ML20206H791

Request for OMB Review & Supporting Statement Re Pilot Program on QA Concerning Medical Use of Byproduct Matl. Estimated Respondent Burden Is 3,500 H

ML20206H791
Person / Time
Issue date:	11/08/1988
From:	Mcdonald W NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM)
To:
References
NUDOCS 8811230326
Download: ML20206H791 (11)

Text

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l SUPPORTING STATEMENT FOR l I

PILOT PROGRAM ON QUALITY ASSURANCC l

ON MEDICAL USE OF BYPRODUCT MATERIAL DESCRIPTION OF THE INFORMATION COLLECTION i

10 CFR Part 35 provides safety regulations for the medical use of radioactive byproduct material by hospitals, cli,11cs, and individu61 physicians. However. {

there were several incidents involving medica: use of b,vproduct material caused f by simplo human error. 'From 1980 through 1987, 52~ incidents involving' radiation l

or radiopharmaceutical therapy and 23 incidents involving todine-131 with a  !

resulting thyroid dose of several thousand rads were reported to the NRC. The NRC is proposing to amend its regulations that would require its medical licensees to implement quality assurance (QA) procedures in order M avoid, detect, and I correct simple human errors.

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i The NRC will conduct a pilot program to determine whether the proposed QA procedures would interfere with the proper delivery of edical care. The i pilot program would involve trial use of the proposed QA procedures by volunteer hospitals or clinics for a specified period of time and reports to the NRC on the impacts from the trial use. A copy of the draft protocol for f thepilotprogramisenclosed(Enclosure 1). l I

, I 1 INFORMATION COLLECTION /ATSE 10/13/88 I

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?. . Justification I

1. Need for Collection of Information i

The NRC believes that the imposition of QA procedures without being tested  !

my, in certain situations, interfere with the proper delivery of medical  !

care. The infora tion to be collected from the pilot program will provide a i partial basis for the NRC to make a determination whether the proposed QA procedures should be modified to avoid or reduce the potential interference.  :

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2. Agency Use of Inform tion j a  !

The NRC will analyze the information collected during the pilot. program and l detemine whether the proposed regulation and the accompanying draf t 3 regulatory guide (both documents are under preparation by the NRC staff) should be revised in order to reduce any potential interference with medical i i

practice but still meet the intent of the proposed regulations, j i

3. Reduction of Burden Through Information Technology ,

L There is no legal obstacle W the use of information technology. Moreover, l the NRC encourages it, i

4. Effort to Identify Duplicate Information The Inforntion Requirements Control Automted Systen. (IRCAS) data base has i

been searched and no duplication with other collections of information have I been found. [

f 10/13/88 2 INFORMATION COLLECTION /ATSE i

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5. Effort to U3e Lib Mar Information ,

r There is no source for the required information other than NRC sedict1 licensees, f f

6. Effort to Reduce Small Business Burden i

Information collected from small businesses participating in the pilot program will be examined by the NRC to determine whether a reduction of small business burden is warranted. ,

i e i 4 7. Consequences of Less frequent Collection l t

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This information. collection is a one time effort. . _ _

! 8. Circumstances which Justify Variation from OMB Guidelines I This information collection follows OMB Guidelines.

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9. Consultants Outside the NRC l

Brookhaven National Laboratory has been retained under contract to assist the NRC in conducting the pilot program. I I

10. Confidentiality of Information e i

i NRC provides no pledge of confidentiality for this information collection.

3 INFORMATION COLLECTION /ATSE i 10/13/88

11. Justification of Sensitive Questions Thi, ' on collection does not involve sensitive or private in'

12. Estimated Cost to the Fr.deral Government The one time cost for the staff to review and analyze the information is estimated to be $12,000 (about 3 staff-months). In addition, the cost of the contractor is estimated to be $220,000. Therefore, the total Federal cost is

$252,000.

13. _ Estimate of potential Industry. Burden and_ Cost .__ ._ ___

The number of medical licensees that will be participating in the pilot program is estimated to be 50. Each participant will need about 40 staff-hours to set up the pilot program, including participating in two workshops, a subtotal of 2,000 staff-hours. In addition, each participant will average 1 staff-hour per day to implement the proposed QA procedures for about 30 days, a subtotal of 1,500 staff-hours. The total estim ted industry burden is 3,500 staff-hocrs. Assuming a labor ccst of $60 per hour, the total one time industry cost would be about $?10,000.

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i 14. Reasons for Change in Burden i

This is a new program.

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4 INFORMATION COLLECTION /ATSE 10/13/88 l

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15. Publication for Statistical Use The NRC plans to publish a NUREG/CR report about 4 months following completion of the program, B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Information collection provisions of 10 CFR Part 35 do not require the use of statistical methods.

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l 10/13/88 5 INFORMATION COLLECTION /ATSE

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WORKlf+G PAPER SEP83 ges WORKING PAPER DRAFT PROTOCOLS FOR PILOT PROGRAM

1. Purpose of the pilot program The purpose of the pilot program is to determine the impacts of the proposed QA prodedures, including whether these procedures would interfere with the proper delivery of medical care. These QA procedures are designed to reduce simple human errore in medical uses of byproduct material. However, the pilot program is not designed to obtain a statistically significant quantitative cost benefit ratio because the frequency of occurrence of misadministrations is very low.

Participants may be selected from volunteers that responded to the FR notices announcing a relevant Subcommittee meeting, the proposed rulemaking, and the pilot program.

2. Selection of hospital (clinic) participants A. Factors to be considered in selecting participants

a. Size of hospitals or clinics (in terms of No. of beds):

Large hospitals, small hospitals, or private clinics.,

b. Financial resources:

Private, or public hospitals.

c. Geographical locations:

East, central, or west coast

d. Population charateristics:

Urban and suburban, or rural arears.

B. Number of participants About 50 participants (see matrix on next page).

3. QA procedures to be tested l

QA procedures specified in the preliminary regulatory guide.

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4. Test period Test period is 30 calendar days.

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MATRIX FOR DETERMINING NUMBER OF PARTICIPANTS PRIV. NO OF PARTICIPANTS SIZE /PUBLIC GEOGRAP. POPULATION IN THIS CATEGORY L PR E E

U R

M -

L PR L PR C U L PR C R L PR W U L PR W R L PU E U L PU S R L PU C U L PU C R L PU W U L PU W R S PR E U g S PR E R TO BE DETERMIND

.S PR C- - - - -. - U - - - - - - . - - A _-.

S PR C R S PR W U S PR W R S PU E U S PU E R S PU C U S PU C R S PU W U S PU W, R C PR E U C PR E R C PR C U C PR C R C PR W U C PR W R C PU E U C PU E R U PU C U C PU C R C PU W U g C PU W R (

Estimate total participants: 50

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5. Information to be collected For each QA procedure, record the following information A. Economic impacts:

a. additional direct cost ($),

b. additional manpower (man-hours.for i2rious types of personnel, such as physician, physicists, etc.)

c. other costs B. Unavailability of qualified personnel:

a. types of personnel needed

b. how many do you need c, how many are available to you

d. how did you obtain the additional personnel during the pilot testing period.

e. how would you obtain the personnel if this procedure would be required in the future C. Interference with medical practice:

a. the_ circumstances under which_a medical. procedure _is interfered with because of implementing a QA procedure

b. how could the interference be avoided or reduced but still satisfy the intent of the QA procedure D. Benefit:

a. ' types of human errors detected because of implementing a QA procedure

b. types of, human errors you believe might be prevented because of a QA procedure

c. other benefit

6. Alternatives to be considered based on test results A. Interference with medical practice

a. profide other specific alternative QA procedures that could avoid or reduce the interference with medical practice i

b. if no other specific alternative exists, consider a more general QA procedure D. Unavailability of qualified personnel

! a. provide alternatives that may reduce the need for l

a special type of personnel l b. consider special alternatives for certain types of hospitals or clinico l

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C. Economic impacts

a. Provide alternatives that may reduce the economic impacts

b. consider special alternatives for small entities

7. Anticipated problems A. Severe impact or interference from a QA procedure If a licencee encounters a severe impact or interference with the delivery of medical care, the licensee should immediately notify the contractor's principal investigator or the NRC project manager. Depending upon the seriousness of the problem, che NRC project manager may take one of the following cetions:

a. discontinue the QA procedure, or

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b. provide alternatives 7-~

B. Implementation problems for testing QA prodcedures The contractor's principal investigator should periodically contact'each licensee's principal investigator to ensure that the pilot testing at that facility is functioning properly. If there are any problems, the#NRC project manager should be immediately notified. Depending upon the seriousness of the problem, conference telephone calls or meetings among the licensee, the contractor, and the NRC project manager should be arranged to resolve the problem promptly.