Key Biscayne Pediatric Associates Inc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on January 17, 2023 for Key Biscayne Pediatric Associates. Key Biscayne Pediatric Associates is not in compliance with the 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 2022, the laboratory did not have successful performance in proficiency testing for analytes 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 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 17, 2023 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes; white blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), platelet count (PLT), and electronic white blood cell differential, for two out of three testing events in 2022 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 for analytes in the specialty of hematology. Findings include: On January 17, 2023 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 analytes: white blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), platelet count (PLT), and electronic white blood cell differential, as shown below. Event #2, 2022 WBC- 0% RBC-0% Hgb-0% Hct-0% PLT-0% electronic white blood cell differential-0% Event #3, 2022 WBC-0% RBC-0% Hgb-0% Hct-0% PLT-0% electronic 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 in proficiency testing for analytes found in the specialty of hematology. Findings include: On January 17, 2023, 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 analytes: white blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), platelet count (PLT), and electronic 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 -- 2 of 3 -- 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 in proficiency testing for analyte(s) found 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 January 17, 2023, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events for the analytes shown below. Event #2, 2022 WBC-0% RBC-0% Hgb-0% Hct-0% PLT-0% electronic white blood cell differential-0% Event #3, 2022 WBC-0% RBC-0% Hgb-0% Hct-0% PLT-0% electronic white blood cell differential-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 3/24/2021 at Key Biscayne Pediatric Associates Inc. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and interview, the laboratory failed send their 2nd proficiency testing (PT) event package to American proficiency institute (API) in a timely manner for the specialty of Hematology which resulted in a 0% score. Findings Included: Review of API PT folder revealed a 0% score during the 2nd PT event for the specialty of Hematology in 2020 and the package was not received by the API. During an interview on 3/24/2021 at 3:30pm, the laboratory manager confirmed that the packet was not received by the API agency which resulted in a 0% score for the second PT event in the specialty of Hematology for 2020. 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 D0000 A desk review survey of the laboratory's proficiency test results was performed on January 25, 2021 for Key Biscayne Pediatric Associates. The Key Biscayne Pediatric Associates 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 2019 and 2020, the laboratory did not have successful performance in proficiency testing for 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 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 January 25, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, red blood cell count (RBC) for two out of three testing events in 2020. 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 January 25, 2021, 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, red blood cell count (RBC), as shown below. Event #2, 2020 RBC-0% Event #3, 2020 RBC-20% 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 January 25, 2021, 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, red blood cell count, 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 -- 2 of 3 -- director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, red blood cell count (RBC) 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 January 25, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2020 RBC-0% Event #3, 2020 RBC-20% -- 3 of 3 --

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 and 2019, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2131. 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 June 13, 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 and 2019. 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 -- 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 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 specialty of hematology. Findings include: On June 13, 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, albumin, as shown below. Event #3, 2018 white blood cell differential-0% Event #1, 2019 white blood cell differential-7% 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 June 13, 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 D2131. 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 in proficiency testing for -- 2 of 3 -- the analyte, white blood cell differential 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 June 13, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2018 White blood cell differential-0% Event #1, 2019 White blood cell differential-7% -- 3 of 3 --

Summary Statement of Deficiencies 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 record review of American Proficiency Institute (API) proficiency testing records and interview with Office Manager (OM), the laboratory failed to score at least 80 % on Blood Cell Identification (BCI) for 1 (3rd event of 2018) out of 6 events for Hematology reviewed. Findings include: Review of API proficiency records revealed a score of 0% for BCI in the 3rd event of 2018. During an interview on 04/16 /2019 at 11:30 AM, the OM confirmed the failed analyte proficiency testing score. 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 record review of American Proficiency Institute (API) proficiency testing records and interview with Office Manager (OM), the laboratory received an unsatisfactory score in 1 (2rd event of 2017) out of 6 events for Hematology specialty reviewed. Findings include: Review of API proficiency records for 2017 and 2018 revealed that the laboratory received a 20 % score for Red Blood Cells, Hematocrit and Hemoglobin resulting in an overall score of 60 % during the second event of 2017. During an interview on 04/16/2019 at 11:30 AM, the OM confirmed that the laboratory failed the event of reference. 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 --