ML20205J674
| ML20205J674 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/1999 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20205J657 | List: |
| References | |
| CCS, PROC-990127, NUDOCS 9904120146 | |
| Download: ML20205J674 (33) | |
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j NUCLEAR REGULATORY COMMISSION j
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j NRC INSPECTION MANUAL iuNS MANUAL CHAPTER 1360 USE OF PHYSICIAN AND SCIENTIFIC CONSULTANTS IN THE MEDICAL CONSULTANT PROGRAM 1360-01 PURPOSE This chapter establishes policy and procedures for the use of physician and scientific consultants in the Medical Consultant Program and incorporates current policy as given in Management Directive 8.10. "NRC Medical Event Assessment Program."
1360-02 OBJECTIVE OF MEDICAL CONSULTANT PROGRAM The objective of the Medical Consultant Program is to have qualified medical and technical i
individuals available to: (1) assist U.S. Nuclear Regulatory Commission staff in evaluating radiation exposure incidents (including medical events); and (2) provide technical support in areas such as radiation biology and medical physics. Assistance / support may include, but is not limited, to the following areas:
a.
Expert and independent medical evaluations of the probable deterministic effects of radiation exposures.
b.
Interpretation of bioassay results and other data related to a radiation exposure.
c.
Calculation of internal and external radiation doses, as necessary, d.
Participation in NRC inspections and investigations to determine the root cause of the radiation exposure incident and the nature and probable deterministic effects of the radiation exposure on the exposed person (s).
e.
Evaluation of reports submitted by the licensee to NRC and to the exposed individual after a radiation exposure incident or medical event.
f.
Provision of expert testimony regarding inquiries or hearings, and as requested by the NRC, participation in selected conferences on the biological effects of radiation and radioactive materials.
g.
Provide technical support to NRC as necessary (e.g., rulemaking activities, validation and verification of research results).
1 9904120146 990218 PDR ORG NRCCO PDR
,L Date 1/27/1999 1360
1360-03 DEFINITIONS 03.01 Authorized User. A physician, dentist, or podiatrist who is:
(1) Board certified by at least one of the boards listed in Paragraph (a) of $$35.910,35.920, 35.930, 35.940, 35.950, or 35.960; (2) Identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (3) Identified as an authorized user on a permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material.
03.02 Deterministic Effect. Health effect, the severity of which varies with the dose, and for 1
which a dose threshold is believed to exist. (Also called non-stochastic effect.) Examples of deterministic effects are cataracts, hypothyroidism, erythema, blood dyscrasia, radiation pneumonitis, and epilation.
03.0? Guardian Person legally responsible for a patient. (See also
- Responsible Relative.")
03.04 Medical Consultant Generic term intended to address the physician or scientific consultant. All medicci consultants must be appointed by NRC as Special Government.
j Employees. Appointment procedures can be found in NRC Management Directive 10.6, "Use of Consultants and Experts."
03.05 Medical Consultant Program. Program established to provide physician and scientific consultants to NRC.
03.06 Medical Event All medical misadministration events and any other event occurring at a medical licensee's facility that are believed by the Director, Division of industrial and Medical Nuclear Safety (IMNS), Office of Nuclear Material Safety and Safeguards (NMSS), to indicate a significant programmatic breakdown in the licensee's Quality Management Program required by 10 CFR 35.32, or an event that raises a significant question concoming issues such as the adequacy of a device, a regulation, a licensing / certification practice, or an exposure to a patient, which did not exceed the radiation dose threshold for a misadministration, but did exceed the prescribed dose. For purposes of this Manual Chapter, a Medical Event can be considered to be a ' radiation exposure incident." (See also " Radiation Exposure incident")
03.07 Misadministration. (See 10 CFR 35.2," Definitions,"
- Misadministration.")
l 03.08 NMSS Coordinator. Individual appointed by the Director, IMNS, NMSS, to function as NMSS Medical Event / Medical Consultant Coordinator for the Medical Consultant Program.
03.09 Patient's Physician or Individual's Physician. A physician who is retained by the patient or exposed individual to provide medical care to that patient or individual. In the case of a medical misadministration, the patient's or individual's physician may, or may not, be the referring physician and/or the physician authorized user.
l' 03.10 Physician Consultant A licensed physician trained and experienced in the use of
! radioactivity in medical diagnosis and/or therapy and/or experienced in the evaluation of th medical effects resulting from radiation exposures, whose services are retained by the NRC to provide expert opinion and independent evaluation of the medical information related to radiation exposures of individuals.
j 1360-
-2,-
Date 1/27/1999
..a 03.11 Radiation Exoosure incident (Incidentt G:niric tsrm intsndId to addr:ss any situ tion where an individual or embryo / fetus may have been or has been exposed to radiation levels that may warrant use of a medical consultant.
03.12 Referrina Physician. A physician who refers the patient to a radistica oncologist, a nuclear medicine physician, or other category of authorized user and requests treatment, consultation, or diagnostic tests for the patient. In most cases, the referring physician will not be the authorized user.
03.13 Resoonsible Relative. A relative who would make decisions regarding the patient when the patient cannot (e.g., the patient is a minor; the patient is unconscious or incapable of comprehending the information; or the patient has died) or who would make decisions for the patient if felling the patient of a misadministration would be harmful to the patient (based on medimi pdgment). The responsible relative is usually the next of kin. (See also " Guardian.")
03.14 Scientific Consultant. A medical or health physicist, radiobiologist, or other specialist who is retained by NRC to provide expert opinion and independent evaluation of the circumstances surrounding a radiation exposure incident, resulting doses, and/or dose consequences.
1360-04 POLICY ON USE OF MEDICAL CONSULTANTS 04.01 The time frame for initial activation of the procedures in this Manual Chapter should be based on the initial assessment of the severity of the event. This assessment will typically be performed by the regional office, with input from IMNS/NMSS, as necessary.
The following guidelines may be used when establishing the time frame for activation:
a.
Radiation Exposure incident resulting in a fatality - 2 working days after NRC is informed of the event.
b.
Radiation Exposure incident (other than a misadministration) that has not resulted in a fatality - 5 working days after NRC is informed of the event.
l c.
Misadministration resulting in administered dose greater than prescribed to a patient - 5 working days after the event is determined to be a misadministration by NRC.*
d.
Misadministrations involving the wrong individual, wrong treatment site, wrong radiopharmaceutical, wrong radioisotope, failure to remove source, or a leaking source
- 5 working days after the event is determined in be a misadministration by NRC.*
e.
Misadministration resulting in administered dose less than prescribed to a patient - 10 working days after the event is determined to be a misadministration, by NRC, if a medical consultant is used.*
l 04.02 Medical Consultantsmugt be used under the following circumstances:
a.
Incidents where an individual has received one or more of the following doses:
1.
A suspected total effective dose equivalent of 25 rem (0.25 Sv) or more.
2.
A suspected eye dose equivalent of 75 rem (0.75 Sv) or more.
- The specified time frame assumes that the misadministration occurred within the last 2 months. If the misadministration occurred in the past, consideration should be given to extending the time frame.
Date 1/27/1999 1360
=
3.
A shillow-dose equiv: lent to the skin or extrsmiti:s of 250 red (2.5 Gy) or mora.
' 4.
A suspected committed effective dose of 250 rem (2.5 Sv) or more to any individual organ er tissue other than the lens of the eye.
b.
Incidents where an individual is demonstrating physical symptoms (erythema, nassea, vomiting, etc.) consistent with radiation syndromes, and the source of the radiation may be attributable to NRC-licensed radioactive material.
c.
Medical Misadministrations, as defined in 10 CFR 35.2, where the patient receives an l
administered dose greater than prescribed.
d.
Medical Misadministrations, as defined in 10 CFR 35.2, which involve the wrong individual, wrong treatment site, wrong radiopharmaceutical, wrong radioisotope, failure to remove source, or a leaking source.
l Incidents where a r.ursing infant or an embryo / fetus may have been inadvertently e.
exposed to radiation or radioactive material as a result of the intentional or unintentional exposure of the mother of the nursing infant or an embryo / fetus to radiation or radioactive material.
04.03. Medical Consultantsmay be used under the following circumstances:
a.
Incidents where members of the public or occupationally exposed individuals may have been exposed to radiation during a radiation exposure incident.
b.
Incidents where the staff believes that the assistance of a medical consultant would be beneficial to fulfilling the NRC mission.
1360-05 RESPONSIBILITIES AND AUTHORITIES 05.01 Director. Division of industrial and Medical Nuclear Safety. Office of Nuclear Material Safety and Safeauards. The Director is responsible for the following:
a.
Establishing and maintaining procedures and instructions for the Medical Consultant Program.
b.
Designating an NMSS Coordinator for the Medical Consultant Program.
c.
Approving the use of physician or scientific consultants under NRC's Medical Consultant Program by: (1) NRC organizations / offices other than regional materials branches; (2) organizations in headquarters other than IMNS; and (3) Agreement States.
d.
Establishing and maintaining a list of physician and scientific consultants who have l
been appointed by the Office of Human Resources as Special Govemment Employees to provide consultative services to NRC. This list will be provided to the regional l
Directors, Division of Nuclear Material Safety (DNMS) on an annual basis by the NMSS Coordinator.
l 05.02 NMSS Medical Event / Medical Consultant Coordinator. The Coordinator is responsible for the following:
a.
Determining the number and type of medical consultants necessary to satisfy NRC needs and to coordinate with the Advisory Committee on Medical Uses of isotopes (ACMUI) Coordinator, appropriate program managers, and the Program Management, i
1360 Date 1/27/1999
m._..
Pclicy Devslopmsnt, and AnIlysis (PMDA) Stiff, NMSS, to ensura thIt NRC's mrdical l
consultant needs are met.
~
b.
Centrally maintaining for each medical consultant, a copy of Form 50-B, " Notification of Personnel Action." (NOTE: Responsibility in this area may be delegated to NRC project managers for specific contracts, such as the NMSS contract for cytogenetic studies.)
c.
Preparing and updating, on at least an annual basis, the master list of appointed consultants that is part of the Policy and Guidance Directive 9-13, "Use of Consultants." l d.
Acting as liaison between the IMNS Director and NRC organizations / offices, other than regional materials branches, that have requested permission to use physician or scientific consultants.
e.
Providing information on.the U. S. Department of Energy's (DOE's) Long-Term Medical l
Study Program to the exposed individual's physician or referring physician, if applicable. This program is maintained for DOE by Radiation Emergency Assistance Center / Training Site of the Oak Ridge Institute of Science and Education, Oak Ridge, Tennessee. (See Enclosure 10.)
f.
Coordinating any information transfer, for DOE's Long-Term Medical Study program, with DOE's Office.of Epidemiology and Health Surveillance, in which the NRC medical consultant provides a summation and evaluation of case data. 'See I:nclosure 12.)
g.
Maintaining one copy of the inspection report, medical consultant's report, and l
licensee's report required by 10 CFR 35.33, if applicable, on file in NMSS.
h.
Providing one copy of the inspection report, medical consultant's report, and licensee's report required by 10 CFR 35.33, if applicable, to both the Office of Enforcement and the Office for Analysis and Evaluation of Operational Data, to ensure that the incident is entered into the Nuclear Materials Events Database (NMED).
05.03 Director. Proaram Manaaement. Policy Development. and Analysis Staff. NMSS. PMDA is responsible for the following:
a.
Overseeing the administration of the Medical Consultant Program.
b.
Coordinating with the NMSS Medical Consultant and ACMUI Coordinators, on any personnel actions taken, to ensure that appropriate numbers and types of medical consultants are available.
05.04 NRC Reaional Office and All Headauarters_ Offices. These organizations are responsible for the following:
a.
implementing Management Directivs 8.10 and the Medical Consultant Program in their respective offices.
b.
Evaluating the need to use a physician or scientific consultant, based on criteria in Section 1360.04.
c.
Following procedures provided in Enclosure 1 and using the form in Enclosure 2, after a l
)
decision has been made to retain the services of a medical consultant.
d.
' Distributing copies of the inspection report in accordance with NRC policy for inspection report distribution. The copies should include the NMED tracking number. In addition, provide copies of the inspection report and the medical consultant's report to the referring physician or the individual's physician, as well as to the NMSS Coordinator.
5-1360 Date 1/27/1999
e.
Det:rmining that the consultant would not be in a conflict of int; rest or cn cpperrcnce of a conflict of interest situation if asked to provide consuming services on a particular case.
f.
If advised by a medical consultant that consulting services 6:re not warranted, obtain a written statement from the medical consultant, based on the specifics of the case, as to why further consulting services are not needed. The written statement will ba considered the medical consultant's report. The report may be in the form of a letter, a facsimile, or an e-mail. After receipt of the report, send written confirmation and a voucher (NRC Form 148) to the consultant.
g.
Approve vouchers submitted by the consultants after verifying that the vouchers are complete and accurate. Forward the approved vouchers and copies as described in, item 13.
h.
Provide information to the NMSS Medical Event / Medical Consultant Cooroinator for referral to in DOE's Long-Term Medical Study Program.
1 05.05 Physician Consultant. The physician consultant's responsibilities begin after they have been contacted by NRC and they have agreed to assist NRC. Once retained for the evaluation of a particular radiation exposure incident, the physician consultant is responsible for the following:
a.
Performing requested tasks, as specified in the NRC Physician Conruitant Charter (see ). Examples of tasks that the physician may be aske
Enclosuro 8 l
l' RESTRICTIONS ON SERVICE WITH OTHER FEDERAL DEPARTMENTS OR AGENCIES l
U.S. Nuclear Regulatory Commission policies and procedures for obtaining the services of consultants are defined in a Commission Directive.' The following information is contained in the Directive and has direct implications for the physician and scientific consultant.
Service with Other Acencies An employee who serves two or more Federal Departments or agencies is required to inform each of his or her arrangement (s) with the other. If the individual's appointments are made on the same date, the aggregate of the estimates of the days of services will determine the decision, by each agency, as to whether the individual is " Regular" or "Special." If, after being employed by one department or agency, a Special Govemment Employee is appointed by another agency, the second agency must make an estimate of the individual's days of service for the remaining portion of the 365-day period which was initiated by the first appointment. The sum of the estimate and of the actual number of days of service to other departments or agencies, during the prior portion of such 365-day period,willdetermine whethertheindividualis" Regular"or"Special." Closecoordination between the agencies and the appointee must be maintained to insure that the 130-day limitation is not inadvertently exceeded.
END
- information taken from U.S. Nuclear Regulatory Commission, Management Directive Chapter 4139, " Utilization of Consultants, Members, and Other Advisory and Assistance Services," Part I, Appendix D, Paragraph 4.
Date 1/27/1999 E8-1 1360, Enclosure 8
1 Enclosura 9 MEDICAL CONSULTANT REPORT (To Be Completed By Medical Consultant)
Official Use Only Medical Consultant Name:
Report Date:
/ /
Signature:
Lic;nsee Name:
License No.
Fccility Name:
l Individual's/ Patient's identification No.:
In:Ident Date:
/ /
Individual's/ Patient's Physician Name and address:
l R; ferring Physician Name and address:
(Medical Misadministration Only)
Individuals Contacted During investigation:
J (N:me and Title) l l
Records Reviewed: (General Description) l l
l l
l l
E;timated Dose to Individual or Target Organ:
Probable Error Associated with Estimation:
Prescribed Dose (Medical Misadministration Only):
l 1
C'ethod used to Calculate Dose:
1360, Enclosure 9 E9-1 Date 1/27/1999 I
Official Use Only
....._.....m..
I Offici:1 Una Only De:cription ofincident:
l Aressment of probable deterministic effects of the radiation exposure on the individual:
b Criefly describe the current medical condition of the exposed individual:
1 Was individual or individual's physician informed of DOE Long-Term Medical Study Program?
Y N
If yes, would the individual like to be included in the Program?
Y N
i Date 1/27/1999 E9-2 1360, Enclosure 9 Official Use Only
3 l
COMPLETE FOR MEDICAL MISADMINISTRATION (To Be Completed by Medical Consultant)
Official Use Only 1.
Based on your review of the incident, do you agree with the licensee's written report that was submitted to NRC pursuant to 10 CFR 35.33 in the following areas:
- a. Why the event occurred Y
N
- b. Effect on the patient Y
N
- c. Licensee's immediate actions upon discovery Y
N
- d. Improvements needed to prevent recurrence Y
N 2.
In areas where you do not agree with the licensee's evaluation (report submitted under 10 CFR 35.33), provide the basis for your opinion:
- 3. Did the licensee notify the referring physician of the misadministration?
Y N
Did the licensee notify the patient's or the patient's responsible relative or guardian?
Y N
if the patient or responsible relative or guardian was_n_qt notified of the incident, did the licensee provide a reason for not providing notification, consistent with 10 CFR 35.33?
Y N
Explain rationale for response.
1 1360, Enclosure 9 E9-3 Date 1/27/1999 Official Use Only
7
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- 4. Provide an opinion of the licensee's plan for patient follow-up,if available.
t I
l l
i Date 1/27/1999 E9-4 1360, Enclosure 9 Official Use Only
l Enclosura 10 NRC PROCEDURE FOR NOTIFYING THE REFERRING OR INDIVIDUAL'S PHYSICIAN OF THE U. S. DEPARTMENT OF ENERGY (DOE)
LONG-TERM MEDICAL STUDY PROGRAM This procedure should be initiated by the Nuclear Material Safety and Safeguards (NMSS) l Coordinator immediately following receipt of the medical consultant's report. The NMSS Coordinator has the overall responsibility for performing these tasks.
l 1.
Review the medical consultant's report to determine if the consultant made the referring l
orindividual's physician aware of the DOE Long-Term Medical Study Program and marked the appropriate box on Enclosure 9. If the consultant has made the physician aware of the program, no further action is necessary. If the consultant has not made the physician aware of the program, continue with the procedure.
2.
Review the medical consultant's report and determine if the estimated dose to the individual exceeds the criteria established by DOE for selection of cases for the Long-Term Medical Study Program. No further action is needed if the dose does not exceed the threshold. If the threshold is exceeded, continue with the procedure.
l 3.
Inform the referring or individual's physician of the DOE Study. This can be done by using the sample letters found in Enclosure 11. The letters should be sent together, by certified mail with a request for retum receipt. The latter is necessary to provide assurance that the letters were received by the physician.
A copy of the letters and the retum receipt should be maintained by the NMSS Coordinator.
l l
l END l
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l l
l 1360, Enclosure 10 E10-1 Date 1/27/1999
Enclosura 11 I
l l
SAMPLE LETTER PROVIDING INFORMATION ON l
U. S. DEPARTMENT OF ENERGY LONG-TERM MEDICAL STUDY PROGRAM TO THE MEDICAL FACILITY (Licensee)
ATTN: (Person's name) l (Person's position)
(Street address)
(City, State, Zip code)
Dear Sir:
On (date), a patient at your facility r 'iv'.d a misadministration of radioactive material during (teletherapy using
.manuaU
,.nerapy using
. brachytherapy using from a remote afterloader, a diagnos'
..,y using
. treatment with
).
The U.S. Nuclear Regulatory Commission (NRC,
suld like to make that patient's referring physician and, if the referring physician deems it ar.)priate, that patient aware of a voluntary life-time morbidity follow-up program for personnelinvolved in radiation incidents. The program is being conducted by the Radiation Emergency Assistance Center / Training Site (REAC/TS) for the U.S. Department of Energy, Office of Health.
NRC does not routinely retain the names of patients involved in misadministrations or the names of their referring physicians. We ask, therefore, that you add the name of the patient involved in the (date), misadministration and the name and address of the patient's referring physician to the enclosed letter and transmit that letter, along with its enclosure, to the referring physician. The letter and its enclosure provide information about the follow-up program being conducted by REACTTS and ask the referring physician to inform his or her patient about the REAC/TS program. If you have any questions regarding the NRC's request, please contact me at (Medical Event / Medical Consultant Coordinator Teleohone Number).
Sincerely, Medical Event / Medical Consultant Coordinator Operations Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Docket No.
License No.
Enclosure:
Letter to the referring physician of the patient involved in a misadministration on (date) cc: Dr. Ronald Goans, REAC/TS Date 1/27/1999 E11-1 1360, Enclosure 11
v I
i-
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d l
l L..
SAMPLE LETTER PROVIDING INFORMATION ON U. S. DEPARTMENT OF ENERGY LONG-TERM MEDICAL STUDY PROGRAM TO THE REFERRlNG OR INDIVIDUAL'S PHYSICIAN
Dear Madam or Sir:
On (date), one of your patients received a misadministration of radioactive material during (a diagnostic study using
. treatment with teletherapy using manual brachytherapy
. brachytherapy using from a remote afterloader), at (licensee),(city, state). The U.S. Nuclear Regulatory Commission (NRC) does not routinely retain the names of patients involved in misadministrations or the names of their referring physicians. I have therefore asked (licensee) to add the name of the patient, ( oatient name). and your name and address to this letter.
NRC would like to make you aware of a voluntary life-time morbidity follow-up program of personnel l
involved in radiation incidents. The follow-up program is being conducted by the Radiation l
Emergency Assistance Center / Training Site (REAC/TS) for the U.S. Department of Energy, Office of Health. A summary of the program is enclosed.
)
1 We ask you to review the attached summary and, if you believe it appropriate, provide the information to the patient involved. If your patient is interested in participating in the follow-up program or would like additional information on the follow-up program, he or she should contact Dr.
Ronald Goans, REAC/TS, at (423) 576-3131. If you have any questions regarding this transmittal letter, please contact me at (Medical Event / Medical Consultant Coordinator Teleohone Number).
Sincerely, Medical Event / Medical Consultant Coordinator Operations Branch Division ofindustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
Summary of the U.S. Department of Energy, Office of Health, Long-Term Medical Follow-up Program Enclosure l
END l
1360, Enclosure 11 E11-2 Date 1/27/1999
, 2
SUMMARY
OF U. S. DEPARTMENT OF ENERGY, OFFICE OF EPIDEMIOLOGY AND HEALTH SURVEILLANCE'S LONG TERM MEDICAL STUDY PROGRAM The Office of Epidemiology and Health Surveillance of the U. S. Department of Energy (DOE) sponsors a voluntary life-time morbidity study of personnel involved in radiation incidents, which is maintained by the Radiation Emergency Assistance Center / Training Site (REAC/TS). This study includes the gathering of clinical and epidemiological data at an early stage, after a significant
. exposure to radiation, and continues throughout the lifetime of the individualinvolved. The purpose of this study is to compile the best human radiobiological data available for improving immediate medical care, to develop the best prophylactic and anticipatory care for possible late effects, and to upgrade the bases for radiation risk estimates.
Personnel sought to participate in the study are those involved in a radiation incident or misadministration during which one or more persons received radiation exposure that equals or exceeds the selection criteria listed in the accompanying table. If an individual is willing to participate in the study, direct contact with the individual will be made by the DOE contractor at which time the details of the program will be explained fully, a consent form will be signed, and a schedule for future contacts will be arranged.
Generally, the follow-up program will consist of obtaining copies of all medical records associated with the treatment of the individual, immediately after the incident, and then annual contacts with the individual, to follow his/her medical history. Initially, the types of information sought will include a complete medical history before and after the incident or misadministration, and copies of all relevant hospital, laboratory, and physicians' records covering the period of observation. The annual contact will be made to determine whether the individual has had any illnesses or physical examinations during the year, and to obtain additional medical records as they appear to relate to the radiation exposure.
Participation in the follow-up program is totally voluntary and individuals may stop their participation at any time. The medicalinformation obtained during participation is covered by legal constraints, to protect the identity and privacy of living participants. Any expenses involved in providing medical records to the follow-up program are borne by the DOE long-term medical study program, not the individual. Any expenses for either short-or long-term medical care of the individual are the
~
responsibility of the program participant and not the responsibility of DOE, Oak Ridge Institute for Science and Education, or REAC/TS.
Date 1/27/199g '
E12-1 1360, Enclosure 12 I
i
CRITERIA FOR SELECTION OF CASES FOR LONG-TERM MEDICAL STUDY PROGRAM Condition Criteria l
1.
Dose to whole body, active Greater than or equal to blood-forming organs, 25 rem (0.25 Sv) i i
or gonads 2.
Dose to skin of whole body or Greater than or equal to extremities 600 rem (6 Sv) 3.
Dose to other tissues ur Greater than or equal to organs from external source 75 rem (0.75 SV) 4.
Internal burdens Greater than or equal to 50% of NCRP' Permissible Body Burden 5.
Medical misadministration Misadministrations as defined in 10 CFR 35.2 where the patient has received an administered dose greater than prescribed
" National Council on Radiation Protection and Measurement END 1360, Enclosure 12 E12-2 Date 1/27/1999
' 3 MEDICAL CONSULTANT REPORT (To Be Completed By Medical Consultant, if Consultation is Not Necessary)
Cer':cai Oonsultant Name:
Report Date:
/ /
Signature:
(if mailed or faxed)
Lic:nsee Name:
License No.
F:cility Name:
Incident Date:
/ /
Estimated Dose to Individual or Target Organ:
Pr:bable Error Associated with Estimation:
Pre:cribed Dose (Medical Misadministration Only):
M;thod Used to Calculate Dose:
i De:cription of incident:
Why Consultation is Not Required:
A^A:ssment of probable deterministic effects of the radiation exposure on the Individual:
Date 1/27/1999 E13-1 1360, Enclosure 13
CONGRESSIONAL CORRESPONDENCE SYSTEM DOCUMENT PREPARATION CHECKLIST This check list is to t._, submitted with each do:::ument (or group of Os/As) sent for processing into the CCS.
1.
BRIEF DESCRIPTION OF DOCUMENT (
M&v4(G1k adu[udT7M p mee o 2.
TYPE OF DOCUMENT _ X CORRES NDENCE HEARINGS (Os/As) 3.
DOCUMENT CONTROL __ SENSITIVE (NRC ONLY)
X NON-SENSITIVE 4.
CONGREE90NAL COMMITTEE AND SUBCOMMITTEE (if applicable)
Congressional Committee Subcommittee 5.
SUBJECT CODES.
(A)
(B)
(C) 6.
SOURCE OF DOCUMENTS (A) 5520 (DOCUMENT NAME (B)
SCAN (C)
ATTACHMENTS (D)
OTHER 7.
SYSTEM LOG DATES
/ ((Af h DATA OCA SENT DOCUMENT TO CCS
/
(B)
DATE CCS RECEIVED DOCUMENT (C)
DATE RETURNED TO OCA FOR ADDITIONAL INFORMATION (D)
DATE RESUBMITTED BY CC4 TO CCS (E)
DATE ENTERED INTO CCS BY (F)
DAT E OCA NOTIFIED THAT DOCUMENT IS IN CCS COMMENTS:
RELEASE TO PDR 11/0398 P\\DISRTLIS. CMS
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