Affinity Physicians Services

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 reviews of the CMS (Centers for Medicare and Medicaid) CASPER reports and Medical Laboratory Evaluations (MLE), and interviews with a MLE representative on 7/20/2022 at 12:07 PM, and labortory testing personnel, the surveyor determined the laboratory failed to successfully participate in proficiency testing for WBC (White Blood Cell Differential) for three consecutive events, Event 3, 2021 and Events 1 and 2, 2022. These failures resulted in a non-initial unsuccessful PT participation. Refer to D2130. . D2130 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 3 -- 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 reviews of the CMS (Centers for Medicare and Medicaid) CASPER reports and Medical Laboratory Evaluations (MLE), and interviews with a MLE representative on 7/20/2022 at 12:07 PM, and the testing personnel, the surveyor determined the laboratory failed to satisfactorily perform in WBC (White Blood Cell Differential) testing for three consecutive events, Event 3, 2021 and Events 1 and 2, 2022. These failures resulted in a non-initial unsuccessful PT participation. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following for the WBC Differential: a) Event #3, 2021 = 73 % b) Event #1, 2022 = 46 % c) Event #2, 2022 = 66% 2. On 7/20/2022 at 12:07 PM, the surveyor spoke to a MLE representative, who confirmed the laboratory failed PT and provided the following reports: a) MLE M3, 2021 = 73 % b) MLE M1, 2022 = 46 % c) MLE M2, 2022 = 66% 3. On 7/21/2022 at 4:52 PM, the testing personnel left a voicemail message confirming the failures of the WBC differentials, because the absolute numbers were reported instead of the percentages. On 7/26/2022, the testing personnel left another voicemail message, explaining the samples were rerun, and the WBC differential values repeated the same. The error was in the reporting. At 2:43 PM, the testing personnel stated the laboratory would cease testing, until further notice. 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 reviews of the CMS CASPER reports and MLE proficiency testing reports, interviews with a MLE representative and laboratory testing personnel, the laboratory director failed to ensure the testing personnel successfully participated in proficiency testing for White Blood Cell (WBC) Differential (Hematology) for three consecutive testing events, Events #3 2021, and Events #1 and #2, 2022. These failures resulted in a non-initial unsuccessful participation. Refer to D6016. . 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: -- 2 of 3 -- Based on reviews of the CMS CASPER reports and MLE proficiency testing reports, interviews with a MLE representative and laboratory testing personnel, the laboratory director failed to ensure the testing personnel successfully participated in proficiency testing for White Blood Cell (WBC) Differential (Hematology) for three consecutive testing events, Events #3 2021, and Events #1 and #2, 2022. These failures resulted in a non-initial unsuccessful participation. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following for the WBC Differential: a) Event #3, 2021 = 73 % b) Event #1, 2022 = 46 % c) Event #2, 2022 = 66% 2. On 7/20/2022 at 12:07 PM, the surveyor spoke to a MLE representative, who confirmed the laboratory failed PT and provided the following reports: a) MLE M3, 2021 = 73 % b) MLE M1, 2022 = 46 % c) MLE M2, 2022 = 66% 3. On 7/21/2022 at 4:52 PM, the testing personnel left a voicemail message confirming the failures of the WBC differentials, because the absolute numbers were reported instead of the percentages. On 7/26/2022, the testing personnel left another voicemail message, explaining the samples were rerun, and the WBC differential values repeated the same. The error was in the reporting. At 2:43 PM, the testing personnel stated the laboratory would cease testing, until further notice. -- 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 reviews of the CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing evaluations, the laboratory failed the WBC Differential (White Blood Cell Differential) for two consecutive testing events, Event #3, 2021 and Event #1, 2022. These failures resulted in an initial unsuccessful participation. The findings include: 1. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 reviews of the CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing evaluations, the laboratory failed the WBC Differential (White Blood Cell Differential) for two consecutive testing events, Event #3, 2021 and Event #1, 2022. These consecutive failures resulted in an initial unsuccessful participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored 73 % for the WBC Differential for Event #3, 2021 and 46 % for Event #1, 2022 (unsatisfactory performances). 2. The MLE evaluations confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Procedure Manual, the current Laboratory Director failed to approve the Policy and Procedure Manual once starting as Laboratory Director. The findings include: 1. A review of the Procedure Manual revealed that the former Laboratory Director signed the Policy and Procedure Manual 06/03/2020, 06/06/2019, and 05/08/2018. The current Laboratory Director started at the first of 2021. 2. A review of the Procedure Manual revealed in the Quality Assessment #6 Policies and Procedures - "...All procedures will be reviewed annually be the laboratory director or designee (Technical Consultant)." 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 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 a review of the MLE (Medical Laboratory Evaluation) proficiency testing (PT) records and an interview with Testing Personnel #4, the laboratory failed to retain the attestation statements for five out of six 2016-2018 survey events. The findings include: 1. A review of MLE proficiency testing records revealed the laboratory failed to retain the attestation statements for five Hematology surveys: 2016-M2 and M3, 2017-M1 and M2, and 2018-M1. 2. During an interview on 5/2 /2018 at 1:45 PM, Testing Personnel #4 stated she had mailed the attestation statements with the results to MLE, but had failed to make a copy of the attestation statements for their records. Thus the above noted findings were confirmed. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, 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 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)