BONE DENSITOMETRY

HEALTH ARTS SCREENING


Those activities which involve the use of ionizing radiation sources for screening purposes require submission of a screening program plan to the Department of Health. Following review of the screening program plan by the Department approval may be granted if it can be demonstrated that the activity will be conducted safely and in accordance with applicable regulations. Your screening plan must provide adequate responses to the following concerns:

  1. Describe the physical characteristics of the ionizing radiation source, including at least information concerning the X-ray tube (diagnostic?), beam restriction and exposure control.
  2. Describe the operational characteristics of the ionizing radiation source, including at least the maximum kilovoltage, current, and exposure timer limits, and positive indication of X-ray production.
  3. Describe the radiation output characteristics of your specific unit and indicate how this information was determined.
  4. Describe what shielding or radiation barriers will be used and the exposure reduction between inside and outside measurements of radiation output and confirm that the installation will conform to NRCP handbook 49 specifications for shielding.
  5. Describe the training you will provide for operators of the equipment, including a copy of safety rules that will be provided to the operator(s).
  6. Describe emergency procedures, including how an emergency will be identified, what corrective action(s) will be taken, and what notification procedures will be followed.
  7. Describe how procedures will be ordered by a licensed healing arts practitioner to ensure that individuals are exposed to radiation only when a clinical need exists.
  8. Describe how patients will be restrained - the method or mechanism used-- or why restraint will not be necessary.
  9. Describe how you will maintain control over the operation of the device and prevent operation by unqualified individuals near the screening environment.
  10. Describe how you will prevent children, pregnant women, and other individuals who are not patients from inadvertently being exposed to radiation.
  11. Describe any restrictions you plan to impose on use of the device as a screening tool. For example, will you exclude individuals under age 18, or pregnant women from testing?
  12. Describe your procedure for identification, notification and follow up in the event that an incident occurs.
  13. Describe how radiation exposures will be monitored, if any.
  14. Describe how radiation area signs will be used, if any.
  15. Describe the location(s) where this device will be used for screening purposes.
  16. Indicate how long the unit will be located at this temporary site, including the beginning and ending dates.
  17. Indicate that the patient will be provided with results of the test.
  18. If the device will be used on property not owned by the registrant attach an affidavit from the owner testifying that he/she understands that a source of radiation may be used and they have no objection to that use on their property.

Attach the following section to the bottom of your plan:

_________________________________
Printed Name of Individual Responsible For Safe Use of the Device

_________________________________
Signature

_________________________________
Printed Name of Individual Who Completed This Form

_________________________________
Signature

Telephone Number: ________________

Date: ____________________________

Name of Organization/Corporation/Agency: ________________________________

Address: _____________________________________________________________

Send your completed plan to:
Section of State Laboratories
Radiological Health/DHSS
State of Alaska
4500 Boniface Parkway
Anchorage, AK 99507

All radiation sources must be registered with the state within 30 days of installation, and calibrated prior to first use on human patients.


HEALTH ARTS SCREENING ACTIVITIES - AFFIDAVIT This is to confirm that I, ____________________________, plan to use an ionizing radiation bone densitometry unit for health arts screening purposes in accordance with the following:
  1. Name of company/organization, corporation or individual owner of the unit. ________________________
  2. Name of individual responsible for safe use of the unit: _________________________________________
  3. Manufacturer and model of diagnostic unit: __________________________________________________
  4. Location/address where screening will be conducted: ___________________________________________
  5. How long will unit be at this location? (Inclusive dates) _________________________________________
  6. Is the unit registered with the State of Alaska, Department of Health? ______________________________
  7. Will the operator(s) be provided with a written set of instructions for safe use of the unit? ______________
  8. Will the operator(s) be adequately trained and competent in operating the unit? ______________________
  9. What selection criteria will be used to select or exclude patients for this procedure? ___________________
  10. Will the patient be provided results from the study? ____________________________________________
  11. Affirm that the unit will be used in a manner that prevents inadvertent operation by unqualified individuals.
    __ Yes_ _ _ _ _ _ _ _ _ _ _ __ No

    Please attach to this form a copy of:

_________________________________

Printed Name of Individual Responsible For Safe Use of the Device

_________________________________
Signature

_________________________________
Printed Name of Individual Who Completed This Form

_________________________________
Signature

Telephone Number: ________________

Date: ____________________________

Name of Organization/Corporation/Agency: ________________________________

Address: _____________________________________________________________

This form may be sent by facsimile to: Radiological Health, 907-334-2161, or by mail to the address at the top of this page. If you have any questions call radiological health at (907) 334-2107.


In order to register the actual source with the state of Alaska the registration form may be downloaded from the State of Alaska website, using this link... Radiation Device Registration Form. The fee is $80.00 per x-ray tube.

Mail

Home