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POLICY FOR THE USE OF CONSCIOUS SEDATION IN PORTSMOUTH HOSPITALS NHS TRUST
Version / 7Name of responsible (ratifying) committee / Formulary and Medicines Committee
Date ratified / 20 July 2018
Document Manager (job title) / Consultant Anaesthetist, Trust Sedation Lead
Date issued / 16 August 2018
Review date / 15 August 2020
Electronic location / Clinical Policies
Related Procedural Documents / See section 9 of this policy
Key Words (to aid with searching) / Sedation; Conscious sedation; Sedationists; Sedatives; Drug administration; Patient monitoring; Risk management; Training needs; Patients; Medical Staff
Version Tracking
Version / Date Ratified / Brief Summary of Changes / Author7 / 20/07/2018 / Inclusion of updated patient leaflet as an appendix / V Tucker/
D Carapiet
6.1 / 31/10/2016 / Inclusion of patient leaflet as an appendix / -
6 / 20/05/2016 / 1. Introduction updated to include Academy of Royal Colleges document on Safe Sedation for Health Care Practice (2013)1
2. Recommendations in section 6 updated to:
a) Ensure adequate stocks of flumazenil and naloxone are available where benzodiazepines and opiates are stocked
b) Complete a SLER form if flumazenil or naloxone are administered.
c)Recommendation to convene a Trust Sedation Committee / M Wood/
H McHale
5 / 17/01/2014 / Conscious sedation checklist as an appendix (based on WHO checklist)
Pre-procedural Assessment form for procedures involving conscious sedation / V Tucker/
A Bali
CONTENTS
QUICK REFERENCE GUIDE
1.INTRODUCTION
2.PURPOSE
3.SCOPE
4.DEFINITIONS
5.DUTIES AND RESPONSIBILITIES
6.PROCESS
7.TRAINING REQUIREMENTS
8.REFERENCES AND ASSOCIATED DOCUMENTATION
9.EQUALITY IMPACT STATEMENT
10 MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
EQUALITY IMPACT SCREENING TOOL
APPENDIX 1: Patient Information Leaflet
QUICK REFERENCE GUIDE
- Departments carrying out procedures under sedation should be aware of and follow this policy.
- Each department carrying out procedures under sedation should develop their own set of local guidelines in line with Trust and national guidance.
- There should be a named specialty consultant and consultant anaesthetist responsible for the development, implementation and monitoring of the local sedation techniques and guidelines.
- All staff involved in administering sedation should have undergone formal training in use of sedation techniques, identification and management of the complications of those techniques.
- Sedation should be administered by a dedicated, suitably trained member of the team who is different from the clinician performing the procedure.
- Operator sedationists should only be responsible for patients undergoing defined procedures.
- Appropriate levels of monitoring defined by local guidelines should be available for all cases.
- Functioning resuscitation equipment and tilting trolleys should be available in all treatment and recovery areas wherever sedation techniques are used.
- The WHO checklist should be used in all cases where procedures are carried out.
- A Trust sedation committee has been established, which will meet biannually and be responsible for reviewing policies and protocols related to conscious sedation, audit, review of any critical incidents and dissemination of any learning events
1.INTRODUCTION
Several bodies have published guidelines for the provision of sedation services. Concerns have been raised both nationally and locally, in the light of large national studies and local adverse incident reports, about the safety of current practice that sometimes ignores guidelines and recommendations. More recent recommendations made in NCEPOD (Scoping our Practice, 2004) report on endoscopy and the updated Academy of Royal Colleges document on Safe Sedation for Health Care Practice (2013)1 make explicit recommendations about training in sedation techniques among specialties using sedation and the introduction of Trust Sedation Committees.
This policy, an update of an original produced in 2002, describes how Portsmouth Hospitals NHS Trust (PHT) will ensure the implementation of safe sedation practice in all clinical areas.
The latest version of this policy reflects the recent adoption of the WHO checklist (January 2009)2and recent Rapid Response Reports from the National Patient Safety Agency regarding high concentration preparations of Midazolam3.
2.PURPOSE
This policy has been written in response to Trust Risk Management Review systems and Anaesthetic Morbidity and Mortality (M&M) meeting. These systems along with department Risk Management Review systems will be used to monitor outcomes.
The purpose of the document is to set out the responsibilities of departments who carry our procedures under sedation to ensure maximum patient safety undergoing such procedures.
3.SCOPE
This policy applies to all Portsmouth Hospitals NHS Trust departments and their staff using sedation techniques.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’
4.DEFINITIONS
Conscious sedation
A technique in which the use of a drug or drugs produces a state of depression of the central nervous system enabling treatment to be carried out, but during which verbal contact with the patient is maintained throughout the period of sedation.
Deep sedation
A more profound depression of the central nervous system such that the patient is no longer able to maintain verbal contact and may not be able to protect their airway.
General Anaesthesia
A temporary state of depression of the central nervous system, during which the subject is unaware and unable to respond to their external environment, is unable to protect their airway and may exhibit profound depression of the cardiac and respiratory systems.
Operator
A practitioner responsible for carrying out a diagnostic or therapeutic procedure
The Sedation Team
A minimum of a three person team. The operator is responsible for the carrying out of the procedure, with the operators assistant. Another designated person will be responsible for monitoring the patient. This person may administer drugs, if iv competent, on behalf of the operator.
Operator Sedationist
Someone performing a diagnostic or therapeutic procedure whilst administering a sedation
technique
Sedation techniques
Sedative drugs can be administered by inhalation, enteral (oral and sublingual) and parenteral (intra-muscular and intravenous) routes. Benzodiazepines (midazolam, diazepam), intravenous anaesthetics (propofol, ketamine) and opioids (fentanyl or pethidine) are the commonly used agents.
SLE form
Safety learning and event report form
5.DUTIES AND RESPONSIBILITIES
Elements of the process may be delegated to a suitably trained and qualified professional but the ultimate responsibility for the quality of medical care lies with the Consultant responsible for the patients.
Each department performing procedures requiring a sedation service should nominate a consultant with explicit responsibility for establishing department guidelines for sedation. A consultant anaesthetist will also be nominated to assist in this process.
The Trust Sedation Committee will comprise these clinical leads as well as representatives from anaesthetics and pharmacy. The committee will meet twice a year and will be responsible for issues such as assessment, training, drug regimens, monitoring required, discharge criteria, monitoring of standards and complications as well as operational implications.
The Trust will ensure provision of appropriate training opportunities in sedation practice to all professionals involved.
The author of the policy has responsibility and authority to audit compliance with the Policy among all departments.
6.PROCESS
ACTION / RATIONALE / EVIDENCE / Potential Risks/HarmsAssessment of all patients should take place before any sedation technique is contemplated. / Establish need for sedation.
Identify:
- risk factors
- need for further investigations
- contra-indications or technical difficulties of particular sedation technique.
- provide information to patient.
Increased risk of complications of sedation techniques
Inadequate consent acquired with risk of litigation
Appropriate sedation techniques should be used / Some procedures are painful. Most sedative drugs do not have analgesic properties and analgesics would be more appropriate / Overdose of sedative drugs to overcome response to painful stimulus causing cardio-respiratory depression
Operator-sedationists should only be responsible for patients undergoing defined procedures in exceptional circumstances as agreed by the sedation committee / Operators responsible for the safe performance of a procedure cannot administer, monitor or treat the complications of sedation in a timely manner / Delayed recognition and treatment of complications of sedation by a distracted operator may result in cardiopulmonary decompensation hypoxic injury and death
Generally only one sedative drug should be used according to agreed protocols defining increments and maximum doses. / The synergy of different types of drug significantly reduce the margin of safety between conscious sedation and general anaesthesia / The state of anaesthesia carries risk of death and require greater levels of support and intervention
Sedative and opioid analgesic drugs should be stored and handled in line with Trust Policy on Controlled Drugs / Most of the drugs used in sedation techniques are controlled and there are legal restrictions on their use and storage / Controlled Drugs Policy / Failure to comply with the Policy puts the Trust at risk of prosecution under the Misuse of Drugs Act, 1971
Only low (1mg/ml) concentration solutions of midazolam used / High concentration solutions of Midazolam are reported by NPSA to have lead to inadvertent overdose with attendant complications. / Reference3 / Overdose of Midazolam can cause complications including respiratory depression and death.
Ensure adequate stocks of flumazenil and naloxone are available where benzodiazepine sedatives and opiates are used. / To ensure that if an inadvertent overdose is administered it can be treated appropriately. / Reference 3 / Overdose of Midazolam can cause complications including respiratory depression and death.
Complete a SLE form if flumazenil or naloxone are given to manage over sedation / To ensure incidents are investigated and learnt from to minimize the risk of them occurring again in the future / A trust wide problem of inappropriate prescribing may go unnoticed without incident reporting
Each department should have a Sedation Lead who works with a named Consultant Anaesthetist / The two clinicians should develop appropriate sedation regimens and ensure training for all members of the team providing sedation / Reference 4,5 / Lack of appropriate safe sedation regimens for the procedures carried out in the department that all staff are familiar with.
Inadequate training of staff in administration of sedation and management of the complications
Trusts should convene Trust Sedation Committee / The committee should act as a forum for national, local and departmental best practice, should set local standards and policies, audit practice and review any significant learning events / Reference 5 / Failure to implement best practice will put patients at risk and deprive them of benefits of new techniques and safety standards
Sedationists should have formal training in sedation and should only use defined techniques that they have received training in. / Familiarity with a technique optimizes safety. / Reference4 / Increased risk of complications, failure to recognise complications and inadequate treatment of them puts patients at risk. Clinicians failing in their professional responsibilities and makes Trust vulnerable to litigation
Use of a Conscious Sedation check list adapted from the WHO Checklist / Because the use of sedation can obtund patients response the use of the WHO Checklist can contribute to ensuring that the correct procedure on the correct site is carried out and the team is made aware of any patient specific concerns. / Reference2 / Reduced risk of incorrect procedure being performed and improved patient safety
The levels of monitoring equipment should be defined according to agreed guidelines. / Appropriate levels of monitoring are needed for different patients with varying levels of dependency. / Reference5 / Risk of failure to recognise complications of sedation technique.
Functioning resuscitation equipment and tilting trolleys should be available in treatment and recovery areas whenever sedation techniques are used. / Resuscitation may be required at any time during or after a sedative technique is used. / Inadequate treatment of complications of sedation cause worse outcomes.
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7.TRAINING REQUIREMENTS
All members of the team involved providing sedation need to have knowledge of sedation techniques and be aware of their role in the event of serious complications. Those members of the team who are sedationists need further training in the provision, monitoring and treatment of the complications of conscious sedation.
What will that training comprise?
- Background to local and national regulations
- Assessment of patients
- Cardio-respiratory and neurological physiology
- Clinical pharmacology
- Applied Anatomy
- Cannulation skills
- Airway management skills
- Function and limitations of monitoring equipment
- Basic and advanced life support
OUTCOMES OF TRAINING
Teams working within the Trust offering a sedation service should be able to:
- State the indications and contra-indications for the use of sedation techniques and methods of assessment of patients
- Describe the sedation techniques provided by the service
- Define the number of staff and their skills, present during procedures carried out under conscious sedation
- Ensure staff administering the sedation techniques are appropriately and adequately trained and describe how they will maintain their skills
- Ensure systems are in place for monitoring of patients, record keeping, monitoring of the outcomes of the use of sedation and demonstrate that local and national guidelines are being followed
Who will deliver it?
Recognised ‘trainers’ within the Trust
Who will ensure those that need to have it have it?
The nominated clinician within each department will be responsible
8.REFERENCES AND ASSOCIATED DOCUMENTATION
- Academy of Medical Royal Colleges - Safe Sedation Practice for Healthcare Procedures: Standards and Guidelines. October 2013
- WHO Surgical Safety Checklist. NPSA January 2009.
3.Rapid Response Report RRR011.-Reducing the risk of overdose with Midazolam injection in adults. NPSA December 2008.
4.UK Academy of Medical Royal Colleges and their Faculties-Implementing and ensuring Safe Sedation Practice for healthcare procedures in adults-2002
5.Association of Anaesthetists of Great Britain and Ireland Recommendations for Standards of Monitoring during Anaesthesia and Recovery. 4th Edition 2007
9.EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
Our valuesare the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace.
Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do.
We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust:
Working together for patients
Working together with compassion
Working together as one team
Working together always improving
This policy should be read and implemented with the Trust Values in mind at all times
Policy for the use of Conscious Sedation
Version: 7
Issue Date: 16 August 2018
Review Date: 15 August 2020(unless requirements change)Page 1 of 14
10 MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
The compliance with this policy will be responsibility of theclinical leads and the sedation committee in liaison with the Clinical Director of the specialty area.
Monitoring of compliance will be the responsibility of the author of the policy and will involve site visits and observational audits which will occur annually. The key indicators of compliance (see table below) will include:
- Identity of named clinician and anaesthetist responsible for the department guidelines for sedation.
- Evidence of completed training by staff involved in the provision of sedation.
- Evidence of collection of adverse incident reports and discussion at mortality and morbidity meetings.
- Documentary evidence of outcomes including patient satisfaction.
- Review of staffing levels and equipment
Minimum requirement to be monitored / Lead / Tool / Frequency of Report of Compliance / Reporting arrangements / Lead(s) for acting on Recommendations
Identity of named clinician and anaesthetist responsible for the department guidelines for sedation. / Department Sedation Lead / Self reporting tool / Annual / Policy audit report to:
Trust Sedation Committee
Trust Clinical Governance Group / Department Clinical Director
Evidence of completed training by staff involved in the provision of sedation. / Department Sedation Lead / Self reporting tool / Biannual / Policy audit report to:
Trust Sedation Committee
Trust Clinical Governance Group / Department Clinical Director
Evidence of collection of adverse incident reports and discussion at mortality and morbidity meetings. / Department Sedation Lead / Self reporting tool / Monthly / Policy audit report to:
Trust Sedation Committee
Trust Clinical Governance Group / Department Clinical Director
Documentary evidence of outcomes including patient satisfaction. / Department Sedation Lead / Patient satisfaction survey / Annual / Policy audit report to:
Trust Sedation Committee
Trust Clinical Governance Group / Department Clinical Director
Review of staffing levels and equipment / Departmental sedation lead / Self reporting tool / Annual / Policy audit report to:
Trust Sedation Committee
Trust Clinical Governance Group / Department Clinical Director
Reporting of these results will be to theTrust Sedation Committee and the Trust Governance Committee.
In the event of a major flu epidemic or major incident compliance with this policy may be difficult or impossible and will require a risk assessment of the ability to provide safe sedation for procedures carried out by the department.
Policy for the use of Conscious Sedation
Version: 7
Issue Date: 16 August 2018
Review Date: 15 August 2020(unless requirements change)Page 1 of 14