COVID-19 Pandemic-Related Impacts on Newborn Screening Public Health Surveillance
2.1. Key Resources in COVID-19 Response
2.1.1. National Technical Assistance Center
2.1.2. National Webinars
2.1.3. Public Health Emergency Funding
2.2. Data in COVID-19 Response
2.2.1. Survey Instrument
2.2.2. Quality Metrics and Data Collection
3.1. National Technical Assistance Center
- Early discharge from hospitals impacted the time of specimen collection. The national recommendation for newborn screening dried blood spot specimen collection is 24–48 h after birth . It was noted that many birth hospitals were discharging healthy mothers and babies before this timeframe to reduce potential for exposure and due to limited space in maternity wards at hospitals;
- Specimen quality was impacted due to burdens on nursing staff and redistribution of responsibilities as well as due to staff shortages;
- Courier issues severely limited deliveries of specimens from birthing centers to public health laboratories during certain points in the pandemic. During the 2020 election, an increase in mail-in ballots placed especially burdensome delays on the United States Postal Service. All states rely on specimen transport services to ensure continuity of newborn screening ;
- Decreased courier pick-ups, as well as changes in courier pick-up locations, at hospitals further compounded specimen collection and transport activities.
- Biosafety of specimens became a concern, with protocols required around handling dried blood spot cards that may have potentially been exposed to infected blood;
- Laboratory workflows were impacted by the necessity to (1) perform time-critical testing with limited staff; (2) stagger shifts to reduce the potential for exposure within the laboratory workforce; (3) observe physical distancing in the laboratory to maintain staff safety;
- Managing the impact on staffing due to daycare and school closures was a compounding issue as the pandemic permeated other aspects of day-to-day life in the US;
- Follow-up staff members were able to transition to working remotely, with laboratory staff required on-site;
- Program managers integrated planning for the possibility of multiple staff out of work or under quarantine.
- Families’ refusal to return to the hospital/birthing facility for repeat/second screen specimen collection and confirmatory testing required modifications to protocols to err on the side of testing all specimens regardless of quality;
- Hospitals/birthing facilities practicing physical distancing and turning away “non-essential” patients impacted the timeliness of subsequent specimen receipt and confirmatory testing;
- Some outpatient laboratories and clinics closed, impacting the necessity to evaluate all results without the confidence that repeat and confirmatory tests would be conducted in a timely fashion.
- NBS programs incorporated age-related cut-offs to account for early specimen collection;
- NBS laboratories initiated or, in some cases continued, screening unsatisfactory specimens and reporting results accordingly;
- Disorder specific nuances became more pronounced, especially when screening for time-critical versus time-sensitive disorders;
- An increased reliance on electronic results reporting enabled more efficient information transfer.
- Increases in home births required ongoing midwife education, typically using electronic training resources;
- Telehealth for continuity of follow-up and clinical services became a viable alternative to in-person services;
- Genetic consultations and access to specialists became more challenging due to COVID-19-related competing priorities across healthcare systems;
- Increases in education about newborn screening to the extended healthcare community became necessary.
- Personal Protective Equipment (PPE) for laboratory and hospital staff was limited in quantity at the start of the pandemic (2020);
- Reagents, testing kids, and other laboratory supplies became impacted by pervasive supply chain issues throughout the pandemic.
3.2. Topical COVID-19 and NBS Continuity Webinar Solutions
3.3. Public Health Emergency Funding
- California utilized the funding to develop a comprehensive, virtual, interactive virtual site visit module that allowed for continuity of compliance assessments and education and support for California’s 246 birth facilities. The funding was timely because the COVID-19 pandemic caused the suspension of mandated in-person triennial site visits, which have proven to be essential for assessment to ensure the integrity of birth facilities’ NBS specimen chain of custody processes;
- Colorado utilized the funding to strengthen and add structure to the NBS follow-up program by expanding the availability of educational materials for stakeholders and formalizing outreach. Within Colorado, the COVID-19 pandemic highlighted how crucial it is for NBS programs to possess the technological capability to collaborate and to utilize tools that are essential to take necessary actions to achieve goals of early detection, despite pandemic challenges;
- Washington, DC, utilized the funding to design an NBS care model that implements immediate telemedicine for NBS, providing virtual telemedicine options incorporating community-based and patient feedback for optimal clinical and educational interventions;
- Georgia utilized the funding to implement filter paper testing to avoid social contact required for laboratory blood draw during the global pandemic after the COVID-19 related closure of a genetics lab for biochemical testing in the state. The program was able to maintain uninterrupted continuity of monitoring of blood enzyme concentrations for an NBS disorder that requires comprehensive and continued long term follow-up and treatment;
- Puerto Rico utilized the funding to procure scarce PPE, which was essential for the continuity of safe testing protocols during the COVID-19 global health crisis;
- Tennessee utilized the funding to address the COVID-19 related issue of parents being reticent to bring their newborn infants to hospitals for repeat screens necessary to clarify a potentially false-positive result from a newborn screen. To reduce the number of false positives and simultaneously alleviate parental anxiety created by the pandemic, the Tennessee NBS program implemented a second-tier, in-house test for a subset of disorders;
- Virginia utilized the funding to hire additional NBS scientists for on-call coverage, as well as NBS data entry/verification staff to alleviate the staff shortages caused by symptom monitoring policies for COVID-19, sicknesses, and reallocation of human capital to support COVID-19 testing within the department of health.
3.4. Telehealth Expansion
3.5. Survey Results
3.6. Consumable Shortages Addressed
3.7. Data Analysis
- Timeliness medians did not suffer in 2020, compared with 2017, 2018, and 2019. However, there were data from individual states that showed some significant delays in timeliness, compared with prior years, but this was in a small number of states reporting data and did not impact the overall median;
- The median percent of specimens that were unacceptable did not increase in 2020 compared with 2017, 2018, and 2019 in states reporting data;
- The median percent of specimens with missing essential information increased in 2020 compared with 2017, 2018, and 2019 in states reporting data;
- The median percent of infants that were lost to follow-up after the receipt of an unacceptable dried blood spot specimen increased in 2020 as compared with 2017, 2018, and 2019 in states reporting data;
- The median percent of infants that were lost to follow-up after an out-of-range result increased in 2020 as compared with 2017, 2018, and 2019 in states reporting data.
3.8. State Experiences
3.8.2. New York
Data Availability Statement
Conflicts of Interest
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|May 2021–December 2021|
|Topic||Date||Presented By||Key Takeaway|
|Screening of Unsatisfactory Specimens||8 May 2020||Tennessee,|
|During the COVID-19 pandemic a number of staff shortages within the clinical healthcare system, coupled with the risk of exposure to the virus, greatly lessened the number of visits that were being made to hospitals for non-essential services. NBS programs experienced increased hesitancy of families with newborns to return to the clinic for the collection of repeat blood spots for newborn screening. Response to the limitations of re-testing included screening and reporting results on unsatisfactory initial specimens to ensure that each newborn was screened a minimum of one time.|
|Newborn Screening COVID-19 Challenges and Response||21 May 2020||HRSA, APHL, NCHAM, New York, North Carolina, Genetic Alliance, Hands and Voices||Challenges, barriers, and solutions to dried blood spots and newborn hearing screening, as well as family engagement perspectives during the COVID-19 pandemic in the US.|
|Telehealth in Newborn Screening||22 May 2020||Hawaii,|
|Telehealth initiatives were utilized for continuity of operations by newborn screening in response to the COVID-19 pandemic.|
|Biosafety||28 May 2020||Centers for Disease Control and Prevention (CDC)||Addressing biosafety of dried blood spot specimens in response to the COVID-19 pandemic requires data on the viability of the virus on specimens from mothers or babies who are COVID-19 positive.|
|Staffing and Telework||11 June 2020||Iowa,|
|Addressing staffing and telework during the COVID-19 pandemic requires the following considerations: access to equipment; permission for telework; connectivity; effective communication; productivity; loss of in-person team environment; ethical concerns; staff disparities in ability to telework; minimal needs for robust telework, such as a business phone line, video capabilities, e-faxing, secure email.|
|9 July 2020||Genetic Alliance,|
|Addressing virtual engagement in response to the COVID-19 pandemic is an ongoing imperative. Conference applications and planning software can be instrumental in planning virtual events.|
|Electronic Reporting||12 August 2020||Nevada,|
|The COVID-19 pandemic required programs to reduce NBS results reporting using paper and transition to electronic results reporting and messaging. Privacy concerns and data security challenges must be identified and tackled to implement electronic reporting.|
|Resource Shortages and Staffing Limitations||5 October 2020||Open Discussion||Discussion among all state NBS programs participants around individual experiences with resource shortages and staffing limitations during the COVID-19 pandemic.|
|Resources and Best Practices for Remote Follow-Up Work||17 December 2020||Open Discussion||Discussion among all state newborn screening program participants around the latest practices and protocols for performing follow-up from home during the COVID-19 pandemic.|
|Resources and Best Practices for Managing Staff during COVID-19||28 January 2021||Open Discussion||Geared toward supervisors of NBS programs. NBS laboratory and follow-up staff shared strategies for training employees, supporting remote staff, and how to manage employee productivity and accountability during the COVID-19 pandemic.|
|Staff Training and Onboarding During COVID-19||16 February 2021||Open Discussion||Geared toward supervisors and staff in charge of training newborn screening laboratory and follow-up staff, participants shared experiences and lessons learned around training new staff both virtually and on-site during the COVID-19 pandemic.|
|Cleaning Methods for Pipette Tips||23 March 2021||New York,|
|Cleaning methods for pipette tips as a short-term solution to address supply limitations, addressing method validation and concerns around cross-contamination.|
|Building More Resilient Newborn Screening Systems||7 April 2021||APHL||Information sharing regarding continuous quality improvement (CQI) tools and strategies for developing more adaptive and resilient newborn screening systems.|
|Contingency Planning||16 December 2021||South Carolina, Louisiana, Iowa||Discussion of newborn screening contingency planning and lessons learned from state experiences in addressing emergency situations and the use of Continuity of Operations Planning (COOP) during the COVID-19 pandemic.|
|NewSTEPs Quality Indicator||Year||Number of States Reporting (Births Represented)||Median||NewSTEPs Quality Indicator||Year||Number of States Reporting (Births Represented)||Median|
|Percent of Dried Blood Spot Specimens that were Unacceptable (Unsatisfactory)||2017||34 (3,150,513)||1.47||Percent of Infants with No Resolution Following an Out of Range Result from a Dried Blood Spot Specimen||2017||6 (760,307)||1.32|
|2018||33 (2,725,317)||1.63||2018||9 (1,151,034)||1.5|
|2019||29 (2,522,850)||1.6||2019||11 (1,306,753)||1.22|
|2020||23 (1,731,157)||1.12||2020||13 (1,139,682)||2.42|
|Percent of Dried Blood Spot Specimens Missing Essential Information||2017||30 (2,932,360)||1.8||Percent of Dried Blood Spot Specimens Collected within 48 Hours of Birth||2017||34 (2,998,524)||94.18|
|2018||32 (2,690,628)||1.22||2018||34 (2,796,433)||94.62|
|2019||28 (2,489,112)||1.39||2019||28 (2,396,738)||96.26|
|2020||14 (1,233,014)||2.1||2020||20 (1,522,389)||97.75|
|Percent of Eligible Newborns Not Receiving a Dried Blood Spot Newborn Screen||2017||9 (1,088,165)||0.49||Percent of Dried Blood Spot Specimens Received at NBS Laboratory within 24 h of Collection||2017||34 (2,998,524)||36.47|
|2018||11 (1,012,836)||0.32||2018||34 (2,796,433)||41.36|
|2019||13 (1,206,276)||0.29||2019||28 (2,396,738)||48.25|
|2020||13 (1,097,817)||0.35||2020||20 (1,522,389)||51.75|
|Percent of Infants with No Recorded Final Resolution Following Receipt of an Unacceptable Dried Blood Spot Specimen||2017||8 (1,034,884)||3.11||Percent of Time Critical Specimen Results Reported within 5 Days of Birth||2017||23 (2,161,746)||37.93|
|2018||10 (1,213,919)||2.12||2018||24 (2,287,170)||47.82|
|2019||13 (1,405,017)||2.77||2019||25 (2,249,817)||45.89|
|2020||12 (1,083,658)||4.25||2020||20 (1,593,377)||48.25|
|Percent of Infants with No Recorded Final Resolution Following a Borderline Result from a Dried Blood Spot Specimen||2017||5 (288,649)||0.83||Percent of Non-Time Critical Specimen Results Reported within 7 Days of Birth||2017||24 (2,172,191)||74.08|
|2018||8 (924,796)||2.43||2018||24 (2,287,170)||69.33|
|2019||11 (1,120,609)||1.03||2019||24 (2,223,498)||61.02|
|2020||12 (1,106,234)||1.58||2020||20 (1,549,528)||69.59|
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Singh, S.; Caggana, M.; Johnson, C.; Lee, R.; Zarbalian, G.; Gaviglio, A.; Keehn, A.; Morrison, M.; Becker, S.J.; Ojodu, J. COVID-19 Pandemic-Related Impacts on Newborn Screening Public Health Surveillance. Int. J. Neonatal Screen. 2022, 8, 28. https://doi.org/10.3390/ijns8020028
Singh S, Caggana M, Johnson C, Lee R, Zarbalian G, Gaviglio A, Keehn A, Morrison M, Becker SJ, Ojodu J. COVID-19 Pandemic-Related Impacts on Newborn Screening Public Health Surveillance. International Journal of Neonatal Screening. 2022; 8(2):28. https://doi.org/10.3390/ijns8020028Chicago/Turabian Style
Singh, Sikha, Michele Caggana, Carol Johnson, Rachel Lee, Guisou Zarbalian, Amy Gaviglio, Alisha Keehn, Mia Morrison, Scott J. Becker, and Jelili Ojodu. 2022. "COVID-19 Pandemic-Related Impacts on Newborn Screening Public Health Surveillance" International Journal of Neonatal Screening 8, no. 2: 28. https://doi.org/10.3390/ijns8020028