CLINICAL ISSUES

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This Month
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Developing a surgical checklist

Key words: surgical safety checklist, patient safety.

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Updating a latex allergy policy and procedure

Key words: latex, allergy, sensitivity.

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Establishing a policy and procedure for maintaining surgical

patient images
Key words: digital imaging, privacy, informed consent, patients rights.

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Developing a surgical checklist

QUESTION:
We have assembled a multidisciplinary team to
develop a surgical checklist. The checklist will
be generic in form and tested in a select cohort
of surgical patients. Is there evidence to support using a checklist? What items should we
include in the checklist? We are using the
AORN Comprehensive Surgical Checklist,1 the
World Health Organization (WHO) Surgical
Safety Checklist,2 and the Joint Commission
Universal Protocol3 as guides.

ANSWER:
The use of a surgical checklist has been found to
affect patient safety in a variety of ways. One of
the better known research studies4 was conducted

to determine whether using the Surgical Safety

Checklist based on the WHO Guidelines for Safe
Surgery5 would improve team communication and
lead to reduced complications and death rates for
surgical patients. Facilities in eight cities around
the world, including Seattle, Washington, participated. Overall, there were improvements in surgical outcomes for patients at least 16 years of age
who underwent noncardiac inpatient surgeries.
Rates of postoperative complications (eg, deep
vein thrombosis, surgical site infection, unplanned
return to the OR) declined at all participating test
sites from 11% at baseline to 7% after implementation of the checklist.4
de Vries et al6 conducted a study in six hospitals in The Netherlands to test the Surgical Patient

indicates that continuing education contact hours are available for this activity. Earn the contact hours by
reading this article, reviewing the purpose/goal and objectives, and completing the online Learner Evaluation at
http://www.aorn.org/CE. The contact hours for this article expire April 30, 2014.
doi: 10.1016/j.aorn.2011.01.005

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CLINICAL ISSUES
Safety System (SURPASS), a multidisciplinary
comprehensive checklist that was used from admission to discharge. After implementation of the
checklist, the total number of complications for
patients in all six hospitals decreased by 16.7%.
The study included a control group of five hospitals in which complication and mortality rates did
not change significantly during the study period.
This result increased the likelihood that the complication rates in the test group decreased as a
result of use of the checklist.
Lingard et al7 studied the effects of using a
perioperative checklist and team briefing on communication. Surgeons, anesthesia professionals,
and nurses participated in a preoperative team
briefing in the form of a checklist for patients
undergoing elective general surgery. Trained observers collected data before and after implementation of the briefing. The outcome measure was
the total number of communication failures for
each surgical procedure. Most of the briefings
occurred either before or after induction of general anesthesia. One of the more important findings was that the number of communication
failures that were linked to at least one observed
negative consequence declined by 64% postintervention.
Berenholtz et al8 evaluated implementation of a
one-page briefing and debriefing tool to determine
its effect on team members perceptions. The surgical team conducted the briefing portion after the
patient was positioned and before skin incision.
The circulating nurse conducted the debriefing
after the first closing count. The average lengths
of time were 2.9 minutes for the briefing and 2.5
minutes for the debriefing. Results showed that
team members recognized the value of the tool,
and its use improved interdisciplinary communication and teamwork.
Makary et al9 evaluated implementation of a
team briefing to determine its effect on team
members perceptions. Surgical personnel completed a questionnaire before and after implementation of an OR briefing program. Items in the

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questionnaire related to coordination of care and

awareness of the surgical site. Results indicated
that after implementation of the OR team briefing,
surgical team members perceived that risk of
wrong site surgery was reduced and collaboration
among team members increased.
Several important questions will be generated
during the process of developing a checklist.
These questions will relate to

supportive evidence,
items to include on the list,
mandating use of the checklist,
team member buy-in,
implementation, and
quality measures.

The first step in developing a surgical checklist is

to review the current evidence on the topic. In
addition, an understanding of the workplace systems and needs of the team requires knowledge of
human factors engineering. Human factors engineering is the study of how human capabilities
and limitations relate to a system, product, or process. It recognizes that humans have limitations
and that these limitations should be factored into
the design of a safe, effective, and efficient system.10 Knowledge of human factors engineering
leads to a better-developed checklist that is more
closely matched to the users needs.
Determining which items to include in the
checklist depends on several factors. It is important to standardize the who, what, when, how, and
by whom.11 The team may begin by asking the
following questions while keeping in mind the
need to keep the checklist brief:
Are there specific items that must be included
because of regulatory or accreditation
requirements?
Is the item critical for patient safety?
Is the item a standard of care that is already
practiced?
Would the item be missed if it were not included on the checklist?

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Are there specific items that have been identified as being performed inconsistently and
thus creating risks to patient safety?
Can certain items be bundled into one
checkpoint?

Many checklists are designed to address specific points in time (eg, preoperative, time out,
postoperative), so each time should be clearly
defined. For example, the purpose of the time out
is to facilitate communication and perform a final
check for identification of the correct patient, site,
and procedure. Team members may identify items
that are more critical at one point in time than at
another. Marking of the surgical site should be
completed during the preoperative phase, not after
the patient is draped. There should be a section in
the checklist that allows the team members to introduce themselves and freely speak up regarding any
concerns they have about the patient or process.
Open-ended questions should be encouraged (eg,
Are there any questions about specimens?).
The team should avoid creating the perception
that the checklist is nothing more than a series of
boxes to be checked off by rote. It is critical that
team members use the checklist because they believe that it increases patient safety, not because
they are mandated to do so. Checklists can be paper
forms or part of an electronic health record. Some
facilities do not require an actual box to be checked,
and in some facilities, the checklist is not maintained as part of the patients health record.
After the checklist is developed, it should be pilot
tested. Quality measures should be used to evaluate
the usefulness of the checklist. Specific areas to
evaluate include the amount of time required to
complete the list, negative effects on patient or caregiver safety, and team member feedback.11 Team
members should recognize that the checklist is an
evolving tool that will change as newer evidence to
support patient safety practices becomes available.
AORN has several resources that can be used during the development and implementation of a surgical checklist, including the Comprehensive Surgical
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Checklist1; human factors,12 patient hand off13 and

correct site surgery14 tool kits; and the Recommended practices for transfer of patient care
information.15
Editors note: Universal Protocol is a trademark of
the Joint Commission, Oakbrook Terrace, IL.
ROBIN CHARD
PhD, RN, CNOR
PERIOPERATIVE NURSING SPECIALIST
AORN CENTER FOR NURSING PRACTICE
References
1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

AORN Comprehensive Surgical Checklist. AORN, Inc.

http://www.aorn.org/PracticeResources/ToolKits/Correct
SiteSurgeryToolKit/Comprehensivechecklist. Accessed
January 3, 2011.
Surgical Safety Checklist. World Health Organization.
http://whqlibdoc.who.int/publications/2009/97892415985
90_eng_Checklist.pdf. Accessed January 19, 2011.
Universal Protocol. The Joint Commission. http://www
.jointcommission.org/standards_information/up.aspx.
Accessed January 19, 2011.
Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery
Saves Lives Study Group. A surgical safety checklist to
reduce morbidity and mortality in a global population.
N Engl J Med. 2009;360(5):491-499.
World Health Organization. WHO Guidelines for Safe
Surgery 2009: Safe Surgery Saves Lives. Geneva, Switzerland: WHO Press; 2009:98.
de Vries EN, Prins HA, Crolla R, et al; SURPASS Collaborative Group. Effect of a comprehensive surgical
safety system on patient outcomes. N Engl J Med.
2010;363(20):1928-1937.
Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons,
nurses, and anesthesiologists to reduce failures in communication. Arch Surg. 2008;143(1):12-17.
Berenholtz SM, Schumacher K, Hayanga AJ, et al.
Implementing standardized operating room briefings
and debriefings at a large regional medical center. Jt
Comm J Qual Patient Saf. 2009;35(8):391-397.
Makary MA, Mukherjee A, Sexton JB, et al. Operating
room briefings and wrong site surgery. J Am Coll Surg.
2007;204(2):236-243.
Boston-Fleischhauer CB. Enhancing healthcare process
design with human factors engineering and reliability
science, part 1: setting the context. J Nurs Adm. 2008;
38(1):27-32.
Winters BD, Gurses AP, Lehmann H, Sexton JB,
Rampersad CJ, Provovost PJ. Clinical review: checkliststranslating evidence into practice. Crit Care.
2009;13(6):210.
Human Factors in Health Care Tool Kit. AORN, Inc.
http://www.aorn.org/PracticeResources/ToolKits/Human
FactorsInHealthCareToolKit. Accessed January 3, 2011.
Perioperative Patient Hand-Off Tool Kit. AORN, Inc.
http://www.aorn.org/PracticeResources/ToolKits/Patient
HandOffToolKit. Accessed January 3, 2011.

CLINICAL ISSUES
14.

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Correct Site Surgery Tool Kit. AORN, Inc. http://

www.aorn.org/PracticeResources/ToolKits/CorrectSite
SurgeryToolKit. Accessed January 3, 2011.

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15.

Updating a latex allergy policy and procedure

QUESTION:
We are updating our policy and procedure for
patients with latex allergies. Are there new
practice changes that we should be aware of?

ANSWER:
A sharp increase in reported latex allergies began
in the late 1980s after implementation of standard
precautions by the Centers for Disease Control
and Prevention.1 The new precautions caused an
increase in the annual use of surgical gloves from
800 million to more than 20 billion.2 The increased use of gloves and other latex products led
to an increase in natural rubber latex (NRL)associated reactions (eg, sensitivity, allergy), including anaphylaxis. As a result, in 1997, the US
Food and Drug Administration required that all
medical devices containing latex be labeled as
such and carry a caution that latex can cause allergic reactions.3 Since that time, practices such
as advanced identification of patients with latex
allergies, room preparation to minimize or avoid
use of latex products, and ensuring the availability of latex-free products have become routine.
Currently, people who are sensitized to NRL
are grouped according to risk:
less than 1% of the general population in the
United States (ie, approximately 3 million
people);
8% to 17% of health care workers;
patients who have undergone multiple surgical
procedures, and
up to 68% of children with spina bifida because of frequent surgeries.4

Latex allergies are defined as

type I (ie, immediate-type sensitivity);
type IV (ie, delayed-type hypersensitivity);
and

irritant contact dermatitis.

Type I is the most serious; reactions occur within

minutes of exposure. Routes of exposure include

Recommended practices for transfer of patient care information. In: Perioperative Standards and Recommended
Practices. Denver, CO: AORN, Inc; 2010:371-377.

direct external contact (ie, to gloves or other

latex products);
airborne exposure;
direct contact of the mucous membranes;
internal patient exposure from health care provider use of NRL gloves during surgical procedures; and
internally placed devices (eg, wound drains).5

People who have other types of allergies, such as

food allergies (eg, banana, kiwi, avocado), hay
fever, and asthma, also may be at increased risk
for NRL-associated reactions.6
Critical areas that should be addressed in a latex allergy policy and procedure include
measures to identify patients at risk,
patient education, and
interventions developed to reduce undue latex
exposure.

First and foremost, a latex-safe environment is

recommended. A latex-safe environment is one in
which every reasonable effort has been made to
prevent high-allergen and airborne latex sources
from coming into direct contact with affected individuals.7 Health care providers should assess all
patients undergoing a surgical or invasive procedure for NRL-associated reactions. This can be
done by using a separate screening questionnaire
or can be included in the general preoperative
assessment tool. A patient who is identified as
latex sensitized or latex allergic should wear a
wristband, bracelet, or other form of identification, and the patients health record and bed
should be labeled accordingly. Latex-free alternative items should be collected and stored in a
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quick-access location (eg, a cart) for ease of identification and use. As a result of the increased
number of latex-free products now available,
some facilities are becoming completely latexfree, so a cart may not be needed to store latexfree alternatives. Health care providers must communicate about the patients allergy or sensitivity
through all phases and transfers of care.
Some interventions remain controversial
because of limited or dated evidence. For example, if the facility is latex safe, the patient with a
latex sensitivity need not be scheduled to undergo
the first procedure of the day. If the facility is not
latex safe, however, best practice would dictate
that the patient be scheduled first in the morning
because it is assumed that the inactivity in the
room during the previous evening hours causes
the content of latex-coated powder in the ambient
air to be lowest in the morning.8,9
The only safe treatment for individuals with
latex allergy or sensitivity includes complete
avoidance of latex.10 Attentive team members
supported by a strong policy and procedure can
provide a safe environment for patients who may
be at risk for NRL-associated reactions. The
AORN latex guideline7 provides additional information, including definitions, pathophysiology,
prevention strategies, and strategies for managing
latex-allergic individuals.
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ROBIN CHARD
PhD, RN, CNOR
PERIOPERATIVE NURSING SPECIALIST
AORN CENTER FOR NURSING PRACTICE
References
1.

Centers for Disease Control. Recommendations for prevention of HIV transmission in health-care settings.
MMWR. 1987;36:S2.
2. Center for Devices and Radiological Health. Medical
Glove Powder Report. Rockville, MD: Food and Drug
Administration; 1987.
3. Natural rubber-containing medical devices; user
labelingFDA final rule. Fed Regist. 1997;62(189):
51021-51030.
4. Latex allergy statistics. American Latex Allergy Association. http://www.latexallergyresources.org/topics
/LatexAllergyStatistics.cfm. Accessed December 10,
2010.
5. Weissman DN, Lewis DM. Allergic and latex-specific
sensitization: route, frequency, and amount of exposure
that are required to initiate IgE production. J Allergy
Clin Immunol. 2002;110(Suppl 2):57S-63S.
6. Brown R, Schauble J, Hamilton R. Prevalence of latex
allergy among anesthesiologists: identification of sensitized but asymptomatic individuals. Anesthesiology.
1998;89(2):287-289.
7. AORN latex guideline. In: Perioperative Standards and
Recommended Practices. Denver, CO: AORN, Inc;
2010:555-570.
8. Lieberman P. Anaphylactic reactions during surgical
and medical procedures. J Allergy Clin Immunol. 2002;
110(Suppl 2):64S-69S.
9. Reider N, Kretz B, Menardi G, Ulmer H, Fritsch P.
Outcome of a latex avoidance program in a high-risk
population for latex allergya five-year follow-up
study. Clin Exp Allergy. 2002;32(5):708-713.
10. Demaegd J, Soetens F, Herregods L. Latex allergy: a
challenge for anaesthetists. Acta Anaesthesiol Belg.
2006;57(2):127-135.

Establishing a policy and procedure for maintaining surgical

patient images

QUESTION:
Which practices should our department have
in place regarding patient images that are
taken during minimally invasive surgery?
ANSWER:
New technology may drive practice changes, and
a facility should have a policy and procedure related to patient images (eg, videotaping, digital
images, photographs) that are taken during minimally invasive surgery and other invasive pro502

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cedures. Policy content should include, but not be

limited to,
disclosure of information,
access to and use of databases,
access to and use of images, and
1
data security.

Additional information specific to images can include ownership rights, storage and release of
images, patient authorization for release, and patient informed consent.2 The policy must comply

CLINICAL ISSUES
with the Standards of Privacy and Security of the
Health Insurance Portability and Accountability
Act (HIPAA),3 which requires patient authorization for the release of protected health information for purposes beyond treatment, payment, and
health care operations.
Aside from regulations and laws, content to
include in the patient consent for imaging is
dependent on each health care organization. If
images are taken as part of a research study, an
institutional review board or HIPAA-directed privacy board should approve of taking the images.
This type of consent should be incorporated into
the overall consent that the patient signs to participate in the research study.2
According to the Joint Commission, a health
care facility can film, photograph, or videotape
the patient but only if the patient or an individual
designated by the patient (eg, family member,
significant other) gives consent. If the patient or
designated individual is unable to give consent,
the facility may film, videotape, or photograph
patient care activities; however, the organization
must have a written policy stating that informed
consent is required before the patients film or
videotape can be used for any purpose.4 In the
event that the patient does not give consent, the
images should be destroyed or that portion which
contains patient information should be removed.
If photographs and digital images are kept in the
patients health record, confidentiality practices

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should be in place as determined by the facility.

For example, depending on the size, photographs
and digital images can be kept in sealed envelopes in the patient health record.2
As patient advocates, perioperative nurses are
concerned about privacy and confidentiality issues for their patients. All policies and procedures related to these concerns should have
clear language; adhere to existing laws, regulation, and accreditation requirements; and be
subject to periodic review. The less ambiguous
perioperative nurses are about the interventions
to ensure patient privacy and confidentiality,
the more confident patients will be in entrusting
their care.
ROBIN CHARD
PhD, RN, CNOR
PERIOPERATIVE NURSING SPECIALIST
AORN CENTER FOR NURSING PRACTICE
References
1.

2.

3.

4.

Recommended practices for minimally invasive surgery.

In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2010:139-173.
American Health Information Management Association.
Practice brief. Patient photography, videotaping, and
other imaging (updated). J AHIMA. 2001;72(6):64M64Q.
OCR Privacy Brief. Summary of the HIPAA Privacy
Rule. Washington, DC: US Department of Health and
Human Services; 2003.
Patient rights and informed consent when videotaping or
filming. The Joint Commission. http://www.jointcommission
.org/standards_information/jcfaqdetails.aspx?Standards
FaqId223&ProgramId1. Accessed December 10,
2010.

The author of this column has no declared affiliations that could be perceived as posing a potential
conflict of interest in the publication of this article.

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LEARNER EVALUATION
CONTINUING EDUCATION PROGRAM

1.2

Clinical Issues

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his evaluation is used to determine the extent to

which this continuing education program met
your learning needs. The evaluation is printed
here for your convenience. To receive continuing education credit, you must complete the Learner
Evaluation online at http://www.aorn.org/CE. Rate
the items as described below.
PURPOSE/GOAL
To educate perioperative nurses about providing safe
nursing care throughout the perioperative continuum.
OBJECTIVES
To what extent were the following objectives of this
continuing education program achieved?
1. Discuss practices that could jeopardize safety in
the perioperative area.
Low 1. 2. 3. 4. 5. High
2. Discuss common areas of concern that relate to
perioperative best practices.
Low 1. 2. 3. 4. 5. High
3. Describe implementation of evidence-based practice in relation to perioperative nursing care.
Low 1. 2. 3. 4. 5. High
CONTENT
4. To what extent did this article increase your
knowledge of the subject matter?
Low 1. 2. 3. 4. 5. High
5. To what extent were your individual objectives
met? Low 1. 2. 3. 4. 5. High
6. Will you be able to use the information from this
article in your work setting? 1. Yes 2. No

7. Will you change your practice as a result of

reading this article? (If yes, answer question
#7A. If no, answer question #7B.)
7A. How will you change your practice? (Select all
that apply)
1. I will provide education to my team regarding
why change is needed.
2. I will work with management to change/implement a policy and procedure.
3. I will plan an informational meeting with physicians to seek their input and acceptance of
the need for change.
4. I will implement change and evaluate the effect of the change at regular intervals until the
change is incorporated as best practice.
5. Other:
7B. If you will not change your practice as a result
of reading this article, why? (Select all that
apply)
1. The content of the article is not relevant to my
practice.
2. I do not have enough time to teach others
about the purpose of the needed change.
3. I do not have management support to make a
change.
4. Other:
8. Our accrediting body requires that we verify
the time you needed to complete the 1.2 continuing education contact hour (72-minute) program:

This program meets criteria for CNOR and CRNFA recertification, as well as other continuing education requirements.
AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centers Commission on Accreditation.
AORN recognizes these activities as continuing education for registered nurses. This recognition does not imply that AORN or the American Nurses Credentialing Center
approves or endorses products mentioned in the activity.
AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this
activity for relicensure.

Event: #11008; Session: #4061 Fee: Members $6, Nonmembers $12

The deadline for this program is April 30, 2014.
Each applicant who successfully completes this program can immediately print a certificate of completion.

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