A complimentary publication of Issue 51, October 17, 2013 The Joint

www.jointcommission.org

Published for Joint

Commission accredited

organizations and interested

health care professionals,

Sentinel Event Alert identifies

specific types of sentinel and

adverse events and high risk

conditions, describes their

common underlying causes,

and recommends steps to

reduce risk and prevent future

occurrences.

Accredited organizations

should consider information in

an Alert when designing or

redesigning processes and

consider implementing

relevant suggestions

contained in the Alert or

reasonable alternatives.

Please route this issue to

appropriate staff within your

organization. Sentinel Event

Alert may only be reproduced

in its entirety and credited to

The Joint Commission. To

receive by email, or to view

past issues, visit

www.jointcommission.org.

__________________________

A complimentary publication of I ssue 51, October 17, 2013

The Joint Commission

Preventing unintended retained foreign objects

The unintended retention of foreign objects (URFOs) – also called retained surgical

items (RSIs) – after invasive procedures can cause death, and surviving patients

may sustain both physical and emotional harm, depending on the type of object

retained and the length of time it is retained. There may be an extended time frame

between occurrence and detection of an URFO. Retained foreign objects are most

commonly detected immediately post-procedure; by X-ray; during routine follow-up

visits; or from the patient’s report of pain or discomfort.

URFOs refer to any item or foreign object related to any operative or invasive

procedure that is left inside a patient.

Objects most commonly left behind after a

procedure are:

• Soft goods, such as sponges and towels

• Small miscellaneous items, including unretrieved device components or

fragments (such as broken parts of instruments), stapler components, parts of

laparoscopic trocars, guidewires, catheters, and pieces of drains

• Needles and other sharps

• Instruments, most commonly malleable retractors

A New York Times article published in September 2012 illustrates the adverse

effects of an URFO. Four years after having a hysterectomy, a woman in Kentucky

began to experience severe abdominal pain. A CT scan revealed a surgical sponge

left behind by the surgical team that had performed the hysterectomy. Upon

surgical exploration, the retained sponge was found to have caused a serious

infection, which required bowel resection. The patient suffered from severe health

issues, anxiety, depression, disability and social isolation.

Not only does an URFO harm the patient, it adds significantly to the average total

cost of caring for the patient. In a recent review, the Pennsylvania Patient Safety

Authority estimated that the average total cost of care related to an URFO is about

$166,000.

This cost includes legal defense, indemnity payments, and surgical

costs not reimbursed by the Centers for Medicare & Medicaid Services. Another

study estimated medical and liability costs to be $200,000 or more per incident.

Events, risk factors and root causes

From 2005 to 2012, 772 incidents of URFOs were reported to The Joint

Commission’s Sentinel Event database.* Sixteen deaths resulted from these

incidents. About 95 percent of these incidents resulted in additional care and/or an

extended hospital stay. In hospital settings, these incidents occurred in operating

rooms, labor and delivery areas, as well as ambulatory surgery centers and other

areas where invasive procedures are performed (e.g., cath lab, GI lab,

interventional radiology, emergency department).

According to the sentinel event data, the most common root causes of URFOs

reported to The Joint Commission are:

• The absence of policies and procedures

• Failure to comply with existing policies and procedures

* The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small

proportion of actual events. Therefore, these data are not an epidemiologic data set and no conclusions

should be drawn about the actual relative frequency of events or trends in events over time.

Sentinel Event Alert, Issue 51

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• Problems with hierarchy and intimidation

• Failure in communication with physicians

• Failure of staff to communicate relevant patient

information

• Inadequate or incomplete education of staff

According to one study, the most common risk

factors for URFOs include: patients with high body

mass index (risk ratio for each one-unit increment,

1.1 [95 percent confidence interval, 1.0 to 1.2]); an

emergent or urgent procedure; and unanticipated/

unexpected change during the procedure.

(Some

examples of changes that can occur during a

procedure include: a change in approach/incision,

type of procedure, added procedure, or the

development of a complication during the

procedure). Other risk factors include intra-

abdominal surgery; more than one surgical

procedure; involvement of multiple surgical teams;

multiple staff turnovers during the procedure; and

unexpected intraoperative development.

Occurrence of an URFO was nine times as likely

when an operation was performed on an

emergency basis and four times as likely when the

procedure changed unexpectedly (see examples of

change above).

An additional risk factor is long

procedure duration.

6,7

URFOs also occur in

patients who exhibit none of these risk factors.

In order to prevent retained surgical items and

sponges, surgeons and operating room staff have

traditionally relied on “cavity sweeps” and manual

counting protocols – both of which are prone to

human error. Current practices for counting

sponges have a 10 to 15 percent error rate.

addition, 80 percent of retained sponges occur with

what staff believe is a correct count.

Sentinel

event data show an incorrect or “discrepant” count

in 52 of the 772 URFO sentinel events reported to

The Joint Commission. The Pennsylvania Patient

Safety Authority’s Reporting System database

shows 22.3 percent of URFOs were associated

with a discrepant count.

Many counting procedures lack the elements of

high reliability but are entrenched and difficult to

change, said Verna C. Gibbs, M.D., professor of

clinical surgery, University of California, San

Francisco, and director of

No Thing Left Behind

, a

national surgical patient safety project to prevent

retained surgical items. High reliability science

studies organizations such as those in the

commercial aviation industry, which manage great

hazard extremely well, and in which the goal is

zero harm. In order to achieve high reliability,

leadership must commit to this goal; the culture

must support workers who identify and report

unsafe conditions; and systematic quality

improvement approaches need to be implemented

that reliably measure the magnitude of the problem

(e.g., days between procedures with an URFO),

identify the contributing factors and root causes,

and develop solutions for the most important

causes.

10,11

Studies show that the risk of URFOs is significantly

reduced following improvements to counting

procedures. Team members need to move from

varying practices to standardized practices – to

develop and sustain reliable counting practices that

ensure all surgical items are accounted for (i.e.,

are reconciled).

One children’s hospital reduced

the number of reported incorrect counts and count

discrepancies by 50 percent between 2009 and

2010, and also improved its entire count process.

Recommendations and potential strategies for

improvement

Guidelines, processes and tools have become

available to help team members develop risk-

reduction strategies that can be adopted and

followed organization-wide.

1,12,14

These strategies

include improved multi-stakeholder perioperative

processes, enhanced team communication, and

the use of assistive technology.

1,12,14,15,16

Organizations should provide continuous education

or training to appropriate staff about new and

existing policies and procedures that are in place

to prevent URFOs. The following recommendations

and potential strategies can be used to help

prevent URFOs. Should your organization discover

and remove an URFO, follow your organization’s

established policy for reporting, analyzing and

communicating the event to staff and the patient

and his or her family.

Effective processes and procedures

1. Create a highly reliable and standardized

counting system to prevent URFOs – making sure

all surgical items are identified and accounted for.

The counting system should be supported by

organizational leaders, and developed using a

multidisciplinary approach, involving surgeons,

proceduralists, nurses, surgical technologists,

anesthesiologists, radiologists, and radiology

technologists working together as a team in an

environment that promotes the exchange of

knowledge and information.

1,12,14,16,17

2. Develop and implement effective evidence-

based organization-wide standardized policy and

procedures for the prevention of URFOs through a

collaborative process promoting consistency in

practice to achieve zero defects. Use resources

published by The Joint Commission,

World

Health Organization, American College of

Surgeons,

Association of periOperative

Sentinel Event Alert, Issue 51

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Registered Nurses,

No Thing Left Behind, and

other organizations and publications as a guide.

The policy should apply to all operative and other

invasive procedures, and should address the

following.

A counting procedure should:

• Be performed audibly and visibly by two

persons engaged in the process, usually scrub

tech or scrub nurse and circulating registered

nurse. The surgical team should verbally

acknowledge verification of the count.

• Include counts of items added to the surgical

field throughout the surgery or procedure.

• Include counts of soft goods (including

therapeutic packing), needles/sharps,

instruments, and small miscellaneous items,

and document unretrieved device

fragments.

1,12

• Verify that counts printed on prepackaged

sponges and instrument sets are correct.

1,12

Handle the discrepancy per the organization’s

policy.

• Be performed before the procedure begins, in

order to establish a baseline count; before the

closure of a cavity within a cavity; before

wound closure begins; at skin closure or end

of procedure; and at the time of permanent

relief of either the scrub person or the

circulating registered nurse.

• Be applicable in all settings where invasive

procedures are performed.

• Be reviewed periodically and revised as

appropriate.

12,14

Wound opening and closing procedures should

include:

• Inspection of instruments for signs of breakage

– before and after use – to prevent the

retention of device fragments.

• Adherence to the organization’s established

counting procedure.

• Methodical wound exploration,

1,14

including

visual and, whenever possible, manual

examination.

This can and should be done

for laparoscopic procedures as well.

• Empowerment of any member of the operative

team to call a “closing time out” prior to the

initial closing count to allow for an

uninterrupted count.

Intra-operative radiographs should be performed:

• When the surgical count is “incorrect” (i.e.,

discrepant).The entire surgical field should be

radiographed, and it should be interpreted by a

physician at the completion of the operative

procedure, prior to the patient’s transfer from

the OR. Ensure direct communication between

the surgical team and radiologist. The

requisition should include the name of the

missing item and the results of the radiologic

image should be directly communicated to the

surgical team.

• When the operative procedure is determined

by the surgical team to be at high risk for

retained surgical items, even though

methodical wound exploration has been

performed and the surgical item count is

correct.

• If counts remain unreconciled after initial

radiologic examination, the surgical team

should consider additional imaging or further

wound exploration.

12,21

Effective communication

3. Institute team briefings and debriefings as a

standard part of the surgical procedure to allow the

opportunity for any team member to express

concerns they have regarding the safety of the

patient, including the potential for an URFO. This

will promote open communication among surgical

team members. Examples: Before the procedure

or as part of the time out, the surgeon could remind

the team that the patient or procedure is at risk for

an URFO; during the procedure, a white board

could be used to display the count and to help

foster team awareness and shared

responsibility;

22,23

at the end of the procedure, team

members can raise or be asked about any

concerns related to the procedure or the patient’s

recovery.

Team training, based on crew resource

management (CRM), is effective in promoting

assertiveness and overcoming hierarchical barriers

to communication.

4. Ensure that the surgeon verbally verifies the

results of the counting procedure.

Appropriate documentation

5. Document the results of counts of surgical items,

instruments, or items intentionally left inside a

patient (such as needle or device fragments

deemed safer to remain than remove), and actions

taken if count discrepancies occur.

Tracking

discrepant counts is important to understanding

practical problems; tracking reports and data also

can be discussed at improvement meetings.

Collecting, analyzing and sharing accurate data is

key to understanding your organization’s frequency

or risk of URFOs, identifying the types of URFOs

that occur most frequently, and determining how to

address certain kinds of URFOs.

Safe technology

6. Research the potential of using assistive

technologies

1,12,14,16,24,25

to supplement manual

counting procedures and methodical wound

exploration. More commonly used technologies

Sentinel Event Alert, Issue 51

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include bar-coding to aid counting, radio-opaque

material or radiofrequency (RF) tags to detect

technology-enabled soft goods, and radio

frequency identification (RFID) systems to aid

counting and detection.

8,26

Related Joint Commission requirements

The unintended retention of a foreign object in a

patient after surgery or other invasive procedure is

considered a reviewable sentinel event by The

Joint Commission. Accredited organizations are

expected to respond to sentinel events as part of a

patient safety program outlined in the following

standards and elements of performance (EP) for

hospitals, ambulatory and office-based surgery

facilities.

LD.04.01.07: The organization has policies and

procedures that guide and support patient care,

treatment and services.

LD.04.04.05: The organization has an

organization-wide, integrated patient safety

program [within its performance improvement

activities]. (Wording in brackets is added for

hospitals only.)

EP 5: As part of the safety program, the

leaders create procedures for responding to

system or process failures.

EP 7: The leaders define “sentinel event” and

communicate this definition throughout the

organization.

EP 8: The organization conducts thorough and

credible root cause analyses in response to

sentinel events as described in the "Sentinel

Events" (SE) chapter of the manual.

EP 9: The leaders make support systems

available for staff who have been involved in

an adverse or sentinel event.

RI.01.02.01: The organization respects the

patient’s right to participate in decisions about his

or her care, treatment, and services.

EP 21: The organization informs the patient or

surrogate decision-maker about unanticipated

outcomes of care, treatment, and services that

relate to sentinel events considered reviewable

by The Joint Commission.

EP 22: [Hospitals only] The licensed

independent practitioner responsible for

managing the patient's care, treatment, and

services, or his or her designee, informs the

patient about unanticipated outcomes of care,

treatment, and services related to sentinel

events when the patient is not already aware

of the occurrence or when further discussion is

needed.

Resources

WHO guidelines for safe surgery 2009: safe surgery

saves lives: See Objective 7: The team will prevent

inadvertent retention of instruments and sponges in

surgical wounds, and Objective 9: The team will

effectively communicate and exchange critical

information for the safe conduct of the operation

World Health Organization: Surgical Safety Checklist

Pennsylvania Patient Safety Authority: Retained Foreign

Object Audit Form

References

NoThing Left Behind

: A national surgical patient-safety

project to prevent retained surgical items.

www.nothingleftbehind.org (accessed March 18, 2013)

O’Connor A: When surgeons leave objects behind. The

New York Times, September 24, 2012

Beyond the count: preventing retention of foreign

objects. Pennsylvania Patient Safety Advisory, June

2009;6(2):39-45,

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLi

brary/2009/Jun6(2)/Pages/39.aspx (accessed May 16,

2013

Regenbogen, et al: Prevention of retained surgical

sponges: A decision-analytic model predicting relative

cost-effectiveness. Surgery, 2009;145:527-35

Gawande AA, et al: Risk factors for retained

instruments and sponges after surgery. New England

Journal of Medicine, January 16, 2003;348(3)229-35

Stawicki S, et al: Retained surgical items: a problem yet

to be solved. Journal of the American College of

Surgeons, January 2013;216(1):15-22

Judson, TJ, et al: Miscount incidents: A novel approach

to exploring risk factors for unintentionally retained

surgical items. The Joint Commission Journal on Quality

and Patient Safety, October 2013;39(10):468-473

Tips for reducing retained surgical items. Same-Day

Surgery, September 2009;91-92

Martindell D: Update on the prevention of retained

surgical items. Pennyslvania Patient Safety Advisory,

September 2012;9(3):106-110,

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLi

brary/2012/Sep;9(3)/Pages/106.aspx (accessed May 16,

2013

Chassin M, Loeb J: The ongoing quality improvement

journey: Next stop, high reliability. Health Affairs, April

2011;30(4),

http://content.healthaffairs.org/content/30/4/559.full?ijkey

=UoA7j1SNli6pQ&keytype=ref&siteid=healthaff

(accessed May 14, 2013)

Chassin MR, Loeb JM: High-reliability health care:

Getting there from here. The Milbank Quarterly,

September 2013;91(3):459-490,

http://www.jointcommission.org/high-

reliability_health_care_getting_there_from_here/

(accessed September 25, 2013)

Goldberg JL, Feldman, DL: Implementing AORN

recommended practices for prevention of retained

surgical items. AORN Journal, February 2012;95(2):205-

219

Sentinel Event Alert, Issue 51

Page 5

www.jointcommission.org

Norton EK, Micheli, AJ: Patients count on it: An

initiative to reduce incorrect counts and prevent retained

surgical items. AORN Journal, January 2012;95(1)

American College of Surgeons: Statement on the

prevention of retained foreign bodies after surgery.

2005;90(10):15

Cima RR, et al: Incidence and characteristics of

potential and actual retained foreign object events in

surgical patients. Journal of the American College of

Surgeons, 2008;207:80-87

Cima RR, et al: A multidisciplinary team approach to

retained foreign objects. The Joint Commission Journal

on Quality and Patient Safety, March 2009;35(3):123-132

The Joint Commission: Resources for managing

hospital-acquired conditions. Foreign objects retained

after surgery,

http://www.jcrinc.com/foreign-objects-

retained-after-surgery (accessed March 18, 2013)

Department of Veterans Affairs, Veterans Health

Administration: VHA Directive 2010-017. Washington,

DC,

http://www.va.gov/vhapublications/ViewPublication.asp?p

ub_ID=2186 (accessed June 20, 2013)

U.S. Food and Drug Administration, Public health

notification; unretrieved device fragments. January 15,

2008,

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotic

es/PublicHealthNotifications/ucm062015.htm (accessed

April 15, 2013)

Gibbs VC: Sponge ACCOUNTing System. Methodical

Wound Examination. Online supplement to Same-Day

Surgery, September 2009

World Health Organization: WHO guidelines for safe

surgery 2009: safe surgery saves lives. Geneva,

Switzerland, 2009;pp. 72-75, 78-82,

http://whqlibdoc.who.int/publications/2009/978924159855

2_eng.pdf (accessed May 24, 2013)

ECRI Institute: The case of the missing sponge:

Practice variation is culprit. Risk Management Reporter,

June 2012

Edel, E: Increasing patient safety and surgical team

communication by using a count/time out board. AORN

Journal, October 2010;92:4

White SV, interviewer: Interview with a quality leader:

Dr. Verna Gibbs on surgical safety. Journal for

Healthcare Quality, November/December 2012;34(6):21-

Asiyanbola, et al: Prevention and diagnosis of retained

foreign bodies through the years: past, present and

future technologies. Technology and Health Care,

2012;20(5):379-386

Steelman, VM and Cullen, JJ: Designing a safer

process to prevent retained surgical sponges: A

healthcare failure mode and effect analysis. AORN

Journal, August 2011;94(2):132-141

_________________________________________________

Patient Safety Advisory Group

The Patient Safety Advisory Group informs The Joint

Commission on patient safety issues and, with other

sources, advises on topics and content for Sentinel

Event Alert. Members: James P. Bagian, M.D., P.E.

(chair); Michael Cohen, R.Ph., M.S., Sc.D. (vice chair);

Paul W. Abramowitz, Pharm.D., FASHP; Jane H.

Barnsteiner, R.N., Ph.D., FAAN; James B. Battles, Ph.D.;

William H. Beeson, M.D.; Patrick J. Brennan, M.D.;

Cindy Dougherty, R.N., B.S., CPHQ; Frank Federico,

B.S., R.Ph.; Marilyn Flack; Steven S. Fountain, M.D.;

Suzanne Graham, R.N., Ph.D.; Martin J. Hatlie, Esq.;

Robin R. Hemphill, M.D., M.Ph.; Jennifer Jackson,

B.S.N., J.D.; Paul Kelley, CBET; Heidi B. King, FACHE,

BCC, CMC, CPPS; Jane McCaffrey, M.H.S.A.,

DFASHRM; Mark W. Milner, R.N., M.B.A., CPHQ,

FACHE; Jeanine Arden Ornt, J.D.; Grena Porto, R.N.,

M.S., ARM, CPHRM; Matthew Scanlon, M.D.; Ronni P.

Solomon, J.D.; Dana Swenson, P.E., M.B.A.