To all DEP high dose-rate remote afterloader (HDR) licensees
This Information Notice stresses the importance of verifying the accuracy of treatment parameters prior to HDR procedures in order to provide high confidence that administrations are in accordance with written directives. This notice is based on NRC Information Notice 2013-16 (PDF).
As a result of reported events involving HDR treatments, the NRC identified apparent weaknesses in the licensees' procedures to provide high confidence that administrations are in accordance with written directives as required by 10 CFR 35.41. Specifically, the procedures did not verify the HDR treatment parameters as noted in the written directive.
While the regulations regarding which parameters must be verified prior to administration are not prescriptive, licensees should ensure parameters are in accordance with the written directive in order to provide high confidence that HDR administrations are in accordance with their respective written directives. This regulation was written to allow the licensee more flexibility in developing procedures that meet their needs. The NRC, and therefore the department, has determined that while it is not possible to foresee and prevent every error, an effective verification program will minimize the potential for errors to go undetected prior to HDR treatment.
This notice alerts licensees who perform sentinel lymph node biopsy (SLN) procedures of the regulatory requirements for excised tissue removed during this procedure. No specific action or written response is required. This notice is based on NRC Regulatory Issue Summary (RIS) 2008-31 (PDF).
DEP has had a recent increase in the number of inquiries regarding the surgical centers that routinely perform these procedures and their need for licensure. Therefore it was deemed appropriate to issue this Information Notice to help answer these questions.
The U.S. Nuclear Regulatory Commission (NRC), and therefore DEP, has determined that the surgical removal of the tissue portion of the SLN procedure may be completed without a medical use license, provided the limit in 10 CFR 30.71 (100 microcuries) isn’t exceeded.
The pathology portion of the procedure may also be completed at a non-license facility provided the tissue does not contain more than 100 microcuries of technetium 99m (Tc-99m), which is the limit set forth in 10 CFR 30.71. DEP also recognizes that these surgical facilities may not possess the necessary equipment to properly measure the activity of the tissue sample and therefore may rely on the data provided by the administering medical licensee.
This information notice alerts licensees of the upcoming expiration of the Certificate of Compliance (CoC) (No. 9283) on June 30, 2013, for all Sentenial Model 660 Series radiographic projectors. The manufacturer, QSA Global, Inc., is allowing the CoC to lapse on that date. US and international regulations require that a valid certificate must be in place to allow legal transport. On July 1, 2013, the Model 660 Series (i.e., model numbers 660, 660A, 660B, 660E, 660AE and 660BE) will no longer be authorized by the U.S. Nuclear Regulatory Commission (NRC) and so cannot be transported legally.
After June 30, 2013, licensees must use a certified Type B overpack container to lawfully transport the projectors containing a radiography source inside. Since the 660 Series device incorporates depleted uranium as shielding, even an empty device must still meet transportation requirements for a manufactured article containing depleted uranium.
Licensees are encouraged to evaluate their programs for the best option for regulatory compliance regarding transporting the 660 Series projectors. This is not limited to, but may include making final disposition of any devices in their possession prior to June 30, 2013.
Licensees are reminded that changes in material possessed under their Pennsylvania radioactive materials license shall require an amendment to remain in compliance with current regulations.
This information notice informs dental x-ray registrants of the use of a new x-ray test device, the DIQUAD Analyzer™, for enhancing the evaluation of intraoral dental radiographic equipment.
Recent professional medical and dental journal articles have linked patient radiation exposure to increased cancer risk. This concern and the trend towards digital imaging has prompted the Bureau of Radiation Protection to review our dental inspection procedures, as well as implement the use of a new x-ray test device, the DIQUAD Analyzer™. The additional data gathered will assist BRP in facilitating patient does trend analysis and improving image quality.
Selected dental facilities were sent DIQUAD Analyzers™ with instructions for performing tests. However, last year, for purposes of greater consistency, DEP inspectors began testing using the Analyzers™ during scheduled facility inspections.
The Bureau’s dental facility inspection cycle will not change from the normal four-year cycle, however, follow-up visits utilizing the Analyzer™ and other equipment may occur. Please note, DEP inspectors make every effort to schedule inspections to minimize disruption of normal dental clinic operations, however, we will continue to inspect during normal business hours.
To all Pennsylvania Department of Environmental (DEP) specific radiography licensees
This information notice alerts licensees of recent events that resulted in radiography workers receiving occupation doses in excess of the dose limits specified in Title 25 Pa Code §219.5. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
During 2011 and 2012, the U.S. Nuclear Regulatory Commission (NRC) received four radiography events involving radiography workers having received occupational whole body doses in excess of 0.05 sievert (5 rem) limit or 0.5 sievert (50 rem) limit to the skin of any extremity. These event scenarios include: failing to retract the source fully into the camera; paying little to no attention to survey meters; and continuing work after noting that monitoring equipment was not functioning properly.
CRCPD may offer financial assistance as needed to generators who choose to participate in SCATR. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to help dispose of unwanted material.
To all Pennsylvania Department of Environmental Protection (DEP) dental and veterinarian X-ray registrants
This information notice calls attention to dental and veterinarian registrants of the illegal sale of hand-held dental X-ray units that have not been reviewed by the U.S. Food and Drug Administration (FDA). FDA is aware of hand-held dental X-ray units being sold online by manufacturers outside of the United States and directly shipped to customers in the U.S. These devices may not be safe or effective and could potentially expose the user and the patient to unnecessary and potentially harmful X-rays.
All hand-held dental X-ray units that have been certified by the manufacturer to meet the FDA's radiation safety standards bear a certification label/tag, a warning label, and an identification label/tag on the unit's housing. All labels/tags should be in the English language and permanently affixed or inscribed on each product so that they are legible and readily accessible when the X-ray unit is fully assembled for use.
This Information Notice may require registrant action or response as applicable and as addressed in the recommendations. If you have any questions about the information in this notice, please contact the Radiation Control Division, (717) 787-3720, or the appropriate DEP Regional Office.
To all Pennsylvania DEP high dose-rate remote afterloader (HDR) licensees
This information notice reminds HDR licensees of the physical presence requirements described in Chap. 217 of Title 25 of the Pennsylvania Code, which incorporates by reference 10 CFR 35.615(f)(2). It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
NRC regulations, 10 CFR 35.615(f)(2), state that the licensee shall “for HDR units, require an authorized user (AU) and an authorized medical physicist (AMP) to be physically present during the initiation of all patient treatments involving the unit; and an AMP and either an AU or a physician under the supervision of an AU who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.” NRC defines “physically present” as “within hearing distance of normal voice.” During routine inspections dating from 2008 through 2011 the NRC has observed several issues with the implementation of this regulation.
To all Pennsylvania Mobile Medical X-ray Registrants
The Department of Environmental Protection is issuing this information notice (IN) to bring to the attention of all X-ray registrants, and in particular mobile X-ray registrants, the regulations and requirements for X-ray screening of asymptomatic individuals.
The Department has jurisdiction over this activity in its regulatory authority over radiation-producing equipment when the equipment is being used in an inappropriate manner. This regulatory framework is set forth in 25 PA Code Section 215.1 (relating to purpose and scope).
To all Pennsylvania Dept. of Environmental Protection (DEP) specific and general fixed gauge licensees.
Fixed gauges containing licensed radioactive materials are used by specific and general licensees in a wide variety of environments. Fixed gauges routinely operate in a continuous mode with the shutter open, exposing the radioactive source inside. During normal facility operations the use of such gauges produces little or no radiation exposure to operating personnel. During maintenance activities, however, equipment may be opened or partially disassembled, creating the significant potential for radiation exposure to workers.
This Information Notice (IN) reminds gauge users of the requirements in lockout/tagout procedures to prevent uncontrolled exposure of personnel to radiation. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
Recommendations contained in this IN are not new; therefore, no specific action or written response is required. This notice is based on a 2009 event which resulted in exposures to non-radiation workers conducting welding and other fabrication activities in the vicinity of fixed gauges due to apparent inadequate lockout/tagout procedures.
It is expected that recipients (i.e., Pennsylvania DEP specific and general fixed gauge licensees) will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents. Recommendations contained in this IN are not new DEP requirements; therefore, neither specific action nor written response is required.
Fixed gauges containing licensed radioactive materials are used by specific and general licensees in a wide variety of environments. Fixed gauges routinely operate in a continuous mode with the shutter open, exposing the radioactive source inside, this increases the chances of corrosion, the buildup of rust, or debris to affect the ability of the shutter to close.
Licensees who possess fixed gauges with shutters are required to test their shutters to ensure that they can be closed. This requirement is imposed by license condition for specific licensees and for general licensees the requirement is found in 10 CFR 31.5 (c)(2), incorporated by reference in Pa. Code Title 25 § 217.142. The typical timeframe for conducting a shutter check is every six months, which is acceptable for most applications where fixed gauges are used.
To all medical facilities performing high-dose diagnostic and/or therapeutic procedures and all radioactive material specific licensees within Pennsylvania and regulated by the Department of Environmental Protection (DEP), Bureau of Radiation Protection (BRP).
A request for feedback regarding the potential impacts associated with changes to radiation protection standards currently defined in 10 CFR Part 20 and incorporated by reference in Pa. Code Title 25 Sec. 219.5
To all Pennsylvania portable nuclear gauge licensees. This information notice alerts all portable nuclear gauge licensees of recent incidents involving violations of radiation safety requirements, license conditions and U.S. Dept. of Transportation (DOT) hazardous material regulations.
Licensees are responsible for compliance with physical security, radiation safety and hazardous materials shipping requirements. If licensees are unsure of specific areas of compliance there are a number of technical resources available.
To all Pennsylvania irradiator licensees and irradiator service providers. This information notice alerts of a contamination event that occurred during a non-routine maintenance operation on a Gammacell 40 blood irradiator. It is expected that all Pennsylvania irradiator licensees and service providers will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
To all Industrial Radiography, Nuclear Pharmacy, and certain other licensees subject to reporting individual monitoring results under 10 CFR 20.2206. (Program Codes 2500, 2511, 2513, 3211, 3212, 3214, 3310, and 3320): To clarify reporting requirements for individual monitoring of workers by licensees subject to 10 CFR 20.2206 and to clarify potentially conflicting portions of 25 Pa. Code 219.5 and 219.6.
To all medical facilities performing high-dose diagnostic and/or terapeutic procedures within Pennsylvania and regulated by the Department of Environmental Protection (DEP), Bureau of Radiation Protection (BRP): To alert medical facilities of the potential radiological hazards and "medical event" reporting requirements associated with certain patient radiation exposures that may result from unnecessary, inappropriate or improperly calibrated medical diagnostic or therapeutic X-ray or accelerator procedures and devices.
To all U.S. Nuclear Regulatory Commission (NRC) specific and renewal fixed gauge materials licensees, all Agreement State Radiation Control Program Directors and State Liaison Officers: To alert fixed gauge specific and general licensees about the potential for the failure of shutter closure mechanisms on fixed gauges and the requirements for reporting these events to the NRC. It is expected that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Patients should follow their doctor’s recommendations for receiving CT scans.
Bureau of Radiation Protection supports the Image Gently Campaign
Pennsylvania’s Bureau of Radiation Protection, along with the Conference of Radiation Control Program Directors (CRCPD) is participating with The Alliance for Radiation Safety in Pediatric Imaging in promoting a new campaign known as the Image Gently Campaign. The goal is to change practice by increasing awareness of the opportunities to lower radiation dose in the imaging of children. There were over 4 million pediatric CT scans in 2006, and the number continues to increase! The coalition encourages facilities to "child-size" their technique, not over-scan, and work as a team to optimize technique. Additional information, such as, the latest research and educational materials to help imaging providers determine the appropriate radiation techniques to use in the imaging of children and helpful protocols may be accessed via The Image Gently Web site: www.imagegently.org.
New NRC guidance recommends that patients given therapeutic doses of radioactive iodine-131 should avoid direct or indirect contact (for example, through shared living space) with infants and young children for a specific period of time following the therapy. The guidance also recommends that physicians should consider hospitalizing patients whose living conditions may result in the contamination of infants and young children.