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SDS Accreditation Update
What requirements from The Joint Commission must your program meet for informed consent?
When developing a policy on informed consent, you must use accreditation standards, as well as state law and the Hospital Conditions of Participation (CoPs) or Ambulatory Surgery Conditions for Coverage, says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, director of hospital patient safety at The Doctors Co./OHIC Insurance Co., Columbus, OH.
Dill Calloway recently spoke on "Informed Consent: CMS, The Joint Commission, and Other Standards Every Healthcare Provider Should Know" in an audio conference sponsored by AHC Media, which publishes Same-Day Surgery. There are differences in consent requirements by CMS for hospitals and critical access hospitals, she points out.
The Joint Commission (TJC) uses the same informed consent standards for ambulatory and hospital-based programs, except that for ambulatory programs, the Elements of Performance (EP) 4 and 5 in the Ethics, Rights, and Responsibilities section RI.01.03.01. do not apply. EP4 policy describes the process to be followed: The surgeon talks to the patient; the consent form is signed, if the surgery is elective, it is sent to hospital, and it is put on the chart before the patient goes to surgery. EP5 describes how to document consent in the medical record: in the progress notes section.
TJC standards say a facility honors the patient's right to give or withhold informed consent. TJC and CMS expect a signed consent form to be on the chart before surgery, unless it's an emergency, Dill Calloway says. As for how long consents are valid, neither the Centers for Medicare & Medicaid Services (CMS) nor TJC specify a time period for the informed consent to be done, she says. Dill Calloway queried 50 hospitals, and most said conduct informed consent within 30 days or within 60 days. "You get to pick," she says. If you receive a consent form that doesn't fit within those parameters, have the patients reaffirm that they've received informed consent, and have them re-sign the form, Dill Calloway suggests. The time period and the policy on expired consent forms should be included in your policies and procedures and followed, she says.
For its part, the Accreditation Association for Ambulatory Health Care (AAAHC) says informed consent of the patient or representative is obtained before the procedure is performed. It also says one consent form can be used for anesthesia and surgery. TJC has gone from requiring an anesthesia consent to now recommending one, but Dill Calloway highly recommends that one is done.
What you might be missing
One important note for TJC-accredited health care facilities is that they must list the procedures performed and whether they require informed consent. "We know that some hospitals don't have this," Dill Calloway says. Update your list every year with new procedures for which physicians have received privileges, she says.
Additionally, most providers don't seem to know about EP 12, in RI.01.03.01, that says the informed consent process includes a discussion about any circumstance under which information about the patient must be disclosed or reported. This section refers to laws requiring mandatory reporting to the departments of health, she says. "This could include mandatory reporting requirements for HIV, [tuberculosis], viral meningitis, and other diseases to the [Centers for Disease Control and Prevention] or the state department of health," Dill Calloway says.
Another standard requires the hospital to honor the patient's right to give or withhold informed consent regarding the use of recordings, films, or other images of the patient for purposes other than his or her care. A sample consent form for photos is available from the American Health Information Management Association (AHIMA). [Editor's note: To access the Patient Brief: Patient Photography, Videotaping and Other Imaging and Sample Consent for Photography/Videotaping (For Media or Educational Purposes), go to library. ahima.org. For requirements by DNV Healthcare, see story, below.]
For more information on informed consent, contact:
For consent forms that list the risks, complications, and alternatives of many procedures by the Queens-land government in Australia, go to:
The CD and MP3 download from the audio conference "Informed Consent: CMS, The Joint Commission, and Other Standards Every Healthcare Provider Should Know" are available for $299 each. Call (800) 688-2421 and mention Priority Code T09312/7758. Or go to www.reliasmedia.com, and on the left side of the page, click on "Audio Conferences." Under "Past Audio Conferences Available on CD," click on the audio conference title.
Access standards from DNV Healthcare
DNV Healthcare, which has been approved by the Centers for Medicare & Medicaid Services (CMS) for deemed status, is a little more stringent than CMS, and unlike The Joint Commission, it has no separate standards for critical access hospitals, says Sue Dill Calloway, RN, Esq., BSN, MSN, JD, director of hospital patient safety at The Doctors Co./OHIC Insurance Co., Columbus, OH.
DNV's standards are available on its web site, www.dnv.com. The standards are free, but you must register to access them. The informed consent standards are on p. 96 in the Patient Rights section.