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The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a Sentinel Event Alert Nov. 30 that says human and medical errors involving the use of infusion pumps have led to several deaths and near-fatal drug overdoses. But industry representatives fault JCAHO for failing to provide adequate guidance for ongoing assessment.
Russell Massaro, MD, JCAHO’s executive vice president, says the Joint Commission is especially concerned about the use of pumps that do not provide protection from the free-flow of intravenous fluid/medication into the patient. "Joint Commission surveyors will inquire about use of these pumps during on-site surveys in 2001," he warns.
JCAHO maintains that improper use of infusion pumps already has led to several deaths and near-fatal drug overdoses. While experts say human and mechanical error are factors, the main problem is the use of pumps that do not provide protection from the free-flow of intravenous fluid/medication into the patient, according to the Joint Commission.
As evidence, JCAHO cites reports by U.S. Pharmacopeia in Rockville, MD, about six cases between October 1991 and November 1999 in which patients died and four others almost died because an intravenous pump did not provide protection from free-flow of intravenous solutions.
Charlene Hill, a JCAHO spokeswoman, says that when surveyors visit health care organizations next year, they will be inquiring whether the organization is aware of the information in the sentinel event alert. "If not, surveyors will be educating them about those issues," she says. "If they are, surveyors will be asking the organization what they have done to ensure the safety of these pumps." Organizations that say they are aware of the alert but have not addressed potential problems and could be cited for being out of compliance under one of JCAHO’s performance standards, Hill explains. "They could get a Type I or a recommendation for improvement," she says.
According to Rad Dillon, national pharmacy manager with Apria Healthcare, the infusion industry is suffering under an "accreditatory yoke" imposed by the Joint Commission. "Technically, it is a voluntary organization," he says. "But what [JCAHO] has done is create a monopoly that Bill Gates would be proud of," he argues. He says that is why some people in the infusion industry are examining potential legal avenues on the basis that JCAHO is effectively restraining trade.
As things stand, he says the Joint Commission more or less forces service providers to become JCAHO-accredited in order to work with hospitals. "I would like to be in a position to tell JCAHO to peddle its wares elsewhere because we have convinced payers that we have an effective alternate route with other accrediting bodies."
According to Dillon, the ORYX project is a case in point. He says anybody would be hard pressed to find an infusion provider that has derived any benefit from that project because the data are collected without adequate controls. "[JCAHO] can’t do it right, but for a variety of reasons, [it is] not going to let it die," he asserts. "Yet, all of us are being forced to spend large sums of money to do this." Even if the data were more accurate, this should not be JCAHO’s role responsibility, Dillon argues. He says that’s why the infusion industry is trying to establish its own standards through voluntary efforts such as the operational benchmarking project sponsored by the National Home Infusion Association.
(JCAHO’s Sentinel Event Alert on infusion pumps can be found on-line at www.jcaho.org/sentinel/sentevnt_frm.html.)