Historic Deficiencies
The Emerging New Problems of Surgical Informed Consent
According to the Dictionary of Health Insurance and Managed Care, informed consent is the oral and written communication process between a patient and physician that results in the agreement to undergo a particular procedure, surgical intervention or medical treatment. Unfortunately, a lack of standardization surrounding this process represents a major risk for patients and surgeons, and may lead to inaccurate patient expectations, lost or incomplete consent forms, missing encounter documentation and delays in critical surgeries and procedures.
History: Render S. Davis of Emory University [2008 recipient of the Health Care Ethics Consortium’s Heroes in Healthcare Ethics Award] writes for us in the Business of Medical Practice, that the concept of informed consent is rooted in medical ethics and codified as a legal principle. It is based on the assertion that a competent person has the right to determine what is done to him or her [self-regulated autonomy].
Rationale: The American Medical Association recommends that its members disclose and discuss the following with their patients:
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The patient’s diagnosis, if known,
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The nature and purpose of a proposed treatment or procedure,
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The risks and benefits of a proposed treatment or procedure,
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Alternatives (regardless of cost or health insurance coverage),
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The risks and benefits of the alternative treatments, and the
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The risks and benefits of not the procedure.
The requirements for informed consent are spelled out in statutes and case law in all 50 states. It is a necessary protocol for all hospitals, medical clinics, podiatry practices and ASCs.
Inadequacy of Traditional Consent Forms-to-Date
The typical informed consent process, particularly one that relies solely on traditional generic consent forms, is often inadequate, incomplete or offers the potential for not fully explaining and documenting a particular procedure to a given patient.
Traditional consent forms are subject to errors and omissions, such as missing signatures (patient, provider or witness), missing procedure(s), and missing dates that place the validity of consent at risk. Lost or misplaced forms may result in delayed or postponed procedures often at the expensive of costly operating room time. Moreover, far too many forms are generic in nature and wholly unsuited for a specific patient or increasingly sophisticated podiatric procedure.
Patient Safety Background
According to the Institute of Medicine’s [IOM] repot, To Err is Human, more than 1 million injuries and nearly 100,000 deaths occur annually in the United States due to mistakes in medical care. Wrong patient, wrong-side, wrong-procedure and wrong-toe surgery are particularly egregious. In fact, these are among several other “never-events” that Medicare, and an increasing number of private insurance companies are refusing to reimburse.
Based on the need to make healthcare safer, the Agency for Healthcare Research and Quality (AHRQ) undertook a study to identify patient safety issues and develop recommendations for “best practices”.
AHRQ Evidence Report
The AHRQ report identified the challenge of addressing shortcomings such as missed, incomplete or not fully comprehended informed consent, as a significant patient safety opportunity for improvement.
The authors of the AHRQ report hypothesized that better informed patients “are less likely to experience errors by acting as another layer of protection.” And, the AHRQ study ranked a more interactive informed consent process among the top 11 practices supporting more widespread implementation.
General Accounting Office report found that malpractice insurance premiums were relatively flat for most of the 1990’s, but projections began to increase dramatically to 2010.
Results of Improper Informed Consent
Failure to obtain adequate informed consent, depending on state law, may place surgeons, resident, fellows, ambulatory and office surgery centers, medical clinics and hospitals at risk for litigation ranging from medical negligence to assault and battery.
Proceedings Involving Informed Consent
Informed consent is often a factor in medical malpractice litigation. Some attorneys note that physicians are liable, and that plaintiffs may be able to recover damages, in cases involving improper informed consent, even if the procedure is successful. Inadequate informed consent is often cited as a secondary cause in malpractice complaints and anecdotal evidence suggests this strategy may be especially pursued in podiatric malpractices cases.
Avoiding Litigation
The AMA advises its membership of the following regarding informed consent:
“To protect yourself in litigation, in addition to carrying adequate liability insurance, it is important that the communications process itself be documented. Good documentation can serve as evidence in a court of the law that the process indeed took place. A timely and thorough documentation in the patient’s chart by the physician providing the treatment and/or performing the procedure can be a strong piece of evidence that the physician engaged the patient in an appropriate discussion.”
Impact of Comprehensive Informed Consent Forms
Another study found that providing informed consent information to patients in written form increased comprehension of the procedure. It was also hypothesized that:
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Better informed patients are more compliant with medical advice and recover faster.
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Informed consent discussions strengthen physician-patient relationships and increase patients’ confidence in their doctor.
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Well informed patients are more engaged in their own care, and are thus less likely to experience surgical errors than more passive, or less informed patients.
Medical Ethics
The ethical foundation of informed consent is based on the creation of an environment that supports respect for patients and protects their right to autonomous, informed participation in all collaborative Healthcare 2.0 decisions.
In conclusion, this is the essence of the informed consent problems of modern podiatry today.
Readings and References:
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Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Archives of Surgery; 2000; 135: 26-33.
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Marcinko, DE [editor]: Risk Management and Insurance Panning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006.
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Davis, Render, S: Ethical Issues in Modern Medical Practice. In Marcinko; DE [editor]: The Business of Medical Practice [Advanced Profit Maximizing Techniques for Savvy Doctors]. Springer Publishers, New York, NY, 2005.
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Fenton, Charles, F: Risk Management in Modern Medical Practice. In, Marcinko, DE [editor]: Risk Management and Insurance Panning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006.
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Grife, Jay, S: Medical Malpractice Trial Risks. In, Marcinko, DE [editor]: Risk Management and Insurance Panning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006.
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Kohn KT, Corrigan JM, Donaldson MS, Eds: To Err Is Human: Building a Safer Health System. Washington, DC: Committee on Quality Health Care in America, Institute of Medicine, National Academy Press; 1999.
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Marcinko, DE [editor]: Risk Management and Insurance Panning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006.
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Medical Malpractice Insurance: Multiple Factors Have Contributed to Increased Premium Rates. United States General Accounting Office. Washington, D.C. June 2003. Report GA-03-702.
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Marcinko; DE [editor]: The Business of Medical Practice [Profit Maximizing Techniques for Savvy Doctors]. Springer Publishers, New York, NY, 2000.
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Marcinko, DE and Hetico, HR: The Dictionary of Health Economics and Finance. Springer Publishing, New York, 2006-08 [www.HealthDictionarySeries.com] and [www.SpringerPub.com]
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Marcinko, DE and Hetico, HR: The Dictionary of Health Insurance and Managed Care. Springer Publishing, New York, 2006-08 [www.HealthDictionarySeries.com] and [www.SpringerPub.com]
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Marcinko, DE [editor]: Risk Management and Insurance Panning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006
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Marcinko, DE [editor]: Financial Planning for Physicians and Advisors; Jones and Bartlett Publishers [http://www.JBPub.com], Sudbury, MA, 2006
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Marcinko, DE and Hetico, HR: Healthcare Organizations [Financial Management Strategies]. Standard Technical Publishers, Blaine, WA, 2007-09
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Marcinko, DE [editor]: Financial Planning for Physicians and Healthcare Professionals. Aspen Publishers, New York, NY 2001, 2002 and 2003
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Informed Consent: American Medical Association http://www.amaassn.org/ama/pub/category/4608.html
The ePodiatry Consent Forms Solution
e Podiatry Consent Forms 
Good for ESL Use
e-Podiatry Consent Forms are ideal for new, mid-life and all mature practitioners not familiar with modern Agency for Healthcare Research and Quality [AHRQ] recommendations.
And, they are especially useful in English as a Second Language [ESL] situations.
Risk Manager
Risk Manager
October 4, 2008 at 10:31 pm
Lawyer versus Podiatrists
I just found this on the internet, and thought I’d pass it along to all podiatric colleagues:
“The law states that the podiatrist, or any health care provider, must get the patient’s consent to the surgery after giving the patient information including the risks, benefits, and alternatives to surgery, including NOT HAVING THE SURGERY at all.
Most consider a signed consent form, without explanation, inadequate to get the patient’s informed consent. The podiatrist should sit down with the patient and verbally explain the surgery.
Some podiatrists get the patient’s consent moments before the surgery. Some consider that to be bad practice. More important is whether the patient is calm enough to understand the details of the procedure and all the risks and alternatives. Most patients would rather not have these important information moments before surgery, but rather days or weeks before the surgery so they can discuss it with their family or friends or just take their time and think it over.”
Directly from the Website
The Law Office Firm of:
Lawrence M. Karam, PC
41 West 72nd Street
New York, NY 10023
212.712.0008
http://www.podiatrymalpractice.com
PS: I think these document production tools are the best thing that’s happened to help defend DPMs against guys like this, in a long time!
Anonymous Doctor
Anonymous Doc
October 5, 2008 at 12:18 am
Consent Forms Designed with Patient Literacy in Mind
By Dr. David Edward Marcinko; MBA, CMP™
Three years ago, according to Eric Rabinowitz writing in the October 2008 issue of Managed Healthcare Executive, Jessica Ridpath [communications coordinator for the Group Health Center for Health Studies] realized that average people just didn’t understand her organization’s printed materials.
A further audit of the center’s print material revealed that it was written mostly at an 11th grade level, well above industry guidelines.
Ridpath then began revising the print materials, especially the center’s consent forms, into plain language, while simultaneously training her staff to do the same.
Now, according to medical industry risk management expert Hope Rachel Hetico; RN, MHA, CMP™, the chief operating officer of our company;
“Plain language and standardized forms, for both doctors and patients, will help simplify the informed consent process for the benefit of all concerned, as well as payers, government and employers. And, this was our goal, upon inception, at e Podiatry Consent Forms™.”
Conclusion
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Medical Risk Management: http://www.jbpub.com/catalog/9780763733421
Healthcare Organizations: http://www.HealthcareFinancials.com
Health Administration Terms: http://www.HealthDictionarySeries.com
Physician Advisors: http://www.CertifiedMedicalPlanner.com
Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko MBA, is available for seminar or speaking engagements.
Contact: MarcinkoAdvisors@msn.com
Dr. David E. Marcinko; FACFAS, MBA
October 15, 2008 at 2:52 pm
Doctors Must Provide Every Relevant Alternative and Risk
In two separate state rulings, in both Maryland and Wisconsin State Supreme Courts, the requirement that doctors provide “every” alternative treatment and risk was made. But these rulings go even further. Plaintiffs now have the ability to sue for “informed consent” claims even in the ABSENCE of proof of negligence. This is a new high water mark against healthcare providers. Unfortunately, without tort reform, it is unlikely that these issues will be solved. At this time, tort reform is absolutely off the table.
Podiatrists now (already) try to seriously provide extensive information and obtain informed consent for procedures. But with the bar higher now, it will probably mean that podiatric physicians inform their patients about attendant risks of many non-surgical treatment choices, like injection and drug therapies. Remember, it will no longer be necessary for your patient to prove “negligence” if you practice in either of these states.
Since I am not an attorney, I cannot provide legal advice. However, I would suggest that carriers that presently insure podiatrists take heed of the new rulings, and try to prepare their insured against this new threat. This might start out with patients’ signing informed consent for injection therapy and various drug therapies, including potent antibiotics that podiatric physicians routinely order.
Source: Michael M. Rosenblatt, DPM, San Jose , CA
[Podiatry Management August 31, 2009]
Editors
August 29, 2009 at 8:47 am
$750,000 Verdict – Failure To Obtain Informed Consent For Foot Surgery (NY)
Posted on October 17, 2008 by Michael Quinn
A damages-only case in New York involved the plaintiff’s right to decide whether or not to receive additional medical treatment/surgical procedures to the feet, which established the podiatrists’ duty to inform the patient (informed consent).
The plaintiff maintained that the two defendant podiatrists misrepresented her rights as to the nature of the surgery that they proposed to perform. She alleged that the surgeons did not obtain informed consent and that they negligently performed the surgeries, leaving her with a fused joint in her large and small toes, ataxic gait and ongoing pain and in her smaller toes, preventing her from walking properly, enjoy jogging, and race walking, as she once did, and to live a pain-free life.
The trial lasted three days and the trial judge entered a verdict in favor of the plaintiff. He awarded her $ 250, 000 for past pain and suffering and $ 500,000 for future pain and suffering, for a total award of $ 750,000.
Source: Jury Verdict Review Publications, Volume 16, Issue 11 [PM NEWS]
Editors
August 29, 2009 at 7:58 pm
Excellent advice.
I’m going to post a link of this Historic Deficiencies and related articles on my blackboard website for my students, residents and surgical fellows.
Greg Morris; DPM
Dr. Greg Marris
December 28, 2009 at 6:31 pm
GEORGIA [Lack] INFORMED CONSENT
Settlement for client in the amount of $35,000.00.
Client underwent surgery on the fifth (smallest, little) toes for which inadequate consent was given and complications developed. This required two additional surgeries.
http://www.FootLaw.com
Foot Law Group
February 13, 2010 at 2:45 pm
True Informed Consent
James Gottesman and Robert O’Hara effectively highlighted the many advantages of automating the informed consent process [H&HN OnLine, September 28th 2010].
Inadvertently, however, they neglected to acknowledge three vital components of the process that must be addressed irrespective of whether it is automated.
http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HHNMAG/PubsNewsArticle/data/0601HHN_Letters_Hofmann&domain=HHNMAG
Stanford
Stan
July 22, 2010 at 11:57 am
Malpractice: Your Informed Consent May Not Be Good Enough
You told your patient about the risks of a treatment or procedure before it began. Now he’s unhappy about a bad result and is suing you — and he could win! What gives?
It’s important for doctors to know exactly what they need to tell patients before a recommended treatment; and it’s important to do it the right way.
http://www.medscape.com/viewarticle/736411
Many doctors are not aware that it’s not only in advance of a major procedure or serious medication regimen that informed consent is required; it’s also required for treatments or procedures that doctors may believe require no “disclosure” or informed consent. As a result, many doctors are not as vigilant with informed consent as they should be.
Editors
February 11, 2011 at 3:36 pm
A Balanced Approach to Informed Consent
Informed consent has continued to generate a lot of interest in medicine worldwide.
The reason is because patients in medicine and subjects in clinical trials need protection from the multitude of injuries and harms that have been caused by intentional or accidental actions. The controversies generated by various lapses of informed consent, in my opinion, have not been addressed and more safeguards need to be put in place to guard against harm.
Read more here:
http://www.kevinmd.com/blog/2011/02/balanced-approach-informed-consent.html#more-51089
Editors
February 25, 2011 at 1:38 am
A Balanced Approach to Informed Consent
Informed consent continues to generate interest here for DPMs, and in the medical world.
The reason is because patients need protection from the multitude of injuries and harms that have been caused by intentional or accidental actions.
http://www.kevinmd.com/blog/2011/02/balanced-approach-informed-consent.html
The controversies generated by various lapses of informed consent, in my opinion, have not been addressed and more safeguards need to be put in place to guard against harm. And, this essay is a helpful read in this regard.
Dr. David Edward Marcinko MBA
[Publisher-in-Chief]
Dr. Marcinko
March 28, 2011 at 8:56 pm
Patient safety checklists mandated by state law
Patient safety checklists are now state law, as Nevada signed the Patient Protection Checklist bill (AB 280) into legislation this week.
More recently spearheaded by advocate Atul Gawande, MD, author of the Checklist Manifesto, the concept is simple: providers on the healthcare team should call out basic patient information and a plan prior to procedure with the aim to prevent medical errors and improve patient outcomes.
Read more: Patient safety checklists mandated by state law – FierceHealthcare http://www.fiercehealthcare.com/story/patient-safety-checklists-mandated-state-law/2011-05-26?utm_medium=nl&utm_source=internal#ixzz1VzycQjvV
Dr. David Edward Marcinko MBA
http://www.BusinessofMedicalPractice.com
Editors
August 25, 2011 at 1:12 am
Informed Consent Forms Target 11th Grade Readers
If one wants to make something understandable for the largest possible population, then it might make more sense to offer language that can be absorbed by an 8th grader, instead of an 11th grader, for instance. Institutional review boards, for instance, recommend the lower level.
However, a recent analysis of informed consent documents from 15 studies found that the forms are aiming too high.
http://www.anesthesiologynews.com/ViewArticle.aspx?d=Policy+&+Management&d_id=3&i=December+2011&i_id=793&a_id=19827
NOTE: At http://www.ePodiatryConsentForms.com, we aim right.
Ann Miller RN MHA
[Executive-Director]
Ann Miller RN MHA
December 12, 2011 at 2:44 pm
Lawsuits for Surgeons are Common, Often Preventable, Almost Always Winnable – Experts Say Documentation Is Best Defense [General Surgery News – December 2011]
Several attorneys and surgeons weigh in on the challenges associated with medical malpractice claims – litigation faced by 15.3 percent of general surgeons, on average, each year. The experts note that the most commons claims against surgeons arise from informed consent issues and from intraoperative and postoperative complications.
http://www.dialogmedical.com/2011/12/13/lawsuits-for-surgeons-common-often-preventable-almost-always-winnable-experts-say-documentation-is-best-defense/
Informed consent claims are almost entirely preventable and all three categories of complaints are effectively handled with two basic strategies: 1) appropriate management of patient expectations – balancing the discussion of risks along with the discussion of benefits, and 2) use of a detailed consent form documenting the potential complications and surgical risks along with a supplemental note to the patient’s medical record.
Editors
Editors
March 10, 2012 at 4:58 pm
Informed Refusal
An essay by Richard Gunderman MD.
http://thehealthcareblog.com/blog/2013/08/18/informed-refusal/
Editors
Editors
August 18, 2013 at 9:59 pm