Standard operating procedures for clinical practice

Abstract

Byline: T. Sathyanarayana Rao, Rajiv. Radhakrishnan, Chittaranjan. Andrade What are standard operating procedures (SOPs)? These are a specific set of practices that are required to be initiated and followed when specific circumstances arise. For example, emergency room physicians have SOPs for patients who are brought in an unconscious state; nurses in an operating theater have SOPs for the forceps and swabs that they hand over to the operating surgeons; and laboratory technicians have SOPs for handling, testing, and subsequently discarding body fluids obtained from patients. The origins of the term SOP are obscure. The Encyclopedia Britannica indicates that the abbreviation came into use around the mid-1900s [sup][1] and was already in use during World War II. Today, SOPs exist in contexts ranging from military operations to business routines, and from manufacturing processes to medical activities. In military circles, the term standard operating procedure or standing operating procedure is used to describe a procedure or set of procedures for the performance of a given action or for a reaction to a given event. There is a popular misconception that SOPs are standardized across the universe of practice. However, the very nature of an SOP is that it is not universally applied, such as across a large military element (e.g. a corps or division), but rather describes the unique operating procedure of a smaller unit (e.g. a battalion or company) within that larger element. That the operating procedure in question is said to be standing indicates that it is in effect until further notice, and that it may later be amended or dissolved. In the context of clinical trials, the International Conference on Harmonisation (ICH), born in 1990 out of an effort to harmonize regulatory requirements for medicinal products, defines SOPs as detailed, written instructions to achieve uniformity of the performance of a specific function. This is also in keeping with the goal of Good Clinical Practice. [sup][2] In present day medicine, clinicians are familiar with SOPs in restricted contexts, such as those described at the beginning of this article. Clinicians are also aware of the use of SOPs in the context of clinical trials, either with regard to the functioning of ethics committees or with regard to screening, consenting, assessing, and treating patients across the course of the clinical trial. An idea whose time has now come is the introduction of SOPs into routine clinical practice; that is, not for special patients (e.g. those who are unconscious) or for special circumstances (e.g. clinical trials), but for every patient in everyday clinical care. To understand why such SOPs are necessary, let us first pose a question to the reader: How often in routine practice do we ask female patients of reproductive age about the date of their last menstrual period, or about contraceptive precautions that they may have adopted? Do we record these details? Chances are that such information is not regularly obtained; yet, it should be obvious that this information should be sought and recorded at every consultation (whether initial or follow-up) with every female patient in whom pregnancy is even a remote possibility. If SOPs are set in place, it is unlikely that such information would be neglected. Digressing briefly, how are SOPs different from practice guidelines? The terms SOPs, guidelines and pathways are defined by different medical bodies. [sup][3],[4],[5],[6],[7],[8] Furthermore, whereas clinical practice guidelines are systematically developed statements that assist decisions about appropriate health care for specific circumstances, [sup][9],[10] SOPs are more specific than guidelines and are defined in greater detail. They provide a comprehensive set of rigid criteria outlining the management steps for a single clinical condition or aspects of organization. [sup][11] Guidelines are rigorously developed using evidence-based medicine criteria and consist of two distinct components: the evidence summary and the detailed instructions for the application of that evidence to patient care. …