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July 9, 2007

The 411 on Informed Consent
By Mary Anne Gates
For The Record
Vol. 19 No. 14 P. 18

New guidelines and the availability of automation technology are affecting how facilities approach the requirement.

Much like seemingly every other aspect of the healthcare industry today, there is change in the air for informed consent. Recently, the Centers for Medicare & Medicaid Services (CMS) announced changes to informed consent policies dealing with medical records and surgical services.

According to industry experts, the new and revised guidelines should have a significant impact on the entire hospital, but it’s in the medical records department where the greatest changes will take place.

For example, according to the CMS, the following must occur:

• A properly completed informed consent form must be present in the patient’s medical record prior to surgery.

• Virtually any surgical procedure covered by a CPT code may necessitate a properly executed informed consent form.

• Hospitals are responsible for ensuring that physicians performing procedures obtain consent in a manner consistent with the hospital’s informed consent policy.

• A well-designed informed consent process should include a description of the procedure, the patient’s diagnosis, the procedure’s risk, the potential benefits, treatment alternatives, the patient’s prognosis if he or she declines treatment, whether other practitioners will be involved, and a discussion of the role(s) of residents (if present).1

Another example impacting medical records occurs as part of the changes affecting surgical survey procedures. CMS surveyors will interview two or three postsurgical patients to assess satisfaction with the informed consent discussion prior to their surgery.

“It is dramatic having CMS surveyors actually interview patients. That is the first time CMS has ever done that with informed consent. It’s not simply an interview with providers and a review of forms, which they are going to do, but they are now going to interview patients as well to gauge their satisfaction,” says Tim Kelly, vice president of marketing at Atlanta-based Dialog Medical.

Crafting an Informed Consent Policy
A search of medical records for “properly executed informed consent forms” and interviews with patients are just two compelling reasons for hospitals to review and possibly rewrite their informed consent procedures.

It’s incumbent on every single hospital to sit down with the revised CMS guidelines, their accreditation organization guidelines, and their state guidelines to review their own informed consent policy, says Kelly.

“Typically, those policies are crafted to be in alignment with three things. Policies and forms need to be in alignment with the standards set forth by the accreditation organization the hospital is using and most frequently, that’s going to be The Joint Commission. They must be in alignment with state law. And since most hospitals are seeing Medicare and Medicaid patients, they must be in alignment with CMS guidelines,” says Kelly.

Designing the Informed Consent Form
After the hospital’s informed consent policy is in place, the actual informed consent form must be designed to meet specific requirements.

According to Muta M. Issa, MD, MBA, informed consent should contain a description of the proposed treatment and the diagnosis prompting consideration of that treatment. The benefits, risks, and alternative therapies must also be included. Finally, says Issa, “patients must understand and voluntarily agree to the proposed treatment.”2

Informed Consent From the Patient’s Perspective
In addition to meeting specific legal requirements and other regulatory guidelines, informed consent from the patient’s perspective is more than just a piece of paper.

It should be viewed by all concerned parties as a communication process by which the patient (or his or her representative) is made aware of his or her medical condition and is able to discuss the options available to achieve the best outcome.

Additionally, after the patient has been “informed,” he or she may need time to comprehend the recommended procedure or treatment then ask questions for clarification.

“Consent for major procedures, when it is done properly, should have been obtained long before the surgery occurs,” says Kelly.

The Physician’s Point of View
Physicians, too, have several concerns regarding the informed consent process. “What we hear from physicians is they want access to the forms. Physicians want the information at their fingertips without having to ask other people to go around and look for it. And they want to know before they start a procedure if this information [a signed consent form] is in the [patient’s] chart or not,” says Sam Rubinsztain, vice president of product development at gMED (General Medical Applications).

Additionally, physicians want patients to have enough time to consider the information and ask questions about their condition, the anticipated procedure, their prognosis, and other pertinent information after they have been given information.

They want the form distributed to patients before they reach the hospital so they have an opportunity to talk to the doctor or call the office for more information about the procedure, says Rubinsztain.

Standardization of Forms
Designing a legal document that meets regulatory guidelines and ensures compliance while meeting the patient’s rights to be informed is a monumental task.

“That is a very challenging requirement if hospitals have not done an exceptional job of putting very good policies in place and if they’re not doing an exceptional job of ensuring compliance from all the providers who perform procedures in that hospital with that policy. And there is probably not a really effective way of accomplishing that unless you are using technology,” says Kelly.

Standardization of informed consent forms is one way to accomplish the goals of ensuring compliance and meeting the patient’s needs to receive consistent information throughout a large network of hospitals.

The Department of Veterans Affairs (VA) chose to adopt an electronic consent system nationally in 2004.3 Currently, iMedConsent, a comprehensive, computer-based patient education solution developed by Dialog Medical, provides the basis for the informed consent process in every VA medical center, says Kelly. “They wanted standardization from facility to facility and provider to provider,” he says.

The VA is the largest structural organization for visiting medical residents in the country. According to the VA, 83,000 health professionals are trained in VA medical centers each year, and more than one half of all practicing physicians receive some professional education in the VA healthcare system. “So consequently, with a lot of turnover of providers, having that ‘consistency of process’ was absolutely essential to them,” Kelly says.

Customized Consent Forms
While it may be important to standardize the process of informed consent, the actual forms may still need to be customized to meet a healthcare facility’s demands.

“We do supply an automated informed consent tool. But what we find ourselves doing is, for every one of our clients, we help them customize it to comply with whatever their policy is for informed consent,” says Kelly.

For example, university hospitals, because they are teaching institutions, will typically have listed on informed consent documents a question asking if the patient agrees to observers and photography during the procedure. Conversely, in a community hospital setting, that question typically would not be included on the consent form.

Another facility that employs a customized informed consent form, says Kelly, is the University of Texas M. D. Anderson Cancer Center in Houston. They have some very specific questions in their consent documents about the use of tissue samples for tissue-banking purposes.

“They do a tremendous amount of research on tissues that are removed from patients who have particular cancers. Those tissues are used by researchers, after securing all appropriate approvals, in various studies. As part of the consent process, the patients may consent to use of their tissues for research purposes,” says Kelly.

Also, patients may be asked to consent to release of diagnosis data and disease state data because that is of potential use to researchers, he says. “Every facility is a little bit different,” says Kelly.

“That is where trying to come up with an electronic means of doing this is helpful. Working with the institution, we can come in and configure that electronic informed consent process to do exactly what is required by that facility. That process is then repeatable from physician to physician, be they within the walls of the hospital or outside the hospital,” says Kelly.

Why We Need the Technology
Most facilities do not have the informed consent technology in place, says Kelly. They have one or two types of documents, and they’re both existing in paper-based forms, he says.

The first type of document is a general consent to treat form. It’s typically a one-size-fits-all type of form.

The second type is a fill-in-the-blank form. This form allows providers to write in the name of the procedure, the risks, and possibly the benefits and alternatives of the procedure.

So, in the first instance, hospitals don’t have a good record of what has been described to the patient. It also means there is a tremendous amount of variability from provider to provider. In the second scenario, an institution does tend to have a better record, but the problem once again is tremendous variability from provider to provider, says Kelly.

Problems With Written Informed Consent Forms
There are numerous examples of consent forms that contain illegible handwriting, medical jargon, abbreviations, and other deficiencies that make them challenging for a patient to understand.4

Some other inadequacies and inconsistencies that became apparent when paper-based consent forms were studied include the following:

• Out of a total of 78 individuals responding to a patient satisfaction survey, 96.1% (75 individuals) preferred the new electronic process over the paper-based consent forms.2

• A review of 89 written records documenting consent for blood transfusion in retropubic and perineal prostate procedures showed only 25.8% of those patients had documented consent for blood transfusions while 92.1% received blood transfusions (See figure 1).2

• A review of 540 written consent forms from 157 hospitals found the four basic elements of informed consent (risks, benefits, alternatives, and other key aspects of the procedure) were present in only 26% of the documents.5

• A review of 91 written urological procedure consent forms from a VA medical center found that only 15% contained all appropriate risks of the procedure.4-6

Reasons to Use Automated Informed Consent Process
Understanding that many areas of the hospital are affected by the informed consent process may be key to looking more closely at an automated process.

Dialog Medical has consulted several sources and identified the following seven areas where hospitals are affected by informed consent.7

• Accreditation: It is estimated that the average 500-bed hospital survey process costs are $80,000 to $100,000. Consequently, hospitals invest heavily to ensure their consent policies meet Joint Commission compliance standards.

• CMS compliance: Compliance with informed consent guidelines is essential for CMS reimbursement.

• Medical malpractice risk: Failure to obtain informed consent is one of the top 10 reasons medical malpractice claims are filed against hospitals.

• Eliminating paper: The average annual cost of scanning patient consent forms and advanced directives in three VA medical facilities was estimated to be $80,000 per facility.

• Wrong site surgery: Estimates suggest having a properly completed consent form could eliminate 45% of wrong site surgeries.

• Operating room efficiency: Lost or misplaced consent forms is said to be a major source of operating room inefficiency.

• Charge capture: Increasingly, more invasive procedures requiring informed consent are being performed at the bedside. Informed consent documents the procedure and serves as a record to charge for the procedure.

Changes in the CMS guidelines for informed consent will likely require hospital management to look carefully not only at the informed consent policy and the resulting process but to examine all areas of the hospital. A study of how other areas are affected by changes in informed consent and a thorough review of an automated informed consent process may lead to better, safer, and more cost-efficient healthcare.

— Mary Anne Gates is a medical writer based in the Chicago area.

CMS Interpretive Guidelines for Medical Records §482.24(c)(2)(v)
The medical record must contain a document recording the patient’s informed consent for those procedures and treatments that have been specified as requiring informed consent. Medical staff by-laws should address which procedures and treatments require written informed consent. There may also be applicable federal or state laws requiring informed consent. The informed consent form contained in the medical record should provide evidence that it was properly executed.1

1. Centers for Medicare & Medicaid Services. Memorandum: “Revisions to the Hospital Interpretive Guidelines for Informed Consent.” April 13. 2007. Available here.

2. Issa MM, Setzer E, Charaf C, et al. Informed versus uninformed consent for prostate surgery: The value of electronic consents. J Urol. 2006;176(2):694-699.

3. Spotswood S. VA Patient Consent Goes Electronic. U.S. Medicine. February 2005. Available here.

4. O’Hara R. Electronic Support for Patient Decisions: Automating and Integrating the Informed Consent Process. Presented at the 21st Annual TEPR Conference, Salt Lake City, May 17, 2005.

5. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: Facilitating quality patient-physician interaction. Arch Surg. 2000;135(1):26-33.

6. Issa MM, Miller E, Kimberly J, et al. Standardization of consent forms for urological procedures: A new standard of care. Association of VA Surgeons—Twenty-sixth Scientific Symposium. Houston, Tex., April 27-30, 2002.

7. Dialog Medical. “Healthcare’s Most Expensive Piece of Paper.” May 2007. Available here.