الفهرس 
Adverse events in neonatal intensive care units (NICUs)Only 14 pages are availabe for public view
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Abstract
There is international recognition that patients are harmed in hospitals because of adverse events, and the neonatal intensive care unit (NICU) patients are not exempted. Patients in NICUs often are critically ill, require complex care, and their small size and immature physiology leave little margin for adverse events and errors and anyone who works in the environment recognizes that there are multiple opportunities to improve the care and make it safer.
Although newborn babies represent a high-risk population, data are still scarce. Human factors and system deficiencies, such as inadequate protocol, communication problems, and equipment dysfunction are all contributing factors to adverse events in NICU. By reducing system faults, one can make it difficult for the individual to err. Changing the culture in NICUs into a safer one requires the support of leadership as well as personal commitment from all care team providers.
This study aims to:
1. To determine organizational characteristics of the NICU.
2. To describe patient characteristics (birth weight, gestational age, gender, diagnosis, length of stay).
3.
a) To estimate the frequency of adverse events in the NICU and determine those that could be considered preventable.
b) To analyze the types of adverse events occurring in NICU and the contributing factors (root causes) that cause these adverse events.
c) To assess the severity of adverse events.
4. To recommend a quality improvement system for diminishing adverse eventsin the NICU.
The study was conducted at the medical non profit section of NICU of El-Shatby University Children’s Hospital. The study design was descriptive. The study has two parts prospective part which is observation of neonates from admission to discharge and retrospective part which is reviewing the same neonates’ medical records.
The study sample consisted of all consecutive admissions to NICU with minimum 2 days length of stay and their medical records (550 neonates). All physicians and nurses in El-Shatby NICU at the time of the study were included.
As regards data collection, observation was done to neonates from admission to discharge about 3 times weekly and observations were distributed evenly between all work shifts in the NICU. Observation was done to by noticing the change in the medical condition of the neonates in the form of appearance of new adverse events, and confirming these adverse events by referring to medical records, asking residents, specialists, and nurses about them and their severity and preventability. An observation sheet was designed to obtain data about neonates during their stay in the El-Shatby NICU and it included two main sections. The first section included patient administrative data and clinical characteristics and the second section included adverse events specific data about their types, preventability, and severity. After discharge of patients their medical records were reviewed by a NICU focused trigger tool. Also any additional adverse events that were not associated with triggers were included in the sheet used for reviewing the medical records. Specifically designed questionnaires for collection of data were administered to the NICU director, physicians and nurses. The raw data was coded and entered for the computer by the researcher using the SPSS program “version 16” and suitable statistical methods were used.
The study revealed the following findings:
Part A: Adverse events detected in study sample of neonates of El-Shatby NICU
1. Patient characteristics
• The greater proportions of neonates were males (54.2%), from 32-35 weeks gestational age (37.8%), their birth weight from 1.000-1.499 Kg (37.3%), single (81.6%), appropriate for gestational age (68.4%), stayed 2-7 days (29.8%), discharged home (73.5%) and death occurred in 25.15% of sample neonates.
• As regard assisted ventilation and vascular lines, 48.0% of sample neonates were on Continuous positive airway pressure (CPAP) and peripheral venous catheters were inserted in 92.2% of neonates.
• The most frequent admission diagnosis was congenital pneumonia (50.2%) followed by early onset sepsis (41.5%).
2. Adverse events rates and types
• The total number of adverse events detected by all methods was 3947 detected in 92.2% of cases, while the mean adverse events detected by all methods were 7.2 adverse events per neonate with a rate of 717.6 adverse events per 100 admissions, and 337.5 adverse events per 1000 patient days.
• Observation method identified 3650 adverse events (92.5%) which were slightly higher than medical record review which identified 3595 adverse events (91.1%) while NICU focused trigger tool measured 3357 adverse events (85.1%).
• Adverse events detected by observation occurred in 91.8% of cases, while adverse events detected by medical record review occurred in 91.6 % of cases.
• By observation 8.2 % of neonates didn’t develop adverse events while 44.4 % of the sample developed 1-5 adverse events and the mean adverse events was 6.6 per patient with a rate of 312 adverse events per 1000 patient days.
• A total number of 4935 triggers was discovered by using the NICU trigger tool and these triggers were associated with a total number of 3357 unique adverse events occurring in 91.3 % of cases with mean unique adverse events of 6.1 and a rate of 287.1 adverse events/ 1000 patient days.
• Catheter adverse events were the most frequent adverse events detected by all methods constituting 54.7% of all adverse events, followed by respiratory adverse events comprising 18.1% of all adverse events, followed by nosocomial infections constituting 11.3% of all adverse events.
• The greater proportion of adverse events occurred in the night shift (38.6 %) followed by evening shift (33.8%), followed by morning shift (27.6%).
• By observation the greater proportion of adverse events was falling into category E (E: contributed to or resulted in temporary harm to the patient and required intervention) (68.6 %), followed by category H (H: required intervention to sustain life) (13.5 %), followed by category F (F: resulted in temporary harm to the patient and required initial or prolonged hospitalization) (9.5 %).
• According to professor opinion most of the adverse events were definitely preventable (71.3 %), while researcher mentioned that the greater proportion of adverse events was probably preventable (81.2%) and resident’s opinion was different saying that (60.4 %) were not probably preventable.
• When length of stay increases, the number of adverse events increases, and when gestational age and birth weight decrease the number of adverse events increases and females are less liable for developing adverse events.
• The catheter infiltration/ burn (T7) was the most frequent trigger (41.8 %), associated with 2059 triggered adverse events followed by antibiotic use (T2) (26.3 %), associated with 262 adverse events.
• As regards adverse events detected by trigger tool, the greater proportion of adverse events (68.5 %) contributed to or resulted in temporary harm to the patient and required intervention, followed by 14.8 % of adverse events contributed or resulted in the patient’s death. As regards non triggered adverse events, the greater proportion of adverse events (44.1 %) was in the H category, followed by E category represented by 29 % of non triggered adverse events.
• The highest percentages of adverse events identified by trigger tool (88%) and of non triggered adverse events (90.3 %) were preventable. Also 99 % of adverse events identified by trigger tool and 96.2 % of non triggered adverse events occurred inside NICU.
Part B: Organizational characteristics of El- Shatby NICU and possible contributing factors to occurrence of adverse events
1. Results of director’s questionnaire
• Certain criteria required for Level III NICUs were present such as: infection control and biohazard precautions, maintenance of health records, while other criteria were not present in El-Shatby NICU such as: clear referral policies and lines of communication with other specialties and policies and procedures for transfer and retrieval of babies.
• Absence of clinical protocols in El-Shatby NICU, while presence of the majority of criteria of staff education, quality improvement program, diagnostic services and support services.
• The total number of equipment (including cots and incubators) was 322 of which (92.9%) was functioning at the time of study, the actual number of physicians was 17 of which 47.1 % were residents, and the actual number of nurses was 70 of which 60% comprised nurses with nursing diploma.
2. Results of physicians’ questionnaires
• The greater proportions of physicians were females (52.4%), held a bachelor degree (61.9 %), in resident position (61.9%), the mean years of experience in working in NICUs were 6.2 years, the mean years of work in El-Shatby NICU were 5.2 years, the mean working hours per week were 84.0 hours and 47.6 % received training.
• The highest percentages of physicians mentioned that working staff numbers were below requirements in their opinions regarding teaching staff (57.1 %), residents (57.1 %), nursing supervisors (81.0 %), nurses (100%), and radiology technicians (71.4 %).
• The greater percentages of physicians indicated that the following problems occurred almost always at the time of study: lack of coordination and difficult communication between NICU and other departments (38.1%), inadequate security leading to problems with patient’s relatives (33.3 %), lack of presence of members of the security staff in night shifts (71.4%), high census or increased workload (57.1%), high patient acuity in unit (52.4%), poor physical or psychological status (28.6%), fatigue and lack of sleep (38.1%), and work schedule doesn’t allow adequate sleep (47.6%).
• The greater proportions of physicians indicated that the following problems usually occurred in the unit: lack of adequate supervision on nursing staff in night shifts (47.6%), inadequate security leading to problems with patient’s relatives (33.3%), noise (52.4 %), lack of space in rooms (28.6 %), and stress (47.6%).
3. Results of nurses’ questionnaires
• The greater proportions of responding nurses (60.0%) graduated from nursing schools, with mean working hours per week of 46.8 hours and 24.3% received training.
• There is decrease in the number and percentage of working nurses from morning to night shifts while regarding mean nurse to neonate ratios: in Level III room (LIII) one nurse took care of mean neonates of 4.5, in Level II room (LII) one nurse took care of mean neonates of 9.2, in isolation room (Ld) one nurse took care of mean neonates of 7.4, and finally in grower room one nurse took care of mean neonates of 11.8.
• The most frequent problems were increased workload and unit census stated by 70.0 % of nurses and shortage of nursing staff stated by 65.7 % of nurses.
Based on the study conclusions the following recommendations can be suggested:
1. Incident reporting system should be introduced in El-Shatby NICU preferably of the voluntary anonymous type.
2. The level of adverse events should be regularly monitored by using the NICU focused trigger tool.
3. A common language for treating and dealing with cases should be established through setting written clinical medical and nursing protocols especially those related to the prevention of catheter and respiratory adverse events and nosocomial infection.
4. Policies and procedures related to the unit should be developed particularly patient safety policies and admission policies.
5. There should be a written protocol for adequate communication between NICU and other departments to include strict policies for ways of consultation and referral of neonates.
6. Human resources should be developed in the form of continuous education and conduction of training programs involving all the working staff especially nurses, and residents about the proper methods and guidelines for the most frequently detected adverse events.
7. To allow delivery of appropriate care to patients, the number of nursing staff should be increased based on the actual work load to reach the acceptable patient: nurse ratio and the work schedule of physicians should be modified taking into consideration limiting working hours.