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- TABLE 1.
Summary of Release Criteria, Required Instructions to Patients, and Records to Be Maintained*
Patient group Basis for release Criteria for release Instructions needed Release records required All patients, including patients who are breastfeeding 1. Administered activity 2. Retained activity Administered activity of 131I <33 mCi Retained activity of 131I <33 mCi Yes, if administered 131I >7 mCi Yes, if retained 131I >7 mCi No Yes, see Regulatory Guide 3. Measured dose rate Measured dose rate from 131I <7 mrem/h Yes, if dose rate 131I >2 mrem/h Yes, see Regulatory Guide 4. Patient-specific calculations 131I calculated dose to other than patient <500 mrem Yes, if calculated 131I dose >100 mrem Yes, see Regulatory Guide, and discussed below Patients who are breastfeeding All the above bases for release Yes, complex, see Regulatory Guide Yes, complex, see Regulatory Guide ↵* Synopsis of Table 4 from U.S. Nuclear Regulatory Guide 8.39.
Medical condition Extrathyroidal component Thyroidal component Uptake fraction F1 Effective half-life T1eff (day) Uptake fraction F2 Effective half-life T2eff (day) Hyperthyroidism 0.20 0.32 0.80 5.2 Post-thyroidectomy for thyroid cancer 0.95 0.32 0.05 7.3 ↵* From Table B-1 in NRC Regulatory Guide 8.39.
Patient's Name Patient ID Number 1. Will the administered activity of 131I exceed 33 mCi? No → The patient may be treated as an outpatient. Ensure that written and oral patient instructions are provided, and a written directive completed. Yes → The patient may require hospitalization for treatment. Continue to Item 2. 2. Determine if the following criteria apply: Yes No □ □ The patient will maintain a prudent distance from others for at least the first 2 days. □ □ The patient will sleep alone in a room for at least the first night. □ □ The patient will not travel by airplane or mass transportation for at least the first day. □ □ The patient will not travel on a prolonged automobile trip with others for at least the first 2 days. □ □ The patient will have sole use of a bathroom for at least the first 2 days. □ □ The patient will drink plenty of fluids for at least the first 2 days. 3. If the answer is No to any one or more of the criteria in Item 2 above, the patient must be hospitalized for treatment if the administered activity exceeds 33 mCi 131I. 4. If the answer is Yes to all of the criteria in Item 2, perform the necessary calculations in Item 5, below, to determine whether the patient can be released immediately in accordance with NRC Regulatory Guide 8.39, Appendix B, as discussed below. 5. Patient-specific dose calculations (Check 1 of the 3 boxes, whichever applies, and calculate D). □ For Na131I treatment of a patient post-thyroidectomy for thyroid cancer: D (mrem) = 2.27 Qo = ________ mrem, where D (mrem) is the maximum likely dose to an individual exposed to the patient and Qo is the administered activity in millicuries (e.g., if you administer 100 mCi to the patient, then D (mrem) = 2.27 ∗ 100 = 227 mrem). □ For Na131I treatment of hyperthyroidism: D (mrem) = 8.84 Qo = ________ mrem, where D (mrem) is the maximum likely dose to an individual exposed to the patient and Qo is the administered activity in millicuries. Note: the above 2 calculations use occupancy factors discussed in Appendix B, section B.1.2 of NRC Regulatory Guide 8.39, and effective half-lives and uptake components found in Table B-1 of NRC Regulatory Guide 8.39. If you use other values, as determined for your specific patient, you must use Equation B-5 of the Regulatory Guide. You must write the entire equation below: □ D (mrem) = 6. Answer the following: Yes No □ □ The maximum likely dose to an individual exposed to the patient [D (mrem)] is less than 500 millirem? If yes, the patient may be released. Keep this worksheet (including any other calculations) and a copy of the patient instructions for documentation of compliance with 10 CFR 35.75. 7. Further restrictions apply if the patient is breast-feeding (see Regulatory Guide). Yes No □ □ This patient is breast-feeding an infant or child. Worksheet completed by _____________ Date ____________________ (Signature) - APPENDIX B
Instructions to Patients Containing More Than 6.9 mCi Na131I Released from the Medical Center
Patient name __________ Patient ID number __________ . _____ mCi of Na131I was administered orally at _____ am/pm on ___ / ___ / ___ . Patient released from the medical center at __________ am/pm on ___ / ___ / ___ . Patient and Family Learning Needs The patient: □ does not have special learning considerations. □ has special learning considerations which will change the method of instruction (specify if present). Patient and Family Instructions (write additional instructions on the back as needed) Safe and effective use of medications. 1. Resume previous thyroid medications as follows: Diet and nutrition. 1. Do not eat for 2 hours following the administration of Na131I, however you may drink clear liquids (water, coffee, tea, fruit juices, and/or soft drinks). 2. Drink as much fluid as tolerable for 48 hours following administration. 3. Chew gum, or suck on hard or sour candy, frequently for 48 hours to encourage the flow of saliva. 4. Use disposable cups, plates, and other dishes and tableware for ___ days. Suggestions to minimize the radiation dose to other people. 1. Avoid sustained close contact with other people for ___ days, especially infants, children, and pregnant women. Remember that radioactive contamination may spread to others through your perspiration, saliva, urine, and feces. 2. Sleep alone for ___ days. 3. Avoid conception for 6 months. Personal hygiene and grooming. 1. Urinate frequently (every 2 hours if possible) for ___ days. Men need to sit down to urinate during this time. 2. Flush the toilet twice after each use and keep your hands clean for ___ days. 3. Shower daily and use separate towels for ___ days. 4. Wear clothing that can be laundered (not dry cleaned) for ___ days. 5. After ___ days wash your clothing, towels, and bedding separately (put through wash/rinse cycles twice). 6. In the rare chance you should vomit within 2 hours of receiving therapy, use paper towels to soak up the material and flush it down the toilet. Try not to spread the material around, as it will be radioactive. Wash your hands. Inform the nuclear medicine staff as soon as possible at __________ [telephone number]. Special Instructions: If you experience any of the following symptoms, contact your physician: Increased shakiness Rapid heart rate Shortness of breath Increasing pain or swelling in the neck over the next 2–3 weeks Difficulty breathing. Important Telephone Numbers After hours urgent calls can be made to the Medical Center Operator at __________ and ask the operator to connect you to the Emergency Care Unit at ext. ___ . During normal business hours (8:00 am–4:30 pm) call Nuclear Medicine at __________ . If you have an Emergency, call 911. Additional Instructions: Follow-Up Appointments Clinic Confirmed date and time Special instructions Initials I have reviewed the release instructions with the patient and/or family or caregiver. The patient or caregiver was able to verbalize understanding of the instructions. A copy of these written instructions was given to the patient or caregiver. Name __________ Date ___ Time ___ am/pm (Person giving the instructions) Release instructions have been explained to me and/or my family or caregiver. I have received a copy of the instructions and I understand them. Name __________ Date ___ Circle one: Patient/Family/Caregiver signature Place the original in the medical record and give the patient and/or family 1 copy.
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