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{{org_field_name}}

Registration Number: {{org_field_registration_no}}

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Aseptic Technique Policy

1. Purpose

The purpose of this policy is to ensure that all procedures requiring an aseptic technique at {{org_field_name}} are undertaken safely, consistently and by staff who have the appropriate knowledge, skills, competence and authority to perform them. The aim is to prevent the introduction or transfer of microorganisms to susceptible body sites and to minimise the risk of healthcare-associated infection.

{{org_field_name}} will ensure that aseptic procedures are undertaken in accordance with:

• the Regulation and Inspection of Social Care (Wales) Act 2016;
• the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, as amended, particularly the requirements relating to standards of care and support, staffing, staff training and competence, hygiene and infection control, health and safety, medicines and records;
• statutory guidance issued by the Welsh Ministers for service providers and responsible individuals;
• current national infection prevention and control guidance adopted or endorsed for use in Wales;
• relevant Public Health Wales guidance;
• relevant professional standards and codes of practice; and
• manufacturers’ instructions for equipment, devices and products used.

Aseptic technique will be used whenever indicated by the nature of the procedure, the individual’s assessed needs, the individual’s personal plan, current clinical instructions or relevant national or professional guidance.

This policy supports the service in protecting, promoting and maintaining the safety and well-being of individuals and in providing care and support with sufficient care, competence and skill.

2. Scope

This policy applies to all staff at {{org_field_name}} who undertake, assist with, supervise, delegate, assess competency for, manage or audit a procedure requiring aseptic technique.

A staff member must not undertake an aseptic or invasive clinical procedure unless:

• the procedure falls within their role and agreed scope of practice;
• they have received appropriate training for the specific procedure;
• their practical competence has been assessed and documented;
• their competence remains current;
• any required delegation or authorisation has been provided by an appropriately registered healthcare professional;
• they understand the individual’s personal plan, relevant risk assessments and current clinical instructions; and
• they have access to the equipment and support necessary to undertake the procedure safely.

Where a healthcare activity has been delegated by a registered healthcare professional, the activity must be undertaken strictly within the terms of that delegation and in accordance with current national guidance and applicable professional standards. Staff must not accept or undertake a delegated activity where they do not have the necessary knowledge, skill or competence.

This policy applies to procedures requiring aseptic technique including, where clinically indicated, wound care, management of urinary catheters, enteral feeding tube or PEG site care, administration of injectable medicines, management of other invasive devices and any procedure where a susceptible body site or critical equipment could be contaminated.

Where there is uncertainty about whether a procedure requires an aseptic technique, or about whether a member of staff is authorised and competent to undertake it, advice must be obtained from an appropriately registered healthcare professional before the procedure proceeds, unless immediate action is necessary to respond to a clinical emergency within the staff member’s competence.

3. Related Policies

This policy should be read in conjunction with:
CHW11 – Safe Care and Treatment Policy
CHW17 – Infection Prevention and Control Policy
CHW18 – Risk Management and Assessment Policy
CHW21 – Medication Management and Administration Policy
CHW24 – Management of Accidents, Incidents, and Near Misses Policy
CHW40 – Assisting with Personal Care Policy

4. Policy Statement and Definitions

Aseptic technique is a set of practices used to protect susceptible body sites and critical parts of equipment from contamination by microorganisms during clinical procedures.

The aim of aseptic technique is asepsis: preventing harmful microorganisms from being introduced into a susceptible site during a procedure. It does not mean that the whole environment must be sterile.

For the purposes of this policy:

Aseptic Non-Touch Technique (ANTT) means an aseptic practice framework in which identified Key-Parts and Key-Sites are protected from contamination, principally by ensuring that they are not touched directly or indirectly.

Key-Parts are the critical parts of equipment which, if contaminated, could transfer microorganisms to the individual or to another Key-Part or Key-Site. Examples may include syringe tips, needle hubs, sterile dressing contact surfaces, catheter connection points and other critical device components.

Key-Sites are susceptible body sites or access sites which must be protected from contamination, such as wounds, catheter insertion sites, injection sites or invasive device access sites.

Standard aseptic technique is used for technically straightforward procedures where Key-Parts and Key-Sites can be protected effectively using a relatively small aseptic field and non-touch technique.

Surgical aseptic technique is used where procedures are technically more complex, involve larger or numerous Key-Parts or Key-Sites, require a larger aseptic field, or where effective asepsis cannot be maintained by non-touch technique alone.

The choice of aseptic technique must be determined by the procedure, the individual’s clinical needs and risks, current evidence-based guidance and any instructions issued by the responsible healthcare professional.

At {{org_field_name}}, staff must identify and protect Key-Parts and Key-Sites throughout every procedure requiring aseptic technique and must follow Standard Infection Control Precautions at all times.

5. Key Principles of Aseptic Technique

The following principles must be applied whenever an aseptic procedure is undertaken:

• assess the procedure and identify the Key-Parts and Key-Sites that must be protected;
• perform effective hand hygiene at the required points before, during and after the procedure;
• prepare and maintain an appropriate aseptic field;
• use a non-touch technique to prevent direct or indirect contamination of Key-Parts and Key-Sites;
• use sterile equipment where sterile equipment is required for the procedure;
• select gloves and other personal protective equipment according to the procedure and an assessment of the anticipated risk of exposure to blood, body fluids, non-intact skin, mucous membranes or other hazards;
• use sterile gloves where they are required to maintain asepsis because Key-Parts or Key-Sites cannot otherwise be protected from touch;
• ensure that personal protective equipment is put on, removed and disposed of safely and that hand hygiene is undertaken as required;
• ensure equipment is intact, within its expiry date where applicable and used in accordance with the manufacturer’s instructions;
• prepare the procedure in a clean environment with unnecessary activity, interruptions and contamination risks minimised;
• clean and decontaminate reusable equipment in accordance with current infection prevention and control guidance and the manufacturer’s instructions;
• dispose of sharps and other waste immediately into the correct waste stream; and
• stop and re-establish asepsis if a Key-Part, Key-Site, aseptic field or sterile item becomes contaminated.

Standard Infection Control Precautions must be applied to every individual regardless of whether an infection is known or suspected.

A procedure must not continue using equipment or an aseptic field known or suspected to have been contaminated. Where contamination occurs, the affected equipment must be replaced or the aseptic field re-established as appropriate before the procedure continues.

Any significant breach of aseptic technique that may have exposed an individual to harm must be documented, reported and clinically escalated in accordance with the organisation’s incident reporting and infection prevention and control arrangements.

6. Staff Competence and Training

Only staff who have received appropriate training and have been assessed and documented as competent for the specific procedure may undertake an aseptic procedure.

Attendance at training alone does not constitute evidence of competence.

Competency assessment must include, as appropriate:

• understanding of the principles of asepsis and Aseptic Non-Touch Technique;
• identification and protection of Key-Parts and Key-Sites;
• effective hand hygiene;
• appropriate selection and use of gloves and other personal protective equipment;
• preparation and management of an aseptic field;
• safe use of sterile and single-use equipment;
• prevention and recognition of contamination;
• safe management of sharps and healthcare waste;
• recognition of infection, deterioration, complications or other circumstances requiring escalation;
• accurate documentation;
• understanding of the individual’s personal plan, risk assessment and relevant clinical instructions; and
• practical observation of the staff member carrying out the procedure safely.

Where the procedure is a delegated healthcare activity, the staff member must also have been assessed as competent for the delegated activity in accordance with the requirements of the delegating registered healthcare professional and any applicable national or professional guidance.

Competence must be reassessed whenever there is concern about a member of staff’s practice, following a significant change to equipment or procedure, where the activity has not been undertaken for a period sufficient to raise concern about continued competence, or where required by the delegating healthcare professional. {{org_field_name}} will additionally undertake the organisation’s scheduled competency review at least annually for staff routinely undertaking aseptic procedures.

Staff must not undertake an aseptic procedure if they consider themselves insufficiently trained or competent. They must report this immediately to the Registered Manager, nurse in charge or relevant registered healthcare professional so that safe alternative arrangements can be made.

Records of training, delegated authority where applicable, and competency assessment must be maintained and available for management oversight and regulatory inspection.

The Registered Manager, {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}, is responsible for ensuring that appropriate systems are in place to verify staff competence. The Infection Control Lead, {{org_field_infection_control_lead_name}}, supports monitoring of infection prevention and control practice within the service.

7. Procedures Requiring Aseptic Technique

An aseptic technique must be used whenever required by the nature of the procedure, current evidence-based guidance, the individual’s assessed clinical needs or instructions from an appropriately registered healthcare professional.

Procedures for which aseptic technique may be required include:

• wound assessment, cleansing and dressing procedures;
• care of surgical wounds and other wounds where aseptic technique is clinically indicated;
• insertion or management of urinary catheters and manipulation of relevant catheter connection points;
• PEG or other enteral device site care and procedures involving critical components of the device;
• insertion, access or management of invasive devices;
• administration of injections where aseptic technique is required;
• application of sterile dressings; and
• any other procedure involving a susceptible body site or critical equipment where contamination could introduce infection.

The exact technique to be used must be determined according to:

• the individual’s personal plan and current clinical needs;
• the procedure being undertaken;
• the identified Key-Parts and Key-Sites;
• the individual’s infection risks and other relevant risk assessments;
• instructions from the responsible registered healthcare professional;
• current national and professional guidance; and
• the manufacturer’s instructions for any device or equipment being used.

Before commencing the procedure, staff must ensure that all required equipment is available, intact, within its expiry date where applicable and appropriate for the intended use.

Any clinical procedure that is outside the staff member’s assessed competence, professional scope or delegated authority must not be undertaken. Advice or assistance must instead be obtained from the appropriate registered healthcare professional.

8. Environment and Equipment

Aseptic procedures must be carried out in an environment that allows the procedure to be undertaken safely while minimising the risk of contamination.

Before the procedure, staff must:

• select an appropriate area that protects the individual’s privacy and dignity;
• ensure the immediate procedure area is visibly clean and free from unnecessary clutter;
• clean and, where required, disinfect the preparation surface using the approved product and method;
• minimise unnecessary movement, interruptions and activity around the procedure;
• ensure that hand hygiene facilities or an appropriate alcohol-based hand rub are available;
• ensure that all required equipment is available before the procedure begins; and
• prevent sterile or otherwise critical equipment from coming into contact with contaminated surfaces or items.

Sterile and other clinical supplies must:

• be stored in a clean and dry location protected from contamination and damage;
• remain in their original packaging until required unless an alternative system has been specifically approved;
• be checked for package integrity and expiry date before use;
• not be used where packaging is wet, damaged, opened or otherwise compromised; and
• be used in accordance with the manufacturer’s instructions.

Items designated by the manufacturer for single use must not be reused.

Reusable medical or care equipment must be appropriately cleaned and decontaminated between uses in accordance with current infection prevention and control guidance and the manufacturer’s instructions.

If sterility or cleanliness of an item is uncertain, it must not be used for an aseptic procedure.

9. Documentation and Personal Planning

Where an individual requires ongoing procedures involving aseptic technique, the requirement must be reflected appropriately in their personal plan and any relevant clinical care documentation.

The personal plan and associated clinical documentation must provide staff with sufficient information to understand how the individual’s care and support needs are to be met and must identify any relevant risks, precautions, professional instructions and escalation arrangements.

Following an aseptic procedure, staff must make an accurate and timely record appropriate to the procedure. The record must include, where relevant:

• the date and time of the procedure;
• the procedure undertaken;
• the name or other identifiable record of the staff member undertaking it;
• relevant observations and clinical findings;
• condition of the wound, site or device where applicable;
• treatment, dressing, device or product used;
• any pain, distress or other response reported or observed;
• any signs of infection, deterioration or complication;
• any breach of aseptic technique and action taken;
• advice sought or escalation undertaken;
• any follow-up action required; and
• the date or arrangements for the next review or procedure where applicable.

Records must be accurate, complete, legible, secure and sufficiently detailed to enable continuity of care.

Any material change in the individual’s condition, treatment or clinical needs must prompt review of the relevant risk assessment and personal plan and, where necessary, referral to or review by an appropriate healthcare professional.

Where instructions from a registered healthcare professional change, the relevant documentation and personal plan must be updated promptly so that staff have access to current instructions.

10. Monitoring, Audit and Compliance

{{org_field_name}} will maintain effective arrangements to monitor compliance with this policy and the safety and quality of aseptic practice.

Monitoring will include, as appropriate:

• direct observation of aseptic technique;
• hand hygiene practice;
• identification and protection of Key-Parts and Key-Sites;
• selection and use of personal protective equipment;
• maintenance of the aseptic field;
• staff training and competency records;
• documentation and care records;
• storage, integrity and expiry dates of sterile and clinical supplies;
• availability and appropriate use of equipment;
• waste segregation and sharps disposal;
• incidents, infections, near misses or identified breaches of aseptic technique; and
• actions arising from previous audits or reviews.

The Infection Control Lead will undertake audits at the frequency determined by the service’s infection prevention and control risk assessment and quality assurance arrangements. Additional audits must be undertaken where concerns, incidents, changes in practice or previous findings indicate that increased monitoring is necessary.

Findings must be reported to the Registered Manager and appropriate corrective action taken where shortcomings are identified. This may include immediate action to protect individuals, supervision, competency reassessment, additional training, procedural changes or referral to an appropriate healthcare professional.

Significant findings and identified improvement actions must feed into the service’s wider quality assurance and quality-of-care review arrangements.

Where non-compliance creates an immediate risk to an individual, action must be taken without waiting for the completion of a scheduled audit or review.

11. Infection Control, Sharps and Waste Disposal

Standard Infection Control Precautions must be applied throughout every aseptic procedure.

Waste generated during a procedure must be assessed and segregated into the correct waste stream according to its contents, infection risk and the current Welsh healthcare waste requirements. Waste must not automatically be classified as infectious clinical waste solely because it was generated during an aseptic procedure.

In particular:

• infectious healthcare waste must be placed into the designated infectious waste stream;
• non-infectious offensive or hygiene waste must be placed into the designated offensive waste stream where applicable;
• medicines-contaminated or chemically contaminated waste must be placed into the waste stream specified for that type of waste;
• general and recyclable waste must be segregated in accordance with applicable Welsh waste requirements; and
• staff must follow the service’s waste-management arrangements and the requirements of the authorised waste contractor.

Sharps must be discarded immediately after use at the point of care into an appropriate approved sharps container. Sharps must not be left for later disposal, carried unnecessarily between areas, bent, broken or manipulated after use except where a specific safe procedure requires otherwise.

Sharps containers must be:

• appropriate for the type of sharp and any pharmaceutical contamination involved;
• correctly assembled and labelled;
• positioned safely and as close as practicable to the point of use;
• kept upright;
• not filled beyond the manufacturer’s fill line; and
• closed and replaced in accordance with the manufacturer’s instructions and the service’s waste procedures.

Personal protective equipment and dressings must be disposed of according to the appropriate waste classification and must not routinely be placed into an orange infectious waste bag unless the waste meets the criteria for that stream.

Blood and body-fluid spillages must be managed promptly in accordance with current infection prevention and control guidance and the organisation’s Infection Prevention and Control Policy.

Any sharps injury, splash exposure or other occupational exposure to blood or body fluids must receive immediate first aid and be reported and managed in accordance with the organisation’s exposure-incident and incident-reporting procedures.

12. Communication, Consent and Mental Capacity

Before undertaking a procedure, staff must explain to the individual, in a way they can understand:

• what is proposed;
• the purpose of the procedure;
• what the procedure is likely to involve;
• any material risks or discomfort relevant to the decision;
• any available alternatives where applicable; and
• the individual’s right to ask questions and, where they have capacity, to refuse or withdraw consent.

Consent must be obtained before the procedure is undertaken. Consent may be expressed verbally, in writing or through the individual’s actions where this is appropriate to the procedure and the circumstances. The obtaining of consent and any refusal of treatment must be documented appropriately.

Staff must not assume that an individual lacks capacity because of their age, appearance, diagnosis, disability, behaviour or communication difficulty.

Where there is reason to doubt an adult’s capacity to make the particular decision, capacity must be assessed in relation to that specific decision and at the time the decision needs to be made, in accordance with the Mental Capacity Act 2005.

All practicable steps must first be taken to support the individual to make the decision themselves, including providing information in an accessible form and using the individual’s preferred communication method.

Where an adult is assessed as lacking capacity to consent to the specific procedure, any decision or act on their behalf must be undertaken in accordance with the Mental Capacity Act 2005 and in their best interests, unless another lawful authority applies.

The service must establish whether any person holds relevant lawful decision-making authority, including a valid and applicable lasting power of attorney or deputyship order, and whether there is any valid and applicable advance decision relevant to the proposed treatment.

Family members, friends and representatives should be consulted where appropriate as part of determining the individual’s best interests, but they do not acquire legal authority to consent to healthcare treatment solely because they are a relative or representative.

Where there is significant disagreement, uncertainty about lawful authority, or uncertainty about whether treatment can proceed, advice must be obtained from the responsible healthcare professional and, where necessary, appropriate legal or safeguarding advice must be sought before proceeding, except where immediate action is legally justified to address an emergency.

The individual’s privacy, dignity, communication needs, cultural needs, religious beliefs and personal preferences must be respected throughout the procedure.

13. Policy Review

This policy will be reviewed at least annually and sooner where necessary.

An earlier review must take place where there is:

• a change in applicable legislation or statutory guidance;
• a change in CIW requirements or inspection expectations relevant to this policy;
• new or revised national infection prevention and control guidance applicable in Wales;
• new or revised Public Health Wales guidance;
• new relevant professional guidance;
• a significant infection prevention and control incident;
• a significant breach of aseptic technique;
• an adverse audit finding or identified trend;
• introduction of a new procedure, device or item of equipment;
• evidence that current arrangements may no longer represent safe practice; or
• a relevant change to the service’s statement of purpose or the needs of individuals receiving the service.

The Registered Manager will ensure that operational changes arising from a review are implemented, communicated to relevant staff and incorporated into training or competency assessment where required.

The Responsible Individual will ensure that suitable arrangements are in place for this policy to be kept up to date in accordance with the requirements applying to the regulated service.

Staff must be informed of material changes to the policy and have access to the current approved version.

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Responsible Person: {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}
Reviewed on: {{last_update_date}}
Next Review Date: {{next_review_date}}
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