CMS SOM App. A, Tag A-1035

Radioactive materials must be prepared, labeled, used, transported, stored, and

disposed of in accordance with acceptable standards of practice.

§482.53(b)(2) There is proper storage and disposal of radioactive material.

Interpretive Guidelines §482.53(b) and (b) (2)

The hospital must establish, in writing, and implement policies and procedures

addressing the use of radioactive materials within the hospital. The policies and

procedures must be based on acceptable standards of practice for the medical use of

radioactive materials and must address, at a minimum:

• Security of radioactive materials at every stage and location of their use within the

hospital, including determining who may have access to them, implementing

procedures to control access, and a system to track the receipt, usage and disposal of

all radioactive materials;

• Safe storage of radioactive materials, including radioactive waste awaiting disposal

outside the hospital;

• Clear, recognizable labeling of radioactive materials, waste, and hazardous areas in

all locations of the hospital, including during the preparation of such materials, if

applicable;

• Safe and secure transport of radioactive materials between locations within the

hospital;

• Safe handling with the appropriate personal and container protections, as applicable,

by personnel who prepare and administer radiopharmaceuticals within the hospital;

• Protection of patients from radiation hazards, including screening for high-risk

patients (for example, possible pregnancy, multiple nuclear medicine studies,

children, etc.);

• Maintenance and proper use of personal radiation monitoring devices (dosimeters) for

staff working in the vicinity of radiopharmaceuticals, according to manufacturer’s

instructions, particularly regarding the appropriate placement of the dosimeter on the

body, as indicated on the dosimeter;

• Safe and secure disposal of radioactive waste, including unused but unneeded

radioactive materials as well as, when extra precautions are applicable, human waste

products.

Survey Procedures §482.53(b)

• Verify through observation and document review that radioactive materials are

prepared, labeled, used, transported, stored, and disposed of in accordance with

hospital policies that are based on acceptable standards of practice.

• Ask the hospital to demonstrate how it limits access to radioactive materials at all

times.

o Verify that the hospital maintains accurate records of the receipt, distribution, and

disposal of radioactive materials, including radiopharmaceuticals.

o If the hospital prepares radiopharmaceuticals on site, observe the preparation to verify

that proper safety precautions are utilized to protect staff from excess radiation and

once prepared, stored in appropriate containers. If the radiopharmaceuticals are

obtained from an outside source, verify that the receipt and storage are appropriately

tracked.

o Verify that a clear, recognizable label for nuclear material is appropriately displayed

in all relevant areas throughout the hospital and on all radioactive materials.

o Verify that safety precautions are followed in the operations of the nuclear medicine

service and that personnel and patients maintain and wear appropriate body shielding

(e.g., lead aprons, lead gloves, thyroid shields) when appropriate.

 Observe a staff member deliver a nuclear medicine procedure to a patient, paying

particular attention to adherence to hospital safety protocols during the delivery of the

radiopharmaceutical.

o Through interview and observation, determine if staff use their dosimeters according

to manufacturer’s instructions, particularly in the appropriate placement of the

dosimeter on the body, as indicated on the dosimeter.

o Ask the responsible staff to demonstrate how they ensure safe transport of radioactive

materials in the hospital.

o Interview the responsible staff to determine whether the appropriate container

protection devices—e.g., lead for gamma emitters—are being utilized for storage and

administration of radioactive materials.

o Ask staff to show the policy for disposal methods for radioactive waste or unused

material and to explain how they ensure that these procedures are followed.