The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

The recent emergence of Zika virus, which has been linked to severe birth defects, 41 underscores the need for clinical laboratories to have rapid access to diagnostic tools. When the Secretary of Health and Human Services declared Zika virus to be a public health emergency, the first FDA Emergency Use Authorization for Zika virus testing was granted to a test available only to the public health laboratory system, not to hospital laboratories on the front lines of patient care (https://www.fe deralregister.gov/documents/2016/03/28/2016-06888/authori zation-of-emergency-use-of-an-in-vitro-diagnostic-device-fordiagnosis-of-zika-virus. Accessed April 27, 2017). As a result, the public health system quickly became overwhelmed, as it has been during past outbreaks, such as influenza. 42 In many areas, turnaround times for Zika virus testing exceeded 4 to 8 weeks (http://www.nytimes.com/2016/09/13/us/zika-testdelays-florida-pregnant.html?_r¼0. Accessed April 27, 2017, http://medicalxpress.com/news/2016-10-lab-constraints-zikaresults.html. Accessed April 27, 2017, http://www.miamiher ald.com/news/health-care/article104856631.html. Accessed April 27, 2017). These delays critically impact patient care, particularly for pregnant women with possibly affected fetuses. In comparison, many hospital-based and national reference laboratories are able to report results within hours (http:// www.usatoday.com/story/news/2016/02/23/texas-hospitalsdevelop-rapid-zika-test/80776382/. Accessed April 27, 2017, http://www.nytimes.com/2016/09/13/us/zika-test-delays-flor ida-pregnant.html?_r¼0. Accessed April 27, 2017). For example, in Miami-Dade Florida, where more than 1000 people have been confirmed Zika positive and the virus is circulating in the local mosquito population, the public health laboratory system encountered a backlog of nearly 1000 untested specimens (http://www.miamiherald.com/news/health-care/arti cle104856631.html. Accessed April 27, 2017). Diagnostic assays for Zika and other emerging pathogens will continue to evolve, 43 but it is clear that rapid identification of pathogens during other outbreaks facilitates rapid treatment and appropriate isolation of patients, leading to improved patient outcomes and potentially slowing the spread of infections such as influenza (http://www.cdc.gov/flu/professionals/diagnosis/molecu lar-assays.htm. Accessed April 27, 2017). Implementation of the first rapid diagnostic tests for influenza was directly associated with reduced length of hospital stay, decreased mortality, and reduced costs. 44 Access to diagnostic tests, early in the course of an outbreak and in hospital laboratories, has a positive public health impact.