NeoPed Quality – About Healthcare Quality in NICU and Pediatrics

Specialists who help deliver babies (obstetricians) and those who care for them after birth (neonatologists) are exposed to a high risk of litigation if a bad outcome occurs. Malpractice cases from both Great Britain and the USA prove that point. According to a survey of American neonatologists who had been in practice for 15 years, 60% of the physicians working in NICU experienced at least one case of malpractice litigation. Across the ocean in the UK, 9% of all clinical negligence cases were from obstetrical and neonatal claims. However, they constituted much larger monetary value, representing 50% of the total requested compensation in those cases. In my article, I will present the most common diagnoses, errors, and contributing factors associated with legal actions against neonatologists and owners of NICUs. What are the most common neonatal diagnoses associated with malpractice cases? The most frequent diagnoses in neonatal malpractice cases are the need for resuscitation at birth, jaundice, hypoglycemia, and late prematurity. I will explain those and a few other "risk" diagnoses below (source article). Respiratory failure at birth and the need for CPR Time of birth is critical. If a baby does not start breathing in the first few minutes, how we manage that situation will decide a child's future. There are strict guidelines regarding cardiorespiratory resuscitation issued in the USA by major professional organizations (AAP, ACOG, AHA). All staff that attend neonatal birth should be trained and skilled in performing required reviving procedures. Unfortunately, institutions often do not have well-trained personnel on site, equipment or medications are not readily available, or providers do not follow CPR guidelines. Delay in starting full resuscitation or not implementing all necessary steps may have grave consequences for the baby. You will find my full article on the legal aspects of newborn resuscitation here. These mistakes may contribute to poor long-term neurodevelopment outcomes or even death. Meconium Aspiration Syndrome Sometimes, a baby passes the first bowel movement before birth. That first bowel movement is called meconium, and the situation is known as "Meconium-stained amniotic fluid." Although most babies will do well after such an episode, some may swallow and inhale that meconium into their lungs and develop Meconium Aspiration Syndrome. In severe cases, babies develop serious breathing problems with low oxygen levels. The key to the treatment is early recognition of the gravity of the situation and vigorous treatment. Treatment will depend on the severity and may include antibiotics, oxygen delivery, and various types of respiratory support. Some babies may need mechanical ventilation, nitric oxide treatment, or even ECMO (ECMO = artificial oxygenation of the blood in the machine outside our body). Finally, a few babies will develop a complication called Pneumothorax, and some may die. Missteps in diagnosing and treating this complicated condition may cause long-lasting harm to affected children. Pneumothorax Pneumothorax almost always develops suddenly. It is a condition in which a small portion of the lung ruptures and air gathers in the space between the lung and internal chest wall. As a result, the compressed lung can not expand properly, and the patient has problems getting oxygen into their body and getting carbon dioxide out of it. In addition, the heart may also be affected, and a patient may develop low blood pressure (hypotension). Pneumothorax may occur spontaneously in healthy term newborns (in about 3% of babies); for them, it is usually asymptomatic or mild disease without severe consequences. However, in premature babies, this condition is more common (4%-7%), may be sudden, and may lead to severe respiratory distress and even death if not treated promptly. Diagnosis is always a challenge. One can diagnose it based on the history and clinical assessment, but the ultimate diagnosis is made by chest x-ray. Unfortunately, due to the severity of respiratory distress, sometimes clinicians have to rely only on their clinical skills and start treatment without confirmation by chest x-ray. For some inexperienced clinicians, this decision is tough to make. Treatment of Pneumothorax may involve just watching and providing oxygen, but in more severe cases, it requires placement of a chest tube into the chest cavity and mechanical ventilation. Diagnosis of Pneumothorax may be associated with malpractice claims due to delay in diagnosis, inappropriate treatment decisions, or complications from treatment procedures (puncture of the lung, blood vessels, or heart while placing the needle or chest tube). I wrote more about Pneumothorax in my article here. Hypoxic Ischemic Injury Hypoxic Ischemic Injury is a pathological condition that develops due to decreased blood flow and oxygen to vital organs. Most obstetricians and neonatologists talk about Hypoxic Ischemic Encephalopathy (HIE), which pertains to brain dysfunction. It is OK to focus on the brain as its function will determine future neurodevelopmental outcomes. However, in clinical situations, the lack of oxygen and blood flow will affect many other organ systems. Patients with this diagnosis may have symptoms originating from different sites of our body: Brain - lethargy, seizures, slow and irregular breathing, high or low muscle tone, future poor neurodevelopment outcomes. Heart - low blood pressure, arrhythmias Kidneys - low or absent urine output Liver - increase in liver enzymes Hematology - hemolysis, thrombocytopenia Metabolic changes - low or high glucose levels, more acid in the blood There are numerous causes of HIE in newborns. Continuing natural delivery instead of conducting emergency cesarean section is the most common claim against obstetricians. Neonatologists are often implicated in malpractice litigation because those babies do not breathe after birth and need prolonged resuscitation. In addition, parents and lawyers will carefully review the management of HIE in the NICU and claim that specific treatments were not provided in an expedited manner. The newest treatment for serious HIE relies on decreasing a baby's body temperature for several days after birth (= Hypothermia treatment, brain cooling, or whole body cooling)). The treatment can not be offered in all NICUs; therefore, patient transport may be indicated. The baby has to meet specific inclusion criteria for the treatment, and the therapy needs to be initiated soon after birth (usually within 6 hours after birth). Neonatologists may also commit errors in managing low blood pressure, kidney failure, or acidosis while treating HIE. Intraventricular Hemorrhage and its complications The human brain consists of neural tissues and empty chambers called ventricles. They contain cerebral fluid. Premature babies are at higher risk of developing bleeding in these areas, called Intraventricular Hemorrhage (IVH). A more premature baby has a higher risk of bleeding. Neonatologists must be aware of those risks and screen babies for that possibility. In babies diagnosed with IVH, doctors must keep imaging the brain regularly to look for hydrocephalus. The latter condition may require surgery to minimize effects on neurodevelopmental outcomes in the future. As in many other medical conditions, being aware of IVH risks, prompt diagnosis and follow-up, and recognizing complications to avoid bad outcomes are key behaviors necessary to minimize harm to the patients and risks of malpractice litigation. Newborn jaundice (Hyperbilirubinemia) Jaundice describes the presence of yellow skin in a baby due to elevated levels of a chemical we all produce in our bodies called bilirubin. There are a few essential facts we all should know about this condition: For the majority of babies, this condition is self-limited and benign. There is no single "safe level of jaundice," "treatment level," and "dangerous levels" keep changing depending on gestational age, additional risk factors, and the age of the baby after birth. The condition may be life-threatening for a few babies with extremely high bilirubin levels (kernicterus) and cause death or inferior neurodevelopmental outcomes (including cerebral palsy). Lack of awareness of risk factors for jaundice, delay in diagnosis of significant jaundice, delay in appropriate treatment, or lack of proper follow-up after discharge home are reasons for litigation due to mismanagement of newborn jaundice. Hypoglycemia Hypoglycemia is frequently cited as a diagnosis associated with litigation against neonatologists, but in my opinion, that has changed in recent years. Of course, lawsuits related to this diagnosis occur, but they are much less common. Several factors influenced that. All hospitals developed policies identifying newborn patients needing screening for hypoglycemia and telling clinicians what to do if glucose levels are low. The guidelines developed by the AAP committee helped in that regard, too. The majority of protocols follow these guidelines. Trouble starts if a provider does not follow guidelines or nurses forget to test a baby that should have been included in a screening program. Finally, proving a cause-effect relationship in hypoglycemia malpractice cases is not easy. Evidence regarding harm to the baby from low glucose is not of great quality. We still do not know how low glucose needs to be and for how long in each baby to cause a deleterious effect on their future development. Regardless of what I said, If screening for glucose levels is missed, or providers do not act appropriately and quickly when glucose levels are low, they risk being sued. Late preterm infant Babies who are born between 34 weeks 0 days and 36 weeks 6 days are called late preterm newborns. Often, they look almost like full-term infants, and medical providers and parents treat them like that. Unfortunately, there are cases where such an approach leads to disasters and lawsuits. It is common knowledge that late preterm babies may develop temperature instability, poor feeding skills, glucose problems, or breathing problems. However, sometimes doctors forget that two or three days of observation in the hospital may not be enough to ensure that those babies will be well after discharge home. Numerous cases exist where a presumably healthy baby went home after three days of observation. Then, in a day or two after discharge, babies developed significant jaundice, lost a lot of weight, had fulminant infection, or developed apneas (pauses in breathing pattern). It is well-known that discharge home of late preterm babies carries a much higher risk of hospital readmission than other babies, including more premature ones. When outcomes of late premature babies become unfavorable, allegations against neonatologists include a lack of appropriate screening, treatment, and follow-up. Also, plaintiffs often claim they did not receive information and education on what to expect and how to care for late preterm babies after discharge. Procedure complications (up to 25% of cases, according to some studies) Newborn babies staying in the NICU frequently need invasive procedures during their treatments. The most common performed procedures in NICU are: intubation = insertion of the breathing tube into the trachea peripheral IV access central line catheter insertion blood products transfusion spinal tap bladder catheterization chest tube placement Surfactant administration There are many possible complications associated with these procedures: malfunctioning equipment perforation of organs during a procedure leaving a line or tube in the wrong location bleeding infections obstruction of the blood vessels development of the thrombus The development of a complication does not necessarily lead to liability. Some complications can be avoided, but some can not. Nonetheless, in all cases, neonatologists need to recognize them early and treat them promptly. Doctors increase their exposure to lawsuits related to procedure complications if they do not obtain proper informed consent, do not perform it safely, and do not continue to watch for any complications. For example, complications may occur during the actual central line placement procedure. However, they can also develop two weeks later while the patient still has that central line in their body (infection, thrombus, perforation). What are the most frequent errors alleged in neonatal medico-legal cases? For the liability case to be successful, the plaintiff has to allege an error that contributed to a bad outcome and resulted in clearly related harm. The most common medical errors that cause harm in neonatal malpractice claims include: Delayed or incorrect diagnosis. Delayed or incorrect treatment. Communication issues. Medication errors. Lack of equipment. Missed data. Delayed or incorrect diagnosis Delayed or incorrect diagnosis will cause litigation, mainly when a misdiagnosed condition is life-threatening, or its effects can have long-lasting negative impacts on a child. An example of that may be a missed bleeding disorder that causes hemorrhage in the brain, leading to cerebral palsy or seizure disorder. Delayed or incorrect treatment When a physician diagnoses a condition, it is expected that its treatment is implemented promptly. Quick treatment implementation is crucial if a situation may cause severe consequences or prolonged harm to the child. Example: Mismanagement of extremely high levels of jaundice (hyperbilirubinemia) falls under this category. High bilirubin levels harm a child's brain and may negatively impact their future development. Therefore, aggressive treatment of severe jaundice with phototherapy, immunoglobulin, and double exchange transfusion when indicated is a must. Delays in resuscitation Whenever a baby is born without spontaneous respirations and with low or absent heart rate, what happens in the next few minutes matters the most for that child. Delay in initiation of resuscitation, delay in starting positive pressure ventilation, or not administering Epinephrine via IV route if indicated are commonly cited problems. Mishandling of neonatal resuscitation can lead to bad outcomes such as death or severely impaired future development of the baby. Communication issues All neonatal providers must communicate relevant information to the parents of their little patients. Issues such as lack of information and misleading or hiding essential facts, particularly if complications occur, are common complaints from families. In addition, not obtaining informed consent for the procedure or not following parents' wishes regarding their treatment choices may also lead to litigation against neonatologists. Medication error Doctors use a very limited number of medications in neonatology compared with adult medicine. However, newborns are patients with low birth weight, and their needs regarding dosing are unique. The best-known medication error in NICU is administering a large dose of Heparin to a baby. Heparin can cause severe bleeding in many parts of our body, including the brain, and lead to a patient's death. However, we should remember that any medication given to a baby in the wrong dose or by the wrong route (for example: intravenously instead of by mouth) may cause short or long-lasting harm. Lack of or malfunctioning equipment Neonatal Intensive Care Units utilize a lot of specialized equipment. Similarly, neonatologists who treat tiny babies need certain pieces of equipment that are only used in tiny babies. It is unfortunate, but sometimes an essential piece of equipment or instrument is needed to provide care for babies, and they are missing, staff can not locate it, or it is malfunctioning. Situations like that add to stress among healthcare providers and sometimes contribute to adverse patient outcomes. Missed data from medical records As medical providers, we gather enormous information on our patients. In the case of neonatology, we need to review the mother's medical history and that of the baby. In addition, neonatologists are responsible for passing pertinent information to a pediatrician who will care for the baby after discharge home. There have been cases when a physician did not gather all the information or receive appropriate follow-up instructions, resulting in harm to patients. For example: The pediatrician did not receive a recommendation from the neonatologist that the baby needed a follow-up bilirubin level after discharge home. That baby was readmitted to a hospital with severe jaundice a few days later. The neonatologist did not obtain information that the mother had diabetes during pregnancy. As a result, a newborn baby has not been screened for hypoglycemia (low sugar levels). When the nurse checked the baby's glucose 24 hours after birth, the sugar level was 20 mg/dl (extremely low). The neonatologist missed information about the mother having herpetic lesions during labor and did not conduct any diagnostic work-up or treatment on the baby. One week later, while at home, the baby developed herpes encephalitis and seizures. As you can see from these examples, not gathering a good medical history, missing important facts from medical records, or not passing relevant information to other providers or consultants can lead to grave consequences. What additional factors contribute to the increased risk of litigation in neonatology? Medical providers in neonatology work in large teams. Many professionals, such as doctors, NNPs, nurses, lab and radiology, or respiratory technicians, care for the same baby. In addition, policy, financial decisions, and training decisions will also affect those professionals' work. Multiple factors will always contribute to good and bad outcomes for patients under their care (source article). Inadequate supervision A neonatologist is like a captain of the ship. Even though it is not always true, one could blame them for almost everything or anything that goes wrong in the NICU. They give medical and lab orders to nurses and technicians; therefore, they should follow up on how and if these orders have been done. Working with other junior doctors (residents, fellows), nursing, and medical students requires extreme vigilance and awareness of how that can affect patients under your care. Limits of responsibility are murky here, but neonatologists will find themselves in the hot seat if something was done by junior doctors and resulted in complications for the patient. Neglectful behavior Failing to care for a patient when one has such duty may be characterized as neglectful behavior with criminal consequences. Rare but not unheard of examples would be when a doctor on duty uses drugs, is drunk, or does not respond to emergency calls from patients and other medical providers. Lack of training Many malpractice claims allege that provided medical care was not within standards or did not follow national and professional guidelines. Additionally, plaintiffs often claim that a procedure or treatment was inappropriately implemented or without appropriate follow-up. We can prevent these issues by organizing frequent training and education sessions for staff. Quality initiatives and ongoing reviews that hospitals can undertake may also help. Not using consultants or experts in the field Neonatologists are pediatric specialists for newborn babies. However, they do not have advanced knowledge in managing each body organ. There are situations when a sub-specialist, such as a pediatric cardiologist, nephrologist, or surgeon, should be called for help and consultation. These specialists are not available in all hospitals caring for babies; therefore, transfer to another institution may be needed. Not asking for help and consultation when needed may expose a neonatologist to a malpractice suit. Staff shortages and high workload Poor planning, remote locations of hospitals, and low volumes of patients contribute to staff shortages. That, in turn, causes work overload in staff that remain working. Work overload and stressful environments may influence the frequency of committed errors at work and affect each institution's overall quality of care. Human factors such as exhaustion and poor communication skills There are published studies proving how the number of hours or shifts worked per week by residents and nurses contributes to higher rates of hospital complications and deaths. Institutions must pay more attention to these numbers and limit hours worked even if their employees are willing to fill all available schedule holes. Given the high number of institutions struggling with getting enough staff to work, it is still way too rare to hear about limits on admissions or temporary closures of units. I am trying to understand why hospital administrators still think it is better to keep service running rather than limit its scope to preserve better quality of care. Communication skills play a significant role in health care. The exchange of information among hospital workers and family members impacts the quality of care. Sadly, in the era of electronic medical records, we (doctors) tend to rely too much on what is stored in digital format rather than on personal and verbal information gathering. Thus, we may get a lot of information noise and miss critical facts. Another pessimistic scenario is when people's personality traits affect their abilities to interact with others. I have in mind here rude doctors who are always unhappy when a nurse calls them to ask a question or confirm an order. This type of behavior should be dealt with and corrected by hospital administrators. It may easily lead to a situation where a new or previously intimidated nurse is afraid to notify a doctor about a patient's deteriorating condition. Information Technology Systems (new and unfamiliar systems, viruses, upgrades) Informatization of the healthcare industry changed the ways medical providers operate. All the information, from the registration process through billing, medical history gathering, ordering process, and laboratory and radiology results, is in electronic format. We all suffer from information overload, sometimes missing important points. In addition, there are numerous occasions on which a newly introduced or upgraded system leads to erroneously ordered medications or procedures causing harm to patients. Reports show that unfamiliar medical record systems lead to higher rates of medication errors in hospitals. Hospitals must emphasize training all staff on planned changes and upgrades to their information systems to avoid those situations. New employees and moonlighters need to undergo the most demanding training. Training in electronic medical systems should include proficiency testing for all employees. In Summary: Neonatal chart reviewers must be aware of all potential errors and systemic factors that may contribute to bad outcomes in newborns. For any malpractice lawsuit to be successful, lawyers will have to prove harm to a patient.

Neonatal Malpractice: Common Diagnoses & Errors

Neonatal Malpractice: Common Diagnoses & Errors

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