ML20205J674

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NRC Insp Manual Chapter 1360, Use of Physician & Scientific Consultants in Medical Consultant Program
ML20205J674
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Issue date: 01/27/1999
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CCS, PROC-990127, NUDOCS 9904120146
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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." l 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 NMSSNMSS MedicalCoordinator.

Event / MedicalIndividual appointedfor Consultant Coordinator bythe the Director, Medical IMNS, Consultant NMSS, to function as 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 medical effectsinresulting medical diagnosis from and/or therapy radiation exposures, and/or are whose services experienced in the retained by the NRCevaluation to of th provide expert opinion and independent evaluation of the medical information related to  !

radiation exposures of individuals. ,

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1360- -2,- Date 1/27/1999 l

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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.

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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

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A shillow-dose equiv: lent to the skin or extrsmiti:s of 250 red (2.5 Gy) or mora.

3.

. ' 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 e. Incidents where a r.ursing infant or an embryo / fetus may have been inadvertently 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

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Pclicy Devslopmsnt, and AnIlysis (PMDA) Stiff, NMSS, to ensura thIt NRC's mrdical l consultant needs are met.

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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. 1
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.

Date 1/27/1999 1360

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 Enclosure 1, 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 Enclosure 5). Examples of tasks that the physician may be aske<i to perform are as follows:
1. Act for, and on behalf of, the Commission, to gather medical information for the evaluation of the effects of radiation exposure incidents on those exposed to radiation.
2. Assist in NRC inspection / investigative activities related to radiation exposure incidents; degree of assistance is defined in the Consultant's Charter.
3. Provide a professional opinion on the magnitude of the dose received by the exposed individual (s) and the probable error associated with the estimated dose (s).
4. Assess any probable deterministic effects of the radiation exposure on the patient or exposed individual.
5. Fumish expert testimony at inquiries or hearings and p6rticipate in selected conferences on bioeffects of radiation and radioactive materials.
6. In the case of a medical misadministration: (1) evaluate the licensee's notification to the exposed patient or to the patient's responsible relative or guardian, or, attematively, evaluate the licensee's reason for not informing the patient or the patient's responsible relative of the misadministration; (2) evaluate the licensee's plan for patient follow-up, if available; and (3) review and evaluate the report submitted by the licensee, pursuant to 10 CFR 35.33, for accuracy and completeness of the description.
b. Submitting final written reports of findings to the appropriate NRC office within 30 days of completing the requested task (s),
c. Complete NRC Form 148, " Voucher for Professional Services," within 30 days of completion of requested tasks. If the service requested by NRC resulted in travel, complete NRC Form 64/64A, " Travel Voucher " for non-local travel, or SF1164, " Claim 1360 Date 1/27/1999

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for R:imbursem;nt f:r Expenditur~s on Official Business," for local trsvIl. If miscellaneous expenses were incurred, complete form SF1034, "Public Voucher for Purchases and Services Other Than Personal." All vouchers should be completed within 30 days of the travel or expenditures.

05.06 Scientific Consultant. The scientific 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 scientific consultant is responsible for the following:

a. Performing requested tasks, as specified in the Scientific Consultant Charter (see Enclosure 6). Examples of tasks that the scientific consultant may be asked to perform are as follows:
1. Act for, and on behalf of, the Commission, to gather technical iaformation for the evaluation of radiation exposure incidents.
2. Assist in NRC inspection / investigative activities related to radiatica exposure incidents; degree of assistance is defined in the Consultant's Charter.
3. Provide a professional opinion on the magnitude of the dose received by the exposed individual (s) and the probable error associated with the estimated dose (s).
4. Perform and/or evaluate the results of cytogenetic studies.
5. Provide radiation dose estimates and related dosimetry services for internal and external exposure.
6. Interpret bioassay results.
7. Fumish expert testimony at inquiries or hearings and participate in selected conferences on bioeffects of radiation and radioactive materials.
b. Submitting final written reports of findings to the appropriate NRC office within 30 days of completing requested task (s).
c. Complete NRC Form 148, " Voucher for Professional Services," within 30 days of completion of requested tasks. If the service requested by NRC resulted in travel, complete NRC Form 64/64A, " Travel Voucher," for non-local travel, or SF1164, " Claim for Reimburseinent for Expenditures on Official Business," for local travel. If miscellaneous expenses were incurred, complete form SF1034, "Public Voucher for Purchases and Services Other Than Personal." All vouchers should be completed within 30 days of the travel of ex@anditures.

Date 1/27/1999 1360

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1306-07 FUNDING FOR MEDICAL CONSULTANT PROGRAM

. Physician and scientific consultants' time will be charged against IMNS, NMSS, full-time )

equivalent allocations. Travel expenses shall be charged against reginnal travel funds, or, in the case of use by another NRC office, against that office's travel funds.

1360-08 BASIC REQUIREMENTS This Chapter and its Appendix provide the guidance and procedures that apply to the use of physician and scientific consultants in the Medial Consultant Program.

END Enclosures

1. NRC Procedures for the Medical Consultant Program
2. Sample Memorandum Requesting Consultant Services
3. Sample Letter of Confirmation to Physician or Scientific Consultants
4. Preliminary Description of incident Form
5. Physician Consultant Charter
6. Scientific Consultant Charter j
7. Medical Consultant Liability
8. Restrictions on Service with Other Federal Departments or Agencies
9. Medical Consultant Report Form
10. NRC Procedure for Notifying the Referring er Individual's Physician of the i U.S. Department of Energy (DOE) Long-Term Medical Study Program

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11. Sample Letter Providing information on U. S. Department of Energy Long-Term Medical Study Program to the Referring or Individual's Physician
12. Summary of U. S. Department of Energy, Office of Epidemiology and Health Surveillance's Long-Term Medical Study Program
13. Medical Consultant Report l

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1360 Date 1/27/1999 l

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Enclosuro 1 NRC PROCEDURES FOR THE MEDICAL CONSULTANT PROGRAM A. GENERAL GUIDANCE These are general administrative procedures for the Medical Consultant Program. For non-reactor incidents, this Chapter should be used in conjunction with incident response procedures in Manual Chapter 1301, where applicable.

B. SPECIFIC GUIDANCE

1. Decide, based on the evaluation of available information on a radiation exposure incident and on the criteria established in Mar ual Chapter 1360, Section 1360-04 whether the services of a physician and/or scientific consultant are needed.
2. Select a consultant (s) from the list distributed by the Division of Industrial and Med: cal Nuclear Safety (IMNS), Office of Nuclear Material Safety and Safeguards (NMSS). This list will be an enclosure to the latest revision of the Policy and Guidance Directive (P&GD) 9-13, ."Use of Consultants." In selecting a consultant, regional or Headquarters !

management (i.e., branch chief or delegate) should ensure that there will be no conflict of interest or an appearance of a conflict of interest between the consultant and the  !

licensee and that the consultant's expertise is appropriate to the nature of the incideat and beneficial to the evaluation of the incident.

It is recommended that, if possible, a consultant from a region other than the one in which the consultant ic located should be chosen.

If the services of a particular consultant are to be procured under a U. S. Nuclear Regulatory Commission task order contract the Project Manager for that specific contract is to arrange for consulting services. The task order contracts for scientific consultants and the respective project managers are listed in the latest revision of P&GD 9-13. l DO NOT CONTINUE WITH THE PROCEDURES DESCRIBED IN THIS PART FOR SCIENTIFIC CONSULTANTS WHO ARE WORKING UNDER A TASK ORDER ,

CONTRACT. i l

ALL INTERACTION 'NITH THE CONSULTANT SHOULD BE THROUGH THE TASK ORDER CONTRACT PROJECT MANAGER NAMED (OR DESIGNATED) IN THE LATEST REVISION OF P&GD 9-13. l j

3. Request approval to use a physician or scientific consultant from the Division Director,

' IMNS/NMSS, in the case of; an incident involving non-NRC licensed byproduct material; an incident in an Agreement State, involving Agreement State licensed material, or naturally occurring radioactive material; or in the situation where the consultant will be used by an NRC group outside IMNS or the regional materials branches. This approval abould be requested in writing. A sample memorandum requesting use of a specific consultant can be found in Enclosure 2.

4. Contact the selected physician or scientific consultant, by telephone, to obtain en oral agreement for his/her services; provide him/her with a description of the incident and the tasks to be performed; and discuss, based on available information, whether an on-site visit appears necessary. The oral agreement should include an agreed upon date on when services will be performed / completed.

Date 1/27/1999 E1-1 1360, Enclosure 1

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L If the consultant declines to assist on the case because, in his or her opinion, use of a consultant is not warranted, the region shall do the following:

Obtain a written statement from the medical consultant, based on the specifics of the case, as to why further consultive services are not needed. The written statement may be in the form of a letter, a facsimile, or an e-mail. An example form to be_ set to the consultant may be found in Enclosure 13. This statement should be placed in the docket file. A copy of the statemut should also be provided to the NMSS Coordinator.

If the consultant declines to assist on the case for reasons other than discussed above, l the region should document, in a memorandum, in a facsimile, or in an e-mail to the NMSS Coordinator, the contact with the consultant and reason that the consultant declined to assist on the case. The region should then contact another consultant, to review the case.

5. Inform the NMSS Coordinator, by phone, electronic mail, and/or facsimile, that a consultant has been contacted. If not done previously, a brief description of the incident (e.g., preliminary notification (PN), draft PN, or draft inspection report) should be provided to the NMSS Coordinator at this time. If the NMSS Coordinator is not available, notify the Programmatic Safety Section Chief, Operations Branc: ,

IMNS/NMSS.

6. Send the consultant a letter of confirmation. NOTE: A copy of the confirmation letter should also be sent to the NMSS Coordinator.

A sample letter of confirmation is provided in Enclosure 3. Enclosed with the letter

! should be the hilowing documents, as necessary:

Physician Consultant:

- Preliminary Description of Incident Form (Enclosure 4) or PN, if available

- Physician Consultant Charter (Enclosure 5)

- Medical Consu! tant Liability (Enclosure 7)

- Restrictions on Service with Other Federal Departments or Agencies (Enclosure 8)

- Medical Consultant Report Form (Enclosure 9)

- NRC Procedure for Notifying the Referring or Individual's Physician of the U. S. Department of Energy Long-Term Medical Study Program (Enclosure 10)

- NRC Form 148, Voucher for Professional Services

- NRC Form 64/64A, Travel Voucher (non-local travel)

-SF1164, Claim for Reimbursement for Expenditures on Official Business (local travel)

-SF1034, Public Voucher for Purchases and Services Other Than Personal Scientific Consultant:

l- - Preliminary Description of incident Form (Enclosure 4) or PN, if available

- Scientific Consultant Charter (Enclosure 6)

- Medical Consultant Liability (Enclosure 7)

- Restrictions on Service with Other Federal Departments or Agencies (Enclosure 8)

- NRC Form 148, Voucher for Professional Services ,

- NRC Form 64/64A, Travel Voucher (non-local travel) j

-SF1164, Claim for Reimbursement for Expenditures on Official Business (local travel)

-SF1034, Public Voucher for Purchases and Services Other Than Personal  ;

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7. If applicable, arrange for the consultant's travel.

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8. In coordinition with the physiciIn or sciintific consultrnt, finiliza a sch;dula for completion of all tasks, including the final report.

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9. Inform the licensee that a medical consultant has been retained by NRC and describe, l as appropriate, the consultant's role in the inspection or investigation of the incident.

Provide the consultant's name to the licensee and suggest that the licensee inform the involved individual's physician (s) and/or referring physician of the NRC consultr ant's identity and function.

10. Continue the NRC inspection or investigation, to include gathering information on: (1) the licensee's actions, to include patient / individual notifications, as required by applicable provisions in 10 CFR Parts 19,20,21, and 35; and (2) the medical status of the patient / exposed individual.
11. Forward a copy of the report submitted by the licensee under 1r' CFR 35.33 to the physician consultant for review.
12. Obtain a final report from the consultant within 30 calen-lar days of completion of the l case review and/or site visit, unless there are extenuatir7 circumstances. (NOTE: The medical consultant should have informed the regional ontact of extenuating circumstances before the 30-day period has expired.' l (NOTE Send a copy of the consultant's report to the referring physician or the individual's physician and the NMSS Coordinator.)
13. Complete and issue the final NRC inspection investigation report. The report should be !

prepared in accordance with NRC Inspection Manual Chapter 610, " Inspection Reports," and Management Directive 8.10, "NRC Medical Event Assessment Program."

(NOTE Send a copy of the finalinspection report to the referring physician or the individual's physician and the NMSS Coordinator.)

14. Receive the voucher for professional services (NRC Form 148) submitted by the l consultant. The appropriate regional contact (staff person), in coordination with the branch chief, should verify hours / days claimed by the consultant, sign approval block, and forward the voucher to the Chief, Program implementation Branch, Program Management, Policy Development, and Analysis Staff, NMSS, for processing and reimbursement.

(NOTE: A copy of the voucher should also be forwarded to the NMSS Coordinator.) All consultant time will be charged against IMNS, NMSS full-time equivalent allocations.)

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15. Receive the voucher for miscellaneous expenses (SF 1034) submitted by the consultant. The appropriate regional contact (staff person), in coordination with the branch chief, should verify expenses claimed by the consultant and forward the voucher '

to the Divition of Accounting and Finance, Office of the Chief Financial Officer, for processing and reimbursemont.

(NOTE: A copy of the voucher should also be forwarded to the NMSS Coordinator.)  !

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l Date 1/27/1999 E1-3 1360, Enclosure 1 .

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16. R;ceive voucher f:r consultrnt's tr v:;l (NRC Form 64/64A cr SF1164). Vrrify cnd process the completed NRC Form 64/64A or SF1164 for travel performed while working

. in the region.

(NOTE A copy of the voucher should also be forwarded to the NMSS Coordinator.

Travel expenses will be charged against regional program support (travel) funds or, in the case of use by a headquarters office, against the user office's travel funds.)

END i

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I 1360, Enclosure 1 E1-4 Date 1/27/1999

Enclosura 2 SAMPLE MEMORANDUM REQUESTING CONSULTANT SERVICES (For Use by Offices Other Than Regional Materials Branches, or within IMNSINMSS)

MEMORANDUM TO: . Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:

SUBJECT:

REQUEST FOR USE OF MEDICAL CONSULTANTS The (Office) requests authorization to use one of the (ohysician or scientific) consultants who are under contract to your Division. This written request is being made pursuant to NRC Manual Chapter 1360, "Use of Physician and Scientific Consultants." The following is a brief description of the task to be performed.

Consultant requested: (name)

Description of service:

Erfimated hours needed to complete task:

Site visit anticipated? _ Yes _ No CONTACT: (name)

(telephone number) cc: NMSS Coordinator END 1

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Date 1/27/1999 E2-1 1360, Enclosure 2

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Enclosure 3 SAMPLE LETTER OF CONFIRMATION TO PHYSICIAN OR SCIENTIFIC CONSULTANTS

Dear  :

This letter is to confirm our telephone agreement of(date) that you will assist this U. S. Nuclear Regulatory Commission regional office by serving as a (ohvsician or scientific) consultant with respect to the (incident or misadministration) described in Enclosure 1. A Charter detailing the tasks that should be completed under this contract is provided as Enclosure 2. (For Misadministrations d only: NOTE, you should not evaluate the appropriateness of the prescribed treatment orits medical effectiveness.) If you encounter difficulty in completing these tasks or identify additional tasks that should be performed, please contact (NRC contact) . the NRC office contact for this matter. This individual should also be contacted if you believe that your involvement in the case would result in a possible conflict ofinterest situation. In addition, please note the infnrmation in Enclosures 3 and 4 regarding medical consultant liability and service with other Federal departments or agencies.

Please notify (NRC contact) if you are currently performing work for other Federal departments or agencies.

It is our understanding, based on our telephone agreement of(date), that you (will/w lngi) conduct i an on-site visit. Your evaluation of the incident shall include a review of all pertinent documents  !

available, regardless of whether an on-site visit is conducted.

The licensee, (name), has been notified by our office of your participation in this incident evaluation and has been asked to contact the individual's (or individuals') physician (s) ani;llor the referring physician, regarding your involvement in NRC activities, INSERT FOR PHYSICIAN CONSULTANTS ONLY: Enclosure 5 contains a brief summary of the U.S. Department of Energy (DOE), Office of Epidemiology and Health Surveillance Long-Term Medical Study Program. DOE sponsors this life-time morbidity study of personnel involved in radiation incidents through The Radiation Emergency Assistance Center / Training Site of the Oak Ridge Institute of Science and Education. NRC will provide information on the Study to the individual's physician or referring physician, after NRC has investig'ted the incident. However, you may want to discuss this information with the individual's physician or the referring physician.

Please inform (NRC contact) when you have completed the tasks specified in the Charter. A report of your findings and conclusions shall be provided to us within 30 calendar davs of the completion' of the case review unless there are extenuating circumstances that have been discussed with (NRC contact) before the 30-day period ends.

Please followThese reimbursement. the instructions claims shouldprovided in the be submitted on a Charter when monthly basis preparing (Enclosures and 6,7, andsubmitting

8) but claims no later than 30 days after the completion of your report. You should submit your vor her to, ,

(NRC contact) .

Thank you for your assistance 'in this matter. (NRC reoional contact injag, hone number and);

number) is the NRC regional office contact for this case.

Sincerely, NRC Regional Administrator l i

1360, Enclosure 3 E3-1 Date 1/27/1999

.._- _ ....-..m._... _

Enclosures:

"ONLY FORWARD APPLICABLE ENCLOSURES ***

1. Description of incident
2. Charter for (Physician or Scientific) Consultants
3. Medical Consultant Liability
4. Restrictions on Service with Other Federal Departments or Agencies
5. Summary of U.S. Department of Energy Office of Epidemiology and Health Surveillance

, Long-Term Medical Study Program

6. NRC Form 64/64A, " Travel Voucher", or SF1164, " Claim for Reimbursement for Expenditures on Official Business" NRC Form 148, " Voucher for Professional Services" l 7.8. SF1034, "Public Voucher for Purchases and Services Other Than Personal" cc: NMSS Coordinator, with Transmittal Letter and Enclosures 1 and 2 END 1

l l

1 l

Date 1/27/1999 E3-2 1360, Enclosure 3

Enclosura 4 PRELIMINARY DESCRIPTION OF INCIDENT FORM

. NRC Regional Office: Date of Incident: / /

Date of Notification: / /

NRC inspector (Regional Contact):

Phone:

Medical Consultant:

Specialty:

Preliminary Descriotion of incident (s):

Name, address, and phone number of organization (s) involved:

(if more than one organization is involved, provide a separate enclosure for each.)

NRC License No.

NRC Docket No.

Name, phone number, and title of licensee contact:

Dates of incident:

Preliminary description of incident and summary of known circumstances resulting in radiation exposure, including all known radionuclides and activities.

Individual (s) exoosed:

Home Estimated Radiation Name.. Home Address Telephone Dose

    • NOT FOR RELEASE-DOCUMENT CONTAINS INFORMATION WHICH IS EXEMPT FROM DISCLOSURE UNDER 10 CFR 2.790**

END 1360, Enclosure 4 E4-1 Date 1/27/1999

)

. _ . . _ _ . _ _ _.._..3.., . . . . -. .

Enctsura 5 PHYSICIAN CONSULTANT CHARTER A. GENERAL INFORMATION The U. S. Nuclear Regulatory Commission's authority and responsibility for conducting special inspections of radiation exposure incidents are provided under the Atomic Energy Act of 1954, as i amended, and under the Energy Reorganization Act of 1974. The purpose of these inspections is to ascertain the facts and other related information surrounding the incident. This may involve the following tasks: determining the circumstances surrounding the incident and the root cause of the {

. incident; evaluating the actions taken by the licensee at the time of the incident, in providing medical care to exposed persons; evaluating corrective actions taken by the licensee, to preclude future similar incidents; verifying or estimating dose to the exposed individual (s); evaluating the probable

~

deterministic effects of the exposure; evaluating the notifications made by the licensee, and the licensee's follow-up plan, if available; and gathering evidence to support any necessary enforcement actions by NRC.

B. SPECIFIC GUIDANCE AND TASKS TO BE PERFORMED

1. The physician consultant shall not do the following:
a. Enter into a physician-patient relationship with the exposed individual.
b. Provide medical opinions or recommendations to anyone other than NRC, without NRC's written permission, unless compelled by legal process to do so. To minimize the risk of liability, any recommendations made by a physician consultant should be accompanied by a disclaimer that the recommendation is not a substitute for the professional judgment of any physician involved with, or respontible for, the patient's or individual's care.
c. Recommend a particular expert. The physician consultant may indicate that the services of an expert are needed, and if asked, the consultant may identify, after consultation with NRC management, sources for identification and location of such experts.

Recommendations will be in accordance with 5 CFR 2635.702, which prohibits Federal employees from using public office for the endorsement of any product, service, or enterprise. Information on 5 CFR 2635.702 is available from the regional contact listed in the cover letter.

d. Divulge or make known to the licensee, individual, individual's physician, or referring physician any official findings or conclusions resulting from the NRC inspection, without NRC's permission.
e. Evaluate the appropriateness of the prescribed treatment, or its medical effectiveness.
f. Volunteer advice, to the licensee, about corrective actions to be taken by the licensee.
2. The physician consultant shall do the following:

NRC OFFICE REQUESTING PHYSICIAN CONSULTANT SERVICES MUST DESCRIBE THE REQUESTED SERVICE.

Items a -I are examnles of tasks that should be considered for use in the charter.

when followina un on a red!ehn exposure incident other than a misadministration.

Items a - m are avamoles of tasks that should be considered for use in the charter.

when followina un on a misadministration.

Date 1/27/1999 ES-1 1360, Enclosure 5

.- -. ~ . ~ . . . . . . . .

o. Provide the dita of cny on-sita visits at the licensee's ficility, to th3 NRC regional contact, as soon as a visit has been scheduled.
b. Gather information regarding the circumstances surrounding the incident, to assist in determining the root cause(s).
c. Provide an estimate of the radiation dose to the patient / exposed individual, and the probable error associated with the estimation of the dose. If necessary, request that the licensee and/or individual's physician fumish information on bioassays, medical history, written directive, physical examinations, and other pertinent laboratory work, etc.
d. ' Assess any probable deterministic effects on the exposed individual / patient.
e. Evaluate the medical data provided by each exposed individual'a/ patient's physician and interpret the result 6 for the NRC regional office staff; keep the NRC regional or Headquarters staff informed (as appropriate) of the medical condition of the individual.
f. Evaluate the promptness and effectiveness of the licensee's immediate actions, in response to the incident, and corrective actions to prevent recurrence.
g. Prepare and submit, to the NRC regional office, a report of findings and conclusions, within l 30 calendar days of completion of the case review and/or site visit, unless there are extenuating circumstances. These circumstances should be communicated to NRC l regional management as soon as they are discovered. If information is discovered that is directly relevant to a potential violation of NRC regulations, it should be promptly communicated to NRC.

The report may be submitted on the enclosed report form. If the enclosed form is not used to submit the findings, you shall, at a minimum, address the items listed on the form.

s

h. Promptly prepare and submit NRC Form 148, " Voucher for Professional Services," to the

? NRC regional contact, indicating days / hours claimed. Per NRC Management Directive

$ 10.6, *Use of Consultants and Experts," these vouchers should be submitted monthly,

! when work is performed.

i. Prepare and submit NRC Form 64/64A, " Travel Voucher," (non-local travel) or SF1164,

" Claim for Reimbursement for Expenditures on Official Business," (local travel) to the NRC regional contact, for expenses incurred during days / hours worked in the region or Headquarters.

(NOTE: The regional offices shall make travel arrangements through an NRC travel request (NRC Form-279).) .

j. - Prepare and submit SF 1034, "Public Voucher for Purchases and Services Other Than Personal," to the NRC regional contact, for administrative expenses other than those associated with salary and travel.

I k' Gather information regarding the radiation dose actually received by the patient, as

- compared with the prescribed dose, to determine whether the misadministration was medically or biologically significant.

l li Evaluate the licensee's notification to the exposed patient or patient's responsible relative or guardian, or, attematively, the licensee's reason for not informing the patient or patient's responsible relative of the misadministration.

1360, Enclosure 5 E5-2 Date 1/27/1999 L-

- ..-. . - . a .. .. . .. . . . . .

m. Review and evaluate the report submitted by the licensee under 10 CFR 35.33, to include l an evaluation of the licensee's description of the incident, immediate actions taken in response to the incident, steps taken or proposed, regarding long-term corrective actions to prevent recurrence, and the probable effects on the patient.
n. Evaluate the licensee's plan for patient follow-up, if asallable. l
3. The physician consultant may consider performing the following:

Informing.the individual's physician of the U.S. Department of Energy, Office of Epidemiology and Health Surveillance's Long-Term Medical Study Program. This life-time morbidity study of personnel involved in radiation incidents is maintained by the Radiation Emergency Assistance Center / Training Site of the Oak Ridge Institute of Science and -

Education. Information on the study is attached to the confirmation letter.

(NOTE: NRC will make the referring or individual's physician aware of the study if the consultant does not inform the physician.)

END l

l 1

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)

Date 1/27/1999 E5-3 1360, Enclosure 5 i L.

. . - . - . ~ . . . .

Enclosura 6

~

SCIENTIFIC CONSULTANT CHARTER A. GENERAL INFORMATION The U. S. Nuclear Regulatory Commission's authority and responsibility for conducting special inspections of radiation exposure incidents are provided under the Atomic Energy Act of 1954, as amended, and under the Energy Reorganization Act of 1974. The purpose of these inspections is to ascertain the facts and other related information surrounding the incident. This may involve the

' followirig tasks: determining.the circumstances surrounding the incident and the root cause of the incident; evaluating corrective actions taken by the licensee to preclude future similar incidents; verifying or estimating dose (s) to the exposed individual (s); evaluating probable deterministic effects of the exposure; and gathering evidence to support any necessary enforcement actions by NRC.

B. SPECIFIC GUIDANCE AND TASKS TO BE PERFORMED

1. The scientific consultant shall not do the following:
a. Provide medical opinions or recommendations to anyone other than NRC, without NRC's written permission, unless compelled by legal process to do so. To minimize the risk of liability, any recommendations made by a scientific consultant should be accompanied by a disclaimer that the recommendation is not a substitute for the professionaljudgment of any physician involved with, or responsible for, the patient's or exposed individuars care,
b. ~ Recommend a particular expert. The scient'?c r consultant may indicate that the services of an expert are needed, and if asked, the consultant may identify, after consultation with NRC management, sources for identification and location of such experts. Recommendations will be in accordance with 5 CFR 2635.702, which prohibits Federal employees from using public office for the endorsement of any product, service, or enterprise. Information on 5 CFR 2635.702 is available from the regional contact listed on the cover letter.
c. Divulge or make known to the licensee, individual, or individual's physician any official findings or conclusions resulting from the NRC inspection, without NRC's permission.
d. Volunteer advice about corrective actions to be taken by the licensee.
2. The scientific consultant.shall do the following:

NRC OFFICE REQUESTING CONSULTANT SERVICES MUST DESCRIBE THE REQUESTED SERVICE.

a. ' Provide the date of any on-site visits at the licensee's facility, to the NRC regional contact, as soon as a visit has been scheduled.
b. Prepare and submit, to the NRC regional office a roport of findings and conclusions, within 30 calendar days of completion of the case review and/or site visit, unless there are extenuating circumstances. These circumstances should be communicated to NRC regional management as soon as they are discovered. If information is discovered that is directly relevant to a potential violation of NRC regulations, it should be promptly communicated to NRC.

1380, Enclosure 6 E6-1 Date 1/27/1999 i

c. Promptly pr:;p;ra End submit NRC Fcrm 148, "Vouchtr for Profissional Services,"

to the NRC regional contact, indicating days / hours claimed. Per NRC Management Directive 10.6, "Use of Consultants and Experts," these vouchers should be submitted monthly, when work is performed.

d. Prepare and submit NRC Form 64/64A, " Travel Voucher," (non-local travel) or l SF1164, " Claim for Reimbursement for Expenditures on Official Business," (local travel) to the NRC regional contact, for expenses incurred during days / hours worked in the region or Headquarters.
e. Prepare and submit SF 1034, "Public Voucher for Purchases and Services Other Than Personal," to the NRC regional contact, for administrative expenses other than those associated with salary and travel.

(NOTE: The regional offices shall make travel arrangements through an NRC travel request (NRC Form-279)).

END l

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Date 1/27/1999 E6-2 1360, Enclosure 6

Enclosuru 7 MEDICAL CONSULTANT LIABILITY  ;

Medical consultants who are appointed as Special Govemment Employees are considered to be Federal employees. When a Federal employee is personally sued for a common law tort committed within the scope of employment, the United States will be substituted as the defendant pursuant to the Federal Tort Claims Act. Govemment counsel will defend the suit on behalf of the United States. The United States will be responsible for any damages that might be awarded. In addition, the consultant would have absolute personal immunity for injury or damage arising from common

. law torts. A Federal employee (including present and former employees) may also be provided <

personal representation by the Govemment in a proceeding in which he or she is sued, subpoenaed, or charged in his or her individual capacity, provided the actions for which representation is requested reasonably appear to have been performed within the scope of the employee's appointment, and representation is in the interest of the United States.

The consultant's provision of professional opinions and recommendations to the U.S. Nuclear Regulatory Commission does not constitute " practice of medicine" within the scope of State licensing laws, provided the consultant does not anter into a physician-patient relationship with the patient.

END I

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I 1360, Enclosure 7 E7-1 Date 1/27/1999

i l>

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:

l Prescribed Dose (Medical Misadministration Only):

1 C'ethod used to Calculate Dose:

1360, Enclosure 9 E9-1 Date 1/27/1999 I Official Use Only  ;

l

. _ . .. ....._.....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

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 1

I

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 l

l I

l 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

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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.
3. Inform the referring or individual's physician of the DOE Study. This can be done by using l

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 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)

(Person's position) l (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 . _ . - . ..

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d l

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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

'- Date 1/27/1999 1360, Enclosure 11 E11-2

Enclosure 12

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

l CRITERIA FOR SELECTION OF CASES FOR LONG-TERM MEDICAL STUDY PROGRAM Condition Criteria

1. Dose to whole body, active Greater than or equal to l 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

Enclosure 13 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:

1 Why Consultation is Not Required:

l I

l A^A:ssment of probable deterministic effects of the radiation exposure on the Individual: l 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

%00Fl

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