Healthcare Facility Certification: The 6th Cycle, a New Era for Quality of Care

Healthcare facility certification is an essential process in France, designed to ensure and improve the quality and safety of care provided to patients. In place for over 25 years, this independent and mandatory procedure externally evaluates the level of quality and safety in public and private healthcare facilities. In 2025, certification enters a new phase with the launch of its sixth cycle. Building on the successes of previous cycles and continuously striving for improvement, this new cycle aims to strengthen requirements on key issues, adapt to public health priorities, and fully integrate patients as partners in their care pathway. This article explores in detail the foundations, objectives, and new features of this sixth certification cycle.

What is healthcare facility certification?

Healthcare facility certification is a process for evaluating the quality and safety of care. It is administered by the High Authority for Health (HAS) under the 1996 ordinances. This process applies to all healthcare facilities, whether public or private. It is conducted by expert visitors, who are practicing healthcare professionals appointed by the HAS. These experts assess the quality of care during a visit to the facility. The assessment is based on a framework that establishes objectives broken down into criteria. These objectives are collectively defined at the national level by professionals and users.

Certification is a process independent of the facility and its supervisory bodies. It focuses specifically on the quality and safety of patient care. The main objective is to support healthcare facilities in their efforts to continuously improve the quality and safety of care. Certification results are published on Qualiscope, the HAS’s online information service. It is important to note that certification is not a ranking of hospitals and clinics and does not interfere with other regulatory assessments applicable to healthcare facilities. In France, it is the only national system offering a comprehensive framework for the analysis and external evaluation of the quality of care and patient management. Certification encourages improvement pathways tailored to each facility and serves as a lever for mobilizing healthcare professionals and patient representatives. The certification process began 25 years ago and reflects a general desire to ensure optimal safety in healthcare delivery. It also addresses a demand for greater transparency regarding the quality of care provided to patients, their representatives, public authorities, and healthcare professionals. Over the years, certification has undergone several changes, notably with the implementation of stricter requirements regarding patient care and risk management (V2010), and the strengthening of facilities’ capacity to continuously identify and control their risks through the introduction of the patient tracer method (V2014). Since 2021, certification has undergone a profound transformation, with three major objectives set by the HAS College.

The goals of the 6th certification cycle (2025)

The sixth cycle of healthcare facility certification, which will begin in 2025, builds on previous approaches while being guided by three main objectives:

• Strengthening requirements on key issues: This new cycle will focus on areas where there is still room for improvement, such as the management of risks associated with the use of medicines. The HAS’s annual analysis of serious adverse events related to drug use and the results of the 5th cycle highlighted insufficient control in this area, justifying a revision of the objectives and evaluation criteria. Adapting to public health priorities: The 6th certification cycle will take into account major, unanimously recognized public health priorities, such as the fight against antimicrobial resistance, emergency care, and psychiatry. Certification has an important role to play in addressing these issues. For example, the standard criterion regarding the appropriateness of antibiotic prescriptions will become a mandatory criterion to help preserve the effectiveness of antibiotics. Similarly, the evaluation criteria in psychiatry will be reviewed in a context where mental health has been declared a major national priority for 2025. Consideration of difficulties in accessing care across the country and the aging population, which impact emergency services, will also be integrated. Making patients full partners: Patient engagement as active participants in their care is a major goal of this new cycle. Certification must be based on patients’ perspectives regarding their experience at the facility and evaluate outcomes not only in terms of health but also in terms of the overall experience (reception, information, team coordination, discharge). The involvement of patients and their representatives in the life of the institution is valued.

By committing to quality of care certification, institutions are encouraged to foster patient engagement, to rely on the analysis of the effectiveness and outcomes of their practices, to promote teamwork, and to seek integration within the local community in collaboration with other healthcare and social care providers. For care teams, certification allows them to have their commitment to the continuous improvement of the quality and safety of care recognized. For the institution, it guarantees respect for patient rights, their access to information, and their involvement in their care plan, as well as team coordination, risk management, safety in high-risk areas, a culture of relevance and results, overall quality management, resource management, territorial positioning, and adaptation to eco-responsible care and digital innovations.

Continuity and optimizations of the certification process

The 6th certification cycle is part of the ongoing process that began in 2021. Its overall approach builds on the previous cycle, with adjustments designed to further facilitate its implementation and adoption by professionals. The framework remains organized into the same three chapters: the patient, the care teams, and the institution. However, the number of objectives has been reduced and rebalanced to four objectives per chapter, for a total of twelve. The number of criteria has also been reduced, and their wording optimized. The five assessment methods, which are already well-established—particularly the tracer patient method—have been slightly adjusted. The organization of visits and the four levels of certification (certified with distinction, certified, conditionally certified, and non-certified) remain unchanged. This continuity aims to optimize the process by building on successes and promoting improvements identified during previous cycles. Simplifying the framework, with a reduction in the number of objectives and criteria, aims to make the process more readable and operational for healthcare professionals. Adjusting the evaluation methods allows us to maintain a pragmatic and field-based approach, while taking into account the experience gained during previous implementations. Maintaining decision-making levels ensures clarity and stability in communicating certification results.

Strengthening requirements on key issues

Despite the progress made, the analysis of serious adverse events related to medication use and the results of the 5th certification cycle revealed insufficient control of medication-related risks. Consequently, the 6th certification cycle includes significantly strengthened requirements regarding these practices. The objectives and evaluation criteria related to medication use are being thoroughly reviewed, covering the entire process, from procurement to dispensing, including prescribing. This strengthening of requirements translates into increased attention to best practices in prescribing, dispensing, and administering medications. Healthcare teams will have to demonstrate rigorous prescription analysis by pharmacists, dispensing in accordance with the indications, and safe administration respecting the 5 Rights (right patient, right medication, right dose, right route, right time). The traceability of medication administration in the patient’s medical record will also be a key aspect of the evaluation. Furthermore, the promotion of patient-administered medication (PAAM) during hospitalization will be encouraged, while ensuring the safety of this practice.

Alignment with Public Health Priorities

The 6th certification cycle is aligned with widely recognized public health priorities. The fight against antimicrobial resistance, emergency care, and psychiatry are major challenges that will be specifically incorporated into the new framework.

With regard to antimicrobial resistance, the standard criterion for the appropriateness of antibiotic prescriptions becomes a mandatory criterion. This means that a negative assessment of this criterion could have a significant impact on the certification decision. Teams will have to demonstrate that they comply with best practice guidelines for antibiotic therapy, and that prescriptions are justified and reassessed regularly (between the 24th and 72nd hour). The monitoring of antibiotic use and bacterial resistance by the Operational Hygiene Team (OHT), the clinical teams, the antibiotic therapy specialist, the hospital pharmacy (HPC), and the microbiology laboratory will also be evaluated.

Given the growing pressure on emergency services—driven by reduced access to care and an aging population—the certification will place particular emphasis on the organization and efficiency of emergency care. An important criterion will be the timely referral of patients to appropriate care pathways upon arrival. Organizing interagency meetings with local stakeholders to prevent unnecessary emergency room visits by older adults will also be highly valued.

Finally, the results of the fifth certification cycle in psychiatry highlighted the need for substantial improvements in practices within this sector. Given that psychiatry has been designated a major national priority for 2025 and that the HAS (French National Authority for Health) has made mental health a priority, the evaluation criteria for psychiatry are being revised to encourage these improvements. The organization of emergency mental health care and the regional distribution of mental health facilities will be taken into account.

The Sixth Framework Programme: Structure and Developments

The framework forms the foundation of the certification system. It lists the criteria that healthcare facilities must meet and provides all the necessary information for understanding and evaluating them. To account for changes in the healthcare system and feedback from institutions, the framework is updated annually in consultation with all stakeholders. The 6th cycle framework is structured around 12 objectives, divided into three chapters: Chapter 1: The Patient; Objective 1.1: Respect for patient rights; Objective 1.2: Patient information; Objective 1.3: Patient engagement in their care plan; Objective 1.4: Quality of the patient pathway (Although mentioned in the overall structure, the details of this objective are not explicitly presented in the extracts.)

Each objective is broken down into criteria. The framework includes three levels of requirements for these criteria:

• 92 standard criteria that meet the certification requirements.
• 21 mandatory criteria that correspond to fundamental requirements. A negative assessment of a mandatory criterion may result in the establishment not being certified.
• 5 advanced criteria that reflect desired but not currently required standards and that could become the standard criteria of the future.

The framework is tailored to each facility based on its specific characteristics (size, activities, and populations served). Each facility is evaluated based on generic criteria—which apply to the entire facility—as well as specific criteria that apply to it. Facilities can access their customized framework via the Calista collaborative platform.

How does the certification process work?

The certification process consists of four main steps:

• Commitment to the certification process: The institution registers for the process, typically as a legal entity. It receives its login credentials to access Calista and the self-assessment tools, if it chooses to do so.
• Evaluation: This step includes:
  • The internal evaluation conducted by the institution itself to facilitate the adoption of the framework and to assess its own compliance with the applicable criteria. It is no longer necessary to submit this assessment to the HAS.
  • The external evaluation visit is conducted by HAS expert visitors. The facility is notified of the visit date and the composition of the expert team approximately three months in advance. The visit lasts between three and five days and is conducted by a team of two to eight experts and a coordinator. The visit program is developed by the HAS in collaboration with the coordinator, based on the facility’s profile. The expert visitors use five evaluation methods that reflect real-world practice: patient tracer, pathway tracer, targeted tracer, system audit, and observation.
• Decision: After the visit, the HAS sends a visit report to the facility within 15 days. The facility has one month to submit its comments. The Healthcare Facility Certification Commission (CCES) then makes a decision based on the expert visitors' report and the facility's observations. The HAS may issue four types of decisions:
  • Certified establishment with distinction (valid for four years).
  • Certified establishment (valid for four years).
  • Certified establishment with conditions: A new procedure is scheduled to take place within a maximum of two years to verify compliance with the conditions.
  • Non-certified facility: a new procedure is implemented within a timeframe set by the HAS (maximum two years).
• Publication and dissemination of results: The certification decision is communicated in a certification report, which is made public on the HAS website (Qualiscope). The facility must ensure that the report is distributed internally and must inform patients of the results. The sticker corresponding to the certification level must be displayed in reception areas.

Certification is increasingly based on patient outcomes, making quality and safety of care indicators (QSCIs) a measure of a facility’s progress toward improvement. The QSCI results are used during the evaluation to assess the effectiveness of collecting, sharing, analyzing, and using these indicators, as well as the implementation of improvement plans.

In conclusion, the sixth cycle of healthcare facility certification marks an important step in the ongoing improvement of the quality and safety of care in France. By strengthening requirements on key issues, adapting to public health priorities, and placing the patient at the center of the process, this new cycle aims to address the current challenges facing the healthcare system and contribute to providing increasingly relevant and safe care. The continuity of the approach, combined with targeted improvements, aims to facilitate the adoption of the system by healthcare professionals, while ensuring a rigorous and transparent evaluation of healthcare facilities.