Integrated Medical Professionals, Pllc

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 four of four consecutive testing events in the Hematology specialty for the Cell Identification or White Blood Cell Differential (Cell ID or WBC Diff), Red Blood Cell (RBC), Hematocrit (HCT) (Non-Waived), Hemoglobin (HGB) (Non-Waived), White Blood Cell (WBC) Count, and Platelets test analytes in 2023 and 2024 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 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for four of four consecutive testing events for the specialty Hematology in the analytes Cell ID or WBC Diff, 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. Cell ID or WBC Diff Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 2. RBC Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 3. HCT (Non-Waived) Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 4. HGB (Non-Waived) Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 5. WBC Count Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% 6. Platelets Test Analyte: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% b. A review of the PT scores from API (2023 and 2024) 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 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for four of four consecutive testing events for the specialty Hematology. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2023 First Event = 0% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 0% b. A review of the proficiency testing scores from API (2023 and 2024) 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. -- 2 of 3 -- 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 2023 and 2024, 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 2023-1, 2023-2, 2023-3, and 2024-1 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the corrected report standard operating procedure, the laboratory failed to define result verification objective criteria when a corrected report was generated. Confirmed findings by interview with the laboratory director on August 22, 2023, at approximately 1:30 P.M. 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, 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)

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of laboratory's API PT summary report of second and third event of year 2021, the laboratory failed to document evaluation and verification activities Findings 1. API 2021 Second event: bacteriology susceptibility 97%, mycology candida culture 80% 2. API 2021 third event: iron total 80% 3. Confirmed in an interview with laboratory director on 11/29/2022 about 2:00pm 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 --