Cfp Physicians Group

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 17, 2022 to June 24, 2022. CFP Physicians Group clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have all testing personnel rotate through testing of proficiency testing (PT) samples for 5 (2020 2nd & 3rd; 2021 2nd & 3rd; 2022 1st) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory also failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 6 (2020 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) of 7 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) in the subspecialties of Routine Chemistry and Endocrinology. This is a repeat deficiency from the recertification survey of 02/05 /2022. Findings: Review of the American Proficiency Institute (API) PT attestation forms showed Testing Personnel A performed the PT for Hematology for 2020 2nd & 3rd events; 2021 2nd & 3rd events; and 2022 1st event. Review of the API PT records for Hematology testing listed the following submission deadlines: 2020 2nd event 07 /24/2020 2020 3rd event 11/20/2020 2021 1st event 03/31/2021 2021 2nd event 08/04 /2021 2021 3rd event 11/23/2021 2022 1st event 03/30/2022 Review of the API PT attestation forms showed Testing Personnel A performed PT for Chemistry Core (Routine Chemistry and Endocrinology) for the 2020 3rd event; 2021 1st, 2nd & 3rd; 2022 1st & 2nd. Review of the API PT records for Chemistry Core testing listed the following submission deadlines: 2020 2nd event 06/05/2020 2020 3rd event 09/11 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- /2020 2021 1st event 02/03/2021 2021 2nd event 06/09/2021 2021 3rd event 09/15 /2021 2022 1st event 02/02/2022 2022 2nd event 06/08/2022 Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 06/17 /2022 listed three Testing Personnel (A, B, C). Testing Personnel A had competency evaluations performed on 01/13/2020, 01/14/2021, and 12/20/2021. Testing Personnel B had competency evaluations performed on 01/04/2021 and 01/19/2022. Testing Personnel C had competency evaluations performed on 01/13/2020, 01/14/2021, and 12/20/2021. Testing Personnel D was no longer employed by the laboratory and had competency evaluations performed on 12/19/19. The laboratory was unable to locate Personnel D's 2020 competency evaluation. Testing Personnel E was no longer employed by the laboratory and had competency evaluations performed on 01/13/20. On 06/17/2022 at 10:30 AM, the Technical Consultant stated Testing Personnel A did most of the PT. On 06/17/2022 at 3:00 PM, Testing Personnel A stated Testing Personnel B started working in the laboratory in 10/2020 and Testing Personnel C started working in the laboratory in 2/2022. Testing Personnel A also stated Testing Personnel D's last day of work in the laboratory was 07/20/2021 and Testing Personnel E's last day working in the laboratory was 06/20/2021. 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 interview, the laboratory failed to maintain copies of the testing results (instrument printouts) from the proficiency testing (PT) for 2 (2020 2nd & 3rd) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory failed to maintain copies of testing results (instrument printouts) from proficiency testing (PT) for 2 (2020 2nd & 3rd) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the subspecialties of Routine Chemistry and Endocrinology (Chemistry Core). Findings: Review of the American Proficiency Institute (API) PT records showed instrument printouts for the 2020 2nd and 3rd events in Hematology and the 2020 2nd and 3rd events in Chemistry Core were missing On 06/17/2022 at 1:55 PM, the Technical Consultant stated they were unable to locate the instrument printouts. 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 -- 2 of 5 -- 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 all SARS-COV- 2 (Severe Acute Respiratory Syndrome Coronavirus 2) test results as required to Florida Department of Health (FDOH) since testing began on 12/08/2020. Findings: Cross Reference D3009. Based on observation and interviews, the laboratory failed to report their negative Corona Virus Disease 2019 (COVID-19) test results and failed to provide documentation of reporting positive test results as required by the Florida Department of Health from 12/08/2021 to 06/17/2022. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to report negative Corona Virus Disease 2019 (COVID-19) test results and failed to provide documentation of reporting positive test results as required by the Florida Department of Health (FDOH) from 12/08/2021 to 06/17/2022. Findings: The mandatory reporting requirements outlined by FDOH Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, noted laboratories must report both negative and positive COVID-19 test results. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 06/17/2022, the laboratory listed they performed COVID-19 testing using the Abbott Diagnostics ID instrument. A tour of the laboratory on 6/17/20 at 9:40 AM, revealed the laboratory had Abbott Diagnostics ID NOW Instrument, a box containing Package #1, the test base, and a box containing Package #2, the transfer cartridge. On 06/17/2022 at 3:25 PM, the Office Manager stated they faxed the positive COVID-19 test results to FDOH and they had not reported the negative COVID-19 results. On 06/17/2022 at 3:27 PM, the Office Manager stated that she kept records showing the positive results were faxed for a while, then stopped and threw all the records out. On 06/21/2022 at 8:31 AM, Testing Personnel A reported in an email the first day of COVID-19 testing was 12/18/2020. On 06/24/2022 at 3:27 PM, the Office Manager reported in an email the laboratory had performed 636 COVID-19 tests. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in -- 3 of 5 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, observation, and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and identify problems. Findings: Cross Reference D5415. Based on observation and interview, the laboratory failed to properly label quality control and calibrator bottles currently in use in Hematology and Chemistry testing from 06/13 /2022 to 06/17/2022. This is a repeat deficiency from the 02/05/2020 recertification survey. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to properly label quality control and calibrator bottles currently in use in Hematology and Chemistry testing from 06/13/2022 to 06/17/2022. This is a repeat deficiency from the 02/05/2020 recertification survey. Findings: According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 06/17/2022, the laboratory had a total estimated annual test volume of 68,433 tests per year. 1. A tour of the laboratory on 6/17/20 at 9:40 AM, revealed the low, normal, and high Cell-Dyn 18 Plus Controls (lot #L2094, N2094 & H2094) for the Cell-Dyn Emerald Hematology analyzer did not have the new expiration date on the opened vials. Review of the Assay Sheet for the Cell-Dyn 18 Plus Controls noted the controls had a "8 Consecutive Day Open - Tube Stability." 2. A tour of the laboratory on 6/17/20 at 9:40 AM revealed the Beckman Coulter Lyophilized Chemistry Calibrator - Level 1 (lot #9610101) and Level 2 (lot #9610101) for the Beckman Coulter AU 480 Chemistry analyzer did not have the new expiration date on the opened vials. Review of the package inserts for the Beckman Coulter Lyophilized Chemistry Calibrator noted "Reconstituted calibrator materials are stable for 7 days from the date of reconstitution . . . ." On 6/17/20 at 9:45 AM, Testing Personnel A stated they only wrote the opened date on the reagents. 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 record review, and staff interview, the Laboratory Director failed to provide overall management and direction of the laboratory. Findings: Cross Reference -- 4 of 5 -- D6016. Based on record review and interview, the Laboratory Director failed to ensure proficiency testing was performed for all testing personnel in the laboratory as required by Subpart H from 06/2020 to 06/17/2022. 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 record review, and interview, the Laboratory Director failed to ensure proficiency testing was performed by all testing personnel in the laboratory as required by Subpart H from 06/2020 to 06/17/2022. Findings The Laboratory Director failed to ensure all testing personnel rotated through testing of proficiency testing (PT) samples for 5 (2020 2nd & 3rd; 2021 2nd & 3rd; 2022 1st) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 6 (2020 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) of 7 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) in the subspecialties of Routine Chemistry and Endocrinology. This is a repeat deficiency form the recertification survey on 02/05/2022. (See D2007) -- 5 of 5 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 17, 2022 to June 24, 2022. CFP Physicians Group clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have all testing personnel rotate through testing of proficiency testing (PT) samples for 5 (2020 2nd & 3rd; 2021 2nd & 3rd; 2022 1st) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory also failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 6 (2020 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) of 7 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) in the subspecialties of Routine Chemistry and Endocrinology. This is a repeat deficiency from the recertification survey of 02/05 /2022. Findings: Review of the American Proficiency Institute (API) PT attestation forms showed Testing Personnel A performed the PT for Hematology for 2020 2nd & 3rd events; 2021 2nd & 3rd events; and 2022 1st event. Review of the API PT records for Hematology testing listed the following submission deadlines: 2020 2nd event 07 /24/2020 2020 3rd event 11/20/2020 2021 1st event 03/31/2021 2021 2nd event 08/04 /2021 2021 3rd event 11/23/2021 2022 1st event 03/30/2022 Review of the API PT attestation forms showed Testing Personnel A performed PT for Chemistry Core (Routine Chemistry and Endocrinology) for the 2020 3rd event; 2021 1st, 2nd & 3rd; 2022 1st & 2nd. Review of the API PT records for Chemistry Core testing listed the following submission deadlines: 2020 2nd event 06/05/2020 2020 3rd event 09/11 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- /2020 2021 1st event 02/03/2021 2021 2nd event 06/09/2021 2021 3rd event 09/15 /2021 2022 1st event 02/02/2022 2022 2nd event 06/08/2022 Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 06/17 /2022 listed three Testing Personnel (A, B, C). Testing Personnel A had competency evaluations performed on 01/13/2020, 01/14/2021, and 12/20/2021. Testing Personnel B had competency evaluations performed on 01/04/2021 and 01/19/2022. Testing Personnel C had competency evaluations performed on 01/13/2020, 01/14/2021, and 12/20/2021. Testing Personnel D was no longer employed by the laboratory and had competency evaluations performed on 12/19/19. The laboratory was unable to locate Personnel D's 2020 competency evaluation. Testing Personnel E was no longer employed by the laboratory and had competency evaluations performed on 01/13/20. On 06/17/2022 at 10:30 AM, the Technical Consultant stated Testing Personnel A did most of the PT. On 06/17/2022 at 3:00 PM, Testing Personnel A stated Testing Personnel B started working in the laboratory in 10/2020 and Testing Personnel C started working in the laboratory in 2/2022. Testing Personnel A also stated Testing Personnel D's last day of work in the laboratory was 07/20/2021 and Testing Personnel E's last day working in the laboratory was 06/20/2021. 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 interview, the laboratory failed to maintain copies of the testing results (instrument printouts) from the proficiency testing (PT) for 2 (2020 2nd & 3rd) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory failed to maintain copies of testing results (instrument printouts) from proficiency testing (PT) for 2 (2020 2nd & 3rd) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the subspecialties of Routine Chemistry and Endocrinology (Chemistry Core). Findings: Review of the American Proficiency Institute (API) PT records showed instrument printouts for the 2020 2nd and 3rd events in Hematology and the 2020 2nd and 3rd events in Chemistry Core were missing On 06/17/2022 at 1:55 PM, the Technical Consultant stated they were unable to locate the instrument printouts. 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 -- 2 of 5 -- 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 all SARS-COV- 2 (Severe Acute Respiratory Syndrome Coronavirus 2) test results as required to Florida Department of Health (FDOH) since testing began on 12/08/2020. Findings: Cross Reference D3009. Based on observation and interviews, the laboratory failed to report their negative Corona Virus Disease 2019 (COVID-19) test results and failed to provide documentation of reporting positive test results as required by the Florida Department of Health from 12/08/2021 to 06/17/2022. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to report negative Corona Virus Disease 2019 (COVID-19) test results and failed to provide documentation of reporting positive test results as required by the Florida Department of Health (FDOH) from 12/08/2021 to 06/17/2022. Findings: The mandatory reporting requirements outlined by FDOH Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, noted laboratories must report both negative and positive COVID-19 test results. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 06/17/2022, the laboratory listed they performed COVID-19 testing using the Abbott Diagnostics ID instrument. A tour of the laboratory on 6/17/20 at 9:40 AM, revealed the laboratory had Abbott Diagnostics ID NOW Instrument, a box containing Package #1, the test base, and a box containing Package #2, the transfer cartridge. On 06/17/2022 at 3:25 PM, the Office Manager stated they faxed the positive COVID-19 test results to FDOH and they had not reported the negative COVID-19 results. On 06/17/2022 at 3:27 PM, the Office Manager stated that she kept records showing the positive results were faxed for a while, then stopped and threw all the records out. On 06/21/2022 at 8:31 AM, Testing Personnel A reported in an email the first day of COVID-19 testing was 12/18/2020. On 06/24/2022 at 3:27 PM, the Office Manager reported in an email the laboratory had performed 636 COVID-19 tests. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in -- 3 of 5 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, observation, and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and identify problems. Findings: Cross Reference D5415. Based on observation and interview, the laboratory failed to properly label quality control and calibrator bottles currently in use in Hematology and Chemistry testing from 06/13 /2022 to 06/17/2022. This is a repeat deficiency from the 02/05/2020 recertification survey. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to properly label quality control and calibrator bottles currently in use in Hematology and Chemistry testing from 06/13/2022 to 06/17/2022. This is a repeat deficiency from the 02/05/2020 recertification survey. Findings: According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the Laboratory Director on 06/17/2022, the laboratory had a total estimated annual test volume of 68,433 tests per year. 1. A tour of the laboratory on 6/17/20 at 9:40 AM, revealed the low, normal, and high Cell-Dyn 18 Plus Controls (lot #L2094, N2094 & H2094) for the Cell-Dyn Emerald Hematology analyzer did not have the new expiration date on the opened vials. Review of the Assay Sheet for the Cell-Dyn 18 Plus Controls noted the controls had a "8 Consecutive Day Open - Tube Stability." 2. A tour of the laboratory on 6/17/20 at 9:40 AM revealed the Beckman Coulter Lyophilized Chemistry Calibrator - Level 1 (lot #9610101) and Level 2 (lot #9610101) for the Beckman Coulter AU 480 Chemistry analyzer did not have the new expiration date on the opened vials. Review of the package inserts for the Beckman Coulter Lyophilized Chemistry Calibrator noted "Reconstituted calibrator materials are stable for 7 days from the date of reconstitution . . . ." On 6/17/20 at 9:45 AM, Testing Personnel A stated they only wrote the opened date on the reagents. 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 record review, and staff interview, the Laboratory Director failed to provide overall management and direction of the laboratory. Findings: Cross Reference -- 4 of 5 -- D6016. Based on record review and interview, the Laboratory Director failed to ensure proficiency testing was performed for all testing personnel in the laboratory as required by Subpart H from 06/2020 to 06/17/2022. 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 record review, and interview, the Laboratory Director failed to ensure proficiency testing was performed by all testing personnel in the laboratory as required by Subpart H from 06/2020 to 06/17/2022. Findings The Laboratory Director failed to ensure all testing personnel rotated through testing of proficiency testing (PT) samples for 5 (2020 2nd & 3rd; 2021 2nd & 3rd; 2022 1st) of 6 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd; 2022 1st) in the specialty of Hematology. The laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 6 (2020 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) of 7 events (2020 2nd & 3rd; 2021 1st, 2nd & 3rd, 2022 1st & 2nd) in the subspecialties of Routine Chemistry and Endocrinology. This is a repeat deficiency form the recertification survey on 02/05/2022. (See D2007) -- 5 of 5 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on November 4, 2021 for CFP Physicians Group. CFP Physicians Group 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 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 November 4, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, blood urea nitrogen, BUN, for two out of three testing events in 2021. 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 November 4, 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, BUN, as shown below. Event #1, 2021 BUN-60% Event #3, 2021 BUN-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 subspecialty of routine chemistry. Findings include: On November 4, 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, BUN, in the subspecialty of routine chemistry. 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; -- 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 subspecialty of routine chemistry. 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 November 4, 2021 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #1, 2021 BUN-60% Event #3, 2021 BUN-20% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 01 /25/2021 for CFP Physicians Group. The CFP Physicians Group 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 subspecialty/specialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review 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 -- of 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 had unsatisfactory testing scores for the analyte, White Blood Cell Differential. Refer to 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 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, White Blood Cell Differential (WBC diff) as shown below. Event #22, 2020 WBC diff-73% Event #3, 2020 WBC diff-73% 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, 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; -- 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 for 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 January 25, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2020 white blood cell differential-73% Event #3, 2020 white blood cell differential-73% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on February 5, 2020. CFP Physicians Group was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 6 out of 6 events in Hematology (2018 1st, 2nd & 3rd; 2019 1st, 2nd & 3rd), 3 out of 6 events in Chemistry Core (2018 1st, 2nd & 3rd) (2018 1st, 2nd, and 3rd, 2019 1st, 2nd & 3rd), and 2 out of 4 events in Chemistry Miscellaneous (2018 1st & 2nd) (2018 1st & 2nd, 2019 1st & 2nd). Findings: Review of the American Proficiency Institute (API) PT attestation forms showed that Testing Personnel A performed the PT for: Hematology - 6 out of 6: 2018 1st, 2nd & 3rd, and 2019 1st, 2nd & 3rd Chemistry Core -3 out of 6: 2018 1st, 2nd & 3rd Chemistry Miscellaneous 2 out of 4: 2018 1st & 2nd. Review of the CMS-209 form "Laboratory Personnel Report (CLIA)" that was signed and dated by the Laboratory Director on 10/30/20 listed 3 testing personnel. During an interview on 2/5/20 at 3:40 PM, the Testing Personnel confirmed that she had performed all the proficiency testing for 2018 and 2019 in Hematology, and 2018 in Chemistry Core and Chemistry Miscellaneous. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- 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, the laboratory failed to receive at least 80% score for two analytes for the second testing event of 2019 for the specialty of Chemistry. Findings: Review of the American Proficiency Institute (API) proficiency testing records revealed that the laboratory received a score of 0% for the analyte Glucose and 60% for the analyte Calcium for the second event of 2019. During an interview on 2/5/20 at 3:41 PM, Testing Personnel A confirmed the laboratory the proficiency testing results. 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 and interview, the laboratory failed to receive at least 80% score for two analytes for the third testing event of 2018 for the specialty of Hematology. Findings: Review of the American Proficiency Institute (API) proficiency testing records revealed that the laboratory received a score of 0% for the analyte Erythrocyte Count and 60% for the analyte Hemoglobin for the third event of 2018. During an interview on 2/5/20 at 3:41 PM, Testing Personnel A confirmed the laboratory the proficiency testing results. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to properly label quality control and calibrator bottles currently in use in Hematology, Chemistry and Endocrinology testing. Findings: 1. A tour of the laboratory on 2/5/20 at 9:25 AM revealed that the low, normal, and high Cell-Dyn 18 Plus Controls (lot #L9350, N9350 & H9350) for the Cell-Dyn Emerald Hematology analyzer did not have the new expiration date on the opened vials. Review of the Assay Sheet for the Cell-Dyn 18 Plus Controls noted that the controls are stable for 8 consecutive days once opened. 2. A tour of the laboratory on 2/5/20 at 9:30 AM revealed that the A Pointe Scientific Level 1 Cont Serum (lot #926301-323 & 929001-022), Level 2 Cont Serum (lot #920501-323 & 920501-022), and Chemistry Calibrator (lot #930103-325) for the Mindray BS-200 Chemistry analyzer did not have the new expiration date on the opened vials. Review of the package inserts for the A Pointe Scientific controls and calibrators noted that the reconstituted controls and calibrators are stable for seven days. 3. A tour of the laboratory on 2/5/20 at 9:40 AM revealed that the Access -- 2 of 3 -- Calibrator bottles for the Beckman Coulter Access 2 Immunoassay Endocrinology analyzer did not have an open date on the bottles. The Access Hybritech PSA Calibrators (lot #921357) were labeled "recd 11/15/19" on the box. The Access TSH (3rd IS) Calibrators (lot #920910) had no date on the box or bottles. The Access Vitamin B12 Calibrators (lot #921025) were labeled as "11/21" on the box. During an interview on 2/5/20 at 10:25 PM, Testing Personnel A acknowledged she did not write the new expiration dates on the Hematology controls and Chemistry controls and calibrator, and that the open dates for Endocrinology calibrators were not recorded on the bottles. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the daily background check for the Cell-Dyn Emerald Hematology analyzer from 2/5/18 to 2/5 /20. Findings: Review of the quality control records showed that there were no records to show the results of the daily background check on the Cell-Dyn Emerald Hematology analyzer. During an interview on 2/5/20 at 4:00 PM, Testing Personnel A confirmed that the laboratory performed background counts on the Cell-Dyn Emerald Hematology analyzer, that they didn't printouts the background check results, and she didn't know how to retrieve the results from the analyzer. -- 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 subspecialty of routine chemistry. Refer to D2096. 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 October 24, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, blood urea nitrogen, BUN, for two out of three testing events in 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 -- 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 October 24, 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, blood urea nitrogen (BUN) as shown below. Event #1, 2019 BUN-60% Event #3, 2019 BUN-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 October 24, 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, blood urea nitrogen, (BUN), in the sub specialty of routine chemistry. 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 -- 2 of 3 -- the analyte, blood urea nitrogen, (BUN), in the sub specialty of routine chemistry. 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 October 24, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2019 BUN-60 % Event #3, 2019 BUN-60% -- 3 of 3 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on examination and interview with Testing Personnel A, the laboratory failed to perform function checks on four out of four timers used in the laboratory from 1-24- 16 through 1-24-18. Findings included: During a tour of the laboratory on 1-24-18 at 2:35 PM revealed that four out of four timers were out of calibration. Timer #1 was due for calibration on 2-1-08 Timer #2 was due for calibration on 11-28-09 Timer #3 was due for calibration on 6-20-09 Timer #4 was due for calibration on 8-4-12 During an interview on 1-24-18 at 2:35 PM, Testing Personnel A confirmed that the timers had not been calibrated. 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 --