CLINICAL ISSUES
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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 Protocol™3 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 patient’s 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 500
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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 Editor’s 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.
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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: checklists—translating 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.
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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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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 patient’s health record and bed should be labeled accordingly. Latex-free alternative items should be collected and stored in a AORN Journal
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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 patient’s 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 guideline”7 provides additional information, including definitions, pathophysiology, prevention strategies, and strategies for managing latex-allergic individuals. f f
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 labeling—FDA 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 allergy—a 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 patient’s 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 patient’s 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.
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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 FaqId⫽223&ProgramId⫽1. 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
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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 Center’s 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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© AORN, Inc, 2011