Are you among those who don’t always label containers on a sterile field?

With new patient safety goals, Joint Commission will watch meds closely

The ramifications for not labeling medications on the sterile field can be severe for patients and for providers, due to liability and now, a new National Patient Safety Goal from the Joint Commission on Accreditation of Healthcare Organizations.

Here’s just one example: A patient being treated in a hospital-based physician’s office sustained severe burns to his genitals when the physician, believing vinegar was in an unlabeled bottle, mistakenly applied TBQ (a cationic germicidal detergent with a pH of 13) to bleach a wart to improve visibility.1

Incidents such as this one have gotten the attention of the Joint Commission. The just-announced 2006 patient safety goals require hospitals, ambulatory care facilities, and office-based surgery facilities to label all medications, medication containers (such as syringes, medicine cups, and basins) and other solutions on and off the sterile field in perioperative and other procedural settings.

Less than half (41%) of hospitals always label such medications on the sterile field even when just one product or solution is present, according to a recent study conducted by the Institute for Safe Medication Practices (ISMP) in Huntingdon Valley, PA.1 Eighteen percent do not label medications and solutions on the sterile field at all, and another 42% apply labels inconsistently, ISMP says.

". . . Surprisingly, this rather basic safety measure is not widely implemented in hospitals," the institute says. "This is particularly disturbing because patients undergoing a surgical procedure cannot intervene on their own behalf. They are typically sedated or anesthetized and, thus, feel more vulnerable to errors at this time."

Based on a six-year analysis of all perioperative medication errors by the United States Pharmacopeia (USP) in Rockville, MD, most errors occur in the OR sterile fields, says Rodney Hicks, MSN, MPA, ARNP, research coordinator for the Center for the Advancement of Patient Safety (CAPS) at USP.

"We know that absence of labeling occurs when meds are removed from their original containers and introduced into the sterile field," he says. The move involves collaboration between the circulating nurse and the scrub person, Hicks points out. "We have several incidences of [errors] where things were not labeled," he says.

Why is this happening? "I give you the short answer: normalization of deviance in risk," says Betsy Hugenberg, BSN, MSA, RN, CIC, senior health care consultant with AIG Consultants, Healthcare Management Division, in Atlanta.

Outpatient surgery managers set up policies, build in safety features, and take extra steps to make sure their staffs are following best practices for patient safety, Hugenberg points out. "But it’s human nature for policies to be degraded over time and shortcuts to be taken and policies worked around," she explains.

Health care providers often are given tremendous workloads and are being asked to handle increasingly growing caseloads, while throughput is rushed, Hugenberg adds.

"They want to do a crisp and smart job, and they find workarounds to get it done, but these can fail," she says.

It’s the manager’s responsibility to set up processes that won’t impede patient safety, Hugenberg emphasizes. The Association of periOperative Registered Nurses (AORN) in Denver and ISMP have helpful material, she says.

"I think that’s one of the key things: Compare and contrast what your facility has against those published items," Hugenberg says. "Amend [policies] if you need to tune up something," she notes.

Consider the following recommendations from ISMP, most of which are mentioned in the AORN’s Guidance Statement: Safe Medication Practices in the Perioperative Practice Settings.1*

  • Provide labels.

Purchase sterile markers, blank labels, and pre-printed labels prepared by the facility or commercially available that can be opened onto the sterile field during all procedures, ISMP advises.

Some nurses have improvised by using sterile marking pens and sterile strips of tape to label containers, Hugenberg says. "You can’t hold nurses back when they need to improvise," she says.

Prepare surgical packs ahead of time with sterile markers, blank labels, and pre-printed labels for all anticipated medications and solutions for the case, ISMP suggests.

  • Require labels.

Even if only one medication or solution is involved, require labels on all medications, medication containers (syringes, medicine cups, and basins), or other solutions on and off the sterile field, ISMP advises.

Require labels on all solutions, chemicals, and reagents, including formalin, saline, Lugol’s solution, and radio contrast media, that are used in the perioperative settings, the institute says.

Many providers don’t think of irrigation fluid as a medication, but it is, says Sharon Giarrizzo-Wilson, RN, MS, CNOR, perioperative nursing specialist at the Center for Nursing Practice at AORN.

  • Differentiate look-alike products.

If drug or solution names are similar, use capital letters on the labels to differentiate them, or highlight/circle the distinguishing information on the label, ISMP advises.

"When possible, purchase skin antiseptic products in prepackaged swabs or sponges to clearly differentiate them from medications or other solutions and eliminate the risk of accidental injection," the institute says.

If you are using multiple solutions, you might have multiple containers of the same size and shape, Hicks warns. Labeling is the only thing to help you differentiate, he adds.

Clear medicine and irrigation can be confused, Giarrizzo-Wilson warns.

  • Label one at a time.

Individually verify each medication and complete its preparation for administration, delivery to the sterile field, and labeling on the field before another medication is prepared, ISMP advises.

"Verify any medication listed on the physician’s preference list with the physician before delivery to the sterile field, labeling, and/or administration," the institute adds.

The advantage of this system is that you don’t have several items that you’re going to put a label on "in just a minute," Hugenberg continues.

"Then you get distracted," she adds.

For example, while the circulator is trying to calculate a medication dose, something happens on the sterile field that requires the nurse to stop and attend to a need, Giarrizzo-Wilson says. "The most critical priority obviously will take precedent," she says.

  • Discard unlabeled medications.

Don’t assume that you know what is contained in an unlabeled syringe, cup, or basin, ISMP warns. "Discard any unlabeled solution or medication found in the perioperative area [including the sterile field], and report the event as a hazardous condition," the institute says. "Nothing should leave the hand unless it is labeled."1

James A. Yates, MD, surgeon at Plastic Surgery Center in Camp Hill, PA, has a rule that if there is a syringe filled with unidentified fluid on the surgical table, it is thrown out, even if the nurse verbally identifies it.

"One of the main concerns in surgery, especially outpatient surgery, is cost savings," Yates points out. "Many times a nurse says, I know what that is, and if you throw it away, you’ll lose money.’ But if you don’t throw it away, you may lose a life."

When changing policies, avoid resistance from your physicians and staff by making it clear that you’re changing policies based on best practices from professional groups, Hugenberg says.

"Spin it positively," she advises. "When patient safety is your goal, it’s hard to argue."


  1. Institute for Safe Medication Practice. Loud wake-up call: Unlabeled containers lead to patient’s death. ISMP Medication Safety Alert!Dec. 2, 2004. Web site:

    * Association of periOperative Registered Nurses Standards, Recommended Practices, and Guidelines, 2005, pp. 197-198. © AORN Inc., 2170 S. Parker Road, Suite 300, Denver, CO 80231. Reprinted with permission.


At press time, the Association of periOperative Registered Nurses’ (AORN’s) 2004 Guidance Statement on "Safe Medication Practices in Perioperative Practice Settings" was the most recent one posted on the web site at

AORN has other resources for members and nonmembers. To order these resources, contact AORN, 2170 S. Parker Road, Suite 300, Denver, CO 80231-5711. Phone: (800) 755-2676, ext. 1. Web: (Under "What’s New, click on "Medication Tool Kit.")

  • Safe Medication Administration Toolkit. Includes videos, a computerized graphic presentation, and a pocket reference that provides calculations conversions. Provides 4.8 contact hours. Hard copies of the kit are being mailed to AORN members who are managers and educators, plus 4,500 CEOs, COOs, and risk managers. AORN members who don’t receive a kit (staff nurses) in the mail can download/view the components free on the web site or purchase the hard copy of the kit for $25, including shipping and handling. Nonmembers can purchase for kit for $100, including shipping and handling.
  • Dietary herbal interaction poster. Free for members on the web site. Nonmembers can purchase for $20, including shipping and handling.

To obtain a copy of a medication safety alert from the Institute for Safe Medication Practices, go to

To obtain pre-printed sterile labels, contact:

  • Health Care Logistics, P.O. Box 25, Circleville, OH 43113-0025. Phone: (800) 848-1633 or (740) 477-3755. Fax: (800) 447-2923 or (740) 477-2923. E-mail: Web: Three hundred pre-printed sterile labels (item 16071) are available for $425 plus shipping and handling.


For more information about labeling medications on the sterile field, contact:

  • Center for Nursing Practice, AORN, Denver. Phone: (800) 755-2676. E-mail: Web:
  • Rodney Hicks, MSN, MPA, ARNP, Research Coordinator, Center for the Advancement of Patient Safety (CAPS), United States Pharmacopeia, Rockville, MD. E-mail:
  • Betsy Hugenberg, BSN, MSA, RN, CIC, Senior Health Care Consultant, AIG Consultants, Healthcare Management Division, Atlanta. E-mail:
  • James A. Yates, MD, Surgeon, Plastic Surgery Center, 205 Grandview Ave., Suite 401, Camp Hill, PA 17011-1714. Phone: (717) 763-7814. Fax: (717) 763-4918. E-mail: