Consent

Obtaining consent for procedures is a legal and ethical requirement and an accepted part of good medical practice. Excluding medical emergencies, patients must be provided with adequate information about a procedure to enable them to make informed decisions. This includes the benefits, possible adverse effects or complications, alternatives and the likely result if the procedure is not performed.

For a patient’s consent to be valid all of the following criteria must be met:

The person must have the capacity to give consent

Adequate information must be provided

The patient must be informed in a way the patient can understand

Consent must be freely given

Consent must be specific to the procedure

Capacity

Capacity to provide consent means the patient can comprehend and consider the information in order to reach a decision. Some patients will have the capacity to make some, but not all, decisions concerning their care.

Common reasons a patient may lack capacity include:

Temporary factors such as the patient’s medical condition (e.g. intoxication, reduced level of consciousness)

Intellectual impairment, dementia, or brain damage

Mental illness currently impairing decision making

Children (generally aged 14 or less)

An adult patient with capacity is entitled to decline a medical procedure. Treating a competent patient who has declined treatment could constitute assault.

Outside of emergency situations, if a person is incapable of giving consent, the consent of the patient’s ‘person responsible’ will be required. The person responsible for a patient will often be the patient’s spouse or de facto, a parent, guardian, guardianship board or local authority.

Medical emergencies

In an emergency, where the patient is unable to give consent, a procedure may be carried out immediately if it is required to:

Save the person’s life

Prevent serious injury, or

Prevent the patient from suffering significant pain and distress

We often perform procedures on seriously ill or injured patients under these circumstances (e.g. chest drains insertion in an unconscious trauma patient). Brief verbal discussion of the procedure with the patient is always recommended if the situation allows.

Example: when intubating a conscious patient for severe respiratory failure, it would be reasonable and sufficient to inform the patient: ‘We are going to give you an anaesthetic, take control of your breathing and look after you in the intensive care unit. It is the best way to treat you. We do this regularly and will take good care of you’.

Documenting consent

Consent is a process (not a signature) which may be provided orally or implied by body language.

Australian law does not require consent in writing. However, obtained consent in writing may assist practitioners provide a comprehensive discussion of procedural risks and benefits with the patient. This may also be useful if reviewed later, supporting the view that treatment had been discussed with the patient and that valid consent has been obtained.

We suggest written consent using a state prescribed consent form for major procedures especially those including intravenous sedation and procedures with significant risks. State legislation varies and may mandate additional requirements for consent depending on your region of practice. If you have discussed consent with a patient, this process should also be document in the medical notes.

The consent levels used in this guide are as follows.

Medical emergency

Consent is not required if the patient lacks capacity or is unable to consent

Brief verbal discussion is recommended if the situation allows

Verbal consent

Less complex non-emergency procedures with low risks of complications

Written consent

More complex non-emergency procedures with higher risks of complications

Pre-prepared material (translated where relevant) about a procedure or treatment may be useful as a means of stimulating discussion and for guiding the clinician when informing the patient. Interpreters should be used for any non-English speaking patients, or for those who request it

Advance care directives

A medical practitioner can assume a signed advance care directive will have been made by a competent patient to be used when they are not competent and should comply with that advanced care directive provided it applies to the current situation.

A medical practitioner should not provide futile treatment or perform a procedure where there is a valid direction by the patient that such treatment is not to be provided in any circumstances.

Minors

Children cannot refuse life-saving or health-saving treatment until they are 18 years or older. The protective powers of the state override a minor’s refusal of life-saving treatment. This is in contrasts to adults (18 years and over) who can decline life-saving treatment, even if this results in their death.

Such treatment of children may be provided without the consent of the parent or guardian.

Excluding life-saving or health-saving treatment, children are given autonomy based on their level of maturity. A competent child (usually aged 14 and above) may consent to their own treatment. However, it is prudent for practitioners or hospitals to also obtain the consent of the parent or guardian, unless the patient objects. Non-emergency treatment of children who are not competent to consent requires the consent of the parent or guardian.

Cultural diversity and vulnerable groups

Within a culturally diverse population the delivery of care requires communication and a patient centred approach. Respectful consideration must be given to ensure cultural practices, social circumstances, patient age, mental health, cognitive ability and disability factors are incorporated into the patient’s journey.  Vulnerability in our patients requires a trauma informed care approach and where possible every effort should be made to reduce the perceived experience of trauma by our patients.

References

Australian Law Reform Commission. Equity, capacity and disability in Commonwealth laws: Final report. Canberra: Commonwealth of Australia; 2014 Aug. 324 p. ALRC Report 124. Available from: https://www.alrc.gov.au/publication/equality-capacity-and-disability-in-commonwealth-laws-alrc-report-124/

NSW Ministry of Health. Consent to medical and healthcare treatment manual. Sydney: Government of NSW; 2020. Available from: https://www.health.nsw.gov.au/policies/manuals/Pages/consent-manual.aspx

NSW Ministry of Health. Clinical Procedure Safety. Sydney: Government of NSW; 2017 Sept. Policy directive: PD2017_032. Available from: https://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=PD2017_032

Test

Infection Control

We universally apply measures to prevent infection to the patient and proceduralist. These measures are named standard precautions. If we do not apply standard precautions, we are providing substandard infection prevention to both parties.

The components of standard precautions are:

Hand hygiene

Respiratory hygiene and cough etiquette

Personal protective equipment

Aseptic non-touch technique

Environmental cleaning

Safe handling and disposal of sharps

Reprocessing of reusable medical equipment and instruments

Waste management and appropriate handling of linen

Procedures should be undertaken in a clean area. All exposed surfaced of hands and wrists should be cleaned with 60-80% ethanol or washed with soap and water if visibly soiled. The nose or mouth should be covered when coughing or sneezing and hands then washed. Intact patient skin should be prepared with 70% isopropyl alcohol with at least 0.5% chlorhexidine (or locally recommended antimicrobial) and all wounds should be irrigated with running tap water (aseptic but not sterile) or sterile saline. Waste products disposed of appropriately with the procedural clinician responsible for the safe use and disposal of all sharps.

The procedural clinician also requires an understanding of the principles of aseptic non-touch technique and personal protective equipment. These must be tailored to each procedure by the clinician.

Aseptic non-touch technique

Asepsis means ‘freedom from infectious material’

Aseptic technique aims to prevent pathogenic organisms, in enough quantity to cause infection, from being introduced to susceptible sites. Aseptic does not mean sterile.

Sterile conditions, meaning ‘free from micro-organisms’

Sterile conditions are not possible to achieve in a typical healthcare setting. The commonly used term, ‘sterile technique’ is therefore inaccurate.

We perform invasive procedures (crossing epithelium) using aseptic non-touch technique. We prevent contamination of aseptic sites or wounds (“key sites”) and aseptic procedure equipment that must remain aseptic throughout the procedure (“key parts”). Key parts and key sites may contact each other during the procedure but should not touch anything else (“non-touch”).

If key parts must be touched by hand, the proceduralist’s hands are also treated as a key part. Hand hygiene is increased to mechanical and antimicrobial cleaning (e.g. surgical scrub with running water) and sterile gloves are worn.

If a working field is required this must also be managed as a key part, with an aseptic field created with wide skin preparation and sterile drapes.

If contact between the proceduralist’s body and the aseptic field is possible the proceduralists body must also be treated as a key part and sterile gown is also required

Examples:

Simple procedures

A clean area and non-sterile gloves are sufficient for these procedures.

All key parts are sterile and can be used on key sites without needing to be touched.

Example: a venepuncture or cannulation

A sterile venepuncture needle is housed in a sterile sheath.

It is used on aseptically prepared skin without touching the skin or needle.

Complex procedures

Complex procedures have multiple key parts which must be touched by hand (requiring sterile gloves), the working field is large (requiring sterile drapes) and contact between the proceduralist’s body and the working field is possible during the procedure (requiring a sterile gown).

Example: obtaining central venous access

The cannulating needle, wire, dilator, catheter and other key parts must be touched by hand (sterile gloves are required), the field is large and will be used to rest key parts during the procedure (a sterile field is required), the proceduralist works within the field and cannot avoid touching it (a sterile gown is required).

Variations in practise

Aseptic field size may vary depending on the proficiency of the provider performing the procedure. Highly skilled practitioners require less working space and margin for error and require smaller aseptic fields.

We suggest providers apply these principles independently to each procedure.

Personal protective equipment

Personal protective equipment (PPE) refers to barriers used to protect mucous membranes, airways, skin and clothing from contact with infectious agents to protect the proceduralist and patient.

For each procedure we list recommended PPE given below:

Protecting the proceduralist

Non-sterile gloves: always required due to risk of exposure to infectious material and body substances

Aprons: if increased risk of contamination of clothing with infectious material or body substances

Surgical mask: required for procedures that generate splashes or sprays

Protective eyewear or shield: required for procedures that generate splashes or sprays

P2 respirator mask: required for procedures that may aerosolise particles of infectious material

Protecting the patient

Sterile gloves: required for aseptic non-touch technique requiring hand contact with sterile parts or sites

Sterile surgical gown: required for aseptic non-touch technique if body contact with sterile parts or sites is possible

Surgical mask: required if the proceduralist respiratory droplets might enter the aseptic field

Sterile ultrasound cover and gel: if probe contact with sterile parts or sites is possible during asepsis

Simple procedures can be completed with non-sterile gloves alone (e.g. venepuncture and cannulation) while maintaining the same high standard of infection prevention (standard precautions with aseptic non-touch technique), as complex procedures that require increased higher levels of personal protective equipment.

Transmission-based precautions

We employ extra work practices if there is increased risk of specific infections:

Contact precautions

Infection transmission by touch or via contact with blood or body substances

e.g. COVID-19, multi-resistant organisms, Clostridium Difficile, Norovirus and skin infections (e.g. impetigo)

Single room or cohort

Gloves & gown

Surgical mask if agent isolated in sputum

Single use equipment or reprocess before reuse on next patient

Visitors use same precautions as staff

Droplet precautions

Infectious particles > 5 microns in size transmitted to susceptible mucosal surfaces < 1m away

e.g. COVID-19, influenza virus and meningococcus.

Single room or cohort

Surgical mask

Single use equipment or reprocess before reuse on next patient

Visitors use same precautions as staff, restrict numbers

Airborne precautions

Infectious particles that remain infective over time and distance and are inhaled.

They may be created by suction, intubation and non-invasive ventilation

e.g. COVID-19 (if aerosolising procedures are performed), Measles (Rubeola) virus, Chickenpox (Varicella), Mycobacterium tuberculosis

Single room or cohort

Negative pressure

P2 (N95) respirator

Single use equipment or reprocess before reuse on next patient

Restrict visitor numbers with precautions as for staff

Time-critical procedures

For time-critical emergency procedures (e.g. needle thoracostomy, thoracotomy in cardiac arrest from penetrating chest trauma, surgical cricothyroidotomy) the increased risk to the patient from infection using non-aseptic technique may be insignificant compared to the risk of delaying the procedure for even a few seconds. In these rare situations, skin cleaning and the preparation of sterile fields can be avoided if it will cause any time delay.

The risks of sharps injuries and exposure to body fluids to the proceduralist increases in such high-pressure situations. The importance of personal protective equipment and safe use and disposal of sharps increases and should not be omitted.

References

National Health and Medical Research Council. Australian guidelines for the prevention and control of infection in healthcare. Canberra: NHMRC; 2010. Available from:https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2010

National Health and Medical Research Council. Australian guidelines for the prevention and control of infection in healthcare (2019). Canberra: NHMRC; 2019. https://nhmrc.govcms.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019

Aseptic Non-Touch Technique (ANNT)[Internet]. The Association for Safe Aseptic Practice; 2019. Available from: http://www.antt.org

Terminology

This section outlines the inclusions, exclusions, rationale and general practice principles underlying each section within each procedure guide.  Not all procedure guides include all sections and some procedures have additional sections.

Procedure title

We deem a procedure includes any situation in which there is a potential for contact between the skin of the healthcare worker and the patient’s tissues, body cavities or organs, either directly or via surgical instruments or therapeutic devices.

Indications

Indications occurring in emergency practice at least occasionally are listed

Indications occurring outside the emergency department are not listed

More common indications are listed higher up

Contraindications

Absolute contraindications are highlighted in bold

Contraindications we consider more significant are listed higher up

Alternatives

Alternatives to the proposed procedure we recommend should be considered and discussed with the patient.

The risks and benefits of the alternatives should be balanced against those of the procedure.

Consent

We describe how consent should be recorded for the procedure.

We have separated the principles of consent into a separate overview document applicable for all procedures. Providers should have a clear understanding of these key concepts and apply them independently for each procedure.

Complications

We list possible complications of a competently performed procedure listed chronologically.

These complications should be discussed with the patient during a non-emergency consent process.

Adverse events which should not occur and might be considered clinical negligence are not listed.

Procedural hygiene

For each procedure, we list a level of recommended procedural hygiene as follows:

Standard precautions

Aseptic non-touch technique (for invasive procedures)

Recommended personal protective equipment (listed)

We do not explain each step (e.g. cleaning the skin) or list specific pieces of equipment (e.g. drape) required to achieve the recommended level of hygiene

We have separated the principles of procedural hygiene into a separate overview documents applicable for all procedures. Providers should have a clear understanding of these key concepts and apply them independently for each procedure.

Procedure

We describe the procedure in six sections:

Area: suitable areas to perform the procedure

Staff: proceduralist and additional staff required

Equipment: listed in order of use

Medications: listed as dose per kilo titrated to endpoint

Positioning: non-medical terminology

Sequence: stepwise tasks to complete procedure

If continuous cardiac monitoring is required, this is mentioned in the area section

Post-procedure care

Post-procedure care is detailed in four areas. We detail the following where required:

Observation and monitoring

Ongoing care

Patient advice including pain relief

Documentation completion of procedure, complications, procedure specific aspects

Tips

We list practical evidence-based or expert consensus advice

Discussion

Our rationale and key evidence in debatable or contentious areas are explained

Peer Review

This section outlines the expert groups that were involved in the development and endorsement of the clinical information.  Additionally, an email address is given in order to provide feedback, ACI-ECIs@health.nsw.gov.au

References

We have followed a consistent search strategy throughout the production of this guide.  References may disagree with each other on minor or important issues. We list the references in order of preference for each guide.  A full explanation of search methodology can be made available on request.