Law or Compliance Standard

HTH 1301, Medical Law and Ethics 1

Course Learning Outcomes for Unit IV Upon completion of this unit, students should be able to:

3. Classify current compliance standards related to health information initiatives. 3.1 Outline research concerning laws or standards regarding protection of heath information.

5. Summarize proper procedures regarding the release of patient information to authorized users,

including informed consent. 5.1 Identify best practices regarding patient information and informed consent.

Course/Unit Learning Outcomes

Learning Activity

3.1

Unit Lesson Chapter 7 Article: “HIT and MIS: Implications of Health Information Technology and

Medical Information Systems” Unit IV Outline

5.1 Unit Lesson Chapter 7 Unit IV Quiz

Required Unit Resources Chapter 7: Medical Records, Informed Consent, and Health Information Technology In order to access the following resource, click the link below. Goldschmidt, P. C. (2005). HIT and MIS: Implications of health information technology and medical

information systems. Communications of the ACM, 48(10), 69–74. Retrieved from https://libraryresources.columbiasouthern.edu/login?url=http://search.ebscohost.com/login.aspx?direc t=true&db=bsu&AN=18391446&site=ehost-live&scope=site

Unit Lesson Informed Consent Informed consent is the process of communication that must take place between a physician and a patient, resulting in the patient’s understanding of and authorization for the doctor to proceed with a specific medical procedure (Judson & Harrison, 2019). Most of you have signed a piece of paper prior to a medical procedure, and you may tend to think of that piece of paper or that signature as informed consent when, truly, it means so much more than that. Healthcare administrators need to thoroughly understand this concept and process. In this lesson, the aim is to provide a solid understanding of what informed consent really means and how you can make certain to obtain such consent in your healthcare organizations. Why is Informed Consent Needed? Why should we devote an entire lesson in this course to the concept of informed consent? First, it is simply the right thing to do for patients. It is the ethical high road. Patients need to understand what is being proposed to do to them or for them. They need to understand why a particular course of action is being

UNIT IV STUDY GUIDE

Medical Records and Informed Consent

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recommended, about alternatives if there are any, and the risks associated with the recommended procedures. Beyond ethical considerations, informed consent is a safety and quality-of-care issue. It is plainly unsafe to perform any medical procedure without the patient’s clearly documented consent and understanding. Quality of care is compromised if lack of informed consent takes place. Finally, it is the law! There is a legal term for the performance of any medical procedure on a patient without that patient’s informed consent. The term is battery, and the courts look upon medical battery no differently than other forms of battery. In fact, physicians have been charged with battery in cases of sloppy informed consent practices. When a physician is charged with battery, the hospital in which he or she practices is typically also charged, so things get increasingly worse. This is avoidable by following safe and standardized informed consent processes. When is Informed Consent Needed? First, it may be useful to point out that you do not need to get documented informed consent for every single thing done in medicine. When you take a blood pressure, listen to the patient’s lungs, or perform an electrocardiogram (EKG), you do not need a separate informed consent process and document. The patient signs a general consent form before receiving services, and most routine aspects of patient care are covered by that general consent. You, however, do need informed consent for certain procedures shown in the graphic. Specific laws vary from state to state about exactly when informed consent must be provided, but the above list applies in most jurisdictions. What is Needed for Informed Consent? At a minimum, the physician must disclose and discuss many things with the patient. Please note that this duty cannot be delegated to a nurse or anyone else. That is a mistake that is made in some healthcare facilities. The physician must discuss the following aspects:

 the patient’s diagnosis, if known prior to the procedure;

 possible diagnoses, if the physician is uncertain about the diagnosis;

 the nature and purpose of the proposed treatment or procedure;

 the known risks of the proposed treatment or procedure;

 any alternatives to the proposed treatment or procedure (and these should be discussed regardless of the costs involved and regardless of coverage from insurance, Medicare, or Medicaid. The patient has a right to choose or reject an alternative without our judgement about whether it is too expensive or not);

 risks of the alternatives considered;

 benefits of the alternatives considered;

 risks of not receiving treatments or procedures; and

 benefits of not receiving treatments or procedures (Judson & Harrison, 2019). That is a great deal to cover, but that is what it takes to meet the high legal standard for informed consent. Barriers to Informed Consent There are certainly barriers to informed consent (i.e., things that make it difficult to obtain). The most common barrier is simply lack of physician time to do the consent process well. Some physicians are not certain about when informed consent is truly needed. They may consider a particular procedure minor enough that informed consent is not an issue, but state law may look upon that differently, especially if there is an adverse

Partial list of procedures requiring informed consent

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outcome. Some doctors are cautious about giving patients too much information and thereby scaring those away from care that they truly need to receive. Patients themselves can be a barrier when they consider the informed consent document to be just another paper to sign and do not give it sufficient attention. Finally, many patients do not understand that they can in fact refuse a procedure or delay a decision about a procedure until they have a better understanding. Language and cultural issues are very common in health care today. It is important to have an interpreter available to assist the patient in understanding the details listed above before the patient signs the informed consent document (Judson & Harrison, 2019). Additionally, there is a subscription service called AT&T On Demand Interpreter Powered by Language Line Services available at all times to assist with interpretation services in such situations when an interpreter is not available on-site. Poorly designed consent forms also can be an issue, as well as inadequate educational materials for patients. Patient inability to understand the information presented can be a factor. You may deal with elderly patients, those who have experienced strokes or have developmental disabilities that interfere with their understanding. In such cases, they may need a designated Healthcare Proxy or Durable Power of Attorney for Health Care, who provides informed consent on the their behalf. Toward Better Informed Consent If informed consent is so important, what can you do as healthcare professionals to optimize it? You can certainly redesign your informed consent documents to make them easier to read and understand. Using simple sentences and reducing the medical terminology can help. The form itself should be written at a fifth- grade reading level and should also be available in at least the two or three most common languages spoken in your geographic area. In addition, using teach-back techniques in which the patient restates the procedure, the risks, and the benefits can be a very positive step. Hearing the patient restate your words and key concepts can help to assure understanding. Finally, you must make time for this very important process, explaining things thoroughly to the patient and giving the patient time to ask any questions. Non-physician personnel cannot obtain informed consent, but they can help with patient teaching in advance and help to make sure that patient concerns and questions are addressed in the informed consent session. A rushed informed consent session is a huge mistake for all involved.

Reference Judson, K., & Harrison, C. (2019). Law & ethics for health professionals (8th ed.). New York, NY: McGraw-Hill

Education.