Rainbow Pediatrics Of Fayetteville - Hope Mills

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API (American Proficiency Institute) proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for RBC (red blood cell count) and Hemoglobin, and failed to achieve overall test event scores of satisfactory for Hematology on 2 of 3 consecutive test events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiencies cited at D2130 and D2131. 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) (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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory failed to achieve satisfactory performance for RBC and Hemoglobin on 2 of 3 consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and 2024 API proficiency testing results revealed the laboratory received a score of 20% for RBC and a score of 40% for Hemoglobin on the 2024 Hematology/Coagulation 2nd Event. 2. Desk review of CMS Casper reports 153D and 155D and 2025 API proficiency testing results revealed the laboratory received a score of 20% for RBC and a score of 40% for Hemoglobin on the 2025 Hematology/Coagulation 1st Event. 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory failed to achieve an overall test event score of satisfactory performance for Hematology on 2 of 3 consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and 2024 API proficiency testing results revealed the laboratory received an overall score of 73% for Hematology on the 2024 Hematology/Coagulation 2nd Event. 2. Desk review of CMS Casper reports 153D and 155D and 2025 API proficiency testing results revealed the laboratory received an overall score of 60% for Hematology on the 2025 Hematology /Coagulation 1st Event. 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 desk review of CMS Casper reports 153D and 155D on 7/30/25 and desk review of 2024 and 2025 API proficiency testing results 9/3/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiencies cited at D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2020, 2021, 2022, and 2023 API (American Proficiency Institute) proficiency testing records, the laboratory failed to test proficiency samples in the same manner that patient specimens are routinely tested for 9 of 10 test events. Review of the laboratory's quality assessment policies and procedures revealed "... General Laboratory Systems ... Proficiency Testing PT samples are tested to the extent possible, exactly like patient specimens, i.e., the same number of times and using the same personnel and methods as for patient testing. ..." The laboratory's quality assessment policies and procedures also stated "... Panic/Alert Value Procedures ... Recheck, Remix, Rerun, repeat & report". Review of the laboratory's policies and procedures revealed the following policy for patient testing "CBC Results Testing personnel will rerun cbs's when results are out of range or there is a message on the results then all results are given to the provider and they review all cbc results and determine if the results are acceptable or if they need to be reran or if follow up lab work is required." Review of 2020, 2021, 2022, and 2023 API proficiency testing records revealed there was no documentation that proficiency samples were rerun for flags or panic values on the following samples: 1. 2020 a. 1st hematology test event - samples HSY-01, HSY-03, HSY-05; 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 -- b. 2nd hematology test event - samples HSY-06, HSY-07, HSY-09; c. 3rd hematology test event - samples HSY-11, HSY-12, HSY-14, HSY-15. 2. 2021 a. 1st hematology test event - samples HSY-01, HSY-02, HSY-03, HSY-05; b. 2nd hematology test event - samples HSY-08, HSY-09, HSY-10; c. 3rd hematology test event - samples HSY-11, HSY-13, HSY-15. 3. 2022 a. 1st hematology test event - samples HSY-02, HSY-03, HSY-04; b. 2nd hematology test event - samples HSY-06, HSY-07, HSY- 09; c. 3rd hematology test event - samples HSY-13, HSY-14, HSY-15. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of 2020, 2021, 2022, and 2023 maintenance records, the absence of records, and interview with TP (testing personnel) 5/25/23, the laboratory failed to perform and document the manufacturer's specified maintenance for the Medonic M-Series hematology analyzer daily for 22 of 22 days in April 2020, and failed to perform and document the monthly maintenance for the Medonic M-Series hematology analyzer for 41 of 41 months from January 2020 to May 2023. Findings: Review of the Medonic M-series Procedure Manual revealed "...Maintenance: Daily cleaning should be performed according to the Medonic M-Series User's Manual. Instrument maintenance is performed monthly and semi-annually according to the manufacturer's instructions utilizing the Boule Cleaning kit. ... All maintenance should be documented (a maintenance log is recommended), and the documentation saved for a minimum of 2 years. ..." Review of 2020, 2021, 2022, and 2023 Medonic M-Series maintenance records revealed: 1. The laboratory failed to utilize the maintenance log provided by the manufacturer. 2. The laboratory failed to perform and document daily maintenance for 22 of 22 days in April 2020. 3. The laboratory failed to perform and document monthly maintenance for: a. 12 of 12 months in 2020; b. 12 of 12 months in 2021; c. 12 of 12 months in 2022; d. 5 of 5 months (January - May) in 2023. During interview at approximately 12: 27 p.m., TP #1 confirmed that the monthly maintenance was not documented as required. -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) differential in two consecutive testing events. See the deficiency cited at 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 3 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential on 2 consecutive testing events. Findings: Review of CMS Casper report 155D and review of 2018 and 2019 API proficiency testing results revealed: 1. For the 2018 3rd hematology testing event, the laboratory provided unacceptable responses for 2 of 5 lymphocytes % samples and 2 of 5 neutrophils/granulocytes % samples, resulting in a score of 73% for WBC Differential. 2. For the 2019 1st hematology testing event, the laboratory provided unacceptable responses for 4 of 5 monocytes % samples, resulting in a score of 73% for WBC Differential. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: Review of CMS Casper report 155D and review of 2018 and 2019 API proficiency testing results revealed: 1. For the 2018 3rd hematology testing event, the laboratory provided unacceptable responses for 2 of 5 lymphocytes % samples and 2 of 5 neutrophils/granulocytes % samples, resulting in a score of 73% for WBC Differential. 2. For the 2019 1st hematology testing event, the laboratory provided -- 2 of 3 -- unacceptable responses for 4 of 5 monocytes % samples, resulting in a score of 73% for WBC Differential. -- 3 of 3 --