We are all familiar with the adage “What you see is what you get.” But can we rely on it when it comes to safe medication administration in the perioperative setting — or should “Looks are deceiving” be our motto?

This module explores patient safety goals, related challenges, and strategies for effective medication and solution labeling on and off the sterile field in the perioperative environment. Perioperative nurses must be knowledgeable about these concepts so they can promote patient safety and desirable outcomes.

Play it safe

Safe and effective patient care is the very core of perioperative practice. The Association of periOperative Registered Nurses (AORN), the professional organization of perioperative registered nurses, has published Perioperative Patient Focused Model, which recognizes that “there is nothing more important to the practicing perioperative nurse than his or her patient.”¹ Materials such as the AORN Standards, Recommended Practices and Guidelines, articles in peer-reviewed journals, research, safe practice guidelines, and tool kits provide valuable resources for safe patient care. However, failures in patient care processes and systems still occur and can result in errors in patient care. These occurrences and “near misses” can harm patients. When the error is detected before the care or treatment is administered (a “good catch”), patient harm is avoided. Sometimes, the care is administered but does not appear to cause patient harm. Unfortunately, sometimes the care, treatment, or medication is administered erroneously, resulting in temporary or even long-term harm to the patient. These negative outcomes, including medication errors, receive intense national attention when they become sentinel events.²

This attention, in particular in the Institute of Medicine’s 1999 report on medical errors, To Err Is Human: Building a Safer Health System, has made patient safety initiatives a priority for healthcare organizations and government agencies.³ In 2002, AORN launched the Patient Safety First initiative to focus on reducing errors in surgical settings and creating resources to help perioperative clinicians provide safe patient care.^4,5 Specific practices include correct patient and surgical site verification and surgical counts, as well as medication safety.

The Joint Commission established its National Patient Safety Goals (NPSGs) in 2003. Goal 3 addresses safe medication and solution administration. Perioperative care areas must meet the three requirements of Goal 3, plus a retired requirement, 3A. (See “Requirements of National Patient Safety Goal 3.”) Requirement 3D involves the labeling of medications and solutions on and off the sterile field and the improvement of patient safety during the intraoperative phase. Other organizations with a focus on safe medication administration include the Institute for Safe Medication Practice (ISMP), United States Pharmacopeia (USP), and the American Society of Health System Pharmacists.

A medication error is a preventable event that may cause or lead to inappropriate medication use and harm while the medication is in the control of the healthcare professional, patient, or consumer.⁶ The outcome of medication errors can be minimal — no risk to the patient — to life-threatening. Information about the incidence of medication errors is available through two important databases. The Sentinel Event Advisory Group, appointed by the Joint Commission, has reviewed 4,074 sentinel event reports from member facilities from January 1995 through December 2006. Medication errors account for 10% of the reports. Communication and procedural noncompliance are identified as primary root causes.⁷

The second database, MEDMARX (managed by USP), provides voluntary and anonymous reporting of medication errors. Eighty-one percent of all medication errors reported to MEDMARX are from OR and PACU. Further, the effects of medication errors in perioperative care are more harmful on average than those in other settings.⁸ The primary root cause identified in the MEDMARX data is in medication administration. Three of the four top sentinel event categories in the Joint Commission’s Top 20 sentinel events occur in the perioperative arena, with medication errors as the fourth most reported event.⁷

Goal 3D

The NPSGs are intended to develop standards and directions for practice to create a national movement for patient safety. Goal 3D — the first to specifically address intraoperative practice — recognizes a risk point in the safe administration of medications in the perioperative setting.⁹ 3D requires clear labeling for medications and solutions that have been removed from their original containers or packaging and transferred to other containers for use on and off the sterile field by a person other than the preparer. This requirement applies to the pre-, intra-, and postoperative and procedural components of any patient care setting in which operative or invasive procedures are performed, including medications used by anesthesia providers.¹⁰

Patient preparation areas, preoperative holding and PACU areas, radiology and imaging services, endoscopy units, and patient care units where “bedside procedures” are performed must meet these implementation expectations.¹⁰

Characteristics of the perioperative setting

A healthcare facility is a complex and integrated environment with many departments and patient care units. In general, facilities have similarities in the management of patient care. However, the OR is a different and separate entity with unique nuances and distinct management processes and methods of delivering patient care. In many organizations, the perioperative continuum of care is the most involved, with many critical factors, steps, and processes influencing patient outcomes. Several departments and caregivers hand off the perioperative patient in a short period of time.

Generally, the medication process is a triad of the prescribing physician, the preparing and dispensing pharmacy, and the registered nurse, who is the final check before medication administration.⁶ Unique to the operating room is the additional team member, the scrub person (who may be a RN). The scrub person is an intermediary between the medication preparation and dispensing pharmacy and/or RN, and the surgeon as the final administrator of the medication or solution to the patient. The surgeon, pharmacist, and RN have complementary and unique roles. As licensed professionals, they have primary accountability for their respective responsibilities in the medication administration process as compared to an unlicensed scrub person. (The scrub person is often an unlicensed surgical technologist with limited pharmacology knowledge.)

Medication orders

The medication process involves the following steps:

• Prescribing (physician’s order)
• Processing the order (transcribing and documenting)
• Preparing the medication or solution
• Dispensing
• Administering the medication to the patient
• Monitoring the effect of the medication

In the OR, the preference card has long been viewed as the primary source for the physician’s written medication orders and as “standing orders.” However, a study evaluating the relationship of preference cards to medication errors found that relying on preference cards may provide a false sense of security.⁸ The study identified major concerns involving information on preference cards, including outdated, incomplete, or inaccurate information; revisions that are not reviewed or approved by the surgeon; inconsistent nomenclature — generic vs. brand name; abbreviations that don’t comply to best practices or the facility’s or Joint Commission’s standards; and unclear and nonnumeric instructions for dosage and concentration calculations. In addition, medications are sometimes listed with options: If local, use medication “A”; if general, use medication “B.” It is particularly frustrating when there isn’t a preference card specific to the operating surgeon or scheduled procedure, making it necessary to use a “similar” procedure card. Since the medications listed on the substitute preference card may not be what the surgeon intends to use, the required medications and solutions must be reviewed and confirmed with the surgeon before the procedure.

Medication orders may be given verbally in a variety of scenarios: in the preoperative holding area, in the break area, or during an OR procedure. All have the potential for errors, particularly medication orders given verbally in the OR. Masks can muffle speech, several conversations are under way at the same time, and the circulator is juggling concurrent and immediate priorities. Verbal orders should be repeated back and written down as soon as possible, with the physician signing the order.

Medication preparation

One surgical procedure can require the preparation and mixing of several medications and solutions. Clear, complete, and accurate instructions and conversion charts for the dosage and concentration calculations (including age-specific information) are critical. Satellite pharmacies are the best model for preparing medications and solutions. However, the RN circulator is responsible for this step when the OR is not supported by a satellite pharmacy and when additional medications and solutions are ordered during the case.

Typical practice also includes preparing medications and solutions for the following case during the current case or during room turnover and case setup. Sometimes medications must be prepared on the sterile field. The challenge is to maintain one’s focus despite multiple activities and distractions.

Medication dispensing

Using a medication or solution within the sterile field requires removing it from its original container and aseptically transferring it to the sterile field. Sterile dose packaging is not available for many medications and specific mixtures used intraoperatively. Goal 3D requires that two qualified practitioners verbally and visually confirm medications transferred to the sterile field.

Medication administration

Another unique characteristic of the perioperative medication process is that two or three practitioners prepare and dispense the medication or solution before the surgeon administers it. The pharmacist or RN circulator prepare and dispenses the medication. The scrub person — with his or her often limited pharmacology knowledge — receives and transfers the medication to the surgeon. The surgeon typically does not see the original container or the preparation of the medication.

Medication intensive

The OR is medication intensive. Multiple medications are used for one surgical procedure. One study showed that preference cards listed on average 4.93 medications.⁸ One procedure may require multiple categories of medications — topical and local anesthetics, contrast dyes, gases, antibiotics, anticoagulants — and solutions (plain or with additives) administered by various routes (topical, injection, infusion, or irrigation).

Additionally, high-alert medications, such as heparin and epinephrine, are common in the OR. Researchers found that 14% of preference cards included three high-alert medications.⁸ Once on the sterile field, “look-alike” concerns extend beyond similarities in medications’ names. Many medications and solutions are clear and look similar, such as fluids and local anesthetics, whether plain or with additives. Requirement 3D mandates labeling even when there is only one medication or solution on the field.⁹

Complex procedures

With advanced technology and ever-expanding surgical techniques, surgical procedures are increasingly more complex. A multitude of equipment, such as infusion pumps and ultrasonic irrigation and aspirators, delivers solutions to the sterile field. Multiple procedures and specialty teams, including the surgeon, scrub, and circulator, can be involved for one surgical patient.

Patient population

OR patient populations span the age continuum, from neonates to geriatric patients. It is common to care for pediatric and adult patients in one day, whether within one or several surgical specialties. Age-specific medication information and guidelines should be readily available.^11,12

OR conditions

Many surgical procedures require that room lights be dimmed or turned off. The X-ray view box, a lamp on the anesthesia cart, surgical spotlights, or a lighted workspace provides alternative “lighting.” Visibility is compromised, especially for reading medication labels and preparing and managing medications and solutions within the sterile field. Workspace can be small and cluttered with equipment and retrofitted computers and keyboards.

From “patient-in” to “patient-out,” the OR is a busy area. Conversations are taking place between team members. Distractions and interruptions are common. During the surgical procedure, the circulator manages multiple priorities of the patient, anesthesia provider, surgeon, and scrub person.

Staffing

Adequate staffing with the appropriate skill mix and assignments is important for safe patient care. Current realities of short staffing, temporary and contract staff, and novice team members create challenges. In addition, complex or multiple specialty procedures requiring additional staff create further demands.

Time as a quality indicator

Time is an important indicator when evaluating performance and productivity in the OR. Shorter procedure times, quicker turnover, increased case volume, and total procedure minutes are monitored. A sense of “faster, faster, faster!” exists. Some procedures, such as D&C and arthroscopies, can leave the team with the feeling the case is over before it starts. It is an environment of rapid interventions.

Administrative support

Essential to quality or process improvement is the support and ongoing follow-up from leadership. Managers provide leadership for a collaborative, multidisciplinary systems approach to optimize processes. They also play an important role in establishing safe practice protocols and identifying necessary core competencies to create highly reliable patient care. This collaborative teamwork fosters mutual respect, with each practitioner knowing his or her role, understanding the roles of fellow caregivers, and having a sense of responsibility and accountability to teammates.¹³ Leadership must champion the resources staff need to ensure this culture of safety. These resources include:

1. Staffing that provides the appropriate number, skill mix, and assignments
2. Time for education and training, case setup, and medication preparation
3. A safe work environment with reduced distractions and interruptions and appropriate lighting and work area
4. A nonpunitive culture in which reporting of errors is a routine professional responsibility
5. Information for increased awareness, quality data, and education and training
6. Tools and supplies that support safe practice and compliance with policies including labels and markers and alternative lighting for work areas on and off the sterile field.¹³

Label information

Unlabeled medications are unidentifiable. Transferring medications to the sterile field without labeling is an unsafe practice that neglects basic principles of safe medication management.⁹ Requirement 3D mandates labeling for medications on and off the sterile field. Label information must include a medication’s name and strength — and amount when medications are mixed, as with antibiotic irrigations, tumescent and heparin solutions, and epinephrine. The unit of measure — percent, grams, milliliters, or units — must be recorded along with the date the medication is prepared. An expiration date is applicable when the medication is not used within 24 hours of opening the container or if a specific time limit after reconstitution exists. Original containers must be kept in the operating room for verification until the procedure is completed. Medications in unlabeled containers must be disposed of immediately. The only exception to labeling is when the medication is immediately used or disposed of.¹⁰ Basic to any treatment, the adage “if it isn’t written, it isn’t given” applies to medication labeling.

Label quality

Containers on which labels are placed include syringes, medicine cups, pitchers, bulb syringes, and solution bags made of metal, glass, and plastic. The labels are subjected to a wet field for several hours. Therefore, labels should be evaluated for:

• Adhesive durability
• Ink that resists smudging when wet or handled frequently
• Adequate size to allow all required information to be legible and clearly visible
• Adaptability to fit on a variety of shapes and sizes of containers
• Cost-effectiveness and availability

Many institutions have included labeling supplies in the sterile packs and supply separate sterile label kits.

Transferring to a sterile field

When preparation and administration of medications and solutions within the intraoperative setting involves two or more people, active communication must take place when transferring medications and solutions to the sterile field.¹⁰ Two qualified people must verbally and visually confirm the medication label contents. To maintain consistency with counting policies, some facilities require that an RN must be one of the people involved. When one person both prepares and administers the medication, the two-person verification is not required.¹⁰ If the medication is prepared but not given immediately, labeling is required.

Labeling

Medications must be labeled as they are received on the sterile field, labeling one medication at a time to prevent mislabeling. Even if only one medication or solution is on the sterile setup, it must be labeled. An effective strategy is the use of preprinted labels, which can be included in the supply pack as well as in separate sterile packaging. Prelabeled containers, such as bowls and basins, are not acceptable since the risk exists for a different medication or solution to be transferred to the container.¹⁰ Consistent labeling protocols must be practiced throughout the department in all specialty services. Requirement 3D focuses on medications removed from their original containers that are both on and off the sterile field with the intent to administer to the patient during the procedure. Solutions with additives, such as electrolytes, antibiotics, and epinephrine, that are delivered from the original container by a device such as an irrigation pump must also be clearly labeled. Labeling is required for “one-person scenarios,” i.e., when one person prepares the medication or solution but does not administer it immediately.¹⁰

Verification on the field

When passing a medication or solution to the surgeon, the scrub person must verbalize the medication or solution name and strength. Many times, the surgeon cannot take his or her focus from the immediate surgical field, has asked for several items at a time, or may be continuing discussion with other team members. The surgeon must confirm the name and strength of the medication or solution, as well.

Communication

Another unique aspect of patient care in the OR is that the primary scrub person and RN circulator can transfer responsibilities of direct and indirect patient care activities. Procedures and protocols must be established for communication of medication information during temporary relief for turnover, case setup, and breaks, and during permanent relief for patient hand-offs at change of shift and to specialty teams. Information discussed by the entering and exiting team members must include medication or solution name, strength, concentration, and amount administered.

Staffing

Additional staffing is beneficial during complex or multiple specialty procedures with extensive setup and during the initial patient positioning, prepping, and incision time. Typically, these procedures have multiple priorities for the patient, anesthesiology provider, and surgeon. A second circulator can work exclusively with the scrub person to dispense and label the medication or solution. The work schedule should be managed to avoid extended work hours since fatigue contributes to medical errors.

The perioperative setting is medication intensive. Goal 3D provides a focus for safe medication administration in intraoperative practice. A review of the facility’s medication administration process will identify revisions and resources required for safe practice protocols and policies. Consistent medication labeling and verification among the perioperative team as the standard of practice contributes to reducing medication errors.