ML20044A239

Request for OMB Review & Supporting Statement Re Medical QA Assessment.Estimated Respondent Burden Is 1,450 H

ML20044A239
Person / Time
Issue date:	06/26/1990
From:	Norry P NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0148, OMB-3150-148, NUDOCS 9006280248
Download: ML20044A239 (34)

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. ARTlit.-Complete This Part only if the Reevest is for Approvalof a Collection of infortr.ation Uncer the Paperwork Recuction Act and 5 CFR 1320.

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-4 The assessment will be conducted through a questionnaire that will be completed by NRC 11spectors during inspections of medical licensees.

The assessment will provide information to NRC on the quality assurance programs and procedures at licensees' medical institutions.

.Results will be used in NRC's quality assurance rulemaking.

- 1 Type De it3*prrtation to lettion eCnet A on'y One)

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Patricia G. Norry, Designated Senior Official

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SUPPORTING STATEMENT i

FOR HEDICAL QUALITY ASSURANCE ASSESSMENT Description of the Information Collection As part of an effort to modify the regulatory framework concerning medical use i

quality assurance (QA), the NRC plans to continue its one-time assessment of QA programs and procedures at all NRC medical use licensees' facilities.

This assessment, which will continue te be concucted through a questientiaire that will be completec curing IEC inspections of medical licensees, provides i

specific information on the QA programs ano procedures that are in use et licensees' medical institutions. The assessment will also provide information on the QA procedures in use, as well as a thorough description of the iredical licensees' teletberapy, brachytherapy, ano nuclear medicine progras. This assessmer,t was begun in October,1989, and will take 6 bout three more years to complete. This supporting statement is for the second, third, anc !curth years of the assessment; the first year of the assessment was conducted under the previous clearance.

NRC inspectors will complete the questionnaire during a reyuinrly wl.ccu'to safety inspection, recording answers provided by the licensee. Then the regionally-based inspectors will send a copy of the finished questionnaire back to NRC Headquarters, where it will be analyzed.

If necessary because of the unavailability of inspectors, NRC may arrange for assessment questionnaire interviews to be conducted by a contractor. The information collected and results of the analysis are expected to assist the NRC in the following manner:

1)

Results of the assessments will guide NRC's QA rulemaking effort by providing information about QA prectices that may require regulatory modifications.

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s,c 2)

Answers provided in the assessment will apprise NRC of existing QA programs and procedures used by medical licensees and general practices commonly used among the medical community.

3)

Licensee's responses to the questionnaire will be used to identify parameters that indicate the licensee's level of quality assurance and overall ability to control radioactive material in accordance with license conditions and NRC regulations, pilot Program on QA for Medical Use of Byproduct Material This assessment is separate TrcLi unotner information collection being conoucted by NRC involving mecical queilty assurance. That collection is also related to the proposed rulemaking to require medical licensees to implement quality assurance procedures. 1100 plans to conduct a pilot program to determine whether the proposed QA procedures uuuld interfere with the proper delivery of aadical care. ihe pilot program would involve trial use of the proposed QA procedures by volunteer hospitals or clinics for a specified period of time and r epor I;; to fiRC on the impacts from the trial use.

There is no duplicatinn between the informatior, to Le collected under the pilot program and the l

informatico to be collected under this Medical Quality Assurance Assessment.

The information collection under the pilot program has been submitted to and approved by OMB under clearance number 3150-0145.

1 A.

JUSTIFICATION 1.

tieea for the Collection of Information.

On October 2, 1987, the fiRC published a proposed rule on " Basic Quality Assurance in Radiation Therapy"intheFederalRegister(52FR36942).

In that document, the liRC proposed to amend its regulations in 10 CFR Part 35 concerning the medical use of byproduct material to require NRC medical licensees to implement certain quality assurance steps that would reduce the chance of therapy misadministrations.

In the same issue of the Federal Register (October 2, 1987, 52 FR 36949), the NRC published ar. acvance notice of proposed rulemaking concerning 2

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" Comprehensive Quality Assurance in Medical Use and a Standard of l

Care." The advance notice :,tated that the NRC was considering an f

amendment to its regulations that apply to the use of byproduct

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material for radiation therapy and diagnostic uses involving large raciation dosages. The document also noted that in addition to the current requirements for quality assurance, the contemplatec amendments would require licensees that of fer teletherapy or brachytherapy services to implement a comprehensive quality assurance program to reduce the chance of misadministration.

Both notices were I

published in response to several licensee reports of nedical-misadministrations that have occurred over the ye6rs. The goal of l

these rulemakings is to reduce the chance that patients, who are 2

members of the public, will'be carelessly exposed to ha: arcus levels of radiation. Aln.ost all the quality assurance information currectly required of licensees deals with the rodlation safety program rather than with tht neo1 cal care program t

The QA rulemaking process is now at a stage where the NRC must gather information on existing QA programs and procedures in use by necict.1 licensees.

Such inictmation is necessary to assure that the ilRC's medical QA regulations address real concerns and problems at the licensee level. Before proposing effective regulations, the liRC must understand to what extent QA systems are in place among medical licensees, and, equally important, to what degree licensees lack QA programs.

Furthermore, the NRC must know how effective those QA prograus are in preventing misadministrations, as well as how QA l

programs, and their effectiveness, vary among different types of medicallicensees(e.g.,differentsizes, missions, funding, staffing,etc.). This information will help ensure that the proposed rulemaking does not interfere with existing voluntary national standards for medical use quality assurance. The information may 1

show that voluntary national standards could be improved to the extent that there would be no need for rulemaking.

The consolidated intorn.ation may show certain high potential risk licensees that their quality assurance programs r.eed strengthening.

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i TheNRCproposestocontinuetousetheattacheoquestionnaire(see

> ) to gather this information.

The questionr. aire is designed to elicit information that is easy to characterize, not subject to distortion by the licensee or inspector, and inaicative of licensee support of the QA program, i

Information-gathering activities will continue to take place curing regularly scheduled NRC inspections.

Inspectors will devote part of L

the inspection time to completing the questionnaire with each raedical licensee. An inspector will ask the licensee the questions given in and record the licensee's response.

M necessary because of the unavailability of inspectors, NRC m6y arrange for assessment L

questionnaire interviews to be conducted by a contracter. Licensees f

will be asked to verbally provice the information; the licensee will not be expected to complete the form in writing or to interpret any of the information, in some cases, the inspector may note the information during the existing inspection process.

For instance, informatton on rutthers and braan or i.uC, car medicine equipment 'nsy already be an11able as the inspector performs thc safety inspection l

of the licensee's facility; information on misadministrations is obtained when the inspector reviews licensee records during the inspection.

In these types of cases, the inspector will Just consolidate already available information with the questionnaire.

Since NRC inspections of medical licensees occur at this time, the L

information-gathering will not require new forms of interaction l

between the NRC and licensees.

The use of the questionnaire duritig 1

inspections will only lengthen the inspection time by an estimatea L

two(2)hoursperinspection.

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The assessraent serves as one action being taken by NRC in accordance with the l

NRC's policy statement published February 9, 1979 (44 FR 8242).

That policy statement. notes, in part, that:

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a.

The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public, b.

The NRC will regulate the radiation saf ety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.

c.

The NRC will minimue intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice c1 Leuicine.

The questionnaire only serves as an information gathering tool for the inspector.

Inspecton will use the questionnaire to gather information for.the QA regulatory development study and to !dentify areas which may merit further inspection.

Once the questior.naires are complete, they will be filed at the NRC Regional Office, with a copy sent tc NRC Headquarters.

personnel at NRC licacquarters will collect, process, code, and analyze the information reported on the

- questionnaires.

The results will then be usea to identify areas where medical QA rulemaking should be initiated, modified, or stopped, i

The questionnaire is intended for cne-time use with each medical licensee. The NRC has issued licenses for the use of byproduct material for medical purposes to various individuals and institutions throughout the Uniteo States and its L

Territories. Each licensee has an assigned NRC inspection frequency, based upon the type of 11conse, and inspection frequencies range from annually for certain types of medical licensees to once every seven years for other licensees. Most medical licensees that possess radionuclides for human usr are i

inspected at least once every four years.

NRC will continue to use the-questionnaire once with each n.edical licensee. The questionnaire will be completed at the licensee's next regularly scheduled inspection.

i Finally, this information collection is necessary because medical QA issues and programs have evolved and changed rapidly over the past several years.

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independent medical advisory and accrtoitation groups have placed increased emphasis on quality assurance in the tredical consnunity, and licensees' programs have presuuably changed (or, in some cases, have failed to change) to meet expecteo standards. These changes have occurred since the NRC began addressing niedical QA issues'in the early 1970's. The NRC neecs up-to-date informaticn on QA programs in use by medical licensees to assure that NRC rulemaking addresses current problems, not ones that occurred years ago.

Since October 1987, the NRC's medical QA rulemaking process has progressed.

Comments on both notices were received, and the NRC's Advisory Cor,inittee on the Medical Uses of Isotopes offered guidance to NRC staff on the appropriate i

r direction of QA rulemaking.

One of the fundarrental public comments made at an ACMUI meeting was that any proposed QA rule should be tested with a pilot program to measure the rule's safety and efficacy. One physician practitioner who questioned the utility of the October 1987 basic QA rule reported that her l

informal test of the rule identified certcir. requirements that were buroensome l

but did rot enhance quality assurance, in some cases, quality assurance information that the staff assurced was avail 6ble to every practitioner was frequently not available at all.

In some cases, timely delivery of meoical care did not allow for the in-depth quality assurance measures required by the rule.

To ensure that the new, niore flex 1ble basic QA rule that was published January 16, 1990, will not be similarly flawec, the staff developed a Pilot Program on Quality Assurance, which was submitted for ONB clearance under 3150-0145. Both URC and Agreement State licensees that provide a wide range of medical services in a variety of geographic and socio-economic settings have i

been osked to oevelop a QA prograu that conforms to the proposed rule, and implement it for two months.

Then these volunteer licensees will discuss their experiences. This will provide the staff with real data, as opposed to

^

estimates or projections, on the costs and benefits associated with the rule; the information will be used by the Cor,miission when decicing whether to approve the final rule that the staff prepares.

2.

Agency Use of Information. Refer to Enclosure 1, " Medical Use Quality Assessment" Questionnaire.

The following sub-headings provide the agency use of information for each subheading reflected in the questionnaire.

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Questiornaire Heacing ano Licensee Identification Data - Identifying data on the licensee, contact telephone number, and inspection information is needed for future identification, analysis, and follow-up, if necessary.

The NRC needs to reference each set of responses with the particular institution being assessed.

Licensee numbers and occket numbers are necessary for NRC filing systems. Licenste contact information is needed for follow-up, if incomplete or unusual responses are given at the time of the inspection.

Fort 1. LEfJkAL A.

Licensee Type - The NRC issues licenses to varioLs types of medf ral entities -- hospiteis, physicians, cHnics, large institutions, sn. ail facilities, etc. These different organizations also provide a tariety of services and are manapert in different ways.

Information on the facihty, tcanagement, service, and bed size will provide c general characterization of the licensee and will tell NRC whether to be more clert for QA problems in certain types of licensees.

B.

Quailty Assurance Program - The NRC believes that QA programs are not stanaaroi:ed accog its raedical licensees.

Thus, information on the QA program specific to radiation medicine is neeoed from each licensce.

If a written policy statenent is uvailable, NRC will collect it, analyze it, and compare it to misaaministration occurrences and/or poor regulatory compliance by the licensee. The extent of licensee use of major medical organization guidelines is unknown, so this informatico gives hhc a raeasure of how licensees are using incustry standaros.

Specific information on the licensee's auditing procedures, time spent on radiaticn tasks, and qualifications of person performing i

raciation saf ety tasks gives URC feedback on how the licensee's written QA policy is implemented.

The facility's responses will j

indicate whether the radiation safety /QA program is integrated into i

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C the licensee's management or whether it is an additional duty within the licensee's organization.

Human factors is a developing field in radiation safety organizations. The NRC requests information on human factors analysis at medical licensees to gauge the extent and type of such analysis among the mcoical community.

C.

Misadministratirmg - Responses concerning misadministrations, which are defined in 10 CFR 35.2, will allow the NRC to understana how licensees it; vest 1pate events. NRC will usc this to examine licensees' nethods of misadministrution investigation.

Hist.1 ministrations -- characterized ari a mistake in the P

administiotion of radiopharmaceuticals or radiation therapy --

represent a possible breakdown in radiation safety procedures.

L1cer; sees with functioning QA programs should identify, investigate, correct, and prevent, it upp opr16te, any misadministrations. A licensee's actions regarding misaaministrations will inform the NRC cbout the licensee's QA program effectiveness.

Part II:

TELETHERAPY Part II:. DRACHYTHERAPY Part IV:

NUCLEAR MEDICINE (These three parts are constructea in parallel, with similar questions in each part. They are describec together, below.)

A.

Procram - Each of the three parts (teletherapy, brachytherapy, and nuclear medicine) icentifies whether the licensee provides a particular type of service.

If that service is provided then the questionnaire continues on to the next question.

If the service is not provided, the inspector will skip the _part and continue on to the next part of the questionnaire.

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s0 The. teletherapy part requests information on the licensee's x-ray teletherapy and electron teletherapy programs, in addition to the cobalt teletherapy program. Although x-ray teletherapy and electron

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teletherapy programs are not regulated by the NRC, many medical licensees use the same QA programs and procedures for these programs as they do for licensed activities.

In addition, the NRC regulates total exposure of radiation workers who work with byproduct material, so NRC is concerned with the total radiation environment at medical licensees' facilities. 1 hat environment includes possible exposure to non-licensed sources, too.

Thus, information on licensee x-ray teletherapy and electron teletherapy issues also provides information l

on the licensed programs.

B.

Equipment - NRC will examine responses to the equ 4 ment section te identify the equipment used by the licensee to provide radiation medicine services.

Such a characterization of the equipment may provide an indicator of the licensee's fiscal support of a particular service and will also tell if the licensee is keeping up-to-date with current medical care standaros. Maintaining medical equipment standards and providing sufficient fiscal support are critical QA areas.

Number, brands, ages, and characteristics of equipment are l

indicative of the licensee's devotion to providing quality medical l

care.

l l

The equipment section in the brachytherapy part questions the I

licensee about radium, as well as other radionuclides. Racium is not a byproouct material, so its use is not regulated by the NRC;'but as l

explained earlier for teletherapy programs, licensees routinely apply the same QA procedures to both licensec ano non-licensed programs with no distinction between the two.

Also, NRC regulates total exposure of radiation workers using byproduct insteritis, even if L

those workers also use non-licensed materials. Therefore, information on radium QA is directly applicabie to the 11censeo byproduct material QA program. Adverse conoitions in one could demonstrate a problem in the other.

So, QA issues are rarely 9

t separable between the licensed and non-licensed activities. The same ratict. ale is used in questioning about linear accelerators in the teletherapy part.

C.

Computer Haroware and Sof tware - NRC is seeking responses from licensees concerning their computer treatment planning hardware and software because computers are now integrated into most medical licensees' radiation therapy programs.

Furthermore, NRC knows of some cases in which incorrect use of computer software was a major cause of misadministrations; so correct use of computer hardware and sof tware should be addressed in radiation medicine quality assurance programs.

Information of this type collected by the NRC may lead to changes in regulations to insure that computer generated information is accurate, valid, and not inadvertently misused.

D.

Staffing - The questionnaire asks for data concerning numbers of diff erent types of medical staff members invohed in the radiation medicine program, their certification, and whether the members are full time or part time workers.

The questionnaire also requests the number of procedures performed by the licensee (i.e., " load") during the previous year.

This it. formation, in conjunction with the staffing levels, will tell NRC whether regulhtions are needed on the nur.iber of responsibilities and tasks assigned to dif ferent types of workers.

The licensee's responses will help NRC to evaluate whether current training requirements and staffing levels are appropriate to provide adequate assurance of public health and safety. The questionnaire will also provide a comparison between the staffing levels at different institutions.

E.

Clinical / Treatment Process for Patients - Each part of the questionnaire calls on the licensee to provide information concerning which of its employees performs specific steps in the clinical 10 i

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process for teletherapy, brachytherapy, and nuclear medicine. The steps are standard within the medical industry.

Responses will provide specific information on the extent of voluntary licensee compliance with national standards of practice published by major medical organizations. Compliance with these organizations' standards presumably offers a greater assurance of quality care and minimizes chances for misadministrations.

F.

Miscellaneous - Information collected on continuing eoucation provides NRC with date u. khether or not licensees are training and supporting training of their radiation safety and radiation medicine persor.nel. Licensee responses on managenent support of training, frequency, personnel attending, and topict presented will indicate to the NRC whether redical industry training 1s sufficiant or whether NRC should change training regulations or modify regulatory guidance.

The teletherapy part of the questionnaire also questions licensees on quality assurance practices that are of ten used in teletherapy programs, namely chart reviews and port fiin.s. Licensees' answers on these two items will provioe information on specific QA steps that the NRC believes may be essential to early detection of mistakes.

In the post, mistakes not detected by such means have evolved into reportable misaoministrations.

3.

Reduction of Burden Through Information Technology.

There are no legal-obstacles to reducing the burden associated with this information collection.

However, because of the types of informotion sought and the one-time collection, the assessment does not lend itself readily to the use of automated information technology for transfer.

4 Effort to Identify Duplication. The Information Requirements Control Automated System (IRCAS) was searched to identify duplication. None was found.

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5.

Effort tn Lie similar Information. Some information requested on the questionnaire is alreacy collected or available curing the existing inspection process.

Information concerning facility characteristics, equipment, misadministrations, and training are examples of areas where the inspector can record information that is already made available during the safety inspection.

In those cases, the inspector will enter the available information on the questionnaire, thereby minimizing the burden on the licensee.

However, for a large part of the questionnaire, similar intcrottien is not available to the NRC.

6.

F.ffort to Recur.e Small Business Burd g.

The need to determine extent and effectiveness of QA programs and proceoures at tredical licensees' facilities is the same for iarge ano smali entities.

However, small entities which oc nct hae some of the programs in the questicnnaire, such as teletherapy or brachytherapy, will not be asked to provide responses to l

those sections.

It is not poss1bie to reouce the burden on small entities by itss frequent or less complete collection of information because c

information is neeato on all kinds of and s u es of licensees.

l 7.

Conseauences of Less Frequent Collection. This information collection l

will be on a one-time-only basis.

Lessfrequentcollection(i.e.,notat all) would impair the ability of the NRC to evaluate licenstes' QA programs and to issue effective QA regulations, 8.

Circumstances Which Justify Variation from OilB Guidelines.

There is no l

vuriation frcm OMB guidelines.

9.

Consultations Outside the NRC.

The Advisory Committee on the 11edical Uses of Isotopes provided guidance to NRC steff on the need to collect information on medical industry QA practices to help provide an informed basis for the QA rulemaking.

10.

Conficentiality of Infor g n.

NRC provides no pledge of confidentiality for the collection of it..ormation, except for proprietary inforraation.

12

.o io.

i Responses and results obtained through the questionnaires, except for proprietary information, may be released to the public.

11. Justification for Sensitive Ouestions. None. The questionnaire does not contain any sensitive questions.

12.

Estimate of Burden. See Enclosure 2.

13.

Estimated Annualized Cost to the federal Government. See Enclosure 3.

14 Reason for Change in Burden.

This assessment covers the last three years of the four-year assessment. More assessments will be done in the last three years as f ewer were completec in the first yehr than expected.

15.

Publication for Statistical Use. None.

Publication of the collected responses and analysis is not intended.

13

i ENCLOSURE 1 MEDICAL USE QUALITY ASSESSMENT j

PLEASE FILE THIS COMPLETED FORM IN THE INSPECTION DOCKET FILE, AND FORWARD A COPY TO JAMES H. MYERS MEDICAL AND ACADEMIC SECTION, NMSS MAIL STOP 6H3, HEADQUARTERS Licensee:

i Docket Numbers:

License Numbers:

j Licensee Contcct:

Licensee Contact Telephone Number: (

)

Date of Inspection:

Inspector:

Region:

PART 1: GENERAL A.

Licensee Type:

1.

Facility:

a.

hospital b,

clinic c.

private practice d.

other (specify) 2.

Management:

a.

government b.

not for profit c.

for profit d.

Other(specify) 3.

Service a.

conventional care b,

teaching and research c.

specialty d.

other (specify) 4.

Number of beds:

1

i B.

Quality Assurance Program:

l 1.

Does the licensee have a written policy statement (or statements) on quality assurance specific to radiation medicine?

YES NO (if NO, go to question C).

2.

Attach copy of policy statement (s) if available.

ATTACHED l

NOT AVAILABLE 3.

Does the policy statement reference the guidelines of major medical organizations such as the Joint Comission for Accreditation of i

Healthcare Organizations, American Board of Radiology, or others?

YES NO If YES, list the organizations:

a.

b.

c.

4.

Does the policy statenmnt call for periodic audits of the quality assurance program?

YES N0 l

If YES:

a. Are audits performed by individuals or organizations that are independent of the licensee?

YES N0

b. How often are audits performed?

audits /

(month, quarter, year, etc.)

c. Lists dates and auditing organization for last four audits.

4 l

5.

How many hour:: aweekdoestheperson(eithertheRSOoradesignated technologist) who does the bulk of the radiation safety tasks spend on those tasks?

hours / week 6.

Qualifications of the person who does the bulk of the radiation safety tasks:

a. Education:

0JT AA/AS BA/BS Advanced Degree

b. Experience:

Years in field Years at facility

c. Certification:

(ABR,ABHP,ARRT,JNMTCB,A0BR,etc.orNA) i l

l L

?

7.

Is the licensee's radiation safety program analyzed by a human factors specialist?

YES NO If YES, list the departments:

,[

if YES, give examples of procedures that are analyzed:

8.

Inspector's overall observations and comments about the licensee's quality assurance program:

C.

Misadministrations:

1.

Did che licensee have any misadministrations over the past twelve months?

YES NO 2.

If any misadministrations have occurred, did the licensee perform an investigation?

YES NO N/A 3.

If an investigation was performed, is the report readily available?

YES NO N/A 4.

Is the information provided by the licensee consistent with the NRC's inspection file reports?

YES NO N/A Discuss as appropriate:

5._

Did the licensee's ' Radiation Safety Committee attempt to identify the cause of the misadministration (s)?

YES N0 N/A 6.

Did the licensee take corrective action to prevent further occurrences of misadministrations?

l YES N0 N/A 7.

Discuss corrective actions:

3

6

,e

.O, o

PART 11:

TELETHERAPY A.

Program:

1.

Does the licensee have a cobalt teletherapy program?

YES N0 3

2.

Does the licensee have an X-RAY teletherapy program?

YES N0 3.

Does the licensee have an electron teletherapy program?

YES NO (If N0 to all three above questions, go to PART !!!: BRACHYTHERAP7)

B.

Capital Equipment 1.

Number, brand, age and exposure rate (RHM) of cobalt units (the whole unit, not just the source):

a. Number:

i

b. Brand (s):

c. Age (s):

d. RHM:

e. Not Applicable:

2.

Number, brand, age, and photon and electron energies of linear accelerators,

a. Number:

b. Brand (s):

c. Age (s):

d. Photon and Electron energies:

e. Not Applicable:

3.

Number, brand, and age of simulators:

a. Number:

b. Brand (s):

c. Age (s):

d. Not Applicable:

Number, brand, and age of the following dosimetry equip (ment:

4.

Equipment Number Brand (s)

Ages)

N/A a.

Primary standard chamber and electrometer:-

b.

Secondary standard chamber and electrometer:

1 4

6 I-Equipment Number Brand (s)

Age (s)

N/A c.

Isodose plotter:

d.

Chamber constancy checker:

e.

Other(e.g.,

Monitrex or custom-madedevice):

C.

Computer Hardware and Software:

1.

Does the licensee use a computer (or computers) in telotherapy treatment planning?

YES NO (IfNO,gotoD).

2.

Number, brand, and age of teletherapy treatment planning computers:

a. Number:

b. Brand (s):

c. Age (s):

3.

Is the computer system:

a.

Dedicated turnkey hardware / software package?

b.

Standard desk to Other (specify) p computer and off-the-shelf sof tware?

c.

4.

If computers are used for teletherapy treatment planning:

a. What percentage of cobalt patients?

% or NA.

b. What percentage of X-ray patients?

~ % or NA.

c. What percentage of electron patients? _~ J or _~ NA.

5.

Does the licensee:

a. Develop its own software?

YES, N0

b. Only use commercially availab"Te sof tware?

YES, E N0

c. Buy and extensively modify commercial software?

N0

d. Name and manufacturer of commercial software used or NA.

6.

Does the licensee " lock-out" programs that are not to be used on the treatment planning computers?

YES NO 7.

How does the licensee maintain quality assurance of treatment unit data that is loaded into the treatment planning computers? (Describe QA of data, QA of loading process, and whether phantoms are used as a check on the system.)

5

,d O.o, i

8.

How are computer calculations for individual patient doses checked?

l (describe)

I D.

Staffing

1. Cer *

1. Not

1. In-FT/PT**

tified Certified Training 1.

Oncologists(MD):

2.

Physicists (Phys):

3.

Dosimetrists(Dos):

4 Technologists (Tech):

5.

Consultant (C):

6.

Others: Nurse (N)

SocialWorker(SW)

Transporter (Tr)___

LabAssistants(LA)

TechnologistAssistants(TA)

Current certification by any national certifying body, such as ABR, ABHP, ARRT, JNMTCB, A0BR, etc.

FT = full Time, PT = Part Tine i

E.

Load Number of new Not patients last Applicable year 1.

Cobalt 2.

X-ray 3.

Electron l

l 6

i F.

Treatnant process for cobalt patients Step

• Done by" Reviewed by*,

1.

Clinical Evaluation 2.

Therapeutic Decision-Making

]

3.

Target Volume Localization j

Definition of tumor L

Identification of sensitive organs and tissues j

L l

Heasurement of patient

)

i l

Construction of patient l

contours Shaping of field 4

Treatment Planning Selection of treatment technique j

Computation of dose distribution Calculation of dose / time / volume relationship 5.

Simulation of Treatment 6.

Fabrication of Treatment Aids l

Construction of custom blocks, compensating filters Selection of innobilization I

devices See " Radiation Oncology in Integrated Cancer Management," 1986.

If step is not performed, write "NA."

If step is performed, use the l'

following abbreviations for the person performing the test, or write in the position if none of these applies:

MD

= oncologist C

= consultant Tr = transporter Phys = physicist N

= nurse LA = lab assistant Dos = dosimetrist.

SW

= social worker TA = tech assistant Tech = technologist i

7

p

.' o

.c i

bone by""

r.eviewed by**.

7.

Trectnent initial verification of l

treatment set-up l.

Verification of accuracy of L

repeated treatments Ccntir,uhl assessment of quipment performance Periodic checks of dosimetry, l

record-keeping 8.

Patient Evaluation During Treatment 9.

Followup Evaluation l

10. QA Physicial Measurements 1

Weekly spot-checks Annual calibration Measurements ur. custom patient devices l

• See " Radiation Oncology in Integrated Cancer flanagement," 1986.

• • Use abbreviations from page 7.

If step is not performeo, write "ilA."

l G.

Miscellaneous 1

1.

Chart reviews a.

How frequently are they scheduleo?

b.

Who attends?

l 2.

How of ten dces the licensee take port films?

l.

3.

On-site continuing education a.

Doesthelicenseesupport(tine, tuition, travel) continuing education?

l on-site

YES, N0, l

off-site

YES, N0.

i b.

How frequently is this provided?

i l

c.

Who attends?

I d.

What kinds of topics are presented? (Give examples) i I

4.

On what percentaoe of patients is a physica 1 measurement made to l

con 11rm de cose~ rate for that specific pat'ent?

u g

l i

j l

.o

'.o PART !!!: BRACHYTHERAPY A.

Does the licensee have a brachytherapy program?

YES, NO.

(If NO, go to PART IV: Nuclear Medicine) 8.

Equipment Total

1. of Sources Not Activity or Seeds on Applicable on Hand Hand 1.

Cesium inventory:

mC1 sources 2.

Radium inventory:

mci sources 3.

Usual iridium inventory on hand:.

mCl seeds 4

Usual iodine seed inventory on hand:

mci seeds 5.

High Dose Rate brachytherapy unit:

mci

_ sources 6.

Strontium eye applicator:

mci 7.

Other(specify):

C.

Computer hardware and software (do not duplicate if same as for teletherapy) 1.

Does the licensee use a computer (or computers) in brachytherapy treatment planning?

YES, NO 2.

Number, brand, and age of brachytherapy treatment planning computers:

a. Number:

b. Brand (s):

c. Age (s):

3.

Is the computer system:

a.

The same as used for teletherapy?

b.

Dedicated turnkey hardware /sofware rackage?

Standard desk to Other (specify) p computer and off-;he-shelf hardware?

c.

d.

(

1

\\

9 i

I l

.4 - '.r 4

4.

What portion of brachytherapy patients have their doses calculated on a computer system?

Percentage Not Applicable cesium:

radium:

iridium:

iodine:

5.

Does the licensee:

a. Develop its own software?

YES, NO.

b. Only use commercially available software?

c. Buy and extensively modify commercial software?YES,"YU, NO.

NO.

6.

Does the licensee lock-out" programs that are not to be used on the treatment planning computers?,_ _ YES, NO.

7.

How does the licensee maintain quality assurance of treatment unit data that is loaded into the treatlent planning computers?

(Describe both QA of data and QA of loading process.)

8.

How are computer calculations for individual patient doses checked?

(describe)

D.

Staffing *

1. Cer **

1. Not

1. In-FT/PT***

tified Certified Training l

1.

Oncologists (MD):

2.

Physicists (Phys):

3.

Dosimetrists(Dos):

4.

Technologists (Tech):

5.

Consultant (C):

6.

Others: Nurse (N)

SocialWorker(SW)

Transporter (Tr) _

LabAssistants(LA)

TechnologistAssistants(TA)

If you completea this information in Part 1: Teletherapy, do not repeat.

Current certification by any national certifying body, such as ABR, ABHP, ARRT, JNMTCB, A0BR, etc.

I FT = Full Time, PT = Part Time 10

b l

,, o o.-

J l

E.

Load Number of patients Not treated last year Applicable 1.

Cesium

(

2.

Radium 3.

Iridium 4.

Iodine 5.

High Dose Rate Unit 6.

Strontium 7.

Other (specify)

F.

Trau..ent process for brachytherapy patients Step

• Doce by**

peviewed by" 1.

Clinical Evaluation 2.

Therapeutic Decision-Making 3.

Target Volurre Localization Definition of tumor laentification of sensitive organs and tissues 4.

Treatment Planning Selection of volune for implantation Appraisal of dosimetry Estimation of tolerance to procedure Check-off of equipment Arrangement for surgical suite and anesthesia See " Radiation Oncology in Integrated Cancer Management," 1986.

Use abbreviations from pdge 7.

If step is not performed, write "NA."

11

Step

• Done by**

Reviewed by**

5.

Treatment Examination of anesthetirec patient Review of initial treatment plan Implantation 6.

Verification of implantation 7.

Dosimetry Calculation from actual implant 6 tion Establishment of time for removal 8.

Patient Evaluation During Treatment i

9.

Removal of implant 10.

Follow-up Evaluation See " Radiation Oncology in integrated Cancer Management," 1986.

Use abbreviations from page 7.

If step is not performed, write "NA."

G.

Miscellaneous Continuing ecucation (do not repeat inforraation provided under Pert 1: Teietherapy) i 1.

Does the licensee support (time, tuition, travel) continuing ecucation?

on-site

YES, NO, off-site YES.

NO.

2.

How frequently is this provided?

3.

Who attends?

4 What kinds of topics are presented?

(Giveexamples) i 12 l

r

. c !

• 1c o :

PART IV: NUCLEAR MEDICINE i

A.

Does che licensee have a nuclear medicine program?

YES, NO(IfNO,theformiscomplete).

I

.B.

Capital Equipment t.

O 1.

Number, brand, and age of cameras:

Number:

Brand (s):

I Age (s):

Not Applicable:

1 2.

Number, brand, and age of imaging manipulation computers:

Number:

Brand (s):

Age (s):

Not Applicable:

3.

Number, brand, and age of dose calibrators:

Nunter:

Brand (s):

Age (s):

Not Applicable:

4 Number, brand, and age of survey instruments:

Number:

Brand (s):

Age (s):

Not Applicable:

i 4

13

C.

Staffing

1. Cer *

1. Not

1. In-FT/PT**

tified Certified Training 1.

Physicians (MD):

2.

Physicists (Phys):

3.

-Technologists (Tech):

4.

Technicians (Ten):

5.

Consultant (C):

6.

Others:, Nurse (N)

Social Worker (SW)

Transporter (Tr) _

LabAssistants(LA)

TechnologistAssistants(TA)

I i

Radiopharmacists(RadPh)

Current certification by any national certifying body, such as ABR, ABHP, ARRT, JNMTCB, A0BR, etc.

FT = Full Time, PT = Part Time D.

Number of imaoing procedures last year:

E.

Clinical process-for imaging patients Step Done by**

Reviewed by**

la. DosagePreparation(on-site)

Generator elution Moly test 1

Kit reconstitution Tagging test Dosage preparation If step is not performed, write "NA."

If step is performed, use the following abbreviations for the person performing the test, or write i

in the position if none of these applies:

j MD

= physician C

= consultant LA

= lab assistant Phys = physicist N

= nurse TA

= tech. assistant

. Tech = technologist SW

= social worker RadPh = radiopharmacist Ten = technician Tr

= transporter 14

m

. ; *- ~e, Step Done by" Reviewed by**

Ib.; Dosage Ordering (nuclear pharmacy)

Prepare order list 1'

Place order L

Verify packing slip 7

2.

Referral review 3.

ScheCuling.

L 4.

Dosage administration t

E 5.

Imaging and data collection Simple static Simple dynamic Cornplex dynamic 6.

Computer processing of images 7.

Evaluation i

h b

8.. QA f hysical Measurements Dose calibrator 7

1 Camera Film processor Use abbreviations from page 14 If step is not performed, write "NA"

[

F.

Miscellaneous Continuing education i

1.

Does the licensee support (time, tuition, travel) continuing education?

l.

on-site

YES,

.l10,

.off-site YES,.

NO.

l 2.

How frequently is this provided?

l 3.

Who attends?

4.

What kinds of topics are presented? (Give examples) 1 15

..e..

ENCLOSURE 2 L

ESTIMATE OF BURDEN l

1.

Time Burden l

1 L

The estimated one-time burden for this-information collection is i

l approximately two (2) hours for each meaical licensee. Table A (Enclosure 4 to the Supporting Statement) shows the types and numbers of licensees that will complete the questionnaire. A total of approximately 2383 licensees will be assessed over a period of about four years, with the i

number of assessments completed (industry-wide) decreasing in each l

succeeding year of the requested clearance period. During the first year of questionnaire use, about 209 licensees participated in the assessment.

Total industry burden over the life of the program is approximately 4766 hours0.0552 days <br />1.324 hours <br />0.00788 weeks <br />0.00181 months <br /> (2383 licensees x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> / licensee). Total industry burden for the three years covered by this supporting statement is approximately 4546 hours0.0526 days <br />1.263 hours <br />0.00752 weeks <br />0.00173 months <br /> (2174 licensees x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> / licensee).

t 2.

Cost Burden Estimated one-time cost per respondent, based on an assumed $100/ hour professional labor rate, is approximately $200.

($100 per hour x 2 hoers). Total average industry cost each year is approximately $145,000 (725 licensees x $200 per licensee). Total industry cost over the life of.

the program is approximately $477,000 (2383 licensees x $200 per licensee; rounded to the nearest thousand).

3.

Labor Rate Assumptions The $100/ hour labor rate useo above is an assumption of the hourly cost of licensees' professional medical staff to provide responses to the questionnaire.

In many instances, technicians or technologists may provide responses to the questionnaire, in which case the labor rate (and, therefore, licensees' costs) would be substantially lower.

In other instances, professional staff such as doctors or administrators may arovide responses, in which case the labor rate and associated costs might ae higher. The $100/ hour pra sssonal labor rate is considered by NRC staff to be a conservative estimate.

4.

Number of Medical Licensees The number of respondents is based on the number of medical licensees as of May 1990. The number of medical licensees has remained fairly constant over time.

Barring any unforeseen major regulatory or industry actions that might cause changes, the number of medical licensees is expected to remain stable over the period of questionnaire use.

It is possible that within the next few years, certain States may enter into agreement with the NRC to regulate their own medical licensees.

If such events do occur the total number of respondents (and associated industry burden and cost) would decrease.

However, as a conservative estimate, it is assumed in the above calculations that the number of medical licensees will remain stable and that data for May 1990 is representative of the number of medical licensees over the next three years.

,,4a.

O i

i ENCLOSURE A ESTIMATED ANNUAll2ED COST TO THE FEDERAL GOVERNMENT The questionnaire will be used with a total of approximately 2383 medical licensees (see Enclosure 4 to the Supporting Statement, " Table A").

Since it is used on a one-time basis during the medical licensee's next regularly scheduled inspection, and since inspection frequencies vary among the different types of licensees, the 2383 medical licensees will be assessed over a period-of approximately four years; this supporting statement is for the second, thira, and fourth years. To estimate the annualized cost to the Federal government, the average number of licensees to be assessed each year will be used in the following.calulations (that is, the total remaining licensees diviceo by three years). That average number of licensees assessed per year is about 725 licensees / year (2174 remaining licensees divided by 3 years). All of the following cost estimates are rounced to the nearest thousana collars.

'l.

Completing the Questionnaire Estimatea NRC time to complete T3 = 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> / licensee questionnaire with the licensee Approximate overage labor L3 = $92/ hour rate for NRC staff time Average number of licensees N1 = 725 licensees to be assessed each year So, estimated annualizea cost to the Federal government to complete (but not analyze) the questionnaire is:

I Cost; = Ty 1

3 xL xN 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> / licensee x $92/ hour x 725 licensees a

Cost = $133,400 y

II. Administrative Functions (Coding, copying, filing, followup, etc.)

Estimated NRC staff time for T2 = 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> / questionnaire aaministrative functions Approximate average labor L, = $46/ hour rate for NRC staff time Average number of questionnaires N2 = 725 questionnaires to be assessoa each year

).C ua O

-So, estimated annualized cost to the Federal government to complete administrative functions associated with the questionnaire.is:-

Cost 2=T2*L2 2 = 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> / quest. x $46/ hour x 725 questionnaires xN Cost 2 = $33,350

!l:

III. Analysis Approximately 725 hours0.00839 days <br />0.201 hours <br />0.0012 weeks <br />2.758625e-4 months <br /> / year, an average of one hour per questionnaire, will be used for analysis of the licensees' responses to the questionnaire, At a labor rato for NRC professional time of $92/ hour, the analysis will cost the Feceral government:

Lost 3 = 725 hours0.00839 days <br />0.201 hours <br />0.0012 weeks <br />2.758625e-4 months <br /> / year x $92/ hour Cost 3 = $66,700 1

IV. Materials and Other Operating Expenses

(

Additional cost for materials, copy supplies, mailing, and other operational expenses is estimated to be approximately $1000/ year.

Cost 4 = $1000 1

8

l6, %e

.c

-C The total estimated annualized cost to the Feoeral government for the use of-this questionnaire is incurred from the labor costs and from the cost of materials and other operating expenses.

That total annualized cost for an average year is:

1 Totai Anr;ualized Cost = Cost

+ Cost

+ Cost

+ Cost y

2 3

4

= $133,400

+ S33,350

+ $66,700

+ $1000 Total Annualized Cost = $234,450 e

Again, it should be recognized that this is the averace annualized cost to the Federal government to use the questionnaire. Actual costs will differ over the three remaining years of the program, with costs being greatest in the second year and decreasing substantially in successive years.

3

TABLE A:

' BREAKDOWN OF QUESTIONNAIRE RECIPIENTS S

M I

2 4

4 4

" Program Title

1. oi Inspec. 3 # in

1. in

1. in

1. in Code Licences - Priority 1st 2nd 3rd 4th Year Year Year Year 02110 Medical Institution Broad 118 1

10 108 0

0

'02120 Medical Institution Other - Group 1407 3

123 428 428 428 02121 Medical Institution Other - Nongroup 14 4

1 5-4 4

'02200 Medical private Practice - Group 301 4

27 92 91 91 02201 Medical Private Practice - Nongroup 174 4

15 53 53 53 02209 Grandfathered General Hedical Use - 35.31 73 4

7 22 22 22 02210 Eye Applicators Strontium-90 49 4

4 15 15 15 02220 Mobile Nuclear Medicine Service 22 2

2 10 10 0

02300 Teletherapy 225 1

20 205 0

0 TOTALS 2383 209 938 623 613 I Current as of May 11, 1990.

2 Frequency of inspection is determined by inspection priority. The inspection priority is the interval, in years, between successive NRC inspections. For example, an inspection priority of 4 means one inspection every four years.

3 The "i'in 1st Year" is the approximate number of licensees that have alit:aq participated in the one-time

~

questionnaire assessment in the first year of.its use, under infomation collection 3150-0148.

4 The approximate number of licenstes that will participate in the given year.

.o

.f.

o G

u z

m