HEALTHCARE REGULATION IN LATIN AMERICA

Health sector reform efforts in the Latin America and Caribbean (LAC) region have, in recent years, focused on strengthening the stewardship role of the public sector in regulating healthcare and assuring the quality of health services. Through regulatory approaches, governments establish expectations for the competence of healthcare providers and institutions and for the quality of services these provide. This paper was commissioned to examine experiences in the region with the regulation of the quality of care of healthcare providers and facilities, to derive lessons and implications for future policy development, programming, and research. The research was carried out through literature review and interviews with key informants. While this research is certainly not exhaustive of this extensive subject area, it aims to provide insights into the challenges facing current initiatives in healthcare quality regulation and provide direction for the future.

Three main approaches to quality regulation have been used by governments and professional bodies to ensure, maintain, and improve the quality of healthcare: licensing, certification, and accreditation. The three approaches are not mutually exclusive—each has a distinct purpose and can contribute to a country’s overall strategy for ensuring quality of healthcare services—and indeed are complementary. All three approaches are based on evaluation of adherence to explicitly defined standards and strive to create uniformity of practice by service providers and delivery systems. The three approaches also differ in important ways: whether they are mandatory or voluntary; in the nature of the issuing or enforcing organization; with respect to what entity is the object of evaluation; in the level of detail of requirements and the scope of the standards; in the frequency with which evaluation in carried out; and in the assessment methodology used.

Licensing is a statutory mechanism by which a governmental authority grants permission to an individual practitioner to engage in an occupation or to a healthcare organization to operate and deliver services. Licensing allows governments to ensure basic public health and safety by controlling the entry of healthcare providers and facilities into the healthcare market and by establishing standards of conduct for maintaining that status.

Certification and accreditation, in contrast, are voluntary processes undertaken by a provider or a facility to demonstrate special competence or capability beyond the minimum required for licensure. Certification is a process by which a recognized authority—either a governmental agency or nongovernmental organization—evaluates and recognizes an individual provider or an organization as having met pre-determined requirements, usually to demonstrate competence in a specialty area. Accreditation is the formal process by which a recognized accrediting body assesses and recognizes that a healthcare organization meets pre-established performance standards.

Certification generally implies a specialization in a single technical area, while accreditation reflects overall facility performance and competence. Accreditation standards are usually regarded as optimal yet achievable and are designed to encourage continuous improvement efforts within accredited organizations. The standards used to assess performance for accreditation are commonly developed by expert committees working with the accrediting body and revised periodically to reflect advances in technology or policy changes.

By focusing on optimal rather than minimum standards of care, accreditation instills a strong performance improvement orientation, stimulating healthcare organizations to pursue increasingly  higher levels of quality. A recent adaptation of the traditional accreditation model has been to focus on specific services or areas of care, in a process often referred to as focused accreditation.

Focused accreditation has drawn interest in the region as a tool for improving the quality of selected health services and of primary care facilities.

A strong legal foundation and support for the regulation of healthcare facilities and personnel exists throughout the region, and many regulatory initiatives that affect quality are in the process of development. All countries in the LAC region have licensing programs for healthcare personnel and

facilities as well as explicit requirements for the legal practice of healthcare professions.

Certification programs for health professionals are less prevalent, and few countries have explicit continuing education requirements for health professionals. While only four countries in the region have well established hospital accreditation programs (Argentina, Brazil, Chile, and Costa Rica), several others are considering or are in the process of developing accreditation programs, including focused accreditation. Annex 3 of the report provides more detailed descriptions of experiences with quality regulation in Argentina, Brazil, the Caribbean Community, Colombia, the Dominican Republic, and Honduras.

Regional efforts to effectively regulate the quality of care of health facilities and practitioners face a number of challenges. A major weakness in most countries is the lack of enforcement of sanctions or consequences for loss or reversal of quality evaluation status. This includes procedures for disciplinary action against licensees who fail to maintain the conditions of licensing as well as procedures for reporting and handling impaired or incompetent providers and facilities.

A related problem is lack of ongoing inspection of facilities or periodic review of provider competence to ensure that desired performance is sustained over time. Licensing and certification only at the point of entry into the healthcare market are insufficient to provide assurance to the public and to health sector institutions that providers maintain competency throughout the span of their careers. Time-limited licenses and certificates and clear requirements for renewal are essential to create an impetus for providers to remain current through continuing education and for

organizations to maintain physical infrastructure and capacity.

Monitoring and evaluation continues to be a weak link in healthcare regulation in the region. Ongoing evaluation of quality regulation programs is important to ensure that regulatory agencies are accountable to the public and to demonstrate that the investment in quality regulation is costeffective.

Providing sufficient resources to effectively implement any quality regulation approach is also critical. Decision makers must address funding sources and sustainability at each phase of development of a quality regulation program. To have impact, regulatory bodies must have the resources and mechanisms to exert their authority and must regularly collect and act on monitoring data to verify compliance. Facilities also need resources to enable the achievement of standards.

While the number of countries implementing hospital accreditation is growing, to date there is little conclusive evidence that accreditation actually improves the quality of hospital care. Since accreditation programs entail substantial costs, determining whether accreditation is likely to be effective and sustainable is crucial prior to embarking on this approach to quality regulation.

Another opportunity to strengthen healthcare regulation in the LAC region that consistently arises throughout country examples is the need for stronger incentives to improve and maintain quality of care. Providing incentives to motivate providers and organizations to participate in and maintain quality performance is as important as sanctions, particularly in voluntary programs like accreditation. Another challenge for all programs is keeping standards up to date with changes in

technology, scientific evidence, and medical practice.

As the demand for private sector services continues to grow throughout the LAC region, addressing the private sector is a major regulatory challenge. Governments need to engage private sector stakeholders in the development of healthcare regulation while also exercising their steering

role of regulating and controlling the facilities, services, and personnel of both private and public health institutions. Though many Ministries of Health have the legal authority to regulate private providers, many do not exercise this power, resulting in largely unknown quality in the private sector.

Finally, it is important to remember quality regulation is only one of many quality assurance strategies that impact quality of care. Quality regulation will have its maximum effect when coordinated with other quality assurance activities at various levels. To truly ensure the quality of health services, governments must not only examine their role as stewards and regulators, but also take steps to inculcate a culture of quality and support quality improvement at all levels of the healthcare system, from individual community clinics to specialized referral hospitals.