Proof of Concept of Using Electronic Notification to Improve Surveillance and Quality of Newborn Screening Pre-analytic Processes
Project Status: Proposed
Point of Contact: Bin Chen
Keywords: Newborn screening, specimen submission, pre-analytic systems quality assessment, quality improvement
Project Description: Newborn screening (NBS) is a state-based public health system that tests almost all (≥97%) of the 4 million babies born in the US each year for serious or life-threatening metabolic and other conditions that, when detected early, might be managed or treated to prevent death, disability, or other severe consequences. Timely identification of presumptively affected infants relies on collection of clinical information and quality specimens from newborn infants and timely submission to the NBS laboratory. These are essential activities in the pre-analytic (pretesting) phase of laboratory testing requiring time-sensitive follow-up actions that are crucial for accurate diagnosis and timely treatment and interventions.
Most NBS specimens are collected between 24 and 72 hours after birth by nurses or other trained medical professionals in hospitals and birthing facilities, and should be submitted to NBS laboratories either by courier services or mail within 24 hours after specimen collection. However, NBS specimen submission practices vary nationwide, with delays in specimen submission, diagnosis, and treatment endangering infants’ health and survival.
Federal regulations require laboratories to establish and follow defined policies and procedures to continuously monitor, assess, and correct problems of the pre-analytic systems. Laboratory quality assessments (LQA) of the pre-analytic systems include review corrective action effectiveness for problem resolution, revision of policies and procedures which prevent recurrence, and discussion of these LQA findings with appropriate staff (42 CFR§493.1249). Professional guidelines, education resources, and training materials are available and all state newborn screening laboratories provide specimen collection and submission instructions to their healthcare providers. However, it is challenging for NBS laboratories to assess effectiveness of pre-analytic procedures because the laboratory usually does not receive information about new births or NBS specimens until the filter paper cards arrive in the laboratory. Additionally many state newborn screening laboratories are closed on weekends, therefore specimens which arrive on weekends might not be accessioned into the laboratory information system until the next workday. Further delays could result when specimens are collected from small or rural birthing facilities lacking daily courier pick-up services.
These practical limitations present challenges to newborn screening laboratories in monitoring and assessing the quality of the pre-analytic activities. The increases in inherited metabolic diseases and other congenital disorders included in state NBS programs require a robust and reliable surveillance mechanism for NBS laboratories to initiate laboratory records for a newborn and monitor specimen collection, submission and transport to effectively coordinate the timeliness and quality of the specimens received by the laboratory. These measures would ensure timely screening, diagnosis, and intervention for affected infants with greater potential for improved health outcomes.
Methodology – This proof-of-concept project could be awarded to a state NBS laboratory to test the feasibility of establishing a birth notification mechanism and the value of conducting surveillance on NBS pre-analytic processes to improve the timeliness and quality of specimen collection, submission, and transport for NBS. Specifically, the awardee will develop or establish an electronic mechanism which will notify the NBS laboratory about newborn births and allow the laboratory to receive or access relevant information about the newborns, such as the infant’s name, the date and time of birth, birth weight, mother’s name and gestational age, the infant’s race/ethnicity, family history relevant to newborn screening, health and nutritional status, the birth facility, responsible clinician/pediatrician, etc. The laboratory will test the feasibility to initiate case documentation and specimen tracking based on the infant’s information prior to receipt of the blood spot card. The laboratory will then provide necessary guidance to the healthcare providers at the birth facility about specimen collection, submission, and transport to the NBS laboratory.
The funded NBS laboratory could utilize existing EMR/EHR systems or collaborate with a hospital or health system that has EMR in place to conduct this project. The awardee will also document and assess the extent to which this notification and surveillance system improves newborn screening processes including:
- Reduction in delays of specimen submission and transport;
- Improved ability to communicate with specimen submitters about specimen collection, submission and handling issues;
- Reduction in specimen arrival on weekends (or coordination with an alternate testing site) if the laboratory is closed;
- Improved accuracy of information about the newborn to support results interpretation;
- Improved test turnaround time;
- Improved result reporting and follow-up practices.
Measure of success – Outcomes of this project would include the following:
- Proof of concept for establishing a surveillance network that integrates birth notification, NBS specimen collection, and timely submission to the NBS laboratory.
- Demonstration of the feasibility to use the notification and surveillance system to improve NBS processes.
- Insights that could be broadened and applied to NBS in the state and to other state NBS programs.
- Lessons learned and identification of barriers, concerns, and logistical issues that should be resolved before broader implementation.
- Information necessary for developing next steps and further projects.
Impact: An effective surveillance network integrating birth notification, NBS specimen collection, and timely submission to NBS laboratories could significantly improve the turnaround time and quality of NBS results, leading to timely and accurate diagnosis and intervention for affected infants, improved health outcomes, and decreased infant mortality.
The experience gained from this project could be applicable to wider audiences within CDC who are interested in improving public health surveillance and using the surveillance data to inform public health interventions. Outcomes of this proof-of-concept project could form the basis for wider implementation by newborn screening programs and enhanced input from relevant CDC programs