HealthBiz: Creating a safety culture

By ELLEN BECK  |  Dec. 2, 2004 at 4:45 PM
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WASHINGTON, Conn., Dec. 2 (UPI) -- Lots of companies use the slogan "Safety is Job 1" and it is a good one for healthcare because it makes safety a culture creature from the executive suite to the mail room.

A new study on patient safety -- and a lot of people follow this since the Institutes of Medicine in 1999 reported up to 98,000 people die each year because of medical errors -- finds, however, that U.S. healthcare providers have not done a very good job at creating the culture and implementing system changes needed to reduce errors.

"It's both top down and bottom up," Dr. Robert Wachter, associate chairman of the Department of Medicine at the University of California, San Francisco, told UPI's HealthBiz. "There has to be a commitment from senior leaders ... that 'Safety is Job 1.'"

U.S. healthcare five years after the IOM bombshell still gets only about a C+ grade on patient safety in Wachter's study. There has been improvement, but many challenges remain -- some simple and some obvious. Though technology can be a big part of the solution, human interaction and organization still are cheaper and easier.

"Doctors and nurses have to learn new ways of talking to each other," Wachter said. Add to that adoption of safety standards, using check lists, reading orders aloud back to the patient or to a colleague, having surgeons mark the spot on the patient where the operation is to take place -- detail items, Wachter said, all of which were self-evident in other fields but ignored in medicine.

Electronic records and e-prescribing will greatly enhance patient safety, but for many providers it remains somewhere down the road and there still is uncertainty over who is going to pay for what.

Wachter issued his report card in conjunction with The Commonwealth Fund, a non-partisan research group in New York City.

Fund President Karen Davis said areas of improvement included the number of states with mandatory adverse-event-reporting systems increasing from 15 to 22 -- covering 64 percent of the U.S. population.

"The challenge is to expand this practice to all states and to use the information reported in a proactive way to identify and spread safer practices," Davis said.

Wachter broke down the report card into five areas. The error-reporting-system category, despite the gains, still got a C. He said hospitals make the mistake of thinking that implementing a system is the answer when really what is needed is translating the problem into a meaningful solution.

Regulatory solutions to patient safety, however, scored an A- grade. That includes standardizing procedures and cross-checks in hospitals -- many now repeat a patient's name back to them or ask a person to give their name at various points during their stay. Wachter said virtually no hospital was doing that back in 1999.

Information technology got a B- grade, but Wachter said it holds the most promise for dealing with medical errors. The issue here is that nationwide, healthcare has yet to embrace IT in a systematic and integrated fashion.

Workforce training got a B on the report card, because issues such as the nursing shortages, resident fatigue and poor work environments have reached the public eye.

What many people consider a major issue -- malpractice -- scored only a D+ on Wachter's analysis, mainly because it is a complex issue that is overstated in its effect on safety.

"There is an instinct among many doctors to blame the malpractice system for many of the world's ills," he said. "I think the malpractice situation is bad -- but it's not the problem."

Mandates for safety standards might be in store for the future, but for now, Wachter noted, a step forward is getting doctors to get over the idea they are going to do everything their own way.

Wachter also is editor of an online patient safety journal and author of a recent best-selling book, "Internal Bleeding: The Truth Behind America's Terrifying Epidemic of Medical Mistakes." The report is published in the journal Health Affairs.


The Pennsylvania Department of Health has thrown the state's ambulatory surgical centers for a loop -- issuing a notice that a laparoscopic cholecystectomy to remove gallstones -- which has since 1988 been deemed minimally invasive and performed at ACSs nationwide, really is an invasive surgery and must be done in a hospital.

It was a notice -- which means it did not go through the usual rulemaking process of issuing a draft, obtaining and considering industry comments and then finalizing a rule. This has, of course, implications well beyond gallbladder procedures -- appendectomies and tubal ligation, to name a couple, also might also run afoul of the new decision.

Laparoscopic procedures generally are considered less invasive than regular surgery, requiring less recovery time, causing less pain and lowering healthcare costs. During a laparoscopic cholecystectomy, instruments, a light and camera are passed through several small incisions in the abdomen and the surgeon views inside a patient's stomach by looking at a video monitor. A lap chole does not require the abdominal muscles to be cut.

Kathy Bryant, vice president of the Federated Ambulatory Surgery Association, told HealthBiz Thursday though she had met with Pennsylvania health officials this fall on this issue, she had only a one-day notice before the announcement of a change was made. She said she tried to find out how to determine the parameters better and what was to be included other than the gallbladder procedure.

"The meeting was not particularly illuminating," she said, "in the sense that we said, 'What makes it a major invasive procedure as distinguished from a minimally invasive surgery?' Their only response was that doctors could call it whatever they wanted, but it's still a major invasion."

Bryant said it is difficult to argue the point without more guidance.

"We're kind of at a loss at what makes the distinction here."

The state notice does not give much guidance: "The method used to enter these body cavities, through incision or via laparoscope (or similar instrument), is not determinative of whether the invasion is a major one. The incisions used for laparoscopic procedures are generally smaller than those used for open procedures, but the risk of injury remains."

Health Department spokesman Richard McGarvey told HealthBiz the issue was potential complications.

"We were concerned about the invasive nature of the procedure and the complications that might be associated with it."

He said the state was concerned if a problem occurred, patients would not have access to a hospital or "medical backup" in an emergency.

The state notice said there have been reports in the medical literature that the risk of injury may be increased with the laparoscopic procedure but McGarvey said the state had not received any complaints or reports of adverse events that prompted their decision. He said, in fact, he knew of only a couple ASCs in the state that were performing the procedure.

Bryant said though she was told the state's decision was not based on prompting by hospitals or any other healthcare organization.

FASE estimates up to 44,000 laparoscopic cholecystectomies were performed nationwide in surgery centers in 2003. Its data show about 99 percent of the procedures were performed free of complications.

Bryant said the association is trying to move quickly to determine what types of procedures surgical centers in Pennsylvania are performing -- focusing on those that might now be brought to the attention of state officials for review.

McGarvey told UPI the notice was not the beginning of any systemic review but the department would investigate and make decisions when issues were brought to its attention.


An attorney reacting to the TAP Pharmaceuticals Products Inc. settlement of a class action suit over the drug Lupron made an interesting comment about consumers who purchased from the company.

"This settlement is an enormous victory for everyone who was illegally overcharged for Lupron. Consumers will get 100 cents on the dollar for their damages," Alex Sugerman-Brozan, director of the Prescription Access Litigation Project, said in a statement. "This is the high-water mark for drug pricing cases, and is the result of aggressive consumer participation in the case."

PAL is a nationwide coalition of over 100 consumer organizations that is involved with some 20 class action suits on drug prices. Sugerman-Brozan's comment shows these cases are different from other class actions in which consumers -- the ones really ripped off -- get 10 cents or less on the dollar, or a token product settlement or maybe even nothing -- while the lawyers cash in big.

If approved by a federal court in Boston, the settlement calls for TAP, which admitted no wrongdoing, to pay $150 million -- $55 million to certain health plans and $95 million to consumers, additional health plans and legal fees.

Individuals would get payments based on the amount of Lupron they bought. Lupron is used to treat prostate cancer in men, endometriosis and uterine fibroids in women, and premature puberty in children.

The lawsuit actually consolidated numerous federal cases and named TAP, Abbott Laboratories and Takeda Pharmaceutical Co. as defendants. The suit claimed consumers paid inflated prices for the drug when the companies artificially inflated the "Average Wholesale Price," giving free samples to doctors knowing they would charge patients and insurers for them, and giving incentives to prescribe Lupron instead of cheaper alternatives.

TAP Pharmaceuticals previously pled guilty to criminal and civil charges regarding Lupron and paid $875 million in penalties in 2001.



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