Safety is one of the basic human needs, and patient safety is an essential component of health care quality (1). Since "To Err is Human: Building a Safer Health System report" was published, it has been considered a significant health approach that led to some movements in the world (2). These movements prompted every health care system to work to reduce incidents and errors and build a safe environment, in addition to providing health care services. The neonatal intensive care unit (NICU) is one of the accident-prone environments in the health care system due to the provision of special care, equipment complexity, need for specialized knowledge and skills, and high vulnerability of infants (3–5). In this environment, errors occur eight times more than in others (6). Also, the rate of unexpected incidents is more than 74 incidents per 100 infants (7), and many factors can be threatening the hospitalized infant safety.
Infant safety in the NICU includes the wide range of structures and practices of health care professionals and family involvement. Poorly designed care processes, not the well-designed environment, lack of facilities and human resources can endanger patient safety (8, 9). Also, stressors like light and noise, Infection, Sudden endotracheal tube extubation, and implementing invasive procedures increase the risk of infant injury and affect the growth and neurodevelopmental outcomes (10–15). Thus, organizational processes and structures should be designed in such a way as to provide safe care for hospitalized infants in the NICU and improved expected outcomes (16).
Investigations on the processes, structures, and expected outcomes in the NICUs of the Islamic Republic of Iran (IRI) reported low quality of care. They have shown that neonatal nutritional support processes (17) and discharge processes have low quality in the NICU (18). Likewise, developmental care has not widespread yet (19). Moreover, need to standardize the physical space of units and equipment to achieve the expected neurodevelopmental outcomes (21).
Expected outcomes such as infant developmental status, time to start oral feeding, breastfeeding, weight gain, and length of hospital stay, family satisfaction, and infant cognitive development in the future (22) play a role in assessing the effects of structures and processes and evaluating the degree of achieving to goals in the NICU. However, some problems in documenting hospitalized infant information, such as uncertainty about the validity and reliability of data, lack of supervisory authority on the accuracy of completing and information, and lack of access to information in the patient's subsequent visits, make it difficult to assess the expected outcomes. Identifying safety needs and taking proper and correct actions prevent the mentioned factors in the three areas of structure, process, and outcome (23).
Some countries have developed standards for understanding and meeting safety needs. National standards of England, Scotland, and Wales were developed based on unique conditions. Besides, other organizations such as the British Association of Perinatal Medicine (BAPM) (24) and the National Institute for Health and Care Excellence (NICE) (25) have developed standards that can use across the UK. Reference standards in eleven main areas covering the most significant issues related to preterm birth and neonatal complications have been developed interdisciplinary by the European Foundation for the Care of Newborn Infants (EFCNI) (26). Therefore, considering the needs of each context and available resources, the development of standards based on valid evidence is part of the health care system.
Designing and developing evidence-based standards is considered one of the most important aspects of modern management in the health sector. In the IRI, The Ministry of Health, and Medical Education (MOHME) has established accreditation programs and has planned to implement the standards of the safety-friendly hospitals of the World Health Organization (WHO), too. But, barriers to implementation standards, lack of adequate attention to safe care processes, limited resources, specific characteristics, and conditions of each health care center, and the need to adapt and update to global conditions and developments on the other hand, as well as the lack of comprehensive attention to the main factors in standards development such as health care professionals, infant, family, and other stakeholders, lack of consideration of differences, and critical characteristics of NICUs, increases the need to develop an integrated set of evidence-based standards focused on these characteristics to improve the hospitalized infant safety.
Developing standards based on current knowledge, available resources, and context that provide care, determine patient injury prevention requirements. Also, it can be a source for the development and national application of guidelines, protocols, and laws. Therefore, designing a study to develop patient safety standards in the NICU. Using the developing standards may increase the efficiency and effectiveness of structures and processes, improve outputs, facilitate assessment and evaluation, and provide equitable and high-quality services.