Regulatory approaches

Regulatory approaches help maintain and improve quality, ensure patient safety, provide legal recognition to qualified health professionals, and verify that design or maintenance specifications are met. The main regulatory approaches used to enforce health care quality include accreditation (facility), certification and re-certification of professionals and facilities, and professional licensure and renewal (Rooney & van Ostenberg 1999).


Accreditation is a formal process used by a recognized body—either governmental or nongovernmental—to assess and recognize that a health care organization meets pre-established performance standards. Accreditation standards usually are 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, treatment regimes, or policy changes. Evaluation for accreditation is performed by a group of surveyors that carry out a variety of assessment techniques, such as a review of documents and records, interviews, observation, inspections of the facility, and evaluation of achievements. Based on the results of this thorough evaluation, the survey team recommends whether the facility should be accredited or should implement further improvements and be re-evaluated in the future. Renewal of accreditation status is usually required every two to three years.

Standards and criteria for accreditation generally are developed through consensus among stakeholders, such as medical associations, Ministries of Health, and nongovernmental organizations. Accreditation programs generally are funded through survey fees or government or donor support, and may be expensive for individual facilities to finance. Even if facilities or non-governmental organizations do not elect to undergo the full accreditation process, the use of accreditation standards for internal self-assessment can help in identifying areas where a facility or organization needs to improve to reach expected levels of care quality. Accreditation traditionally has been a voluntary process sought by hospitals, although in a few countries, accreditation standards have been issued for services at lower-level facilities. More recently, however, some countries have made participation of health care organizations in accreditation programs compulsory. Other countries, such as the United States, have tied accreditation systems to financing mechanisms, thereby creating a strong incentive to achieve and maintain accredited status.

The introduction of accreditation programs into developing-country public-sector health systems has resulted in recognition of the need to adapt traditional accreditation methodologies to the realities of the severe resource constraints and weak underlying performance of many health systems. Providing sufficient resources to effectively implement an accreditation program is also critical because starting up an accreditation program without assuring its continued funding is likely to waste resources. USAID-supported evaluations of accreditation in South Africa (Salmon et al. 2003) and Zambia (QAP 2005) did not find strong evidence of sustainable impact of accreditation on quality of care.

A recent adaptation of the traditional accreditation model is focused accreditation, which looks at a specific service or area of care. In focused accreditation programs, health care organizations that meet certain pre-established standards receive recognition from the assessing body and may be awarded a symbol (e.g., gold star, special plaque) or designation (e.g., “adolescent-friendly clinic”) to recognize their achievement. The symbolic quality award or designation and ensuing public recognition is intended to encourage desired organizational performance. Many hospitals and clinics operated by non-governmental organizations will be familiar with the UNICEF-sponsored “Baby-Friendly Hospital” initiative and seek accreditation by submitting an application, which includes a letter of intent, a fee, and self-appraisal on adherence to the “10 steps to successful breastfeeding” established by UNICEF and WHO.


Certification is a voluntary process undertaken by a provider or a facility to demonstrate special competence or capability in a particular area. To undergo certification, an established authority, such as a government agency, professional association, or specialty board, evaluates and recognizes either an individual or an organization as having met pre-determined criteria, such as expert knowledge, skills, and demonstrated competence in a specialty area. These criteria go beyond the minimum requirements set for licensing (Rooney & van Ostenberg 1999).

The intent of certifying health care providers is to show evidence that the provider has successfully completed an approved educational program and evaluation process and possesses the knowledge, skills, and educational experience required to provide quality patient care in a specific field. Certification also may be tied to scopes of practice, which are legally sanctioned definitions of what types of services a particular health professional may deliver.

Professional societies in many countries exercise a function of certifying competence in their specific clinical specialty. For example, certification of professional nurse-midwives by the American College of Nurse Midwives requires graduating from an accredited teaching program, passing a national certification exam, seeking continuing education, and, more recently, re-taking the certification exam every eight years. When applied to a facility or an organization, certification implies that the facility or organization has additional services, technology, or capacity beyond those found in similar facilities or organizations. Certification distinguishes the facility or organization as capable of practicing or delivering services in a specialty area and may even grant the organization the legal authorization and funding to perform specialized activities. For example, certification of readiness to provide HIV/AIDS treatment and care is a prerequisite in many countries for a facility to receive and dispense antiretroviral drugs.


Licensing is a form of quality regulation of health care services. It is a statutory mechanism a governmental authority uses to grant permission to either an individual health care practitioner to engage in an occupation or to a health care organization to operate and deliver services. Licensing allows governments to ensure basic public health and safety by controlling the entry of health care providers and facilities into the country’s health care market and by establishing standards of conduct for maintaining that status (Rooney & van Ostenberg 1999).

Licensing differs from other approaches to quality regulation; it is mandatory and performed uniquely by a government agency. Licensing regulations also specify the period of time period that the license is valid and the required procedure for maintaining or renewing the license. Assuming that problems with the provider or facility have not been identified or reported, licenses often may be renewed with the payment of a specific fee or submission of documentation.

Licensing standards typically are set at a minimum level, defined by the government as that needed to ensure health and safety in the country. For individual providers, licensing standards are usually defined by training (e.g., completion of degree from an acceptable training institution) and demonstrated technical competence (e.g., passing of a licensing examination).

The licensing of health care facilities differs from accreditation and certification; it is mandatory, thus providing the government control over the entry and operation of facilities in the health sector (Zeribi & Marquez 1995). In some countries, however, a new registration or licensing process has been proposed for existing health care facilities that more closely resembles accreditation in the sense that detailed standards covering various functional areas have been proposed, with initial and subsequent evaluation of compliance, and the possibility of assistance to facilities to help them achieve the standards.

A critical requirement for achieving the intended impact of licensing is to build in mechanisms to ensure that the desired performance or competence is sustained over time. Time-limited licenses and clear requirements for renewal are essential to create an incentive for providers to remain current through continuing education and for organizations to maintain physical infrastructure and capacity. A related issue is the need for enforcement of sanctions or consequences for loss or reversal of licensing status. This includes procedures for disciplinary action against licensees who fail to maintain the conditions of licensing and procedures for reporting and handling impaired or incompetent providers and facilities.