Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Preferred Pediatrics at Snowden on June 24, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a review of the laboratory's policies and procedures, Cell-Dyn Emerald's Operator's Guide, calibration records, quality control records, lack of documentation and interviews, the laboratory failed to follow their established policy to run quality control (QC) after calibration of the Cell-Dyn Emerald for two (2) of 2 calibrations from 1/2025 until 6/2025. The findings include: 1. Review of the laboratory's policies and procedures revealed a statement, "Calibrate CBC every 6 months-see CBC manual for detailed instructions." 2. Review of the Cell-Dyn Emerald hematology analyzer's Operator's Guide revealed a statement, "Abbott recommends you, run controls: ... After calibration (confirmatory step)." 3. Review of the laboratory's calibration records for the Abbott Emerald revealed calibrations were performed on 01 /28/2025 and 06/10/2025. Further review of the calibration records revealed a lack of post-calibration QC for 01/28/2025 and 06/10/2025. The surveyor requested to review the post-calibration QC for the 2 above listed calibration events. The laboratory provided no documentation for review. 4. In an exit interview with the laboratory manager on June 24, 2025 at 12:15 PM, the findings were confirmed. 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 -- D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Cell-Dyn Emerald's operator's manual, hematology calibration records, and interview, the laboratory failed to perform the Cell-Dyn Emerald calibration procedures every six months from July 27, 2023 up to the date of the survey on June 24, 2025. The findings include: 1. Review of the Cell-Dyn Emerald's operator's manual the Abbott Emerald hematology analyzer, revealed a section, "When to Calibrate", with a statement, "Calibration verification criteria include: When indicated by Quality Control data; After major maintenance and service procedures; At least every six months." 2. Review of the hematology calibration documents for the Abbott Emerald analyzer from July 2023 up to the date of the survey on June 24, 2025 revealed calibration procedures performed on 12/13 /2023, 6/20/2024 (6 months), 01/28/2025 (7 months) and 6/10/2025 (5 months). The surveyor requested to review additional calibration procedures for the above mentioned time frame. The laboratory provided no further documentation for review. 3. In an exit interview with the laboratory manager on June 24, 2025 at 12:15 PM, the findings were confirmed. D5781