar years 2021 and 2022 Medical Laboratory Evaluation (MLE) proficiency testing results, the laboratory failed to attain an overall testing event score of at least 80 percent for the subspecialty of Routine Chemistry as evidenced by the following analyte testing event scores: 1. 2021 MLE testing event 3 - score of 0 % (failure to participate). 2. 2022 MLE testing event 1 - score of 0 % (failure to participate).. 3. 2022 MLE testing event 2 - score of 0% (failure to participate). D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency testing record review of Medical Laboratory Evaluation (MLE) proficiency testing results for calendar years 2019, 2020, 2021 and 2022, the -- 3 of 4 -- laboratory failed to participate in the second testing event of 2022 for the White Blood Cell differential and Hemoglobin analytes resulting in scores of zero (0) percent for the testing 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 record review of calendar years 2019, 2020, 2021 and 2022 Medical Laboratory Evaluation (MLE) proficiency testing results, the laboratory failed to attain a testing event score of at least 80 percent for all hematology analytes as evidenced by the following analyte testing event scores: White Blood Cell Differential Analyte: 1. 2019 MLE testing event 1 - score of 0 %. 2. 2019 MLE testing event 3 - score of 0 %. 3. 2021 MLE testing event 3 - score of 20%. 4. 2022 MLE testing event 2 - score of 0% (failure to participate). Hemoglobin: 1. 2019 MLE testing event 1 - score of 60 %. 2. 2019 MLE testing event 3 - score of 60 %. 3. 2020 MLE testing event 3 - score of 60 %. 4. 2022 MLE testing event 1 - score of 40%. 4. 2022 MLE testing event 2 - score of 0% (failure to participate). . 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 deficiencies cited herein, the laboratory director failed to ensure that effective remedial action was instituted in response to unsatisfactory proficiency testing results resulting in repeated unsuccessful performance for the subspecialty of Routine Chemistry and White Blood Cell differential and Hemoglobin analytes under the specialty of Hematology. Refer to D2016, D2089, D2097, D2123, and D2130. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Jose A. Monteiro MD PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on personnel training record review and interview with testing person #1 (TP1) on 6/29/21, the technical consultant (TC) failed to identify training needs and assuring each testing person (TP) receives appropriate training and education prior to patient testing as evidenced by the following: The surveyor asked for the personnel training records for review. The review revealed that the TC failed to document that two (2) out of four (4) TP's performing moderate complexity testing received training before reporting patient results. TP1confirmed in an interview on 6/29/21 at 11:45 AM that TP1 and TP2 did not have any training documentation on file for moderate complexity testing. The laboratory performs 72,139 Routine Chemistry tests and 18,325 CBC's annually. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with Testing Person #1 (TP1) on 6/29/21, the Technical Consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that semiannual competency evaluations were not performed and documented for two (2) out of the four (4) testing persons (TP) in their first year of performing moderate complexity testing. TP1confirmed in an interview on 6/29/21 at 11:45 AM that the TC failed to perform and document semiannual competency evaluations for TP1 and TP2 in their first year of performing moderate complexity testing. The laboratory performs 72,139 Routine Chemistry tests and 18,325 CBC's annually. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with Testing Person #1 (TP1) on 6/29/21, the Technical Consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually, after the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that annual competency evaluations were not performed and documented at least annually for two (2) out of the four (4) testing persons (TP) after the first year of performing moderate complexity testing. TP1confirmed in an interview on 6/29/21 at 11:45 A.M. that the TC failed to perform and document annual competency evaluations for TP1 and TP2 after the first year of performing moderate complexity testing. The laboratory performs 72,139 Routine Chemistry tests and 18,325 CBC's annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted on 1/17/20 for the Jose A. Monteiro, MD, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of unsuccessful proficiency testing performance for the hemoglobin, white blood count, and white blood cell differential analytes in the specialty of Hematology, the following Condition level deficiencies were deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. Condition 42 CFR 493.1403 - Laboratory Director . 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: 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 -- . Based on an off-site proficiency testing desk review for calendar years 2018 and 2019, the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the Medical Laboratory Evaluation (MLE) proficiency testing program for the hemoglobin, white blood cell count, and white blood cell differential analytes resulting in ongoing unsuccessful proficiency testing performance in the specialty of Hematology. Refer to D2123, D2130, and D2131. . D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency testing record review of Medical Laboratory Evaluation proficiency testing results for calendar years 2018 and 2019, the laboratory failed to participate in the first and third testing events of 2019 for the white blood cell differential analyte resulting in scores of zero (0) percent and unsuccessful performance for the analyte as evidenced by the following test scores: White Blood Cell Differential Analyte: 1. 2019 MLE testing event 1 - score of 0 % 2. 2019 MLE testing event 3 - score of 0%. 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 record review of calendar years 2019 and 2019 Medical Laboratory Evaluation (MLE)proficiency testing results, the laboratory failed to attain a testing event score of at least 80 percent for all hematology analytes as evidenced by the following testing event scores: White Blood Cell Differential Analyte: 1. 2018 MLE testing event 1 - score of 66 %. 2. 2018 MLE testing event 3 - score of 53 %. 3. 2019 MLE testing event 1 - score of 0 %. 4. 2019 MLE testing event 3 - score of 0 %. Hemoglobin: 1. 2019 MLE testing event 1 - score of 60 %. 2. 2019 MLE testing event 3 - score of 60 %. White Blood Count: 1. 2019 MLE testing event 1 - score of 60 %. 2. 2019 MLE testing event 3 - score of 40 %. .. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is -- 2 of 3 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on Medical Laboratory Evaluation (MLE) proficiency testing performance review for calendar year 2019, the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three testing events for the specialty area of Hematology leading to unsuccessful performance as evidenced by the following scores obtained: 1. 2019 MLE testing event 1 - score of 66 %. 2. 2019 MLE testing event 3 - score of 56 %. . 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 deficiencies cited herein, the laboratory director failed to ensure that effective remedial action was instituted in response to unsatisfactory proficiency testing results resulting in repeated unsuccessful performance for the white blood cell differential, hemoglobin, and white blood count analytes in the specialty of Hematology Refer to D2016, D2123, D2130, and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Jose A Monteiro, MD PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer of a new test system before reporting patient test results as evidenced by the following: The laboratory began D-dimer patient testing using the Alere Triage MeterPro analyzer on 1/18/17. Record review revealed that the laboratory did not perform validation studies prior to patient testing. The technical consultant confirmed through interview at 10:30AM that the laboratory did not demonstrate the Alere Triage MeterPro can obtain performance specifications comparable to those established by the manufacturer for D-dimer testing prior to reporting patient test results. The laboratory performs 66 D-dimer tests annually. 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 --