Which would be the consequences if a healthcare organization follows the guidelines?

What is Patient Safety?

Patient Safety is a health care discipline that emerged with the evolving complexity in health care systems and the resulting rise of patient harm in health care facilities. It aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care. A cornerstone of the discipline is continuous improvement based on learning from errors and adverse events.

Patient safety is fundamental to delivering quality essential health services. Indeed, there is a clear consensus that quality health services across the world should be effective, safe and people-centred. In addition, to realize the benefits of quality health care, health services must be timely, equitable, integrated and efficient.    

To ensure successful implementation of patient safety strategies; clear policies, leadership capacity, data to drive safety improvements, skilled health care professionals and effective involvement of patients in their care, are all needed.

Why does patient harm occur?

A mature health system takes into account the increasing complexity in health care settings that make humans more prone to mistakes. For example, a patient in hospital might receive a wrong medication because of a mix-up that occurs due to similar packaging. In this case, the prescription passes through different levels of care starting with the doctor in the ward, then to the pharmacy for dispensing and finally to the nurse who administers the wrong medication to the patient. Had there been safe guarding processes in place at the different levels, this error could have been quickly identified and corrected. In this situation, a lack of standard procedures for storage of medications that look alike, poor communication between the different providers, lack of verification before medication administration and lack of involvement of patients in their own care might all be underlying factors that led to the occurrence of errors. Traditionally, the individual provider who actively made the mistake (active error) would take the blame for such an incident occurring and might also be punished as a result. Unfortunately, this does not consider the factors in the system previously described that led to the occurrence of error (latent errors). It is when multiple latent errors align that an active error reaches the patient.

To err is human, and expecting flawless performance from human beings working in complex, high-stress environments is unrealistic. Assuming that individual perfection is possible will not improve safety (7). Humans are guarded from making mistakes when placed in an error-proof environment where the systems, tasks and processes they work in are well designed (8). Therefore, focusing on the system that allows harm to occur is the beginning of improvement, and this can only occur in an open and transparent environment where a safety culture prevails. This is a culture where a high level of importance is placed on safety beliefs, values and attitudes and shared by most people within the workplace (9).

The burden of harm

Every year, millions of patients suffer injuries or die because of unsafe and poor-quality health care. Many medical practices and risks associated with health care are emerging as major challenges for patient safety and contribute significantly to the burden of harm due to unsafe care. Below are some of the patient safety situations causing most concern.

Medication errors are a leading cause of injury and avoidable harm in health care systems: globally, the cost associated with medication errors has been estimated at US$ 42 billion annually (10).

Health care-associated infections occur in 7 and 10 out of every 100 hospitalized patients in high-income countries and low- and middle-income countries respectively (11).

Unsafe surgical care procedures cause complications in up to 25% of patients. Almost 7 million surgical patients suffer significant complications annually, 1 million of whom die during or immediately following surgery (12).

Unsafe injections practices in health care settings can transmit infections, including HIV and hepatitis B and C, and pose direct danger to patients and health care workers; they account for a burden of harm estimated at 9.2 million years of life lost to disability and death worldwide (known as Disability Adjusted Life Years (DALYs)) (5).

Diagnostic errors occur in about 5% of adults in outpatient care settings, more than half of which have the potential to cause severe harm. Most people will suffer a diagnostic error in their lifetime (13).

Unsafe transfusion practices expose patients to the risk of adverse transfusion reactions and the transmission of infections (14). Data on adverse transfusion reactions from a group of 21 countries show an average incidence of 8.7 serious reactions per 100 000 distributed blood components (15).

Radiation errors involve overexposure to radiation and cases of wrong-patient and wrong-site identification (16). A review of 30 years of published data on safety in radiotherapy estimates that the overall incidence of errors is around 15 per 10 000 treatment courses (17).

Sepsis is frequently not diagnosed early enough to save a patient’s life. Because these infections are often resistant to antibiotics, they can rapidly lead to deteriorating clinical conditions, affecting an estimated 31 million people worldwide and causing over 5 million deaths per year (18).

Venous thromboembolism (blood clots) is one of the most common and preventable causes of patient harm, contributing to one third of the complications attributed to hospitalization. Annually, there are an estimated 3.9 million cases in high-income countries and 6 million cases in low- and middle-income countries (19).

Patient Safety - a fundamental component for Universal Health Coverage

Safety of patients during the provision of health services that are safe and of high quality is a prerequisite for strengthening health care systems and making progress towards effective universal health coverage (UHC) under Sustainable Development Goal 3 (Ensure healthy lives and promote health and well-being for all at all ages) (7).

Target 3.8 of the SDGs is focused on achieving UHC “including financial risk protection, access to quality essential health care services, and access to safe, effective, quality, and affordable essential medicines and vaccines for all.” In working towards the target, WHO pursues the concept of effective coverage: seeing UHC as an approach to achieving better health and ensuring that quality services are delivered to patients safely (20).

It is also important to recognize the impact of patient safety in reducing costs related to patient harm and improving efficiency in health care systems. The provision of safe services will also help to reassure and restore communities’ trust in their health care systems (21).

WHO response

Resolution (WHA 72.6) on Patient Safety 

Recognizing that Patient Safety is a global health priority, the World Health Assembly (WHA) adopted a resolution on Patient Safety which endorsed the establishment of World Patient Safety Day to be observed annually by Member States on 17 September.

1. Patient Safety as a global health priority

• https://mailchi.mp/who.int/wha-72-achievements-commitment-accountability
• https://www.who.int/patientsafety/policies/global-health-priority/en/
• (WHA 72.6)

The purpose of World Patient Safety Day is to promote patient safety by increasing public awareness and engagement, enhancing global understanding and working towards global solidarity and action.

2. World Patient Safety Day

Key strategic action areas

The Patient Safety and Risk Management unit at WHO has been instrumental in advancing and shaping the patient safety agenda globally by focusing on driving improvements in some key strategic areas through:

• providing global leadership and fostering collaboration between Member States and relevant stakeholders
• setting global priorities for action
• developing guidelines and tools
• providing technical support and building capacity of Member States
• engaging patients and families for safer health care
• monitoring improvements in patient safety
• conducting research in the area

By focusing on these key areas to facilitate sustainable improvements in patient safety, WHO aims to enhance patient experience, reduce risks and harm, achieve better health outcomes and lower costs.

WHO initiatives to date

WHO's work on patient safety began with the launch of the World Alliance for Patient Safety in 2004 and this work has continued to evolve over time. WHO has facilitated improvements in the safety of health care within Member States through establishment of Global Patient Safety Challenges. Each of the Challenges has identified a patient safety burden that poses a major and significant risk. The challenges thus far have been:

• Clean Care is Safer Care (2005); with the goal of reducing health care-associated infection, by focusing on improved hand hygiene.
• Safe Surgery Saves Lives (2008); dedicated to reducing risks associated with surgery.
• Medication Without Harm (2017); with the aim of reducing the level of severe, avoidable harm related to medications globally by 50% over five years.

WHO has also provided strategic guidance and leadership to countries through the annual Global Ministerial Summits on Patient Safety, which seek to advance the patient safety agenda at the political leadership level with the support of health ministers, high-level delegates, experts and representatives from international organizations.

WHO has been pivotal in the production of technical guidance and resources such as the Multi-Professional Patient Safety Curriculum Guide, Safe Childbirth Checklist, the Surgical Safety Checklist, Patient Safety solutions, and 5 Moments for Medication Safety (available in print and in App form).

To promote global solidarity, WHO has also encouraged the creation of networking and collaborative initiatives such as the Global Patient Safety Network and the Global Patient Safety Collaborative. Recognizing the importance of patients’ active involvement in the governance, policy, health system improvement and their own care, the WHO also established the Patients for Patient Safety programme to foster the engagement of patients and families.

References

1. Jha AK. Presentation at the “Patient Safety – A Grand Challenge for Healthcare Professionals and Policymakers Alike” a Roundtable at the Grand Challenges Meeting of the Bill & Melinda Gates Foundation, 18 October 2018 (https://globalhealth.harvard.edu/qualitypowerpoint, accessed 23 July 2019).

2. Slawomirski L, Auraaen A, Klazinga N. The economics of patient safety: strengthening a value-based approach to reducing patient harm at national level. Paris: OECD; 2017 (http://www.oecd.org/els/health-systems/The-economics-of-patient-safety-March-2017.pdf, accessed 26 July 2019).

3. de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008;17(3):216–23. http://doi.org/10.1136/qshc.2007.023622 https://www.ncbi.nlm.nih.gov/pubmed/18519629

4.National Academies of Sciences, Engineering, and Medicine. Crossing the global quality chasm: Improving health care worldwide. Washington (DC): The National Academies Press; 2018 (https://www.nap.edu/catalog/25152/crossing-the-global-quality-chasm-improving-health-care-worldwide, accessed 26 July 2019).

5. Jha AK, Larizgoitia I, Audera-Lopez C, Prasopa-Plaizier N, Waters H, W Bates D. The global burden of unsafe medical care: analytic modelling of observational studies. BMJ Qual Saf Published Online First: 18 September 2013. https://doi.org/10.1136/bmjqs-2012-001748 https://www.ncbi.nlm.nih.gov/pubmed/24048616

6. Slawomirski L, Auraaen A, Klazinga N. The Economics of Patient Safety in Primary and Ambulatory Care: Flying blind. Paris: OECD; 2018 (http://www.oecd.org/health/health-systems/The-Economics-of-Patient-Safety-in-Primary-and-Ambulatory-Care-April2018.pdf, accessed 23 July 2019).

7. Systems Approach. In: Patient Safety Network [website]. Rockville (MD): Agency for Healthcare Research and Quality; 2019 (https://psnet.ahrq.gov/primers/primer/21, accessed 23 July 2019).

8. Leape L. Testimony before the President’s Advisory Commission on Consumer Production and Quality in the Health Care Industry, November 19, 1997.

9. Workplace Health and Safety Queensland. Understanding safety culture. Brisbane: The State of Queensland; 2013 (https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0004/82705/understanding-safety-culture.pdf, accessed 26 July 2019).

10. Aitken M, Gorokhovich L. Advancing the Responsible Use of Medicines: Applying Levers for Change. Parsippany (NJ): IMS Institute for Healthcare Informatics; 2012 (https://ssrn.com/abstract=2222541, accessed 26 July 2019).

11. Report on the burden of endemic health care-associated infection worldwide. Geneva: World Health Organization; 2011 (http://apps.who.int/iris/bitstream/handle/10665/80135/9789241501507_eng.pdf?sequence=1, accessed 26 July 2019).

12. WHO guidelines for safe surgery 2009: safe surgery saves lives. Geneva: World Health Organization; 2009 (http://apps.who.int/iris/bitstream/handle/10665/44185/9789241598552_eng.pdf?sequence=1, accessed 26 July 2019).

13. Singh H, Meyer AN, Thomas EJ. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf. 2014;23(9):727–31. https://doi.org/10.1136/bmjqs-2013-002627 https://www.ncbi.nlm.nih.gov/pubmed/24742777

14. Clinical transfusion process and patient safety: Aide-mémoire for national health authorities and hospital management. Geneva: World Health Organization; 2010 (http://www.who.int/bloodsafety/clinical_use/who_eht_10_05_en.pdf?ua=1, accessed 26 July 2019).

15. Janssen MP, Rautmann G. The collection, testing and use of blood and blood components in Europe. Strasbourg: European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe; 2014 (https://www.edqm.eu/sites/default/files/report-blood-and-blood-components-2014.pdf, accessed 26 July 2019).

16. Boadu M, Rehani MM. Unintended exposure in radiotherapy: identification of prominent causes. Radiother Oncol. 2009; 93(3):609–17. https://doi.org/10.1016/j.radonc.2009.08.044 https://www.ncbi.nlm.nih.gov/pubmed/19783058

17. Shafiq J, Barton M, Noble D, Lemer C, Donaldson LJ. An international review of patient safety measures in radiotherapy practice. Radiother Oncol. 2009;92:15-21 https://doi.org/10.1016/j.radonc.2009.03.007

18. Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med 2016; 193(3): 259-72. https://doi.org/10.1164/rccm.201504-0781OC https://www.ncbi.nlm.nih.gov/pubmed/26414292

19. Raskob E, Angchaisuksiri P, Blanco N, Buller H, Gallus A, Hunt B, et al. Thrombosis: A major contributor to global disease burden. Thrombosis Research. 2014; 134(5): 931–938 (https://www.sciencedirect.com/science/article/pii/S0049384814004502, accessed 23 July, 2019).

20. Proposed programme budget 2020–2021. Seventy-Second World Health Assembly, provisional agenda item 11.1. Geneva: World Health Organization; 2019 (http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_4-en.pdf, accessed 23 July 2019).

21. Patient safety- Global action on patient safety. Report by the Director-General. Geneva: World Health Organization; 2019 (https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_26-en.pdf, accessed 23 July 2019).