CMS revises guidelines on informed consent
List those performing specific significant tasks
Under newly revised interpretive guidelines from the Centers for Medicare & Medicaid Services (CMS) for informed consent, hospitals are required to list all people performing "specific significant surgical tasks." According to at least one legal expert, ambulatory surgery centers (ASCs) also should follow this guideline, which that expert says will be the new standard of care.
The previous interpretive guidelines had raised the ire of many outpatient surgery providers because they required providers to list all persons performing parts of the procedure, including closing of a wound. "The issue, particularly with teaching hospitals, was that a resident may be asked to close or do a portion of the procedure, and that may or may not have been identified during the informed consent process because residents may be floating around ORs," says Lew A. Lefko, partner at Haynes and Boone in Dallas.
The revised guidelines say significant tasks include "harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues," but wound closure is not listed and apparently is exempted, Lefko says. "That gives teaching hospitals a little leeway," he says.
The revised guidelines also seem to contain a loophole with some added language: "We recognized that at the time of the surgery, unforeseen circumstances may require changing which individual practitioners actually are involved in conducting the surgery."
The interpretive guidelines for surgery centers involving informed consent have not changed. ASCs must simply document properly executed informed consent. However, surgery centers should follow the hospital guidelines and document who is conducting significant tasks as part of informed consent, Lefko says. "For professional liability reasons, you don't want to do different informed consent in the ASC than in the hospital," he says.
CMS letter supports alcohol-based skin preps
In other news, CMS has issued a letter to all state surveyors supporting the use of alcohol-based skin preps in surgical settings.
The letter says the following fire risk reduction measures are appropriate:
- Use skin prep solutions that are packaged to ensure controlled delivery to the patient in unit dose applicators, swabs, or other similar applicators; and provide clear and explicit manufacturer/supplier instructions and warnings. "These instructions for use should be carefully followed," CMS says.
- Ensure that the alcohol-based skin prep solution does not soak into the patient's hair or linens. "Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location prior to draping the patient," CMS says.
- Ensure that the alcohol-based skin prep solution is completely dry prior to draping. "This may take a few minutes or more, depending on the amount and location of the solution," CMS says. "The prepped area should be inspected to confirm it is dry prior to draping."
- Verify that all of the above has occurred prior to starting the surgical procedure. "This can be done, for example, as part of a standardized preoperative 'timeout' used to verify other essential information to minimize the risk of medical errors during the procedure," CMS says.
Hospitals that use alcohol-based skin preparations in anesthetizing locations should establish appropriate policies and procedures to reduce the risk of fire, CMS says. "They should also document the implementation of these policies and procedures in the patient's medical record."
According to the Association for Professionals in Infection Control and Epidemiology, the support of skin preps removes the risk of individual states banning their use, following such action in Pennsylvania and Nebraska.
(Editor's note: To view the letter sent Jan. 12, 2007 to CMS Surveyors, go to www.premierinc.com.)
While we need to budget for new equipment in the surgical suites, we don't necessarily need to spend it. With already escalating costs for energy and labor, any area where we can save money or "capital" is wise planning.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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