Allied Physicians Group Pllc

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of waived test manufacturer's instructions, lack of urine analysis (UA) Quality Control (QC) records, as well as interview with the Technical Consultant (TC), the laboratory failed to comply with manufacturers' instructions for performing the test. FINDINGS: 1. There was no documentation of QC performance for Siemens Multistix 10 SG reagent test strip bottles from 2023 through the survey date. 2. This is contrary to Siemens Multistix 10 SG manufacturer's instructions which indicated QC must be performed when opening a new bottle. 3. The TC confirmed the findings September 23, 2025, at approximately 11:30 A.M. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Testing (API) PT (Proficiency Testing) records as well as interview with the Technical Consultant (TC), the laboratory failed to document attestation to the routine integration of the samples into the patient workload using the laboratory's routine methods. FINDINGS: 1. There was no Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- documentation of API testing personnel attestation for the following PT events: a. 2024 Throat Culture First Event. b. 2024 Throat Culture Second Event. c. 2024 Throat Culture Third Event. 2. The TC confirmed the findings September 23, 2025, at approximately 11:00 A.M. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency and training documentation, Standard Operating Procedures (SOPs), as well as interview with the TC, the laboratory failed to comply with written policies and procedures to assess employee and, if applicable, consultant competency. perform competency and training documents for technical consultant (TC) #2. FINDINGS: 1. There was no documentation of TC #2 competency and training performance and assessment. 2. The current, approved SOPs did not include instructions for performing such activity. 3. It was noted that TC #2 was responsible for Proficiency Testing (PT) review and

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on February 12, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology specialty for the Red Blood Cell (RBC), Hematocrit (HCT) (Non-Waived), Hemoglobin (HGB) (Non-Waived), White Blood Cell (WBC) Count, and Platelets test analytes in 2022 and 2023 resulting in unsuccessful performance. Refer to D2130 and 2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 CMS PT CASPER 0155D and API PT summary reports from 2022 and 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty Hematology in the analytes RBC, HCT (Non-Waived), HGB (Non-Waived), WBC Count, and Platelets. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. RBC Test Analyte: 2022 Third Event = 0% 2023 Second Event = 40% 2. HCT (Non-Waived) Test Analyte: 2022 Third Event = 0% 2023 Second Event = 40% 3. HGB (Non-Waived) Test Analyte: 2022 Third Event = 0% 2023 Second Event = 40% 4. WBC Count Test Analyte: 2022 Third Event = 0% 2023 Second Event = 40% 5. Platelets Test Analyte: 2022 Third Event = 0% 2023 Second Event = 60% b. A review of the proficiency testing scores from API (2022 and 2023) confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2022 and 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the specialty Hematology. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2022 Third Event = 0% 2023 Second Event = 53% b. A review of the PT scores from API (2022 and 2023) confirmed the above findings. 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 review of CMS PT CASPER 0155D and API PT summary reports from -- 2 of 3 -- 2022 and 2023, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT 2022-3 and 2023-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require