Safe surgery: reducing the risk of retained items.
Research from the United States which explores events related to
the surgical count has identified that there are opportunities to review
our practice in order to reduce risks to surgical patients. The Safe
Surgery Saves Lives Campaign highlights this aspect of perioperative
patient safety, ensuring that poor processes and poor communication,
often the reasons for retained surgical items, become part of the team
'sign-out' at the end of every operation.
'People working in health care are among the most educated and dedicated workforce in any industry. The problem is not bad people; the problem is that the system needs to be made safer.' (Kohn at al 1999 p49)
KEYWORDS Retained surgical items / Surgical count / Patient safety
(Safety and security measures)
Foreign bodies (Medical care) (Prevention)
Medical errors (Prevention)
|Publication:||Name: Journal of Perioperative Practice Publisher: Association for Perioperative Practice Audience: Academic Format: Magazine/Journal Subject: Health; Health care industry Copyright: COPYRIGHT 2009 Association for Perioperative Practice ISSN: 1750-4589|
|Issue:||Date: Oct, 2009 Source Volume: 19 Source Issue: 10|
|Topic:||Event Code: 260 General services|
|Product:||Product Code: 8000410 Surgical Procedures; 9139340 Institute of Medicine NAICS Code: 62 Health Care and Social Assistance; 54171 Research and Development in the Physical, Engineering, and Life Sciences|
|Organization:||Organization: Institute of Medicine; World Health Organization|
|Geographic:||Geographic Scope: United Kingdom Geographic Code: 4EUUK United Kingdom|
Since the startling revelations contained in the Institute of Medicine report To Err is Human (Kohn et al 1999) the world of healthcare has woken up to the fact that we are not perfect.
The Safe Surgery Saves Lives campaign initiated by the World Health Organisation's World Alliance for Patient Safety, and launched last year in Washington DC, has highlighted just how much we need to focus our attention on the culture of safety in our operating theatres.
The expert group, that first met in Geneva in January 2007 led by Atul Gawande an eminent Harvard surgeon, was comprised of many surgeons from around the globe, a few equally eminent anaesthetists, a few microbiologists, some professionals from patient safety organisations, and a lay member. I was privileged to represent perioperative practice, and at the first meeting was the only nurse at the group, after which I was joined by a Kenyan perioperative nurse and a Thai infection control nurse.
The key task of the group was to review the available evidence in different areas particularly:
* Clean surgery
* Safe anaesthesia
* Surgical teams
* Monitoring and measuring mechanisms
From research evidence in each of these areas, the aim was to define a core set of standards which can be applied universally to improve surgical outcomes for patients, regardless of circumstance or environment. It would be impractical to produce a host of complex standards which would improve patient safety but might well cloud the issues and be subsequently difficult to implement universally. Uncomplicated measures are the easiest to implement and could have a profound impact in a variety of settings (WHO 2007a).
The second principle is wide applicability--it would be pointless to provide standards which were targeted specifically at some health settings whilst leaving other patients vulnerable. And thirdly, the standards must be measurable. It ought be possible to measure success and evaluate changes to safety in surgery, in every health setting. The development of a systematic framework of standards which are universally applicable, once established should indicate where meaningful improvements can be made to the culture of safety for all surgical patients.
The outcome of the deliberations by the WHO expert group was a checklist of evidence based recommendations which have been shown to reduce perioperative adverse events (WHO 2008a).
The product which we will all learn to use is a Surgical Safety Checklist of basic tasks to be either completed prior to, during or after the operation. Interventions such as delivering antibiotics prior to skin incision, confirming the appropriate procedure is performed on the correct patient, and improving communication between the surgeon, anaesthetist and other members of the perioperative team, will all improve the safety of surgery.
In January 2009 the National Patient Safety Agency hosted the European launch of the checklist and published an alert (NPSA 2009). The alert requires NHS organisations in England and Wales to implement the surgical safety checklist by February 2010.
Examples of elements on the checklist are:
* communication between the operative team and the patient confirming the procedure and the consent for treatment
* confirmation of patient allergies
* comprehensive examination of the anaesthetic machinery and medications
* routine examination of the patient's airway
* communication between the surgeon and anaesthesia provider.
* appropriate and timely administration of antibiotics
* confirmation of sterility of the instruments and equipment
* confirmation of imaging and laboratory results
* communication of critical events that will occur during the procedure.
Immediate postoperative period
* reconciliation of instrument and sponge counts
* communication between the surgeon, nurse/ODP, and anaesthesia provider regarding the intra-operative events and the postoperative care plan.
Completing the specific steps outlined in the surgical safety checklist promotes communication between all members of the surgical team including anaesthesia professionals, nurses, surgical providers, and the patients and family members (WHO 2007b ). The National Patient Safety Agency has adapted the WHO checklist slightly (NPSA 2009) to meet identified imperatives in England and Wales, noting that local changes may also be made.
In all the complexity of modern surgery, there are many hazards and we all owe a duty of care to the patient to do as well as we can, wherever in the world surgery is taking place. Errors in healthcare know no geographical boundaries. No country--rich or poor--can claim to have fully come to grips with the problem of patient safety (Brennan 2004). Medical errors have been estimated to range from 4 to 16% of all hospitalised patients (Brennan 2004, DH 2000, Wilson 1995) and surgery accounts for more than half of the avoidable adverse events that result in death or disability. However, patient safety is not about statistics, as it damages the lives of real people--patients and families--who are harmed and sometimes die as a result of unsafe care (Gawande et al 2003).
For the purposes of this article, the author has elected to write about one particular aspect of the Safe Surgery Saves Lives surgical checklist, the surgical count. Many elements of the checklist are already commonly practised in UK operating theatres--although others will be challenging to implement. In the immediate post operative period, as identified above, it is envisaged that after the final count, the team will explore aspects of the patient's operation which can focus the entire team on safety. They will take a 'Sign-Out' between them to ensure that everything that should have been done, has been done, safely. The audible confirmation of a correct count will be made by the scrub practitioner as part of this interlude.
The surgical count
One of the key areas where perioperative practitioners have specific responsibility to patients, together with surgical colleagues, is the surgical count. The techniques we use are broadly similar around the world in developed countries but nonetheless we occasionally unintentionally fail, with severe consequences for patients.
Data on how often we fail is hard to find, but remain on the top ten issues referred to AfPP by practitioners since the inception of the professional advisory service in 1997. Data from the US has therefore been sought, and the author is of the opinion that prevalence per surgical episode is unlikely to vary in the UK.
It seems obvious to state this, but there are many items that are intentionally left in the patient during surgery such as vascular grafts, aneurysm clips and staples. Clearly these are not the items being discussed. It is the unintentional items which cause patients harm and distress, possibly a second procedure to remove the items and potentially death from sepsis and fistulae.
Estimates of unintentional retained surgical items in surgical procedures range from 1 case per 8,000--18,000 operations (Gawande et al 2003) which translates to one case per year for hospitals which undertake 10,000 operative procedures. Retained surgical items may be swabs of a variety of sizes, needles and instruments or parts of instruments or needles. Leaving items in patients unintentionally are avoidable errors which should be addressed by a systematic approach to prevention and a heightened focus on patient safety. These events are said to occur because of faulty processes of care in the theatre or poor communication between surgical team members (Gibbs 2005).
Examples of poor processes include inadequate or incomplete wound exploration prior to cavity closure, poorly performed surgical counts, and inadequate intra-operative X-rays. Poor team communication may occur for a variety of reasons but includes instances where the scrub practitioner and surgeon fail to work collaboratively or effectively together to rectify an incorrect count, where surgeons dismiss requests to look for missing items and where scrub staff change over between counts and perform handover counts ineffectually (Gibbs 2005). Gawande et al found that the risk of retained items increases in emergencies (nine times as likely), with unexpected changes in procedure (four times as likely) and in patients with a high body mass index (Gawande et al 2003).
Whenever there is an incorrect count, the patient may experience additional anaesthetic time and potentially the exposure to ionising radiation. Implications for hospitals related to these errors, may include:
* increased costs due to unplanned x rays
* extended theatre utilisation which may lead to cancellation of subsequent patients
* time required for incident reporting and investigation
* risk of litigation.
The most common item left behind during surgery is the swab, perhaps not surprisingly as there are so many used in each procedure. During procedures where swabs may have been left behind, it is disturbing to think that we rely on x-rays to find them. Research has found that radiological diagnosis of a retained swab is difficult because the radio-opaque line may become twisted, misshapen or hidden behind dense tissue. In one report (Kopka et al 1996) of 13 patients with a retained swab, the radio-opaque marker was only visible in 9 x-rays and even then was not recognised for what it was.
Surgical instruments may be straightforward to identify on post--operative x-rays, but needles or parts of needles pose a considerable challenge. One study (Ponrartana 2008) identified the difficulties of finding needles smaller than 10mm. The Association of PeriOperative Registered Nurses' recommended practices say that when needles smaller than 4mm are lost x-rays are not useful (AORN 2007). AfPP standards and recommendations (AfPP 2007) cite the Australian Standard (ACORN 2006), suggesting that in the case of missing micro items, a microscope may be employed to find the missing item.
In a report (Gonzalez-Ojeda 1999) of 24 retained items after intra-abdominal surgery, complications presented as perforation of the bowel, sepsis and in two patients, death. Although data is sparse, it has been estimated that the incidence of intra-abdominal retained items is as high as 1 in every 1,000 to 1,500 operations (Gawande et al 2003).
Gibbs describes that retained items may not present themselves for some years, often after patients have symptoms of persistent but unexplained pain. The informed consent process requires that if it is suspected that patients have retained surgical items, then full and open disclosure must be made.
The best way to reduce unintentional retention of swabs, instruments or needles is to re-examine all the methodologies designed to prevent harm to surgical patients. The AfPP recommended standards (AfPP 2007) are accepted as best practice exemplars and would be highly likely to be used in court, should the need arise. It follows that every operating theatre team should be following all the principles as written, incorporating the processes into local policy documents.
The surgical count, which in UK law is not compulsory, but is widely and for the most part effectively practised, should be undertaken for every surgical procedure in which it is possible to retain items. There is little solid evidence about how effective our counting processes are, but it is the only current methodology available and must be undertaken with care and diligence every time. Beyea (2003) suggests that there may be some contributing factors to counting problems; firstly that counting has become an automatic process, which may make practitioners complacent about their attention to detail. Secondly, the environment of the modern theatre is full of distractions such as phone calls, circulators having to leave the room for additional supplies, and excessive talking by team members.
The surgical count must be a team process, using well established and consistent methods of counting on every occasion. The Kaiser study (Kaiser et al 1996) showed that falsely correct surgical counts may have been caused by team fatigue, difficult operations, swabs sticking together or a poor counting system. Incorrect counts that were accepted prior to closure resulted from either surgeons dismissing the incorrect count without re-exploring the wound or perioperative staff allowing an incorrect count to be accepted. There should be zero tolerance of behaviours that deter the performance of the surgical count checks.
Devices to enable and assist safe counting are also in wide use, such as hanging pockets, 'counters', needlemats and white boards for continuing visibility of the count. AfPP Standards and Recommendations for Safe Practice (AfPP 2007) set out the principles, standards and responsibilities for swab, instrument and needle counts. It is stated that it is the responsibility of the user to return the items used in the wound and that it is 'custom and practice' that the scrub practitioner implements the checking procedure so that it can be categorically stated at the end of the procedure, during the Sign-Out, that all items are accounted for and have been returned.
AfPP recommends that the scrub practitioner is responsible for accurate documentation. However, local policies in hospitals do not always keep up to date with recommended changes to practice, as cited by AfPP. For example, local policies may not clearly make recommendations for when counts of instruments are required, leaving this to the discretion of practitioners. Practices may therefore vary from theatre to theatre within a trust, and from hospital to hospital. It is possible that the lack of standardisation across the UK may be one of the reasons that incidents of retained surgical items persist. However it is also clear that there are many human factors which contribute to unintentional harm. Theatre users groups, teams and safe surgery implementation leads should be reviewing the softer aspects of their safety culture surrounding the surgical count, and ensuring that best practices may be followed consistently.
Gawande et al (2003) identified in their study that there are some procedures, especially closure of an episiotomy or after vaginal tears at obstetric delivery, where no counts were performed. In addition, they found that of all the cases they reviewed, one third of surgical counts were not recorded. Strong recommendations were made on compliance, with counting required for every cavity procedure and improved documentation. It was also recommended that all high risk cases, particularly bariatric patients, might be post-operatively x-rayed as a way of detecting the possibility of retained items, but concluded that this should be further explored from a cost--benefit perspective.
Practitioners and teams should pay particular attention to the US Accreditation for Hospitals organisation, which identifies that poor communication is the basis of many serious patient safety incidents. The sentinel event website of the Joint Commission (www.jointcommission.org /sentinelevents/statistics) reports that communication is a root cause of more than 65% of the 3,548 serious patient safety events reported to the organization from 1995-2005. Lingard et al (2008) have identified that if team briefings prior to surgery are implemented, adverse events can be reduced by one third. This is based on deliberate, focussed communication about the patient, the surgery, the anaesthetic and other team matters during the briefing, enabling fewer communication errors and an increased emphasis on patient safety.
Developments in technology may assist with the inexact science of manual swab, instrument and needle counts. Radio frequency devices--which are uniquely manufactured--may be able to be attached in future to all our accountable devices and using a wand, be identified to a depth of 24 inches. The wand is merely passed over the body as a scan and all the devices present which contain a radio-frequency device, respond. The radio--frequency device would be incorporated into the swabs by the manufacturers. The count would be reconciled by the wand, after the manual count is complete--thus allowing professionals complete reassurance. Since the greatest number of retained surgical items occurs when the count is thought to be correct, use of this futuristic technology may offer a system we can all believe in. Clinical trials of these systems are taking place currently in the US (www.rfsurg.com) and in January 2008 the system received the CE mark approval in Europe.
There is also a research project being undertaken currently on bar coding swabs. Final outcomes from the trials of these potentially helpful technologies have yet to be fully evaluated.
In the absence of UK data on the number of serious events related to retained surgical items, it is perhaps difficult for teams and individual practitioners to get to grips with the need for constant vigilance. However, there appear to be many good reasons why we should review our policies and practice to ensure that we reduce risks to patients during surgery.
Safe Surgery Saves Lives surgical checklist (WHO 2008a, b) will, it is hoped, be used as an exemplar of best practice, ensuring that a new focus on patient safety emerges amongst all surgical team members. There are enormous opportunities for all perioperative practitioners and medical personnel to have an equal voice in matters relating to patient safety. If we can by any means reduce the harm we cause patients during surgery, we should focus our attention in that direction. The opportunity to improve our quality of care, particularly the surgical count, should not be missed.
Australian College of Operating Room Nurses 2006 Counting of accountable items used during surgery Standard 53 In: Standards for Perioperative Nursing Adelaide, ACORN
Association of PeriOperative Registered Nurses 2007 Recommended practices for sponge, sharp and instrument counts In: Standards, Recommended Practices and Guidelines Denver, AORN Inc
Association for Perioperative Practice 2007 Standards and Recommendations for Safe Perioperative Practice Harrogate, AfPP
Beyea SC 2003 Counting Instruments and sponges [Patient Safety First] AORN Journal 78 290-294
Brennan TA, Leape LL, Laird NM et al 2004 Incidence of adverse events and negligence in hospitalised patients: results of the Harvard medical practice study 1 Quality & Safety in Health Care 13 145-151
Department of Health 2000 An Organisation with a Memory London, DH
Gawande A, Studdert DM, Orav J, Troyen A, Brennan M, Zinner M 2003 Risk factors for retained instruments and sponges after surgery New England Journal of Medicine 348 229-35
Gibbs VC 2005 Patient safety practices in the operating rooms: correct site surgery and nothing left behind Surgical Clinics of North America 85 1307-19
Gonzalez-Ojeda A, Rodriguez-Alcantar DA, Arenas-Marquez H et al 1999 Retained foreign bodies following intra-abdominal surgery Hepatogastroenterology 46 808-12
Kaiser CW, Friedman S, Spurling KP, Slowick T, Kaiser HA 1996 The retained surgical sponge Annals of Surgery 224 79-84
Kohn L, Corrigan J, Donaldson M eds 1999 To Err is Human: Building a Safer Health System Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academy Press
Kopka L, Fischer U, Gross AJ, Funke M, Oestmann JW, Grabbe E 1996 CT of retained surgical sponges (textilomas): pitfalls in detection and evaluation Journal of Computer Assisted Tomography 20 919-23
Lingard L, Regehr G, Orser B et al 2008 Evaluation of a perioperative checklist and team briefing amongst surgeons, nurses, anaesthesiologists to reduce failures in communication Archives of Surgery (1) 12-17
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Ponrartana S, Coakley FD, Yeh B et al 2008 Accuracy of plain abdominal radiographs in the detection of retained surgical needles in the peritoneal cavity Annals of Surgery 247 (1)8-12
Wilson RM, Harrison BT, Gibberd RW et al 1995 The quality in Australian health care study Medical Journal of Australia 163 (9) 458-471
World Health Organisation 2007a Safe Surgery Saves Lives--background paper draft unpublished) World Alliance for Patient Safety
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World Health Organisation 2008a Safe surgery saves lives Available from: http://www.who.int/patientsafety/safesurgery/en/ind ex.html [Accessed September 2008]
World Health Organisation 2008b World Alliance for Patient Safety: Forward Programme Geneva, WHO Available from: www.who.int/patientsafety/information_centre Accessed June 2009]
Director, KMW (Healthcare Consultants) Ltd, President IFPN 2002-2006, Chairman AfPP 1998-2001
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