CMS SOM App. A, Tag A-1036

supervision of, an appropriately trained registered pharmacist or doctor of

medicine or osteopathy.

Interpretive Guidelines §482.53(b)(1)

If the hospital prepares radio pharmaceuticals in-house, such preparation must be

performed by, or supervised by, a registered pharmacist or MD/DO who is qualified

through education, experience and training, in the preparation of radio pharmaceuticals,

consistent with Federal and State law. Hospitals must establish policies and procedures

for in-house preparation of radiopharmaceuticals, including by nuclear medicine

technologists under supervision.

The policies and procedures must identify the qualifications, roles and responsibilities of

staff preparing radiopharmaceuticals under supervision. The hospital must ensure that all

staff who are involved in the preparation and/or supervision of radiopharmaceuticals are

trained and demonstrate competencies in accordance with acceptable standards of

practice.

Hospitals are expected to develop policies and procedures with respect to supervision of

nuclear medicine technologists. CMS anticipates that most hospitals will follow the

supervision recommendations of the Society of Nuclear Medicine and Molecular

Imaging, but there is no mandate that every hospital does so. (79 FR 27120, May 12,

2014) Recommendations are available at:

http://www.snmmi.org/files/docs/NMT%20SOP%20Clinical%20Performance%20Standa

rds%20June%202013.pdf If a hospital is not following this guidance, then it must be

able to explain the basis for the supervision policies and procedures it has developed.

Survey Procedures §482.53(b)(1)

o If radio pharmaceuticals are prepared in-house, determine that the preparation

is performed by, or supervised by, a registered pharmacist or MD/DO.

• Review personnel records of pharmacists, MDs/DOs and nuclear medicine

personnel involved in the preparation and supervision of radio

pharmaceuticals to verify they have required qualifications per State law and

hospital policy.

• Verify that the hospital has policies regarding the supervision of nuclear

medicine personnel and the in-house preparation of radio pharmaceuticals.

• Ask the supervising pharmacist or MD/DO how technicians who prepare radio

pharmaceuticals are supervised. Are the supervision policies based on the

recommendations of the Society of Nuclear Medicine and Molecular

Imaging? If not, what is the basis for the supervision policies?

• Ask what policies/procedures the hospital uses to assure proper preparation.

• Ask what guidelines the hospital relies upon for radio pharmaceutical preparation.