ML20214M447
| ML20214M447 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 11/01/1981 |
| From: | Gavazzi A VETERANS ADMIN. MEDICAL CENTER, WASHINGTON, DC |
| To: | |
| Shared Package | |
| ML20213D562 | List: |
| References | |
| PROC-811101, NUDOCS 8609110118 | |
| Download: ML20214M447 (40) | |
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11-19 v
VETERANS ADMINISTRATION ME0! CAL CLNTER 50 Irving Street, N.W.
Washington, DC 10422 MEDICAL CEliTC'I /CLICY PEi'CaAi! Dull NO.11-19 1:over':or 1,1981 PURPOSE------------------------------------------------------------------
1 POLICY-------------------------------------------------------------------
2 PROCEDURE----------------------------------------------------------------
3 REFERENCE---------------------------------------------------------------- 4 RESCISION------------------------------------------------------------
--- 5 RADIATION SAFETY GUIDE FOR RADIO!SOTCPE USE 1.
PURP01:
To establish a policy for radiation safety for radioisotope use.
2.
POLICY _: The attached publication outlines in detail policies and pro-cedures for radiation safety in this medical conter as approved by the Nuclear Regulatory Connission.
3.
PROCEDURE: The attached publication is divided into fnur sections:
Section I:
Mministrative Procedures Section !!:
Rules and Regulations Section !!!: Special Instructions Section IV:
Appendices 4.
REFERENCE:
M-2, Part XX; Medical Center Policy Ponorandom Hos.151-2, 115-1, and 0;i-24;DM/,5 Cire.nlar 10-80-253; Title 10, CFR, Parts 19 and 20.
5.
RESCISION: Hospital Policy Memorandum No. 11-19 dated May 15, 1978.
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SECTION I ADMINISTRATIVE PROCEDURES A.
Radioisotope and Radioactive Drug Research Comittee (RI4RDRC). This committee is established as the administrative body responsible for the safe use of radioactive materials within the medical center and has the following responsibilities and authority:
Review a. d grant persission for, or disapprove, all proposals for 1.
1 research, diagnostic, and therapeutic uses of radioisotopes in human sub-jects, animals, and in-vitro laboratory procedures.
2.
Establish policy regarding the safe use of radioisotopes.
3.
Assure the cbservance of all safety standards established by the NRC and this medical center.
4.
Assure that any investigator who uses radioactive isotopes is qualified by training and experience, has the facilities to handle the materials safely, and proposes a use which is safe to all concerned.
5.
Prescribe special conditions that will be required during a pro-posed use of radioactive material such as requirements for bioassay and phy-sical examinations of users, minimum level of training and experience of users, etc.
6.
Provide technical advice to the radioisotope users and to the Radiation Safety Office.
7.
Receive and review records and reports from the Radiation Safety Office concerning health safety practices in this medical center.
8.
Periodically review the overall use of radioisotopes in the medi-cal center.
9.
Review all instances of alleged infraction of usages and/or safety procedures with the Radiation Safety Office and recommend appropriate remedtil actinn.
- 10. To suspend or teminate any project or procedure which it finds to be a threat to health or property.
The RIARDRC functions under the following administrative procedures:
1.
The full committee meets routinely on the first Friday of the second month of the calendar quarter. The regular schedule is supplemented by additional meetings as required by specific problems that relate to the use nf radioisotopes.
2.
A majority of the comittee members must be present before the meeting is called to order. The approval of the majority of the members must be obtained to approve an application for radioisotope use.
9 3.
The minutes of the meetings are recorded by the Radiation Safety Office and copies are sent to members, the Medical Center Director through the Chief of Staff, the HSR0, Coordinator, and the AA/ACOS for Research and Development for distribution to the RAD Comittee members.
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Radiation Safety Office. This office is established to assure compli-ance ieTDi all applicable NRG regulations and medical center policy through personal inspection. of all laboratories utilizing radioactive materials.
The office has the following responsibilities:
1.
Insuring that all laboratories and personnel involved with the use of radioactive materials are operating with the prescribed rules and regula-tions of titis medical center and the NRC.
2.
Assisting individual users of radioisotops in the development of safety procedures and periodically checking to see that approved procedures are being used.
3.
Reporting all instances of non-compli.cance to the RIARDRC for their review and action.
r 4.
Performing periodic radiation surveys and wipe tests as required for radiation safety.
The Radiation Safety Officer (R50) has the following authority:
1.
To enter any laboratory where radioactive materials are being used or stored, at any time, for the purpose of conducting radiological surveys, i
records inspections, or for observing laboratory procedures.
2.
To inmediately suspend, pending RIARORC review, any project or t
procedure which is believed to be a threat to property or to the health of,
i the worker.
The R50 observes the following administrative procedures:
1.
Reporting to the RIARDRC and Medical Center Director, through_*h --
Chief of Staff, quarterly, and the HSR0 Coordinator annually, on the status l
of the radiation safety program.
i 2.
Producing and maintaining those records required to assure main-tenance of radiations safety.
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3.
Developing, for review and approval by the RIARDRC, radioisotope i
laboratory safety procedures and administrative procedures rquired to insure t
compliance with the dictates of this guide and NRC regulations.
4.
Formulating, in consultation with the RIARDRC institutional train-i ing programs for the safe use of radioisotopes.
t 5.
Reviewing any suspended radioisotope projects or procedures with the R!aRORC in special session.
l C.
Procedures and Requirements for Investigator Authorization for Radioiso-j tope Use.
I 1.
A separate application is required for each protocol that contem-plates the use of radioisctopes. The R!aRDRC recognizes four basic types of l
applications:
in-vitro laboratory, animal research, routine human use, and non-routine human use.
Each requires distinct levels of training and exper-l l
tence and supporting information.
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2.
The RIARDRC'recosamends that the investigator call on the RSO when-ever a project involving radioisotopes is contemplated in order to smooth out potential problems before the protocol is submitted, and to delineate those areas that may require specific attention.
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3.
Upon completion, the application should be forwarded to the RSO.
If the application ts approved by the RIARDRC, a radioisotope use permit will be issued'to the investigator. This constitutes authorization, under the terms of the application, to procure and use radioactive materials for j
the purposes described in the application.
4.
Each authorization will be marked with an expiration date, which will usually be two years after.the month of approval. The investigators should anticipate the expiration of their projects by at least three months in order to apply for renewal of the authorization. For this purpose, it is necesary to submit a memorandum requesting renewal of the application with modification.
5.
If questions re9arding details of an application should arise in the course of the R!aRDRC s consideration, the investigator will be invited to meet with the Cossnittee and discuss details of the proposal.
D.
In-Vitro 1.aboratory Appl.ications 1.
Investigators applying for this type of use must have the follow-ing qualifications:
a.
A working knowledge of the principles and practices of radia-tion safety, radioactivity measurements, standardization and monitoring techniques, instrument use, biological effects of radiation, and mathematics j
and calculations basic to the use and measurement of radioactivity.
I b.
Experience in the use of the byproduct material for the types and quantities for which the appitcation is being made, or an equivalent experience.
2.
The application must contain the following:
i a.
A copy of the protocol submitted to the RAD Committee.
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b.
A description of laboratory facilities available.
c.
The specific step-by-step procedure to be followed.
1 E.
Animal Research Applications 1.
Investigators applying for this type of use must satisfy the pre-ceeding requirements and must atso have experience or training in handling radioactive animals.
2.
App 1tcations must include the following, in addition to the infor-mation Itsted under in-vitro applications:
a.
The type of animal to be used (including weight), how it is to be cared for, and the number to be used in the study.
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b.
The isotope and amount to be given to each animal, the fre-quency that the does is given, and the effective half-life of the isotope in the animal.
c.
An estimate of the exposure rate at one meter from the animal cages.
3.
The application must have contemporaneous approval of the Animal Research Subcommittee.
F.
Routine Diagnostic and Therapeutic Human Use Applications 1.
Diagnostic and therapeutic human use applications fall into the same category as " routine use" as defined by the NRC. A listing of accept-able routine uses is listed in the NRC Licensing Guide for Medical Programs and is available in the Radiation Safety Office. The RIARORC also exercises jurisdiction over these radioactive materials which are not subject to the NRC licensure.
2.
Investigators applying for this type of use must satisfy the NRC requirements for physicians as stated in the Licensing Gaide for Medical Programs. These requirements are listed in Appendix 1.
3.
The application must contain a description of:
- a. ' The laboratory facilities.
b.
The methods used to insure radioisotopic purity, sterility and non-pyrogenicity, if the radioisotopic compound is not obtained in sterile pyrogen-freo form from a manufacturer who has certified its fitness for human use.
4.
All such use shall be under the direct supervision of the Chief, Nuclear Medicine Service.
G.
Non-Routine Diagnostic and' Therapeutic Human Use Anplications 1.
Physicians who wish to use radioactive materials in human subjects must meet the requiremnts described in the HRC Licensing Guide for Medical Programs (Appendix 1) before their application is approved. The R!aRORC also exercises jurisdiction over those radioactive materials which are not subject to NRC licensure.
2.
A protocol is submitted to each member of the RIARORC.
It must contain the following information:
A narrative description of the project, which shall include a.
the title of the project, a statement of the purpose and justification for the use of radioactive materials, the methods of administering doses, and the anticipated results.
b.
A reference to previous work published by the applicant or others concerning animal experimentation or human use.
If no prior refer-ence work is ava'lable and b& sic knowledge concerning the investigation is meager, pertinent animal studies by the investigator regarding the biologi-cal fate, excretion and toxicity data of the compound must be included.
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6-l The nuuIber, age, nature of disease process, and the methods of j
c.
selection of patients to be studied, together with similar data on any con-trol subjects.
l d.
A confimation that.an infomed consent will be obtained from patients who will participate in the study.
If the study plans provide for r
the use of radioactive material for normal human subjects, the minimum age of the subjects must be specified and the fact that they will be fully informed of possible radiation or other hazards of such studies must be included.
The chemical and physical characteristics of the radioisotope e.
(half-life, nature and energy of emission, mode of decay, etc.).
f.
The estimated dose range in m1111 curies of the radioisotope to be used and the rationale of using the estimated dose.
The estimated radiation dose delivered to the subjects, based g.
cn the expected half-life of the radioisotope in various tissues of the body.
(The RIARORC requires a clear, concise calculation of the anticipated l
whole body and critical organ exposure in rems and a statement of the period of such exposure and the potential radiation hazards, if any. The fomula used for such calculations should be clear, with all tems defined and the source and estimated reliability of the formula should be indicated.
)
Assumptions used for estimates should be stated.)
h.
The effects of complementary or supplementary drugs on radio-isotope distribution or excretion.
1.
The methods used to detemine the radioisotopic calibration.
l the methods of processing to insure chemical purity, sterility, and absence of pyrogenicity, etc., of the radioisotopic compound; if such a compound is not obtained as a precalibrated, refined, sterile and pyrogen-free radio-pharmaceutical.
- j. The safety precautions that will be initiated to protect the,
j patient, other patients in the vicinity, the patient care staff and adjunct personnel.
1 k.
A statement of the resources and facilities available to the l
investigator.
i 1.
The estimated time needed to complete the study.
3.
The investigator must immediately notify the Chairman of the 1
RIARORC if a patient exhibits any adverse reactions to the radiopharmaceuti-i cal administered. The investigator should describe the reaction and include an interpretation of its nature and cause. The Chaiman can then decide whether or not the project should be continued, modified, or teminated, pending review of the entire Committee.
t 4.
Research studies involving the use of radioactive drugs in human subjects are also regulated by the Food and Drug Administration, Department of Health, Education and Welfbre. The R!aRDRC is authorized to approve the j
use of radioactive drugs provided the conditions mentioned in Title 21 CFR, Part 370.100 are met.
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5.
Clinical trials intended to determine the safety and/or effective-ness of a radioactive drug are subject to the requirements of an investiga-tional new drug protocol as defined in 21 CFR, Part 312.1, in addition to approval by the RIARDRC.
6.
All such use shall be under the direct supervision of the Chief.
Nuclear Medicine Service.
H.
Criterra for Approval 1.
The policy of the NRC Subcommittee on human Applications is that radioactive substances should never be used in humans except when the inves-tigation or treatment justifies the risk involved.
It is the policy of this medical center to encourage the use of the most sensitive instrumentation and assay procedures available and to promote progressively better tech-niques, all aimed at reducing radiation doses. All research and diagnostic procedures should be designed with these policies in mind. The therapeutic uses of radiation in other than malignant diseases require sound justifica-tion.
2.
As a general guide for the maximun permissible dose, we are sub-ject to the NRC restrictions and regulations listed in Appendix 2.
As much as is practical in diagnostic and experimental procedures, the RIARORC con-siders that irradiation exposure of patients should be kept within the dose limitations specified. When it is anticipatad that the purposes of research or diagnosis make it necessary to exceed this dosage, the applicant will be required to provide complete justification.
The guideline for radiation expcsures to patients follow the a.
maximum permissible dose outlined for " Radiation Worker" in Appendix 2.
For all normal volunteer subjects, this radiation ilmit is redead by a factor of one-quarter.
b.
The use of larger doses may be censidered by the R!aRDRC in patients with limited life expectancy (two years or less).
The applicant must justify the procedure adequately and dem%1 strate the importance of a definite clinical or experimental contribution which is anticipated to be achieved by the use of such doses.
c.
The RIARORC considers carefully the following factors when evaluating the use of radioactive materials for research and diagnosis in humans:
(1) Whole-body retention of the radioactive materials.
(2) Accumulation in critical organ and tissues.
(3) Size of the critical organ.
(4)
Radiosensitivity of the tissue.
(5) Biological half-life.
(6) Effective half-life.
(7) Relative biological effectiveness of the emissions.
(8)
Energy of the radiation.
(9) Accumulation of potential effects from sequentially administered radioactive materials.
3.
Prior to their human administration, all isotopes are to be cali-brated and tested for radiochemical purity, sterility and pyrogenicity.
4.
The lot number, type and amount of any dose of a radioisotope adminstered to a patient shall be recorded.
5.
The radioactive contamination of room air and sewerage shall not exceed the 11mit' approved by the NRC as stated in Appendix 3.
s I.
Procurement of ha'dioisotopes 1.
The following procedures for the procurement of radiation sources are intended to insure compliance with the terms of the broad license issued by the NRC and the regulations imposed by this medical center.
2.
The Radiation Safety Office must approve, in advance, the procure-ment of all radioisotopes. Purchase orders for radioactive materials will be approved and packages of radioisotopes will be delivered only if the fol-lowing criteria are met:
a.
The department has an approved protocol for the isotope com-pound on file with the Radiation Safety Office.
b.
The millicurie units ordered will not exceed the department's limits or the medical center's license limits.
c.
The department's radioisotope inventory on file with the Radi-ation Safety Office is up-to-date.
3.
The radioisotope may be requisitioned in the usual manner by com-pleting VA Fom 07-2237. The purchase order is to be completed in all normal respects with the following exceptions:
a.
Purchase orders for radioactive materials shall not contain requests for non-radioactive materials or other laboratory supplies.
l b.
Purchase orders shall be clearly labeled with the words
" RADIO!SOTOPE. ORDER".
Delivery shall be specified to the Radiation Safety Office. -
c.
Room GD-206.
4.
After the purchase order is completed, it shall be routed through Radiation Safety for approval.
Once approved, Radiation Safety will forward it to the Supply Service, retaining one copy of the 2237 for its records.
5.
All purchase orders placed by outside agencies, hospitals, univer-sities, etc. for radioactive materials that are to be dolivered to this medical center must also he approved by Radiation Safety.
In place of a purchase order and prior to ordering, a memorandum must be sent to Radiation Safety indicating the radioisotope compound to be ordered, millicurie units of activity, shipping company, and estimated date of arrival. The purchase order shall specify delivery to Radiation Safety.
6.
All orders for radioisotopes that are not approved will be re-turned to the requesting department along with a memorandum stating reasons for disapproval.
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The Radiation Safety Office is the official receiving point for all radioactive materials delivered to the medical center. The investigator will be notified by telephone upon delivery of a radioisotope. The retained copy of the purchase request will serve as a reference for proper disposi-tion of the caterial.
8.
T))e investigator must notify the RSO instead of tha Shipping and Receiving Unit when radioactive material is to be shipped from the medical center. Such material will be packaged by the investigator under the super-vision of the RSO.
9.
The ordering investigator must first notify the Radiation Safety Office when cepty radioisotope containers are to be returned to the sup-plier. After they have been demonstrated to be free of contanination, the containers may be returned through normal channels.
- 10. The investigator is cautioned that the medical center license covers only those areas under VA Medical Center control.
J.
Procedures for Receiving and Monitoring Packages 1.
All shipments of radioactive materials received by the medical center shall be delivered immediately to Radiation Safety and/or locked in Room GD-210 for temporary storage.
2.
All radioactive shipments received are logged in upon their re-ceipt. The date of receipt, radioisotope, compound, mil 11 curie units of activity, manufacturer, and the ordering department are noted.
3.
Each package of radioactive material will be inspected upon re-ceipt. If the pacakge is exempt from a NRC required inspection, the follow-ing tests sho.ild be performed if time permits.
Visual inspection of the package for external damage.
a.
Inspection of the isotope container for leakage.
b.
Wipe test of the exterior of the shipping package,sr signiff-c.
cant removable contamination.
Meter survey of the container to insure adequate shielding.
d.
Results of these tests will be recorded in the radioisotope receipt 109 4.
If the package is not exempt from required inspection (see Appen-dix A), the tests specified at 10 CFR 20.205 must be perfnrrmd within three i
hours if received during.nnrmal working hours or within 1A hours if received l
after normal working hours. These tests are:
Measure and record the exposure rate at one meter from the l
a.
package surface.
If the reading is greater than 10 mR/hr, notify the car-l rier and the NRC Regional Office (10 CFR 20, Appendix 0).
b.
Measure and record the surface exposure rate.
If the reading is greater than 200 mR/hr, notify the carrier and the NRr..
Wipe a 100 cm2 area with a dry wipe.
If the assay indicates I
c.
greater than 0.01 microcurie *(22,000 DPM) of removable contamination, notify the carrier and the NRC.
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K.
Radioisotope Inventory i
1.
Under the provisions of the broad license issued to this medical center by the NRC, we are limited to certain millicurie amounts of radioac-tive materials that can be in our possession at any one time. The NRC also i
requires that detai, led reports be maintained of the receipt, transfer, and disposal of all radioisotopes in this medical center.
2.
Each department is limited as to the types of radioisotopes and to the millicurie units of activity that it may have in its possession at any one time. These limits are determined by the current radioisotope inventory and by the needs of each department as indicated by the radioisotope project protocols on file with the RSO. The limits will be set by the RI&RDRC and will be reviewed periodically. Temporary increases in the pemitted limits 4
may be obtained through the Radiation Safety Office provided that there.is adequate justification for the increase. All such requests will be reviewed at the next RISRDRC meeting.
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3.
A log of radioisotope use must be maintained by each department.
A sammary report of this log is to be sent to the Radiation Safety Office at the end of each month. The total millicurie amount of each radioisotope in j
the laboratory must be listed.
l 4.
It should be noted that many isotopes have a shnrt half-life. The inventory sheets should be adjusted accordingly to account for this.
4 t
l S.
All inventory lists and records shall be made available to the RSO i
upon request.
l L.
Interdepartmental Transfer of Radioactive Materials I
1.
No radioactive materials shall*be transferred between departments l
without prior approval of the Radiation Safety Office.
2.
All radioisotopes that are to be transferred must be taken to the Radiation Safety Office. At that time, each vial will be logged in and placed in Room GD-210 for storage until it is picked up by a representative of the receiving department.
M.
RadioactiveNastePackagingInstructions 1.
Do not package non-radioactive ' waste such as,left-over cold rea-gents, boxes, disposable test-tube racks. etc.
Obliterate all trefoils by removal or with a marking pen or china pencil.
2.
Dry waste has no visible liquid.
Examples are disposable gowns, gloves, counter-top paper, glassware, dry titer plates, etc. Do not include any vial, tube, reagent bottle, etc., which has any visible liquid.
Package the dry waste in small, clear plastic bags so that the total content of each bag can be inspected prior to disposal. While in use, the bag should be in a container with a tight fitting lid.
If several bags will be brought to the waste room at one time, put them in a cardboard box to avoid spillage in transit.
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3.
Liquid waste of neutral pH which presents no known environmental I
hazard (carcinogens, heavy metals, infectious agents, and flammables to present environmental hazards) and which is readily soluble in water may be discarded in a posted lab sink.
Do not discard more than 100uCi in one day.
Log the date, isotope, activity, and your initials.
4.
Liquid waste which cannot be discarded in a posted lab sink can be
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absorbed in half-galfon plastic containers available from the Radiation Safety Office. When not being filled, the container should be tightly capped. Do not put more than 500cc liquid in one container. There must be aboslutely no visible standing liquid when finished.
Label with date, iso-tope, estimated activity in mci or uC1, department, and your name.
5.
The medical center is recycling liquid scintillation vials.
It is the user's responsibility to empty and air dry vials and caps and then transport them to the Radiation Safety Office for storage.
(The fume hood in GD-213 may be used.)
The vials and caps will be washed and dried by Central Glassware Research personnel. They may be stored in GD-213 until needed. The bulk liquid scintillation cocktail will be picked up by the Radiation Safety Office for transfer to a disposal agent.
6.
The proper method for carcass disposal depends on the isotope, total activity administered, and biodistribution.
In general, carcasses with less than 0.05uCi or 3H or 14C per gram animal weight are turned over to the District of Columbia for incineration. Carcasses with other radio-isotopes or higher concentrations are gerarally either incinerated on campus or transferred to a disposal agent.
Consultation with the RSO prior to I
initiation of work is required.
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SECTION II RULES AND REGULATIONS A.
Individual Responsibilities. Each individual in the medical center who uses radioactive materials is responsible for:
1.
Keeping his/her exposure to radiation as low as reasonably achiev-able and specifically below the maximum permissible exposure (Appendix 2).
2.
Wearing the prescribed monitoring equipment such as film badges or pocket dosimeters in radiation areas (see Appendix 7).
3.
Surveying hands, shoes, and body for radioactivity and removing all loose contamination before leaving the laboratory to eat, smoke, etc.
4.
Utilizing all appropriate protective measures such as:
Wearing protective clothing whenever contamination is possible f
a.
and not wearing such clothing outside of the laboratory area. Disposable gloves should also be used in handling radioactive material and should be checked for contamination after use.
b.
Using protective barriers and other shields when possible.
Using mechanical devices such as remote pipettors, handling c.
equipment, etc., whenever their aid will assist in reducing exposure.
d.
Using pipette filling devices.
Never pipette any solution by mouth.
Performing radioactiv6 work within the confines of an approved e.
hood or glove box unless serious consideration has indicated that working in the open would be safe.
5.
Avoid smoking or eating in, radioisotope laboratories.
1 Congregating in areas designated as radiation areas is not 6.
allowed.
7.
Maintaining good personal hygiene:
Keep fingernails short and clean, a.
Do not woik with radioactive materials if there is a break in b.
the skin below the wrist that is not covered with a waterproof bandage or other suitable covering.
Wash hands and arms thoroughly before handling any object c.
which goes into the mouth, nose or eyes.
Checking for contamination in the inunediate areas in which radio-8.
Any contamination observed should be active materials are being used.
removed inanediately.
If such removal is not possible, the area should be clearly marked and the Radiation Safety Office notified.
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9.
Keeping the 1aboratory neat and clean:
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Work areas should be free from equipment and materials not a.
required for the procedure.
Keep or transport materials in such a manner as to prevent b.
spillage (double container) or to prevent breakage and to insure adequate shielding, Keep work surfaces covered with absorbent material, preferably in a plastic or stainless steel tray or pan to limit and collect spillage in c.
case of an accident.
Labeling and isolating radioactive waste and equipment, such as 10.
Once used for glassware, used 1. laboratories for radioactive materials.
1 radioactive substances, equipment should not be used for other work or sent Glassware from the area until demonstrated to be free of contamination.
decontamination is the responsibility of the user.
(Empty LSC vials are not considered contaminated.)
Reporting accidental inhalation, ingestion, or injury involving 11.
radioactive materials to the laboratory supervisor and the Radiation Safety The indi-Office and carrying out their recommended corrective measures.
vidual shall cooperate in any and all attempts to evaluate the exposure.
Carrying out decontamination procedures when necessary and taking I
12.
steps to prevent the spread of contamination to other areas.
Keeping accurate records of the receipt, transfer, and disposal of 13.
, radioisotopes.
B.
Investigator Responsibility:
Investigators who use radioisotopes are responsible for insuring that the individual responsibilities previously listed are discharged by those under their control. They are further re-sponsible for:
- 1. ' Planning adequately for the experiments. Before an experiment is performed, the supervisor should determine the types and amounts of radia-This will generally give a good tion or radioactive materials to be uc.ed.The procedure must be well outlined.
indication of the protection required.
In many cases before the procedure is actually performed with radioactive materials, it should be rehearsed so as t.o preclude any slip-ups or une pected circumstances.
hazard, the Radiation Safety Office should be consulted before proceeding.
Instructing subordinates in the use of safe techniques and in the 2.
application of approved radiation safety practices.
Furnishing the Radiation Safety Office with information concerning 3.
individuals and activities in their areas, particularly pertinent changes in their personnel rosters.
Contacting the Radiation Safety Office whenever major changes in 4.
operational procedures, alterations in physical plant, or new operations which might lead to personnel exposure are anticipated.
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5.
Complying with regulations governing the use of radioactive mater-ials as established by the NRC and the RISRDRC for:
Procuring radioactive materials by purchase or transfer by the a.
correct procedure.
b.
Posting. radiation areas.
Seeing that each sign carries the name of the person currently c.
responsible for the radiation area.
d.
Accounting for the amounts and disposition of radioactive' materials in the area.
Assuring that all radioactive waste materials are consigned to e.
the Radiation Safety Office for disposal.
f.
Preventing transfer of radioactive materials to unauthorized individuals.
C.
Regulations for the Use of Radioisotopes 1.
Do not smoke, eat or drink in radioisotope laboratories.
It is reconmiended that eating be done in the cafeteria or other designated areas.
Smoking or eating may be permitte'd in an office area of the laboratory that has been demonstrated to be free of contamination.
2.
Do not bring food or food containers into radioisotope labs.
Refrigerators having radioactive materials 3591 not be used for foods.
3.
Wash hands and arms thoroughly before handling any objects that contact the mouth, nose or eyes (e.g., food, cigarettes, cosmetics).
4.
Use pipette filling devices.
Never pipette solutions by mouth.
5.
Wear disposable gloves whenever possible.
6.
Label radioactive solutions and materials appropriately as radia-tion hazards. Keep or transport materials in such a manner as to prevent breakage or spillage.
7.
Do not perform radioactive work outside exhaust hoods or glove boxes until serious consideration has indicated that it would be radiologic-ally safe to do so.
8.
Keep the laboratory neat and clean. The work area should be free from equipment and materials not required for the immediate procedure.
9.
Immediately notify the supervisor and/or Radiation Safety Office in the event of any radiological emergency.
- 10. The individual responsible for radioisotopic contamination will be required to perform the major portion of any decontamination under the supervision of the RSO.
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- 11. Work in trays or on absorbent paper to prevent permanent contamin-ation of working surfaces.
- 12. Dispose of radioactive waste carefully and in conformance with these regulati'ons. Consistent with the safe fulfillment of your work, mini-mize the volume of waste generated.
- 13. Before alloiing any physician to treat you with radiation for a disease, be certain that he/she knows you are a radiation worker.
This does not apply to x-rays used for diagnostic purposes.
- 14. Pregnant women must exercise special precautions against exposure to radiation, since present knowledge of radiation effects on the unborn child is incomplete. The NRC has published a general guide on this subject (see Appendix 5).
I D.
Radioisotopes in Experimental Animals: The use of radioisotopes in experimental animals must be approved by the Chief of the Animal Research Facility, the RI&RDRC, Animal Studies Subcomittee, and the R&D Comittee.
1.
The investigator is responsible for the care of the animals for the duration of the experiment and for safe use of the radioisotopes in-volved. The RSO or his/her desigee is responsible for insuring that the use of radioisotopes complies with rules and regulations of the NRC and this medical center. The Animal Research Facility is responsible for insuring that animals are maintained according to the American Association for Lab-oratory Animal Care regulations.
)
l 2.
All experiments involving the use of radioisotopes should be per-formed in the Animal Radioisotope Room (GD-242). All animals will be main-l
.tained there for the duration of the experiment. The door is to be locked at all times.
Keys are possessed by Radioisotope Research and Animal Re-search Facility personnel. All cages containing radioactive animals must bear the radiation caution sign indicating the isotope, total activity used, and date of administration.
3.
Investigators using the animal radioisotope room shall imediately notify the Radiation Safety Office and Chief, Animal Research Facility, if contamination is suspected.
4.
Upon termination of the experiment, all animals are sacrificed.
The cppropriate packaging and disposition of carcasses is based on an esti-mate of the activity contained therein. Contact the RSO for instructions.
All cages, equipment used, and the room shall be considered as contaminated.
The investigator is responsible for requesting a radioisotope contamination survey. Radiation Safety personnel will monitor the area. The investigator is responsible for decontamination of the area and equipment.
5.
Each unit using the facility shall provide names and telephone numbers for notification if an emergency situation develops involving their animals during off-duty hours.
Physical emergencies in off-duty hours will be reported by the medical center police to the supervisor, Animal Research Facility, who will notify individuals involved.
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Policies and Procedures for Radioisotope Areas E.
t f
1.
All laboratory areas where radioactive materials are used or stored shall have " CAUTION RADI0 ACTIVE MATERIALS" conspicuously posted on the doors. The signs shall not be removed from any room except by Radiation Safety personnel folloging an inspection survey.
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2.
Containers in which materials are transported or stored shall bear a durable, clearly visible label bearing the radiation caution symbol. This label shall also state the quantities and kinds of radioisotopes in the cor.-
tainers and the date of measurement of the quantity.
(This does not apply to containers exempted at 10 CFR 20.203(f)(3).)
3.
All equipment contaminated with radioactive material shall be carked with signs, decals, or other conspicuous means.
l, 4.
Radioactive sources or stock solutions in the laboratory shall be appropriately shielde.d. Various shielding materials should be readily available.
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5.
Procedures involving aerosols, dusts or gaseous products, or pro-cedures which might produce airborne contamination shall be conducted in a I*
hood, dry box, or other suitable closed system. Radioactive gases shall be stored in gas tight containers and must be kept in areas having approved ventilation. Suitable air monitoring equipment shall be kept available.
6.
All work areas (bench tops, hoods, etc.) as well as storage areas and areas adjacent to permanent setups and sinks should be covered at all times with stainless steel or plastic trays, uncracked glass plates, or For some purposes absorbent p eer will be other impervious materials.
satisfactory.
However, if such paper is used, it should be discarded fre-quently to prevent radioactive materials from dusting off the surface.
Equipment once used for radioactive substances shall not be used 7.
for other work or sent from the laboratory to cleaning facilities, repair shops, sunlus, or returned to the source of supply, until demonstrated to-
~
be free free contamination.
Equipment to be repaired by shop and maintenance personnel or by 8.
commercial. service contractors shall be demonstrated to be free of contamin-ation prior to servicing.
If it becomes necessary to make emergency repairs on contaminated equipment, the work will be supervised by Radiation Safety It is the personnel who will assure that necessary safeguards are taken.
responsibility of the laboratory personnel to request this supervision from the Radiation Safety Office.
If Medical center vacuum lines are vulnerable to contamination.
9.
vacuum lines are to be used, precautions must be taken to ensure that the -
It is most advisable to use a withdrawn gas is free of radioactivity.
separate vacuum system whenever possible, or to use a vacuum pump exhausting into a hood.
No uncontrolled radioactive contamination can be tolerated. Cer-10.
tain hood trays, dry boxes, stainless steel trays, or other equipment which is used frequently for radioactive work may become temporarily contaminated.
All of these must be clearly marked with the standard radiation caution
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O signs or stickers. Any contamination that is not confined to protected sur-faces should be reported insnediately to the Radiation Safety Office, and decontamination procedures should be started. The area or equipment will be considered contaminated until proven otherwise by the RSO.
F.
Periodic Surveys of Radioisotope Laboratories t
1.
All laboratories where radioactive materials in millicurie amounts are used should be checked for contamination at least once daily.
Also I
these areas should be inspected every time there is reason to question the degree of contamination. When micorcurie amounts are used, only monthly surveys may be needed except when contamination is suspected.
2.
All laboratories using' radioisotopes shall perform monthly wipe tests. The RSO will mail wipe forms to users to be returned by the date indicated.
3.
The Radiation Safety Office will perform periodic wipe tests of the laboratories as a further check against contamination by radioactive materials.
4.
All laboratory areas shall be decontaminated when a wipe test
',reveals more than 2,200 DPM for each 100 square centimeters wiped. When a meter survey shows a reading of more than twice room background (with no radiation sources present), that area shall be considered contaminated. A wipe test must be taken to determine the extent of contamination.
G.
Radiological Health Emergencies l
As used here, the term " radiological health emergency" shall apply 1.
to any incident pursuant to the uncontrolled release of radioactive sub-stances which might irradiate or contaminate personnel or laboratory areas.
2.
The RSO shall be notified immediately of any radiological health Upon notification he/she will take appropriate remedial action.
emergency.
3.
The following steps should be taken:
If the contamination is airborn, hold breath or hold a wet a.
handkerchief over the. nose and mouth. Close all windows and doors, and leave the room as quickly as possible. Do not turn off the ventilating equipment. The air in the laboratories is vented directly to the roof of the medical center.
b.
If the contamination is in a solid or liquid form, all effort must be made to contain the spill.
l' (1) Permit no one to leave the area without clean footwear.
Exception must be made in case rapid departure is necessary in order to avoid overexposure to radiation.
(2) Do not allow any personnel to enter the contaminated area without proper protective clothing.
If it can be done safely, decontamination procedures should be c.
started.
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is-4.
Removal of radioactive contaminants falls into two general cate-gories: decontaminaton of " people" and decontamination of " things".
Every effort should be made to control and limit the spread of contamination.
5.
People are decontaminated for two reasons:
(a) to prevent possi-ble transfer to internal organs ~ by ingestion or through cuts and abrasions, and (b) to pre, vent' external exposure or possible radiation burns.
In both cases prompt removal of radioisotopes will reduce the potential hazard, but methods used to effect decontamination must not spread material that was in-l itially localized or assist the contaminant to enter the body (e.g., exces-sive scrubbing which abrades the skin).
a.
Notify the laboratory supervisor isenediately after a contamin-ating accident. The supervisor will contact the Radiation Safety Office.
b.
Wash the area thoroughly for two to three minutes repeatedly soaping and rinsing. Consideration should be given to the chemistry of the contaminant and an attempt made to find a suitable agent for removing it.
Any cleansing agent may be used but synthetic detergents are preferred to soaps. Avoid prolonged use of any one decontamination procedure.
Irrita-tion of the skin may impede the success of more suitable procedures. Avoid the use of organic solvents on the skin. These may make the skin more per-meable to contamination.
l c.
Flush well under running tap water any contaminated open cuts or wounds.
d.
Remove any contaminated clothing.
e.
Seek medical aid to induce vomiting if radioactive material has been ingested. Vomiting should be induced repeatedly, with ingestion of two to four glasses of lukewarm water between times.
f.
Notify the RSO and proceed at once to the Medical Officer in charge of the Employee Health Unit. Special decontaminating agents such as Versene, Radiacwash, etc., may be used under the direction of the Medical l
Officer.
~
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A report will be made to the Radiation Safety Office concern-ing the accident and recommendations for further work will be established.
6.
In case an area becomes contaminated, preparations for decontamin-ation should be started promptly.
a.
Prevent flow of liquid radioisotopes: apply absorbers, raise barriers (putty, etc).
b.
Remember that all run-off solutions, sops, rags and brushes used are potentially contaminated.
c.
Notify th RSO who will assist in determining the extent and hazard of contamination.
d.
Methods of decohtamination:
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(1) Solutions of detergents, EDTA, Radiacwash, etc., may be used to decontaminate many smooth, non-porous surfaces.
(2) Metals - oily surfaces may have to be removed first.
High normality acids, concentrated acids, or aqua regia may be used if needed and if the surfaces will withstand this treatment.
-(3) Coh~ crete or brick - solutions of HCL used with commercial scrubbers.
(4) Glassware - ordinary chromic acid cleaning solution, or discard.
(5) Linoleum - if well waxed before contamination, removal of wax with solvents or scouring power and steel wool with decontaminate.
It may be replaced.
(6) Wood - sand, plane, or discard.
(7)
Painted surfaces - paint removers.
f.
An area is considered free from radioactive contamination when a wipe test shows less than 2,200 DPM per 100 square centimeters.
H.
Personnel Monitoring 1.
Film badges will be issued by the RSO (see Appendix 7).
2.
Persons working with Hydrogen-3, Carbon-14, or Sulphur-35 in mil-licurie quantities as an unsealed source may be required to submit urine samples to the Radiation Safety Office.
The frequency of the bioassay will be determined by the RSO.
3.
Persons working with radioiodine in millicurie quantities shall h"o thyroid uptake studies performed on a quarterly basis.
All persons involved in todination procedures shall have thyroid uptake studies per-t formed 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the iodination.
4.
If there is a suspected accidental inhalation, ingestion, or skin puncture involving radioactive material, the RSO should be contacted imme-diately.
5.
The Radiation Safety Office maintains permanent records of all personnel exposures on appropriate forms.
Each individual's record is available for review at all times.
I.
Nuclear Powered Cardiac Pacemakers: Under a special license issued by the NRC, this medical center is authorized to implant pacemakers using l
Plutonium-238 as a sealed source. The Chief, Cardiology Section, will sub-mit semi-annual reports on the status of each patient who has received a l
nuclear pacemaker to the Radiation Safety Office. Any malfunction, adverse l
reaction, or patient related problem shall be reported immediately to the RSO who will determine if a report must be suomitted to the NRC.
I
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Radiation Therapy Cobalt-60 Unit Under a special license issued by the NRC, this medical center is 1.
authorized to treat patients using Cobalt-60 as a sealed source.
The Chief, Radiation Therapy Service, is responsible for the safe cperation of the teletherapy unit and is responsible for notifying the 2.
Radiation Safety Office in case of a radiological emergency.
The Radiation Safety Office is responsible for performing wipe 3.
tests, meter surveys and other surveys and tests as may be required to assure compliance with NRC regulations.
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SECTION III SPECIAL INSTRUCTIONS A.
General Instructions to Nurses for Sealed Source Radiation Therapy _
1.
The patient will be put in a private room and restricted to this room for the duration for the therapy.
7 2.
The Radiation Safety Office has indicated a " safe distance line" This line indicates those areas where the by a strip of tape on the floor. Generally, all personnel are to remain outside radiation is below 2 mR/hr.
this line as much as possible until the restrictions are lifted.
3.
The patient may or may not be allowed to have visitors. This will i
depend on the radiation levels in the room.
Visiting times will generally be limied to a few minutes.
4.
Building Management personnel should be in the room only long enough to perform their duties.
5.
The nursing staff should be alert to any sealed source which has moved from its origin 31 position.
If any implant source becomes separated from the patient, the physician in charge shall be notified finnediately.
A The source shall not be picked up with the hands, but by long forceps.
lead receptacle is available for temporary storage.
6.
All dressings, bedclothes, sanitary napkins, bedpans, etc., or any l
material removed from the vicinity of the treatment site shall be carefully monitored in order to assure that the source has not been removed or dis-t.urbed.
7.
Pregnant women are not permitted in the patient's room.
In situations requiring prolonged bedside caro, all ward staff 8.
engaged in handling the patient will be issued pocket dosimeters and read-ings will be monitored by a member of the Radiation Safety Office.
General Instructions to Nurses for Radioisotope Radiation Therapy _
B.
Above 30 mC1 It is the responsibility of any person invovled with radioisotope 1.
procedures to minimize his/her exposure to radiation as much as possible.
This may be accomplished by keeping as much distance and shielding between the radioactive patient and attendant personnel as possible and by spending the minimum time in the vicinity of the patient. Contamination with radio-active fluids should always be avoided by wearing rubber gloves and other suitable protective clothing when necessary.
With most 2.
Not all procedures involve the same radiation hazard.
diagnostic isotope procedures and with some isotopes like Phosphorus-32, the radiation hazard may be very small. With some other procedurcs, the hazard may be considerable.
- - - -. - - - +
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O O Amounts of radioactive materials that do not exceed certain " safe I
3.
1evels" are to be regarded as requiring no special precautions other than l
The " safe level" is the appitcatfor. of the general prinicples in (a) above.
I defined as that amount of isotope delivering 1.0 mR/hr or 40 mR/ week at a l
distance of one.neter from the patient.
The, Radiation Safety 0ffice has indicated a " safe distance line"
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4.
This line indicates those areas where the by a strip of tape on the floor. Generally, all personnel are to remain outside radiation is below 2 mR/hr.
this line until the restrictions are lifted.
5.. The patient will be in a private room with toilet facilities.
6.
Ambulatory and self-care patients will take care of their own wants, collect their own specimens, etc., when possible.
I This will
- i. The patient may or may not be allowed to have visitors.
Visiting times will generally depend on the radiation levels in the room.
l be limited to a few minutes.
8.
Building Management personnel shall not be in the room.
Urine from the patient will be disposed of via the patient's toi-9.The toilet will be flushed three times per disposal. Special care in let.
the collection and handling of urine should be noted in order to avoid con-tamination. The nursing staff should wear gowns and rubber gloves when handling radioactive fluids.
Incontinence or spillage of urine should be prevented by suitable means.
- 10. Feces should be passed in the toilet when feasible.
If a bedpan must be used, it must be handled with rubber gloves. The same bedpan will
~
be used by the patient during the treatment period.
If an emesis occurs within the first few hours after the patient 11.
received the therapeutic dose, or if there is spillage of or contamination by urine within the room within-the first few days, the area of contamina-tion shall be restricted and the Radiation Safety Office notified for moni-
~
toring and decontamination procedures.
When possible, linens, pillow coverings, etc., will be disposable.
12.
Mattresses should be covered with a protective rubber or plastic sheet.
Dressers, chairs, etc., should be covered by absorbent paper to be l
13.
discarded as necessary.
All objects and materials coming in contact with the patient in 14.
the first few days shall remain in the room and placed in marked plastic bags to be monitored and handled by the Radiation Safety Office for dispo-sal. Dinnemare and silvemare are included.
During the first few days, meals will be served on disposable 15.
plates.
In situations requiring prolonged bedside care, all ward staff en-16.
gaged in handling the patient will receive pocket dosimeters and daily read-ings will be recorded by the Radiation Safety Office.
-.. -..- -.--.-._.. - - ---. - ------- _._ _.... - - - -, - - - - - - - A ~?
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- 17. After the patient has been discharged, the room will be monitored l
by the Radiation Safety Office prior to reuse.
C.
1.aboratory. Specimens Following Therapeutic Doses of Radioisotopes: All specimens from patients under radioisotope therapy instructions which are to Preferably, the be sent to a laboratory shall be labeled "RADI0 ACTIVE".
laboratory should be called in advance to provide additional information such as the amount of activity and special handling techniques required, if This includes tissue specimens, ascitic fluids, blood, urine, feces, any.
emesis, etc. EXCEPTIONS: When the time between administering the isotope j
and the time of obtaining the specimen is long enough, the amount of radio-activity in the specimen may no longer be a hazard from either a health or a l
contamination standpoint. This will require an opinion from the physician in charge or the RSO. When the' radioisotope is administered in such a way that it remains localized and does not enter significantly into the general circulation (for example, colloidal gold injected into prostate), it may be unlikely that the specimen contains a significant amount of the radioisotope l
used.
D.
Safe Handling of Bodies Containing Radioactive Materials 1.
If a patient who has received a therapeutic dose of any radioiso-l tope dies in the medical center while still under therapy precautions, the l
physician in charge shall follow the procedures listed below:
Cover the top sheet of the patient's chart with a new sheet a.
i j
with the words " RADIOACTIVE BODY" written on it.
b.
Notify the Radiation Safety Office. During off duty hours, the guard office should be requested to notify one of the persons on the l
call list maintained for such emergencies.
2.
Embalming Procedures No special procedures are required with bodies containing less a.
than 30 mil 11 curies of any radioisotope provided that the embalming is done with the standard aspiration and injection methods and that the body is not opened.
All persons coming in contact with the body should wear rubber b.
gloves and protective clothing to prevent contamination.
The Radiation Safety Office must be contacted if the body con-c.
tains more than 30 mil 11 curies of any radioisotope, as special precautions A detailed listing of procedures is in the NBS Handbook 65, l
must be taken.
" Safe Handling of Bodies Containing Radioactive Isotopes (A Guide for Sur-This handbook j
geons, Pathologists and Funeral Directors)," dated May 1965.
4 is available in the Radiation Safety Office.
3.
Autopsy Procedures Procedures for autopsy will depend on the amount of radioac-a.
The chart accom-i tive material present in the body at the time of autopsy.
panying the body will include data such as the radioisotope, amount adminis-I' From this information, the amount of radio-tered, and date administered.
l isotope remaining in the bo'dy may be determined from Table 1 of the hand-i book. The RSO will assist in needed calculations.
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b.
If there is less than 5 milliciries of any isotope in the body at the time of autopsy, no special precautions are required other than wear-ing rubber gloves and protective clothing.
If'there is more than 5 mil 11 curies of any radioisotope in the c.
body, the following, procedures must be followed:
(1) The RSO, or his/her designee, will be present during the autopsy to assure that all aspects of radiation safety are observed.
(2) The physician doing the autopsy must:
(a) Wear goggles or eye glasses.
l (b) Wear double thick autopsy gloves unless the delicacy of the procedure prohibits this; then two pair of surgical gloves must be worn.~
(c) Work with long handled instruments to keep the hands l
l as far as possible from the radioactive areas.
(3) Additional special procedures will be instituted on a case-by-case basis. NBS Handbook 65 will be the reference guide for these i
procedures.
4 I
E.
Instructions for Supply Personnel 1.
The Radiation Safety Office is the official receiving point for radioactive materials packages.
The packing slip must remain with the package as it is needed a.
for Radiation Safety Office records.
b.
The receiving report is signed by the RSO upon receipt of the package and the paperwork is sent on to the appropriate office.
2.
It is important that all shipments of radioisotopes received be delivered to the Radition Safety Office promptly where they can be monitored for degree of activity and opened and inspected for leaks, damage, etc., so that proper action can be taken to avoid contamination.
Shipments of radioisotopes are shielded in accordance with Depart-3.
The necessary ment of Transportation regulations an dpose a minimal hazard.
handling instructions are usually listed on the package.
Radioisotope shipments are sent back to the supplier on occasion.
These are monitored for safety by the Radiation Safety Office prior to shipping to ensure safe handling.
F.
Instructions for Building Management Personnel 1.
Radiation precautions signs apply to all prsonnel. However, this does not mean that Building Management personnel cannot enter laboratories for ordinary clearing duties.' The sign indicates that shielded radioactive materials are present and that all personnel should be aware of this fact.
It further indicates that radioactive labeled bottles, reagents, etc.,
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-2s-Levels of radiation are frequently checked should not be touched or moved.
in working areas of the laboratories to be sure they are safe areas in which to clean.
Building Management personnel shall not enter rooms occupied by 2.
patients undergoing radioisotope therapy unless authorized to do so by the nurse in charge, who will in turn be guided by the precautions listed in the patient's chart.
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SECTION IV APPENDICES Appendix 1 Acceptable"Tra ning and Experience for Medical Uses of Byproduct Material I.
General Training To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups I, II and/or III, Section 35.100 of 10 CFR Part 35, a physician should have:
A.
Training in basic radioisotope handling techniques consisting of lecture, laboratory sessions, discussion groups or supervised experience in nuclear medicine laboratory in the following areas:
1.
Radiation physics and instrumentation (100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />) 2.
Radiation protection (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />) 3.
Mathematics pertaining to the use and measurement of radioacti-v.1ty (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) 4.
Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />) 5.
Radiopharmaceutical chemistry (30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />)
(The listed hours next to each of the five subjects above are suggested values and should not be interpreted as specific requirements.)
8.
Experience with the types and quantities of byproduct material for which the application is being made, or equivalent experience (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />).
C.
Supervised clinical training in an institutional nuclear medicine program (500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br />). The clinical training should cover,all appropriate types of diagnostic procedures and include:
1.
Supervised examination of patients to determine the suitability for radioisotope diagnosis and recommendation on dosage to be prescribed.
2.
Collaboration in calibration of the dose and the actual admin-1stration of the dose to the patient, including calculation of the radiation l
dose, related measurements and plotting data.
I 3.
Follow-up of patients when required.
l 4.
Study and discussion with preceptor of case histories to esta-blish most appropriate diagnostic procedures, limitation, contraindication ~,
etc.
NOTE: The requirements specified in Sections A, B and C may be ' satisfied concurrently in a three month training program if all three areas are inte-grated into the program.
9
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r 1-2 Alternative: Certification by the American Board of Nuclear Medicine will be accepted as evidence that a physician has had adequate training.nd exper-ience to use Groups I, II and III.
II. Training Requirements for Therapy Procedures Involving Radio-Pharmaceutica's To qualify as adequately trained to use or directly supervise the use of byproduct material listed in Groups IV and/or V, Section 35.100 of 10 CFR Part 35, a physician should have:
A.
Training in basic radioisotope handling techniques including:
1.
Radiation physics and instrumentation (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) 2.
Radiation protection (25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) 3.
Mathematics pertaining to the use and measurement of radioacti-vity (10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />) 4.
Radiation biology (20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />)
(These requirements are in lieu of, not in addition to, those specified in Section IA above).
B.
Clinical training in specific therapy procedures:
1.
Group IV a.
Iodine-131 for treatment of hyperthyroidism and/or cardiac conditions: Clinical experience in teh diagnosis of thyroid function and active participation in the treatment of ten patients.
b.
Phosphorus-32 for treatment of polcythemia vera, leukemia and/or bone metastases: Treatment of three patients with any combination of these three conditions.
c.
Colloidal phosphorus-32 for intracavitary treatment:
Active partiicpation in the treatment of three patients.
2.
Group V a.
Iodine-131 for treatment of thyroid carcinoma: Clinical experience in diagnosis of thyroid function and treatment of hyperthyroidism and/or cardiac dysfunction, and active participation in the treatment of three patients with thyroid carcinoma.
b.
Colloidal gold-198 for intracavitary treatment: Active participation in the treatment of three patients.
I III. Training Requirements for Therapy Procedures Involving Sealed Sources To qualify as adequately trained to use or directly supervise the use of byproduct material listed i.n Group VI, Section 35.100 of CFR Part 35, a physician should have:
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13 A.
Training in 'hasic radioisotope handling techniques (200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) as described in Section IA of this appendix.
B.
Clinic.al training in specific therapy procedures:
1.
Radiation sources for interstitial, intracavitary, or surface treatment of cancer.:
Active practice in therapeutic radiology with a mini-l num of three years experience.
2.
Beta ray applicators for the treatment of superficial eye dis-ease: Active practice in thrapeutic radiology or ophthalmology and experi-ence in the therapeutic use of beta rays or soft x-rays.
(Evidence of certification by the American Board of Radiology in Radiology or Therapeutic Redfology may be submitted in lieu of the information requested in subsec-tions A & B above.)
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Appendig Radiation Exposur,e_, Limits, Exposure of individuals to radiation:
No person shill possess, use, receive or transfer sources of radioactive materials in such a manner as to cause any individual to receive a dose in excess of the following:
Re9s per Rens per Calender Quarter Year Type of Exposure Avg Mi r. '
Whole body, head and trunk, active blood 1 1/4 3
5 forming organs, gonads, lens of eye Skin of whole body, thyroid 7 1/2 10 30 Hands and forearms, feet and ankles 18 3/4 25 75 5
15 i
Other organs The~ total accumulated whole body dose shall not exceed S(N 1 A) Rems, where N = th eindividual's age in years at his/her last birthday.
1 4
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1 O
O Appendix 3 Maximum Concentrations of Radioactive Materials That Can Be Released in Air and Water The following list gives the maximum concentrations'of radioactive materials i
that can be released to the air and water as specified in 10 CFR Part 20.106 and Part 20.303. Table II is to be used in calculating maximum releases to the environment.
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APPENDIX 5 l
POSSIBLE HEALTH RISKS TO CHILDREN OF WOMEN WHO ARE EXPOSED TO RADI ATION DURING PREGNANCY Some recent studies have shown that the risk of All Nuclear Regulatory Commission licensees are leuksmia and other cancers in chBdun increases if the now required
- to inform aR individuals who work in a mother.js exposed to a significant amount of radiation restricted area of the health protection problems asso-during pregnancy. According to a report by the National cisted with radiation exposure.This instmetion would in Academy of Sciences, the incidence of leukemia among many cases include information on the possible risks to childt:n from birth to 10 years of ap in the United unborn babies.' The segulations also state ** that States could rise from 3.7 cases in 10,000 chudren to 5.6 licensees should keep radiation exposures as low as is caps in 10,000 chadren if the chDden were exposed to seasonably achievable. According to the National I re n of radiation before birth (a"sm"is a measure of Council on Radiation Protection and Measurements, radiation). 'the Academy has also estimated that an vigorous efforts should be made to keep the radiation equal number of other types of cancers could result exposure of an embryo or fetus at the very lowest from this level of radiation; Although other scientific '
practicable level during the entire period of pregnang.
studies have shown a much smaDer effect from radiation, Thus it is the esponsibuity of your employer to the Nuclear Regulatory Commission wants women em-playees of its licensees to be aware of any possible risk take au practicable steps to reduce your radiation i
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,so that the women can take steps they think appropriate exposure. Then it is your responsibility to decide whether the exposure you are receiving is sufficiently
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to protect their offspring.
low to protect your unbom child. The advice of your As an employee of a Nuclear Regulatory Commis.
employer's health physicist or radiation protection alon licensee, you may be, exposed to more radiation officer should be obtained to determine whether radia-than the general public. However, the Nuclear Regula-tion levels in your working areas are high enough that a tory Commission has established a basic exposure limit baby could receive 0.5 rem or more before birth. If so, the alternatives that you might want to consider are:
for all occupationally exposed edqtts of 1.25 rems per calendar quarter, or 5 rems per year.No clinical evidence (a) If you are now pregnant or expect,to be soon, of harm would be expected in an adult working within you could decide not to accept or continue assignments these levels for a lifetime. Because the risks of undesir-able efrects may be greater for yoimg people, individuals in these areas, under 18 years of age are permitte<f to be exposed to (b) You could reduce your exposure, where possi-only 10 percent of the adult occupationallimits.(This ble,by decreating the amount of time you spend in the lower limit is also apphed to members of the general radiation area, increasing your distance from the radia.
public.)
tion source, and using shield;ng.
The selentific organization called the National (c) If you do become pregnant,you cnuld ask your Council on Radiation Protection and Measurements hasemployer to reassign you to areas involving less exposure secommended that because unborr babies may be more sensitive to radiation than adults, their radiation door as to radiation. If this is not possible, you might consider a result of occupational exposure of the mother should not exceed 0.5 rem. Other scientific youps, including the Intemation al Commission on Radiation Protection.
- by Title 10 Part 19 of the O'de of I'ederal R.plas,om have also strested the need to keep radiation doses to.
"In Title 10, Pet 20.
l unborn children as low as is reasonably achievable.
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E* N" luving your job. If you decide to take such steps, do so without delay. The unborn child is most sensitive t The amount of radiation an individual receives is radiation during the first three months of your preg.
called the " dose" and is measured in " rems." The
- "'Y-average individual in the United States accumulates a e d one tem fmm natwal s urces nny 12 yean.
(d) You could delay having children until you are dose fwm natwal ra&auon is Nghu in ame stateg.
no longer working in an area where the radiation dose to mch as Colorado, Wyoming, and South Dakota, pn.
your unborn baby could eitceed 0.5 rem.
marily because of cosmic radiation. There the average
- I * "*'""""Y8 I"
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You may also, of course, choose to:
Natural background radiation levels are also much (e) Continue working in the highe.. diation aren, higher in certain local areas. A dose of one tem may be r ra but with full awareness that you are doing so at sonw receised in some areas on the beach at Guarapari, Br44d, smallincreased risk for your unbom child in only about 9 days, and some people in Kerala,Indu, e
get a dose of one rem every 5 months.
The following facts should be.noted to help you make s blany people receive additional radiation for nwdi.
decision:
cal reasons. In 1970, an estimated 212 milhon X ray examinations were performed in the United States. The udmated average surface skin dose from one radio-l.' The first three months of pregnancy are the graphic chest X. ray is 0.027 rem. The estimated average most important, so you should make your decision surface skin dose per abdominal X. ray is 0.62 rem.
Radiation can also be received from natural sources 2.
In most cases of occupa'tlonal exposure, the mch as rock or brick structures, from consumer prod-actual dose received by the~ unborn baby isless than the ucts such as television and glow in the. dark watches, dose received by the mother because sonw of the dose is and from air travel. The possible annual dose fmm absorbed by the mother's body, working 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> a day near a granite wall at the Redcap Stand in Grand Central Station,New York City,is 0.2 3.
At the present occupational exposure limit, the rem, and the average annual dose in the United States,
actual risk to the unborn baby is small, but experis from TV, consumer products, and air travel is 0.0026 disagree on the exact amount of risk.
rem.
- 4. There is no need to be concemed about sterility Radiation,like many things, can be harmful. A large or loss of your ability'to bear children. The radiation dose to the whole body (such as 600 rems in one day) dose required to produce such effects is more than 100 would probably cause death in about 30 days, but such times larger than the Nuclear Regulatory Commission's large doses result only from rare accidents. Control of doselimits for adults.
exposure to radiation is based on the assumption that any exposure, no matter how small, involves some risk.
5.
Even if you work in an area wh'ere you receive The occupational exposure limits are set so low, how-only 0.5 rem per three month period, in nine months ever, that medical evidence gathered over the past 50 you could receive 1.5 reres, and the unbom baby could years indicates no clinically observable injuries to inds.
receive more than 0.5 rem, the full term !!mit sugeested viduals due to radiation exposures when the estabbshed
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by the NCRP.Therefere.if you decide to r: strict your radiation limits are net exceeded.This was true even foi unborn baby's exposure as recommended by the NCRP, exposures received under the early occupational ed be aware that the 0.5 rem limit to the unborn baby Posure limits, which were many times higher than the applies to the full nine month pregnancy.
present limits. Thus the nsk to individuals at the occupational exposure levels is considered to be very tw.Hweer,it is impossible to say that the risk is zero.
The remainder of this docume'nt contains a brief To decrease the risk still further. licensees are expected explanation of radiatio.n and its effects on humans. As t keep actual exposures as far below the limits as la you will see, some radiation is present everywhere and
** "'DI
D''DI'-
Y the levels of radiation most employees of Nuclear Regulatory Commission licensecs receive are not much larger than these natural levels. Because the radiation
- " Pre Release Report: X Ray hposure Study (AFS) Reused levels in the facility where you will be working are btimates of 1994 and 1970 Geneticauy Sirmtscent Dx.,
required by law to be kept quite low, there is not Iwruary 4,1973, U.S. Department of Ilealth. Educatmn.
considered to be a significant health risk to individual and welfare PuNic Health Service. Fedesal Doug Admirustra tion.INieau of Radiutogical Health-adult employees.
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The current exposure limits for people working with
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summary sadiation have been developed and carefully wviewed by
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nationally and internationaDy := cognized groups of Occupational exposures to radiation are being kept scientists. It must be'amembered, however, that shese low However, qualified scientists have acon mended limits an for adults.Special consideration is appropriate that the radiation dose to an embryo or fetus as a mult when the individual being exposed.it, or may be, an of occupational exposure of the expectant mother expectant mother, because th's exposure of an unborn should not exceed 0.5 rem because of possible increased chDd may also beinvolved.
risk of childhood leulemia and cancer. Sir.cc this 0 5 rem is lower than the dose generany permitted to adult workers, women may wa.nt to take special actions to Frenatalleradiation avoid receiving higher exposures, just as thcy might stop The prediction that an unborn eTilfd would be more smoking during pregnancy or might climb stairs more cmfully to reduce possible risks to their unborn sensitive to radiation than an adult is supported by
- children, observations for relatively large doses. Large doses delivered before birth alter both physical development and behavior in experimentaBy exposed animals. A Bibbeysphy report of the National Academy of Sciences states that short term doses in the range of 10 to 20 soms cause
- 1. Donald G. PizzareHo and Richard L. Witcofski, subtle changes in the nerve cells of unbom and infant Basic Radiertion Siciogy, Philadelphia: Lea and rats. The report also. states, however,~that no radiation Febizer.1967.
t Induced changes in development have been demon.
strated to result in experimental animals from doses up 2.
National Academy of Sciences -National Research to about 1. rem per day extended over alerge part of the Coancil, De Effects on Populations ofExposure to period before birth.
Low Levels of Ionizing Rafistion, Washington, The National Academy of Sciences also noted that
~D.C., Nowmber 1972.
doses of 25 to 50 rems to a pregnant hurcan may cause
- 3. National Council on Radiation Protection and Mca-i growth disturbances in her offspring. Such doses sub.
surements, basic Radiation Morection CYiteria, stantially exceed, of course, the maximum permissible NRCP Report No. 39, Washington, D.C., Januasy occupationalexposure limits.
15,1971.
Concern about prenatal exposure (i.e., exposure of a 4.
United Nations, Ionizing Radierions Levels and child while in its mother's uterus) at the permissible Effects, 2 vol., Reports of the United Nations occupational levels is primarily based on the possibility Scientific Committee on the Effects of Atomic that cancer (especially leukemia) may develop during the Radiation, Report No. A/8725, United Nations, first 10 years of the child's life. Several studies have been New York,1972.
performed to evaluate this risk. One study involved the followup of 77,000 children exposed io radiation before
- 5. U.S. Atomic Energy Commission, Division ofTech-I birth (because of diagnostic abdominal X. rays mtde for nical Information, Understanding the Atom Series-l medical purpores during their mother's pregancy).
Another study involved the followup of 20,000 such Atoms, Nature and Man l
children. In addition, 1292 children who received prenatal exposure during the bombing of Hiroshima and De Genetic Effms ofRadiation Nagasaki were studied. Althoue.h contradictory results have been obtr.Ined, most nf the evidence suggests a ne NaturalRadiation Environment relationship between prenatal exposure and an increased I
elsk oichildhood cancer.
YourBodyandRadiation O
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Appendix 4 Quantities of Radioactive Materials. Exempt from Required Monitoring Wipe Test Required Meter Survey if Over Required if Over Isotope (in Mil 11 curies)
(in Curies)
Calcium-45 1
20 Carbon-14 10 Cesium-137 1
3 l
Chromium-51 100 20 Cobalt-57 1
20 Hydrogen-3 10 Iodine-125 10 3
Iodine-131 100 3
I Iron-59 1
20 Molybdenum-00 20,000 20 Phosphorus-32 100 20 Selenium-75 1
20 Sulfur-35 10 Zinc-65 1
20 If the wipe test reveals more than 0.01 microcurie of removable contamina-tion, or if the meter ;urvey is greater than 10 mR/hr at one meter or or 200 mR/hr at the package sur. face, the public carrier and the NRC must be notified.
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