Safety Precaution

Nearly eight years ago, the U.S. Institute of Medicine released a report, bearing the title To Err Is Human, which said that about 98,000 patients a year in the U.S. died from preventable medical errors.

Essentially the IOM report revealed that a number of hospital deaths could be traced to the failure of doctors and nurses to take routine safety precautions such as hand washing. Hospitals and safety experts since then have thought about procedures that could help save lives.

One veteran researcher on hospital safety at Johns Hopkins University devised a 5-point checklist on safety procedures and asked doctors to follow it when they treated patients. The doctor then requested his fellow physicians to provide data that would serve as indicators on whether the safety procedures were effective.

They were. There was no doubt about it: use of the safety checklist helped to prevent infections and saved 1,500 lives by 2006, the year when the New England Journal of Medicine published the findings. 

Safety experts regarded the findings as a significant step in the campaign to cut the number of deaths due to hospital infections annually. Doctors in 70 Michigan hospitals and other participating hospitals continued to use and follow the commonsense checklist and to provide feedback.

Last month, however, government regulators apparently disapproved of what the doctors were doing. The federal Office of Human Research Protections said the idea of using a safety checklist, and making an evaluation of the effects of using it, constituted experimentation without obtaining the prior consent of the patient. They therefore order the doctors in Michigan to stop providing data on infection rates.

The American Hospital Association has branded the decision as “wholly inappropriate.” Other patient safety experts said the ruling was “regulation run amok.”

Federal officials clarified that they are impressed with the findings reported by the medical safety professor at Johns Hopkins and the medical director of the university’s Center for Innovation in Quality Patient Care. Doctors in Michigan, Maryland and elsewhere who are adopting the safety procedures designed for intensive-care units. However, they will not be allowed to report their observations until these have been reviewed by oversight groups, usually called institutional review boards.

The requirement to have institutional review boards examine the findings would delay transmission of data, perhaps for months in some cases. Safety researchers said federal officials may have misapplied regulations that were originally formulated to protect patients participating in trials where new drugs and treatment procedures are being studied.

The checklist was designed to prevent ventilator-assisted pneumonias and infections from central venous catheters, which are usually inserted in patients at the ICU.

The federal officials say hospitals may implement programs to improve care. If they are implementing something they think will help, officials said this does not constitute research.

Checklists are far from being novel ideas. The automotive and airline industries have used them for years.

The Safety Checklist
* Wash hands thoroughly with chlorhexidine soap (a sanitizer)
* Wear masks, gowns and gloves that have been sterilized
* Avoid catheter insertion in the groin area
* Use barrier protections in areas surrounding catheters; clean them thoroughly and regularly
* Remove catheters as soon as possible