Informed Consent Emerging as a New Basic Element in Patient Communications

:dropcap_open:E:dropcap_close:ffective risk management requires every chiropractic practitioner’s daily attention. Consistent attention to detail and regular examination and re-evaluation of the risk-management basics, and now an up-to-date knowledge of and compliance with your state’s official rules are essential to your practice’s protection and the practitioner’s peace of mind. It is vital, on key risk management issues and procedures, that you never let your guard down and do not let staff members drop the ball or cut corners on record keeping and confidentiality issues, and, on the doctor’s  “MUST DO” list, make sure that informed consent documents and procedures are always in place and in play.
informedconsentAt the very outset of this discussion, it is vitally important that doctors understand that the general “terms of acceptance” document that many practitioners have used in their offices for many years is not the kind of informed consent document that is becoming the standard obligation for DCs prior to starting care. A “terms of acceptance” is an educational document. It is important but not sufficient to address the permission dimension that defines informed consent. Informed consent activities are becoming increasingly specific. 
These issues now have a special context for doctors of chiropractic in California, where, on October 7, 2011, a new regulation went into effect that requires that: 
A licensed doctor of chiropractic shall verbally and in writing inform each patient of the material risks of proposed care. “Material” shall be defined as a procedure inherently involving known risk of serious bodily harm. The chiropractor shall obtain the patient’s written informed consent prior to initiating clinical care. The signed written consent shall become part of the patient’s record.1  
To make certain that California practitioners understand the mandatory nature of this new requirement, the same regulation states:  
A violation of this section constitutes unprofessional conduct and may subject the licensee to disciplinary action.
The California chiropractic board offered a reasonable rationale for this new rule in which they cite a growing national trend towards greater clarity and specificity in informed consent for patients of all licensed health care providers. The new California regulation does not specify the exact “manner in which written notice shall be provided to patients” but it does seem to encourage the use of a standardized form which they advised might be obtained from a doctor’s attorney, malpractice insurance carrier or state or national association. Some insurance companies have been providing policy holders with such a form for many years, in recognition of the wisdom of having such consent on-file for every patient.  
Clearly, this is now the law for California practitioners and we are advising all policyholders in that state to be in immediate and ongoing compliance. We are also alerting DCs in other states to expect similar rules to emerge in their respective jurisdictions, since California has always been a regulatory trend-setter and because nationwide pressures all but guarantee that informed consent procedures will become increasingly standardized and specific among the states.  
In recent months other issues surrounding “informed consent” have emerged in a variety of situations that make it well worth your while as a busy practitioner, whether in California or elsewhere, to stop for a moment and seriously consider this question. At the top of the list of nagging issues are the activities of those groups and individuals who continue to promote stroke fears among the public. The impressive safety record of chiropractic, indeed the most impressive safety record of any health care profession, appears to mean very little to those organizations and individuals who have taken on the role of professional critics of our profession. Some of the anti-chiropractic organizations promoting the danger of stroke from upper cervical adjustments have hit upon the informed consent issue as a means to showcase their issues.  
Research and actuarial records, and the failure to make anything but a casual or coincidental link between stroke and chiropractic services, will not deter those interests. Their goal is not to deal with facts or real risks but to hurt the chiropractic profession. Sadly, we have no choice but to deal with the backwash of their campaign, regardless of their destructive intent and deceitful ways and means they are employing. Our job is to do what is right and what makes sense for both the patient and the practitioner.  
Informed consent has become the subject of growing attention as an element in risk management procedures because the lack of it in malpractice cases has become a common and effective claim. Clever and aggressive lawyers have hit upon the informed consent issue as a means to strengthen otherwise weak claims of clinical misjudgment or injury, based on a number of landmark court decisions and trends in other professions.

In a landmark 2005 Wisconsin case, the state court found:

 “Chiropractors, like medical doctors, are health care professionals involved in the application of procedures and treatments to the human body. We see no reason why the scope of an individual’s right to be informed of the risk inherent in bodily intrusions via chiropractic treatment and procedures should be any different from his right to be informed of the risk inherent in bodily intrusions in medical treatment and procedures.”2
Thus, the fact that chiropractic is non-invasive provides no additional margin on demands for informed consent according to the Wisconsin court, a position reaffirmed by an often cited 1999 New Jersey Supreme Court decision, which similarly held that: “…informed consent applies to both invasive and noninvasive procedures, holding that physicians must inform patients of the possible risks and benefits of all “medically reasonable” treatment options – including those he or she does not recommend.”3 If that is not complicated enough, courts are regularly finding that during the course of care, patients must be updated throughout in terms of relative risks and alternate care choices, and that not telling a patient about other care pathways and their risks becomes an issue in itself.4 
In fact, actions based solely or largely on the lack of formal and written informed consent have emerged as a malpractice growth industry, even though such charges may have nothing to do with whether a chiropractor has actually committed an act or acts of malpractice as it has historically been understood.  
The message here is clear:

Be consistent and proactive in obtaining both written and verbal informed consent from every patient, in advance of both examination and the active delivery of care. Yes, get informed consent prior to care to cover your examination procedures, as well as in advance of delivering chiropractic adjustive care. 

Informed consent starts with a standardized form, as encouraged by the California board in their new regulatory explanation. Your malpractice carrier is, indeed, always a good place to obtain a model form, followed by your state or provincial association, with, as is almost always the case, close attention paid to any direction available from your state or provincial regulatory board. On this form, the key information needed will always include the patient’s name, address and, of extreme importance, the date.  
:dropcap_open:Different jurisdictions have different specifics on informed consent.:quoteleft_close:
The exact nature of the form’s contents should reflect the requirements in your jurisdiction. This is why a visit to the regulatory board’s website or information from your local association is so vital. Different jurisdictions have different specifics on informed consent. You will need to comply with state and provincial directions as to the degree of specificity regarding risks inherent in the procedures you are about to apply.  
In recent months, as more and more technology and especially mechanical devices are incorporated into chiropractic practice (from mechanical adjusting devices to spinal decompression units) it is becoming important to obtain separate informed consent forms for each new level of intervention applied by your clinic. A form for the adjustment, a form for traction, a form for mechanical spinal decompression, and a form for any procedure that can be argued to be separate and different, and not arguably covered by a general form, will serve you well. Remember also that the absence of such forms becomes a problem in and of itself.
In addition to the form itself, most legal advisors will encourage that a note stating that the form was signed and that a verbal exchange took place be added to the patient’s file, with you as the provider (not a member of the staff) highlighting the contents of the form. Indeed, some malpractice experts argue that the verbal exchange is the essence of informed consent, where the patient has the opportunity to question the doctor’s choice of procedures, and that without the verbal component, the written form loses much of its meaning. 
Rather than look at the informed consent exercise as a burden, practitioners should look at the interaction with the patient on relative risk and informed consent as an opportunity to orient them to what they can expect from the adjustment process, especially if they are first-time patients. While most patients feel an immediate sense of relief from the adjustment, a frank discussion on possible temporary or short-term discomfort from a first adjustment, possible stiffness, etc., helps patients keep things in a much better and more realistic perspective, and places you as the doctor in a position of both credibility with the patient as well as defensibility should any unforeseen issue arise. Such frank and open dialogue can only strengthen the doctor-patient relationship and enhance the positive nature of the patient’s chiropractic experience.
In today’s litigation-happy (or many might argue litigation-crazy) society, even the best, most conscientious and responsible doctors of chiropractic, applying the highest standards and most established procedures and protocols, can still be named in a malpractice claim. When it comes to informed consent, a whole new dimension of malpractice reasoning comes into play, where patients and their attorneys regularly argue that if a patient was fully informed of all risks and possible negative outcomes, then they may have decided not to receive the care and would not, as a result, have been injured. The proactive doctor of chiropractic will respond accordingly, with sound and well-researched forms and procedures, all consistently applied and included in the patient’s file. It pays to do the work and, consequently, minimize the risk.
And, as every doctor of chiropractic should know by now, a reliable malpractice insurance carrier is your best partner in protecting your practice and yourself from malpractice claims. Make sure that you have the coverage you need, to help implement risk management procedures that will provide the best possible firewall to jeopardy.  
Shop around, compare and see what you find. The result will be both excellent coverage and peace of mind. You deserve both.  
  1. California Code of Regulations, Title 16, Div. 4, Article 2, Section 319.1
  2. Hanumans v. Boyson, No. 2003AP1527, 2005 WL 1522624 (Wis. June 29, 2005).
  3. Matthies v. Mastromonaco, 160 N.J. 26, 37, 733 A.2d 456, 462 (1999). 
  4. Schreiber v. Physicians Insurance Company of Wisconsin, 223 Wis.2d 417, 588 N.W.2d 26 (1999).

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