PROPOSAL TITLE: Implementation of transcutaneous bilirubinometers to reduce unnecessary blood testing and improve patient outcomes in the Intensive Care Nursery (ICN)

PROJECT LEADS: Christine Studenmund, MD, Eisha Jain, MD, Katelin Kramer, MD

EXECUTIVE SPONSORS: Elizabeth Rogers, MD (Neonatologist; Director, ICN Roots Small Baby Programs) and Diane VonBehren, MS, RN, NEA-BC (Associate Chief Nursing Officer, UCSF BCH-SF)

ABSTRACT: Neonatal hyperbilirubinemia requires universal screening of all newborns given its high prevalence and irreversible neurologic consequences if left untreated.¹ Monitoring bilirubin historically required frequent phlebotomy, putting infants at risk of poor short- and long-term outcomes due to frequent painful procedures and iatrogenic anemia.^2–4 The transcutaneous bilirubinometer (TcB) is an excellent alternative as it performs point-of-care bilirubin measurements without puncturing the skin. It is well-studied as a safe and valid tool for bilirubin screening,^5–9 and now is part of the American Academy of Pediatrics practice guidelines.¹ Its use can decrease unnecessary labs in neonates, leading to direct cost savings and improved patient outcomes.^10–12 Despite this, TcBs have not yet been introduced to the Mission Bay ICN. There is an urgent need to align our practices with AAP guidelines. Our QI project aims to reduce phlebotomy for bilirubin screening for all newborns admitted to the ICN by 50% during the first two weeks of life. The primary intervention will be to purchase and roll-out TcB monitoring using QI methodology. In addition to aligning our practices with national standards and reducing patient and family harm, success would result in over $70,000 saved per year from laboratory costs alone, as well as over $250,000 per year in expected direct savings from reduction in blood transfusions and shortened length of stay.

TEAM:

• MD leads: Katelin Kramer, MD (Neonatologist), Christine Studenmund, MD, Eisha Jain, MD
• Executive sponsors: Elizabeth Rogers, MD (Neonatologist; Director, ICN Roots Small Baby Programs), Diane VonBehren, MS, RN, NEA-BC (Associate Chief Nursing Officer, UCSF BCH-SF)
• CNS: Jeannie Chan, MS, RN, NNP, CNS and Gabby Byers, MSN, CNS, RNC-CIC
• Nursing leadership: Jennifer Gantz, MSN, RN, RNC-NIC, Jordan Davis, PhD, MS, MPH, RN, Monica Merino, MSN, RN, RNC-NIC
• NNPs: Laurel Pershall, NNP and Michele Evans, NNP
• Child life: Taylor Park, CCLS
• Parent Liaison: Diana Rogosa

PROBLEM: In our Mission Bay Intensive Care Nursery (ICN), we rely on frequent high-resource, invasive procedures for bilirubin monitoring, while point-of-care (POC) monitoring has been widely adopted for term and preterm infants elsewhere. Our reliance on total serum bilirubin (TsB) measurement via phlebotomy on a daily or more frequent basis negatively impacts patient outcomes, workflow efficiency, and healthcare costs. Frequent phlebotomy-associated noxious stimuli and iatrogenic anemia are associated with poor outcomes for neonates, especially preterm infants. Any opportunity to reduce these risks should be implemented. Transcutaneous bilirubinometer (TcB) utilization in the ICN for POC monitoring of neonatal jaundice is an opportunity to both reduce harm and save healthcare resources.

There have been multiple attempts to purchase TcBs through the traditional avenues in the ICN, however this has been unsuccessful due to budget constraints. Additionally, a successful roll-out of this intervention requires additional QI support up front. To truly see decreased blood draws and cost savings, Apex changes, nursing and provider education, and project champions are needed.

Background - All newborns in care undergo monitoring for neonatal hyperbilirubinemia in the first weeks of life due to its high prevalence and risk of deleterious neurologic effects if missed.¹ This is a universal practice in intensive care nurseries around the world, regardless of gestational age at birth, birthweight, or risk factors. Historically, this practice relied on obtaining daily or more frequent blood draws for TsB monitoring. Guidelines have since adopted non-invasive, easy to use, POC screening with the advent of TcBs, reducing iatrogenic blood loss and frequency of painful procedures, Figure 1 in Supporting File.^5,6,10,11

The American Academy of Pediatrics (AAP) practice guidelines currently recommend TcB screening in infants above 35 weeks gestation to triage the need for TsB collection.¹ Several high quality studies have also found TcBs to reliably predict bilirubin levels in newborns under 35 weeks gestation.^5,7,8 TcB validity in infants as young as 22 4/7 weeks gestation was demonstrated in a California study in 2022 involving 8 local ICNs, including BCH-Oakland.⁵ This study, amongst others, also suggested TcB validity during and after phototherapy when performed on skin protected from blue light treatment.^5,13,14 These findings recommend expanded TcB utilization in preterm infants as well as before and after jaundice treatment.

Associated Costs - The cost of frequent TsB-associated phlebotomy in our ICN reaches upwards of $70,000/year in direct costs of obtaining and processing TsB labs that could otherwise be avoided with TcB utilization (Table 1 in Supporting File). Costs are even greater when accounting for secondary consequences of frequent blood draws described below.

• Poor patient outcomes: Each TsB collected requires 1.0 mL of blood volume. Iatrogenic blood loss, particularly in preterm infants, can worsen anemia of prematurity and need for blood transfusions. Additionally, phlebotomy puts infants at risk of procedure or line-associated infection and subsequent increased length of stay. Finally, frequent painful procedures are associated with injury to the developing brain, with studies showing an independent association with white matter loss, long-term neurodevelopmental delays,² and long-term mental health problems including anxiety and depression requiring care.³
• Psychological harm: The families of our patients also report stress associated with observing their child undergo frequent blood draws. Limiting TsB-associated blood draws would therefore reduce early patient trauma as well as family distress.
• Inequitable care: TcBs are currently utilized in our Newborn Nursery’s (NBN) neonatal jaundice screening protocol, but not our ICN. Non-Hispanic Black infants are more than twice as likely to deliver preterm, have significantly higher rates of ICN admission, neonatal mortality, and comorbidities compared to non-Hispanic White newborns.¹⁵ Our misalignment in care between hospital units and gestational age, therefore, directly contributes to inequitable care.
• Resource utilization: TsB collection and processing requires time and labor, sterile equipment, and lab processing technology that may otherwise be saved for higher risk cases. Unnecessary TsB collection thus burdens our employees and inhibits workflow efficiency.

Urgency - The current neonatal jaundice screening and monitoring practices in our Mission Bay ICN do not effectively follow AAP recommendations and do not align with current practices in our NBN or other ICNs in California, making this an urgent matter. The prompt introduction of TcB monitoring in the Mission Bay ICN is imperative at this time to address unfavorable clinical protocol variability and close gaps in care rooted in socioeconomic differences.

Current Condition - Currently, the Mission Bay ICN relies solely on phlebotomy for screening and monitoring of neonatal jaundice, as described above. Infants are subjected to unnecessary painful procedures and blood draws despite there being a non-invasive option available.

At this time, we have achieved widespread buy-in for a neonatal jaundice protocol change involving TcB introduction from ICN providers, nurses, trainees, and leadership, and intend to act on it as soon as possible. We foresee this initiative to be an extension of our existing NEOBrain work, an active multidisciplinary QI group that aims to reduce noxious stimuli and improve neurodevelopmental care in preterm infants. This team is currently significantly limited in the scope of QI work able to be done with no protected time for QI champions.

TARGET: Our aim is to reduce unnecessary phlebotomy in screening and management of neonatal jaundice in the Mission Bay ICN in order to improve patient outcomes, increase efficiency, and reduce healthcare costs. Our SMARTIE goal is to achieve at least a 50% reduction in phlebotomy for bilirubin screening during the first two weeks of life for neonates of all gestational ages admitted to the Mission Bay ICN within the first year of utilizing TcB monitoring. We believe that our goal is achievable and surpassable.

GAPS: Unnecessary phlebotomy and variability in care across hospital units related to neonatal jaundice screening and monitoring in the ICN exist due to inaccessibility to non-invasive, POC bilirubin testing. Funding is a key missing resource limiting our division’s ability, not only to purchase the TcB devices but also to provide the QI support, Apex support, and education needed for this roll-out to be successful.

Educational and systems gaps also exist that will need to be addressed in order to transition to a lower cost protocol for evaluation of neonatal jaundice in the ICN. These gaps include:

• Practice guidelines for TcB use in neonatal jaundice screening for patients < 35 weeks gestation do not currently exist at Mission Bay.
• Providers, trainees, and nursing staff are not currently trained in using TcB devices and interpreting results.
• Order sets and bilirubin data flowsheets and visualization tools in the ICN EHR context are not currently optimized for a TcB-integrated neonatal jaundice protocol.

INTERVENTION: We propose introducing TcB monitoring in the 58-bed ICN for patients of all gestational ages using hand-held bilimeters (e.g., Drager BiliMeter). Using funds from Caring Wisely, we plan to leverage the resources from an existing interdisciplinary QI team (NEOBrain) composed of neonatologists, neonatology fellows, pediatric residents, hospitalists, neonatal NPs, RNs, RTs, PT/OTs, Child Life, and parent liaisons.

Prior to implementation we plan to develop practice guidelines with the help of our QI team. Bedside nurses will obtain the TcB measurements, as is current practice in the NBN. We propose EHR modifications (see below) that will aid nurses and ordering providers in adopting this new protocol. Nurses and providers will receive training on the new protocols, both with in-person didactics, videos, and flyers / posters located at highly visible locations on the unit. We will use Apex reports (see below for proposed report creation) to solidify our understanding of the baseline rates of TcB and TsB measurements and then follow these rates over time to assess success of our intervention, stratifying data by gestational age and race / ethnicity.

Barriers - Potential barriers to implementation include time, with nurses needing to incorporate obtaining TcB measurements into their care schedule. However, obtaining the measurement takes less than 10 seconds and we will include a streamlined nursing workflow within our practice guidelines. A new protocol will need to be established with consensus among the division for thresholds to verify TcBs with TsB, especially for preterm infants when there is less comfort with this practice.  Changing existing protocols can be challenging, particularly in the ICU setting with critically ill patients where there often is a mindset of frequent serum monitoring. We aim to mitigate this challenge through multiple presentations of the growing body of literature on the validity of TcBs in all gestational ages. We also plan EHR modifications and hosting in-unit training on the new protocol. We will track the outcomes of this QI initiative on the huddle board in the ICN to display the results of this QI effort as a motivating factor.

Possible adverse outcomes - There are very minimal potential adverse outcomes. Studies have demonstrated that incorporating TcB monitoring rarely results in extreme bilirubin measurements or delay in phototherapy.¹⁶ We will use extreme serum bilirubin values as a balancing measure and plan to compare these to pre-intervention rates. Our practice guidelines would create clear TcB levels at which a serum confirmatory measurement would be required, further reducing the risk of adverse outcomes.

PROPOSED EHR MODIFICATIONS: We propose modifications to existing EHR tools as well as creation of new tools below. These modifications will help integrate the practice guidelines into the EHR, decreasing the likelihood of human error and facilitating adoption of the protocol by providers.

• Modification of Bilirubin Summary Tab: Addition of TcB measurements in bilirubin summary tab for the ICN. Currently this only exists in the NBN. Will also propose adding an additional line that is 3 points below the phototherapy threshold at each postnatal age. This would create a visual representation to see if the TcB is above this line, then a TsB is required.
• Creation of bilirubin screening Order Set: Currently, TsB is ordered as needed and there is no option to order TcB in the ICN. An order set would be helpful that includes qAM TcB order with PRN TsB confirmation order.
• Modification of Documentation Flowsheet: Adding TcB to the nursing documentation flowsheet, which is currently only available in the NBN. These values would then pull into the results section and bilirubin summary tab. If possible, the input would include an alert pop up after entering the TcB either stating: 1) No TsB required 2) Obtain confirmatory TsB. The criteria for requiring a TsB will be finalized through meeting with stakeholders.
• Creation of Report: Report for # of TcB and TsB / 100 patient days, stratified by gestational age. 

ROI: The projected savings to the healthcare system are significant. One direct source of cost savings is the reduction of serum bilirubin tests that need to be performed in the laboratory. There is the potential for significant direct cost savings beyond running the lab test, including reducing blood transfusions, length of hospitalization, and rates of infection.

TcB measurements estimate TsB levels within 3 mg/dL if the TsB level is under 15 mg/dL in neonates > 35 weeks gestation. For TcB values > 15 mg/dL or within 3 mg/dL of phototherapy threshold, the AAP recommends confirmatory TsB testing.¹ For preterm infants, studies have shown the same cut-offs for the need of serum bilirubin confirmation.⁵ We estimate that term infants have an average of ~2.5 TsBs drawn per patient. For term infants, TcB screening has been shown to reduce the need for serum confirmation by 70-80%.¹¹ Given term infants in the ICN are more critically ill which puts them at slightly higher risk of hyperbilirubinemia, we conservatively estimate at least a 50% reduction in TsBs with the utilization of bilimeters. We estimate that preterm infants have an average of ~7-10 TsBs drawn per patient. With the roll-out of TcBs, we also estimate at least 50% reduction in TsBs. The N for term and preterm infants admitted in 2022 is in Table 1, attached in the Supporting File.

If we accomplish our goal, we will reduce the number of TsBs performed by 2,047 in a 1 year period (Table 1). Given that the median cost to run TsB is $34.50 per sample, this would result in $70,622 direct cost savings per year from avoided TsBs. This suggests that over 3-4 years, the direct savings will be >$250,000 from laboratory costs alone.

Extremely preterm infants lose at least 1/3 of their blood volume from iatrogenic lab draws, with the vast majority of blood loss occurring in the first week of life.⁴ Reducing serum bilirubins will directly impact blood loss early in life. For example, a 1 kg infant has an estimated blood volume of 100 mL (blood volume ~100 mL/kg). If this premature infant required 7 serum bilirubin measurements at 1.0 ml each, this would be 7.0 mL, or 7% of their total blood volume. Approximately 60% of preterm infants will require a blood transfusion during their hospitalization and this rate is directly associated with iatrogenic blood loss. The direct cost of a blood transfusion at UCSF Mission Bay is ~$750 per unit. With even a minimal reduction in blood transfusions with TcB use (~5%), we have the potential to save ~10 transfusions with a cost savings of $7,500 per year.

Other centers have shown improved outcomes and cost savings with similar QI interventions. For example, the POKE program at Dixie Regional Medical Center NICU used QI frameworks to reduce the number of POKEs (clinical experiences that cause harm without adding value). They decreased POKEs by 50% (eliminating 11,000/year) and saving $940,000/year. Additionally, they decreased length of stay by 21% (reducing by 2 weeks).¹² One hospital day in our ICN has a direct variable cost of $5,500 to the healthcare system. If we reduced the length of stay by even 1 day for only 5% of infants, there would be significant cost savings of $269,500 per year.

Finally, there are also many critically important indirect savings from downstream consequences of painful procedures, such as reducing neurodevelopmental harm and in turn reducing cost of therapies and resources required to manage neurodevelopmental delays.

Based on the above, we estimate a conservative cost saving of $347,622 during FY 2025.

SUSTAINABILITY: A multidisciplinary QI team called “NEOBrain” is already established in the ICN with a primary goal of reducing noxious stimuli and promoting neuroprotective care. The team meets monthly with no end date and has already committed to leading the implementation and sustainment phases of TcBs if funding for the devices and QI support was established. Additionally, the ICN nursing and provider leadership is in complete support of this project and have committed to covering the service fees and ongoing maintenance costs of bilirubinometers if funding is obtained for the initial purchase of the equipment through the Caring Wisely Contest. This will ensure sustainability of this project.

We plan to collaborate with the BCH-Oak NICU on this project, as they are already utilizing TcB for term infants but have not yet rolled-out this intervention in preterm infants. All work we do in this area, including protocol development, Apex changes, and QI analysis may have significant cross-bay impact and cost savings for UCSF Health. Given the relatively new use of TcB in preterm infants, especially during and after phototherapy, our findings may ultimately impact protocols beyond the walls of UCSF.

BUDGET: Please see Table 2 in the Supporting File attached for our proposed line-item budget.

REFERENCES:

1.    Kemper AR, Newman TB, Slaughter JL, et al. Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics. 2022;150(3):e2022058859. doi:10.1542/peds.2022-058859

2.    Walker SM. Long-term effects of neonatal pain. Semin Fetal Neonatal Med. 2019;24(4):101005. doi:10.1016/j.siny.2019.04.005

3.    Valeri BO, Holsti L, Linhares MBM. Neonatal Pain and Developmental Outcomes in Children Born Preterm: A Systematic Review. Clin J Pain. 2015;31(4):355-362. doi:10.1097/AJP.0000000000000114

4.    Counsilman CE, Heeger LE, Tan R, et al. Iatrogenic blood loss in extreme preterm infants due to frequent laboratory tests and procedures. J Matern Fetal Neonatal Med. 2021;34(16):2660-2665. doi:10.1080/14767058.2019.1670800

5.    Sankar MeeraN, Ramanathan R, Joe P, et al. Transcutaneous bilirubin levels in extremely preterm infants less than 30 weeks gestation. J Perinatol. 2023;43(2):220-225. doi:10.1038/s41372-022-01477-4

6.    Bhatt DR, Kristensen-Cabrera AI, Lee HC, et al. Transcutaneous bilirubinometer use and practices surrounding jaundice in 150 California newborn intensive care units. J Perinatol. 2018;38(11):1532-1535. doi:10.1038/s41372-018-0154-3

7.    Ng Y, Maul T, Viswanathan S, Chua C. The Accuracy of Transcutaneous Bilirubin as a Screening Test in Preterm Infants. Cureus. 15(8):e42793. doi:10.7759/cureus.42793

8.    Weber J, Vadasz-Chates N, Wade C, Micetic B, Gerkin R, Rao S. Transcutaneous Bilirubin Monitoring in Preterm Infants of 23 to 34 Weeks’ Gestation. Am J Perinatol. 2023;40(07):788-792. doi:10.1055/s-0041-1731277

9.    Van Den Esker-Jonker B, Den Boer L, Pepping RMC, Bekhof J. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016;138(6):e20162414. doi:10.1542/peds.2016-2414

10.  Klunk CJ, Barrett RE, Peterec SM, et al. An Initiative to Decrease Laboratory Testing in a NICU. Pediatrics. 2021;148(1):e2020000570. doi:10.1542/peds.2020-000570

11.  McClean S, Baerg K, Smith-Fehr J, Szafron M. Cost savings with transcutaneous screening versus total serum bilirubin measurement for newborn jaundice in hospital and community settings: a cost-minimization analysis. CMAJ Open. 2018;6(3):E285-E291. doi:10.9778/cmajo.20170158

12.  Ridout E, Kane T. Deploying POKE Within Intermountain Healthcare (POKE). ClinicalTrials.gov Identifier: NCT03688607. ClinicalTrials.gov. Accessed February 29, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT03688607

13.  Nagar G, Vandermeer B, Campbell S, Kumar M. Reliability of Transcutaneous Bilirubin Devices in Preterm Infants: A Systematic Review. Pediatrics. 2013;132(5):871-881. doi:10.1542/peds.2013-1713

14.  Ten Kate L, Van Oorschot T, Woolderink J, Teklenburg-Roord S, Bekhof J. Transcutaneous Bilirubin Accuracy Before, During, and After Phototherapy: A Meta-Analysis. Pediatrics. 2023;152(6):e2023062335. doi:10.1542/peds.2023-062335

15.  Brown J, Chang X, Matson A, et al. Health disparities in preterm births. Front Public Health. 2023;11:1275776. doi:10.3389/fpubh.2023.1275776

16.  Konana OS, Bahr TM, Strike HR, Coleman J, Snow GL, Christensen RD. Decision Accuracy and Safety of Transcutaneous Bilirubin Screening at Intermountain Healthcare. J Pediatr. 2021;228:53-57. doi:10.1016/j.jpeds.2020.08.079