ML20137E797

Requests Addl Info Re 850618 & 0703 Applications for Amend to License 49-00988-04,including Safe Handling Procedures, Nursing Instructions & Source Accountability Sys for Group VI Matl

ML20137E797
Person / Time
Issue date:	07/18/1985
From:	Adam W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Schwartz J GOOD SAMARITAN MEDICAL CENTER, MILWAUKEE, WI
Shared Package
ML20137E745	List: ML20137E797
References
79286, NUDOCS 8511270311
Download: ML20137E797 (5)

Text

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• UNITED STATES

-  ;/I#Mcg*% NUCLEAR REGULATORY COMMisslON

{ ' ,% f1EGION til 5 799 Roost VELT ROAD

'f S' g cLEN ELLYM, ILLINOl$ 60137

% .s..+ ,e JUL1 8 1985 Good Samaritan Medical Center Lutheran Campus ATTN: Mr. John Schwartz President 2000 W. Kilburn Avenue Milwaukee, WI 53233 License No. 49-00988-04 Gentlemen:

We have reviewed your letters dated June 18, 1985 and July 3, 1985 requesting an amendment to your nuclear medicine license and find that we will need additional information as follows:

1. With the addition of Dr. Richards to your license it would be possible for us to remove the "for storage only" restriction for Group VI material from your license. However, the letters and application currently referenced in your license contain no safe handling procedures, nursing instructions or source accountability system for Group VI licensed material. If it is your intent to be authorized for all of the material listed in 10 CFR Part 35, Schedule 35.100 (f) (enclosed), you will need to submit this information in accordance with Appendix L of Regulatory Guide 10.8 (enclosed). If, on the other hand, it is your intent to use only your strontium-90 eye applicator, you need only submit the information requested in Items 3, 4 and 6 of the enclosed strontium-90 opthalmic applicator guide.

2. With regard to the addition of Drs. Veluvolu and Whalen we note that they z had personal participation in 15,000 and 10,000 generator elutions, respectively (ref. Supplement B, Form 313M) as well as an equal number of kit preparations. Please note that Appendix A, Section 2.b. of Regulatory Guide 10.8 request evidence of personal participation in a minimum of five procedures to elute Tc-99m and preparation of radiopharmaceuticals from Group III reagent kits. The numbers you have provided are in excessive for the time frames involved. (They imply that each physician eluted a generator approximately 100 times per week.) Please review these entries with the physicians involved and revise them accordingly.

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-00988-04

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, . C We will continue our review of your application upon receipt of this information.

.;. Please reply in duplicate, within 30 days, and refer to Control fiumber 79286.

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- Sincerely, c

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William J. Adam, P?u.9.

Materials Licensing Section

Enclosures:

1. 16 CFR Part 35 i

, 2. Regulatory Guide 10.8

3. Information to be Submitted for Strontium-90 Opthalmic Applicator d

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• OCT 2 2 193; e

Rules for Safely Handling a Strontium-90 Eye Applicator

• 1. ~ Wear your personnel dosimeter (s) whenever you handle the strontium-93 eye applicator. Finger ring-type dosimeters should be worn with the detector on the palm side of the hand. .

2. Remove the Sr-90 eye applicator from its secured storage location ju t before use. Do not leave it out any longer than necessary.

3. Af ter removing the Sr-90 eye applicator from its secured storage location, ,

a. Do not touch the treatment end of the applicator with your hands or othen portion of your body.

b. Always hold the applicator by its handle.

c. Except during patient treatment, do not point the treatment end cf the applicator toward another person, especially toward the eyes.

4. If the applicator is to be sterilized, place on a flat surface, use a cotton swab, sponge or gauze dampened with a sterlizing agent, then wipe the treatment end of the applicator across the swab, sponge or gauze. Do not sterilize by holding the swab or gauze in your hand.

5. During treatment, hold the patient's eye lids oper, with tape or other '

device, not with your fingers. ,

6. Immediately after treatment and/or resterilization, return the Sr-90 eye applicator to its storage. container and to its secured location ( e.g.,

locked cabinet).

7. Do not remove any metal or plastic inserts from the canufacturer-supplied storage container. These items are' generally a part of the container's

, shielding. Removal of these items can lead to excessive and unnecessary radiation exposures.

• It is strongly recommended that TLD-ring or film type badges be worn

. when handling a Sr-90 eye applicator.

. ENCLOSURE 2 1

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• APPENDIX L RADIATION SAFETY PROCEDURES FOR  !

THERAPEUTIC USE OF SEALED SOURCES *

1. All patients treated with brachytherapy sources will be be contacted to answer any questions about the placed m a private room Ihat has a toilet. care of these patientsin regard to radiation safety precau tions. j

2. The patient's room will be groperly posted or attended in i accordance with 0 { 20.203 or 20.204 of 10 CFR Part 20. b. Nurses should spend only the minimum time necessary near a patient for routine nursing care

3. Surveys of the patient's room and surroundmg areas Obtain and wear a film or TLD badge or a pocket will be conducted as soon as practicable after sources chamber as instructed by the Radiation Safety are implanted. Exposure rate measurements will be Officer.

taken at 3 feet (or I m) from the patient with sources implanted, at the patient's bedside, at 3 feet (or 1 m) c. When a nurse is assigned to a therapy patient, a from the bed, and at the entrance to the room. The film or TLD badge should be obtained irnmedi-Radiation Safety Officer or his designee will then deter- ately from the Radiation Safety Officer or his mine how long a person may remain at these positions designee. The badge shall be worn only by the and will post these times and the exposure rate at 3 feet nurse to whom it is issued and shall not be ex-for I m) from the patient on the patient's chart. changed among nurses.

4. Immediately after sources are implanted, the form d. Pregnant nurses should not be assigned to the

" Nursing Instructions for Patients Treated with Brachy- personal care of these patients.

therapy Sources ** will be completed and attached to the patient's chart, c. Never touch needles, capsules, or contamers hold-ing brachytherapy sources. If a source becomes

5. Radiation levels in unrestricted areas will be maintained dislodged, use long forceps and put it in the less than the limits specified in paragraphs 20.105(bXI) corner of the room or in the shielded container and (b)(2) of 10 CFR Part 20. provided; contact Radiation Therapy, the Radia-tion Safety Officer, or the Nuclear Medicine

j. 6. Nurses caring for brach> therapy patients will be assigned Department at once.

fdm or TLD badges. TLD finger badges will also be l\

auigned to nurses who must provide extended personal f. Bed hath given by the nurse should be omitted care to the patient. Pocket dosimeters may be assigned while the sources are in place.

in. addition to a film or TLD badge

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g. Perine'ai care is not given during gynecologic 7 At the conclusion of treatment, a survey will be per- treatment, the perineal pad may be changed when formed in accordance with paragraph 35.14(b)(5 Xvii) necessary unless orders to the contrary have been of 10 CFR Part 35 to ensure that all sources other than written.

permanent implants have been removed from the patient and that no sources remaia in the patier.t's room or in h. Surgical dressings and bandages used to cover the any ottier area occupied by the patient At the same area of needle insertion may be changed only by time all radiation signs will be removed and all film the attending physician or radiologist and MAY and TLD badges assigned to nurses will be collected. If NOT BE DISCARDED untildirected by the radi-the patient is to be discharged, the final survey will ologist. Dressings should be kept in a basin until also include a notation on the patient's chart that the checked by the Radiation Safety Officer or his activity remaining in the patient meets conditions for designee.

release from the hospital.

Special orders will be v ritten for oral hygiene for

8. Int'. ructions to Nurses patients with oral implants.

a. Special restrictions may be noted on the precau- i. No special precautions are needed for sputum, tion sheet on the patient's chart. Nurses shoul.1 urine, vomitus, stools, dishes, instruments, or read these instructions before administering to utensils unless specifically ordered, but these the patient. The Radiation Safety Officer should items should be saved for a check with a radia- i Be sure to submit complete responses to items 204 through 20f an tion survey meter to ensure that no sources have I addihop fo rererencing procedures in Appendia L. been inadvertenti displaced into them. )

10.8-47

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j. All bed linens must be checked with n radiation o. I mergency Procedures l survey meter before being removed f rom the patient's room to ensure that no dislodged sources (I) Il an implanted source becomes loose or are inadvertently removed. separated frorn the patient, or (2) If the patient dies, or

k. These patients must stay in bed unless orders to l the contrary are written. In any event. patients (3) If the patient requires emergency surgery, wdl remain in their assigned rooms during the immediately call treatment period.

Telephone No. (days)

1. Visitors will be limited to those 18 years of age or (nights) over unless other instructions are noted on the precaution sheet on the patient's chart. s

p. At the conclusion of treatment,callthe Radiation

m. Visitors should sit at least 3 feet (or I m) from Safety Officer to(l) survey the patient and roont the patient and should remain nolonger than the (2) count the radiation sources to be sure that all time specified on the form posted on the patient's temporary implants have been remnved prior to door and on his chart. discharging the patient, and O) record a summary of the final survey results on the patient's chart.

n. No nurse, visitor, or attendant who is pregnant if any permanent implants are to remain in the should bepermittedin the room of a patientwhile patient, the Radiation Safety Officer will brief brachytherapy sources are implanted in the pa- the patient on precautions for minimizing radia-tient. Female visitors should be asked whether tion exposure to others after discharge from the they are pregnant. hospital.

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