Healthcare hospital certification: the 6th cycle, a new era for quality of care

The certification of healthcare facilities is an essential process in France, aimed at guaranteeing and improving the quality and safety of care offered 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 seeking to improve, this new cycle aims to strengthen requirements on key issues, adapt to public health priorities, and fully integrate patients as full partners in their care pathway. This article explores in detail the foundations, objectives, and innovations of this 6th certification cycle.

What is healthcare facility certification?

The certification of healthcare facilities is a procedure for evaluating the level of quality and safety of care. It is entrusted to the Haute Autorité de santé (HAS) by the ordinances of 1996. This approach is aimed at all healthcare facilities, whether public or private. It is carried out by expert visitors, who are practicing healthcare professionals mandated by the HAS. These experts assess the level of quality of care during a visit to the facility. The evaluation 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 an independent process from the hospital and its supervisory bodies. It focuses specifically on the level of quality and safety of care delivered to patients. The main objective is to support hospitals in their continuous improvement approach to the quality and safety of care. The results of the certification 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 among themselves and that it does not interfere with other regulatory evaluations applicable to healthcare facilities. In France, it is the only national system offering a global framework for analysis and external evaluation of the quality of care and management. Certification encourages improvement pathways adapted to each facility and constitutes a lever for mobilizing healthcare professionals and user representatives.

The certification process began 25 years ago and is part of a general desire to better secure production processes in the healthcare field. It also responds to an expectation of greater transparency on the quality of service provided for patients, their representatives, public authorities, and healthcare professionals. Over the years, certification has undergone several evolutions, including the implementation of increased requirements in terms of patient care and risk management (V2010), and the strengthening of the ability of hospitals to identify and control their risks continuously, with the introduction of the tracer patient method (V2014). Since 2021, certification has been undergoing profound transformation, with three major ambitions set by the HAS College.

The ambitions of the 6th certification cycle (2025)

The 6th cycle of hospital certification, which will begin in 2025, is a continuation of previous efforts 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 managing the risks associated with the use of medicines. The HAS's annual analysis of serious adverse events related to the use of medicines and the results of the 5th cycle have 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, universally recognized public health priorities, such as the fight against antimicrobial resistance, emergency medicine, 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 is declared a major national cause for 2025. Consideration of difficulties in accessing care in the region and the aging of the population, which impact emergency services, will also be integrated.
• Making patients full partners: Engaging patients as actors in their care is a major ambition of this new cycle. Certification must be based on patients' views of their experience in the hospital and assess the outcome not only in terms of health, but also in terms of appreciation of the journey (reception, information, team coordination, discharge). The involvement of patients and their representatives in the life of the hospital is valued.

By committing to certification for quality of care, hospitals are encouraged to develop patient engagement, rely on analysis of the relevance and outcome of practices, promote teamwork, and seek territorial integration in conjunction with other stakeholders in the healthcare and medico-social offer. For care teams, certification provides recognition of their commitment to continuous improvement of the quality and safety of care. For the hospital, it guarantees respect for patient rights, patient information and engagement in their care plan, as well as team coordination, risk management, safety in high-risk sectors, a culture of relevance and outcome, 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 a continuation of the approach initiated in 2021. Its general philosophy builds on the previous cycle, with adjustments designed to further facilitate its implementation and appropriation by professionals. The reference framework remains organized according to the same three chapters: the patient, the care teams, the hospital. However, the number of objectives is reduced and rebalanced to four objectives per chapter, i.e., twelve in total. The number of criteria is also reduced and their wording optimized. The five evaluation methods, largely mastered, especially that of the patient tracer, are simply adjusted. The organization of visits and the four levels of decision (certified hospital with mention, certified, certified under conditions, not certified) remain unchanged.

This continuity aims to optimize the approach by building on successes and promoting optimizations identified during previous cycles. The simplification of the framework, with a reduction in the number of objectives and criteria, aims to make the approach more readable and operational for healthcare professionals. The adjustment of evaluation methods helps to maintain a pragmatic and field-oriented approach, while taking into account the experience gained during previous implementations. Maintaining decision levels ensures clarity and stability in the communication of certification results.

Tougher requirements on key issues

Despite the progress made, the analysis of serious adverse drug events and the results of the 5th certification cycle revealed inadequate control of drug-related risks. As a result, the 6th certification cycle provides for a significant strengthening of requirements concerning these practices. The objectives and assessment criteria relating to the use of medicines have been reviewed in depth, covering the entire process, fromprocurement to prescription anddispensing.

This strengthening of requirements translates into increased attention to good practices in prescribing, dispensing, and administering medications. Care teams will need to demonstrate a rigorous analysis of prescriptions by pharmacists, delivery in accordance with the indications, and safe administration respecting the 5 rights (right patient, right medication, right dose, right route, right time). Traceability of medication administration in the patient record will also be a key point of evaluation. In addition, promoting patient self-administration of medication (PSAM) during hospitalization will be encouraged, while ensuring the safety of this practice.

Adaptation to public health priorities

The 6th certification cycle adapts to unanimously recognized public health priorities. The fight against antimicrobial resistance, emergencies, and psychiatry are major issues that will be specifically integrated into the new reference framework.

Regarding antimicrobial resistance, the standard criterion on the relevance of antibiotic prescriptions becomes a mandatory criterion. This means that a negative evaluation of this criterion could have a significant impact on the certification decision. Teams will need to demonstrate that they comply with good practice recommendations for antibiotic therapy, that prescriptions are justified and regularly reassessed (between the 24th and 72nd hour). The monitoring of antibiotic consumption and bacterial resistance by the operational hygiene team (EOH), the teams, the antibiotic therapy referent, the pharmacy for internal use (PUI), and the microbiology laboratory will also be evaluated.

Faced with increasing pressure on emergency services, as a result of more difficult access to care and an aging population, the certification will pay particular attention to the organization and fluidity of emergency care. Directing patients through appropriate channels and timeframes for their care, from the moment they arrive, will be an important criterion. The organization of intra-sector meetings with local stakeholders to prevent avoidable emergency department visits by the elderly 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 is declared a major national cause for 2025 and where the HAS makes mental health a priority, the evaluation criteria in psychiatry are being revised to encourage these improvements. The organization of unscheduled care in mental health and the territorial positioning of mental health hospitals will be particularly taken into account.

The 6th cycle framework: structure and evolutions

The reference framework constitutes the foundation of the certification system. It lists the criteria to be met by the healthcare facility and provides all the elements necessary for their understanding and evaluation. To take into account the evolutions of the healthcare system and the feedback from the facilities, the reference framework is updated each year, in consultation with all stakeholders.

The 6th cycle framework is structured into 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 journey (Although mentioned in the overall structure, the detail of this objective is not explicitly present in the extracts provided.)
• Chapter 2: The care teams
  • Objective 2.1: Coordination of teams for patient care
  • Objective 2.2: Controlling risks related to practices
  • Objective 2.3: Safety in high-risk sectors (emergency, surgery and interventional, maternity, critical care, emergency medical services, mental health and psychiatry, radiotherapy)
  • Objective 2.4: A culture of relevance and evaluation
• Chapter 3: The hospital
  • Objective 3.1: Overall management through quality and safety of care
  • Objective 3.2 : Mastering professional resources and skills
  • Objective 3.3: Territorial positioning
  • Objective 3.4: Adapting to eco-responsible care and digital innovations

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

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

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

How does the certification procedure work?

The certification process is structured around four main stages:

• Engagement in the certification procedure: The hospital registers for the process, generally by legal entity. It receives its credentials to access Calista and self-assessment tools if desired.
• Evaluation : This step includes:
  • The internal evaluation carried out by the hospital itself to facilitate the appropriation of the reference framework and to evaluate itself on the applicable criteria. It is no longer necessary to transmit this evaluation to the HAS.
  • The external evaluation visit conducted by the HAS's expert visitors. The hospital 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 carried out 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 hospital's profile. The expert visitors use five field-based evaluation methods: the patient tracer, the pathway tracer, the targeted tracer, the system audit, and observation.
• Decision : After the visit, the HAS sends a visit report to the hospital within 15 days. The hospital has one month to submit its comments. La Healthcare facility certification commission (CCES) then takes a decision on the basis of the surveyors' report and the establishment's observations. The HAS can issue four types of decision:
  • Certified hospital with commendation (valid for four years).
  • Certified hospital (valid for four years).
  • Hospital certified under conditions: a new procedure is scheduled within a maximum of two years to verify the implementation of the conditions.
  • Non-certified hospital: a new procedure is implemented within a timeframe defined by the HAS (maximum two years).
• Publication and dissemination of results: The certification decision is notified in a certification report, which is published on the HAS website (Qualiscope). The facility must distribute the report internally and inform patients of the results. The badge associated with the certification level must be displayed at reception points.

Certification increasingly relies on patient outcomes, making quality and safety of care indicators (QSCI) a marker of the improvement dynamic of hospitals. The result of the QSCI is used during the evaluation to assess the effectiveness of the collection, sharing, analysis, and exploitation of these indicators, as well as the implementation of improvement plans.

In conclusion, the 6th cycle of certification of hospitals marks an important step in the pursuit of improving the quality and safety of care in France. By strengthening the requirements on key issues, adapting to public health priorities, and placing the patient at the heart of the process, this new cycle aims to respond to the current challenges of the healthcare system and contribute to providing ever more relevant and safe care. The continuity of the approach, combined with targeted optimizations, aims to facilitate the appropriation of the system by professionals, while ensuring a rigorous and transparent evaluation of hospitals.

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