When President Bush signed into law the Patient Safety and Quality Improvement Act in late July, health policy experts applauded the move to establish a national database to which health care providers can confidentially report medical errors. Patient safety organizations that receive the data can analyze it and share it—without disclosing the identities of patients, doctors, hospitals and other providers—to help prevent future errors. American Medical Association President J. Edward Hill, MD, called the new law “the catalyst we need to transform the current culture of blame and punishment into one of open communication and prevention.”
But by that time hospitals and health-care workers around the country were already embracing two new campaigns to get more patients safely through their hospital stay, heeding the alarm sounded by the Institute of Medicine's 1999 report, “To Err is Human,” which said that between 44,000 and 98,000 hospital patients die from mistakes and other preventable causes each year.
The numbers were widely disputed at the time, but they ignited a process of self-examination that has led 2,600 hospitals—nearly half the nation's acute-care hospitals—to join the 100,000 Lives Campaign launched in December by the Institute for Healthcare Improvement.
And the University HealthSystem Consortium's Patient Safety Net—a program similar to the medical error database envisioned by the Patient Safety and Quality Improvement Act—has enrolled about 30 of the country's 125 academic hospitals.
The Institute for Healthcare Improvement, based in Cambridge, MA, and headed by Donald Berwick, MD, one of the authors of the IOM report “To Err is Human,” figured that 2,000 hospitals could prevent 100,000 patient deaths by adopting six preventive strategies.
One of the most innovative and challenging of the six is the use of “rapid response teams”—typically made up of an in-house physician, a critical care nurse, and a respiratory therapist—that can respond within minutes when a nurse or other staff member thinks a patient is losing ground.
The other strategy is “medication reconciliation,” to make sure drugs are reviewed and updated as necessary, with orders communicated appropriately throughout the different stages of a patient's hospital stay.
The other four strategies are designed to prevent pneumonia in ventilator patients; prevent sepsis in central-line patients; standardize preoperative antibiotics to reduce surgical infection; and give appropriate aspirin and beta-blocker treatment to heart-attack patients.
“By and large, doctors and nurses provide excellent care. They work very, very hard. They do heroic work,” said Joe McCannon, manager of the 100,000 Lives Campaign. “The key to saving patient lives is that we change the standards of care.”
The University of Texas M. D. Anderson Cancer Center was one of the first hospitals in the country to sign on with the 100,000 Lives Campaign, or 100K as it is becoming known.
“For the most part, institutions had one or more of these six interventions up and running” before 100K was launched last year, said Sherry Martin, M. D. Anderson's Vice President for Process Improvement. “The wonderful thing about a campaign such as this is we all are going to learn from one another.”
Gregory Botz, MD, Chief of Critical Care, said the hospital began planning for a rapid response team even before the launch of 100K. The team is called MERIT, for medical emergency rapid intervention team.
“We have in the first six months of this year had about 360 activations of the team,” he said. “About half of the patients that the team saw on the floor could be managed on the floor and did not have to go to the ICU. I think it's fair to say that without the team they would have had ongoing deterioration and would have had to go to a higher level of care.”
M. D. Anderson also is attacking the “low but not zero number of infections” it sees in patients with central lines, Dr. Botz said. The hospital is using new antibiotic-impregnated catheters and dressings that block skin contributions to indwelling catheter infections.
“Any time you have a large academic institution, change does not come easily, and most of the success with improvement projects is transparent,” he said. But doctors and nurses have embraced the rapid response team and other approaches recommended by the Institute for Healthcare Improvement “and they want to do more.”
M. D. Anderson also is working with a communication improvement tool called SBAR—for situation, background, assessment, and recommendation—that facilitates efficient communication about critically ill patients.
Developed by Michael Leonard, MD, and colleagues at Kaiser Permanente of Colorado, the tool “allows a focused discussion of a patient's problem,” between doctors and nurses, and other health care professionals, Dr. Botz said.
“One of the complaints I hear most often from physicians when they get a call from their patient's nurse is that they really can't determine what the nurse is trying to tell them,” Dr. Botz said. “This gives the physician or anybody else who needs the information the right information in a timely manner.”
Dana-Farber Cancer Institute was also one of the first hospitals to sign on to the 100,000 Lives Campaign.
“I hope it works, that it actually saves lives,” Saul Weingart, MD, PhD, Dana-Farber's Vice President for Patient Safety, said of 100K. “But I'm sobered by how hard it is to make improvements. Change is difficult for individuals and organizations.”
“The first part is recognizing there's a problem with the status quo. The second part is figuring out the solution and then figuring out how to get from the problem to the solution. It's both a daunting problem for health care and an urgent imperative.”
Because of its large outpatient facility, most of the 100K prevention strategies don't fit into Dana-Farber's programs. So the institute is concentrating its effort on the medication-reconciliation piece of the campaign.
“In the outpatient setting, the patient gets to play a very important role,” Dr. Weingart said. Dana-Farber recently published a new set of brochures for new patients, which describes the importance of keeping records of their treatment.
The materials include an insert in which patients can record drug, allergy, and key contact information at home and then bring with them to their appointments. In addition, patients are given copies of their medication lists at appointments, asked to update the list as needed and review it with their clinicians.
Patients have been highly compliant with the new program, which has already highlighted some patients' difficulties with adhering to their treatment regimens, Dr. Weingart said. When one patient returned to Dana Farber for a follow-up appointment, he reported that he had not been taking a prescribed oral chemotherapy agent.
“He said he got the prescription, but he wasn't able to get it filled at the pharmacy because his insurance wouldn't pay for it,” Dr. Weingart said. “It was an insurance problem, but the medication-reconciliation program made it transparent to the physician.”
More than 180,000 Lives
The 100,000 Lives Campaign could save more than 180,000 lives each year if every hospital in the country participated, according to Institute for Healthcare Improvement estimates.
The 100,000 goal breaks down as follows:
▪ 60,000 lives saved through the use of rapid response teams.
▪ 10,000 saved by taking steps to prevent pneumonia in ventilator patients.
▪ 10,000 saved by giving beta blockers and aspirin to heart-attack patients.
▪ 10,000 saved by preventing sepsis in central-live patients.
▪ 8,000 saved through the use of preoperative antibiotics.
▪ 2,000 saved through medication reconciliation efforts.
At a local level, a medium-sized community hospital with 15,000 admissions a year could save 75 lives, the institute says: 45 lives saved with rapid response teams; 7.5 saved by preventing ventilator-associated pneumonia; 7.5 by reducing central-line infections; 7.5 with improved heart-attack treatment; 6 by preventing surgical infections; and 1.5 by reducing medication errors.
“Once you get cued into the idea that health care is all about systems and processes, it's not just about individuals, then all of a sudden you have new tools you can bring to bear,” Dr. Weingart said. “Here's a simple example: You may be very good at reading x-rays. But what if you can't find the film? That's a systems problem that affects patients.”
University HealthSystem Consortium's Patient Safety Net
The University HealthSystem Consortium's Patient Safety Net (PSN) takes a different approach to saving hospital patient lives. Rather than recommending specific interventions, PSN provides doctors, nurses, and other hospital workers access to an Internet-based reporting tool where they can report everything from concerns that something might go wrong—“There's a wheelchair patient who appears to be unattended on 3-Northwest”—to sentinel events.
“Who was harmed or nearly harmed?” the computer asks when a person logs on to PSN. The consortium maintains hospitals' confidentiality, and those who report into the system can remain anonymous if they choose. The goal is to get information that can be analyzed and shared, not to point blame.
“Over 50 percent of the events that we are learning about are near-miss events,” said Barbara Youngberg, a vice president of the consortium, based outside Chicago.
“So people are learning to say, ‘We want this addressed before it becomes a problem.’ It's a much more proactive, much more patient-friendly, much more staff-friendly approach than waiting for somebody to hurt someone.”
The 100,000 Lives Campaign of the Institute for Healthcare Improvement (IHI) aims to enlist hospitals to commit to implement changes in care that have been proven to prevent avoidable deaths. These are the six interventions that have been chosen to start with:
▪ Deploy Rapid Response Teams
▪ Deliver Reliable, Evidence-Based Care for Acute Myocardial Infarction
▪ Prevent Adverse Drug Events
▪ Prevent Central Line Infections
▪ Prevent Surgical Site Infections
▪ Prevent Ventilator-Associated Pneumonia
In addition to these six interventions, IHI says it will continuously seek and add others that have been shown to save lives.
Fast-Track Status for Panitumumab for Colorectal Cancer
The FDA has granted fast-track status to panitumumab, an experimental fully human monoclonal antibody targeted against the epidermal growth factor receptor (EGFR) in patients with metastatic colorectal cancer for whom standard chemotherapy treatment has not worked.
“Panitumumab is the first fully human monoclonal antibody to inhibit EGFR, and fast-track designation represents an important milestone in its development,” said Bill Ringo, Chief Executive Officer of Abgenix, which is codeveloping the drug with Amgen.
Current EGFR therapies contain mouse protein, which can induce an immune response in the form of infusion reactions, allergic reactions, and anaphylaxis. Panitumumab is being investigated as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung, and kidney, according to a news release.