adherence

Adherence to a Medication Safety Protocol: Current Practice for Labeling Medications and Solutions on the Sterile Field

DIANA BROWN-BRUMFIELD, RN, APRN-BC, MSN, CNS, CNOR; AGRIPINA DeLEON, RN, MSN, CNOR

ABSTRACT

Medication labeling omissions in the OR and the adverse events that result from them remain a challenge in health care facilities. Standardization of protocols based on guidance from the Joint Commission, AORN, the Institute for Safe Medication Practices, and other organizations is important to ensure that patients do not mistakenly receive the wrong medication. A clinical nurse specialist and a perioperative education coordinator at the Cleveland Clinic, Cleveland, Ohio, undertook a direct observation quality im-provement project to assess the adherence of 21 nurses and 19 surgical technologists to a revised medication and solution labeling protocol implemented in February 2008. Results showed that overall, 70% of staff members adhered to the medication and solution labeling protocol but adherence varied among specialty areas. There was increased adherence to the protocol by junior staff members compared with more experienced staff members. AORN J 91 (May 2010) 610-617. AORN, Inc, 2010. doi: 10.1016/j.aorn.2010.03.002

Key words: medication safety protocol, perioperative errors, medication labeling.

Medication errors in the perioperative setting are recognized as a serious po-tential threat to patient safety,1 and the

practice of safe medication dispensing and label-ing requires consistency across the perioperative spectrum. The Joint Commission focused atten-tion on this issue in 2006 via the National Patient Safety Goals, which direct health care providers to immediately label all medications, medication containers (eg, syringes, medicine cups, basins), and other solutions on and off the sterile field in perioperative and other procedural settings.2 In

2007, specific requirements were added to the goal, stating that all labels should include the medications name, strength, amount, and expira-tion date.3 Each medication should be labeled as it is dispensed, even when there is only one medi-cation or solution on the surgical field.3

Additional process expectations include that no more than one medication or solution should be labeled at a time. If, during the perioperative pe-riod, a solution or medication that is removed from its original container will be used over the course of a procedure, the receiving container

doi: 10.1016/j.aorn.2010.03.002

610AORN Journal May 2010 Vol 91 No 5 AORN, Inc, 2010

MEDICATION SAFETY PROTOCOLwww.aornjournal.org

must be labeled immediately when that medica-tion or solution is transferred from the original packaging. All labels should be verified both ver-bally and visually by two qualified individuals when the person preparing the medication is not the person administering the medication.3

Proactive prevention of medication errors in perioperative settings is vital to positive patient outcomes. To this end, AORN has produced a guidance statement to aid clinicians in the devel-opment and implementation of policies and proce-dures related to safe medication practices in set-tings where invasive procedures are performed.4 AORN also took a leadership role in addressing this issue by developing a Safe Medication Ad-ministration Tool Kit5 that provides strategies that are consistent with evidence-based practice to reduce medication error in the perioperative area.

Despite these recommendations and practice guidelines, there continue to be nationwide prob-lems with medication labeling compliance. This article describes a quality improvement (QI) project we conducted in the OR at the Cleveland Clinic, Cleveland, Ohio, for the purpose of as-sessing staff adherence to a revised medication and solution labeling protocol that was created based on recommendations from the Joint Com-mission and AORN.

THE NEED FOR STANDARDIZATION

Unlabeled medications and solutions on the sterile field have caused many errors and some tragic outcomes. One of the earliest case reports ap-peared in the July 1989 Medication Error Re-ports in Hospital Pharmacy. During an enucle-ation of a cancerous eye, an unlabeled specimen cup containing glutaraldehyde was misidentified as spinal fluid.6 The anesthesiologist had aspirated spinal fluid to decrease the patients ocular pres-sure and had placed it in a small vial marked SF on the sterile field for reinjection at the end of the surgery. An ophthalmology resident entered the room to retrieve the eye for biopsy, but be-cause the specimen was not yet ready to be taken,

he left the specimen storage container on the ster-ile field and left the OR. The container, which was not labeled, contained glutaraldehyde to pre-serve the eye. Near the end of the procedure, the anesthesiologist accidentally administered an intra-thecal injection of the glutaraldehyde, believing it was the patients spinal fluid. The patient experi-enced immediate cardiac arrest and later died.

The Institute for Safe Medication Practices (ISMP) has also reported incidents involving un-labeled medications in procedural settings.7 In Seattle, Washington, a woman died after she was injected with an antiseptic skin preparation solu-tion instead of the intended contrast media.7,8 In another incident, a physician mistakenly applied a germicidal detergent with a pH of 13 to a male patients genitals, believing that it was vinegar. The patient experienced severe burns.7,8

These cases clearly demonstrate that incidents of unlabeled medication in the OR can result in tragic errors, and they support the need for addi-tional diligence in this area of perioperative prac-tice. In each of these cases, a root cause analysis suggested review and revision of current practice and, when analyzed, supported the implementa-tion of standardization in methods for identifying solutions and medications on the sterile field.

Findings from the 2004 ISMP Medication Safety Self Assessment, which included data gath-ered from more than 1,600 hospitals, showed that less than half of staff members (41%) always labeled containers (eg, syringes, basins, other medication or solution storage containers) on the sterile field.9 Forty-two percent applied labels in-consistently, and 18% did not label medications and solutions on the sterile field at all.9 Although these results represented an improvement from the 2000 ISMP findings (ie, 25% reported consistent labeling; 24% reported no labeling), surprisingly, this basic safety measure has not been widely implemented in hospitals.9 This is especially dis-turbing because surgical patients typically are se-dated and cannot intervene on their own behalf and, therefore, may be more vulnerable to

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medication or solution errors. Perioperative pa-tients also are vulnerable to harmful medication errors resulting from poor communication during hand offs and lack of coordination throughout the surgical process.

The 2005 MEDMARX Data Report identified more than 11,000 perioperative medication error records submitted during a seven-year period.10 Errors were segregated by clinical location (ie, outpatient surgery, preoperative holding area, OR, postanesthesia care unit) and by patient popula-tion (ie, pediatric, adult, geriatric). More than 45 recommendations to avoid future errors were given in the report. Some of the recommendations included the following:

The surgical team should expand the time out to allow review of the preference card, confir-mation of the medication directions, confirma-tion of patient allergies, and confirmation of preprocedural antibiotic administration.

Clinicians should adhere to the practice of repeat and verify during hand offs between scrub personnel and surgeons.

Clinicians must examine policies and proce-dures for accuracy and clarity.

Managers must examine why policies are not being followed, which may include an assess-ment of the practitioners awareness of the policies.

Verbal communication between the circulating nurse and scrub person must be clear, and both must confirm the medications on the ster-ile field as well as the labeling of the medica-tions on the field.

All medications should be labeled to accom-modate the needs of the anesthesia care provider.

Medications should be labeled in accordance with generally accepted safety standards (eg, product name, strength, name of staff member preparing).

Miscommunication, inadequate documentation, and failure to follow procedures and protocols

were the most common causes of medication er-rors noted in the report.10

The OR is an area of practice in which many medications are routinely used and multiple medi-cations may be used during individual surgical procedures. One study showed that preference cards listed an average of 4.93 medications.11 A single procedure may require multiple categories of medications that can include topical and local anesthetics, contrast dyes, gases, antibiotics, anti-coagulants, and solutions, with or without addi-tives, that are administered by various routes. Ad-ditionally, high-alert medications (ie, medications that have the highest risk of causing injury when misused), such as heparin and epinephrine, are commonly used in the OR. The researchers found that 14% of preference cards included three high-alert medications.11 High-alert medications re-quire astute handling because of the potential life-threatening events associated with their misuse. Many medications and solutions are clear and look similar (eg, local anesthetics, whether plain or with additives) but have much different ac-tions. When they are unlabeled on the sterile field, there may be no way to safely determine what they are.

THE QI PROJECT

We (ie, a clinical nurse specialist [CNS] and a perioperative education coordinator) conducted a field observation of nurses and surgical technolo-gists with varied amounts of OR experience working in eight different surgical specialty areas to assess staff member adherence to a revised medication and solution labeling protocol. The revised protocol was developed based on recom-mendations from the Joint Commission and AORN, and it was implemented in February 2008. Staff members received education on the new protocol at the time it was implemented.

The design of this project was similar to that of a previous project that assessed staff member adherence to the surgical instrument count policy using OR field observation.12 The observational

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Figure 1. Project sample size and team role.

questions framed for this project included the following:

Would staff members (ie, nurses, surgical technologists) dispense medications and label them according to the medication and solution labeling protocol?

Would adherence to the medication and solu-tion labeling protocol differ by surgical specialty?

Would adherence to the medication and solu-tion labeling protocol differ by years of staff member experience?

We submitted this project to the institutional re-view board at the Cleveland Clinic and the board deemed it a QI project; thus, no sanctions were associated with this project.

Sample

The project sample consisted of nurses (n 21), certified surgical technologists (n 7), and non-certified surgical technologists (n 12) assigned to surgical procedures identified for this project.

One nurse functioned as a scrub person (Figure 1). Ten of the RNs had more than 20 years of experience, 11 of the RNs had less than 20 years

of experience, and all of the surgical technologists had less than 20 years of experience. Surgical specialties included vascular, pediatrics, gynecol-ogy, urology, general surgery, plastics/ENT, neu-rology, and colorectal surgery.

Measures/Instruments

The CNS (ie, the primary investigator) and the perioperative nurse educators (ie, seven experi-enced perioperative staff members) composed the eight-question data collection tool for this field project. This tool consists of four survey ques-tions and four observation questions designed to assess staff members experience and practice behavior (Figure 2). Content validity was based on

the extensive surgical experience of the nurse educators and the CNS and their in-depth knowledge of industry standards regarding medication and solution labeling and

item material content that is directly related to the new Cleveland Clinic medication and solu-tion protocol.

Data Collection

The primary investigator identified surgical proce-dures the day before they were scheduled to occur and reconfirmed them on the same day the data were collected, in case some procedures were cancelled or others were added on. She selected surgical procedures in which frequent medication and solution use was routine and procedures that she determined to be that days optimal opportu-nities or most desirable situations for data collec-tion. The primary investigator varied the surgical specialties (eg, vascular, pediatrics, general) ob-served during the data collection period.

A Nurse of the Future student served as the observer and data collector for this project. The Nurse of the Future program is designed to ex-pand high school students knowledge of science and medicine while exposing them to the wide range of career paths in nursing at the Cleveland Clinic, its community hospitals, and family health

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Figure 2. Data collection form.

centers. This summer internship gives top stu-dents throughout northeast Ohio the opportunity to work and learn alongside nurses in facilities that have earned Magnet status.

The student had worked in this facility the pre-vious summer and was accustomed to the periop-erative environment. In addition, we provided her with an intensive orientation to surgical aseptic technique; perioperative team roles; scrubbing, gowning, and gloving techniques; medication pro-tocol; and the data collection tool. The OR staff members were accustomed to having summer stu-dents observe in the OR, so this was not an un-usual practice. To prevent the Hawthorne effect (ie, the phenomenon in which participants in be-havioral studies change their performance in re-

sponse to being observed), staff members were informed that the student would be observing team dynamics.

This intern program has rigorous criteria for admittance, and the students are considered to be temporary employees who complete hospital ori-entation before coming to their respective clinical areas. Compliance with Health Insurance Portabil-ity and Accountability Act regulations and confi-dentiality are part of their orientation. Patients did not have to give their permission for the students presence because this project was an observation of staff members only.

We briefed the observer for each surgical pro-cedure. The observer used the data collection tool to achieve consistency and to facilitate data

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Figure 3. Adherence to the medication and solution safety protocol.

collection in the OR. The tool included informa-tion on specific services and procedures. She completed forms at the start of each procedure and during relief of scrub or circulating person-nel. She observed the hand-off communication for the medications and solutions.

We provided the observer with a script of ques-tions to ask staff members about the service, status, and length of time in the OR as well as questions about the type of procedure being performed. Data were collected for five days in the OR for surgical procedures scheduled during routine business hours. We reviewed all data collected each day with the observer, and she placed all completed data forms in a file in a secure location known only to us.

Data Analysis

We performed descriptive statistics and analysis with the collected data. The analysis included a written narrative, as well as a presentation with tables and graphs for added clarity and detail.

RESULTS

The observer collected data on 24 surgical proce-dures during a five-day period. This represents the total number of surgical procedures that were available for data collection during the designated period. Eighty-five percent of the time, the data collector observed staff members identifying med-ications and solutions according to the revised protocol. She observed team members labeling medication and solution containers immediately before or after dispensing them onto the surgical field 70% of the time, reconfirming medications and solutions during the procedure 60% of the time, and reviewing all medications and solutions during break, relief, or shift change 75% of the time (Figure 3).

Additionally, the project provided the insight that lack of adherence to the protocol was some-what related to length of employment. In most of the categories observed, nurses with more than 20 years of experience had a higher rate of nonad-herence to the protocol, whereas staff members with less than 20 years of experience were more compliant (Table 1). This was consistent with the earlier QI project on surgical counts in which it was noted that more senior staff members had their own methods and were comfortable that their method worked. They justified this by the fact that they had not experienced problems. Peo-ple who have done something repetitively for a long time without ill effects are often resistant to change. The less-senior staff members were more open to modifying their practice and more accepting of explanations about why the change was needed.

The rate of adherence with the protocol also varied by specialty area, creating an inconsistency of practice among the specialites. Standardizing

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TABLE 1. Compliance With Elements of the Medication and Solution Labeling Protocol by Staff Members Years of Experience

Staff members with less than

Staff members with more than

20 years of experience (n30)

20 years of experience (n10)

Compliant withNot compliant

Compliant withNot compliant

protocolwith protocol

protocolwith protocol

Identified medications/solutions25 (83%)5(17%)8 (80%)2 (20%)

Labeled medications/solutions22 (73%)8(27%)6 (60%)4 (40%)

Reconfirmed medications/20 (67%)10(33%)5 (50%)5 (50%)

solutions during the

procedure

Reviewed medications/22 (73%)8(27%)8 (80%)2 (20%)

solutions during relief or

break

practice is important; however, the investigators recognize that staff members have acceptable variations in how they execute the protocol

and apply it to their practice. With more than 300 staff members and 80 ORs, it is virtually

impossible to monitor how staff members practice daily. In almost every instance, the more-compliant areas were those with the newer staff members and the less-compliant areas were those with the more senior staff members, regardless of the spe-cialty area.

DISCUSSION

Medication dispensing and labeling by OR per-sonnel according to protocol was less than 100%. The rate of adherence varied among specialties, and use of the protocol was inconsistent. Staff members with less than 20 years of experience were more compliant with the medication and solution protocol than staff members with more than 20 years of experience. The results of this project suggest that senior team members may be more reluctant to change their practice patterns, although the sample of senior team members was small, so these results would need further investigation.

To promote an environment of safety for all surgical patients and to mentor new nurses and

others, we must advocate for accountability to maintain a level of competency in our profession and not rely on the way we have always done it. Thus, a focus on reeducation and competency development for all staff members is crucial to break the pattern of apathy that results in resis-tance seen in the OR in regard to policy or proto-col changes.

Recommendations

Our goal is to improve the quality of the current standard of practice to 100% adherence for all staff members in all services by communicating these findings and providing additional education on the protocol, specifically by

improving communication hand offs during breaks, relief, and shift change;

developing a quarterly competency review; and updating orientation modules.

We have identified this as a high-priority com-petency and plan to incoporate it into our annual competency requirements for all staff members.

This QI project will serve as a pilot project to uncover indications for further investigation and provide guidance for other educational activities that support and foster patient safety in the peri-operative environment.

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CONCLUSION

The surgical team is responsible for using all rea-sonable measures to protect the patient. Medica-tion errors in the perioperative setting pose a potentially significant threat to patient safety. Team members must acknowledge that serious medication errors can and do occur even if they themselves have never been involved in a medica-tion mishap. Established guidelines, best practice recommendations, and protocols are available and should be diligently followed to decrease the like-lihood of medication labeling errors and injury to the patients who rely on our care.

Acknowledgement: The authors thank Patricia Adler, PhD, RN, CNS, senior nurse researcher at the Cleveland Clinic Foundation, Cleveland, OH, and Diamond Haynes, student peer mentor, the Cleveland Clinic, for their assistance with the project described in this article.

References

Thompson CA. Surgical units have high potential for harmful medication errors, USP says. AJHP News. May 1, 2007. http://www.ashp.org/import/news/

HealthSystemPharmacyNews/newsarticle.aspx?id 2535. Accessed February 2, 2010.

2006 National Patient Safety Goals. The Joint Commis-sion. http://www.jointcommission.org/PatientSafety/ NationalPatientSafetyGoals/06_npsgs.htm. Accessed February 2, 2010.

2007 National Patient Safety Goals. The Joint Commis-sion. http://www.jointcommission.org/NR/rdonlyres/ 98572685-815E-4AF3-B1C4-C31B6ED22E8E/0/ 07_hap_npsgs.pdf. Accessed February 2, 2010.

AORN guidance statement: safe medication practices in perioperative settings across the lifespan. In: Standards, Recommended Practices, and Guidelines. Denver, CO:

AORN, Inc; 2010:665-671.

Safe Medication Administration Tool Kit. AORN, Inc. http://www.aorn.org/PracticeResources/ToolKits/Safe MedicationAdministrationToolKit. Accessed February 2, 2010.

Cohen MR. Medication error reports. Hosp Pharm. 1989;24(7):549.

Loud wake-up call: unlabeled containers lead to pa-tients death. ISMP Medication Safety Alert! December 2, 2004. Institute for Safe Medication Practices. http:// www.ismp.org/Newsletters/acutecare/articles/20041202.asp. Accessed February 2, 2010.

Unraveling the unlabeled containers issue. ISMP Medi-cation Safety Alert! June 18, 1997. Institute for Safe Medical Practices. http://www.ismp.org/Newsletters/ acutecare/articles/19970618.asp. Accessed February 2, 2010.

Error alert: unlabeled basins in sterile field [news re-lease]. Horsham, PA: Institute for Safe Medication Practices; December 2, 2004. http://www.ismp.org/ pressroom/PR20041202.pdf. Accessed February 2, 2010.

Hicks RW, Becker SC, Cousins DD. MEDMARX Data Report: A Chartbook of Medication Error Find-ings from the Perioperative Settings from 1998-2005.

Rockville, MD: USP Center for the Advancement of Patient Safety; 2006. http://www.usp.org/pdf/EN/ medmarx/2005MEDMARXReport.pdf. Accessed Febru-ary 2, 2010.

Dawson A, Orsini MJ, Cooper MR, Wollenburg K. Medication safetyreliability of preference cards. AORN J. 2005;82(3):399-414.

Brown-Brumfield D. Adherence to new CCF surgical instrument count policy. Poster presented at: 54th An-nual AORN Congress; March 11-15, 2007; Orlando, FL.

Diana Brown-Brumfield, RN, APRN-BC, MSN, CNS, CNOR, is the clinical nurse spe-cialist and manager for perioperative education at the Cleveland Clinic, Cleveland, OH. Ms Brown-Brumfield has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.

Agripina DeLeon, RN, MSN, CNOR, is the education coordinator for perioperative services at the Cleveland Clinic, Cleveland, OH. Ms DeLeon has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.

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Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.

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