Document Type : Original Article


Pediatric Health Research Center, Faculty of Medicine, Tabriz University of Medical Science, Tabriz, Iran


BACKGROUND: Neonatal intensive care unit (NICU) is one of the accident‑prone settings in
the health‑care system. There is a series of structural and process threats to the safety of infants
hospitalized in this unit, which can be prevented by taking the right actions. For this purpose,
developing standards based on current knowledge, available resources, and the context that provides
care can determine patient injury prevention requirements. Likewise, it can be a source for national
development and application of related guidelines and protocols. This study aims to develop patient
safety standards in the NICUs of Iran.
MATERIALS AND METHODS: This mixed‑methods study will apply the exploration, preparation,
implementation, and sustainment framework to develop patient safety standards. In each phase of
this framework, a set of activities take place. Exploration is based on the world health organization
model to develop standards. Determining the validity and applicability of standards will be done in
Phase 2 (Preparation) and Phase 3 (Implementation), respectively. Since the long‑term effects are
not desired, the fourth phase (Sustainment) will not be considered.
DISCUSSION: Patient safety standards from this study will contribute to efficient and effective,
equitable, and high‑quality health‑care delivery. The application of them will further promote patient
safety and the quality of medical care in Iranian NICUs.


1. Berman A, Snyder S, Frandsen G. Safety. In: Trakalo K, Zak T,
Klaas R, editors. Kozier & Erb’s Fundamentals of Nursing:
Concepts, Process and Practice. 11th ed. Boston: Pearson Boston,
MA; 2016. p. 640.
2. Lawati MH, Dennis S, Short SD, Abdulhadi NN. Patient safety
and safety culture in primary health care: A systematic review.
BMC Fam Pract 2018;19:104.
3. Tomazoni A, Rocha PK, de Souza S, Anders JC, de Malfussi HF.
Patient safety culture at Neonatal Intensive Care Units:
Perspectives of the nursing and medical team. Rev Lat Am
Enfermagem 2014;22:755‑63.
4. Tawfik DS, Thomas EJ, Vogus TJ, Liu JB, Sharek PJ, Nisbet CC,
et al. Safety climate, safety climate strength, and length of stay in
the NICU. BMC Health Serv Res 2019;19:738.
5. Farzi S, Farzi S, Taheri S, Ehsani M, Moladoost A. Perspective
of nurses toward the patient safety culture in neonatal Intensive
Care Units. IRAN J Neonatol 2017;8:89‑94.
6. Profit J, Sharek PJ, Cui X, Nisbet CC, Thomas EJ, Tawfik DS, et al.
The correlation between neonatal intensive care unit safety culture
and quality of care. J Patient Saf 2020;16:e310‑6.
7. Eslami K, Aletayeb F, Aletayeb SM, Kouti L, Hardani AK.
Identifying medication errors in neonatal intensive care units:
A two‑center study. BMC Pediatr 2019;19:365.
8. Chatziioannidis I, Mitsiakos G, Vouzas F. Focusing on patient
safety in the neonatal Intensive Care Unit Environment. J Pediatr
Neonat Indiv Med 2017;6:e060132.
9. ELMeneza S. Egyptian Neonatal Safety Training Network:
A dream to improve patient safety culture in Egyptian neonatal
intensive care units. East Mediterr Health J 2020;26:1303‑11.
10. Santos J, Pearce SE, Stroustrup A. Impact of hospital‑based
environmental exposures on neurodevelopmental outcomes of
preterm infants. Curr Opin Pediatr 2015;27:254‑60.
11. Venkataraman R, Kamaluddeen M, Amin H, Lodha A. Is less
noise, light and parental/caregiver stress in the neonatal intensive
care unit better for neonates? Indian Pediatr 2018;55:17‑21.
12. Kambestad KK, Huack A, Nair S, Chapman R, Chin S, Langga L,
et al. The adverse impact of unplanned extubation in a cohort of
critically ill neonates. Respir Care 2019;64:1500‑7.
13. Hatch LD, Scott TA, Slaughter JC, Xu M, Smith AH, Stark AR,
et al. Outcomes, resource use, and financial costs of unplanned
extubations in preterm infants. Pediatrics 2020;145:e20192819.
14. McPherson C, Miller SP, El‑Dib M, Massaro AN, Inder TE.
The influence of pain, agitation, and their management on the
immature brain. Pediatr Res 2020;88:168‑75.
15. van Hinsbergh TM, Elbers RG, Hans Ket JC, van Furth AM,
Obihara CC. Neurological and neurodevelopmental outcomes
after human parechovirus CNS infection in neonates and young
children: A systematic review and meta‑analysis. Lancet Child
Adolesc Health 2020;4:592‑605.
16. LakeET, Hallowell SG, Kutney‑LeeA, HatfieldLA, Del GuidiceM,
Boxer BA, et al. Higher quality of care and patient safety associated
with better NICU work environments. J Nurs Care Qual
17. Lake ET, Staiger D, Horbar J, Cheung R, Kenny MJ, Patrick T,
et al. Association between hospital recognition for nursing
excellence and outcomes of very low‑birth‑weight infants. JAMA
18. Ellsbury DL, Clark RH. Does quality improvement work in
neonatology improve clinical outcomes? Curr Opin Pediatr
19. Najafi Anari HR, Rassuli M, Atashzadeh Shoorideh F, Namdari M.
Auditing preterm neonatal nutrition nursing care. QJ Nurs Manag
20. Rafati M, Nakhshab M, Ghaffari V, Mahdavi M, Sharifi M. Evaluation of nutritional status in a teaching hospital neonatal
Intensive Care Unit. Iran J Neonatol 2015;5:24‑9.
21. Mansouri Arani M, Alaee Karehroudi F, Manochehri H,
Akbarzadeh Baghban A. Audit of neonatal discharge process in
neonatal Intensive Care Unit of Mahdieh hospital in Tehran. Iran
J Pediatr Nurs 2015;2:28‑38.
22. Godarzi Z, Rahimi O, Khalesi N, Soleimani F, Mohammadi N,
Shamshiri AR. The Rate of developmental care delivery in
neonatal Intensive Care Unit. Iran J Crit Care Nurs 2015;8:117‑24.
23. Razavi Nejad M, Heidarzadeh M, Mohagheghi P, Akrami F,
Almasi‑Hashiani A, Eskandary Z. Assessment of physical
environment of Iran’s neonatal tertiary care centers from the
perspective of the neonatal individualized developmental care.
Iran J Neonatol 2017;8:20‑5.
24. Behnam Shafi H, Nasimi F, Boskabadi H, Ketabi D. Noise pollution
in neonatal Intensive Care Units in Qhaem hospital. J Mazandaran
Univ Med Sci 2014;24:235‑6.
25. Zahed Pasha Y, Ahmadpour Kacho M, Alaee E, Foroozesh R,
Rasouli M, Tirgar A, et al. Light and sound consideration in
neonatal Intensive Care Unit. J Babol Univ Med Sci 2014;16:56‑61.
26. El‑Atawi K, Elhalik M, Dash S. Quality Improvement Initiatives
in Neonatal Intensive Care Unit (NICU) for Improved Care
Outcomes – A review of Evidence. J Pediatr Neonatal Care
27. World Health Organization. Standards for Improving Quality of
Maternal and Newborn Care in Health Facilities. Geneva: World
Health Organization; 2016. Available from: https://www.who.
and‑newborn‑care‑in‑health‑facilities.pdf. [Last accessed on 17
October 2021].
28. British Association of Perinatal Medicine (BAPM). Service
Standards for Hospitals Providing Neonatal Care. 3rd ed. British
Association of Perinatal Medicine (BAPM); 2010. https://www.‑standardshospitals. [Last accessed
on 2021 Feb 24; Last updated on 2010 Aug 31].
29. National Institute for Health and Care Excellent (NICE). Infant and
Neonate NICE Quality Standards. NICE Website; 2021. Available
&Status=Published. [Last accessed on 2021 Feb 24].
30. Lindacher V, Altebaeumer P, Marlow N, Matthaeus V, Nikola
Straszewski I, Thiele N, et al. European Standards of Care for
Newborn Health. European Foundation for the Care of Newborn
Infants; 2020. Available from: https://newborn‑health‑standards.
org/standards/overview/. [Last accessed on 2021 Feb 24; Last
updated on 2018 Mar 15].
31. Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA.
Systematic review of the Exploration, Preparation, Implementation,
Sustainment (EPIS) framework. Implement Sci 2019;14:1.
32. Drahota A, Meza RD, Brikho B, Naaf M, Estabillo JA, Gomez ED,
et al. Community‑academic partnerships: A systematic review
of the state of the literature and recommendations for future
research. Milbank Q 2016;94:163‑214.
33. Boaz A, Hanney S, Borst R, O’Shea A, Kok M. How to
engage stakeholders in research: Design principles to support
improvement. Health Res Policy Syst 2018;16:60.
34. Fitch K, Bernstein SJ, Aguilar MD, Burnand B, LaCalle JR,
Lazaro P, et al. The RAND/UCLA Appropriateness Method
User’s Manual. Los Angeles: Defense Technical Information
Center; 2001. Available form:
monograph_reports/MR1269.html. [Last accepted 10 September
35. Berian JR, Baker TL, Rosenthal RA, Coleman J, Finlayson E,
Katlic MR, et al. Application of the RAND-UCLA appropriateness
methodology to a large multidisciplinary stakeholder group
evaluating the validity and feasibility of patient-centered
standards in geriatric surgery. Health Serv Res 2018;53:3350‑72.
36. Cook JM, Thompson R, Schnurr PP. Perceived characteristics of
intervention scale: Development and psychometric properties.
Assessment 2015;22:704‑14.
37. Stevens KR. The impact of evidence‑based practice in nursing
and the next big ideas. Online J Issues Nurs 2013;18:4.
38. Gupta M, Soll R, Suresh G. The relationship between patient
safety and quality improvement in neonatology. Semin Perinatol
39. Tricco AC, Zarin W, Rios P, Nincic V, Khan PA, Ghassemi M, et al.
Engaging policy‑makers, health system managers, and policy
analysts in the knowledge synthesis process: A scoping review.
Implement Sci 2018;13:31.
40. Laird Y, Manner J, Baldwin L, Hunter R, McAteer J, Rodgers S,
et al. Stakeholders’ experiences of the public health research
process: Time to change the system? Health Res Policy Syst