Melissa Myers, BS, RT(R), RDMS

Clinical Research Coordinator

Radiology Research, Cardiovascular Imaging
Hospital of the Univ. of Penn.
3400 Spruce Street
Silverstein 1,
c/o Harold Litt, MD, PhD
Philadelphia, PA 19104


Phone: 215-349-5891
Pager: 215-281-4353
Fax: 215-662-7678
melissa.myers@uphs.upenn.edu

Human Studies & Safety


This document describes the policies and procedures that govern the use of all of Computed Tomography facilities in the Center for Advanced Computed Tomography Imaging Studies (CACTIS) in the Department of Radiology.

These guidelines must be followed by all groups who will have access to the CT Scanners for research purposes. It is the policy of CACTIS to maintain a safe environment and to promote a conscientious approach to research projects and developments.







FACILITIES




The Hospital of the University of Pennsylvania operates a state-of-the-art CT imaging center. The equipment and technology is the latest in archiving, communications, information management and dictation systems. CACTIS currently operates one CT scanner for human and animal research protocols, a Siemens Sensation64 VB20 software platform. The scanner is located on the Ground Floor of the Dulles Building. Access to research scanning requires regulatory approval from all of the following: IRB, IACUC, Radiation Safety and CACTIS.

SCANNER SAFETY




Computed Tomography is an Imaging technique using computer processing to generate an image of the absorption of x-rays in a field of view. The field of view is devised as a slice so that a complete examination of the brain or body may be obtained by taking a series of slices. As with imaging procedures there are safety issues to consider. The most common safety concern is patient radiation exposure. Precaution should be used to ensure radiation dose is kept to a minimum. The Siemens Sensation64 scanner has several built-in methods for reducing subject radiation dose, including CareDose4D, special low dose pediatric protocols, 80 and 100kV scanning for contrast enhanced studies, and ECG modulation of the tube current for cardiac gated studies. Investigators should endeavor to use these and other dose reduction techniques whenever possible.

All groups using the CT facilities after-hours and weekends will have at least one member present during all scanning sessions who is certified in radiography/fluoroscopy and has been trained in proper scanner operation technique by the CT technologist staff. All scanning of human subjects, whether it occurs during peak or off-hours, must be performed by a certified CT technologist. There will be no exceptions to this policy. Animal or phantom experiments may be performed as above by someone with radiography/fluoroscopy operator certification. A physician with training in recognition and treatment of contrast reactions must be present in the CT area during all human subject studies involving administration of intravenous contrast.

Training will include, but not be limited to: emergency procedures - including safe machine shutdown, working within equipment and FDA limits, maintaining records of machine usage, machine performance, malfunctions and providing a safe working environment. In addition, approved users must read and sign off that they comprehend the policies and procedures related to their research (human, animal, phantom, hardware, software, etc.). Additional training may be required by CACTIS or radiation safety.


The approved operator must also be aware of the hospital’s
policies and procedures for emergency situations.

Emergency Telephone Extension
HOSPITAL SECURITY RESPONSE # 2677
FIRE # 3473
CODE BLUE # 2633

All groups will abide by Radiology Department policies for the above emergencies.

In situations involving clinical emergencies or major equipment failure, patient care studies will have priority over research studies.

Under NO circumstance is the CRASH CART to be disturbed or unplugged. The red electrical outlets in the area of the CRASH CART should not be used for anything other than the defibrillator.

Supplies for non-human research are not to be taken from the clinical research supplies. All cabinets used during the day will be locked during the evening and weekend hours.

Research groups are responsible for ensuring that all personnel follow routine safety precautions as outlined by the CT Section, including precautions to ensure minimum radiation exposure to investigators.


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Last Updated:12/26/07 ALK