Surgical Site Marking Protocols and Policy

Reference Number:

7021

Author & Title:

Chris Gallegos, Consultant urologist

Responsible Directorate:

Operations

Review Date:

December 2014

Ratified by (committee):

Clinical Governance Committee

Date Ratified:

December 2011

Version:

Related Procedural Documents

Incident reporting and management policy and procedure; including the management of serious untoward incidents (213)

Index:
1. 2. 3. 4. Introduction ___________________________________________________ 3 Purpose of this policy ___________________________________________ 3 Scope ________________________________________________________ 3 Definitions ____________________________________________________ 3
4.1 4.2 World Health Organisation (WHO) Checklist ___________________________ 3 Time Out Section of WHO Checklist__________________________________ 4

5.

Responsibilities________________________________________________ 4
5.1 5.2 5.3 5.4 5.5
5.5.1 5.5.2 5.5.3

Director of Clinical Standards (Medical Director) _______________________ 4 Lead Clinicians ___________________________________________________ 4 Operating Surgeon (or deputy) ______________________________________ 4 Anaesthetists ____________________________________________________ 4 The Operating Theatre Team________________________________________ 4
Operating anaesthetist __________________________________________________ 4 Operating surgeon ______________________________________________________ 4 Operating Scrub nurse __________________________________________________ 5

6.

Process ______________________________________________________ 5
6.1 6.2 6.3 6.4
6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6

Making the Mark __________________________________________________ 5 Who Marks the site? ______________________________________________ 5 Exceptions to Site Marking _________________________________________ 5 Specialty specific instructions ______________________________________ 6
Spinal Surgery _________________________________________________________ Ophthalmic Surgery _____________________________________________________ Bilateral Treatment _____________________________________________________ ENT Surgery __________________________________________________________ Digital Surgery _________________________________________________________ Anaesthetic Local/Block Procedure_________________________________________ 6 6 7 7 7 7

6.5

Sterility of marking ________________________________________________ 7

7. 8. 9.

Monitoring Compliance _________________________________________ 8 Training Requirements __________________________________________ 8 References ____________________________________________________ 8

Appendix 1: Consultation Schedule _________________________________ 10 Equality Impact Assessment Tool ___________________________________ 11 Ratification Check List_____________________________________________ 12

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1.

Introduction

In a service as large and complex as the NHS, there will be occasions when things do not go as planned. These include such events as wrong site, wrong procedure or wrong person surgery. This policy has been formulated in response to the recommendations made by the National Patient Safety Agency (NPSA) and is designed to complement the World Health Organisation (WHO) checklist implemented on 1 June 2009. The policy has been formulated in response to the Department of Health publications Building a Safer NHS, Doing less Harm and the National Patient Safety Agency publications Building a memory: preventing harm, reducing risks and improving patient safety, and Seven Steps to Patient Safety. However, the ultimate aim is to reduce the risk of harm to patients through improving the safety and quality of services and the environment.

2.

Purpose of this policy

The purpose of this policy is to clarify and inform a universally acceptable method within Royal United Hospital NHS Trust (the Trust), by which patients undergoing a surgical procedure will have their operative site marked appropriately and accurately. It will: Minimise the risk of surgery on the wrong site or wrong patient Minimise the risk of the wrong procedure being performed Inform and guide the operating surgeon as to the method used to mark the skin and operative site Show where anatomically the site will be marked Show when the marking will be undertaken.

3.

Scope

This policy applies to all permanent, locum, agency or their deputies who work in Royal United Hospital NHS Trust and who are responsible for the identification and marking of a patients surgical site.

4.
4.1

Definitions
World Health Organisation (WHO) Checklist

a checklist developed by the WHO and collaborators at the Harvard School of Public Health, the checklist identifies key safety steps during perioperative care that should be accomplished during every single operation no matter the setting or type of

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surgery. It has been shown to significantly reduce complications and deaths from surgery.

4.2

Time Out Section of WHO Checklist

a momentary pause taken by the team just before skin incision in order to confirm that several essential safety checks are undertaken and involves everyone in the team.

5.

Responsibilities

5.1 Director of Clinical Standards (Medical Director) The Director of Clinical Standards has ultimate responsibility for ensuring that appropriate processes are in place for the safe management of surgical patients, including preoperative marking. 5.2 Lead Clinicians Clinical Directors in each specialty have responsibility for ensuring their surgeons mark patients accordingly and carry out the instructions within this policy. 5.3 Operating Surgeon (or deputy) It is the responsibility of the operating surgeon or deputy to mark the operative site in accordance with this policy It is recognised that there will be instances relating to emergency admissions, when patients will be marked by a member of the surgical team who will not be the operating surgeon, but who will be responsible for obtaining consent for the procedure. 5.4 Anaesthetists Anaesthetists are responsible for marking the site of any proposed local/regional block/anaesthesia. The anaesthetist will be responsible for the anaesthetic time out in the anaesthetic room, when such marks will be checked. 5.5 The Operating Theatre Team The operating theatre team has joint responsibility for ensuring that the WHO Checklist is completed prior to surgery and as part of this, that the correct site has been identified prior to commencement of surgery. 5.5.1 Operating anaesthetist The anaesthetist responsible for the patients anaesthetic, is also responsible for ensuring that the WHO safer surgery checklist sign in is completed prior to the anaesthetic being administered and that this is documented appropriately. 5.5.2 Operating surgeon The operating surgeon is responsible for ensuring that the WHO safer surgery checklist time out is completed prior to the surgery commencing and that this is documented appropriately.
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5.5.3 Operating Scrub nurse The scrub nurse responsible for the surgery, is responsible for ensuring that the WHO safer surgery checklist sign out is completed prior to the leaving the theatre and that this is documented appropriately.

6.

Process

6.1 Making the Mark The patient should be marked at the time of confirmation of consent. The patients surgical site is to be marked before the patient is moved to the location where the procedure will be performed. The patient will be involved, awake and aware; preferably before any prescribed pre-medication is administered. The mark is to be an arrow pointing to the site of the operative procedure, as close as possible to the incision site The mark is to be made with an indelible, permanent black marker pen and should be sufficient to remain visible after skin preparation and draping; if practicable The site for all procedures that involve incisions, percutaneous punctures, or insertion of instruments must be marked, taking into consideration surface, spine level, specific digit or lesion to be operated on. For procedures involving laterality of organs, but where the decision or approach may be from the mid-line or natural orifice, the site must be marked and a note made of the laterality All site markings must be made in conjunction with checks made on the patients diagnostic imaging results i.e. X-rays, scans, electronic imaging or other appropriate test results, ensuring these match the patients medical notes and identity band. Other sites that may require marking, are those necessary for some other aspect of care that directly relates to the planned, proposed procedure i.e. dual/multiple surgical sites, stoma sites. 6.2 Who Marks the site? The person who is responsible for making the mark on the patient is the Operating Surgeon who will be performing the procedure, or the person delegated to obtain consent. Where a patient will require a stoma as a result of a planned, elective procedure. The stoma site may be marked by the stoma nurse specialist pre-operatively in collaboration with the surgical team. 6.3 Exceptions to Site Marking 6.3.1 All endoscopies without planned intentional, invasive procedures are considered exempt from surgical site marking. Also, such sites where there is no predetermined site of surgical access, such as cardiac catheterisation and other minimally invasive procedures, would be considered exempt.
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6.3.2 There may also be exemption instances where the laterality of surgery needs to be confirmed following examination under anaesthetic (EUA) or exploration. 6.3.3 Procedures that have a midline approach for specific named treatments intended for a single specific organ i.e. caesarean section, hysterectomy or thyroidectomy, can also be exempted from site marking. 6.3.4 It is acknowledged that there is no practical or reliable way of marking teeth or mucous membranes; especially in the case of teeth planned for extraction. A review of the dental records and radiographs with the tooth/teeth must be undertaken and their anatomical numbers for extraction clearly marked on these records and radiographs. 6.3.5 Other areas/patients where it is anatomically and technically difficult to mark the operative site include areas such as the perineum, friable skin around the site and with neonates or premature infants. 6.3.6 For obvious wounds or lesions, site marking is not applicable if that wound or lesion is the site of surgical intervention. However, if there are multiple wounds or lesions and only some of them are to be treated and this decision is pre-determined, then these sites must be marked as soon as possible after the decision has been made for surgery 6.3.7 For any sites not marked, the proposed operation/procedure must be reviewed to verify patient and procedure at the Time Out part of the WHO Safety Checklist. This must be undertaken in conjunction with a review of all relevant documentation, including: the patients notes; appropriate charts; diagnostic imaging (correctly oriented); and a double person check of all information. The procedure must not commence without this review having occurred. 6.4 Specialty specific instructions (not otherwise covered above) 6.4.1 Spinal Surgery For spinal surgery, a 2-stage marking process will be used. Firstly, before the patient goes to the operating theatre, the general level of the procedure is marked pre-operatively: either cervical, thoracic or lumbar. The surgical site is appropriately marked to show either an anterior or posterior approach with right or left sides being clearly indicated. Secondly, during the operation itself, the exact interspace(s) or levels are demonstrated using standard intra-operative radiographic marking technique. 6.4.2 Ophthalmic Surgery For single eye surgery, a small mark should be made on the temple above and pointing to the correct eye for treatment. The exception is for planned bilateral procedures on both eyes (such as bilateral squint surgery), but the laterality of such procedures should be well documented. The marking of a childs head/face must be assessed at the time of pre-assessment by the surgeon. In general, a mark should always be made, and it is usually straightforward to mark a childs face without
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distressing the child if done in a sensitive manner. If no mark is made, then the procedures referred to at 6.3.7 must be adhered to. 6.4.3 Bilateral Treatment Whilst this policy focuses on laterality, specific anatomical sites, levels and areas, surgeons must consider that it is possible to perform the wrong bilateral procedure(s). Therefore site marking for bilateral, identical, procedures is not required. If no mark is made, then the procedures referred to at 6.3.7 must be adhered to. 6.4.4 ENT Surgery There may be occasions where marking the patients skin to point to the correct site for surgery may be inappropriate e.g. bilateral tonsillectomy/adenoidectomy, laryngectomy. In these cases 6.3.3 / 6.3.4 / 6.3.7 apply. For ENT surgical sites where a skin incision is made on a specific side i.e. surgery on the external pinna and tympanotomy and surgical side/site to take the graft, these should be marked with an arrow accordingly. 6.4.5 Digital Surgery Each and every digit to be operated on must have an individual arrow pointing to and as close as possible to the respective digit. In cases where both the palmar and volar surfaces of a digit are to be operated on both should be marked. 6.4.6 Anaesthetic Local/Block Procedure The site of the local/block procedure must be marked prior to the patient being given a general anaesthetic (if one is to be given) and/or when the pre-operative assessment is carried out by the anaesthetist carrying out the procedure. The site of the block will be marked by the anaesthetist carrying out the procedure. This will take place in the anesthetic room, prior to the anaesthetic time out. The mark must be a circle made using a permanent green marker, to distinguish the mark from that made for the surgical site. 6.5 Sterility of marking Research has been carried out to ascertain whether the use of a permanent ink marker to mark a surgical site, affects the sterility of a patients skin after it has been cleaned with surgical preparation solution. The results showed that no growth was seen in the cultures of swabs taken on both the control group (un-marked) and on the experimental group (marked). Preoperative marking of surgical sites in accordance with the Joint Commission protocol did not affect the sterility of the surgical field, therefore providing support for the safety of surgical site marking (Cronen, et al . 2005).

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7.

Monitoring Compliance
Responsible Lead Evidence Reviewed by / Frequency Theatre Management Team Quarterly Theatre Management Team Quarterly Lead Responsible for any Required Actions Clinical Directors Clinical Directors

Key Performance Indicator 100% of surgical sites will be marked correctly 100% compliance in completion of WHO forms

Lead Clinician

Theatre Link Practitioner

Audit of Millennium documentation Audit of compliance with WHO checklist

Through on-going daily audit of the WHO checklist process incorporating team brief, the theatre staff, anaesthetist and surgeon with the theatre practitioners involved in the checklist will monitor/facilitate this. A copy of each patients WHO checklist will be filed in their health records and details will also be entered into the Millennium database; this all occurs daily. The audit of compliance with the WHO safer surgery checklist, which includes site marking, will be presented to the Surgical Division Governance meeting on a six monthly cycle. In order for the group to identify any areas of non-compliance and determine the actions required to address these. Reported incidents identifying non-compliance with this policy will be referred to the relevant Clinical Lead for investigation and information on action taken to prevent reoccurrence. The Divisional Governance group will review incident themes and trends at each meeting, in order to identify areas of non-compliance and determine the actions required to address these.

8.

Training Requirements

Training of all surgeons and junior doctors must be carried out at their induction covering the WHO Checklist and the guidelines for surgical site marking. This will be facilitated by the designated clinical teams providing any new employee induction for surgical teams. This will be directed by the specialty lead.

9.

References

Internal WHO safer surgery checklist, as adapted for use in Portsmouth Hospitals NHS Trust External Joint Commission Sentinel Event Alert, Lesson learned Wrong Site Surgery (1998)
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Joint Commission Sentinel Event Alert, Issue 4, (2001) National patient safety Agency (NPSA) Patient safety Alert 06 Correct site surgery, making your surgery safer (2005) Joint Commission Universal Protocol, procedure site marking (2009) World Health Organisation (WHO) Implementation manual, Surgical Safety Checklist 1st Ed (2009) Cronen, G. et al. Sterility of Surgical Site Marking. Journal of Bone & Joint Surgery, 2005; 87: p.2193 2195 Department of Health (2011). The never events list 2011/12: Policy framework for use in the NHS. National patient safety Agency (NPSA). Patient Safety Alert WHO Surgical safety Checklist 2009. NPSA/2009/PSA002/U1

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Appendix 1: Consultation Schedule

Name and Title of Individual Annette Jardine, Clinical Lead for ENT Speciality governance lead Mr Shashikant Sholapurkar, Associate specialist in Obstetrics and Gynaecology Speciality governance lead Mr Allister Trezies, consultant orthopaedic surgeon - Speciality governance lead Lesley Jordan, Consultant anaesthetists Speciality governance lead & patient safety lead Mr Tim Bates, Consultant surgeon Speciality governance lead Richard Sutton, Consultant surgeon Speciality governance lead Mark Mallet, Consultant Physician Governance lead for medical division Alexandra Lucas, Head of Risk & Assurance Date Consulted 14.11.11

Name of Committee Surgical Division Governance group Operational Governance Committee

Date of Committee 12 September 2011 14 December 2011

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Equality Impact Assessment Tool

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval Initial Screening Policy, service, function: strategy, procedure or

Lead (e.g. Director, Manager, Clinician): Person responsible for the assessment: Name: Job Title: Is this a new or existing policy, service strategy, procedure or function? New Who is the policy/service strategy, procedure or function aimed at? Patients Carers Staff Visitors Any other: Are any of the following groups adversely affected by the policy? If yes is this high, medium or low impact (see attached notes): Group Disabled people: Race, ethnicity & nationality Male/Female/transgender: Age, young or older people: Sexual orientation: Religion, belief and faith: Affected? No / Yes No / Yes No / Yes No / Yes No / Yes No / Yes Impact High / Medium /Low High / Medium /Low High / Medium /Low High / Medium /Low High / Medium /Low High / Medium /Low

If the answer is yes to any of these proceed to full assessment. This applies whether the impact assessment is high, medium or low. If the answer is no to all categories, the assessment is now complete 1. Does the policy, service strategy, procedure or function include measures which promote equality? 2. If yes, what are these measures? No / Yes

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Ratification Check List

Dear Chairman Please would you review this document at your next meeting and agree final approval and organisational ratification.

Title of meeting: Date of meeting: Policy Title and Reference: Name of author:

Clinical Governance Committee 14 December 2011 Surgical Site Marking (7021) Chris Gallegos, Consultant urologist No

Are there any elements of this policy which present operational issues that require further discussion? If yes, please provide a contact name for the author. Is the policy referenced? Are up to date National Guidelines included? If you are the appropriate forum, have the necessary resources been agreed to implement this document? Is there a plan for policy implementation? Does your meeting recommend further consultation with groups or staff other than listed at the front of the policy?

Yes Yes N/A Yes No

What are the cost implications of implementing this document? Equipment Staffing (additional) Training Other Yes marker pens N/A Yes junior doctors N/A Yes No

Document endorsed without further comment? Further amendments to document suggested? Name of Chair: Carol Peden Signature: Signed at the meeting

Date: 14.12.11

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