RIS 2006-18, Wits200500191/Wits200500192/Wits2005193 - NRC Regulatory Issue Summary 2006-18 Requesting Exemption From the Public Dose Limits for Certain Caregivers of Hospital Patients
| ML061940204 | |
| Person / Time | |
|---|---|
| Issue date: | 08/31/2006 |
| Revision: | 0 |
| From: | Miller C L NRC/NMSS/IMNS |
| To: | |
| Sherbini S | |
| Shared Package | |
| ML053140192 | List:
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| References | |
| NMSS200500130, NMSS200600154, NMSS200600258, WITS200500191, WITS200500192, WITS200500193 RIS-06-018 | |
| Download: ML061940204 (9) | |
UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555August 31, 2006NRC REGULATORY ISSUE SUMMARY 2006-18 REQUESTING EXEMPTION FROM THE PUBLIC DOSE LIMITS FOR CERTAIN CAREGIVERS OF HOSPITAL PATIENTS
ADDRESSEES
All NRC medical licensees.
INTENT
The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)to provide guidance on requesting exemption from the dose limit for members of the public for certain caregivers of hospitalized patient Licensees in should contact theirappropriate State office if they wish to utilize this guidance, because the details andrequirements may vary, and in some cases the State may not grant such an exemption.
BACKGROUND
Patients undergoing medical diagnostic or therapeutic procedures involving the use ofradioactive materials may be released from the hospital, even though they represent sources of potential radiation exposure to members of the public, if they meet certain release criteri These criteria are specified in 10 CFR 35.7 Patients who do not meet these release criteria must remain in the hospital until they do satisfy the Aside from failure to meet release criteria, patients with administered or implanted radioactive materials may remain in the hospital for reasons such as ongoing diagnosis or treatmen Such patients are usually visited in the hospital by family and friends, and these visitors are considered members of the public, subject to the dose limit specified in 10 CFR 20.1301 for members of the publi This limit, normally 1 mSv (0.1 rem) per year, and in some cases 5 mSv (0.5 rem) per year, is easily observed for the vast majority of visitor In some cases, however, this dose limit is insufficient to accommodate situations in which amember of the public, who will be referred to in this RIS as a caregiver, is directly involved in the care of a patient containing radioactive materia Caregivers are usually members of the patient's family, or someone close to the family or the patien They do not include hospitalstaff, who are considered to be occupationally exposed individuals subject to occupational dose limits that are much higher than the limits for members of the publi The role of caregivers often involves close contact with the patient, sometimes for prolonged periods of time, with the result that the radiation doses they receive may be much higher than the dose limit that wouldnormally apply to members of the publi To address this situation, NRC staff proposed to the Commission that dose limits for caregiversbe established on a case-by-case basis by the licensee, and that their doses be limited only bythe demands of their care-giving functions and the needs of the patient, provided the dose notbe permitted to be high enough to present an immediate danger to the health of the caregiver or to increase the potential long-term risks resulting from radiation exposure to unacceptablelevel The rationale behind this approach is that dose limits are normally imposed for the protection of persons who are exposed either involuntarily, as in the case of exposures to members of the public, or who are exposed as a result of their occupations, such as hospital staffs and others whose occupations necessarily involve exposure to radiatio The caregiver situation is different in that it involves a voluntary decision by the caregiver, with the approval ofthe attending medical staff, to incur radiation exposure, and its potential risks, as an incidentalconsequence of the need to perform the caregiving function in the interest of the patien The justification for incurring the exposure is that it is beneficial, or possibly essential, to the well- being of the patient, and may therefore be considered an extension of the patient's medicaltreatment.The Commission approved the staff's proposal, and directed that a graded approach be used in controlling doses to caregiver This approach would initially approve a default limit that experience has indicated would be adequate for most caregiver situations, and the Commission recommended that this default limit be set at 20 mSv (2 rem). The limit may subsequently be increased if it proves too low for a particular cas This RIS provides guidance for NRC licensees who may encounter such caregiving situations at their facilities and who may wish toapply for exemption from the dose limits in 10 CFR 20.130 Requesting this exemption is not different in any essential way from any other exemption request, except that the Commissionhas already approved it in principle, and its approval by the staff in a specific case only requires a determination that a valid caregiver situation exists and that adequate controls will beimplemented once the exemption is grante
SUMMARY OF ISSUE
SLicensees have always been permitted to request exemptions from any part of the regulationsby applying to the NRC and providing adequate justification to support the reques Suchexemptions are granted if the NRC considers the reasons provided to be sufficient to justify theexemptio Exemption of a caregiver from the dose limits applicable to members of the public may also be treated in the same manner as any other exemption, and such exemptions have been approved in the pas However, one characteristic of the caregiver situation that may make it different from other exemption requests is that the situation requiring the exemptionmay arise with little prior notice and may therefore require quick approva For example, the patient's condition may change in a manner that requires additional testing using radioactive materials, or the unanticipated initiation or continuation of the use of radioactive materials in treatment or therapy, or the patient may be dyin Caregivers may at that time elect to involvethemselves directly in the care of the patient, and medical considerations may also indicate that such direct involvement may be beneficial, or even essential, to the patien Hence the need for a rapid exemption from the dose limit for members of the public that may have been enforced up to that point. This RIS provides guidance to licensees on the means that they may use to obtain anexemption for the caregiver situation, whether there is ample time to follow routine applicationprocedures or there is a need for a quick exemptio To ensure that the information needed bythe NRC staff is available at the time of the exemption request, and that the regulatoryconditions that are likely to accompany an exemption are known beforehand to the licensee, this RIS provides a list of the information that should accompany the exemption request, and provides a discussion of the control measures that are likely to be a condition for approval of the exemption reques These conditions have been reviewed by NRC's regional staff, whoconsidered them adequate as a basis to issue the exemptio The exemption requestbecomes, in essence, a request by the licensee to initiate the pre-approved conditions upon acceptance by the NRC of the pre-approved list of information that would be consideredsufficient to justify immediate issuance of the exemptio The procedures to be followed in and the conditions that the States may wish to impose, may differ fromthose described in this RIS, and licensees in these States should contact their State officials foradditional information. It should be emphasized that exemption from a pre-established regulatory dose limit forcaregivers does not in any way imply that radiation safety and control of dose is no longer necessar The potential that a caregiver may receive doses much higher than those normally permitted for members of the public, or possibly for occupationally exposed persons, and also that doses may be accumulated at a rate that is much higher than normally encountered inradiation exposure situations, points to the need for a carefully planned and executed radiationmonitoring and control program, and this is an essential condition underlying the approach to the caregiver exemption described in this RI It should also be emphasized that the normal inspection and enforcement programs applied to any licensed operation continue to be in effect after the exemption is granted.APPLYING FOR THE EXEMPTION NRC licensees may apply for the exemption described in this RIS by contacting the NRCRegional Office that issued the licens The licensee should ensure that the necessarytelephone numbers are available for use when needed, as well as the appropriate fax numbers, to permit transmitting the licensee's request to the Regional Office in written for It is possible, however, that conditions may develop that require an exemption during periods whenthe cognizant NRC staff are not available, such as during the night or outside normal workinghours, on weekends, or during holiday If this occurs, licensees may proceed as though the exemption has been approved, provided that the pre-established conditions described in thisRIS are implemented, and the NRC Operations Center is immediately notified of the action. The telephone number of the NRC Operations Center is (301) 816-510 The NRC staff shouldbe contacted as soon as possible during normal working hours, and in any case, a written request should be forwarded to the NRC by the end of the next business day after OperationsCenter notificatio If the licensing staff determines that there are issues with a licensee's actions that occurred during periods when cognizant NRC staff are unavailable, enforcementdiscretion will be considered, on a case-by-case basis, provided that the licensee hasimplemented the control measures described in this RIS before allowing caregivers to receive exposures above the regulatory limits. The same approach may be used if the licensee finds that the limit approved in a previousexemption proves to be insufficient for a particular case and that a higher caregiver dose limit is neede In any case, if the request is made by telephone, the request for the exemption should be followed by documentation, provided to the region, that describes the manner in which theelements of the caregiver protection program, as described in this RIS, will be implemente Itshould be noted that the caregiver limits referred to in this discussion are in fact controls imposed on the caregiver's radiation exposure to avoid accumulating high doses at rapid rates, without adequate and carefully considered justificatio Additionally, the dose that the caregiveris ultimately permitted to receive is determined by the patient's needs and the caregiver's informed willingness to incur the resulting potential radiation risk Exemptions may be grantedto hospital departments, such as the nuclear medicine department, rather than to a particular caregiver situation, but the required justification and radiation controls remain the sam Itshould be noted that the caregiver situation must be invoked and approved prior to thecaregiver receiving a dose in excess of the public dose limi Exceeding the public dose limit prior to the existence of a formal caregiver situation would be considered a violation of the conditions of the license.INFORMATION THAT SHOULD ACCOMPANY THE EXEMPTION REQUEST The following may be considered to be the minimum information to be provided to NRC'sregional staff to permit them to evaluate the merits of the request and determine whether to grant the exemptio The information should be as complete as possible to make it unnecessary for the staff to request additional information and hence delay approva The list below is not exhaustive, and the licensee should provide any additional information that may help clarify the situation and explain the justification for the reques The NRC Regional officeswill issue the exemption on the basis of the licensee's statement that these conditions havebeen implemented, and the adequacy of implementation will be verified during subsequentNRC reviews or inspections.1.The name of the licensee, the license number, the authorized user involved, and thenames of physicians or staff who made the determination that a caregiver situationshould be invoked.2.Name and telephone number of a contact person or persons in case the NRC needsadditional information, and for notification of approval or denial of the reques Any written exemption requests should be signed by a person authorized to represent the institution in matters pertaining to the NRC license, or by the authorized user who prescribed the dosage. 3.A description of the situation that necessitates the request, the radioisotope, form, andactivity of radioactive material administered to the patient, and the anticipated number of caregiver .The expected duration of the requested exemption, and the needed starting date for theexemption.5.The expected dose that may be incurre A limit of up to 20 mSv (2 rem) will beapproved initiall A second exemption request for a higher dose may be made if the need arise Experience with care giver situations has demonstrated that virtually all such cases can be accommodated within the 20 mSv (2 rem) limit.6.A description of the control program that will be implemented to meet the requirementsdescribed in the section below on exposure control This program description is not a description of the licensee's normal radiation control program, but only the additional measures that will be used to monitor and control the caregiver's exposures.CONTROL MEASURES THAT SHOULD BE IMPLEMENTED An exemption from a dose limit for the caregiver does not mean that no controls on the dosereceived will be require The exemption simply means that the dose that the caregiver will bepermitted to receive will be determined by the needs of the situation rather than beforehand bythe regulatory agency, as is the case with other dose limit Therefore, the exemption must beaccompanied by a control program designed to minimize the dose received by the caregiver and to ensure that the selected dose limit will be observe The general control measures thatshould be implemented are listed below, but the details will depend on the facility and the localcondition These details should be provided with the exemption request, in addition to items one through six in the section above.1.A description of the training and instructions to be given to the caregivers on thepotential risks of radiation exposure, the applicable dose limit, and ways to minimizeexposure Information on the caregivers, in regard to their relationship with the patient and whether they are 18 or more years old, should also be provide This will help theNRC staff ensure that the conditions that warrant approving the exemption have beenmet.2.Copies of any consent forms signed by the caregiver and the responsible licenseepersonnel should be maintained on fil The caregiver should sign a declaration that she is not pregnant or, if pregnant, that she is aware of the risks to the embryo/fetusarising from radiation exposur In general, pregnant women and minors should be discouraged from participating as caregivers if that can be avoided, even though there islittle evidence that the risk of the embryo/fetus will be significantly increased atexposures up to the proposed 20 mSv (2 rem) limi NRC regulations do permitoccupationally exposed pregnant women who do not declare the pregnancy to be exposed up to the occupational dose limit of 50 mSv (5 rem) per yea In general, the eligibility of pregnant women to be caregivers may be determined by hospital policy.3.A description of the radiation protection measures to be used in controlling dose to thecaregiver, including methods for monitoring doses on a real-time basi Real-time in this context means that the accumulated dose to the caregiver is updated with sufficientfrequency to permit the licensee to take corrective action if the dose approaches a limit or is accumulating faster than anticipate Dosimetry that must be sent for processing to determine the dose received, such as film badges, will not serve that function because they are not capable of providing information on doses received oversufficiently small time intervals, so as to serve as a means of controlling that dose andanticipating the need for additional control measures.It should be noted that the above controls will generally require careful consideration andplanning to determine the specific approaches suited for the licensee's facility, such as, forexample, the types of monitoring equipment that are available to monitor caregiver doses or, if necessary, the types that should be acquired to accomplish that functio Since design of such a control program is unlikely to be successfully completed under pressing emergency conditions, licensees who anticipate any possibility of invoking a caregiver situation should plantheir control programs ahead of time, and acquire any instruments and develop any procedures that may be needed if such a situation develop
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the FederalRegister because it is informational, and does not represent a departure from current regulatoryrequirements.SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT NRC has determined that this action is not subject to the Small Business RegulatoryEnforcement Fairness Act of 1996.
PAPERWORK REDUCTION ACT STATEMENT
The information collections contained in the appendix to this RIS are covered by therequirements of 10 CFR Parts 20 and 35, which were approved by the Office of Management and Budget (OMB), approval numbers 3150-0014 and 3150-0010.Public Protection NotificationThe NRC may not conduct or sponsor, and a person is not required to respond to, a request forinformation or an information collection requirement unless the requesting document displays a currently valid OMB control numbe This RIS requires no specific action or written respons If you have questions about theinformation in this summary, please contact one of the technical contacts listed below, or the appropriate regional office./RA/Charles L. Miller, DirectorDivision of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
"List of Recently Issued NMSS Generic Communications"Technical Contacts:
Sami Sherbini, NMSSJoseph E. DeCicco, NMSS (301) 415-7853(301) 415-7833 E-mail: sxs2@nrc.govE-mail: jxd@nrc.gov This RIS requires no specific action or written respons If you have questions about the information in this summary, please contact one of the technical contacts listed below, or the appropriate regional office./RA/Charles L. Miller, DirectorDivision of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
List of Recently Issued NMSS Generic CommunicationsTechnical Contacts:
Sami Sherbini, NMSSJoseph E. DeCicco, NMSS (301) 415-7853(301) 415-7833 E-mail: sxs2@nrc.govE-mail: jxd@nrc.gov DISTRIBUTION: WITS200500191/NMSS200500130, WITS200500192/NMSS200600258 andWITS200500193/NMSS200600154 IMNS r/fRidsOgcMailCenterRidsOiMailCenterRidsEdoMailCenterML053140192OFFICEIMNSNMSSIMNSIMNSOGCNAMESSherbiniEKrausRCorreiaTEssigS.TrebyDATE06/12/056/15/05 6 6/20/056/20/0506/12/05OFFICEOIS/PRANMSSNAMEBSheltonCMillerDATE6/20/0508 /31 /06OFFICIAL RECORD COPY Recently Issued NMSS Generic Communications DateGC No.Subject
Addressees
04/23/06RIS-06-10Use of Concentration Control forCriticality SafetyAll licensees authorized to possess acritical mass of special nuclear material.01/26/06RIS-02-15,Rev. 1NRC Approval of Commercial DataEncryption Products For theElectronic Transmission OfSafeguards InformationAll authorized recipients and holders ofsensitive unclassified safeguardsinformation (SGI).01/24/06RIS-06-01Expiration Date for NRC-ApprovedSpent Fuel Transportation RoutesThe U.S. Nuclear Regulatory Commission(NRC) licensees who transport, or deliverto a carrier for transport, irradiatedreactor fuel (spent nuclear fuel (SNF)).01/13/06RIS-05-27,Rev. 1NRC Timeliness Goals,Prioritization of Incoming LicenseApplications and VoluntarySubmittal of Schedule for FutureActions for NRC ReviewAll 10 CFR Parts 71 and 72 licenseesand certificate holders.07/10/06IN-06-13Ground-Water ContaminationDue to Undetected Leakage ofRadioactive WaterAll holders of operating licenses fornuclear power and research and testreactors including those who havepermanently ceased operations andhave certified that fuel has beenpermanently removed from thereactor and those authorized by Title10 of the Code of FederalRegulations (10 CFR) Part 72licenses to store spent fuel inwater-filled structures.07/06/06IN-06-12Exercising Due DiligenceWhen Transferring Radioactive MaterialsAll materials licensees.06/12/06IN-06-11Applicability of Patient Interventionin Determining Medical Events forGamma Stereotactic Radiosurgeryand Other Therapy ProceduresAll medical licensees.03/31/06 IN-06-07Inappropriate Use of a Single-parameter Limit as a NuclearCriticality Safety LimitAll licensees authorized to possess acritical mass of special nuclear material.03/21/06IN-02-23,Supl. 1Unauthorized Administration ofByproduct Material for Medical UseAll medical licensees.01/19/06IN-06-02Use of Galvanized Supports andCable Trays with Meggitt Si 2400Stainless- Steel-jacketed ElectricalCablesAll holders of operating licenses fornuclear reactors except those who havepermanently ceased operations and havecertified that fuel has been permanentlyremoved from the reactor vessel; and fuelcycle licensees and certificate holders.Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under 6Electronic Reading Room/Document Collections.