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SPECIAL ARTICLE |
* Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts
Blue Cross Blue Shield of Texas, Inc, Richardson, Texas
Henry Ford Health System, Detroit, Michigan
|| Beaumont Hospital, Royal Oak, Michigan
¶ Paul E. Plsek and Associates, Inc, Roswell, Georgia
# HealthCare Quality Initiatives, Boston, Massachusetts
Abbreviations: IOM, Institute of Medicine • AAP, American Academy of Pediatrics • MAJIC, Making Advances Against Jaundice in Newborn Care
Arecent Institute of Medicine (IOM) report describes a chasm in health care quality that we must cross for patients to receive better care in the 21st century. The report calls for a "systems approach," drawing on the rapid evolution of knowledge about complex adaptive systems.1 Understanding how complex adaptive systems work can give physicians insights to develop and modify health care systems. By describing a practical application of the ideas about complex adaptive systems to newborn care, we aim to help pediatricians prepare to lead in this field.
A complex adaptive system is a collection of individual agents who have the freedom to act, but because the agents are interconnected, action by any agent changes the context for other agents in the system. One familiar example is the buyers in a stock market. In the last century, it was usual to see organizations as mechanical systems: in mechanical systems, if we know what each part of a system does, we can predict perfectly how the whole will respond in a given situation. This is obviously not true of the stock market. A complex adaptive system may display sudden unpredictable shifts in behavior caused by interactions among agents. An essential first step in improving the US health care system is to recognize that its member organizations and individuals, with sublevels nested within and interconnected to each other, make up a complex adaptive system.
One of the key attributes of a complex adaptive system is that orderly behavior can emerge among many agents who are acting independently but who share a common drive. For instance, ants, driven to survive, create intricate buildings and foraging systems without any planning by a chief executive ant. So do humans. The citizens of New York City share a drive to eat; with no single individual in charge, a huge food distribution system has emerged in New York City. Emergence of organization within large groups of independent agents can appear when each individual agent follows a common set of high-level rules. For instance, the orderly behavior of a flock of birds whirling to avoid a predator can be simulated realistically by programming "virtual birds" to follow 3 simple rules: avoid collisions, match speeds with your neighbors, and move toward the center of mass of your neighbors.1,2
The IOM report builds on this concept of simple rules. It does not offer a detailed 5-year plan with a health care czar to reform health care. Instead it offers 10 "simple rules" to guide all the relevant agents, as they act independently, toward a better health care system. Here we apply these 10 rules to the evaluation and treatment of newborn hyperbilirubinemia (see Table 1).
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MAKING ADVANCES AGAINST JAUNDICE IN NEWBORN CARE (MAJIC): A CONSORTIUM |
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 TOP MAKING ADVANCES AGAINST JAUNDICE... KEY FEATURES AND SYSTEMS...THE IOM'S SIMPLE RULES...DISCUSSIONREFERENCES |
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In the MAJIC Project, we use multiple methods of collecting information to gain insight for our common purpose. We collect clinical data about newborn care in the birth hospital and for the first 30 days after discharge. We conduct parent surveys and focus groups of providers, parents, and purchasers. Using typical quality-improvement tools we analyze the specific practices and events leading certain newborns to reach extreme levels of hyperbilirubinemia. We conduct ongoing literature reviews and discussions with physician experts and participate in national initiatives and conferences. We use twice-a-year consortium meetings to synthesize this information into a comprehensive view of barriers to safe care for newborns with hyperbilirubinemia. Below, we first review the key features and recent systems of care for newborn hyperbilirubinemia as we have come to see them. Then, using the framework of the IOM’s 10 simple rules, we explore what features are needed to ensure the safe management of newborns in their first week of life.
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KEY FEATURES AND SYSTEMS OF CARE FOR NEWBORN HYPERBILIRUBINEMIA |
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TOPMAKING ADVANCES AGAINST JAUNDICE...KEY FEATURES AND SYSTEMS...THE IOM'S SIMPLE RULES...DISCUSSIONREFERENCES |
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96 hours after birth,9 the greatest risk for extreme hyperbilirubinemia is 72 to 120 hours (3–5 days) of life.6 If detected in a timely manner, hyperbilirubinemia can be treated with phototherapy together with appropriate encouragement of breastfeeding and temporary supplemental nutrition if needed.3 Changes in the health care delivery system over the past decade have drastically changed care for newborns. Historically, hospital staff detected and treated newborn hyperbilirubinemia, which occurred before discharge. The average hospital length of stay for a newborn delivered vaginally in 1970 was 3.9 days,10 by which time significant hyperbilirubinemia usually becomes apparent. Over the past 3 decades there has been a dramatic decline in the average length of stay for newborns delivered vaginally to a low of 1.7 days in 1995.10 This decrease was initially in response to public pressure to foster "natural" childbirth, and then more rapidly in response to increasing cost pressures.11 With earlier discharge, the opportunity and responsibility for observing the newborn during the period of highest risk shifted from hospitals to families and primary care systems.11 Typically, primary care pediatricians were not consulted to plan for this change in their role in delivering care.
The public response to this problem of "drive-through deliveries" came in the mid-1990s in the form of legislative or administrative action by >40 states and the US Congress. Generally, these laws require health care insurers to pay for at least 48 hours of postpartum hospital care unless the mother, in consultation with her provider, chooses earlier discharge.11 These changes have not ensured safe care for newborns with hyperbilirubinemia. Discharge before 72 hours of age can be a risk factor for severe hyperbilirubinemia—staying only 48 hours is not enough to lower risk.12 Furthermore, many mothers leave voluntarily even earlier than 48 hours. More important for safety than length of stay postpartum is having a health care professional observe the newborn after discharge, during the period of risk for hyperbilirubinemia, as recommended by the AAP practice parameter.3,11 Unfortunately, the typical pattern of newborn follow-up care is a 1- to 2-week postdischarge visit, occurring long after the period of high risk and the time for effective intervention has passed.11 Many pediatricians did not change the practice of scheduling a first visit at 2 weeks of age, perhaps because they were unwilling to accept this changing role or were unaware of the importance of monitoring for hyperbilirubinemia in the first few days of life.
This sequence of events illustrates the limitations of applying mechanical thinking to complex systems; well-intentioned changes that do not address the whole system cause unexpected problems. However, adaptive behavior toward a solution began in 2000 as an advocacy organization called Parents of Infants and Children With Kernicterus13 formed and influenced other agents to start taking action.14,15
In the MAJIC Project we set out to consider the whole system including all the interactions among agents by using analogies with the known properties of complex adaptive systems. We describe here how the IOM’s "10 simple rules" can provide direction to guide improvements that ensure a safe first days of life for all newborns.
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THE IOM’S SIMPLE RULES AND IMPROVING CARE FOR NEWBORN HYPERBILIRUBINEMIA |
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TOPMAKING ADVANCES AGAINST JAUNDICE...KEY FEATURES AND SYSTEMS...THE IOM'S SIMPLE RULES...DISCUSSIONREFERENCES |
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The newborn should not be discharged until a postdischarge physician is identified. The postdischarge physician must be willing to take calls and see newborns urgently for bilirubin-related problems. Also, the postdischarge physician must be willing to schedule newborn follow-up appointments with only 1 to 2 days notice, because the AAP guideline recommends follow-up within 48 to 72 hours of discharge from the birth hospital for newborns discharged before 48 hours.3 First newborn visits should occur within this time even when the visit would fall on a weekend day. If this is impossible, an alternative plan must be made to cover these needs. This may involve having the hospital and hospital physician retain responsibility or may involve reliance on appropriately trained home care nurses.
Typically, health care reimbursement systems restrict coverage after discharge in the first week of life to "medically necessary" visits. Although there is no evidence from the recent report of 90 cases of kernicterus that lack of insurance was a contributing factor,7 reimbursement systems could actively promote early detection of hyperbilirubinemia by covering the options described above for routine follow-up in the first week of life.
Rule 2: Customization Based on Patient Needs and Values. The system of care should be designed to meet the most common types of needs but have the capability to respond to individual patient choices.
When dealing with newborn hyperbilirubinemia, 2 patients’ needs must be considered. Current health care systems have difficulty in recognizing this shift from 1 to 2 patients. Typically, newborn information is in the mother’s medical record; the newborn technically does not occupy a bed and does not have an insurance number. It is as though the newborn does not exist from an administrative point of view. Yet the newborn’s own needs must determine discharge, not simply the mother’s readiness to go home. Either the physician responsible for the mother’s care or the physician responsible for the infant’s care in the hospital should inform the mother of her newborn’s needs. Mothers may wish to go home quickly to be with family, especially if there are older siblings. However, if a physician explains the newborn’s need for it, how many mothers value their newborn so little as to refuse a longer stay?
Meeting the needs of the newborn with hyperbilirubinemia is not simple. The differential risk for newborns who are breastfed and who are in high-risk demographic and socioeconomic groups must be reflected in plans for follow-up care. The system of care must detect rapid shifts in newborn physiology. A bilirubin of 8 to 10 mg/dL is unremarkable in a 48-hour-old newborn but signifies the need for urgent intervention in one who is 12 hours old.16 At the very least, laboratory systems must record the newborn’s age in hours at the time the blood for serum bilirubin is drawn.16 Serum bilirubin tests on newborns must be processed and reported urgently. Jaundiced newborns may have undiagnosed problems that accelerate the course of hyperbilirubinemia such as glucose-6-phosphate dehydrogenase deficiency or hemolytic anemia. Although it is not practicable to screen for these rare disorders, close follow-up observation and additional investigation as appropriate should permit their detection. Close follow-up is also particularly necessary in breastfed newborns who are at increased risk of undernutrition, dehydration, and hyperbilirubinemia.
This close monitoring of the newborn during the first week of life must also fit with the mother’s needs. Commonly, mothers are advised not to drive themselves in this period, especially if they are taking narcotic analgesics. Traveling immediately postpartum is uncomfortable and traveling with a newborn is stressful. Home visits may be more appropriate, provided the mother is comfortable with allowing a stranger into her home and the home care nurse knows whether the mother was discharged to her own home or is staying with relatives.
Rule 3: The Patient as the Source of Control. Patients should receive the necessary information and opportunity to exercise the degree of control they choose over health care decisions that affect them.
Newborns must rely on their parents to be the source of control for their care. How can this best be achieved? Key choices about care must be made when the newborn is discharged, which occurs typically within 24 to 36 hours of delivery. Education about newborn hyperbilirubinemia to guide these choices is usually given at discharge. Evidence of temporarily impaired cognition during the first 24 hours after delivery suggests that this is not the best time to educate the mother or offer her choices.17 Important topics such as hyperbilirubinemia need to be addressed prenatally, when the mother is better able to process information. Additionally, the father, who has not undergone labor and delivery, may be available to help with decisions during the birth hospitalization if he too has been adequately educated prenatally. Providing clear written instructions at discharge for review later can reinforce this teaching.
To make sound choices, mothers and fathers must be informed accurately of any risk to their newborn and specifically for the risk of hyperbilirubinemia progressing to cause kernicterus. The rarity of this potentially alarming event, of course, should be emphasized. Informed in this way, a mother should be offered choices at many points about her newborn’s care. What physician will she select to take responsibility for her newborn from the moment of discharge? While in the birth hospital, does she want to be wakened so that staff can observe her newborn in good light? Does she want to exercise her right to stay until the newborn is 48 hours old to permit additional observation of the newborn? What are the options for professional monitoring of the newborn in the first week of life? How should she monitor her newborn’s nutrition and hydration? What can she herself do to detect hyperbilirubinemia? What are the signs that should prompt seeking urgent care for the newborn? What are the options for urgent care if needed even at night and on weekends? If parents are to exercise the degree of control they prefer over health care decisions for their newborn, they must know the answers to these questions.
Rule 4: Shared Knowledge and the Free Flow of Information. Patients should have unfettered access to their own medical information; clinicians and patients should communicate effectively and share information.
Shared knowledge and information is essential for parents to monitor their newborn in the critical first week of life. In addition to receiving prenatal education about the risks of hyperbilirubinemia, new parents must know how they should communicate with providers to ensure good care for their newborn. "Handoffs" of care from one clinician or organization to another are points where mistakes can be made easily. The exact point of handoff must be clear to the family as well as the hospital and postdischarge physicians. Before leaving the hospital, the family must know how to contact the postdischarge physician about needs of their newborn. Parents should leave the hospital with key information about their newborn including exact time of birth and relevant laboratory values and times. This is important for the parent’s own information but also because parents provide an important channel of communication between hospital and postdischarge physician.
Publishers of books of advice for new parents fill an important role in sharing knowledge in our health care system. These publishers also need to shift their provision of knowledge about newborns to the prenatal period. Many such books cover what to do while you are pregnant in one book and what to do after the newborn is born in another volume. This arrangement fits the principle of providing education just when it is needed. However, for new parents, a perverse effect is that the newborn may suffer irreversible harm before they have opened the second volume.
Rule 5: Evidence-Based Decision-Making. Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place.
The AAP is currently updating their practice guideline on the evaluation and treatment of hyperbilirubinemia in newborns on the basis of research evidence.4 The guideline is complex in that the recommendations for treatment vary according to the serum bilirubin level at a particular age in hours. Clinicians caring for newborns must understand the rare but real risk of hyperbilirubinemia and the critical times for risk. Evidence-based recommendations and expertise must be easily accessible to clinicians in all practice settings including home care. Practice supports, such as the pocket cards now being distributed by the AAP, facilitate the use of complex decision rules in day-to-day practice.
The practice of "evidence-based medicine" implies a reliance on the best available information regardless of whether it comes from a randomized clinical trial. Knowledge of newborn physiology suggests the importance of follow-up during the critical first week of life despite the absence of specific evidence on this topic.11
Rule 6: Safety as a System Property. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.
The Joint Commission on Accreditation of Healthcare Organizations recently issued a Sentinel Event Alert entitled "Kernicterus Threatens Healthy Newborns."15 With the publication of this alert comes a mandate for accredited institutions to 1) take steps to raise awareness among neonatal caregivers of the potential for kernicterus and its risk factors, 2) review their current processes of care with regard to the identification and management of hyperbilirubinemia in newborns, and 3) identify strategies that could enhance the effectiveness of these processes. This alert substantially expands the responsibility of hospitals to work with medical staff to ensure safe care for newborns after discharge.
Resources must be made available for timely follow-up observation. Laboratory testing must be provided at a reasonable distance, with adequate hours of operation so that testing and communication of laboratory results can occur over the relatively short time frame required. Access to resources such as breast pumps (to stimulate lactation) and phototherapy must be available as needed, not "after the weekend."
Rule 7: The Need for Transparency. The health care system should make information available to patients and their families that allows them to make informed decisions, which should include information describing the system’s performance on safety, evidence-based practice, and patient satisfaction.
Just as families need to be educated about the risks of newborn hyperbilirubinemia, so must they be educated about the systems in which they may seek care. Hospitals and physicians should make available and accessible their policies and procedures about hyperbilirubinemia evaluation and treatment and newborn follow-up. Health plans should ensure the availability of physicians willing to see newborns within 48 to 72 hours of discharge. Plans should disclose their benefit structures for newborn and hyperbilirubinemia care to potential enrollees of childbearing age and to enrollees who seek care for pregnancy and delivery. In addition to timely evaluation and treatment, a number of key benefits may impact the risk of occurrence of hyperbilirubinemia including coverage for home visits, breast pumps, lactation consultants, and durable medical equipment (eg, phototherapy lights). Those responsible for offering choices of benefit packages to employees and families must understand the value of these benefits and communicate their importance to families.
Rule 8: Anticipation of Needs. The health care system should anticipate patient needs rather than simply reacting to events.
We know up to 9 months ahead of time that the newborn is coming. We know that half of all newborns will have some degree of hyperbilirubinemia. We have an understanding of the natural time cycles of newborn physiology. Aligning the time frame of the system with the newborn it is supporting is critical to providing appropriate care. It is interesting to note that most other areas of clinical care that are routinely described in hours (eg, administration of thrombolytics) have come to be regarded as crisis situations. Mental models about newborn hyperbilirubinemia do not raise the adrenaline levels of most clinicians in similar fashion. However, because newborn hyperbilirubinemia can reach the level of crisis in a matter of hours, appropriate care must be available on an emergency basis.
Given the brevity of hospital stays for newborns, many activities that formerly took place during the admission must now be planned in advance. We can anticipate what systems and providers are needed to ensure a safe first week of life. For instance, we know that some newborns will need serial serum bilirubin testing that can be tracked and compared over time. When newborns remained in the hospital for 4 days, serial bilirubin tests were conducted in the same laboratory, and levels could be trended to detect severe hyperbilirubinemia. Laboratories that serve newborn populations are more likely to use methods that are sensitive even at the extreme levels encountered in the first few days of life and never seen in adult populations. With earlier discharge of newborns, postdischarge serum bilirubin tests are often sent to different laboratories including those serving the postdischarge physician’s office and/or a community hospital emergency department. These laboratories may use different methods yielding substantively discrepant results.18 In planning for postdischarge care, hospitals and their medical staffs should consider solutions to the lack of standardization across laboratories.
Rule 9: Continuous Decrease in Waste. The health care system should not waste resources or patient time.
The AAP’s 1994 guideline was focused in part on reducing unnecessary testing and treatment.3 Now the pendulum has swung, and some pediatricians advocate universal bilirubin screening of all newborns.16 The challenge is to find the right balance between cost and safety, although we lack information about all the costs and benefits.
Failure to prevent severe hyperbilirubinemia creates avoidable expenses associated with readmission for treatment. Newborn hyperbilirubinemia is currently the number one reason for readmission.19 Failure to prevent kernicterus because of inadequacies in detection and treatment leads to a lifetime of specialty services including and well beyond medical care for a devastated child. As a result, malpractice awards to families of children with kernicterus reach into the multimillions.20
Time and money are precious commodities. A new mother at home with a yellowing newborn must frequently make multiple calls and multiple trips to get needed blood tests, supplies (such as a breast pump or phototherapy equipment), and insurance approval for these services. All this occurs at a time when the family is coping with the frequent need for attention by their newborn. The result can be prolonged delays, leading to a worsening of hyperbilirubinemia and increased risk of kernicterus.
Rule 10: Cooperation Among Clinicians. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.
The transition from hospital to home at a time of risk makes coordination of care essential. The handoffs of responsibility from prenatal care to birth hospital and then to postdischarge primary care present many opportunities for communication failure. Clinicians caring for the mother and child at any point in time may not know what education has already been provided to the parents or what education is likely to occur in the future. Coordinated clinical pathways across settings should incorporate specific plans for family education.
We have already highlighted the need to identify a postdischarge physician for the newborn before birth. Hospital staff must know how to reach this physician to facilitate communication at discharge. Typically, obstetricians and hospitals have set up ways to send information from the prenatal record to the hospital when the mother arrives in labor. Now hospitals need to set up reliable ways to send clinical information about the newborn promptly to the postdischarge physician. Such information is critical to optimal evaluation and decision-making for newborn hyperbilirubinemia.
Additionally, if home care is used for postdischarge surveillance, systems are needed to facilitate communication between home care nurses and postdischarge physicians. Unless or until electronic medical records are available, faxing of paper records may be the best alternative to communicate essential information across the continuum of care. One key fact to transmit to a home care nurse is whether the mother will stay with relatives after she takes the newborn home rather than at her usual address.
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DISCUSSION |
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TOPMAKING ADVANCES AGAINST JAUNDICE...KEY FEATURES AND SYSTEMS...THE IOM'S SIMPLE RULES...DISCUSSIONREFERENCES |
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We have observed in the area of newborn hyperbilirubinemia how a single change around early discharge disrupted existing patterns of care in unforeseen ways that threaten newborn safety and contribute to the chasm in quality identified by the IOM. Early discharge shifted the locus of care and created a need for postdischarge observation, a change in venue for patient and family education, gaps in communication as sites of care shifted, and a host of other unintended consequences. Changes to health care delivery do not occur in isolation. When a change is made, everyone needs to move!
Proactive analysis of care systems undergoing organizational change may help identify potential unintended outcomes and facilitate up-front change to reduce the threat to patient safety. The 10 simple rules offered by the IOM report provide us with a template to review other areas of care that may have been similarly impacted and plagued by the unintended consequences of many and frequent changes in the health care delivery system. Taking less than a full-systems view of the impact of change leaves us vulnerable to additional gaps in quality and threats to patient safety. We must act independently, following clear, simple rules to meet these challenges together.
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ACKNOWLEDGMENTS |
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Dr. Maisels received a grant from the Minolta Corporation for testing of the transcutaneous bilirubinometer model JM 103 in routine clinical use during 2001 and 2002.
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FOOTNOTES |
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Reprint requests to (R.H.P.) Center for Quality of Care Research and Education, 677 Huntington Ave, Boston, MA 02115. E-mail: yrhpal{at}hsph.harvard.edu
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REFERENCES |
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TOPMAKING ADVANCES AGAINST JAUNDICE...KEY FEATURES AND SYSTEMS...THE IOM'S SIMPLE RULES...DISCUSSIONREFERENCES |
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This article has been cited by other articles:
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  M. J. Maisels and on behalf of the Subcommittee on Hyperbilirubinemi Hyperbilirubinemia Guidelines and Unintended Harms: In Reply Pediatrics, October 1, 2004; 114(4): 1135 - 1137. [Full Text] [PDF]
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R. H. Palmer, S. Ezhuthachan, C. Newman, M. J. Maisels, and M. A. Testa Hyperbilirubinemia Benchmarking Pediatrics, September 1, 2004; 114(3): 902 - 904. [Full Text] [PDF]
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C. Lannon and A. R. Stark Closing the Gap Between Guidelines and Practice: Ensuring Safe and Healthy Beginnings Pediatrics, August 1, 2004; 114(2): 494 - 496. [Full Text] [PDF]
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