Minimum Requirements for Safe Practice
Concept of Minimum Requirements
In international practice, minimum requirements represent the baseline level of conditions and processes below which perfusion practice is considered unsafe. Professional societies emphasize that these requirements do not limit the development of higher quality standards but establish the foundation of safety.
The standards of AmSECT define the minimum requirements that institutions must ensure for safe perfusion, while the Guidelines provide recommendations for further improvement of practice.
Minimum Organizational Requirements
Safe perfusion practice is not possible without an appropriate organizational environment.
Minimum organizational requirements include:
Minimum Requirements for Personnel and Competence
International standards consider professional competence a key element of safety.
Minimum requirements include:
Self-Assessment Tool for Compliance with Minimum Requirements and Quality Performance Indicators (KPIs)
This tool is designed for perfusionists, ECMO teams, and unit leaders and is used to regularly assess the baseline level of safety in perfusion practice. It is based on international standards developed by AmSECT and SCPS, as well as quality improvement principles applied within ELSO.
The tool is non-punitive and intended exclusively for internal analysis and improvement of clinical practice.
How to Use the Tool
After completion of the assessment, it is recommended to:
AmSECT Standards & Guidelines for Perfusion Practice https://amsect.org/policy-practice/amsects-standards-and-guidelines SCPS Standards of Practice https://www.scps.org.uk/society/society-documents ELSO Guidelines https://www.elso.org/ecmo-resources/elso-ecmo-guidelines.aspx AmSECT Standards & Guidelines for Perfusion Practice https://amsect.org/policy-practice/amsects-standards-and-guidelines SCPS Standards of Practice https://www.scps.org.uk/society/society-documents Human Factors and Teamwork in Cardiac Surgery https://www.cambridge.org/core/books/cardiopulmonary-bypass/human-factors-and-teamwork-in-cardiac-surgery/ED35DB4A9BBA978132322702B120D6CD Exploring Perfusion Safety: A Review of Clinical and Non-Clinical Factors https://www.researchgate.net/publication/374782348
In international practice, minimum requirements represent the baseline level of conditions and processes below which perfusion practice is considered unsafe. Professional societies emphasize that these requirements do not limit the development of higher quality standards but establish the foundation of safety.
The standards of AmSECT define the minimum requirements that institutions must ensure for safe perfusion, while the Guidelines provide recommendations for further improvement of practice.
Minimum Organizational Requirements
Safe perfusion practice is not possible without an appropriate organizational environment.
Minimum organizational requirements include:
- availability of trained and competent personnel;
- clearly defined roles and responsibilities;
- approved local protocols and SOPs;
- access to current standards and guidelines;
- conditions that support teamwork and communication.
Minimum Requirements for Personnel and Competence
International standards consider professional competence a key element of safety.
Minimum requirements include:
- relevant education and training;
- regular updating of knowledge and skills;
- knowledge and application of standards, SOPs, and checklists;
- ability to recognize risks and non-standard situations;
- participation in training and practice review.
Self-Assessment Tool for Compliance with Minimum Requirements and Quality Performance Indicators (KPIs)
This tool is designed for perfusionists, ECMO teams, and unit leaders and is used to regularly assess the baseline level of safety in perfusion practice. It is based on international standards developed by AmSECT and SCPS, as well as quality improvement principles applied within ELSO.
The tool is non-punitive and intended exclusively for internal analysis and improvement of clinical practice.
How to Use the Tool
- Assessment may be conducted individually or as a team
- Frequency: quarterly / biannually / prior to audits
- Each item is rated as:
- compliant / partially compliant / non-compliant
- For items rated “partially compliant” or “non-compliant,” an improvement plan must be developed
- Roles and areas of responsibility of the perfusionist are clearly defined
- Approved perfusion SOPs are in place within the unit
- Current international standards are used in daily practice
- Team briefings are conducted
- A mechanism exists for discussion of risks and incidents
- Availability of up-to-date SOPs (yes / no)
- Percentage of procedures performed using checklists (%)
- Frequency of team briefings (% of cases)
- The perfusionist has appropriate professional education and training
- Ongoing education and regular knowledge updates are maintained
- Standards, SOPs, and checklists are known and applied in practice
- Participation in training activities and practice review is ensured
- Number of training hours per specialist per year
- Participation rate in webinars and conferences (%)
- Percentage of staff who have completed safety-related training (%)
- Functional, inspected, and validated equipment is used
- Circuit checks are performed prior to initiation of extracorporeal support
- Continuous monitoring of physiological parameters is ensured
- Readiness for emergency and non-standard situations is maintained
- Number of technical incidents per 100 procedures
- Percentage of procedures with documented full equipment checks (%)
- Number of emergency interventions performed in accordance with SOPs
- A perfusion record is maintained for each procedure
- Key perfusion parameters are documented
- Clinically significant events are recorded
- Documentation is completed in a timely manner
- Completeness of perfusion records (%)
- Number of procedures with fully completed documentation
- Number of identified documentation errors
- The perfusionist participates in team briefings
- Information is communicated in a structured and standardized manner
- Deviations and risks are communicated in a timely way
- Open and transparent communication is maintained within the team
- Perfusionist participation in team briefings (%)
- Number of incidents related to communication failures
- Outcomes and documented results of team debriefings and case reviews
- Incidents and near-miss events are reported
- Analysis is conducted without assigning blame
- Results of analysis are used to improve practice
- Discussion of risks is a routine and accepted part of clinical work
- Number of reported near-miss events
- Percentage of incidents with completed analysis (%)
- Number of SOPs updated based on incident and near-miss analysis
After completion of the assessment, it is recommended to:
- identify areas of increased risk;
- prioritize improvement actions;
- link corrective measures to SOPs and education programs;
- repeat the assessment after a defined period.
AmSECT Standards & Guidelines for Perfusion Practice https://amsect.org/policy-practice/amsects-standards-and-guidelines SCPS Standards of Practice https://www.scps.org.uk/society/society-documents ELSO Guidelines https://www.elso.org/ecmo-resources/elso-ecmo-guidelines.aspx AmSECT Standards & Guidelines for Perfusion Practice https://amsect.org/policy-practice/amsects-standards-and-guidelines SCPS Standards of Practice https://www.scps.org.uk/society/society-documents Human Factors and Teamwork in Cardiac Surgery https://www.cambridge.org/core/books/cardiopulmonary-bypass/human-factors-and-teamwork-in-cardiac-surgery/ED35DB4A9BBA978132322702B120D6CD Exploring Perfusion Safety: A Review of Clinical and Non-Clinical Factors https://www.researchgate.net/publication/374782348