Hospital executives who were thinking about putting bar-code tech-nology at the bedside someday would have to get serious in a hurry under recommended additions to patient-safety requirements presented to the Joint Commission on Accreditation of Health- care Organizations.
Accredited hospitals also would have to hatch a plan to ensure that any dose calculation programmed into a machine for intravenous delivery by a nurse is subjected to a second check confirming the dosage's safety-which would take more nurse time, new "smart" devices or a combination.
Those requirements and others the JCAHO presented this month for review by the industry could force hospitals to more rapidly commit millions of dollars to patient safety to preserve accreditation. It also would produce a windfall in revenue to companies that produce such products, including a few that have donated money to the JCAHO in the past few years.
'It won't happen'
Already the aggressive milestones for bar-code implementation are being called into question. The proposal would require all accredited hospitals to have a system running by Jan. 1, 2007.
"It won't happen. It's just not going to happen," said James McAllister, director of pharmacy for University of North Carolina Hospitals, Chapel Hill, citing the substantial investigations and internal preparations needed by thousands of hospitals.
The 23 members of an advisory panel, which forwarded its recommendations to the JCAHO, could not all agree on the proposed deadline.
"Frankly not all of us agreed that it should be in there necessarily," said Michael Cohen, president of the Institute for Safe Medication Practices. "I'd be concerned about imposing bar-coding with drug administration that soon."
But vendors of bar-code medication-management systems-who would reap the windfall associated with installing their product in thousands of hospitals in little more than two years-said they could ramp up for the profitable challenge.
Aggressive, but doable
"It's aggressive, but it's doable," said Denean Rivera, president of Bridge Medical, a subsidiary of AmerisourceBergen Corp. "It might be the only thing that makes people stop talking about safety and do something."
The patient-safety goals and requirements were added to the accreditation process two years ago to substitute for a short-lived directive that hospitals fix problems associated with more than 20 warnings about types of patient harm, called sentinel-event alerts, that had piled up since 1998. An advisory panel narrowed the first set of "national patient-safety goals" to six, with 11 requirements for meeting those goals, and were charged with revisiting and revising the lineup of requirements each year.
If adopted by the JCAHO board this summer, the new additions and revisions would take effect in 2005. Hospitals then would have two years to plan for and install bar-code technology to help identify patients and to match them to medication or other treatment.
Despite the stiff challenges and costs, both the American Hospital Association and the Federation of American Hospitals support the proposed goals. "Many of these things make a great deal of sense," said Nancy Foster, AHA senior associate director of policy.
The momentum for adding fail-safe electronic monitoring of medical administration has been building since the Food and Drug Administration mandated in February that all drug manufacturers affix bar codes to single units of medication as of April 2006, said Susan Van Gelder, senior vice president of strategic policy at the federation.
Not a surprise
The FDA has no authority over providers, though, and its regulations did not require hospitals to implement the means to use the codes at the bedside. But the AHA, the federation and safety advocates such as the Institute of Medicine have drawn keen attention to the technology as a big step toward better and safer care, and the proposal to "close the loop" by making it a condition of accreditation was not a surprise, Van Gelder said.
"I think (hospitals) all knew it was coming after the FDA passed the rule," she said. "I think it's a reasonable patient-safety goal for the Joint Commission to propose."
One bar-code technology vendor donated to the JCAHO in 2002: Becton, Dickinson and Co., Franklin Lake, N.J., contributed $41,000. Two makers of infusion pumps with double-checking capabilities contributed in 2002: Alaris Medical Systems, San Diego, $5,000; and Baxter Healthcare Corp., Deerfield, Ill., $32,000 (See related story, p. 16).
Hospital industry representatives said the JCAHO's prospective plunge into the details of safety-related practices would break new ground for an accreditation agency that up to now has prescribed broad standards and left the particulars to each organization.
"It is a change in their approach," Foster said. "They seem to have gotten much more specific on the things they want hospitals to be engaged in."
It's a contrast to the first two years for the safety-directives program, launched in mid-2002 to focus attention on a small number of error-prevention tactics advocated for years by medical experts and professional groups but not uniformly adopted in the field (July 29, 2002, p. 8).
The 11 original measures dealt with elements of care basic to any facility's operational goals: giving the right drug to the right patient, operating on the correct part of the body, maintaining clinical alarm systems properly, or preventing IV infusion pumps from suddenly releasing life-threatening doses. For 2004, the JCAHO added two requirements for reducing the risk of hospital-acquired infections and also called for caregivers to read back critical test orders communicated verbally.
Despite the measures calling greater attention to patient identification and to the need to closely monitor infusion pumps, information from industry sources-including the JCAHO's own database of sentinel events-showed continued problems in those areas, said Henri Manasse Jr., chairman of the patient-safety advisory group and executive vice president of the American Society of Health-System Pharmacists.
In the case of IV-delivered medication, mistakes calculating and administering doses cause 60% of the most severe and costly medication errors, according to research done at Boston's Brigham and Women's Hospital. The hospital has tested a system from Alaris. "When you expose patients to serious harm, that double-check has to occur," Manasse said. Bringing bar-coded information to the bedside would reduce medication errors by 50%, the FDA estimated earlier this year.
However, the case for adding those requirements and others proposed for next year must be balanced against the "feasibility and practicality" of imposing them on healthcare organizations, Manasse added. That's why the panel and the JCAHO settled on releasing this year's proposals for "field review" for the first time, he said. If the new measures were to get "massive resistance," he added, the advisory group would have to reconsider its recommendations.
"I don't think the cost is a huge issue, at least for the bar-coding," Van Gelder said.
For hospitals, the expense of installing a bar-code medication-management system ranges from $300,000 for a smaller facility to $1.5 million for an academic medical center, said Mary Beth Navarra, director of medication safety with the information technology division of McKesson Corp.
The price also would depend on how much of the minimum infrastructure a hospital has in place, including a database, computer integration with pharmacy and nursing documentation systems, and a wireless communication network, she said.
Besides the expense to individual hospitals, however, the bar-code requirement also would put a general burden on a healthcare industry scrambling to install the capability by the deadline. According to the American Society of Health-System Pharmacists, about 3% of hospitals now have such a system.
Installing McKesson's bar-code medication-administration system takes four to six months, Navarra said. The average installation time for Bridge Medical's system is 67 days, Rivera said.
The preparation for such changes goes far beyond the installation, covering ground as basic as cultural changes among nurses and comfort with using computers, Cohen said.
Forcing hospitals to move too quickly might not be in their best interests, he warned. "Asking people to get serious about the technology-I'm for that," he said. "But pushing people like that and putting them under the gun ... could lead to errors if not properly installed."
Timing the JCAHO requirement nine months after the FDA's deadline for manufacturers might not relieve providers of all the costs of applying codes to unit doses of medication, either, McAllister said. The FDA rule requires bar codes for all unit doses of medication, but it doesn't require drug makers to supply unit doses, he said. "An easy way to get around the law is just to package them for stockpiling."
Individual hospitals would have to make a case for meeting the requirement for double-checking dosages through infusion-pump technology as an alternative to independent checks by nurses, Manasse said.
University of North Carolina Hospitals is prepared to make that case, McAllister said, noting the financial difference between hiring nurses and adding double-checking capabilities to the pumps. The 688-bed medical center will begin deploying more than 1,000 "smart" pumps this week at a cost of about $500,000, which McAllister said would avoid the cost of having a second nurse brought in on all IV dose programming.
"If you price it out, it doesn't take a lot of nurse salaries to stack up to a half a mil lion bucks," he said. "Compared to requiring nurses to do twosies, it's a lot more cost-effective."
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