Rainbow Pediatrics

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 a review of the Hematology maintenance records, maintenance record log, and an interview with Testing Personnel #1, the Laboratory failed to perform and document monthly maintenance on the Beckman Coulter DxH 520 Hematology analyzer as per the manufacturer's requirements. This was noted for 15 of 22 months reviewed in 2024 through 2025. The findings include: 1. A review of the Beckman Coulter DxH 520 Hematology analyzer records revealed no documentation of monthly maintenance for the following months: a. 2024: January-June and September- November. b. 2025: February-May, August, and September. 2. A further review of the maintenance record log revealed, "Monthly Maintenance: Clean the WBC Bath Filter." 3. During an interview on October 28, 2025, at 12:15 PM, Testing Personnel #1 confirmed the above findings. 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 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 a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. Three of five testing personnel listed on the Form CMS-209 (Laboratory Personnel Report) performed zero to one PT surveys in the 2019 - 2021 review period. The finding include: 1. A review of the 2019 - 2021 API PT attestation statements revealed the following: A) Testing personnel #3 was listed as a testing personnel during the previous survey, however she failed to perform any proficiency testing in 2019-2021. B) Testing Personnel #4 was a testing personnel in 2019 and 2021 (but not in 2020), however she had not performed any proficiency testing. C) Testing Personnel #5 was hired in December 2019, and performed one Hematology survey in 2020, and no surveys in 2021. 2. In an interview on 12/20/2021 at 1:45 PM Testing Personnel #1 confirmed the above findings, stating she usually did the proficiency testing since she was the primary testing personnel. The surveyor explained all testing personnel listed on the Form CMS-209 should participate in at least one proficiency testing event annually. SURVEYOR ID#32558 Licensure and Certification Surveyor 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 --