Back in October I had a conference call with several people representing Kansas professional organizations that I had invited to discuss my family’s legislative bill. A couple points were brought up that I said I would look into. Here they are.
First, the bill uses the term “harm” in four places—in specifying what patients must be informed of during disclosure conversations and in defining two other terms—but the term “harm” itself is not defined. I see that we did not use the term “harm” in defining either “medical error” (the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. This includes errors of commission, errors that occur as the result of an action taken, and errors of omission, errors that occur as a result of an action not taken) or “unanticipated outcome” (any adverse event, sentinel event or unintended or unexpected outcome or injury, whether or not resulting from an intentional act, that is not due to an underlying medical condition of the patient). But it did end up in the definition of “less serious unanticipated outcome or medical error” (an unanticipated outcome or medical error that results in some harm, but does not inhibit previously planned treatment or prolong a patient’s treatment or recovery). If you are wondering why we needed to distinguish between serious and less serious unanticipated outcomes and medical errors, it is because only the serious ones require written disclosure in our legislative bill.
I agree that the term “harm” needs to be defined. So I headed back into the world of patient safety terminology.
In the process of researching this, I learned that the World Health Organization has been working on patient safety terms and a framework for addressing patient safety issues. Their report from 2009, “The Conceptual Framework for the International Classification for Patient Safety” has definitions for 39 patient-safety terms. (You can download the 158-page PDF from this webpage.) Here is their definition: “impairment of structure or function of the body and/or any deleterious effect arising there from. Harm includes disease, injury, suffering, disability and death.” Of course my family is referring to healthcare-associated harm, which the WHO defines as: “harm arising from or associated with plans or actions taken during the provision of healthcare, rather than an underlying disease or injury.”
The end of the WHO document provides the sources they used in researching their terms and definitions. They cite five for the term “harm”:
- “Temporary or permanent impairment of the physical, emotional, or psychological function or structure of the body and/or pain resulting therefrom requiring intervention.” (National Coordinating Council for Medication Error Reporting and Prevention. NCC MERP Taxonomy of Medication Errors. Rockville, MD: Office of the Secretariat, United States Pharmacopeia. 1998.)
- “The physical injury or damage to the health of people.” (Voges U. Minimisation of risk in medical systems by system design for safety. In: Vincent C, de Mol B, eds. Safety in Medicine. Amsterdam: Pergamon, 2000, pp. 217–230.)
- “Death, disease, injury, suffering and/or disability experienced by a person.” (Kaushal R, Bates DW. Computerized physician order entry (CPOE) with clinical decision support systems (CDSSs). In: Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment, Number 43. Rockville, MD: Agency for Healthcare Research and Quality, 2001.)
- “Any physical or psychological injury or damage to the health of a person, including both temporary and permanent injury.”(National Quality Forum. Standardizing a Patient Safety Taxonomy – A Consensus Report. Washington, DC: National Quality Forum, 2006.)
- “Impairment of structure or function of the body and/or any deleterious effect arising there from.” (World Health Organization, World Alliance for Patient Safety (2007, June) Report on the Web-Based Modified Delphi Survey of the International Classification for Patient Safety. Geneva,Switzerland.)
I rather like the fourth definition in this list. I looked up this report from the National Quality Forum (NQF) (there is a PDF download here) . This is a very helpful document. I particularly like this because the taxonomy was developed by the Joint Commission and then endorsed by the NQF. My family has written our legislative bill to be compatible with Joint Commission disclosure guidelines, so anywhere that we can align our definitions with those used by the Joint Commission, we should do it. There is a lot in this document. It presents a taxonomy for describing patient safety events. This taxonomy has five root nodes (impact, type, domain, cause, and prevention and mitigation). It is going to take me a while to read all this, but the basic definition of harm is “temporary or permanent impairment of physical or psychological body functions or structure.” Under the “Impact” node there are medical and non-medical classifications, and both physical and psychological medical impacts. There are nine degrees of harm for both physical and psychological impacts. (For example, degrees of physical harm range from “no harm” to ”death”.
So I think that using the NQF-endorsed definition for harm from the Joint Commission is the way to go. We can’t possibly define everything in this piece of legislation. Tying our bill into this existing taxonomy can only help. And now that I have found this, I am wondering if we should redefine our “serious”, “less serious”, “minor” classification of unanticipated outcomes and medical errors in terms of the degrees of harm presented in this document. If you have comments or suggestions, please let me know. Our goal is to make the requirements and definitions in our legislative bill clear, practical, and usable.
What if a physician discovers a possible error made by another physician?
The second issue brought up was that the disclosure process that is required could get rather complicated if a physician discovers a possible error made by another physician. Who is responsible for initiating the disclosure process? Is it practical to adhere to the time frame for disclosure (seven days)?
Just a week or so after that phone call, a manuscript appeared in The New England Journal of Medicine that addresses exactly this topic. It is titled “Talking with patients about other clinician’s errors”, and is a set of recommendations by a working group of patient safety experts. The paper discusses the responsibility to explore potential errors made by other clinicians, as well as the need for institutional leadership. It also provides recommendations on how to handle these disclosure conversations and who should be at these conversations, based on five scenarios:
- a clinician at the same institution and who is treating the patient
- a clinician at the same institution who does not have direct contact with the patient (for example, a pathologist)
- a clinician at another institution
- a trainee or interprofessional colleague (such as a nurse) who is on the primary care team
- an error unrelated to current care
I think the recommendations in this paper make a lot of sense. I am not sure whether this amount of detail needs to be written into the legislative bill. I think the responsibility for spelling this out might come down to individual hospital policies, which will be written by individual hospitals (hopefully with the help of some state leadership, perhaps the Kansas Healthcare Collaborative). But some clarification in terms of responsibilities for disclosure and enforcement of disclosure in these situations might be in order. If anyone is concerned about this and has a suggestion, do let me know.