Boca Raton Physicians Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Boca Raton Physicians PA on June 09, 2025 to August 28, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory stored Linearity FD chemistry, Linearity FD bilirubin and Linearity FD Lipids for Roche systems outside of manufacturer's requirements. Findings Included: On 6/9/2025 at 3:42 PM, 2 Linearity FD chemistry, Linearity FD bilirubin and Linearity FD Lipids reagents were stored in freezer with a biohazard sticker. Each Linearity kit read, "store "2 to 8 Celsius (C)." Freezer's temperature gauge read, -17 C. Review of General Maintenance policy read, "Review all package inserts for information on required storage temperatures for reagents, calibrators, quality control and patient specimens. Verify that refrigerators and freezers within the laboratory meet these minimum requirements. Review of Temperature logs read, "Freezer temperature (-10) - (-25) Celsius(C)." On 6/9/2023 at 4:00 PM, the Office Manager and Technical Consultant confirmed the linearities were not stored based on manufacturer's guidelines. 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to identify the specimen source for 2 out of 2 patient reports reviewed. Findings Included: Review of patient reports revealed the following: 1. Patient #1 was collected on 7/10/2024 at 12:17 PM, and tested on 7/10/2024 at 4:01 PM, for complete blood count (CBC) with a specimen source listed as other. 2. Patient #2 was collected on 12/28/2023 at 11:05 AM, and tested on 12/28/2023 at 11:11 AM for CBC with specimen source listed as blank. Review of report policy revealed there was no policy on reports. On 6/9/2025 at 4:00 PM, the Office Manager and Technical Consultant confirmed 2 out of 2 lab reports did not have specimen identity. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/24/2021 found that the BOCA RATON PHYSICIANS PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: -D3000 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report 44 out of 44 negative results for the Cobas SARS-Cov-2 & influenza A/B test from 12/28/2021 to 03/24/2021. Findings include: -Review of patient reports for the Cobas SARS-Cov-2 & Influenza A/B nucleic acid test revealed that the laboratory tested 53 patients from 12/28/2021 to 3/24/2021. -Review of reports to the Department Of Health (DOH) revealed the laboratory failed to report the 44 negative cases. During an interview on 03/24/2021 at 2:00 pm, the office manager confirmed the laboratory failed to report the 44 negative cases for Cobas SARS-Cov-2 & influenza A/B from 12/28/2021 to 03 /24/2021 to the DOH. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 5/24/2019 to 3/24/2021 for hematology and chemistry controls. Findings include: -Review of the Quality Control policy on page QC7 on section J, revealed that the laboratory had to run a new control lot to establish a new mean and verify the values on the manufacturer range report before use for patient testing. -Review of quality control records from 5/13/2019 to 3/24/2021 for Abbot Cell Dyn 1700 (Hematology), Roche Integra 400 Plus (Chemistry) and Roche Cobas e411 (Chemistry), revealed the laboratory failed to perform the lot to lot verification for new control lots. During an interview on 3/24/2021 at 2:30 pm, the TP # A confirmed the laboratory failed to perform lot to lot quality control verification for the period referenced. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/24/2021 found that the BOCA RATON PHYSICIANS PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: -D3000 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report 44 out of 44 negative results for the Cobas SARS-Cov-2 & influenza A/B test from 12/28/2021 to 03/24/2021. Findings include: -Review of patient reports for the Cobas SARS-Cov-2 & Influenza A/B nucleic acid test revealed that the laboratory tested 53 patients from 12/28/2021 to 3/24/2021. -Review of reports to the Department Of Health (DOH) revealed the laboratory failed to report the 44 negative cases. During an interview on 03/24/2021 at 2:00 pm, the office manager confirmed the laboratory failed to report the 44 negative cases for Cobas SARS-Cov-2 & influenza A/B from 12/28/2021 to 03 /24/2021 to the DOH. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 5/24/2019 to 3/24/2021 for hematology and chemistry controls. Findings include: -Review of the Quality Control policy on page QC7 on section J, revealed that the laboratory had to run a new control lot to establish a new mean and verify the values on the manufacturer range report before use for patient testing. -Review of quality control records from 5/13/2019 to 3/24/2021 for Abbot Cell Dyn 1700 (Hematology), Roche Integra 400 Plus (Chemistry) and Roche Cobas e411 (Chemistry), revealed the laboratory failed to perform the lot to lot verification for new control lots. During an interview on 3/24/2021 at 2:30 pm, the TP # A confirmed the laboratory failed to perform lot to lot quality control verification for the period referenced. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 08 /31/2020 for Boca Raton Physicians, PA. Boca Raton Physicians, PA 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 subspecialty of routine chemistry. Refer to D2096. 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 August 31, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the following analytes: ALT (alanine aminotransferase), alb (albumin), ALK PHOS (alkaline phosphatase), amyl (amylase), AST (aspartate aminotransferase), T bil (total bilirubin), Ca (calcium), chloride, Chol-t (total cholesterol), HDL (high density lipoprotein), CK-t (total creatinine kinase), Gluc (glucose), Fe (total iron), LDH-t (total lactate dehydrogenase), Mg (magnesium), K (potassium), Na (sodium), T prot (total protein), BUN (blood urea nitrogen), and UA (uric acid) for two out of three testing events in 2019 and 2020. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 performance in proficiency testing in the subspecialty of routine chemistry. Findings include: On August 31, 2020 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 following analytes: ALT (alanine aminotransferase), alb (albumin), ALK PHOS (alkaline phosphatase), amyl (amylase), AST (aspartate aminotransferase), T bil (total bilirubin), Ca (calcium), chloride, Chol-t (total cholesterol), HDL (high density lipoprotein), CK-t (total creatinine kinase), Gluc (glucose), Fe (total iron), LDH-t (total lactate dehydrogenase), Mg (magnesium), K (potassium), Na (sodium), T prot (total protein), BUN (blood urea nitrogen), and UA (uric acid) as shown below. Event # 3, 2019 ALT-0% alb-0% ALK PHOS-0% Amyl- 0% AST-0% T bil-0% Ca-0% Chol-t-0% HDL-0% CK-t-0% Gluc-0% Fe-0% LDH-t- 0% Mg-0% K-0% Na-0% T prot-0% BUN-0% UA-0% Event #2, 2020 ALT-60% alb- 60% ALK PHOS-60% Amyl-60% AST-60% T bil-60% Ca-60% Chol-t-60% HDL- 60% CK-t-60% Gluc-60% Fe-60% LDH-t-60% Mg-60% K-60% Na-60% T prot-60% BUN-60% UA-60% 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 subspecialty of routine chemistry. Findings include: On August 31, 2020, 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 -- 2 of 3 -- testing scores for two out of three testing events for the following analytes: ALT (alanine aminotransferase), alb (albumin), ALK PHOS (alkaline phosphatase), amyl (amylase), AST (aspartate aminotransferase), T bil (total bilirubin), Ca (calcium), chloride, Chol-t (total cholesterol), HDL (high density lipoprotein), CK-t (total creatinine kinase), Gluc (glucose), Fe (total iron), LDH-t (total lactate dehydrogenase), Mg (magnesium), K (potassium), Na (sodium), T prot (total protein), BUN (blood urea nitrogen), and UA (uric acid). The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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 the following analytes: ALT (alanine aminotransferase), alb (albumin), ALK PHOS (alkaline phosphatase), amyl (amylase), AST (aspartate aminotransferase), T bil (total bilirubin), Ca (calcium), chloride, Chol-t (total cholesterol), HDL (high density lipoprotein), CK-t (total creatinine kinase), Gluc (glucose), Fe (total iron), LDH-t (total lactate dehydrogenase), Mg (magnesium), K (potassium), Na (sodium), T prot (total protein), BUN (blood urea nitrogen), and UA (uric acid) in the subspecialty of routine chemistry. 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 August 31, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event # 3, 2019 ALT-0% alb-0% ALK PHOS-0% Amyl-0% AST-0% T bil-0% Ca-0% Chol-t-0% HDL-0% CK-t-0% Gluc-0% Fe-0% LDH-t-0% Mg-0% K-0% Na-0% T prot-0% BUN-0% UA-0% Event #2, 2020 ALT-60% alb-60% ALK PHOS-60% Amyl-60% AST-60% T bil-60% Ca-60% Chol-t-60% HDL-60% CK-t- 60% Gluc-60% Fe-60% LDH-t-60% Mg-60% K-60% Na-60% T prot-60% BUN-60% UA-60% -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 and interview with laboratory personnel, the laboratory received an unsatisfactory result in routine chemistry. Findings include: During review of the past two years of proficiency testing on 05/15/2019, the surveyor found that the laboratory received an unsatisfactory result of 0% for chloride. During an interview with the testing person at 12:55 p.m. on 05/15/2019, he confirmed that they had received an unsatisfactory score. D2099 ENDOCRINOLOGY CFR(s): 493.843(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 and interview with laboratory personnel, the laboratory received an unsatisfactory result in endocrinology. Findings include: During review of the past two years of proficiency testing on 05/15/2019, the surveyor found that the laboratory received an unsatisfactory result of 40% for triiodothyronine. During an interview with the testing person at 12:55 p.m. on 05/15/2019, he confirmed that they had received an unsatisfactory score. D2122 HEMATOLOGY 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 -- 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 and interview with laboratory personnel, the laboratory received an unsatisfactory result in hematology. Findings include: During review of the past two years of proficiency testing on 05/15/2019, the surveyor found that the laboratory received an unsatisfactory result of 73% for cell identification or white blood cell identification. During an interview with the testing person at 12:55 p.m. on 05/15/2019, he confirmed that they had received an unsatisfactory score. -- 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 review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of endocrinology. Refer to D2108. 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 August 13, 2018 on or about 1:30 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, thyroxine (T4) for two consecutive testing events in 2018. D2107 ENDOCRINOLOGY 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 -- CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in 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 subspecialty of endocrinology. Findings include: On August 13, 2018 on or about 1:30 PM 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, thyroxine, T4, as shown below. Event #1, 2018 thyroxine-0% Event #2, 2018 thyroxine-60% 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 subspecialty of endocrinology. Findings include: On August 13, 2018, on or about 1:30 PM, 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, thyroxine, in the subspecialty of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2108. 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 in the subspecialty of endocrinology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & -- 2 of 3 -- Medicaid Services (CMS) 153 and 155 reports on August 13, 2018 on or about 1:30 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2018 thyroxine-0% Event #2, 2018 thyroxine-60% -- 3 of 3 --