NMSS Licensee Newsletter March 1995 - April 1995
NUREG/BR-0117; No. 95-1
- Dr. Selin to Leave NRC
- Management Changes in NMSS
- Proposed Rule on Medical Administrations to the Wrong Individual
- Proposed Rule on Decommissioning Financial Assurance
- Isotopic Analysis Important to Site Characterization
- Assay of Pure Beta Emitters
- Availability of Report on Safety Programs at Medical Facilities
- Quality Management (QM) Notes
- Generic Communications Issued
- Federal Register Notices
- Draft Regulatory Guides (Notice of Availability)
- Final Regulatory Guides (Notice of Availability)
- Request for Comments
- Proposed Rules
- Final Rules
- A Sampling of Significant Enforcement Actions Against Material Licensees
- A Sampling of Significant Events Reported to NRC by NRC Nuclear Material Licensees
Dr. Ivan Selin, Chairman of the U.S. Nuclear Regulatory Commission, issued the following statement on March 14, 1995:
I have informed the White House of my intention to leave the Nuclear Regulatory Commission as of July 1, 4 years after I took office as Chairman. I do this with mixed feelings because I have enjoyed immensely the challenges of this job. But even if the Commission is left temporarily without a quorum, thanks to steps we took last summer to put in place a contingency plan, the remaining Commissioners will be able to operate with the full authority of the Commission until a quorum is restored.
I have spent the last 6 years of my life in my second tour in government--as Under Secretary of State and as Chairman of this agency. These have been exciting years, years in which I have been proud to serve and proud to be associated with many solid accomplishments. The last 4 years have been particularly eventful, significant ones in the life of NRC. We have accomplished much in adapting our rules, regulations, and procedures to the changes in the world of energy, while never wavering from our primary mission of protecting the health and safety of the American people.
In these 4 years we have also witnessed a revolution in the world of international nuclear power. Previously isolated nuclear power programs--in the former Soviet Union, Eastern Europe, East and South Asia, and South Africa--have joined the world nuclear community, while newer programs in East Asia have taken off. I am proud of the role that NRC has played in meeting the challenges of this unexpected international development, and increasing the safety of these programs.
Now it's time to move on. My intention is to return to the private sector, to start a new business with my son. We're going to explore the possibility of building non-nuclear power plants in Asia where the demand for energy is enormous, as a number of countries strive to improve the quality of life for their citizens. Note that I said non-nuclear, such as gas-fired or coal-fired generating plants. Given what I have been doing for the last 4 years, I don't think it would be appropriate to be involved in nuclear power, even though nuclear power will be part of the national energy mix in any number of places.
Please indulge me for a moment while I underline, briefly, some of the major accomplishments over the past 4 years here:
- continued improvement in the safety of operating reactors;
- increased openness in the way that the Commission conducts its business;
- a one-step process for approving new reactor designs and licensing new reactors;
- renewal of existing reactor licenses; and
- simplification and reduction of a variety of regulations.
All but the last of these were objectives I raised as my priorities in my confirmation hearings 4 years ago, and all have been accomplished while we reduced the NRC budget by 3 percent a year in real terms.
My successors will have plenty more to do. They will have to carry through on these programs, further streamline the regulatory process, and continue to reduce the costs of the agency. They will also have to see through the licensing of facilities for spent fuel and should get NRC out of the business of regulating the medical use of radioactive materials.
NRC is a small but distinguished agency, with about 3000 highly skilled, dedicated people and a budget of slightly more than $500 million. The Agency's principal task is to regulate 108 nuclear power plants that supply more than 20 percent of the country's electricity. Although new plants are not being built today, existing facilities will still be producing electricity at the current high levels for at least 20 more years, making an important contribution to the wealth of the nation. Nuclear power in the United States is among the safest in the world; a vigilant, independent regulator is required to ensure it stays that way.
I feel good about the contributions the Agency has made, with your help; I am confident it will continue to be an agency of which you can be very proud.Management Changes in NMSS
A January 20, 1995, announcement to all U.S. Nuclear Regulatory Commission employees reported the following management changes:
- Mr. Guy A. Arlotto, Deputy Director, Office of Nuclear Material Safety and Safeguards (NMSS), indicated his intention to retire on February 3, 1995, after 33 years of service with NRC and its predecessor, the Atomic Energy Commission.
- Dr. Carl J. Paperiello, Director, Division of Industrial and Medical Nuclear Safety (IMNS), NMSS, was selected to succeed Mr. Arlotto. (See second announcement for new phone number.)
- Dr. Donald A. Cool, Chief, Radiation Protection and Health Effects Branch, Office of Nuclear Regulatory Research (RES), was selected to replace Dr. Paperiello as IMNS Division Director. Dr. Cool's new phone number is 301-415-7197.
- Dr. John E. Glenn, Chief, Medical, Academic, and Commercial Use Safety Branch, in IMNS, was selected to replace Dr. Cool in his former position in RES. Dr. Glenn's new phone number is 301-415-6157.
On March 1, 1995, a second announcement reported the following additional management changes:
- Robert M. Bernero, Director, NMSS, indicated his desire to retire on April 28, 1995, after a long and distinguished career in NRC and its predecessor, the Atomic Energy Commission.
- Dr. Carl J. Paperiello, formerly Deputy Director of NMSS, was appointed Director- designate. Dr. Paperiello's new phone number is 301-415-7800.
- Dr. Malcolm R. Knapp, formerly Director of the Division of Waste Management in NMSS, was appointed Deputy Director of NMSS. Dr. Knapp's new phone number is 301-415-7358.
- John T. Greeves, formerly Deputy Director of the Division of Waste Management in NMSS, was appointed Director, Division of Waste Management. Mr. Greeves' new phone number is 301-415-7437.
- Margaret V. Federline, formerly Chief of the Performance Assessment and Hydrology Branch in NMSS, was appointed Deputy Director of the Division of Waste Management. Mrs. Federline's new phone number is 301-415-6708.
- Dr. John H. Austin, formerly Chief of the Low-Level Waste and Decommissioning Projects Branch in NMSS, was appointed Chief of the Performance Assessment and Hydrology Branch. Dr. Austin's new phone number is 301-415-7252.
- Michael F. Weber, formerly a section leader in the Low-Level Waste and Decommissioning Projects Branch in NMSS, was appointed Chief of the Low-Level Waste and Decommissioning Projects Branch. Mr. Weber's new phone number is 301-415-7297.
- Larry W. Camper, formerly a section leader in the Medical, Academic, and Commercial Uses Branch in NMSS, was appointed Chief of the Medical, Academic, and Commercial Uses Branch. Mr. Camper's new phone number is 301-415-7231.
On January 25, 1995, a proposed rule was published in the Federal Register (60 FR 4872) to clarify that the medical administration of radiation or radioactive materials to any individual, including an individual who is not supposed to receive a medical administration, is regulated by the U.S. Nuclear Regulatory Commission's provisions governing the medical use of byproduct material (10 CFR Part 35) rather than the dose limits in NRC's regulations concerning standards for protection against radiation (10 CFR Part 20).
This proposed rulemaking resulted from a specific case where there was an error in the administration of a diagnostic radiopharmaceutical to a patient who was not supposed to receive any radioactive material. The Commission directed the staff to proceed with rulemaking to clarify that the medical administration of radioactive material to a patient (which includes a "wrong patient") is the exclusive province of the regulations in Part 35. This is not a change in policy, but rather, clarifies that the more specific requirements in Part 35 prevail over the more general requirements of Part 20.
Until such time as the rulemaking is completed, NRC will exercise enforcement discretion and not cite licensees for violations of 10 CFR 20.1301 in cases involving the medical administration of byproduct material or radiation from byproduct material if the total effective dose equivalent to the patient exceeds the limits for a member of the general public (1 millisievert (100 mrem)), but does not exceed the threshold for reporting as a misadministration in Part 35. However, licensees are reminded that an administration of byproduct material, or radiation from byproduct material, to the wrong patient, that exceeds the thresholds specified in 10 CFR 35.2, will continue to be classified as a misadministration.
The comment period for this proposed rulemaking expires on April 10, 1995.Proposed Rule on Decommissioning Financial Assurance
On June 22, 1994, a proposed rule on Decommissioning Financial Assurance was published in the Federal Register for comment (59 FR 32138). The comment period ended September 20, 1994. Six letters were received. The proposed rule addressed concerns that a number of licensees have not put aside adequate funding for decommissioning. These cases involved licensees who were in timely renewal when the rule became effective and have not yet provided adequate funding, or have decided to cease operations and begin decommissioning without adequate funding in place. The proposed rule was intended to clarify that financial assurance must be in place during operations and updated when a licensee decides to cease operations and begin decommissioning. In particular, the proposed amendments would explicitly describe additional financial assurance certification requirements for licensees during operation, as well as implementation and timing requirements for licensees whose licenses have been in timely renewal since the promulgation of the 1988 decommissioning funding rules or who cease operations without adequate funding arrangements in place. Presently, the final rule is before the Commission, awaiting approval for publication.
In summary, the final rule would amend the regulations that licensees must meet to ensure that they have adequate decommissioning funding in place. The major changes in this final rule are: (1) each decommissioning funding plan must contain a licensee certification that funding is in place and a signed original of the financial instrument that is in place; (2) a decommissioning funding plan must be submitted by licensees that are required to submit one, but have not done so because they are presently in the timely renewal process; (3) financial assurance must be submitted by licensees who have submitted a decommissioning plan and have not already provided adequate financial assurance; (4) licensees must increase or decrease the amount of financial assurance, to cover the detailed cost estimate submitted with the decommissioning plan; and (5) licensees may decrease the amount of financial assurance, as decommissioning proceeds.Isotopic Analysis Important to Site Characterization
The U.S. Nuclear Regulatory Commission recently promulgated new regulations that establish timetables and scheduling limitations on licensees that wish to cease nuclear operations and close their facilities. The complete and accurate characterization of the radiological status of a facility is critical to the timely and cost-effective completion of the decommissioning. Recent experience characterizing offsite contamination near a site in Cambridge, Ohio, highlights the potential importance of conducting a complete isotopic analysis of environmental samples for radiological contaminants, using both gamma and alpha spectrometric techniques, to ensure that delays in the decommissioning process are avoided.
NRC Region III and Headquarters staff recently discovered offsite contamination near an NRC licensed facility in Cambridge, Ohio, that contained elevated concentrations of Th-230, Pa-231, and Ac-227. The activities of these radionuclides were in gross disequilibrium with parent radionuclides in the U-238 and U-235 decay chains. Although field exposure rate surveys indicated only slightly elevated radiation levels, laboratory analysis of the soil samples yielded high concentrations of Th-230 (one sample exhibited Th-230 concentrations in excess of 4000 pCi/g). Such high concentrations were not expected because contamination was only expected to include relatively low concentrations of natural thorium and natural uranium, based on licensed activities at the facility and available characterization data. Subsequent re-evaluation of gamma spectra by an NRC contractor indicated elevated levels of Th-230 also occurring in slag that was stored onsite. These elevated levels were not determined in the original analyses because elevated Th-230 had not been suspected (other than in equilibrium with U-238/234). Had NRC not conducted a gamma spectrommetric analysis, it is likely that much of this contamination might have been overlooked. The cause of the elevated levels, especially Pa-231 and Ac-227, is under investigation.
Facility managers should be alert for instances where radioactive materials may be present at elevated levels, yet are overlooked because: (1) they are not known to have been used or produced at a site; (2) they are not readily detected in the field, using exposure rate measurement; and/or (3) their gamma photo peaks (or photo peaks of short-lived decay products) are not readily apparent because of the presence of other gamma-emitting radionuclides. NRC staff is aware of the potential for additional unanticipated radioactive material contamination to be present at decommissioning sites and will review site characterization information with this in mind.Assay of Pure Beta Emitters
On September 29, 1994, the U.S. Nuclear Regulatory Commission issued Information Notice (IN) 94-70, "Issues Associated with Use of Strontium-89 and Other Beta-Emitting Radiopharmaceuticals." This notice discusses assay of radiopharmaceuticals containing pure beta-emitters. The IN states that until appropriate measuring instruments and standards are developed and available, reliance on the manufacturer's stated activity of the unit dosage may be the most accurate means, and an acceptable method, of determining the activity of the patient dosage. This statement implies that there is no instrumentation available that can be used to accurately assay beta-emitters. Since the IN was written, NRC has become aware of certain manufacturers that have developed instrumentation which is capable of accurately assaying beta-emitters. Part 35 does not require licensees to measure patient dosages of radiopharmaceuticals containing pure beta-emitters provided they are unit dosages obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements. Otherwise, the licensee is required to measure by direct measurement, or by combination of measurements and calculations, the activity of each dosage of an alpha- or beta-emitting radionuclide, before medical use. Licensees may also use any available instrumentation to assay patient dosages containing pure beta-emitters, to satisfy this requirement.
Semi-Annual Meeting of the Advisory Committee on Medical Uses of Isotopes
The U.S. Nuclear Regulatory Commission's Advisory Committee on Medical Uses of Isotopes (ACMUI) held its regularly scheduled semi-annual meeting on November 17-18, 1994, at the NRC Headquarters office in Rockville, Maryland. Agenda items included: discussion of the final rule and guidance on the rule "Preparation, Transfer, and Use of Byproduct Material for Medical Use"; status of implementation of the Quality Management Rule; discussion of a reexamination of NRC enforcement policy; a status report of the National Academy of Sciences review of NRC's medical use regulatory program; discussion of fractionated therapy procedures; discussion of the "Abnormal Occurrence Criteria Revisions"; discussion on inadvertent administrations of byproduct material to the wrong patient and related patient notification requirements; and a discussion of misadministration issues regarding followup of patients and use of NRC consultants. NRC staff provided a status report on the rulemaking "Release of Patients Containing Radiopharmaceuticals or Permanent Implants" and provided an overview of a planned Advance Notice of Proposed Rulemaking for 10 CFR Part 35. The ACMUI reviewed and adopted final bylaws for the committee.
Copies of the transcripts and summary minutes for the meeting are available through the Public Document Room (202-634-3273).
The next meeting of the ACMUI will be held May 11-12, 1995, and will be noticed in the Federal Register.Availability of Report on Safety Programs at Medical Facilities
The U.S. Nuclear Regulatory Commission has issued a draft report entitled, "Management of Radioactive Material Safety Programs at Medical Facilities" (NUREG-1516). This draft report, prepared by NRC staff with input from Agreement States and professional medical organizations, is available for review and comment. The comment period expires December 31, 1995. Copies of the report may be obtained by written request or telefax (301-415-2260), at no charge, from Distribution Services, Printing and Mail Services Branch, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. For further information, contact Janet Schlueter, NUREG Project Manager, Office of Nuclear Material Safety and Safeguards, Mail Stop T-8F5, USNRC, Washington, DC 20555-0001.Quality Management (QM) Notes
Quality Management Program Reviews:
All of the quality management programs (QMPs) initially submitted by U.S. Nuclear Regulatory Commission licensees have now been reviewed. As a result of the review letters, many licensees have provided modified QMPs to the NRC regional offices. These revised QMPs will be reviewed as preparation for inspections, when licenses are renewed, or when the license is amended to add a modality. The results of those reviews will be communicated to the licensee at those times.
An article in the September 1994 issue of the NMSS Licensee Newsletter, NUREG/BR-0117, regarding the requirement to specify a specific dose or dosage, rather than a range, when preparing written directives, has generated considerable reaction from the medical community, resulting in numerous telephone inquiries to NRC. Most of the callers represented users of radioactive drugs for therapy, most often sodium iodide (I-131). Typically, the callers explained that the authorized user specified the dosage in a range because the amount of I-131 received varied from that which was ordered. It is understood, from an operating perspective, that licensees may not know in advance precisely the quantity of sodium iodide that a radiopharmacy will have available for distribution at any given time, and, therefore, requesting the dose in a range may be appropriate. This issue can be addressed by assaying the sodium iodide dose received before administration, modifying the written directive, and then having the authorized user, or a physician under the supervision of the authorized user, sign and date the modified written directive. All these steps must occur before administration to the patient. For therapeutic applications of I-131, this approach imposes minimal burden on licensees because authorized users are typically directly involved in administration of the radioactive drug to the patient. In the case of diagnostic applications of greater than 1.1 megabecquerel (30 microcuries) of I-131, licensees may review their clinical procedures to determine what administration steps can be incorporated to achieve this objective.
The requirement to specify a specific dose or dosage, when preparing a written directive, is not a new requirement. The cited article in the September issue was intended to clarify the existing requirement. NRC believes that the prescribed dose or dosage listed on the written directive is the responsibility of the authorized user and should be clearly stated. This is necessary to ensure that the decision regarding the actual amount of radiation to be administered to the patient is made by a licensed medical practitioner. At many licensees' facilities, an individual under the supervision of an authorized user administers doses (dosages) as prescribed on a written directive, with no authorized user present during the procedure. Therefore, the individual administering byproduct material, or radiation therefrom, needs clear instructions as to the intent of the authorized user.Generic Communications Issued
December 1, 1994 - February 1, 1995
Note that these are only summaries of U.S. Nuclear Regulatory Commission generic communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical contacts listed below.
Administrative Letters (ALs)
A.AL 95-01, "Change in Commercial Telephone and Facsimile Numbers at Nuclear Regulatory Commission Headquarters," January 23, 1995.
Rashida Alam, IRM, 301-415-7500 T. Greene, NRR, 301-504-1175
This letter informs addressees that the commercial telephone and facsimile numbers for one of the two office buildings at NRC Headquarters are being changed.
B.AL 95-01, Supplement 1, "Change in Commercial Telephone and Facsimile Numbers at Nuclear Regulatory Commission Headquarters," February 2, 1995.
Henry Bailey, AEOD, 301-415-7483; C. Vernon Hodge, NRR, 301-504-1861
This supplement to AL 95-01 informs addressees that the telephone numbers for the NRC Operations Center will not change even though other telephone numbers at NRC Headquarters are being changed.
Information Notices (INs)
A.IN 89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed Activities," December 7, 1994.
Susan Greene, NMSS, 301-415-7843
This revision to IN 89-25 clarifies previous guidance concerning information to be submitted to NRC before a change of ownership or control. The notice incorporates recent information concerning the transferee's liability for open inspection issues and potential enforcement actions from past violations, and responsibility for decontamination activities and decommissioning of the site.
B.IN 94-89, "Equipment Failures at Irradiator Facilities," December 28, 1994.
Douglas Broaddus, NMSS, 301-415-5847
This notice alerts all irradiator licensees to several equipment failures--some of which have generic implications--that involve wet source storage irradiators.
C.IN 95-01, "DOT Safety Advisory: High-Pressure Aluminum Seamless and Aluminum Composite Hoop-Wrapped Cylinders," January 4, 1995.
Jim Wigginton, NRR, 301-504-1059 Jerry Roth, NMSS, 301-415-7257
This notice alerts all NRC licensees to a safety concern for workers identified in the safety advisory recently issued by the Research and Special Programs Administration of the U.S. Department of Transportation (DOT).
D.IN 95-07, "Radiopharmaceutical Vial Breakage during Preparation," January 27, 1995.
Sally Merchant, NMSS, 301-415-7874
This notice alerts all medical licensees authorized to use byproduct material for diagnostic procedures to a potential problem that can occur when heating radiopharmaceuticals.
A.BL 95-01, "Quality Assurance Program for Transportation of Radioactive Material," January 13, 1995.
Thomas Matula, NMSS, 301-415-7873; John Jankovich, NMSS, 301-415-7274
This bulletin: (1) notifies all radiography licensees about the failure of some licensees to have an NRC-approved quality assurance program for transportation of radioactive materials; (2) requests that all radiography licensees implement the actions described in the bulletin; and (3) requires that all radiography licensees complete and return the form provided in the bulletin.
A.GL 95-01, "NRC Staff Technical Position on Fire Protection for Fuel Cycle Facilities," January 26, 1995.
A. Datta, NMSS, 301-415-8109
This letter notifies all current licensees and applicants for uranium conversion and fuel fabrication facilities about the need to implement a Fire Hazard Analysis and a Pre-Fire Plan, and requires that all addressees submit a written response to the letter.
November 1, 1994 - February 1, 1995
Draft Regulatory Guides (Notice of Availability)
Proposed revision 2 to Regulatory Guide 10.5, "Applications for Licenses of Broad Scope," 59 FR 55141, November 3, 1994.
Proposed revision 1 to Regulatory Guide 8.29, "Instruction Concerning Risks from Occupational Radiation Exposure," 60 FR 3280, January 13, 1995.
Final Regulatory Guides (Notice of Availability)
Revision 3 to Regulatory Guide 5.52, "Standard Format and Content of a Licensee Physical Protection Plan for Strategic Special Nuclear Material at Fixed Sites (Other than Nuclear Power Plants)," 60 FR 2799, January 11, 1995.
Request for Comments
10 CFR Part 35, "Request for Comments Regarding Potential Modification of NRC's Therapy Regulations," 59 FR 55068, November 3, 1994.
Patricia K. Holahan, NMSS (301) 415-7847.
(Note that all Parts under "PROPOSED RULES" are from 10 CFR.)
Part 2, "NRC Size Standards" (used to qualify an NRC licensee as a "small entity" under the Regulatory Flexibility Act), 59 FR 61293, November 30, 1994.
Sarah N. Wigginton, ADM (301) 415-7158.
Parts 11 and 25, "NRC Licensee Renewal/Reinvestigation Program" (for licensee "U" and "R" special nuclear material access authorizations and "Q" and "L" access authorizations), 59 FR 66812, December 28, 1994.
James J. Dunleavy, ADM (301) 415-7404.
Parts 20, 30, 40, 61, 70, and 72, "Termination or Transfer of Licensed Activities: Record-Keeping Requirements," 59 FR 66814, December 28, 1994.
Mary L. Thomas, RES (301) 415-6230.
Parts 20 and 35, "Medical Administration of Radiation and Radioactive Materials," 60 FR 4872, January 25, 1995.
Stephen A. McGuire, RES (301) 415-6204.
(Note that all Parts under "FINAL RULES" are from 10 CFR.)
Parts 30, 32, and 35, "Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 59 FR 61767, December 2, 1994.
Anthony N. Tse, RES (301) 415-6233.
Part 72, "Notification of Events," 59 FR 64283, December 14, 1994.
Naiem S. Tanious, RES (301) 415-6103.
Part 72, "List of Approved Spent Fuel Storage Casks: Addition," 59 FR 65898, December 22, 1994.
Gordon E. Gundersen, RES (301) 415- 6195.
Part 32, "Requirement to Report Transfers of Devices to Generally Licensed Persons," 60 FR 3735, January 19, 1995.
John W. Lubinski, NMSS (301) 415-7868.A Sampling of Significant Enforcement Actions Against Material Licensees
One way to avoid regulatory problems is to be aware of enforcement problems others have faced.
- Michael J. Berna, IA 94-032
An Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately) was issued November 15, 1994, to the above individual. The Order was based on inspection and investigation results that concluded that the individual deliberately violated 10 CFR 30.10 by failing to perform field audits of radiographers, created false audit records, and requested others to create false records. The Order removes the individual from U.S. Nuclear Regulatory Commission-licensed activities for 3 years. In addition, the individual is to notify NRC the first time that he engages in licensed activities after the end of the prohibition period.
- Richard E. Odegard, IA 94-018
An Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately) was issued August 26, 1994, to the above individual. The action was based on the individual providing false testimony to NRC, and deliberately failing to train and certify employees in radiation safety, as required by the license conditions. The Order prohibits the individual from engaging in NRC-licensed activities for 5 years, and after the prohibition has expired, requires him to provide notice to NRC of acceptance of any employment in NRC-licensed activity, for an additional 5-year period.
- William W. Backus Hospital, Norwich, Connecticut, Supplement VI, EA 94-150
A Notice of Violation and Proposed Imposition of Civil Penalty was issued November 7, 1994, to emphasize: (1) the significance of violations associated with a misadministration at that facility; and (2) the importance of vigilant management attention to ensure that similar violations do not recur. The misadministration involved iodine-125 seeds as permanent implants. As a result of the misadministration, the patient's prostate gland, which contained the majority of the seeds, was subsequently removed.
- 4.Indiana Regional Cancer Center, Indiana, Pennsylvania, EA 93-284
An Order Modifying License and Suspending License (Effective Immediately) and Demand for Information were issued November 16, 1993, to modify the license, to remove the Radiation Safety Officer (RSO), and sole authorized user from engaging in activities under the license. NRC had serious concerns about compliance with NRC regulatory requirements, which involved: (1) performance of activities with a strontium-90 source that was not authorized by the license; (2) failure to provide complete and accurate information to NRC inspectors; and (3) failure to have an adequate survey made, which resulted in a November 22, 1992, event at the facility. Subsequently, the licensee requested termination of the license.
- Amoco Oil Company, Whiting, Indiana, Supplements VI and VII, EA 93-128
A Notice of Violation and Proposed Imposition of Civil Penalties and Demand for Information were issued November 15, 1994, to emphasize the licensee's responsibility to properly manage and support licensed activities and NRC's significant concern about licensee supervisors' involvement in willful violations. The action was based on violations involving: (1) failure of the RSO to perform audits; creation of false audit records by the RSO and two assistant RSOs; and the RSO deliberately providing false information to NRC concerning pre-announcement of quarterly audits; and (2) a breakdown in the management of NRC-licensed activities.
- Milwaukee County Medical Complex (John L. Doyne Hospital), Milwaukee, Wisconsin, Supplement IV, EA 94-074
A Notice of Violation and Proposed Imposition of Civil Penalty was issued June 23, 1994, to emphasize the need to ensure that licensed activities are conducted safely and employees are protected from unnecessary radiation exposures. The action was based on an overexposure event, to the licensee's physicist (an authorized user), that had a substantial potential for a far more serious exposure. During calibration of a new teletherapy unit, the physicist and the RSO bypassed interlocks to the teletherapy room and entered the room with the source in the exposed position. The physicist had no survey instruments, and the RSO had a survey instrument with the audible alarm turned off.
- St. Joseph Mercy Hospital, Pontiac, Michigan, Supplement VI, EA 94-156
A Notice of Violation and Proposed Imposition of Civil Penalty was issued October 19, 1994, to emphasize the need for effective management oversight of NRC licensed activities. The action was based on the failure to have written directives signed by an authorized user before administering iodine-131 as sodium iodide in quantities greater than 1.1 megabecquerel (30 microcuries), which led to a misadministration. Other violations involved training, lack of a procedure manual protocol, and incomplete evaluation of previous problems involving written directives.
- Memorial Hospital, Towanda, Pennsylvania, Supplements IV, V, VI, EA 94-191
A Notice of Violation and Proposed Imposition of Civil Penalty was issued October 17, 1994, to emphasize: (1) the importance of aggressive management oversight of the radiation safety program, so as to ensure that licensed activities are conducted safely and in accordance with requirements, and violations, when they exist, are promptly identified and corrected; and (2) the need for ensuring that corrective actions are long-lasting. The action was based on violations that represented a breakdown in the radiation safety program. They included, among others, the failures to: prohibit the storage of food and drink in areas where radioactive materials are used; wear a finger exposure monitor during the assay of radiopharmaceuticals; dispose of radioactive waste in designated, and properly shielded, receptacles; provide radiation safety training to personnel; conduct a complete formal annual review of the licensee's as low as is reasonably achievable (ALARA) program, review radiation surveys quarterly; note the apparent exposure rate from a dedicated check source, determined at the time of calibration on each survey instrument, and check the dose calibrator for constancy each day of use.
- South Bend Medical Foundation, South Bend, Indiana, Supplements IV, V, VI, EA 94-238
A Notice of Violation was issued November 29, 1994, based on violations involving a breakdown in the use of chromium-51. The violations included using licensed material in places not authorized by the license, failing to conduct proper surveys or perform dose calibrator linearity checks, and failing to comply with the requirements of the Department of Transportation. A civil penalty was not issued because of prompt and extensive corrective actions, and because the area of concern--the use of chromium-51--had not been previously inspected and represented only a small segment of the licensee's program, which had a good performance Record.
|Event 1:||Deliberate Overdosing of Patients during Diagnostic Studies, and Falsification of Records|
|Date Reported:||July 19, 1993|
|Licensee:||Ball Memorial Hospital, Muncie, Indiana|
On July 19, 1993, the U.S. Nuclear Regulatory Commission was notified that nuclear medicine technologists employed by the licensee had increased the dosages of radiopharmaceuticals used in diagnostic studies, to reduce imaging time. NRC was also informed that the technologists had falsified the required records of the dosages administered.
An NRC inspection revealed that since 1988, nuclear medicine technologists employed by the licensee had been administering radiopharmaceutical doses above the approved dose ranges for diagnostic image studies, by as much as 40 percent. The inspection also verified that after administering high doses, technologists entered false information in NRC-required records. The dosages were increased for imaging studies of the lung, liver, bone, and gastrointestinal tract, using technetium-99m and xenon-133. NRC inspectors did not identify medical misadministrations, as defined in 10 CFR 35.2, as a result of this practice of administering high doses for diagnostic imaging.
According to the licensee, one technologist told licensee officials that dosages were increased to minimize patient discomfort, to reduce imaging time for critically ill patients, and to enhance the clarity of images for studies performed on obese patients.
The licensee conducted an internal investigation. Based on the findings of this investigation, the licensee initially suspended two nuclear medicine technologists from all NRC-licensed activities. Subsequently, the licensee terminated the employment of one of the two individuals; the other individual was allowed to continue to perform duties that do not involve NRC-licensed activities.
The licensee also committed to a number of corrective actions. Some of the corrective actions included: assigning a pharmacist or a radiologist to verify all radioisotope dosages; implementing a unit dose system; obtaining the services of an assistant radiation safety officer; and conducting monthly and quarterly audits of the Nuclear Medicine Section, for at least 1 year.
On October 20, 1993, NRC issued a Confirmatory Order Modifying License requiring specific procedures and verifications to prevent any further unauthorized increases in patient doses. On May 23, 1994, NRC issued an Order against a former nuclear medicine technologist of the licensee. The Order required the technologist to comply with the following: (1) prohibited the technologist's involvement in NRC-licensed activities for 1 year; (2) required the technologist to provide a copy of the Order to any prospective employer who engages in NRC-licensed activities, for a 3-year period; and (3) required the technologist to notify NRC, within 20 days of accepting employment involving NRC-licensed activities.
|Event 2:||Medical Therapy Misadministration Involving Strontium-89|
|Date Reported:||August 9, 1994|
|Licensee:||Veterans Affairs Medical Center, Long Beach, California|
On August 9, 1994, the licensee's radiation safety officer (RSO) notified NRC of a misadministration involving a therapeutic dose of strontium-89 (Sr-89). The RSO reported that a patient scheduled to receive 185 megabecquerel (MBq) (5 millicurie [mCi]) of thallium-201 (a radiopharmaceutical not regulated by NRC) for a myocardial perfusion study was mistakenly administered 148 MBq (4 mCi) of Sr-89. Based on the misadministration of the Sr-89, the licensee estimated that the patient received 250 centigray (250 rads) to the surface of the bone. The RSO reported that no action was taken to mitigate the consequences of the dose (i.e., administration of calcium as a blocking agent) because the patient had a preexisting heart condition that could have been exacerbated by administering calcium. The licensee also stated that medical experts were contacted to assist in an assessment of potential health effects to the patient. In addition, the licensee reported that with the exception of emergency procedures, it had voluntarily suspended all nuclear medicine procedures involving the intravenous administration of radiopharmaceuticals and had initiated an internal investigation of the misadministration.
The cause of the misadministration was attributed to the administering technologist's failure to verify the dosage (by reading the label on the syringe) before injection.
Corrective actions proposed by the licensee included the following: (1) physically separating diagnostic unit dosages from
therapeutic radiopharmaceutical dosages in the licensee's hot lab; (2) packaging unit dosages received from a local
radiopharmacy in different containers, according to isotopes; and (3) retraining technologists in requirements for
identifying radiopharmaceuticals before injection.
|Event 3:||Medical Brachytherapy Misadministration|
|Date Reported:||August 15, 1994|
|Licensee:||North Memorial Medical Center, Robbinsdale, Minnesota|
On August 15, 1994, the licensee informed NRC that a patient received 1380 centigray (cGy) (1380 rads) to the wrong treatment site during a brachytherapy treatment for metastatic lung cancer. On August 3, 1994, a catheter was inserted into the patient's bronchus and a ribbon containing 20 seeds of iridium-192 having a total activity of 673.4 megabecquerels (18.2 millicuries) was inserted into the catheter and moved to the proper treatment location. The treatment plan was intended to deliver a prescribed dose of 2000 cGy (2000 rads) to the intended target. The treatment began at 11:15 a.m. on August 3, 1994, and continued until its scheduled completion, 10:15 a.m. on August 4, 1994.
At about 7:00 p.m. on August 3, 1994, a nurse informed the physician that the visible portion of the catheter appeared to be protruding approximately 10 to 12 inches from the patient's nose. This was a significantly greater protrusion than previously observed, indicating that the catheter had moved from its initial placement. The nurse secured the catheter in place with additional tape. An x-ray was made, but the physician reported it to be fogged. The physician stated that, based on the information available to him at that time, he determined that the catheter and ribbon had moved, but that the tumor was receiving some radiation dose, and he continued the treatment. The iridium-192 seeds were removed on August 4 as planned. On August 4, 1994, a staff radiologist read the portable x-ray film taken on August 3, 1994, and indicated that the iridium implant was not seen.
Because of catheter displacement, the tumor dose was significantly reduced and estimated to be 620 cGy (620 rads) or 31 percent of the intended dose. The remaining dose of 1380 cGy (1380 rads) was delivered to an unintended site.
The patient and the referring physician were notified of the event by the treating physician on August 4, 1994. An NRC medical consultant was retained to perform a clinical assessment of this misadministration. The medical consultant concluded that it is improbable that the patient will experience any long-term consequences as a result of the exposure to the unintended treatment site.
The licensee has determined that the catheter movement caused a misadministration of the intended dose. Two possible explanations for the catheter movement could be the following: (1) failure to properly secure the catheter in place with tape; or (2) nasal discharge decreasing the adhesive capability of the tape.
The licensee's corrective actions included: amending the nursing staff procedure so that the attending physician will be contacted if there are further questions; nurses will be directed to the standing protocol for obtaining an administrative consultation; additional training during in-service; documenting the final length of the catheter in the patient chart; and documenting the position on each visit to the patient's room.
Comments, and suggestions you may have for information that is not currently being included, that might be helpful to licensees, should be sent to:
NMSS Licensee Newsletter Editor
Office of Nuclear Material Safety and Safeguards
Two White Flint North, Mail Stop 8-A-23
U.S. Nuclear Regulatory Commission
Washington, D.C. 20555-0001