May 16, 2012
The Centers for Medicare & Medicaid Services (CMS) has released a final regulation to revise the existing Conditions of Participation (CoP) for hospitals and critical access hospitals. The Society of Nuclear Medicine (SNM) was referenced on page 116 of the rule:
One commenter suggested modifications to Nuclear medicine at §482.53(b)(1) to remove the word “direct” to reflect the delegation authority of the authorized user. Additionally, the commenter suggested the IGs regarding §482.53(b)(1) should be enhanced focusing on the term “authorized user” (for example, CMS to allow the authorized user be given the authority, as noted and consistent with the Nuclear Regulatory Commission guidelines, to delegate specific tasks, as they are best suited for determining tasks that supervised individuals can perform and the degree of supervision required; further the authorized user should put policies in place to clarify the specific tasks delegated and the supervision and certification necessary for each), certification of uniform competencies, radiopharmaceutical preparation qualifications, relevant practice standards, and certification assessments rather than layering staff.
The report later states that CMS “may consider these suggestions in future notice-and-comment rulemaking and/or through the IGs.”
On November 21, 2011, SNM met with CMS to discuss the issue of “direct supervision” as it relates to the CMS Hospital Conditions of Participation Nuclear Medicine Services 482.53(b)(1). In recent years some technologists have faced the problem of hospitals being cited by state inspectors in response to how the preparation of radiopharmaceuticals is supervised.
Please find the final rule and SNM’s comment letter attached below.