Gallagher, Carol

Subject:Attachments:

FW: Docket ID NRC-2015-00201-131 Worksheet x.doc; Written Directive 1-131 x.doc; Consent for 1-131 Hyperthyroidx.docx; Consent for 1-131 Cancer x.docx; Patient Release x.doc; 1 Hyperthyroid TXPackage 2015 x.doc; 2 Thyroid Cancer Treatment 15 1-200 mCi x.doc; 3 Thyroid CancerTreatment 101-150 mCi x.doc; 4 Thyroid Cancer Treatment 30-100 mCi x.doc

I:rnm_" Inn;•th;n R~r• rmit'p~i•nrr inmlSent: Tuesday, January 05, 2016 4:36 PM 7]-• L-iic_To: Gallagher, Carol <Carol.Gallagher@nrc.gov> __• : ..Subject: [ExternalSender] Docket ID NRC-2015-0020 .-..... :::: •;::

: ... . ,' .- ., ..

Carol,

I found your contact information via a SNMMI article on the call for information. 1 ]!iii..•'::--

I have attached documents we use when evaluating, treating, and releasing out-patients treated with 1-131 forhyperthyroid and thyroid cancer. I've edited the docs to remove our contact information. We work closely with a largelocal Endocrinology practice to ensure we're telling our patients the same information. Both practices align with ourrespective professional associations to keep abreast of the latest trends. Please let me know if you have questions.

Best regards,

• Jonathan A. B erg, M.S.,R.T.CR)(CT),CNMT, PET

NucIea r Medicine/P ET Co ordinator901 W, 38th Street, Suite 100, Austi~n, TX 78705;P 512,519.3456 F 512,498,3706 C 512.619.5887

Austin Radioloqilcal Association

SUNSI Review CompleteTemplate = ADM - 013E-RIDS= ADM-03Add= •_5 /7/L52IJ

1

° Radioiodine Therapy Outpatient Worksheet

I. Patient Information

Patient name Patient IDMale ___________ Female______

Is patient breast-feeding? _________

Note: Patients must discontinue breast-feeding to receive treatment

II. Dwelling Information

Type of dwelling: Single-family____Multifamily Apartment Dorm Other___If not single-family, possible proximity to neighbors feetHousehold members:Gender____ ___

Age _______ _______ _______

Are any household members pregnant? Yes____No___

III. General Contact Information

Are there regular visitors to the house? Yes_____No____Pregnant females? Yes No____If yes, can these visiting arrangements be modified to reduce contact? Yes__

Does the patient visit anyone regularly? Yes No____Pregnant females? Yes No____If yes, can these visiting arrangements be modified to reduce contact? Yes

Can patient be isolated (stay at least 6 feet from other people)? Yes NoDoes patient understand the importance of the isolation? Yes No___Does the patient suffer from incontinence? Yes No____Is the patient capable of self-care? Yes No___Can the patient delay return to work? Yes No____Is the trip home less than 4 hours? Yes No____

No

No____

IV. Items Discussed With Patient___Patient Instructions___Importance of limiting contact with individuals (distance and time)___Sleeping arrangements___Added precautions for children and pregnant women___Personal care___How long to wait before becoming pregnant___Procedures for notification of healthcare workers if hospitalized or receive medical care___Other

V. DeterminationBased on the above, can the patient be released? Yes No____

Authorized Physician or RSO DtD at e

CONSENT FOR RADIOIODINE TREATMENTOF THYROID CANCER

I Consent to the administration of millicuries of

radioactive Jo dine- 131 to for

treatment of Thyroid Cancer.

I understand that this treatment will permanently reduce or eliminate the activity ofmy thyroid gland.

I understand that I may have to take thyroid medication for the rest of my life toprevent illness from too little thyroid activity.

I acknowledge that the radio-iodine treatment and its potential side effects andrisks have been explained to me to my satisfaction, and that no guarantee of cureresulting from this treatment has been made to me.

I therefore consent to the treatment, as above.

SIGNED DATE:

RELATIONSHIP TO PATIENT:

WITNESS

Thyroid Cancer Treatment (151-200 mCi)

INSTRUCTIONS FOR OUTPATIENT TREATMENT WITH IODINE-131

Patient ______________was administered _____mCi of 1-131 on ______

The radioiodine dose that you will receive will be beneficial to you, but other persons with whom youmay come in contact should not be unnecessarily exposed to radiation. If you are currently nursing aninfant, additional instructions will be given to you concerning the need to discontinue breast-feeding.Below are some actions to which you must agree to help keep exposures to others as low as possible.The instructions should be followed for the recommended number of days following the treatment.

1. Stay at home, isolated from the general public for 4 days

2. Maintain a distance of at least 6 feet from others for 4 days

3. Sleep alone for 6 days

4. Do not travel by airplane or mass transportation for 4 days

5. Do not travel with others by automobile for longer than 2 hours for 3 days.

6. Have sole use of a bathroom, if possible, for 5 days. Wash hands thoroughly, men should sitwhen urinating. Flush 2-3 times after each use.

7. Drink plenty of fluids for the first 2 days. Urinate frequently to keep bladder empty.

The above are minimum actions necessary to keep exposures to others as low as possible.

To reduce radiation exposure to the salivary glands, you should suck on lemon drops starting 24 hoursafter treatment. Continue every 2-3 hours for 24 hours. Do not chew gum for 48 hours.

Other precautions to help maintain exposures as low as possible; for the first 7 days:

-Do not engage in strenuous activity that may result in excessive perspiration-Drink plenty of fluids-Flush used facial tissues down the toilet-Don't share eating or drinking utensils-Wash dishes in dishwasher, if available-Launder bath towels, bed linens, and underclothing separately-Use good personal hygiene. Wash hands several times/day, shower or bathe daily-Rinse sink or tub after use-Discard toothbrush at end of one week-Restrict use of contact lenses for one week-Do not prepare food for others-Avoid mouth-to-mouth contact-Avoid sexual intercourse-Sleep alone after initial requirement, if convenient-Limit visitors, for only short periods, and maintain distance of at least 6 feet-Avoid any direct contact with minors and women of childbearing age

-Avoid becoming pregnant for 6 months-If sore throat or neck pain develops, take acetaminophen or aspirin

Possible Side Effects:

-Loss of Appetite- Nausea- Salivary gland swelling / pain- Change in taste

Patient Agreement

I agree to abide by the above recommendations as a condition of my treatment on an outpatient basis. Ihave had the opportunity to ask questions regarding the limitations on my activities following releaseand understand each of the recommendations described above.

Patient/Guardian signature Date

Authorized User/RSO

Contact Number______________

Date

(Important: Make copy of this form for patient - original to patient records.)

Written Directive of the Administration of 131-Sodium IodideGreater than30 microcuries

Date____________

Patient's Name_______________________

Patient's Medical Record Number________________

TSH____________

Ordered Dose______________

Assayed Dose______________

Route of Administration__________

Referring Physician______________________

____ Physician orders have been checked.

____ Pregnancy test perfonrmed or equivalent_______________________

____ Explanation in detail to the patient of the procedure and all questions have been answeredto the patient's satisfaction.

____ Visual check has been made of the dose amount and patient name on the prescription.

____ Patient's identification has been verified with two identifiers before administration of radioisotope.

Authorized User

Date TmTime

RECORD OF JUSTIFICATION OF PATIENT RELEASEBASED ON PATIENT-SPECIFIC DOSE CALCULATION

TREATMENT OF THYROID CANCER USING 1-131

Patient name__________

Radiopharmaceutical administered

Activity administered (Q0)

Date of administration

Date of patient release

Patient ID

1-131

(mCi)

Time of administration

Time of patient release

Calculation of Total Dose Equivalent (TDE)

Dose =Q0 (1.62 + 12.9 F2) (from NRC Regulatory Guide 8.39)

Where F2 is the thyroid uptake fraction = 0.05

Dose = * (1.62 + 12.9 * 0.05)

= * (1.62 + .645)

= * 2.265

______._(mrem)

If the calculated dose is less than 500 mrem, then the patient may be released.

Signature of person performing calculation

Signature of Authorized User

Thyroid Cancer Treatment (101-150 mCi)INSTRUCTIONS FOR OUTPATIENT TREATMENT WITH IODINE-131

Patient ______________was administered _____mCi of 1-131 on_______

The radioiodine dose that you will receive will be beneficial to you, but other persons with whom youmay come in contact should not be unnecessarily exposed to radiation. If you are currently nursing aninfant, additional instructions will be given to you concerning the need to discontinue breast-feeding.Below are some actions to which you must agree to help keep exposures to others as low as possible.The instructions should be followed for the recommended number of days following the treatment.

1. Stay at home, isolated from the general public for 3 days

2. Maintain a distance of at least 6 feet from others for 3 days

3. Sleep alone f'or 5 days

4. Do not travel by airplane or mass transportation for 3 days

5. Do not travel with others by automobile for longer than 2 hours for 2 days.

6. Have sole use of a bathroom, if possible, for 4 days. Wash hands thoroughly, men should sitwhen urinating. Flush 2-3 times after each use.

7. Drink plenty of fluids for the first 2 days. Urinate frequently to keep bladder empty.

The above are minimum actions necessary to keep exposures to others as low as possible.

To reduce radiation exposure to the salivary glands, you should suck on lemon drops starting 24 hoursafter treatment. Continue every 2-3 hours for 24 hours. Do not chew gum for 48 hours.

Other precautions to help maintain exposures as low as possible; for the first 7 days:

-Do not engage in strenuous activity that may result in excessive perspiration-Drink plenty of fluids-Flush used facial tissues down the toilet-Don't share eating or drinking utensils-Wash dishes in dishwasher, if available-Launder bath towels, bed linens, and underclothing separately-Use good personal hygiene. Wash hands several times/day, shower or bathe daily-Rinse sink or tub after use-Discard toothbrush at end of one week-Restrict use. of contact lenses for one week-Do not prepare food for others-Avoid mouth-to-mouth contact-Avoid sexual intercourse-Sleep alone after initial requirement, if convenient-Limit visitors, for only short periods, and maintain distance of at least 6 feet

- Avoid any direct contact with minors and women of childbearing age- Avoid becoming pregnant for 6 months- If sore throat or neck pain develops, take acetaminophen or aspirin

Possible Side Effects:

-Loss of Appetite-Nausea

-Salivary gland swelling / pain-Change in taste

Patient Agreement

I agree to abide by the above recommendations as a condition of my treatment on an outpatient basis. Ihave had the opportunity to ask questions regarding the limitations on my activities following releaseand understand each of the recommendations described above.

Patient/Guardian signature Date

Authorized User/RSO Date

Contact Number

(Important: Make copy of this form for patient - original to patient records.)

CONSENT FOR RADIOIODINE TREATMENTOF HYPERTHYROIDISM

I Consent to the administration of millicuries of

radioactive Iodine-i 131 to for

treatment of Hyperthyroidism.

I understand that this treatment will permanently reduce or eliminate the activity ofmy thyroid gland.

I understand that I may have to take thyroid medication for the rest of my life toprevent illness from too little thyroid activity.

I acknowledge that the radio-iodine treatment and its potential side effects andrisks have been explained to me to my satisfaction, and that no guarantee of cureresulting from this treatment has been made to me.

I therefore consent to the treatment, as above.

SIGNEDS

DATE:

RELATIONSHIP TO PATIENT:

WITNESS

Hyperthyroid

INSTRUCTIONS FOR OUTPATIENT TREATMENT WITH IODINE-131

Patient _____________was administered _____mCi of 1-131 on ______

The radioiodine dose that you will receive will be beneficial to you, but other persons with whomyou may come in contact should not be unnecessarily exposed to radiation. If you are currentlynursing an infant additional instructions will be given to you concerning the need to discontinuebreast-feeding. Below are some actions to which you must agree to help keep exposures to others .aslow as possible. The instructions should be followed for the recommended number of days followingthe treatment. These are the minimum actions necessary to keep exposures to others as low aspossible.

1. Stay at home for the first night.

2. Sleep alone for at least the first night.

3. Maintain a distance of at least 6 feet from others for the first 2 days.

4. Do not travel by airplane or mass transport for at least the first day.

5. Do not travel with others by automobile for longer than 2 hours for the first 2 days.

6. Have sole use of a bathroom for the first 2 days or follow detailed instructions for bathroomuse.

7. Drink plenty of fluids for the first 2 days.

Other precautions you may follow to help maintain exposures as low as possible; for the first 5 days:- Drink plenty of fluids- Flush toilet twice after use, men should sit while urinating- Don't share eating or drinking utensils- Wash dishes in dishwasher, if available- Launder bath towels, bed linens, and underclothing separately- Sleep alone, if convenient- Use good personal hygiene. Wash hands several times/day, shower or bathe daily- Discard toothbrush at end of one week- Restrict use of contact lenses for one week- Keep babies/small children away from your neck except for brief periods- If nervousness, tremors, or palpitations increase, call your physician- If sore throat or neck pain develops, take acetaminophen or aspirin

Patient AgreementI agree to abide by the above recommendations as a condition of my treatment on an outpatientbasis. I have had the opportunity to ask questions regarding the limitations on my activitiesfollowing release and understand each of the recommendations described above.

Patient/Guardian signature Date Authorized User/RSO date

Contact Number

(Important: Make copy of this form for patient - original to patient records.)

Written Directive of the Administration of 131-Sodium Iodide Greater than30 microcuries

Date____________

Patient's Name________________________

Patient's Medical Record Number_______________

TSH____________

Ordered Dose______________

Assayed Dose______________

Route of Administration__________

Referring Physician___________________

_____ Physician orders have been checked.

_____ Pregnancy test performed or equivalent_______________________

____ Explanation in detail to the patient of the procedure and all questions have been answeredto the patient's satisfaction.

____ Visual check has been made of the dose amount and patient name on the prescription.

___Patient's identification has been verified with two identifiers before administration ofradioisotope.

Authorized User

Date Date Time

CONSENT FOR RADIOTODINE TREATMENTOF HYPERTHYROIDISM

I Consent to the administration of millicuries of

radioactive Iodine-i 131 to for

treatment of Hyperthyroidism.

I understand that this treatment will permanently reduce or eliminate the activity ofmy thyroid gland.

I understand that I may have to take thyroid medication for the rest of my life toprevent illness from too little thyroid activity.

I acknowledge that the radio-iodine treatment and its potential side effects andrisks have been explained to me to my satisfaction, and that no guarantee of cureresulting from this treatment has been made to me.

I therefore consent to the treatment, as above.

SIGNEDS

DATE:

RELATIONSHIP TO PATIENT:

WITNESS

I131 PROTOCOL CHECKLIST

Up to one week prior to dosing a patient with 1131, a nuclear medicine technologist should do the following:

[] Call the patient to confirm pregnancy status and review precautions

o] If HCG was performed, confirm HCG results

o] If patient of child bearing age, ask if breast feeding. If yes, inform patient of cessation requirement.

o] Confirm that all necessary lab results are completed and available

Cancer treatment:o TSH - not needed if Thyrogen stim

o Pathology report.

o Whole body scan, if ordered by referring physician - not always necessary for treatment

Hyperthyroid treatment:

o TSH, T4

o Thyroid scan - not always necessary

o TSH - not needed if Thyrogen stim

[] Contact the radiologist scheduled for the date of service.

(If scheduled radiologist is not available, contact Dr. X, if he us not available then contact Dr. X.)

o] Permission to proceed was given by Dr. __________

Nuclear Medicine Technologist Date

Radiologist Date

NOTE: If permission to proceed is not given, the scheduled radiologist must call Dr. X or Dr. X.

Thyroid Cancer Treatment (30-100 mCi)INSTRUCTIONS FOR OUTPATIENT TREATMENT WITH IODINE-131

Patient _________ ___was administered _ ___mCi of I- 131 on______

The radioiodine dose that you will receive will be beneficial to you, but other persons with whom youmay come in contact should not be unnecessarily exposed to radiation. If you are currently nursing aninfant, additional instructions will be given to you concerning the need to discontinue breast-feeding.Below are some actions to which you must agree to help keep exposures to others as low as possible.The instructions should be followed for the recommended number of days following the treatment.

1. Stay at home, isolated from the general public for 2 days

2. Maintain a distance of at least 6 feet from others for 2 days

3. Sleep alone for 4 days

4. Do not travel by airplane or mass transportation for 2 days

5. Do not travel with others by automobile for longer than 2 hours for 2 days•.

6. Have sole use of a bathroom, if possible, for 3 days. Wash hands thoroughly, men should sitwhen urinating. Flush 2-3 times after each use.

7. Drink plenty of fluids for the first 2 days. Urinate frequently to keep bladder empty.

The above are minimum actions necessary to keep exposures to others as low as possible.

To reduce radiation exposure to the salivary glands, you should suck on lemon drops starting 24 hoursafter treatment. Continue every 2-3 hours for 24 hours. Do not chew gum for 48 hours.

Other precautions to help maintain exposures as low as possible; for the first 7 days:

-Do not engage in strenuous activity that may result in excessive perspiration-Drink plenty of fluids-Flush used facial tissues down the toilet-Don't share eating or drinking utensils-Wash dishes in dishwasher, if available-Launder bath towels, bed linens, and underclothing separately-Use good personal hygiene. Wash hands several times/day, shower or bathe daily-Rinse sink or tub after use-Discard toothbrush at end of one week-Restrict use of contact lenses for one week-Do not prepare food for others-Avoid mouth-to-mouth contact-Avoid sexual intercourse-Sleep alone after initial requirement, if convenient-Limit visitors, for only short periods, and maintain distance of at least 6 feet-Avoid any direct contact with minors and women of childbearing age

-Avoid becoming pregnant for 6 months-If sore throat or neck pain develops, take acetaminophen or aspirin

Possible Side Effects:

- Loss of Appetite- Nausea- Salivary gland swelling / pain- Change in taste

Patient Agreement

I agree to abide by the above recommendations as a condition of my treatment on an outpatient basis. Ihave had the opportunity to ask questions regarding the limitations on my activities following releaseand understand each of the recommendations described above.

Patient/Guardian signature Date

Autorized Number/SDate

Contact Number__________________________

(Important: Make copy of this form for patient - original to patient records.)