Conscious Sedation Policy - Portsmouth Hospitals NHS Trust

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POLICY FOR THE USE OF CONSCIOUS SEDATION IN PORTSMOUTH HOSPITALS NHS TRUST



|Version |5 | |Name of responsible (ratifying) |Formulary and Medicines Group | |committee | | |Date ratified |17th January 2014 | |Document Manager (job title) |Matthew Wood. Consultant Anaesthetist | |Date issued |31st January 2014 | |Review date |January 2016 | |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 |Brief Summary of Changes |Author | | |Ratified | | | |4 |14th |The WHO checklist to be used in all |Matthew Wood | | |January |cases undergoing sedation | | | |2014 |Monitoring of processes, training, | | | | |complications and patient satisfaction | | | | |to be carried out by department sedation| | | | |leads | | | | |Transferred into new Trust template | |

CONTENTS

QUICK REFERENCE GUIDE 3



1. INTRODUCTION 4 2. PURPOSE 4 3. SCOPE 4 4. DEFINITIONS 4 5. DUTIES AND RESPONSIBILITIES 5 6. PROCESS 5 7. TRAINING REQUIREMENTS 7 8. REFERENCES AND ASSOCIATED DOCUMENTATION 8 9. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF PROCEDURAL DOCUMENTS 9



QUICK REFERENCE GUIDE

1. Departments carrying out procedures under sedation should be aware of and follow this policy.

2. Each department carrying out procedures under sedation should develop their own set of local guidelines in line with Trust and national guidance.

3. There should be a named specialty consultant and consultant anaesthetist responsible for the development, implementation and monitoring of the local sedation techniques and guidelines.

4. 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.

5. Sedation should be administered by a dedicated, suitably trained member of the team who is different from the clinician performing the procedure.

6. Operator sedationists should only be responsible for patients undergoing defined procedures.

7. Appropriate levels of monitoring defined by local guidelines should be available for all cases.

8. Functioning resuscitation equipment and tilting trolleys should be available in all treatment and recovery areas wherever sedation techniques are used.

9. The WHO checklist should be used in all cases where procedures are carried out.







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 made explicit recommendations about training in sedation techniques. 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)[1] and recent Rapid Response Reports from the National Patient Safety Agency regarding high concentration preparations of Midazolam[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.

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’

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

Operator Sedationist

Someone performing a diagnostic or therapeutic procedure while administering a sedation technique on a patient.

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.

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 nominated clinicians should liaise to discuss common 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.

PROCESS



|ACTION |RATIONALE |EVIDENCE |Potential | | | | |Risks/Harms | |Assessment of all|Establish need for |Reference4|Unnecessary use of | |patients should |sedation. | |sedation. | |take place before|Identify: | |Increased risk of | |any sedation |risk factors | |complications of | |technique is |need for further | |sedation techniques | |contemplated. |investigations | |Inadequate consent | | |contra-indications or | |acquired with risk | | |technical difficulties of | |of litigation | | |particular sedation | | | | |technique. | | | | |Provide information to | | | | |patient. | | | | |Some procedures are | |Overdose of sedative| |Appropriate |painful. Most sedative | |drugs to overcome | |sedation |drugs do not have | |response to painful | |techniques should|analgesic properties and | |stimulus causing | |be used |analgesics would be more | |cardio-respiratory | | |appropriate | |depression | |Operator-sedation|Operators responsible for | |Delayed recognition | |ists should only |the safe performance of a | |and treatment of | |be responsible |procedure cannot | |complications of | |for patients |administer, monitor or | |sedation by a | |undergoing |treat the complications of| |distracted operator | |defined |sedation in a timely | |may result in | |procedures |manner | |cardiopulmonary | | | | |decompensation | | | | |hypoxic injury and | | | | |death | |Generally only |The synergy of different | |The state of | |one sedative drug|types of drug | |anaesthesia carries | |should be used |significantly reduce the | |risk of death and | |according agreed |margin of safety between | |require greater | |protocols |conscious sedation and | |levels of support | |defining |general anaesthesia | |and intervention | |increments and | | | | |maximum doses. | | | | |Sedative and |Most of the drugs used in |Controlled|Failure to comply | |opioid analgesic |sedation techniques are |Drugs |with the Policy puts| |drugs should be |controlled and there are |Policy |the Trust at risk of| |stored and |legal restrictions on | |prosecution under | |handled in line |their use and storage | |the Misuse of Drugs | |with Trust Policy| | |Act, 1971 | |on Controlled | | | | |Drugs | | | | |Correct low |High concentration |Reference2|Overdose of | |concentration |solutions of Midazolam are| |Midazolam can cause | |solutions of |reported by NPSA to have | |complications | |midazolam used |lead to inadvertent | |including | | |overdose with attendant | |respiratory | | |complications. | |depression and | | | | |death. | |Each Department |The two clinicians should |Reference |Lack of appropriate | |should have a |develop appropriate |4,5 |safe sedation | |Sedation Lead who|sedation regimens and | |regimens for the | |works with a |ensure training for all | |procedures carried | |named Consultant |members of the team | |out in the | |Anaesthetist |providing sedation | |department that all | | | | |staff are familiar | | | | |with. | | | | |Inadequate training | | | | |of staff in | | | | |administration of | | | | |sedation and | | | | |management of the | | | | |complications | |Sedationists |Familiarity with a |Reference4|Increased risk of | |should have |technique optimizes | |complications, | |formal training |safety. | |failure to recognise| |in sedation and | | |complications and | |should only use | | |inadequate treatment| |defined | | |of them puts | |techniques that | | |patients at risk. | |they have | | |Clinicians failing | |received training| | |in their | |in. | | |professional | | | | |responsibilities and| | | | |makes Trust | | | | |vulnerable to | | | | |litigation | |Use of WHO |Because of the use of |Reference1|Reduced risk of | |Checklist |sedation can obtund | |incorrect procedure | | |patients response the use | |being performed and | | |of the WHO Checklist can | |improved patient | | |contribute to ensuring | |safety | | |that the correct procedure| | | | |on the correct site is | | | | |carried out and the team | | | | |is made aware of any | | | | |patient specific concerns.| | | |The levels of |Appropriate levels of |Reference3|Risk of failure to | |monitoring |monitoring are needed for | |recognise | |equipment should |different patients with | |complications of | |be defined |varying levels of | |sedation technique. | |according to |dependency. | | | |agreed | | | | |guidelines. | | | | |Functioning |Resuscitation may be | |Inadequate treatment| |resuscitation |required at any time | |of complications of | |equipment, |during or after a sedative| |sedation cause worse| |tilting trolleys |technique is used. | |outcomes. | |should be | | | | |available in | | | | |treatment and | | | | |recovery areas | | | | |whenever sedation| | | | |techniques are | | | | |used. | | | |

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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:

i. State the indications and contra-indications for the use of sedation techniques and methods of assessment of patients ii. Describe the sedation techniques provided by the service iii. Define the number of staff and their skills, present during procedures carried out under conscious sedation iv. Ensure staff administering the sedation techniques are appropriately and adequately trained and describe how they will maintain their skills v. 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





REFERENCES AND ASSOCIATED DOCUMENTATION

1. WHO Surgical Safety Checklist. NPSA January 2009. 2. Rapid Response Report RRR011.-Reducing the risk of overdose with Midazolam injection in adults. NPSA December 2008. 3. Association of Anaesthetists of Great Britain and Ireland Recommendations for Standards of Monitoring during Anaesthesia and Recovery. 4th Edition 2007 4. UK Academy of Medical Royal Colleges and their Faculties- Implementing and ensuring Safe Sedation Practice for healthcare procedures in adults-2002 5. Academy of Medical Royal Colleges - Safe Sedation Practice for Healthcare Procedures: Standards and Guidelines. October 2013

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 values are 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:

Respect and dignity Quality of care Working together No waste

This policy should be read and implemented with the Trust Values in mind at all times.























MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS

|Minimum requirement|Lead |Tool |Frequency of |Reporting arrangements |Lead(s) for acting on | |to be monitored | | |Report of | |Recommendations | | | | |Compliance | | | |Evidence of |Department|Self reporting |Biannual |Policy audit report to: |Department Clinical | |completed training |Sedation |tool | |Trust Sedation Lead |Director | |by staff involved |Lead | | |Trust Clinical Governance| | |in the provision of| | | |Group | | |sedation. | | | | | | |Evidence of |Department|Self reporting |Monthly |Policy audit report to: |Department Clinical | |collection of |Sedation |tool | |• Trust Sedation Lead |Director | |adverse incident |Lead | | |• Trust Clinical | | |reports and | | | |Governance Group | | |discussion at | | | | | | |mortality and | | | | | | |morbidity meetings.| | | | | | |Documentary |Department|Patient |Annual |Policy audit report to: |Department Clinical | |evidence of |Sedation |satisfaction | |• Trust Sedation Lead |Director | |outcomes including |Lead |survey | |• Trust Clinical | | |patient | | | |Governance Group | | |satisfaction. | | | | | |

The compliance with this policy will be responsibility of 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.

Reporting of these results will be to 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. ----------------------- [1] WHO Surgical Safety Checklist. NPSA January 2009. [2] Rapid Response Report RRR011.-Reducing the risk of overdose with Midazolam injection in adults. NPSA December 2008.

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