The Principles

In most countries, health care is a highly regulated sector. Often complex rules apply to aspects such as: facility layout and design, equipment requirements, service provision, employment of health care professionals, pricing, marketing, and ownership.  Similarly, licensing requirements can be complex, and may require substantial effort and time to fulfill. 

However, in some countries such requirements can be vague, outdated, or even contradictory. 

And in many locations, particularly in poorer countries, enforcement of regulations is weak.  As a result, some organizations may ignore the law.

Organizations that flout the law put their own employees, the people who they serve, and communities at risk.  Additionally they risk:

• Incurring legal penalties, which may involve fines or criminal punishment, or revocation of their license
• Breaking international antibribery rules that can apply worldwide
• Opening themselves to requests for bribes from local officials
• Damaging their reputation and that of their investors and partners

• Understand the laws, regulations, policies, and standards that affect the organization
• Follow applicable laws, regulations, policies and standards, wherever the organization operates
• Train staff in these laws, regulations, policies and standards – particularly regarding their areas of responsibility
• Display licenses publicly and prominently
• Where laws are out-of-date or inappropriate, the organization informs local policymakers of the deficiencies

• Using personal contacts and relationships with local officials to gain improper advantage, including noncompliance with regulations
• Paying bribes to avoid penalties or otherwise business, remembering that bribery doesn't have to involve money but can also include gifts or anything else of value
• Turning a blind eye to infringements, e.g. by knowingly outsourcing licensing or compliance requirements to third parties who may pay bribes

Private health care providers are an essential component in the delivery of health services in almost all countries. 

Therefore they have the potential to make a significant impact on the communities they serve and on broader society.

Health care goals, including universal health coverage, are unlikely to be achieved without leveraging private sector capacity, investment and innovation.

Private health care providers should aim to complement public sector health care provision.  Stewardship of the overall health system remains with the government (usually through Ministry of Health) and national standard setting institutions.

Health care providers’ long term success relies on building trust and strong relationships within the communities they serve.

• Understand local health care policies and priorities, as well as the broader goals of the health system
• Support senior staff to initiate, promote, facilitate and monitor effective and sustainable partnerships between the organization and its community partners
• Plan services in coordination with recognized leaders in the community and other health care organizations
• Develop a Disaster Preparedness Plan (or similar) to respond to likely local emergencies, epidemics, and natural or other disasters that have the potential of occurring within the community
• When recruiting, be mindful of the staffing needs of other local health care organizations (including in government and not-for-profit sectors) and the impact such recruitment may have on the capacity of the overall health system to deliver on its goals
• Support local community health initiatives, e.g. including health promotion and education

• Developing services in isolation from local health care organizations, including government policy
• Working "around" policy, legislation and regulation

WHO: Key Components of a Well-functioning Health System

Declaration of Alma-Ata International Conference on Primary Health Care, Alma-Ata, USSR, 1978

Around the world, most patients admitted to a health care facility assume that they are in safe hands. Unfortunately, this assumption is not always true. Patient safety is now a serious global public health issue. Estimates show that in high-income developed countries about one in 10 patients is harmed while receiving hospital care. 

The situation is generally much worse in lower-income countries. For example, a mother undergoing a Caesarian section in a low- or middle-income country is 10 times more likely to die than a similar patient in Western Europe. In Africa, one in ten patients dies in surgery and one in five develops a surgery-related complication [1].

Increasing evidence suggests that poor-quality health care causes more deaths than lack of access to care. According to the National Academies [2], even if the world were to achieve universal health care, billions of people would have access to care of such low quality that "it will not help them, and indeed often will harm them."

As Dr. Margaret Kruk, professor at the Harvard T.H. Chan School of Public Health explained it at a 2018 Lancet Global Health report launch, “Health Systems without quality are like cars without engines; they look like the real thing, but do not generate motion”.

[1] Biccard BM, Madiba TE, Kluyts H-L, et al, and the African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet 2018; 391: 1589–98.

[2] rossing the Global Quality Chasm: Improving Health Care Worldwide. National Academies 2018.

Quality improvement is an essential aspect of risk management.  Risk to patients is a concern for many stakeholders including: patients and their families; staff; insurers; regulators; owners; and investors. 

The consequences of poor quality can be disastrous. The proliferation of social media, even in the world’s poorest countries, means that stories of medical failings can “go viral” – with potentially disastrous consequences for the organization involved.  Given the increasing litigious nature of the sector a single incident can result in a large financial claim and ruin an organization’s reputation.

Quality Improvement can be linked to performance improvement.  IFC’s experience confirms that improving quality through the application of process standardization can also support cost management.  For example, when clinicians are uncertain about the best course of action to take, they tend to do more – more tests, more procedures, and more observation.  Health care organizations that promote evidence-based medicine are more likely to reduce waste.  That’s why some health care leaders say that “the opposite of quality is waste” – and waste reduction requires removing process flaws and non-value adding activities.

Antimicrobial resistance (AMR) is accelerating due to misuse and overuse of antimicrobials.  As a result, standard treatments become ineffective, infections persist and may spread to others.  Poor infection control, inadequate sanitary conditions and inappropriate food-handling also encourage the spread of antimicrobial resistance – putting us all at risk.

The reputation of a health care organization is critical in helping to attract patients.  Organizations with good reputations also benefit from lower recruitment and orientation costs, as staff retention is usually higher and the more qualified professionals tend to seek jobs with them.

Increasing regulation and the development of private and social health insurance in many markets is also placing a greater emphasis on defined quality standards.

From a commercial perspective, all of these outcomes can translate into financial dividends.

• Implement formal policies and procedures to support improvements in quality, including:
  - Ethics, patient, and family rights
  - Medication management and use
  - Quality measurement and improvement
  - Prevention and control of infections
  - Governance, leadership, and direction
  - Facility management and safety
  - Staff qualifications and education
  - Other relevant areas
• Follow evidence-based, internationally recognized practices to support appropriate patient care
• Implement procedures to prevent overtreatment, undertreatment, and inappropriate treatment, including through the use of staff incentives
• Take actions to foster a culture and mindset committed to quality and continuous improvement
• Adopt systems for patients, employees, or others to raise quality concerns confidentially

IFC Self-Assessment Guide for Health Care Organizations—Quality, Safety & Ethics

Patient Safety Guidance from the World Health Organization (WHO)

Good Practice Note: IFC Life and Fire Safety: Hospitals

WHO Resources: Antimicrobial Resistance

Drug-Resistant Infections: A Threat to Our Economic Future

The health care sector is regularly cited as a sector at high risk for corruption.  

It is particularly vulnerable to corruption for several reasons including:

• There is usually asymmetry of knowledge between providers and the users of health care
• This inequity of information is open to exploitation for private gain, opening possibilities for corruption
• The necessity of health care and the volume of funds involved in the sector can create incentives for private gain
• Due to the high number of people involved in decision-making, and the often bureaucratic nature of the health sector, it is susceptible to individual discretion

According to Transparency International, corruption is so pervasive in the health systems that it has become normalized [1]: “From the politician to the patient, corruption often is part of doing business in the health care sector in many parts of the world.  Effects include distorted policy, legislative and clinical priorities; a loss of money from health systems; denied or delayed access to health care services; and a loss of trust in health facilities, personnel and to a wider extent national governance as a whole.”

Research conducted by Transparency International’s Pharmaceuticals & Healthcare Programme has shown that Individuals in the health care sector do not always understand what corruption is and how it may undermine their work.

[1] Transparency International. 2016. "Diagnosing Corruption in Healthcare."

Every day, all around the world, people suffer and die due to corruption in the health care sector.  It is literally a matter of life and death.  This is because corruption weakens the quality of health services and in many cases can deny health care altogether.  It has a corrosive impact on health, negatively impacting health budgets, the price of health services and medicines, and the quality of care provided. 

Potential conflicts of interest abound in many aspects of the health care system (e.g. the incentive to prescribe expensive treatment by a doctor vs. the affordability to the patient.)

Conducting business matters responsibly, preventing abuse and reducing corruption is important to increase resources available for health, to make more efficient use of existing resources and, ultimately, to improve the general health status of the population. It disproportionally affects vulnerable groups, who do not have the knowledge, money or connections to access the care or products they need.

• Ensure that services provided are represented accurately and honestly
• As appropriate, share data on the effectiveness of services offered, as well as any information on their cost
• Ensure that business transactions with vendors, contractors, and other third parties are conducted appropriately, without offers, solicitation, or acceptance of inappropriate gifts, favors or other inducements
• Ensure that all purchases of services and supplies are from qualified and reliable sources and are based upon objective factors, consistent with the organization’s policies and procedures
• Act honestly and responsibly, avoiding non-arm’s-length transactions or conflicts of interest whenever possible, and dealing with any actual or perceived conflicts of interest with transparency and sensitivity
• Enact policies and practices to fight bribery and corruption 
• Establish policies around the acceptance of gifts, entertainment, and participation in professional meetings
• Implement policies and procedures to deal sensitively and humanely with patients who do not have sufficient funds for treatment

Misrepresentation of Services

• Taking unfair advantage of anyone through manipulation, concealment, abuse of privileged information, or misrepresentation of facts
• Engaging in any activity intended to defraud any individual or organization of money, property, or honest services

Conflicts of interest

• Board members and employees using their positions to profit personally, or assisting others in profiting in any way, at the expense of the organization

As a sector, hospitals and other health care facilities account for a disproportionate amount of energy use and emissions.  Hospitals are considered to be among the most energy-intensive types of commercial buildings [1].  They use about 2.5 times the amount of energy as a similar-sized commercial building, because they are typically open 24/7 and have extra commitments - such as air filtration and circulation, air cooling, and waste management. 

In some countries regulations regarding storage and/or disposal of biomedical waste are weak or non-existent.

Many health care facilities store hazardous materials which are potentially highly dangerous to patients, staff, and the environment.  These include:

• Infectious waste
• Pathological and anatomical waste
• Hazardous pharmaceutical waste
• Pressurized containers
• Sharps
• Hazardous chemical waste
• Radioactive waste
• Heavy metals
• Genotoxic/cytotoxic waste

[1] 2012 Commercial Buildings Energy Consumption Survey: Energy Usage Summary

What’s good for the environment is good for health. Climate change and health are interconnected: air pollution is now recognised as the main cause of lung conditions, such as asthma, and a risk factor for poor heart health and cancer.

The waste produced in the course of health care activities, from contaminated needles to radioactive isotopes, carries a greater potential for causing infection and injury than most other types of waste.  Inadequate or inappropriate management may have serious public health consequences and harmful effects on the environment.

Health care waste contains potentially harmful microorganisms that can infect hospital patients, health workers, and the general public.  Other potential hazards may include drug-resistant microorganisms which spread from health facilities into the environment.  Adverse health outcomes associated with health care waste and by-products also include:

• Sharps-inflicted injuries
• Toxic exposure to pharmaceutical products, in particular, antibiotics and cytotoxic drugs released into the surrounding environment, and to substances such as mercury or dioxins during the handling or incineration of health care waste
• Chemical burns arising in the context of disinfection, sterilization, or waste treatment activities
• Air pollution from the release of particulate matter during medical waste incineration
• Thermal injuries occurring during open burning and the operation of medical waste incinerators
• Radiation burns

• Work in ways that minimize the negative impact, or have a positive impact, on the environment
• Look for opportunities to conserve energy and resources, minimize pollution, and reduce waste
• Segregate and properly dispose of waste water
• Raise awareness of the risks related to health care waste, and promote safe practices
• Promote practices that reduce the volume of wastes generated
• Implement a hazardous materials management program (or similar), addressing responsibilities, resource allocation, handling, and disposal. Such a program would typically include:
  - Identifying and listing the type, location, and quantities of hazardous materials and waste
  - Ensuring that infectious (or potentially infectious) biomedical waste is stored in easily recognizable bags (usually yellow), clearly marked, and safely stored with limited access
  - Ensuring that all waste is disposed of in a safe and environmentally responsible manner and in accordance with local regulations (or international guidelines if local regulations do not exist)
• Select safe and environmentally friendly management options to protect people from hazards when collecting, handling, storing, transporting, treating, or disposing of waste
• Where feasible, promote safe and environmentally sound technologies for treatment of hazardous health care waste—such as the use of autoclaving, microwaving, steam treatment integrated with internal mixing, or chemical treatment—instead of incineration
• Take steps to minimize greenhouse gas emissions. Take steps to ensure other partners managing or disposing of waste implement sound environmental practices and comply with regulations

• Storing infectious and biomedical waste in corridors and stairwells
• Disposing of biomedical waste along with general waste
• Outsourcing waste disposal to unvetted waste disposal organizations
• Transporting infectious and biological waste inappropriately

IFC Environmental and Social Management System (ESMS) Implementation Handbook – Healthcare Facilities

WBG Environmental, Health and Safety EHS Guidelines for Health Care Facilities

WHO, Safe Management for Wastes from Healthcare Activities

In some countries, there is little effective protection of patients’ rights.  Staff may be unaware of such terms, or the behaviors/conduct expected from them.

Furthermore, health care organizations frequently serve communities with diverse populations.  For example, patients may be elderly or have disabilities.  Also, they may come from communities that speak multiple languages or dialects, are culturally diverse, or present other barriers that make the process of assessing and receiving care more difficult.  Each patient brings his or her own set of values and beliefs to the care process—and these must be respected.  Patients may desire privacy from staff and other patients, and even from family members.

All patients have the right to participate in their care process—e.g. to choose between alternative methods of treatment or to discontinue care.

To make decisions and judgments, patients need to have information that they can understand about the proposed treatment, alternatives, expected results, costs, possible complications, and likely outcomes of non-treatment.

Sometimes patients are unable to make such decisions themselves—e.g. young children, unconscious, mentally incapacitated.  Therefore, there must be processes governing who, and in what circumstances others, can make such decisions on their behalf.

Medical research, involving clinical trials compares the effects of one treatment with another. It may involve patients, healthy people, or both.  Organizations should have clearly defined rights for research participants before, during, and following such clinical trials.

Patients (and their families) are often vulnerable when they receive medical treatment.  Commonly they are elderly or disoriented, and in strange surroundings. 

Most patients have no medical background and therefore rely on the honesty and integrity of their health care provider. 

Therefore sound ethical values and respect for the rights of patients and their families are crucial to ethical health care organizations.

Rights of Patients and Families

• Implement processes that support patients’ and families’ rights during care
• Inform patients about all aspects of their medical care and treatment.
• Promote participative decision-making around treatment options, including by informing patients about alternative options, as well as their right to refuse or discontinue treatment
• Inform patients and families about their right to complain about or disagree with care provision
• Provide care that is respectful to patients’ personal values and beliefs, and respond to requests related to spiritual and religious beliefs
• Respect patients’ rights to privacy and confidentiality of care and information
• Protect patients from any physical assault, and their possessions from theft and loss
• Take measures to reduce physical, language, cultural, and other barriers to access and delivery of services
• Support patients’ rights to assessment and management of pain and respectful, compassionate care at the end of life
• Provide information about rights in a manner and language that patients can understand

Informed Consent

• Establish a process to obtain informed consent and train staff in this process, ensuring that the consent is obtained in a manner and language the patient can understand
• Establish a process for patients’ representatives to grant consent, e.g. for young children or when patients are unable to grant consent, such as in the case of young children or of patients who are unable to grant consent themselves, in line with any relevant local regulations

Research

• Implement mechanisms to oversee research activities
• Inform persons enrolled in clinical research of the risks and benefits, and of their right to refuse to participate or drop out without risk of reprisal

Information is key to the business of all health care organizations, which are trusted to keep it safe and secure.

Technology advancements and use of technology in health care are opening up new areas to address and regulate.

Health care organizations usually hold information about patients, customers, staff and suppliers.  Considering the sensitive nature of much of this data it is vital to have a robust and reliable system of information security in place.  However, information security in health care organizations is generally regarded as weaker than in other sectors, such as banking.

Regarding use of patients’ data, if an organization fails to get proper consent when first engaging with a patient, it may not be able to utilize data as expected, or may leave itself liable to claims of misuse by data subjects.

• Maintain appropriate administrative, technical, and physical safeguards to ensure that:
  - Organizational records, documents, and reports—whether physical or digital or electronic—are kept accurate, complete, and protected from tampering
  - Medical information is kept confidential
  - Information is protected from loss or misuse (e.g., by controlled access to records, whether physical or electronic)
  - Confidentiality of patient and staff records, and other confidential information, is maintained in accordance with applicable legal and ethical standards
• Train staff not to discuss patients’ conditions in public areas
• Ensure data is not sold or monetized without the consent of those contributing to the data, including patients and providers. Usual basic requirements include:
  - Explicit written consent is freely given, specific, informed, and unambiguous in indicating an individual's wishes
  - Consent is obtained in a manner distinguishable from other issues (i.e., not buried in the middle of a long contract or notice), using an easily accessible form and clear and plain language, with an option for individuals to withdraw their consent easily
  - The provision of health services is not conditional on this consent
• Protect intellectual property (including trademarks, copyrights, patents, etc.) of vendors and other stakeholders

Health care is a staff-intensive sector and commonly involves people from multiple professional groups and diverse backgrounds working together.

Furthermore, health care organizations frequently serve communities with diverse populations.  Patients may come from communities that speak multiple languages or dialects, are culturally diverse, or present other barriers that make the process of assessing and receiving care more difficult.   

The promotion of an ethical, diverse, and fair organization with regards to recruitment, staff development, and gender relations reduces conflict and attracts patients from a wider base. If not, it can undermine the operational dynamics of the organization which in turn can impact quality.

• Promote a positive and respectful environment for everyone including patients, visitors, employees, volunteers, physicians, students, and contract workers
• Implement zero-tolerance policies regarding discrimination, bullying, and harassment, including any such actions directed by patients towards staff or staff towards patients, between staff, or involving others in the health care process
• Implement zero-tolerance policies regarding violence of any kind
• Welcome people from different backgrounds
• Encourage different perspectives 
• Minimize physical, language, cultural, and other barriers of access to services
• Promote a disability-inclusive environment
• Make sure that the workforce represents the communities and customers served
• Implement dispute resolution and grievance procedures
• Train staff in the applicable policies
• Provide safe channels for people to raise concerns

Discrimination (i.e. unjustifiable differentiation) between individuals or groups, for example based on characteristics such as race, color, gender, language, physical ability, religion, political or other opinion, national or social origin, or sexual orientation.

Discrimination is a behavior that excludes individuals or treats them unfairly because they are members of specific groups. According to the Ontario Human Rights Code, individuals cannot be discriminated against in employment based on their race, sex, sexual orientation, gender identity, same-sex partner status, color, ancestry, place of origin, ethnic origin, marital status, age, disability, citizenship, family status, or religion.

Harassment is any physical or verbal behavior that’s not respectful – or that creates a frightening, humiliating, or uncomfortable environment. It only has to happen once to be defined as harassment.

Bullying (or intimidation) is mean, rude or insulting behavior towards another person that causes them upset, discomfort, or humiliation.

IFC Good Practice Note: Non-Discrimination and Equal Opportunity

IFC. Addressing Domestic Violence in the Workplace: A Win-win for Companies and Employees

UN Standards of Conduct for Business: Tackling Discrimination against Lesbian, Gay, Bi, Trans, & Intersex People

Health care is a staff-intensive sector, and commonly involves people from multiple professional groups and diverse backgrounds working together.

Staff skills and qualifications are key factors influencing service quality.

Health care staff often include expat/migrant staff from other countries, and this trend is increasing.

The promotion of an ethical, diverse, and fair organization with regards to recruitment, staff development, and staff relations supports positive operational dynamics of the organization.

The sector is prone to long working hours for many staff including night shifts, which can result in physical and mental stress.

Violence, or conflict, in the workplace can have devastating effects on the quality of life of employees and on the productivity of the organization.

Training and development

• Plan staff numbers and qualifications to meet the needs of patients
• Ensure job descriptions define the requirements for all staff members, e.g. as concerns:
  - education
  - skills
  - knowledge and experience
  - duties and responsibilities
• Ensure that staff knowledge and skills are consistent with the requirements of their positions
• Orient new staff to the organization, specific department, and job responsibilities
• Provide each staff member with ongoing education and training
• Ensure fair employment practices
• Provide staff with the knowledge, qualifications, skills, and experience required to meet patients’ and customers’ needs, as well as the standards of their professional bodies
• Support continuing professional development to keep staff up-to-date on the latest changes in health care practices, and in their professional areas

Staff safety

• Actively promote a safe working environment and a culture of zero harm
• Take steps to minimize and prevent work place injuries
• Implement health and safety policies and procedures and make sure that all staff have the training and tools they need to do their jobs safely
• Abide by all laws and regulations regarding occupational safety
• Enforce zero tolerance for any type of violence in the workplace, during work-related activities, or at work-related events, including violence by patients directed at employees, by staff directed at patients, or between staff 
• Be transparent in sharing data on worker safety

Conflict resolution

• Implement dispute resolution and grievance procedures

Protection of whistle-blowers

• Recognize that staff members have a duty to report suspicions of wrongdoing
• Ensure that individuals who report such cases in good faith are entitled to protection against retaliation
• Take appropriate corrective action to remedy any retaliation against whistle-blowers
• Implement adequate disciplinary measures in cases of misconduct, including those making wrongful accusations

Migrant workforce

• Implement WHO Global Code of Practice on the International Recruitment of Health Personnel (“Healthcare Workforce Migration” – see WHO resources below)
• Establish a supportive working and living environment and opportunities for professional growth so that health workers are less likely to leave the country for other jobs

IFC’s Performance Standard 2: Labor and working conditions

WHO resources: Healthcare workforce migration

The practice of medicine raises a plethora of complex issues—medical, ethical, and legal.  Doctors and other health care professionals increasingly must grapple with these issues, and may sometimes have to do so in the face of contrary opinions expressed by patients and others.

Conversely some health care providers deliberately participate in or condone harmful, proscribed practices.  Potential reasons include:

• They are themselves a part of communities which condone such practices. Therefore, they may agree to perform these practices for the same reasons that other people are requesting them -- in other words, they see the practices as necessary
• They consider the practices to be harmless, or even medically indicated
• While they themselves do not support such practices, they consider it their duty  to fulfill patients' request
• They see their work as a form of harm reduction.  For example, they consider that by performing it they help to prevent even greater dangers if the procedure were to be carried out elsewhere, e.g. in informal settings
• They are motivated by the opportunity for financial gain

Health care organizations are guided, at a minimum, by local laws and regulations. But in some countries, local laws are subjective, nonexistent, or not rigorously applied. This situation may arise, for example, because of rapid technological advances or because of local controversial or “taboo” aspects of medical care.

When such ethical issues arise, the organization must have ways to support staff in addressing them, particularly when these are not clearly covered by laws.

According to the World Medical Association’s Declaration of Helsinki, 1964, it is the mission of the physician to safeguard the health of the people.

Health professionals who participate in practices such as female genital mutilation (FGM) and organ trading are violating people’s right to physical integrity, right to health, and right to life.  They are also violating the fundamental ethical principle: “Do no harm.”

• The organization addresses ethical concerns by formally developing policies, processes, and governance using international standards and accepted international norms as reference points. (This is particularly important where clear relevant legislation is absent)
• Inform patients of these policies, processes, and governance, particularly around critical areas of ethical concerns; establish a mechanism for receiving and addressing concerns
• Inform and train staff in applicable policies, procedures, and governance
• Establishes an ethics committee (or similar) to offer advice and oversight where necessary; include independent external representation
• Proactively address critical areas of ethical concerns, e.g., ethical concerns related to organ and tissue donation and transplantation
• Proscribe, do not condone, and do not participate in harmful practices
• Inform staff and patients about policies via posters, signs, websites, or other communication channels
• Prohibit reprisal or retaliation against those who raise ethical or legal concerns, and take all reasonable steps to protect them

• The organization does not participate in or condone harmful practices including female genital mutilation (FGM)

WHO, Guiding Principles on Human Cell, Tissue and Organ Transplantation

WHO, Global Health Ethics, Organ and Tissue Donation

WHO, Global Strategy to Stop Health Care Providers from Performing Female Genital Mutilation

WHO, Preventing Gender-biased Sex Selection