Hospital labeling policies leave room for error

The mistake that killed a patient at Virginia Mason Medical Center last week — an injection of antiseptic cleanser during a procedure — could have happened at many other hospitals, according to a nonprofit organization that advocates for better medication-safety procedures.

Fewer than half of 1,600 hospitals around the country said they always label syringes, basins and other containers holding solutions used during surgery and other procedures, says a survey this year by the Institute for Safe Medication Practices, a national nonprofit patient-safety organization.

In the same survey, 18 percent of hospitals anonymously reported that they never or rarely labeled such containers.

The good news? The situation has improved in the past four years. In 2000, 33 percent said they never or rarely labeled those containers, a practice Michael Cohen, president of the institute, called "totally unacceptable in any hospital."

Use of unlabeled containers and resulting mix-ups of various kinds of look-alike fluids have been implicated in patient deaths and injury for decades, said Cohen, and always pose a danger. Still, despite well-publicized deaths of patients, many hospitals don't label.

"It seems so basic, yet this unsafe practice is fairly widespread in U.S. hospital operating rooms," he said.

Mary McClinton died Nov. 23 after being injected with antiseptic skin cleaner instead of contrast dye during a procedure for a brain aneurysm, a bulge in a blood vessel.

"At some time during the procedure the clear antiseptic solution was placed in an unlabeled cup identical to that used to hold the marker dye (IV contrast) that is injected into blood vessels to make them visible on x-rays," said a memo to Virginia Mason staff members sent by Dr. Mindy Cooper, chair of the quality-assurance committee, and Dr. Robert Mecklenburg, chief of the department of medicine, a week after the procedure.

Virginia Mason posted a public apology on its Web site and apologized to McClinton's family for the "preventable medical error."

Dr. Robert Caplan, the hospital's director of quality, said yesterday that until this incident, Virginia Mason had always used a "visual and physical or temporal" identification system that relied on visual verification and placement of solutions. Such practices "were an accepted part of medical practice," he said.

The hospital prides itself on its "patient safety alert" system, which is triggered after an adverse incident and stops all similar procedures until the root cause is identified and corrected.

In fact, Martin Memorial Hospital in Florida contacted Virginia Mason to learn more about that system in 1995, Caplan said, after Ben Kolb, a 7-year-old boy, died at Martin Memorial after being injected with the wrong solution during a routine ear operation.

At Martin, the incident resulted in a "whole process change" at the hospital, said spokeswoman Melinda Glasco, including labeling all solutions within the sterile field, the sterile area surrounding a patient during an operation or procedure.

Asked why Virginia Mason, which was well aware of the Kolb case, didn't change procedures then, Caplan said: "Until you have an adverse event, you don't have the opportunity to understand what the system problem is."

Because of McClinton's death, he said, hospital leaders realized they needed to take a hard look at its system "and focus down to our concept of what a label is."

Now, solutions used during procedures at Virginia Mason are identified with a text label, Caplan said.

Cohen, who sits on a committee of the Joint Commission on Accreditation of Healthcare Organizations, has asked that group to include labeling such containers on a list of "national patient safety goals" used to measure hospital safety.

The professional association of nurses who assist in surgeries and other invasive procedures, the Association of periOperative Registered Nurses (AORN), says all medications and containers used during procedures should be labeled and verified.

"Discard any solution or medication found in the OR without an identification label," AORN says in its safe-medication-practices guidance statement, formulated in 2002.

About 7,000 people die each year from medication errors, the Agency for Healthcare Research and Quality estimated in 2002.

Caplan said he believes such errors will continue until every hospital does what Virginia Mason did: openly and honestly admit its error. Surveys that allow hospitals to respond anonymously, he said, should be a thing of the past.

"We cannot make progress in health care if we're looking at anonymous data. ... Until you have a culture that gets away from blame, and gets to open and honest discussion, you will never keep these things from happening again," he said.

While Cohen said no organization is tracking the subset of labeling errors, many who track medication errors believe they are likely common, though most go undetected.

Some of the worst, such as what happened to McClinton, have made headlines steadily over the years.

For example: In 1985, Bob East, a retired Miami Herald photographer undergoing eye surgery at Jackson Memorial Medical Center in Florida, died after he was mistakenly injected with a toxic formaldehydelike substance taken from an unmarked vial. His wife refused early settlement of the case, insisting she wanted to learn how such a mistake could happen, The Associated Press reported. After pretrial depositions revealed the sequence of events, she settled for $2 million.

The recounting of the events was dramatic: The anesthesiologist who injected East told of the moment he discovered he had injected the wrong substance. "At that moment I realized what had happened, and I just screamed: 'Oh my God! Oh my God!' " he said.

Despite widespread media coverage of that case, many medical offices and hospitals continued to use unmarked vials and basins during procedures.

In 1997, the institute told of a report it had received of a 37-year-old man whose genitals were severely burned when his physician mistakenly applied a strong detergent from an unlabeled bottle to a genital wart that was to be removed. The physician assumed the substance was vinegar, commonly used to bleach a wart so it can be more easily seen.

Another report told of hydrogen peroxide being injected instead of an anesthetic; another of a patient being injected with anesthetic instead of a contrast dye.

In all those cases, lack of proper labeling played a key part.

Often, as at Virginia Mason, surgeons, technicians and nurses relied at least in part on placement, rather than labels, to identify various substances, Cohen said.

"When you cook dinner at home, do you use an ingredient that does not have a label? Would you just guess at what it was? Would you assume that, because it was in a certain position on the shelf, it was what you wanted?" Cohen wrote in a 1997 newsletter. "Amazingly, although you don't usually do this at home, it happens again and again in surgical fields, hospitals, physicians' offices and pharmacies every day. Patient harm, or even death, is too often the result."

Caplan, Virginia Mason's quality chief, said the hospital's previous system had been "worked out over many years," using visual identification and location to identify different solutions. "It was a system thought to be safe," he said last week.

Cohen said that's what most hospitals say after a flawed process fails to prevent a tragic mistake.

"A million times you could do it, and it's not a problem," he said. "But the next time, someone gets hurt."

Carol M. Ostrom: 206-464-2249 or costrom@seattletimes.com

Hospital labeling policies


University of Washington: Substances used during procedures and surgery are "absolutely, totally" always labeled, regardless of where it is or what the substance is, says spokesman Craig Degginger.

Harborview Medical Center: All medications that touch the sterile field in operating rooms are labeled. Skin-cleansing preparations such as antiseptics are not located on the sterile field, says spokeswoman Susan Gregg-Hanson.

Overlake Hospital Medical Center: All medications used on the sterile field are to be dispensed, mixed and/or diluted by or under the direct supervision of a registered nurse following a physician's order. All medications are to be properly identified and labeled immediately upon transfer to the sterile field, says pharmacy director Ted Neal.

Northwest Hospital & Medical Center: All solutions and medications in the operating room are first identified in a two-person cross-check and then containers, basins, jars and syringes used in the sterile field are labeled with preprinted labels, says Michael Byrd, staff development coordinator for surgical services. Similar precautions are taken during radiology procedures done in the operating room, says hospital spokesman Kevin Kawamoto.

Swedish Medical Center: Different departments have different policies, including labeling and visual identification, says spokesman Ed Boyle. In light of the Virginia Mason incident, Boyle says the hospital will change to a "uniform policy throughout the hospital that all employees know and follow."

Virginia Mason Medical Center: Previously relied on visual methods of identification; now, says quality chief Dr. Robert Caplan, all substances used during procedures will be "explicitly labeled with a text label."