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Clinical Governance: Quality and Patient Safety in Prehospital Emergency Care

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In prehospital emergency care, high levels of responsibility and time pressure converge with rare HALO (High Acuity, Low Occurrence) procedures.1 Following the handover into hospital, crews often get no report on their patients’ progress going forward, so they have no feedback on their own work.2

There are numerous individual measures for quality assurance in Germany, but there is largely no systematic anchoring point for these measures, which is precisely where clinical governance comes in. For medical management and for crews, this means sharing organizational responsibility and making good care reproducible.

Clinical governance: the key facts in brief

  • Clinical governance is an overarching concept which puts patient safety front and center and makes continuous quality improvement a management task.
  • It meshes just culture, audits, risk management, training, clinical effectiveness, and data usage into a single system.
  • In Germany, some aspects such as the Critical Incident Reporting System (CIRS) and emergency register already exist, but a fully comprehensive system has not been available to date.
  • A start can be made step by step in small units: just culture, structured case conferences, lived standards, data, and networked training.

What is clinical governance?

Clinical governance is a strategic framework used by health organizations to improve the quality of their care systematically and to take accountability for high standards of care. It transfers the governance principles of responsibility, control, and accountability to patient care and bundles individual quality and safety tools into a an overarching system.

The term was coined in 1998 by Gabriel Scally and Liam Donaldson (later Chief Medical Officer for England and WHO’s envoy for patient safety) in the British Medical Journal (BMJ). The key definition they used, which still stands today, describes clinical governance as

“a framework through which NHS (National Health Service) organizations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.”3

The concept was launched in the same year in the British White Paper entitled “A First-Class Service” and the Health Act 1999 made a legal duty of quality binding on all NHS organizations. Clinical governance thus became the first quality framework in state healthcare to be anchored in law.

How does clinical governance differ from quality management?

The key difference: quality management primarily safeguards processes, structures, and their verifiability, whilst clinical governance also looks at patient outcomes, learning and safety culture, and medical responsibility, as well as combining the individual quality tools into an overarching framework.

The two systems complement, rather than mutually exclude one another. Quality management – frequently structured in line with DIN EN ISO 9001 in the healthcare sector - and in Germany, made a legal requirement through § 135a SGB V [German Social Code] and the QM-Richtlinie des Gemeinsamen Bundesausschusses (G-BA) [Quality management guideline of the Federal Joint Committee] – creates the documented, verifiable basis. Clinical governance builds on this and makes continuous quality improvement a management task for medical and organizational managers.

Dimension Quality Management Clinical Governance
Focus Processes, certificates, documentation Patient outcomes, learning and safety culture
Control logic Regulatory conformity, certification Just culture, systematic learning
Range Individual tools (CIRS, QM circles) Overarching framework
Responsibility Quality Officer, Administration Medical managers and crew together

Why clinical governance is relevant in the emergency medical services

A high level of responsibility collides with organizational fragmentation in prehospital emergency care. Clinical governance creates a framework to facilitate systematic learning.

Crews bear the responsibility for critical decisions, often under huge pressure of time and in rare, high-risk procedures. Added to this are organizational stresses such as staff shortages and interfaces with the hospital: the flow of information usually ends on transfer, with crews not hearing how their patients subsequently progressed.4 It is precisely this lack of feedback which makes it harder to assess one’s own quality of care realistically.

Many crews would like an open learning culture, but in practice, strict hierarchies and a perceived blame culture inhibit the open exchange of information in many places.5 This is precisely where clinical governance comes in: it shares responsibility across the organization and thus makes good treatment reproducible, regardless of the individuals involved.1

What advantages does clinical governance offer emergency medical services?

Clinical governance makes concrete changes to care in the daily routine.

  • Greater patient safety: structured risk analysis and a CIRS reveal hazards before they cause harm.
  • Systematic learning instead of blame culture: a lived just culture means that mistakes and near-misses can be addressed and learning points turned into standards.
  • Measurably improved patient outcomes: clinical effectiveness aligns treatment with outcomes - first-pass success in intubation, for example.
  • Reproducible quality: lived SOPs and checklists safeguard consistent care across crews and shifts.
  • Closed feedback loop: data from session documentation and emergency registers replace the often missing feedback from the hospital.
  • Maintaining competence in rare high-risk procedures (HALO): specific, data-based training keeps even rarely-performed procedures safe.
  • Stronger crew and management culture: trust-based management reduces stress, promotes open communication and keeps staff loyal.

The 7 pillars of clinical governance - a summary

Clinical governance consists of seven tight-knit components internationally known as the seven pillars of clinical governance. The initial letters of these components give the mnemonic “CAREUPS”. Just culture runs through all the pillars and is not a pillar in its own right. The specific design of models varies by country and organization.4

The following seven areas are critical for the emergency medical services:

Pillar Meaning Example for emergency medical services
C – Clinical effectiveness The right measure at the right time in the right place for the right person - measurable by patient outcomes First-pass success in intubation; HeliBlut dashboard for prehospital blood transfusion
A – Audits Compare actual process with standards, derive learning points Moderated case conference aligned with SOP; Clinical Forensic Conferences (Berlin/Charité Hospital)
R – Risk management Recognize, assess, and manage risks Structured risk analysis; checklists for emergency anesthesia and resuscitation
E – Education and training Safeguard competence, establish closed learning loop Annual curriculum; crew resource management; structured debriefing; integration
U – Using information & IT Record, analyze, and feed back data Bavarian emergency register; medical line checks; digital session documentation
P – Patient and public involvement Transparency, feedback, and trust Publicly discussed cases on clinical governance days
S – Staff management Management, stress, and development of competence Trust-based management; stress addressed objectively

*Emergency medical service examples taken primarily from the German-speaking region in accordance with Strobel et al. 2026.*1

Clinical effectiveness in emergency medical services

Clinical effectiveness is one of the seven pillars of clinical governance – the pillar which measures the success of care against patient outcomes and feeds it back. Clinical effectiveness means arranging treatment so that it achieves the best possible patient outcomes and does not simply document processes. At its heart are outcomes relevant to patients, not just pure key data. In other words, clinical effectiveness asks not just whether a measure has been carried out, but also whether it had the desired effect.1

One’s own practice is continuously examined for this purpose. If data and experience highlight shortcomings, protocols and SOPs will be further developed.1 Invasive activities and new methods, such as prehospital blood transfusion or point-of-care ultrasound (POCUS), in particular, should be systematically tracked in this process.1

In Germany, only a few CG structures have been published to date.1 A positive example is the HeliBlut (HeliBlood) project of the DRF Luftrettung [German air rescue service): a dashboard was developed in-house to analyze the use of transfusions and cross-check the indication against internal SOPs. A team from Rettungsdienst-Kooperation in Schleswig-Holstein [(RKiSH) - Emergency Medical Services Cooperation in Schleswig-Holstein] is evaluating the use of expanded treatment measures by EMS field providers and giving feedback to those involved.5

SOPs in the emergency medical services

SOPs link the pillars of clinical governance: they deliver the standard a clinical audit uses for comparison and they incorporate information from CIRS, case conferences, and data.

An SOP (Standard Operating Procedure) describes an obligatory process for a defined situation. The case conference compares the concrete process of the session with the SOP to highlight any deviations and potential for improvement.1  If there are deviations, the key thing is to clarify whether the SOP, the training or both need to be modified. 

SOPs are not a rigid tool here, but a living one: feedback from case conferences, CIRS reports, and data flow into them continuously.1 For rare or critical procedures like emergency anesthesia or treatment in the context of resuscitation, the SOPs are supplemented by checklists.1 Checklist work also needs to be trained and must not stay just optional - it works only if practiced and not simply consigned to paper.1

Patient safety and just culture

Patient safety is the overarching objective of clinical governance, whilst just culture is the cultural basis for achieving that objective. It describes an organizational culture which communicates openly and understands mistakes as a learning opportunity instead of only punishing individual incorrect behavior.6 At the forefront is finding out which systemic causes favored an incident rather than seeking guilty parties.

The key factor here is differentiation: just culture makes a distinction between unintended mistakes, risky behavior, and gross negligence. Disciplinary consequences follow only when an individual deliberately breaks rules or is guilty of gross negligence.1 This provides the necessary confidence to speak openly about uncertainties and mistakes.

In Germany, it is almost impossible to assess the extent to which a just culture is lived and experienced in the emergency medical services, as it is neither recorded nor evaluated systematically. Managing with trust and open reflection is therefore a key approach to establishing a learning culture rather than a blame culture.1

Just Culture

  • Mistakes are learning opportunities - if the organization accepts them.
  • It must be safe to make reports - without automatic sanctions.
  • Individual responsibility only applies if rules are deliberately broken.

Case conferences assume a lived just culture.

Risk management and CIRS – learn from near-misses

Risk management recognizes hazards at an early stage. A Critical Incident Reporting System (CIRS) supplements this with anonymous reporting of critical events.

In the prehospital setting, risks arise from pressure of time, rare procedures, numerous interfaces, and the use of technology. Risk management is a continuous, systematic process which recognizes hazards to patients, emergency responders, and organizations at an early stage, then assesses and manages those hazards. 

The basis is a structured risk analysis: sources of mistakes are rated in terms of their likelihood of occurrence and their impact. A decision is then made as to whether the risk needs to be prevented, mitigated or consciously accepted. The framework is supplemented by checklists for rare or critical procedures - there is evidence for emergency anesthesia that these increase safety.1

A CIRS facilitates voluntary anonymous reporting of critical incidents and lowers inhibitions about reporting them, allowing patterns to be detected and solutions translated into standards.

Checklist: 5 steps to the CIRS

  1. Clarify the healthcare trust’s reporting system or set up an internal CIRS.
  2. Communicate just culture – reports will not automatically involve sanctions.
  3. Keep the reporting channel simple and with a low threshold.
  4. Report back to crews what has changed as a result of the reports.
  5. Discuss any patterns together quarterly.

Clinical audit and structured case conferences

Structured, moderated case conferences create an institutional memory. They turn individual experience into shared knowledge.

A clinical audit compares the actual process with defined standards. A case conference goes further: the focus is reflecting on a concrete case together. In contrast to a purely descriptive case presentation, this does not aim to describe what happened, but to find learning points for individual, crew-based, and institutional practice.1

For case conferences to work, a clear sequence is required: cases are selected for their learning effect, with a neutral person moderating. The process is compared to the associated SOP and the learning points are recorded and made accessible to all. As a result, not only the crew involved, but the whole organization benefits.1

Examples occur in Germany and Austria, too: Berufsrettung Wien [Vienna Emergency Medical Services] is developing structured interdisciplinary case conferences, the Berliner Rettungsdienst [Berlin Emergency Medical Services] have joined forces with the Legal Medicine department of the Charité hospital there to set up Clinical Forensic Conferences, and the Faculty of the Vienna Resuscitative Thoracotomy Course (VieRT) facilitates supraregional follow-up meetings about prehospital thoracotomies.1

Process: 6 steps to a case conference

  1. Select case - to start with, deliberately choose cases with a positive outcome.
  2. Prepare: anonymize, associated SOP, time frame.
  3. Have a neutral person moderate to ensure objectivity.
  4. Discussion: what went well? Where were there deviations from the SOP?
  5. Record learning points.
  6. Implement: initiate SOP, training or CIRS follow-up.

Clinical governance in Germany – status quo and challenges

A clinical governance system like that in Great Britain has not yet become established in Germany, but some aspects of clinical governance do exist in the emergency medical services in fragmented form. In Germany, the term appears primarily in the context of announcements in the air rescue service, for example in the form of clinical governance conferences. 

However these are only vaguely defined and cover just one part-aspect - they only become effective in interaction with case conferences, quality standards, and an active feedback culture.

Part-aspects are nevertheless found in various areas of the German emergency medical services, though without an overarching framework concept.

Component Germany
Just Culture Desired but rarely evaluated
Case Conferences Rarely systematic
Training Structured in isolated cases
Clinical Effectiveness Not publicized much
CIRS Widespread, heterogeneous
Data Emergency register (e.g. trauma, resuscitation), medical line checks

Opportunities are being created by the increasing digitalization of session documentation and national registers. The Bavarian emergency register creates a database for anonymized comparisons and could serve as a basis for systemic clinical effectiveness. 

In the air rescue service, Berlin and Schleswig-Holstein have established medical line checks which involve medical colleagues giving structured feedback on medical measures at the end of a shift.

Initial co-operations are also forming between organizations: during the Enneker Forum Tegernsee in 2025, all the German air rescue organizations agreed to set up CG systems and work together to implement them.7 On an international level, the European Governance Alliance has been set up in HEMS.

Considered realistically, clinical governance involves a high level of staff, technical, and administrative complexity. Sustainable financing, in the form of capital expenditure on patient safety, has to be part of the regular financing of emergency medical services and air rescue services.

Implementing clinical governance – 5 steps

Successful implementation of clinical governance is step by step in small units, with resilient experience gained in advance of scaling up.

Relatively small units such as air rescue stations, emergency physician vehicles or specialized teams provide the ideal conditions for launch: structures are straightforward, communication paths short, so it is easier to establish a direct feedback culture. 

1. Establish just culture 

The most important basis for functional clinical governance processes is a lived just culture. This is created through trust-based management, with trust and development the focus, as well as through the readiness of managers to discuss their own mistakes and uncertainties openly.

2. Structure case conferences

The aim is systematic learning: cases are discussed with a moderator, recorded and, where meaningful, reflected on by the wider organization. It is a good idea to start deliberately with cases with positive outcomes before dealing with more problematic sessions.

3. Introduce and live your standards 

SOPs are drafted with the participation of the whole team and treated as agile tools which receive a constant flow of information from CIRS, case conferences, and clinical effectiveness. Checklists for rare or critical procedures supplement the SOPs and must be trained on regularly. They should not simply be consigned to paper.

4. Use data and establish feedback

The recommended approach is to define a small number of clear indicators: better to have five robust metrics with consecutive audit and feedback than an unwieldy list. Seamless digital session documentation and an emergency register create the database for systemic analyses and feedback from the hospital.

5. Network education, training, and research

A systematic integration concept communicates structures, processes, and culture from the outset. Information from sessions, case conferences, and data analyses flows directly into the curriculum to complete the loop: 

practice → analysis → training → changed practice.

Practice → Analysis → Training → Changed Practice.

Clinical governance in the field: how WEINMANN provides support with medical technology and session data

Data, standards, and feedback are the lifeblood of clinical governance. Medical technology alone cannot create just culture or structured case conferences, but it does deliver important components: reliable devices, standardized equipment and structured session data. 

The cloud-based platform WEINMANN Connect bundles digital device management: in combination with MEDUMAT Standard² and MEDUCORE Standard², it transmits function checks and provides session data centrally – MEDUCORE Standard² additionally transmits ECG data to the destination hospital. For emergency medical services in Germany, there is an interface to connect WEINMANN Connect to the RETTpro management system.

In this way, WEINMANN provides medical technology, service, and documentation solutions as a component of the governance approach – though it cannot replace a governance system with just culture and moderated case conferences. If you would like more information or a personal consultation, do get in touch with us.

FAQs

No, there is no federal law requiring clinical governance as an overall system. Quality assurance in the emergency medical services is regulated by regional law, healthcare trusts, medical managers, SOPs, CIRS, and emergency registers. A compliance management system (CMS) governing conformity of regulations is not the same thing as clinical governance.

Medical responsibility is with medical managers. In organizational terms, clinical governance requires the support of both healthcare trust and management - in terms of time, moderation, and documentation. Crews provide experience from the field and the feedback from which the system learns.

A CMS safeguards the conformity of regulations and structured processes. Clinical governance goes further: it looks at quality of care, patient outcomes and learning culture, combining practice, analysis, and training into a single loop.

No, clinical governance links these tools in an overarching framework. Quality circles, CIRS, and case presentations only become effective when they interact with standards, data, and moderated case conferences.

A case presentation outlines the sequence of a session. A structured case conference goes further: the team reflects together, compares the process against the SOP, derives learning points, and records them. 

Anonymization and pseudonymization are essentially recommended - a clearly defined purpose, access restrictions, and analysis which serve to make the system safe, not rate an individual. Concrete implementation depends on the healthcare trust, regional law, and technical matters and should be agreed with the Data Protection Officer. This information is not intended to replace legal advice.

1 Strobel J, Rücker K, Stanley M, Dahmen J: Clinical Governance – Perspektiven für eine bessere prähospitale Notfallversorgung. Notfall + Rettungsmedizin (2026). doi:10.1007/s10049-025-01677-3 

2 Lücker P, Kästner A, Fischer L et al.: Feedback für Rettungsdienstmitarbeitende als Chance für eine bessere Notfallversorgung? Qualitative Interviews. Notfall + Rettungsmedizin (2026). doi:10.1007/s10049-026-01708-7

3https://www.england.nhs.uk/mat-transformation/matrons-handbook/governance-patient-safety-and-quality/

4 The Seven Pillars of Clinical Governance. NHS, North West Postgraduate Medical Deanery.

Gnirke A, Krautz T et al.: Qualitätssicherung … in der RKiSH gGmbH. Notfall + Rettungsmedizin (2023)

6 Khatri N, Brown GD, Hicks LL: From a blame culture to a just culture in health care. Health Care Manage Rev 2009: 312–322

7 Prückner S et al.: Thesenpapier zum Enneker-Forum-Tegernsee 2025. 

Author: Juliane Zepp · Last updated: 06/08/2026