Downloaded from http://journals.lww.com/pidj by BhDMf5ePHKbH4TTImqenVHwt3+2Cz0wZADgUfEuJ92sAHiDFuJLjno7VNN7sr0SI on 03/03/2020 Copyright © 2020 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 188 | www.pidj.com The Pediatric Infectious Disease Journal • Volume 39, Number 3, March 2020 Background: Laboratory-based respiratory polymerase chain reaction (PCR) panels are rarely used in outpatient pediatric practice due to pro- longed turn-around times and cost of medical equipment. The BioFire Fil- mArray Respiratory Panel EZ (RP EZ) is a Clinical Laboratory Improve- ment Amendments–waived respiratory pathogen PCR panel which rapidly tests for 14 common respiratory organisms. The aim of this study was to identify the distribution of organisms seen in pediatric clinics and to deter- mine if utilization of this point-of-care test improved disease management, while exploring impact on clinic workflow. Methods: From January 2018 through January 2019, when clinically appropriate, patients were tested by the RP EZ and/or antigen tests (Clinic A) or antigen test only (Clinic B). Residual samples from Clinic B anti- gen tests were frozen and later tested on the RP EZ for definitive pathogen identification. Patient data and prescription records were extracted from the electronic health record. Results: A total of 430 patients had RP EZ tests performed, and at least 1 organism was detected in 70.4% of patients. The most common organisms identified were human rhinovirus/enterovirus, influenza, and respiratory syncytial virus. Appropriate treatment occurred for 93.6% of patients when the RP EZ was performed (Clinic A) versus 87.9% of patients who had only antigen tests performed (Clinic B, P = 0.0445). Utilization of RP EZ test- ing also significantly reduced appointment duration time (48.0 versus 54.9 minutes, P = 0.0009). Three false-positive influenza B results were identi- fied by antigen testing. Conclusions: A point-of-care PCR panel improved patient care by provid- ing an accurate diagnosis and shortened appointment duration. Key Words: point of care, respiratory polymerase chain reaction panel, pediatrics, outpatient (Pediatr Infect Dis J 2020;39:188–191) I n 2016, the Food and Drug Administration granted a Clinical Laboratory Improvement Amendments (CLIA) waiver to the BioFire FilmArray Respiratory Panel EZ (RP EZ) (BioFire Diag- nostics, Salt Lake City, UT), a respiratory pathogen polymerase chain reaction (PCR) assay which tests for 14 of the most common pathogens causing respiratory infections, including 11 viruses and 3 bacteria. 1 It qualitatively reports results for adenovirus, coro- navirus, human metapneumovirus, influenza A, influenza A sub- type H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus (RSV), Bordetella pertussis, Chla- mydophila pneumoniae and Mycoplasma pneumoniae. The assay requires approximately 3–5 minutes of hands-on time to set up the sample in the machine and approximately 1 hour to complete in its entirety. The majority of the time is sample evaluation by the machine and requires no hands-on support. Because the test is CLIA waived, it can be performed by the majority of clinic staff, including nurses and medical assistants, as long as the clinic has a Certificate of Waiver, 2 which is held by many outpatient pediatric clinics. Tests are given a CLIA waiver if they are simple to perform and have low risk of erroneous results. While molecular-based respiratory panels have become common and demonstrate benefits in hospital and emergency department settings, they are rarely used in outpatient practice due to prolonged turn-around time, high cost and other factors. 3,4 More commonly, rapid antigen tests for influenza and RSV are performed, which suffer from limited sensitivity compared with nucleic acid testing. 3,4 Therefore, the clinical impact of a rapid, point-of-care diagnostic PCR test for respiratory pathogens is unknown in the outpatient setting. We aimed to determine the distribution of organ- isms detected by a comprehensive respiratory PCR panel in the outpatient setting and determine if the utilization of a PCR assay resulted in improved disease management. In addition, we aimed to explore how the PCR assay fits into the workflow of a busy general outpatient pediatric practice. METHODS This quality improvement study occurred at 2 separate Uni- versity of Florida Health outpatient pediatric clinics between Janu- ary 2018 and January 2019. Institutional Review Board approval was waived, and the study was entered into the institution’s Qual- ity Improvement Project Registry. All patients with respiratory symptoms presenting to either of the 2 outpatient pediatric clin- ics (“Clinic A” or “Clinic B”) were eligible to be included. The 2 clinics are located approximately 8 miles apart within the same city and each has 7 providers. Two FilmArray RP-EZ 2.0 mod- ules (EZ) were installed in Clinic A in an isolated section of the clinic’s laboratory, without other possible laboratory exposures, to minimize possible contamination and risk. This area is monitored under strict guidelines by our institution to maintain compliance with CLIA measures. On an annual basis, nurses are all properly trained in how to handle patient’s samples to minimize contamina- tion and risk. These measures, in addition to proficiency testing, are required to maintain CLIA certification. Nursing staff were trained and competency was assessed before patient testing. Clinicians at Clinic A could elect to order the RP EZ and/or influenza and RSV antigen tests (Quidel Sofia, Quidel Corporation, San Diego, CA); however RP EZ testing was encouraged over antigen tests when diagnostic testing was deemed warranted by the provider. When Accepted for publication October 25, 2019. From the *Department of Pathology, Immunology, and Laboratory Medicine, College of Medicine, †Department of Pediatrics, College of Medicine, ‡Department of Health Outcomes & Biomedical Informatics, College of Medicine, and §Division of Infectious Diseases and Global Medicine, Col- lege of Medicine, University of Florida, Gainesville, Florida. Funding was provided by an unrestricted education grant from BioFire Diagnos- tics. BioFire had no role in the study design, data collection and interpreta- tion, or decision to submit the work for publication. The authors have no conflicts of interest to disclose. Address for correspondence: Stacy G. Beal, MD, Department of Pathology, Immu- nology, and Laboratory Medicine, College of Medicine, University of Florida, PO Box 100275, Gainesville, FL 32610. E-mail: stacygbeal@ufl.edu. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. ORIGINAL STUDIES ISSN: 0891-3668/20/3903-0188 DOI: 10.1097/INF.0000000000002544 Performance and Impact of a CLIA-waived, Point-of-care Respiratory PCR Panel in a Pediatric Clinic Stacy G. Beal, MD,* Molly Posa, MD,† Maira Gaffar, MD,* Jennifer Reppucci, DO,* Jasmine A. Mack, MPH,‡ Matthew J. Gurka, PhD,‡ Kenneth Rand, MD,*§ Herbert Houck, MS,* and Maria N. Kelly, MD†