Information Notice 2017-02, Best Practices Concepts for Patient Release

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Best Practices Concepts for Patient Release
ML17101A560
Person / Time
Issue date: 05/17/2017
From: Dapas M
Office of Nuclear Material Safety and Safeguards
To:
Daibes F
References
IN-17-002
Download: ML17101A560 (6)


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL

SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 May 17, 2017 NRC INFORMATION NOTICE 2017-02: BEST PRACTICE CONCEPTS FOR PATIENT

RELEASE

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees and NRC master

materials licensees. All Agreement State Radiation Control Program Directors and State

Liaison Officers.

PURPOSE

The NRC is issuing this information notice (IN) to provide addressees with best practices to

consider for patients treated with Sodium Iodine-131 (NaI-131) (hereafter referred to as I-131)

and released in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 35.75,

"Release of Individuals Containing Unsealed Byproduct Material or Implants Containing

Byproduct Material." The included best practice concepts are intended to provide information to

licensees to consider and individualize for their patients in regards to maximizing radiation

safety and minimizing unnecessary radiation exposure. Information contained in this IN does

not constitute new NRC requirements; therefore, no specific action or written response is

required. The NRC is providing this IN to the Agreement States for their information and for

distribution to their medical licensees, as appropriate.

DESCRIPTION OF CIRCUMSTANCES

The NRC staff has anecdotal data from patients and patient advocacy groups which indicate

that the quality of instructions that medical licensees provide to patients released under 10 CFR

35.75 varies significantly. The data suggest that some patients are provided with instructions

that may not be specific to their needs and are impractical to follow.

BACKGROUND

The NRC regulations in 10 CFR 35.75(a) permit a licensee to "authorize the release from its

control any individual who has been administered unsealed byproduct material or implants

containing byproduct material if the total effective dose equivalent to any other individual from

exposure to the released individual is not likely to exceed 5 millisieverts (mSv) (500 millirem

(mrem))." The provisions in 10 CFR 35.75(b) require a licensee to provide the released

individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably

achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv

(100 mrem). The Commission directed staff to develop, for licensee consideration, best practice release

instructions for patients treated with I-131. Toward that goal, the staff published a notice in the

Federal Register (80 FR 70843) that solicited comments from the medical community and

associated stakeholders about their patient release guidance and best practices based on their

own experiences. The NRC assessed stakeholder responses to identify best practices with

respect to I-131 patient release guidance based on well-established radiation safety concepts.

DISCUSSION

Generally when licensees release patients, it is to the patients home where family or other

caregivers may be present. The NRC believes that the ability of the licensee to provide

adequate release instructions under 10 CFR 35.75(b) is related to the licensees thorough

consideration of the destination to which the patient will be released, and on the ability of the

patient and/or caregiver to understand and follow the necessary release instructions. By

thoroughly ascertaining the patient post-treatment destination, the licensee can best estimate

the likely cumulative radiation exposures to other members of the public (e.g., family and

caregivers, etc.) and direct appropriate protective measures. Stakeholder comments provided

valuable information that helped NRC staff to develop patient release best practice concepts

based on sound radiation protection principles. These best practices are shared in this IN for

licensee consideration.

BEST PRACTICES CONCEPTS

Patient Preparation Assessment

Engaging the patient early in the treatment process (i.e. during treatment planning) may help

licensees better familiarize the patient and caregivers with the treatment procedure, potential

complications, side effects, dietary and medication changes, pre- and post-treatment

expectations, isolation, and protective measures and precautions to follow before, and

immediately after, I-131 administration. Additionally, early engagement with the patient affords

both the patient and the licensee an opportunity to ask and answer questions that will help the

patient be more compliant with the release instructions. It also provides the licensee with an

opportunity to determine if the patient will be able to follow instructions. Sharing information on

the impact of pregnancy and breastfeeding during the treatment process is vital in educating

and preparing the patient for treatment.

As soon as I-131 is considered as a treatment option, the licensee should conduct an interview

with the patient and/or caregiver to aid in assessing the patient's specific circumstances. Topics

to consider include:

  • Type of post-treatment lodging (e.g., group home, apartment, townhome, detached

single family home).

  • Patient travel plans to their post-treatment recovery location:

o Will the patient use a private vehicle, taxi service, or public transportation (i.e.

bus, train, or airplane)? Not using public transportation should be

recommended, if possible.

o If driving, might the patient be too impaired to drive?

o If driving, will the patient drive alone (preferred)?

  • If the patient is traveling with other individuals, what is the duration of the trip and how

does the duration affect instructions for keeping the patient an adequate distance from

others?

  • Household members, if any (gender, age, nursing infant, pregnant woman).
  • Can the patient be appropriately isolated from others in the household post-treatment?
  • Is the patient capable of self-care, compliance with release instructions, and sleeping

alone? Is the patient incontinent?

  • Discuss household and necessary dietary changes prior to treatment.
  • Discuss factors that might be the basis for withholding treatment (e.g., breastfeeding, pregnancy) and consequences if release instructions are not followed.
  • Can the patient delay returning to work?

By gathering this information prior to the treatment (i.e. during treatment planning), the licensee

can provide a patient-specific estimate of the likely cumulative dose to other members of the

public, direct appropriate protective measures, and allow the patient time to plan for his/her

potential isolation after release. The licensee should provide pre-treatment instructions verbally

as well as in writing

Patient Precautions

The following precautions/measures should be adequate for most I-131 patients to keep

radiation exposures to others at or below the 5 mSv (500 mrem) limit:

  • The licensee may consider discussing the following precautions and measures with the

patient (as applicable):

o Emphasize the importance of keeping an adequate distance from others, especially children and pregnant women. Can arrangements be made for family

members (including children and any pregnant household members) to lodge

elsewhere temporarily?

o Encourage the patient not to prepare or share food with others.

o Encourage the use of a bathroom reserved exclusively for the patient, if possible.

o Encourage the use of kitchen utensils dedicated to the patient, not shared with

other household members and washed separately from other dishes.

Alternately, encourage patients to use disposable eating utensils.

o Encourage the use of disposable gloves, flushable wipes, and frequent hand

washing.

o Encourage the laundering of a patient's clothing separately from other household

members clothing.

o Emphasize abstention from all forms of intimate contact:

Advise the patient on recommended length of time the patient should wait

before becoming pregnant to minimize radiation exposures to a

developing fetus.

o Discuss how to clean up an area contaminated with body fluids (e.g., breast milk, vomit).

o Emphasize disposing of patient-related trash in a separate plastic bag that is not

mixed with other household members' trash, and possibly holding the trash to

allow for radioactive decay, as well as how to reduce radiation exposure from this

trash. Holding trash for decay is important because the landfill may detect the

radiation and send the trash back to the patient. * Discuss how the patient may contact the licensee if needed.

  • Provide post-treatment instructions verbally as well as in writing, including how long the

release instructions should be followed.

If the patient is mentally and/or physically unable to comply with the instructions provided, and

the dose is elevated (i.e., >200 millicuries), licensees may have to consider holding the patient

or providing inpatient treatment until the dose to other individuals will not exceed 5 mSv (500

mrem). In this case, the patient should remain hospitalized until he/she can be released without

following any instructions. Similarly, if the patient and/or caregiver informs the licensee that the

patient plans to use public transportation and/or temporary public lodging at the post-treatment

destination, or the patient is unable to meet the release instructions, the licensee should

consider holding or hospitalizing the patient until the dose to other individuals will not exceed 5 mSv (500 mrem).

Numerous stakeholders emphasized that the Radiation Safety Officer should be consulted in

evaluating the doses to members of the public in both routine and unusual situations (i.e., the

patient travels a substantial distance after treatment, or cannot make the trip home without an

overnight stay near the treatment medical facility). In addition, licensees may consider

documenting the patients plans to limit radiation exposure to small children.

With regard to female patients of child-bearing age, the NRC recognizes that pregnancy tests

have limited ability to detect early pregnancies. The NRC encourages licensees to advise their

patients to contact the licensee immediately in instances where a female patient discovers she

was pregnant at the time the medical treatment was administered.

Patients receiving I-131 treatment need to be aware that they might trigger the alarms of

radiation detectors at national borders, airports, within cities, or at their place of employment for

3 months or more following radioiodine treatment. Consequently, the licensee may consider

issuing the patient a letter or card containing appropriate information about the treatment in

case law enforcement agents need to verify that information.

CONCLUSIONS

Operating experience has demonstrated that radiation exposure from released patients can be

safely controlled through the provision of appropriate instructions by the license as required by

10 CFR 35.75, and adherence to those instructions by the patient and/or caregiver. The NRC

believes that the current patient release criteria appropriately balance public safety with patient

access to medical treatment. This notice provides best practices to consider in order to

maintain exposures as low as is reasonably achievable from patients released in accordance

with 10 CFR 35.75, and may be used to augment the guidance in NUREG-1556, Volume 9, Program-Specific Guidance About Medical Use Licenses. NUREG-1556, Volume 9 provides a

variety of suggested protective measures that may be considered for minimizing exposures to

others. It is located at the NRCs Web page entitled Medical Uses Licensee Toolkit at

https://www.nrc.gov/materials/miau/med-use-toolkit.html.

CONTACT

This information notice requires no specific action or written response. Please direct any

questions about this matter to a technical contact listed below.

/RA/

Marc L. Dapas, Director

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Donna-Beth Howe, NMSS

(301) 415-7848 E-mail: Donna-Beth.Howe@nrc.gov

Said Daibes-Figuera, NMSS

(301) 415-6863 E-mail: Said.DaibesFigueroa@nrc.gov

Note: NRC generic communications may be found on the NRC public Web site, http://www.nrc.gov, under NRC Library/Document Collections. SUBJECT: NRC INFORMATION NOTICE 2017-02: BEST PRACTICE CONCEPTS

FOR PATIENT RELEASE

ML17101A560 *concurred via e-mail CAC A34010

OFC NMSS/MSTR NMSS/MSTR NMSS/MSTR/BC NMSS/MSTR/D Tech Ed NMSS/D

NAME SDaibes *AMcIntosh DBollock JNick for MPringle MDapas

DCollins for WMoore

DATE 04/11/17 04/13/17 4/27/17 5/12/17 5/12/17 5/17/17 OFFICIAL RECORD COPY