January 18, 2012
Currently Hospital CoP Nuclear Medicine Services§482.53(b)(1) states: "In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.”
Over the years, some CMS contracted inspectors have cited Hospital Nuclear Medicine Departments for not meeting Hospital CoP requirements. This has happened when the Nuclear Medicine Technologist prepares a radiopharmaceutical without a physician or pharmacist immediately available on hospital premises or physically present.
This has resulted in the discontinuation of afterhour’s stat procedures, limiting access for patients; and requiring physician or pharmacist availability, hiring or training additional staff, and contracting services outside the hospital all of which adds unnecessary additional costs.
The current CoP must be modified by removing the word “direct.” Additionally, it must give the authorized user (AU) the authority to delegate specific tasks. The AU is best suited for determining tasks that supervised individuals can perform and the degree of supervision required.
Please click on the attached document, to view SNM's CoP comment letter.