Information Notice 2012-08, High Dose-Rate Remote Afterloader (Hdr) Physical Presence Requirements

High Dose-Rate Remote Afterloader (Hdr) Physical Presence Requirements

ML11320A228
Person / Time
Issue date:	04/10/2012
From:	Brian Mcdermott NRC/FSME/DMSSA
To:
Rivera-Cappella, Gretchen 415-5944
References
IN-12-008
Download: ML11320A228 (7)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF FEDERAL AND STATE MATERIALS

AND ENVIRONMENTAL MANAGEMENT PROGRAMS

WASHINGTON, D.C. 20555 April 10, 2012 NRC INFORMATION NOTICE 2012-08: HIGH DOSE-RATE REMOTE AFTERLOADER (HDR)

PHYSICAL PRESENCE REQUIREMENTS

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) high dose-rate remote afterloader (HDR)

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 remind addressees of the HDR physical

presence requirements described in 10 CFR 35.615(f)(2). No specific action or written

response is required. It is expected that recipients will review the information for applicability to

their facilities and consider actions, as appropriate, to avoid similar issues. The NRC is

providing this IN to the Agreement States for their information and for distribution to their HDR

licensees as appropriate.

DESCRIPTION OF CIRCUMSTANCES

During inspections of HDR facilities, the NRC staff has identified several issues associated with

implementation of the physical presence requirement in 10 CFR 35.615(f)(2). The following is a

brief overview of NRC staff findings:

Case #1 During an inspection in 2008, NRC inspectors noted that the licensees procedures allowed an

authorized user (AU) to designate and train a non-AU physician to fulfill the physical presence

requirement during the initiation and continuation of HDR treatments.

Case #2 During an inspection in 2008 to follow-up on a reported medical event, NRC inspectors noted

that an AU was not within normal hearing distance of the HDR console and was not able to

assist the authorized medical physicist (AMP) in responding to a device error message. The

AMPs erroneous response to the error message resulted in a medical event. In this event, the

AU was not afforded the opportunity to review the error message or the AMPs response to the

error message, which resulted in a change from the intended treatment position.

ML11320A228 Case #3 During an inspection in 2009, NRC inspectors observed that the only person physically present

at the console during an HDR patient treatment was the AMP, who also served as the Radiation

Safety Officer (RSO). The AMP/RSO stated that the AU had been present for initiation of the

treatment, but then had to leave for a meeting outside of the department. The AU stated they

were typically physically present for the initiation but not during continuation of HDR treatments.

The AU usually remained within the Radiation Oncology Department, seeing other patients or

working in their office, but did not remain within hearing distance of normal voice of the HDR

control console.

Case #4 During an inspection in 2010, NRC inspectors observed a patient undergoing an HDR treatment

and noted when the treatment was initiated the AMP was not present at the console, but a

dosimetrist and the AU were present. The AMP was in another area of the Radiation Oncology

Department, not within hearing distance of normal voice of the HDR control console, at the

initiation of the patient treatment.

Case #5 During an inspection in 2010, NRC inspectors noted that an AU and AMP were present for the

initiation and continuation of patient treatment as required by 10 CFR 35.615(f)(2). However, when reviewing the licensees procedures for HDR treatments, the inspectors noted that the

procedures did not appear to meet the physical presence requirements contained in the

regulations. Specifically, the inspectors noted that the licensees procedures allowed for either

an AU or AMP to be physically present. The licensee indicated that the procedures had been

developed in accordance with the manufacturers instructions.

Case #6 During an inspection in 2011, NRC inspectors identified that after initiation of an HDR treatment, the AU routinely left the console area to conduct various tasks or to sometimes see patients in

other rooms within the Radiation Oncology Department. Typically, the door to the console area

was closed to maintain patient privacy. During HDR treatments, the AU periodically checked

the treatment progress, and met with the patient at the conclusion of the treatment. The

licensee also described that the AU could be summoned by the intercom to return to the

treatment area if needed.

DISCUSSION

After analyzing these incidents, the NRC staff has recognized three types of errors associated

with licensee interpretation of the physical presence requirement for HDR treatments. The

errors are described in detail below and include: (1) the AU or AMP was not physically present

in the HDR console area during initiation or continuation of a patient treatment; (2) the AU or

AMP relied on alternate personnel to meet the physical presence requirements; and (3) the

licensees procedures allowed either the AU or AMP to leave the console area. The regulations in 10 CFR 35.615(f)(2) state that the licensee shall, for [HDR] units, require an

[AU] and an [AMP] to be physically present during the initiation of all patient treatments involving

the unit; and an [AMP] and either an [AU] or a physician, under the supervision of an [AU], who

has been trained in the operation and emergency response for the unit, to be physically present

during continuation of all patient treatments involving the unit. The meaning of physically

present as used in the regulations was defined in the April 24, 2002 Federal Register Notice,Section V, Summary of Changes, (67 FR 20355) as within hearing distance of normal voice.

The word normal as used within the context of normal hearing distance should be given its

dictionary meaning of regular, average, or not deviating from an established rule.

Based on the definition for normal voice, the NRC has determined that the need for a raised

voice in order for the AU and AMP to communicate with each other does not fit the definition of

normal as used within the context of normal hearing distance. Therefore, the location of the

HDR console (for instance, around a corner or behind a door), or high background noise due to

loud equipment, will affect what the normal hearing distance is. Licensees should take into

consideration the specific environment in which the HDR unit is operating, remaining mindful

that communication between the AU and AMP must be such that the use of a raised voice is not

necessary. Furthermore, the NRC has determined for other therapy devices that the use of

communication devices, such as walkie talkies, intercoms, or any device used to transmit or

amplify the human voice, does not meet the description of normal hearing distance [see

Regulatory Issue Summary (RIS) 2005-023], and therefore, their use is not allowed as a means

of fulfilling the physical presence requirement in 10 CFR 35.615.

The NRC found that in some cases, licensees misinterpreted the physical presence

requirements in 10 CFR 35.615 as being met if the AU and AMP were present only during

initiation of the treatment. In other cases, licensees believed that either the AU or AMP could be

present for initiation of the treatment only. And finally, many licensees believed that as long as

the individual not present was able to be rapidly summoned via a raised voice or intercom, that

physical presence was met. In the cases described, the NRC found that licensees either were

not aware of the details of the regulations or were not taking into account their specific operating

conditions when determining what constituted physical presence within hearing distance of

normal voice. Licensee procedures should include consideration of their specific operating

conditions to ensure that both an AU and AMP are physically present within normal hearing

distance of the HDR treatment console during initiation of the patient treatment and that an

AMP and either the AU or a non-AU physician who meets the requirements in 10 CFR

35.615(f)(2)(ii) are physically present within normal hearing distance of the HDR treatment

console during continuation of the patient treatment. In addition, licensees who have adopted

manufacturers guidance should review their procedures to ensure that the regulatory

requirements are correctly stated.

The NRC also notes that the regulations do not define initiation of treatment or specifically

describe whether this statement refers to only the first fraction of a treatment course (e.g.,

during fraction one of five) or to only the first fraction to be delivered on that day, and not to

initiation of each treatment fraction. However, to verify that the correct dose is being delivered, it is important to emphasize that the AU and AMP must be physically present during the

initiation of each treatment fraction. Therefore, initiation of treatment should be considered as

the initiation of each treatment fraction and not solely the initiation of the course of treatment. The NRC also believes that the inherent risk of the HDR procedures justifies the need for a

properly trained AU (or AU-supervised physician for continuation) and AMP to be available at all

times to verify dose, monitor device operations, and respond to an emergency situation.

Therefore, the regulations do not allow for the presence of any other personnel (e.g.,

dosimetrist) to meet the physical presence requirements of an AMP under any circumstances

(initiation or continuation); an AMP must always be physically present during initiation and

continuation of HDR treatments. Also, in addition to the AMP, although 10 CFR 35.615(f)(2)(ii)

allows a non-AU physician under the supervision of an AU to fulfill the physical presence

requirements during the continuation of an HDR treatment, 10 CFR 35.615(f)(2)(i) allows only

an AU to fulfill the physical presence requirements during the initiation of an HDR treatment.

This ensures appropriate personnel are available to verify that the correct dose is being

delivered to the patient (i.e., AU and AMP) and to respond to an emergency (i.e., AMP and

physician trained to respond to emergencies).

For additional information, licensees can find frequently asked questions regarding the physical

presence requirement during HDR treatments on the NRCs Medical Uses Licensee Toolkit

Web site, at: http://www.nrc.gov/materials/miau/med-use-toolkit/faqs-part35.html.

RELATED GENERIC COMMUNICATION

RIS 2005-23, Clarification of the Physical Presence Requirement During Gamma Stereotactic

Radiosurgery Treatments.

CONTACT

This IN requires no specific action or written response. If you have any questions about the

information in this notice, please contact one of the technical contacts listed below or the

appropriate regional office.

/Pam Henderson for/RA/

Brian J. McDermott, Director

Division of Materials Safety

and State Agreements

Office of Federal and State Materials

and Environmental Programs

Penny Lanzisera, RI

(610) 337-5169 E-mail: Penny.Lanzisera@nrc.gov

Enclosure:

List of Recently Issued FSME Generic

Communications The NRC also believes that the inherent risk of the HDR procedures justifies the need for a properly

trained AU (or AU-supervised physician for continuation) and AMP to be available at all times to verify

dose, monitor device operations, and respond to an emergency situation. Therefore, the regulations do

not allow for the presence of any other personnel (e.g., dosimetrist) to meet the physical presence

requirements of an AMP under any circumstances (initiation or continuation); an AMP must always be

physically present during initiation and continuation of HDR treatments. Also, in addition to the AMP,

although 10 CFR 35.615(f)(2)(ii) allows a non-AU physician under the supervision of an AU to fulfill the

physical presence requirements during the continuation of an HDR treatment, 10 CFR 35.615(f)(2)(i)

allows only an AU to fulfill the physical presence requirements during the initiation of an HDR treatment.

This ensures appropriate personnel are available to verify that the correct dose is being delivered to the

patient (i.e., AU and AMP) and to respond to an emergency (i.e., AMP and physician trained to respond

to emergencies).

For additional information, licensees can find frequently asked questions regarding the physical presence

requirement during HDR treatments on the NRCs Medical Uses Licensee Toolkit Web site, at:

http://www.nrc.gov/materials/miau/med-use-toolkit/faqs-part35.html.

CONTACT

This IN requires no specific action or written response. If you have any questions about the information in

this notice, please contact one of the technical contacts listed below or the appropriate regional office.

/Pam Henderson for/RA/

Brian J. McDermott, Director

Division of Materials Safety

and State Agreements

Office of Federal and State Materials

and Environmental Programs

Penny Lanzisera, RI

(610) 337-5169 E-mail: Penny.Lanzisera@nrc.gov

Enclosure:

List of Recently Issued FSME Generic

Communications

ML11320A228 OFC RI/DNMS RI/DNMS FSME/RMSB FSME/RMSB

NAME PLanzisera *MFerdas MFuller AMcIntosh

DATE 10/18/11 10/18/11 10/20/11 10/18/11 OFC FSME/RMSB OGC FSME/MSSA FSME/MSSA

NAME CEinberg BJones PHenderson BMcDermott

DATE 10/23/11 11/3/11 4/10/12 4/1012 OFFICIAL RECORD COPY

Enclosure

IN 2012-08 Page 1of 2 List of Recently Issued Office of Federal and State Material

and Environmental Management Programs Generic Communications

Date GC No. Subject

Addressees

03/20/2012 RIS-2012-04 Notice of Revision to the Criteria for All U.S. Nuclear Regulatory Commission

Identifying Materials Licensees for materials licensees (including fuel cycle

Discussion at the Agency Action facilities and master material licensees),

Review Meeting Agreement State Radiation Control

Program Directors, and State Liaison

Officers.

01/17/2012 RIS-2012-01 Availability of Safety Culture Policy All U.S. Nuclear Regulatory Commission

Statement licensees, certificate holders, permit

holders, authorization holders, holders of

quality assurance program approvals, vendors and suppliers of safety-related

components, and applicants subject to

NRC authority. All Agreement State

Radiation Control Program Directors, State

Liaison Officers, and other interested

stakeholders.

12/14/2011 RIS-2006-20, Guidance for Receiving All community water systems in the U.S.

Rev. 1 Enforcement Discretion When Nuclear Regulatory Commission non- Concentrating Uranium at Agreement States that, while treating

Community Water Systems drinking water, may accumulate and

concentrate naturally-occurring uranium in

media, effluents, and other residuals, above 0.05 percent by weight. All

Agreement State and Non-Agreement

State Radiation Control Program Directors

and State Liaison Officers

09/29/2011 RIS-2011-11 Regarding Long-Term Surveillance All holders of operating licenses for

Charge for Conventional or Heap conventional or heap leach uranium

Leach Uranium Recovery Facilities recovery facilities; holders of licenses for

Licensed Under 10 CFR Part 40 conventional or heap leach uranium

recovery facilities in decommissioning;

companies that have submitted

applications to construct new conventional

or heap leach uranium recovery facilities or

letters of intent to submit such applications;

UMTRCA

Title II sites; Agreement State Radiation

Control Program Directors, and State

Liaison Officers

08/31/2011 RIS-2011-10 Informing Licensees About the All U.S. Nuclear Regulatory Commission

NRCs Public Web Site for licensees, certificate holders, permit

Significant Enforcement Actions holders, applicants, Agreement State

When Evaluating Individuals for Radiation Control Program Directors, State

Employment Liaison Officers, and other interested

stakeholders.

Enclosure

IN 2012-08 Page 1of 2 List of Recently Issued Office of Federal and State Material

and Environmental Management Programs Generic Communications

Date GC No. Subject

Addressees

08/16/2011 RIS-2011-09 Available Resources Associated All U.S. Nuclear Regulatory Commission

with Extended Storage of Low-Level licensees, certificate holders, permit

Radioactive Waste holders, authorization holders, holders of

quality assurance program approvals, vendors and suppliers of safety-related

components, and applicants subject to

NRC authority. All Agreement State

Radiation Control Program Directors, State

Liaison Officers, and other interested

stakeholders.

Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and

State Materials and Environmental Management Programs (FSME). A full listing of all generic communications

may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc- collections/gen-comm/index.html