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

Healthcare facility certification is an essential process in France, aimed at guaranteeing and improving the quality and safety of care provided to patients. Implemented for over 25 years, this independent and mandatory procedure externally assesses the level of quality and safety in public and private healthcare facilities. In 2025, certification enters a new phase with the launch of its 6th 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 6th certification cycle.

What is healthcare facility certification?

Healthcare facility certification is a procedure for evaluating the level of quality and safety of care. It is entrusted to the High Authority for Health (HAS) by the 1996 ordinances. This process applies to all healthcare facilities, whether public or private. It is carried out 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 level of quality and safety of care provided to patients. The main objective is to support healthcare facilities in their continuous improvement efforts regarding the quality and safety of care. Certification results are made public 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 optimally secure production processes in the healthcare sector. It also responds to a demand for greater transparency regarding the quality of service provided for patients, their representatives, public authorities, and healthcare professionals. Over the years, certification has undergone several evolutions, notably with the implementation of increased requirements in terms of patient care and risk management (V2010), and the strengthening of facilities' capacity to continuously identify and control their risks, with the introduction of the patient tracer method (V2014). Since 2021, certification has undergone a profound transformation, with three major ambitions set by the HAS College.

The ambitions of the 6th certification cycle (2025)

The 6th cycle of the certification of healthcare facilities, which will begin in 2025, follows on from previous approaches while being guided by three main ambitions:

• Strengthening requirements on key issues: This new cycle will focus on areas where there is still room for improvement, such as the control 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 on 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. The 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 ambition of this new cycle. Certification must be based on patients' perspectives on their experience in the facility and evaluate the outcome 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 develop patient engagement, to rely on the analysis of the relevance and outcome of practices, to promote teamwork, and to seek integration within the local community in conjunction 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 information and 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 continuity of the process initiated in 2021. Its general philosophy builds on the previous cycle, with adjustments designed to further facilitate its implementation and adoption by professionals. The framework remains organized according to the same three chapters: the patient, the care teams, the institution. However, the number of objectives is reduced and rebalanced to four objectives per chapter, for a total of twelve. The number of criteria is also reduced and their wording optimized. The five assessment methods, which are already well-established, particularly the tracer patient method, are simply adjusted. The organization of visits and the four levels of decision (certified establishment with distinction, certified, conditionally certified, 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 progress made, the analysis of serious adverse events related to drug use and the results of the 5th certification cycle revealed insufficient control of drug-related risks. Consequently, the 6th certification cycle includes a significant strengthening of requirements concerning 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 self-administration of medication (PAAM) during hospitalization will be encouraged, while ensuring the safety of this practice.

Adaptation to Public Health Priorities

The 6th certification cycle is adapted to unanimously recognized public health priorities. The fight against antimicrobial resistance, emergency care, and psychiatry are major challenges that will be specifically integrated into the new framework.

Regarding 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 the best practice guidelines for antibiotic therapy, and that prescriptions are justified and reassessed regularly (between the 24th and 72nd hour). The monitoring of antibiotic consumption and bacterial resistance by the operational hygiene team (OHT), the teams, the antibiotic therapy specialist, the hospital pharmacy (HPC), and the microbiology laboratory will also be assessed.

Faced with the increasing pressure on emergency services, resulting from more difficult access to care and an aging population, the certification will pay particular attention to the organization and efficiency of emergency care. The direction of patients to the appropriate care pathways and timeframes upon arrival will be an important criterion. Organizing inter-service meetings with local stakeholders to prevent unnecessary emergency room visits for elderly individuals will also be valued.

Finally, the results of the 5th certification cycle in psychiatry highlighted the need for substantial improvements in practices in this sector. In a context where psychiatry has been declared a major national priority for 2025 and where the HAS (French National Authority for Health) has made mental health a priority, the evaluation criteria in psychiatry are being revised to encourage these improvements. The organization of unscheduled mental health care and the territorial positioning of mental health facilities will be taken into account.

The 6th Cycle Framework: Structure and Developments

The framework forms the foundation of the certification system. It lists the criteria to be met by the healthcare facility and provides all the necessary elements for their understanding and evaluation. To take into account 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.) provided.)

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

• 92 standard criteria which correspond to the certification requirements.
• 21 mandatory criteria which correspond to fundamental requirements. A negative assessment of a mandatory criterion may result in the non-certification of the establishment.
• 5 advanced criteria which correspond to desired but not currently required requirements and which could become the standard criteria of tomorrow.

The framework is adapted to each establishment according to its specific characteristics (size, activities, populations served). Each establishment is evaluated on the generic criteria, applicable to the entire establishment, as well as on the specific criteria that apply to it. Institutions have access to their personalized framework via the collaborative platform Calista.

How does the certification process work?

The certification process is structured around four main steps:

• Commitment to the certification process: The institution registers for the process, generally as a legal entity. It receives its login credentials to access Calista and the self-assessment tools if it wishes.
• Evaluation: This step includes:
  • The internal evaluation carried out by the institution itself to facilitate the adoption of the framework and to assess itself against the applicable criteria. It is no longer necessary to submit this assessment to the HAS.
  • The external evaluation visit is carried out by HAS expert visitors. The facility is informed of the date of the visit and the composition of the expert team approximately 3 months in advance. The visit lasts between 3 and 5 days and is conducted by a team of 2 to 8 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 close to 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 observations. The Healthcare Facility Certification Commission (CCES) then makes a decision based on the expert visitors' report and the facility's observations. The HAS can 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 within a maximum of two years to verify the implementation of the conditions.
  • Non-certified establishment: a new procedure is implemented within a period defined by the HAS (maximum two years).
• Publication and dissemination of results: The certification decision is notified in a certification report which is made public on the HAS website (Qualiscope). The facility must ensure internal distribution of the report and inform patients of the results. The sticker associated with the certification level must be displayed at reception areas.

Certification is increasingly based on patient outcomes, making quality and safety of care indicators (QSCIs) a marker of the facility's improvement momentum. 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 6th cycle of healthcare facility certification marks an important step in the continued 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 heart 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 optimizations, aims to facilitate the adoption of the system by professionals, while ensuring a rigorous and transparent evaluation of healthcare facilities.