Responding to patient safety incidents: the "seven pillars".

BACKGROUND: Although acknowledged to be an ethical imperative for providers, disclosure following patient safety incidents remains the exception. The appropriate response to a patient safety incident and the disclosure of medical errors are neither easy nor obvious. An inadequate response to patient harm or an inappropriate disclosure may frustrate practitioners, dent their professional reputation, and alienate patients. METHODS: The authors have presented a descriptive study on the comprehensive process for responding to patient safety incidents, including the disclosure of medical errors adopted at a large, urban tertiary care centre in the United States. RESULTS: In the first two years post-implementation, the "seven pillars" process has led to more than 2,000 incident reports annually, prompted more than 100 investigations with root cause analysis, translated into close to 200 system improvements and served as the foundation of almost 106 disclosure conversations and 20 full disclosures of inappropriate or unreasonable care causing harm to patients. CONCLUSIONS: Adopting a policy of transparency represents a major shift in organisational focus and may take several years to implement. In our experience, the ability to rapidly learn from, respond to, and modify practices based on investigation to improve the safety and quality of patient care is grounded in transparency.

Antibody-mediated lung endothelium targeting: in vivo model on primates.

We have recently provided evidence that angiotensin-converting enzyme (ACE) is a rational target and anti-ACE monoclonal antibodies (mAbs) are suitable molecules for directing gene/drug delivery into the pulmonary endothelium of rodents. As a step towards gene therapy clinical trials using this approach, the present study evaluated the potential of anti-ACE mAbs for in vivo lung endothelium targeting in 10 species of primates. Cross-reactivity of 10 distinct mAbs directed to human ACE with ACE from baboon, macaques, cercopithecus and chimpanzee revealed that the highest binding with ACE from baboon and macaques was with mAb i2H5, from chimpanzee - mAb 9B9, and from human - 9B9 and i2H5. Thereafter, in vivo biodistribution of mAbs i2H5 and 9B9 was estimated in Macaca arctoides. MAb i2H5, which binds to macaque ACE with substantially higher affinity than mAb 9B9, also more effectively accumulates in their lungs than mAb 9B9. Immunospecificity of lung accumulation (mAb/control IgG ratio) was 37 for i2H5 and 0.5 for 9B9. Lung selectivity of i2H5 uptake (lung/blood ratio) was around 10. Therefore mAb i2H5 may be useful for in vivo lung targeting in non-human primates, whereas 9B9 may be most useful in primates that are closer to humans (chimpanzee). A combination of these two mAbs may be particularly useful for human clinical trials of gene/drug therapy for lung disorders such as pulmonary hypertension and lung metastases.

Post-operative pain management.

For many years pediatric procedural and postoperative pain has been undertreated or not treated. In some areas this practice still exists and is a likely reflection of persistence of myths related to the infant's ability to perceive pain. Such myths include the lack of ability to perceive pain or remember painful experiences. New literature exists showing that these former beliefs do not hold true. The appropriate management of postoperative pain is contingent on a cooperative effort from pediatric surgeons, pediatric anesthesiologists, pediatricians, and parents. There are many ways to treat postoperative pain. The method of postoperative analgesia depends on the patient, underlying medical conditions, the type of surgery, the patient's disposition following surgery (inpatient vs. outpatient), and the physician's comfort level with a particular analgesic regimen. Many pediatric anesthesiologists and surgeons have excellent success with the utilization of regional anesthetic techniques as treatment for postoperative pain. Caudal epidural blocks, ilioinguinal/iliohypogastric nerve blocks, and penile nerve blocks are some of the commonly used blocks. These blocks not only provide excellent postoperative analgesia, but are great adjuncts to general anesthesia, thus, reducing the amount of general anesthesia required. Additionally, the use of epidural opioids is extremely useful in patients following major abdominal, thoracic, and orthopedic surgery. Traditional medications such as oral and parenteral narcotics, non-steroidal anti-inflammatory drugs, and acetaminophen (paracetamol), are much more commonly used to treat postoperative pain. Regardless of the analgesic regimen chosen, we must assure our pediatric patients the least painful perioperative experience possible.

Craniomaxillofacial surgery in the Jehovah's Witness patient.

The reconstruction of severe craniofacial anomalies in patients who will not accept blood transfusions presents a considerable challenge to the craniofacial team. Traditionally, these patients have been refused major reconstructions, receiving no treatment or a highly compromised substitute. A management protocol was developed utilizing preoperative erythropoietin and ferrous sulfate therapy, intraoperative in-line normovolemic hemodilution, and meticulous intraoperative hemostasis which allows us to perform major craniomaxillofacial reconstructions in Jehovah's Witness patients without the use of homologous or predonated autologous blood transfusions.

Airway management and sedation for pediatric transport.

Appropriate airway management is essential for the successful transport of sick children. Airway management begins with a thorough history and physical examination and may proceed to invasive therapeutic interventions. Successful care of the pediatric airway can be achieved only with a thorough knowledge of airway management technique and equipment. In addition, familiarity and understanding of the pharmacologic adjuvants to airway management and sedation will help to achieve the primary objective of any transport team, namely a safe and smooth transport of the critically ill child.