- Email: [email protected]
Clinical Issues—May 2012
CONTINUING EDUCATION Clinical Issues
1.4
JOAN C. BLANCHARD, MSS, RN, CNOR, CIC; BONNIE DENHOLM, MS, BSN, RN, CNOR
www.aorn.org/CE Continuing Education Contact Hours
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indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article, reviewing the purpose/goal, and completing the online Learner Evaluation at http://www.aorn.org/CE. Each applicant who successfully completes this program can immediately print a certificate of completion.
This program meets criteria for CNOR and CRNFA recertification, as well as other continuing education requirements. 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: #12514 Session: #0001 Fee: Members $7, Nonmembers $14
Conflict of Interest Disclosures
The contact hours for this article expire May 31, 2015.
Purpose/Goal To educate perioperative nurses about providing safe nursing care throughout the perioperative continuum.
Objectives 1. Discuss practices that could jeopardize safety in the perioperative area. 2. Discuss common areas of concern that relate to perioperative best practices. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care.
Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
The authors of this column have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The behavioral objectives for this program were created by Helen Starbuck Pashley, MA, BSN, RN, CNOR, clinical editor, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Starbuck Pashley and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
Sponsorship or Commercial Support No sponsorship or commercial support was received for this article.
Disclaimer 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.
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Reuse of single-use devices Key words: single-use devices, resterilization, reuse, repurposing of single-use devices.
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Use of long-sleeved perioperative warm-up jackets Key words: perioperative attire, recommended practices for attire.
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Requirements for preoperative fasting Key words: NPO, surgical fasting, preoperative fasting.
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Necessity of medication orders for medications on the sterile field Key words: medication orders, perioperative medication use, ambulatory surgery.
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Reuse of single-use devices
QUESTION: The information on reusing single-use devices is sometimes confusing. We are interested in reusing devices that have been opened but not used and reprocessing other items that have been opened and used and would require reprocessing to be used again. Are these acceptable practices?
ANSWER: If a hospital or health care facility reprocesses a device that was marketed or purchased as a single-use device, the US Food and Drug Administration (FDA) considers the hospital or health care facility to be the manufacturer of that device and, therefore, subject to the same adverse event reporting requirements (ie, medical device reporting) as the original equipment manufacturer or commercial reprocessor.1 Reuse of single-use devices may involve reprocessing items that © AORN, Inc, 2012
have expired but were not used, were opened but not used on a patient (eg, for a procedure that has been rescheduled), were opened onto the sterile field but not used on the patient, or 2 were used on a patient.
In 2000, the FDA released “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,” which provides guidance to third parties and hospitals regard-ing their responsibilities as manufacturers reprocessing devices labeled for single use.1 The FDA requires that the hospital or health care facility meet the same requirements as the original manufacturer. These include that the facility
register with the FDA as a reprocessing firm and list all the products that will be reprocessed, May 2012
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send reports to the FDA regarding adverse events, use a tracking mechanism to report device failures that could result in poor outcomes, remove or make corrections (ie, repair, modification, adjustment, relabeling, destruction, or inspection) for devices that are deemed unsafe, and follow and meet the original manufacturer’s labeling requirements.1
The FDA also requires the sterilization process for reprocessed single-use devices to meet the requirements of the Quality System Regulation (21 CFR Part 820).3 Therefore, a hospital reprocessor must validate the sterilizing equipment and process, control the routine processing, and ensure that only a sterile product is released for use.2
The hospital must maintain documentation that shows it has met the requirements of the Quality System Regulation.3 JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE f f
References 1.
2. 3.
Medical Devices. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. US Food and Drug Administration. http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/ucm107164.htm. Accessed January 25, 2012. Dunn D. Reprocessing single-use devices—regulatory roles. AORN J. 2002;76(1):100-125. Quality System Regulation (21 CFR Part 820). US Food and Drug Administration. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart⫽820. Accessed January 25, 2012.
Resources Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended— Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices. May 1, 2006. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ ucm070934.htm. Accessed January 4, 2012. Congressional testimony from 9/26/2006. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ReprocessingofSingleUseDevices/ucm121067.htm. Accessed January 4, 2012. FDA list of documents relating to single-use devices (Page last updated 9/3/2010, but no new entries after 9/26/2006). US Food and Drug Administration. http://www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ucm121544.htm. Accessed January 4, 2012. FDA reprocessing of single-use devices timeline (Page last updated 5/15/2009, but no new entries after 12/29/2006). US Food and Drug Administration. http://www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ucm121072.htm. Accessed January 4, 2012.
Use of long-sleeved perioperative warm-up jackets
QUESTION: Since the release of the “Recommended practices for surgical attire,” we now have to wear long-sleeved warm-up jackets in the OR. When and why did that change?
ANSWER: There has been no recent change in the recommendation that long-sleeved warm-up jackets be worn in the perioperative setting. AORN first recommended this in 1990 in the “Recommended practices for surgical attire.”1 The current practice recommendations are that non660
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scrubbed personnel, which may include the RN circulator, anesthesia care provider, or any observers, should wear a long-sleeved warm-up jacket that is freshly laundered or is made for single use to prevent dispersal of skin and hair shedding.2,3 Long-sleeved warm-up jackets should be snapped closed when worn to prevent possible contamination of the sterile field by the jacket.2 The cuffs should be worn down to the wrist (ie, not pushed up on the arms) to contain shedding from the arms.2 The longsleeved warm-up jacket should be worn by all nonscrubbed personnel.
CLINICAL ISSUES The rationale for this AORN recommendation is that the jackets prevent skin squames from being dispersed into the air and settling onto the sterile field or the surgical site.1 The dispersal of skin squames could increase the risk of contamination of the surgical site and could result in surgical site infections.2,4-6 Some of the pathogens identified in surgical site infections that may be released with skin squames are Staphylococcus aureus, Streptococcus species, and coagulasenegative staphylococci.4,7 Skin squames from health care personnel also have been identified as the major source of bacteria in the OR; thus, it is important to help contain this shedding with the appropriate use of surgical attire. Loose surgical attire (ie, untucked shirts or short-sleeved scrub tops not worn under scrub jackets) may allow squames dispersal from the chest and axilla.5,8 Scrub tops that are secured at the waist, tucked into the pants, or fit close to the body will help prevent skin squames from being dispersed from the bottom of the scrub top. The importance of these attire recommendations is demonstrated by the fact that individuals lose a complete layer of skin every four days, and walking can result in the loss of as much as 10,000 skin squames per minute.6 In addition to the recommendation to wear certain types of clothing in the OR, the type of material it is made of also is important. For example, cotton fabrics with pores that are greater than 80 micrometers should not be used for surgical scrub attire because the material may allow microorganisms attached to the skin squames to f f
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pass through holes created when the attire was sewn.9 Blended fabrics (eg, cotton/polyester blend) help contain and decrease the amount of shedding.2 JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE References 1.
Recommended practices for surgical attire. In: Standards and Recommended Practices for Perioperative Nursing. Denver, CO: AORN, Inc; 1990:III:19 –1–III:19-5 2. Andersen BM, Solheim N. Occlusive scrub suits in operating theaters during cataract surgery: effect on airborne contamination. Infect Cont Hosp Epidemiol. 2002;23(4): 218-220. 3. Recommended practices for surgical attire. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc. 2012:57-71. 4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR; The Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol. 1999; 20(4):247-278. http://www.cdc.gov/hicpac/pdf/guidelines/ SSI_1999.pdf. Accessed January 4, 2012. 5. Centers for Disease Control and Prevention. Guideline for hand hygiene in health-care settings. MMWR Morb Mortal Wkly Rep. 2002;51(RR-16):1-44. 6. Mitchell NJ, Evans DS, Kerr A. Reduction of skin bacteria in theatre air with comfortable, non-woven disposable clothing for operating-theatre staff. Br Med J. 1978; 1(6114):696-698. 7. Woodhead K, Taylor EW, Bannister G, Chesworth T, Hoffman P, Humphreys H. Behaviors and rituals in the operating theatre. A report from the Hospital Infection Society Working Party on Infection Control in Operating Theatres. J Hosp Infect. 2002;51(4):241-255. 8. Noble WC. Dispersal of skin microorganisms. Br J Dermatol. 1975;93(4):477-485. 9. Tammelin A, Domicel P, Hambraeus A, Stahle E. Dispersal of methicillin-resistant Staphylococcus epidermidis by staff in an operating suite for thoracic and cardiovascular surgery in relation to skin carriage and clothing. J Hosp Infect. 2000;44(2):119-126.
Requirements for preoperative fasting
QUESTION: We have many different surgeons at our facility who write differing orders for NPO times for patients scheduled for surgery. Should all preoperative patients be required to fast beginning at midnight on the day before their surgery? Have fasting require-
ments changed and, if so, what are the rationales for these changes? ANSWER: The practice of telling patients to fast (ie, nothing by mouth or NPO) from midnight the night before until their surgeries take place the following AORN Journal
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day is still common in the United States.1,2 The practice of requiring extended fasting may be based on the ideas that a long fast before anesthesia or sedation may prevent pulmonary aspiration during anesthesia induction or emergence; clear liquids, full liquids (eg, milk; creamed soups; nonstrained, nontransparent juices), and solids have the same gastric emptying time; and an increase in vomiting and pulmonary aspiration can result from ingestion of clear liquids two hours or less before surgery.3-7
At the end of the 19th century, Joseph Lister, a British surgeon, stated that While it is desirable that there should be no solid matter in the stomach when chloroform is administered, it will be found very salutary to give a cup of beef tea about two hours previously.4(p39) This advice was followed until after World War II, when C. L. Mendelson, a New York obstetrician, wrote about an asthma-like syndrome of wheezing, dyspnea, cyanosis, and pulmonary lesions after the aspiration of stomach contents by obstetric patients under general anesthesia who were not intubated.8 To avoid this problem, the standard of care for surgical patients soon became NPO after midnight.4,5,7 Prolonged fasting (eg, more than 12 hours), however, is not without concerns. Patients may become thirsty, hungry, anxious, drowsy, or dizzy while fasting, and prolonged fasting can have adverse physiologic effects that include dehydration, insulin resistance, postoperative hypoglycemia, muscle wasting, and a weakened immune system.9-11 The American Society of Anesthesiologists (ASA) recommends that healthy patients be allowed to have clear liquids for up to two hours before elective surgery or conscious sedation (Table 1). Care should be 662
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taken, however, to determine NPO times in patients who have conditions that affect gastric emptying (eg, disorders of gastric motility, pyloric obstruction, gastroesophageal reflux, diabetic gastroparesis), patients who are at risk for fluid volume problems (eg, infants, pregnant women, elderly patients), or patients in whom airway management may be difficult. The ASA guidelines for preoperative clear liquids are not intended for women who are in labor.9-11 During the past 25 years, the anesthesiology associations in the United States, Canada, and Europe have used supporting research-based evidence to revise their guidelines on preoperative fasting for healthy patients.3-7 This evidence shows that healthy patients who ingest clear liquids a few hours before anesthesia or sedation are as safe and are more comfortable than patients who are asked to fast for six to eight hours before surgery.1,11-13 There is evidence that carbohydraterich, clear liquids given two to three hours before surgery are beneficial.14 The European Society of Clinical Nutrition and Metabolism recommends that carbohydrate-loading liquids can lessen thirst, hunger, the anxiety of having surgery, and the effects of fasting on immune TABLE 1. American Society of Anesthesiologists Preoperative Fasting Guidelines for Healthy Patients of All Ages12
Ingested material
Minimum fasting period in hours
Clear liquids Breast milk Infant formula Nonhuman milk Light meal Regular meal
2 4 6 6 6 8
1. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011;114(3):495-511. 2. Crenshaw JT. Preoperative fasting: will the evidence ever be put into practice? Am J Nurs. 2011;111(10):38-43.
CLINICAL ISSUES function, and they may protect against muscle wasting after surgery.14,15 The risk of aspiration also has been reduced with the use of modern anesthesia practices as well as the use of improved anesthetic agents.5 Patients who drink clear liquids a few hours before surgery have lower gastric volumes and similar or higher gastric pH levels than patients who fast for several hours more. Clear liquids may increase gastric emptying and may decrease the risk of pulmonary aspiration because clear liquids leave the stomach quickly and dilute acidic gastric secretions.16-18 A study conducted from November 1999 to May 2000 found that 91% of 155 patients were instructed to remain NPO after midnight even though the ASA guidelines were in place. This represented an average of being NPO for 12 hours for liquids and 14 hours for solids.1 Researchers conducted a follow-up study of 275 surgical patients from June to October 2004 after a new preoperative fasting policy was put in place and extensive education about the new policy was provided. Their findings showed very little change in practice; 85% of the patients were instructed to remain NPO after midnight.2 The overall resistance to changing fasting times has been attributed to
providers being unaware of ASA guideline changes,19 fear of pulmonary aspiration,9 the perception that longer fasting times are safer,9 use of IV fluids to compensate for lengthy fasting,3,5 the belief that instructions for differing fasting durations (ie, solids, liquids, clear liquids) would be confusing for patients,20 the belief that individualized instructions would require more time and personnel,20 and
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the belief that long fasts provide the surgical team with the ability to make scheduling changes.7,20
A prospective study of 5,420 consecutively scheduled patients who were given revised instructions for clear liquids, however, showed that these revisions resulted in no cancellations or delays because of nonadherence to fasting instructions.21 In a systematic review of 22 randomized controlled trials, researchers found that patients who drank clear liquids up to 90 minutes before surgery had no more risk of vomiting, aspiration, or associated morbidity during anesthesia or sedation than patients who were fasting.13 Health care personnel should use this information to enhance the comfort and safety of healthy patients scheduled for surgical procedures. JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE References 1. 2.
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5. 6.
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Crenshaw JT, Winslow EH. Preoperative fasting: old habits die hard. Am J Nurs. 2002;102(5):36-44. Crenshaw JT, Winslow EH. Preoperative fasting duration and medication instruction: are they improving? AORN J. 2008;88(6):963-976. de Aguilar-Nascimento JE, Doc Nascimento DB. Reducing postoperative fasting time: a trend based on evidence. World J Gastrointest Surg. 2010;2(3):57-60. Maltby JR. Fasting from midnight—the history behind the dogma. Best Pract Res Clin Anaesthesiol. 2006; 20(3):363-378. Pandit UA, Pandit SK. Fasting before and after ambulatory surgery. J Perianesth Nurs. 1997;12(3):181-187. Søreide E, Ljungqvist O. Modern preoperative fasting guidelines: a summary of the present recommendations and remaining questions. Best Pract Res Clin Anaesthesiol. 2006;20(3):483-481. Stuart PC. The evidence base behind modern fasting guidelines. Best Pract Res Clin Anaesthesiol. 2006; 20(3):457-469. Mendelson CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946;52;191-205. American Society of Anesthesiologists Committee on Standards and Practice Parameters. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of
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Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011;114(3):495-511. 10. American Society of Anesthesiologists Task Force on Preoperative Fasting. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anesthesiologists Task Force on Preoperative Fasting. Anesthesiology. 1999; 90(3):896-905. 11. American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non- Anesthesiologists. Practice guidelines for sedation and analgesia by nonanesthesiologists. Anesthesiology. 2002;96(4):10041017. 12. Brady M, Kinn S, Ness V, O’Rourker K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009;(4):CD005285. 13. Brady M, Kinn S, Stuart P. Preoperative fasting for adults for preventing complications. Cochrane Database Syst Rev. 2003;(4):CD004423. 14. Braga M, Lingqvist O, Soeters P, Fearon K, Weimann A, Bozetti F. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009;28(4):378-86.
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Crenshaw JT. Preoperative fasting: will the evidence ever be put into practice? Am J Nurs. 2011;111(10): 38-43. Agawal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989;44(8):632-634. Maltby JR. Gastric fluid volume, pH and emptying in elective inpatients. Influences of narcotic-atropine premedication, oral fluid, and ranitidine. Can J Anaesth. 1988;35(6):562-566. Sutherland AD, Maltby JR, Sale JP, Redi CR. The effect of preoperative oral fluid and ranitidine on gastric fluid volume and pH. Can J Anaesth. 1987;34(2):117121. Bosse G, Breuer JP, Speis C. The resistance to changing guidelines—what are the challenges and how to meet them. Best Pract Res Clin Anaesthesiol. 2006; 20(3):379-395. Doswell WM, Jones MA, O’Donnell JM. One size may not fit all: it’s not always possible— or appropriate—to use the ASA guidelines for preoperative fasting. Am J Nurs. 2002;102(6):58-61. Murphy GS, Ault ML, Wong HY, Szokol JW. The effect of the new NPO policy on operating room utilization. J Clin Anesthesia. 2000;12(1):48-51.
Necessity of medication orders for medications on the sterile field
QUESTION: We are preparing for a Centers for Medicare & Medicaid Services (CMS) inspection and have some disagreement about whether an order is necessary for all medications administered in the OR. Do we need to have an order for the medications transferred to the sterile field if they are going to be administered by the person prescribing the medication?
ANSWER: Two important issues should be considered when addressing medication orders: who is administering the medication, and is there an accurate record of all medications administered during the perioperative phases of care. In an e-mail communication on October 31, 2011, Mary Ellen Palowitch, MHA, RN, hospital program analyst for CMS, stated that policies and procedures relating to medication orders must address the following: 664
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All drugs or biologicals given by individuals who do not have prescriptive authority must have an order for their administration. All drugs or biologicals administered to a patient, regardless of who is actually administering the medication (ie, individuals with prescriptive authority versus those with no prescriptive authority), must be documented in the medical record.
The CMS State Operations Manual Appendix L—Guidance for Surveyors: ASCs (Rev 76, 1222-11) under Q-0181 standard 416.48(a) interpretive guidelines states that The ASC must have policies and procedures designated to promote medication administration consistent with acceptable standards. The policies and procedures should address issues including, but not limited to: A physician or other qualified member of the medical staff acting within their scope of practice must issue an order for all drugs or biologicals administered in the ASC.1
CLINICAL ISSUES The CMS State Operations Manual Appendix A—Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev 78, 12-23-11) under A-0406 standard 482-23(c)(2) interpretive guidelines states that All orders for drugs and biologicals, with the exception of influenza and pneumococcal polysaccharide vaccines must be documented and signed by a practitioner who is authorized to write orders by hospital policy and in accordance with state laws, and who is responsible for the care of the patients as specified under §482.12(c).2 In her e-mail, Palowitch clarified that Surveyors should be looking for orders for medications that are administered by someone other than those with prescriptive authority. There does not need to be an order for medications administered by individuals with prescriptive authority; however, every medication administered needs to be documented. Medications that are transferred to the sterile field should be transferred as close as possible to the time of administration. When asked whether medications that will be given by the prescriber at the sterile field need to be transferred to the sterile field under the supervision of the one who will administering the medication, Palowitch stated, “the timing of the transfer to the sterile field is irrelevant; who administers the medication is relevant” when deciding the need for a written medication order. The time-out process should include identifying medications that are planned for the procedure as well as dose limits, patient allergies, and any other special instructions pertaining to the medication plan. Because it is not unusual for a medication to be handled by the RN circulator and the scrub person before it is administered by the prescriber at the sterile field, good communication is essential when transferring medications to the sterile field. The RN circulator should implement the following safety practices to reduce the risk of
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a medication error when transferring medications to the sterile field: verify the medication name, strength, dosage, and expiration date, as well as the established medication dose limits concurrently with the perioperative team member receiving the medication on the sterile field; transfer one medication at a time; and establish an environment without distraction or interruption at the time of the transfer.2
Immediately upon receipt of the medication on the sterile field, the person receiving the medication should implement the following safety practices: label the medication container by including the medication name, strength, and concentration; and confirm the medication verbally when handing a medication to the licensed independent practitioner for subsequent administration, even when only one medication is on the sterile field.3
Both the RN circulator and the scrub person should verify all medications on the sterile field with the relief person during any personnel changes (eg, shift relief, breaks).3 Policies and procedures for documentation and medication orders in the OR should be consistent with other areas of the health care organization (eg, intensive care unit, emergency department, labor and delivery unit) where RNs may prepare medication for the prescriber who administers it. Requirements for medication orders may vary according to state laws and accreditation agencies. Perioperative administrators should collaborate with pharmacists to establish policies and procedures relating to medication orders. They should direct specific questions to state and federal regulatory agencies or the accreditation agency that has deemed status for their organization. BONNIE DENHOLM MS, BSN, RN, CNOR PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE AORN Journal
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References 1.
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CMS Appendix L: Guidance for surveyors: ambulatory surgical centers [Rev. 76, 12-22-11]. In: State Operations Manual. Washington, DC: Centers for Medicare & Medicaid Services; 2011. http://www.cms.gov/manuals/ Downloads/som107ap_l_ambulatory.pdf. Accessed February 8, 2012. 2. CMS Appendix A: Survey protocol, regulations, and interpretive guidelines for hospitals [Rev 78, 12-2211]. In: State Operations Manual. Washington, DC: Centers for Medicare & Medicaid Services; 2011.
http://www.cms.gov/manuals/Downloads/som107ap_1_ hospitals.pdf. Accessed February 8, 2012. 3. Recommended practices for medication safety. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2012:251-300.
Resources AORN Video Library: Medication Safety. Ciné-Med, 2012. http://cine-med.com/index.php?nav⫽aorn. Accessed January 5, 2012. Medication Safety: How do you measure up? [AORN webinar]. AORN, Inc. http://www.aorn.org/Events/Webinars/ Webinars.aspx. Accessed January 5, 2012.
The authors of this column have no declared affiliations that could be perceived as posing potential conflicts 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
© AORN, Inc, 2012
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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 1.4 continuing education contact hour (84-minute) program:
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JOAN C. BLANCHARD, MSS, RN, CNOR, CIC; BONNIE DENHOLM, MS, BSN, RN, CNOR
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indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article, reviewing the purpose/goal, and completing the online Learner Evaluation at http://www.aorn.org/CE. Each applicant who successfully completes this program can immediately print a certificate of completion.
This program meets criteria for CNOR and CRNFA recertification, as well as other continuing education requirements. 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: #12514 Session: #0001 Fee: Members $7, Nonmembers $14
Conflict of Interest Disclosures
The contact hours for this article expire May 31, 2015.
Purpose/Goal To educate perioperative nurses about providing safe nursing care throughout the perioperative continuum.
Objectives 1. Discuss practices that could jeopardize safety in the perioperative area. 2. Discuss common areas of concern that relate to perioperative best practices. 3. Describe implementation of evidence-based practice in relation to perioperative nursing care.
Accreditation AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
The authors of this column have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article. The behavioral objectives for this program were created by Helen Starbuck Pashley, MA, BSN, RN, CNOR, clinical editor, with consultation from Susan Bakewell, MS, RN-BC, director, Perioperative Education. Ms Starbuck Pashley and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
Sponsorship or Commercial Support No sponsorship or commercial support was received for this article.
Disclaimer 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.
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CLINICAL ISSUES
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This Month f f
Reuse of single-use devices Key words: single-use devices, resterilization, reuse, repurposing of single-use devices.
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Use of long-sleeved perioperative warm-up jackets Key words: perioperative attire, recommended practices for attire.
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Requirements for preoperative fasting Key words: NPO, surgical fasting, preoperative fasting.
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Necessity of medication orders for medications on the sterile field Key words: medication orders, perioperative medication use, ambulatory surgery.
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Reuse of single-use devices
QUESTION: The information on reusing single-use devices is sometimes confusing. We are interested in reusing devices that have been opened but not used and reprocessing other items that have been opened and used and would require reprocessing to be used again. Are these acceptable practices?
ANSWER: If a hospital or health care facility reprocesses a device that was marketed or purchased as a single-use device, the US Food and Drug Administration (FDA) considers the hospital or health care facility to be the manufacturer of that device and, therefore, subject to the same adverse event reporting requirements (ie, medical device reporting) as the original equipment manufacturer or commercial reprocessor.1 Reuse of single-use devices may involve reprocessing items that © AORN, Inc, 2012
have expired but were not used, were opened but not used on a patient (eg, for a procedure that has been rescheduled), were opened onto the sterile field but not used on the patient, or 2 were used on a patient.
In 2000, the FDA released “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,” which provides guidance to third parties and hospitals regard-ing their responsibilities as manufacturers reprocessing devices labeled for single use.1 The FDA requires that the hospital or health care facility meet the same requirements as the original manufacturer. These include that the facility
register with the FDA as a reprocessing firm and list all the products that will be reprocessed, May 2012
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send reports to the FDA regarding adverse events, use a tracking mechanism to report device failures that could result in poor outcomes, remove or make corrections (ie, repair, modification, adjustment, relabeling, destruction, or inspection) for devices that are deemed unsafe, and follow and meet the original manufacturer’s labeling requirements.1
The FDA also requires the sterilization process for reprocessed single-use devices to meet the requirements of the Quality System Regulation (21 CFR Part 820).3 Therefore, a hospital reprocessor must validate the sterilizing equipment and process, control the routine processing, and ensure that only a sterile product is released for use.2
The hospital must maintain documentation that shows it has met the requirements of the Quality System Regulation.3 JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE f f
References 1.
2. 3.
Medical Devices. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. US Food and Drug Administration. http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/ucm107164.htm. Accessed January 25, 2012. Dunn D. Reprocessing single-use devices—regulatory roles. AORN J. 2002;76(1):100-125. Quality System Regulation (21 CFR Part 820). US Food and Drug Administration. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart⫽820. Accessed January 25, 2012.
Resources Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended— Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices. May 1, 2006. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ ucm070934.htm. Accessed January 4, 2012. Congressional testimony from 9/26/2006. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ReprocessingofSingleUseDevices/ucm121067.htm. Accessed January 4, 2012. FDA list of documents relating to single-use devices (Page last updated 9/3/2010, but no new entries after 9/26/2006). US Food and Drug Administration. http://www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ucm121544.htm. Accessed January 4, 2012. FDA reprocessing of single-use devices timeline (Page last updated 5/15/2009, but no new entries after 12/29/2006). US Food and Drug Administration. http://www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ucm121072.htm. Accessed January 4, 2012.
Use of long-sleeved perioperative warm-up jackets
QUESTION: Since the release of the “Recommended practices for surgical attire,” we now have to wear long-sleeved warm-up jackets in the OR. When and why did that change?
ANSWER: There has been no recent change in the recommendation that long-sleeved warm-up jackets be worn in the perioperative setting. AORN first recommended this in 1990 in the “Recommended practices for surgical attire.”1 The current practice recommendations are that non660
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scrubbed personnel, which may include the RN circulator, anesthesia care provider, or any observers, should wear a long-sleeved warm-up jacket that is freshly laundered or is made for single use to prevent dispersal of skin and hair shedding.2,3 Long-sleeved warm-up jackets should be snapped closed when worn to prevent possible contamination of the sterile field by the jacket.2 The cuffs should be worn down to the wrist (ie, not pushed up on the arms) to contain shedding from the arms.2 The longsleeved warm-up jacket should be worn by all nonscrubbed personnel.
CLINICAL ISSUES The rationale for this AORN recommendation is that the jackets prevent skin squames from being dispersed into the air and settling onto the sterile field or the surgical site.1 The dispersal of skin squames could increase the risk of contamination of the surgical site and could result in surgical site infections.2,4-6 Some of the pathogens identified in surgical site infections that may be released with skin squames are Staphylococcus aureus, Streptococcus species, and coagulasenegative staphylococci.4,7 Skin squames from health care personnel also have been identified as the major source of bacteria in the OR; thus, it is important to help contain this shedding with the appropriate use of surgical attire. Loose surgical attire (ie, untucked shirts or short-sleeved scrub tops not worn under scrub jackets) may allow squames dispersal from the chest and axilla.5,8 Scrub tops that are secured at the waist, tucked into the pants, or fit close to the body will help prevent skin squames from being dispersed from the bottom of the scrub top. The importance of these attire recommendations is demonstrated by the fact that individuals lose a complete layer of skin every four days, and walking can result in the loss of as much as 10,000 skin squames per minute.6 In addition to the recommendation to wear certain types of clothing in the OR, the type of material it is made of also is important. For example, cotton fabrics with pores that are greater than 80 micrometers should not be used for surgical scrub attire because the material may allow microorganisms attached to the skin squames to f f
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pass through holes created when the attire was sewn.9 Blended fabrics (eg, cotton/polyester blend) help contain and decrease the amount of shedding.2 JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE References 1.
Recommended practices for surgical attire. In: Standards and Recommended Practices for Perioperative Nursing. Denver, CO: AORN, Inc; 1990:III:19 –1–III:19-5 2. Andersen BM, Solheim N. Occlusive scrub suits in operating theaters during cataract surgery: effect on airborne contamination. Infect Cont Hosp Epidemiol. 2002;23(4): 218-220. 3. Recommended practices for surgical attire. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc. 2012:57-71. 4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR; The Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol. 1999; 20(4):247-278. http://www.cdc.gov/hicpac/pdf/guidelines/ SSI_1999.pdf. Accessed January 4, 2012. 5. Centers for Disease Control and Prevention. Guideline for hand hygiene in health-care settings. MMWR Morb Mortal Wkly Rep. 2002;51(RR-16):1-44. 6. Mitchell NJ, Evans DS, Kerr A. Reduction of skin bacteria in theatre air with comfortable, non-woven disposable clothing for operating-theatre staff. Br Med J. 1978; 1(6114):696-698. 7. Woodhead K, Taylor EW, Bannister G, Chesworth T, Hoffman P, Humphreys H. Behaviors and rituals in the operating theatre. A report from the Hospital Infection Society Working Party on Infection Control in Operating Theatres. J Hosp Infect. 2002;51(4):241-255. 8. Noble WC. Dispersal of skin microorganisms. Br J Dermatol. 1975;93(4):477-485. 9. Tammelin A, Domicel P, Hambraeus A, Stahle E. Dispersal of methicillin-resistant Staphylococcus epidermidis by staff in an operating suite for thoracic and cardiovascular surgery in relation to skin carriage and clothing. J Hosp Infect. 2000;44(2):119-126.
Requirements for preoperative fasting
QUESTION: We have many different surgeons at our facility who write differing orders for NPO times for patients scheduled for surgery. Should all preoperative patients be required to fast beginning at midnight on the day before their surgery? Have fasting require-
ments changed and, if so, what are the rationales for these changes? ANSWER: The practice of telling patients to fast (ie, nothing by mouth or NPO) from midnight the night before until their surgeries take place the following AORN Journal
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day is still common in the United States.1,2 The practice of requiring extended fasting may be based on the ideas that a long fast before anesthesia or sedation may prevent pulmonary aspiration during anesthesia induction or emergence; clear liquids, full liquids (eg, milk; creamed soups; nonstrained, nontransparent juices), and solids have the same gastric emptying time; and an increase in vomiting and pulmonary aspiration can result from ingestion of clear liquids two hours or less before surgery.3-7
At the end of the 19th century, Joseph Lister, a British surgeon, stated that While it is desirable that there should be no solid matter in the stomach when chloroform is administered, it will be found very salutary to give a cup of beef tea about two hours previously.4(p39) This advice was followed until after World War II, when C. L. Mendelson, a New York obstetrician, wrote about an asthma-like syndrome of wheezing, dyspnea, cyanosis, and pulmonary lesions after the aspiration of stomach contents by obstetric patients under general anesthesia who were not intubated.8 To avoid this problem, the standard of care for surgical patients soon became NPO after midnight.4,5,7 Prolonged fasting (eg, more than 12 hours), however, is not without concerns. Patients may become thirsty, hungry, anxious, drowsy, or dizzy while fasting, and prolonged fasting can have adverse physiologic effects that include dehydration, insulin resistance, postoperative hypoglycemia, muscle wasting, and a weakened immune system.9-11 The American Society of Anesthesiologists (ASA) recommends that healthy patients be allowed to have clear liquids for up to two hours before elective surgery or conscious sedation (Table 1). Care should be 662
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taken, however, to determine NPO times in patients who have conditions that affect gastric emptying (eg, disorders of gastric motility, pyloric obstruction, gastroesophageal reflux, diabetic gastroparesis), patients who are at risk for fluid volume problems (eg, infants, pregnant women, elderly patients), or patients in whom airway management may be difficult. The ASA guidelines for preoperative clear liquids are not intended for women who are in labor.9-11 During the past 25 years, the anesthesiology associations in the United States, Canada, and Europe have used supporting research-based evidence to revise their guidelines on preoperative fasting for healthy patients.3-7 This evidence shows that healthy patients who ingest clear liquids a few hours before anesthesia or sedation are as safe and are more comfortable than patients who are asked to fast for six to eight hours before surgery.1,11-13 There is evidence that carbohydraterich, clear liquids given two to three hours before surgery are beneficial.14 The European Society of Clinical Nutrition and Metabolism recommends that carbohydrate-loading liquids can lessen thirst, hunger, the anxiety of having surgery, and the effects of fasting on immune TABLE 1. American Society of Anesthesiologists Preoperative Fasting Guidelines for Healthy Patients of All Ages12
Ingested material
Minimum fasting period in hours
Clear liquids Breast milk Infant formula Nonhuman milk Light meal Regular meal
2 4 6 6 6 8
1. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011;114(3):495-511. 2. Crenshaw JT. Preoperative fasting: will the evidence ever be put into practice? Am J Nurs. 2011;111(10):38-43.
CLINICAL ISSUES function, and they may protect against muscle wasting after surgery.14,15 The risk of aspiration also has been reduced with the use of modern anesthesia practices as well as the use of improved anesthetic agents.5 Patients who drink clear liquids a few hours before surgery have lower gastric volumes and similar or higher gastric pH levels than patients who fast for several hours more. Clear liquids may increase gastric emptying and may decrease the risk of pulmonary aspiration because clear liquids leave the stomach quickly and dilute acidic gastric secretions.16-18 A study conducted from November 1999 to May 2000 found that 91% of 155 patients were instructed to remain NPO after midnight even though the ASA guidelines were in place. This represented an average of being NPO for 12 hours for liquids and 14 hours for solids.1 Researchers conducted a follow-up study of 275 surgical patients from June to October 2004 after a new preoperative fasting policy was put in place and extensive education about the new policy was provided. Their findings showed very little change in practice; 85% of the patients were instructed to remain NPO after midnight.2 The overall resistance to changing fasting times has been attributed to
providers being unaware of ASA guideline changes,19 fear of pulmonary aspiration,9 the perception that longer fasting times are safer,9 use of IV fluids to compensate for lengthy fasting,3,5 the belief that instructions for differing fasting durations (ie, solids, liquids, clear liquids) would be confusing for patients,20 the belief that individualized instructions would require more time and personnel,20 and
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the belief that long fasts provide the surgical team with the ability to make scheduling changes.7,20
A prospective study of 5,420 consecutively scheduled patients who were given revised instructions for clear liquids, however, showed that these revisions resulted in no cancellations or delays because of nonadherence to fasting instructions.21 In a systematic review of 22 randomized controlled trials, researchers found that patients who drank clear liquids up to 90 minutes before surgery had no more risk of vomiting, aspiration, or associated morbidity during anesthesia or sedation than patients who were fasting.13 Health care personnel should use this information to enhance the comfort and safety of healthy patients scheduled for surgical procedures. JOAN C. BLANCHARD MSS, RN, CNOR, CIC PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE References 1. 2.
3.
4.
5. 6.
7.
8.
9.
Crenshaw JT, Winslow EH. Preoperative fasting: old habits die hard. Am J Nurs. 2002;102(5):36-44. Crenshaw JT, Winslow EH. Preoperative fasting duration and medication instruction: are they improving? AORN J. 2008;88(6):963-976. de Aguilar-Nascimento JE, Doc Nascimento DB. Reducing postoperative fasting time: a trend based on evidence. World J Gastrointest Surg. 2010;2(3):57-60. Maltby JR. Fasting from midnight—the history behind the dogma. Best Pract Res Clin Anaesthesiol. 2006; 20(3):363-378. Pandit UA, Pandit SK. Fasting before and after ambulatory surgery. J Perianesth Nurs. 1997;12(3):181-187. Søreide E, Ljungqvist O. Modern preoperative fasting guidelines: a summary of the present recommendations and remaining questions. Best Pract Res Clin Anaesthesiol. 2006;20(3):483-481. Stuart PC. The evidence base behind modern fasting guidelines. Best Pract Res Clin Anaesthesiol. 2006; 20(3):457-469. Mendelson CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946;52;191-205. American Society of Anesthesiologists Committee on Standards and Practice Parameters. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of
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Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011;114(3):495-511. 10. American Society of Anesthesiologists Task Force on Preoperative Fasting. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: a report by the American Society of Anesthesiologists Task Force on Preoperative Fasting. Anesthesiology. 1999; 90(3):896-905. 11. American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non- Anesthesiologists. Practice guidelines for sedation and analgesia by nonanesthesiologists. Anesthesiology. 2002;96(4):10041017. 12. Brady M, Kinn S, Ness V, O’Rourker K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009;(4):CD005285. 13. Brady M, Kinn S, Stuart P. Preoperative fasting for adults for preventing complications. Cochrane Database Syst Rev. 2003;(4):CD004423. 14. Braga M, Lingqvist O, Soeters P, Fearon K, Weimann A, Bozetti F. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009;28(4):378-86.
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15.
16.
17.
18.
19.
20.
21.
Crenshaw JT. Preoperative fasting: will the evidence ever be put into practice? Am J Nurs. 2011;111(10): 38-43. Agawal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989;44(8):632-634. Maltby JR. Gastric fluid volume, pH and emptying in elective inpatients. Influences of narcotic-atropine premedication, oral fluid, and ranitidine. Can J Anaesth. 1988;35(6):562-566. Sutherland AD, Maltby JR, Sale JP, Redi CR. The effect of preoperative oral fluid and ranitidine on gastric fluid volume and pH. Can J Anaesth. 1987;34(2):117121. Bosse G, Breuer JP, Speis C. The resistance to changing guidelines—what are the challenges and how to meet them. Best Pract Res Clin Anaesthesiol. 2006; 20(3):379-395. Doswell WM, Jones MA, O’Donnell JM. One size may not fit all: it’s not always possible— or appropriate—to use the ASA guidelines for preoperative fasting. Am J Nurs. 2002;102(6):58-61. Murphy GS, Ault ML, Wong HY, Szokol JW. The effect of the new NPO policy on operating room utilization. J Clin Anesthesia. 2000;12(1):48-51.
Necessity of medication orders for medications on the sterile field
QUESTION: We are preparing for a Centers for Medicare & Medicaid Services (CMS) inspection and have some disagreement about whether an order is necessary for all medications administered in the OR. Do we need to have an order for the medications transferred to the sterile field if they are going to be administered by the person prescribing the medication?
ANSWER: Two important issues should be considered when addressing medication orders: who is administering the medication, and is there an accurate record of all medications administered during the perioperative phases of care. In an e-mail communication on October 31, 2011, Mary Ellen Palowitch, MHA, RN, hospital program analyst for CMS, stated that policies and procedures relating to medication orders must address the following: 664
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All drugs or biologicals given by individuals who do not have prescriptive authority must have an order for their administration. All drugs or biologicals administered to a patient, regardless of who is actually administering the medication (ie, individuals with prescriptive authority versus those with no prescriptive authority), must be documented in the medical record.
The CMS State Operations Manual Appendix L—Guidance for Surveyors: ASCs (Rev 76, 1222-11) under Q-0181 standard 416.48(a) interpretive guidelines states that The ASC must have policies and procedures designated to promote medication administration consistent with acceptable standards. The policies and procedures should address issues including, but not limited to: A physician or other qualified member of the medical staff acting within their scope of practice must issue an order for all drugs or biologicals administered in the ASC.1
CLINICAL ISSUES The CMS State Operations Manual Appendix A—Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev 78, 12-23-11) under A-0406 standard 482-23(c)(2) interpretive guidelines states that All orders for drugs and biologicals, with the exception of influenza and pneumococcal polysaccharide vaccines must be documented and signed by a practitioner who is authorized to write orders by hospital policy and in accordance with state laws, and who is responsible for the care of the patients as specified under §482.12(c).2 In her e-mail, Palowitch clarified that Surveyors should be looking for orders for medications that are administered by someone other than those with prescriptive authority. There does not need to be an order for medications administered by individuals with prescriptive authority; however, every medication administered needs to be documented. Medications that are transferred to the sterile field should be transferred as close as possible to the time of administration. When asked whether medications that will be given by the prescriber at the sterile field need to be transferred to the sterile field under the supervision of the one who will administering the medication, Palowitch stated, “the timing of the transfer to the sterile field is irrelevant; who administers the medication is relevant” when deciding the need for a written medication order. The time-out process should include identifying medications that are planned for the procedure as well as dose limits, patient allergies, and any other special instructions pertaining to the medication plan. Because it is not unusual for a medication to be handled by the RN circulator and the scrub person before it is administered by the prescriber at the sterile field, good communication is essential when transferring medications to the sterile field. The RN circulator should implement the following safety practices to reduce the risk of
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a medication error when transferring medications to the sterile field: verify the medication name, strength, dosage, and expiration date, as well as the established medication dose limits concurrently with the perioperative team member receiving the medication on the sterile field; transfer one medication at a time; and establish an environment without distraction or interruption at the time of the transfer.2
Immediately upon receipt of the medication on the sterile field, the person receiving the medication should implement the following safety practices: label the medication container by including the medication name, strength, and concentration; and confirm the medication verbally when handing a medication to the licensed independent practitioner for subsequent administration, even when only one medication is on the sterile field.3
Both the RN circulator and the scrub person should verify all medications on the sterile field with the relief person during any personnel changes (eg, shift relief, breaks).3 Policies and procedures for documentation and medication orders in the OR should be consistent with other areas of the health care organization (eg, intensive care unit, emergency department, labor and delivery unit) where RNs may prepare medication for the prescriber who administers it. Requirements for medication orders may vary according to state laws and accreditation agencies. Perioperative administrators should collaborate with pharmacists to establish policies and procedures relating to medication orders. They should direct specific questions to state and federal regulatory agencies or the accreditation agency that has deemed status for their organization. BONNIE DENHOLM MS, BSN, RN, CNOR PERIOPERATIVE NURSING SPECIALIST AORN CENTER FOR NURSING PRACTICE AORN Journal
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References 1.
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CMS Appendix L: Guidance for surveyors: ambulatory surgical centers [Rev. 76, 12-22-11]. In: State Operations Manual. Washington, DC: Centers for Medicare & Medicaid Services; 2011. http://www.cms.gov/manuals/ Downloads/som107ap_l_ambulatory.pdf. Accessed February 8, 2012. 2. CMS Appendix A: Survey protocol, regulations, and interpretive guidelines for hospitals [Rev 78, 12-2211]. In: State Operations Manual. Washington, DC: Centers for Medicare & Medicaid Services; 2011.
http://www.cms.gov/manuals/Downloads/som107ap_1_ hospitals.pdf. Accessed February 8, 2012. 3. Recommended practices for medication safety. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2012:251-300.
Resources AORN Video Library: Medication Safety. Ciné-Med, 2012. http://cine-med.com/index.php?nav⫽aorn. Accessed January 5, 2012. Medication Safety: How do you measure up? [AORN webinar]. AORN, Inc. http://www.aorn.org/Events/Webinars/ Webinars.aspx. Accessed January 5, 2012.
The authors of this column have no declared affiliations that could be perceived as posing potential conflicts 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
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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 1.4 continuing education contact hour (84-minute) program:
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