By Ruth Elzer, RN, MS
“I bet you’ve seen it all,” is a comment frequently heard during mock surveys. Indeed, recent consultation with several Compass Clinical Consulting clients concluded with the discovery of radioactive food products being prepared and consumed in the nuclear medicine department. Further investigation and polling of others concluded that this could be happening in your organization.
Nuclear tracers have long been used to trace and diagnose a variety of conditions of various body systems. Gastric emptying studies, commonly used to diagnose gastric emptying dysfunction, have a variety of applications including diagnosis of diabetic gastroparesis and other slow gastric emptying diseases. This study consists of a test meal composed of food inoculated with a radionucleatide tracer that is eaten and then tracked using nuclear diagnostic equipment. Common test meals include scrambled eggs, egg salad, or prepared oatmeal. Where and by whom that meal is prepared varies greatly.
An informal phone survey of Compass Clinical Consulting clients revealed wide variation in the mechanisms in place to assure appropriate safety for these patients and their caregivers. Some departments were found to be preparing eggs for inoculation and consumption in the hot lab; others received prepared, inoculated eggs from a radiopharmaceutical warehouse. While most had appropriate policies and procedures in place for conducting the study, gaps in compliance were seen in the policies governing the preparation of the test meal, storage of food products outside of the kitchen, and care of the patient following the study (including management of contaminated emesis).
From a regulatory perspective, the most common tracer points for this procedure that would come into play would include:
- Storage and preparation of the Technetium for inoculation of the test meal
- Preparation of the food component of the test meal (in compliance with the FDA Food Code)
- Policies, procedures, and protocols for administering the test and contrast agent.
- Post-test care of the patient and relevant precautions.
In the 2008 publication Consensus Recommendations for Gastric Emptying Scintigraphy: A Joint Report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine, recommendations for patients undergoing the procedure are outlined. A survey tool aligned with its recommendations is available from Compass Clinical Consulting.
Where do I Start?
Discovering whether your organization is currently meeting national norms as they relate to gastric emptying studies and similar situations is the first step in coming into compliance. If you discover a need to address this practice, consider the following steps:
- Establish a multidisciplinary group that includes nursing, radiology/nuclear medicine staff, and dietary professionals.
- Establish procedures for each of the major steps outlined above, incorporating relevant standards and guidelines. Refer to the Compass tool for ideas.
- Revisit patient educational information to outline steps for patients and their family.
- Assure that competency assessment mechanisms have been put in place for individuals as it relates to their role in each test.
For further information:
- Obtain Consensus Recommendations for Gastric Emptying Scintigraphy: A Joint Report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine.
- Consult your supplier for relevant MSDS sheets on Technetium 99M.
- Review the 2005 Food Code. Information about eggs and egg product storage, and preparation can be found in Chapter 3.