The “Myth of the Expiration Date” for Consent to Treatment Explained….
By Fay Rozovsky, President, The Rozovsky Group
Unless state law or hospital or ASC policy state otherwise, a documented consent remains valid indefinitely. It is more a convention than a rule cast in stone that consents are only valid for 30 days.
The consent document memorializes details as of the time the patient and care provider agreed upon a course of action, whether it is an outpatient operation, an invasive diagnostic procedure, or medication regimen. It is premised on the idea that unless the underlying conditions change the acknowledged benefits and risks, there is no need for a “redo” every thirty days.
There is precedent for this approach that can be found with dialysis patients receiving treatments three-times-per week and chemotherapy or radiation patients receiving frequent care. Each time these patients present for care a patient safety “speed bump” is utilized in which the care provider asks a series of questions to confirm that the underlying benefits and risks have not changed since the last visit. The questions are not superficial in nature. Thus, it is not sufficient to ask, “Has anything changed since your last visit?” Such a question is too broad and vague.
A more prudent approach is to ask a series of direct, pertinent questions. For example:
- Have you received any treatment from any other care providers since your last visit? I am thinking here about your primary care provider, urgent care, optometrists, dentists, and podiatrists?
- Did you obtain any medical attention or undergo any diagnostic procedures either on a routine scheduled basis or through a hospital emergency department or a walk-in clinic?
- Have you changed your diet since your last visit?
- Have you been taking the medication that the doctor [PA, APRN] instructed you to take as part of your treatment?
- Has any other care provider added or changed your medication plan, including adding over-the-counter medications or supplements?
- Have you on your own changed your medication plan?
- Have you added any supplements or over-the-counter medications to your daily care plan?
- Since your last visit have you had any pain or discomfort?
- Since your last visit have you experienced any of the side effects that the doctor told you might occur?
At the end of the discussion, the care provider documents that this update or “patient safety speed bump” process has been completed. The care provider then signs and dates the repeat test or treatment tool that becomes a part of the patient record.
The update catches potential problems and in effect puts up a red flag to “stop” and check further. The repetitive test or treatment may be stopped when certain conditions exist. For example, if the patient has received treatment elsewhere, received a new diagnosis or added new medications to the care plan. If the care provider decides to change the treatment protocol and thereby modifies the underlying benefits and risks, a new consent process is in order.
For elective procedures whether inpatient or day surgery, most healthcare organizations use the 30-day H&P review in much the same manner. They do not ask just the broad question, “Has anything changed since you received clearance to have the procedure today?” Rather, they ask a series of drill down questions like those listed above. Some may go further and ask:
- Since you received medical clearance for today’s procedure have you received a diagnosis of diabetes? Heart disease? Pneumonia? Bronchitis? High blood pressure?
- Since you saw the doctor who examined you for today’s procedure has there been a change in your medication schedule? If so, how added or told you to stop taking the scheduled medication?
- Have you received any recent immunizations or booster shots?
When the H&P update review is completed, there may be information that points to a sufficient change in the underlying benefits or risks to warrant a new consent process. The attending care provider is notified and a decision may be made to change the time of the procedure or to alter the agreed upon course of treatment.
Should a decision be made that the underlying circumstances have shifted the anticipated benefits and risks requiring a new course of diagnostic test or treatment, the original documented consent would expire. A new diagnostic or treatment authorization process would be completed along with a new documented consent.
Sometimes a scheduled invasive test or treatment is postponed due to an incomplete pre-operative report, the need to accommodate emergency patients, or another reason. As with the repetitive treatment or 30-day H&P review, it is prudent to complete a patient safety update for delayed or postponed procedures.
In each of the instances – repetitive treatment, the 30-day H&P, and delayed or postponed tests or interventions – it is good practice to explain to the patient the rationale for the update inquiries.
Consent to Treatment: A Practical Guide, 5th Edition, (2015), Fay A. Rozovsky, JD, MPH, Wolters Kluwers Law & Business in New York.
Fay A. Rozovsky, JD, MPH , The Rozovsky Group, Inc.
Tel: (860) 242-1302
This is a publication of The Rozovsky Group, Inc./RMS. This publication is not intended to be and should not be used as a substitute for specific legal advice and assumes no responsibility or liability for the discovery or elimination of risks that possibly could cause accidents, injuries, or damages. Compliance with any strategies or opportunities for improvement provided in publications does not assure elimination of risks or the satisfaction of requirements of applicable law. Copyright The Rozovsky Group, Inc. and OneBeacon Professional Insurance. All Rights Reserved. Information may not be redistributed without The Rozovsky Group’s permission.