ML20154R263

Mod 3,revising Matl to Be Covered in Medical Uses of Byproduct Matl Course,To Medical Uses of Byproduct Matl

ML20154R263
Person / Time
Issue date:	09/29/1988
From:	Edgeworth P NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM), TEXAS, UNIV. OF, SAN ANTONIO, TX
To:
Shared Package
ML20154R248	List: ML20154R245 ML20154R263
References
CON-FIN-B-8764, CON-NRC-05-87-121, CON-NRC-5-87-121 NUDOCS 8810040213
Download: ML20154R263 (10)

Text

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1. CON T RACi tO COOL PAGE OF PAGES AMENDMENT OF SOLICITATION /MODIFICA MON OF CONTRACT 1

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2. AMLt40 MEN T/MOOlfiCA TION NO.

J. LF f L T4VE DAT E

4. HLQU4541 EON /PUHCHASE REQ. NO.

5. PROJCCT NO. (t/.pphes6ie)

Thr'ee (3) 9 /,2.h,P/

IE-87-121-dtd'. 8/17/88 ussUco oy j

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7. AOMmis1EHCO nv <st.ea,r ca.. se, si l

cOM U.S. Nuclear Regulatory Commiasion 0 Division of Contracts 6 Property !!gmt.

Washington, DC 20555

c. N Auc ANO ADOHoss OF CON T RAC TOH su..ey<,. e.u er. si.e,.a4 ze c.4,s

<f3 sA. AMcNOucu r OF sOtlCir ATION NO.

The University of Tc::as Science Center at San Antonio Su O^TcOrsestrzu su

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7703 Floyd Curi Drive San Antonio, Texas 78284 ICA. MoosFICAllON OF CON 1 H ACi/ORot;R NO.

X NRC-05-87-121 800. DA1 LO (SEE flLAf J 3/

cOoc j rACluTY CODc 3/30/87

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS Tbe above numtered solicitation is amer +d as set forth in Itern 14. The hour and date specifivo for receipt of Offers is e a tendas.

is not en.

tenctsj.

Of fers must ack nowledge receipt of this amendment prior to the hour and date sfecified in the solicitation or as amended. by one of the foHowing fnethods; (a) 0y compteting items 8 and 15.ar.3 returning copies of the amerusment; (b) 0y acknowla$ging receipt of this amendment on each copy of the of fer sutamittaj; or (cf By separate letter or teleyam which includes a reference to the solicitation and amendment numters. FAlltlRE OF YOUR ACKNOWLEDG.

MENT TO DE RECEIVED AT THE PLACE DESIGNATCD FOR THE ACCE(PT OF OFFERS PAIOR TO THE HOUH AND DATE SPCCIFIED MAY RESULT JN TsCJECTION OF YOUR OF FCH, if by Wetue of this amendment you desire to chanW an of fer already sut>mitted,such chaf95 may Le nu.1e t y telegram os letter, providaf each telegram or letter snakes teference to the solicita0on and this amers$ ment.and is receiwd prior to the openirq hr>ur and date specified.

12. ACCOUN T,4t*G AN D ACPHOPHI A T tOf 4 QAI A (l/ requsMd) 82-19-01-05 B8764 31X0200.828

$23,040.'O l

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS / ORDERS.

i IT MODIFIES THE CONTRACT / ORDER NO. AS DESCR10E0 IN ITEM 14.

A f HIS C H ArdG t: ON OC A 4 5 555UE 0 PUH >u AN T 10) (Specs /y.u rn rity) T H8~. CHANGES SE T FOH1H IN 4 T EM 14 AH L M ADE 1r4 T HE CON.

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X FAR Clause 52.240-1 Changes - Fixed Price - Alt. 1 (Apr. 84)

U. T HC AUOVE NUM BC H E D CON T R ACT/OROCH ls MOOtFIED TO REFLf'CT T HE ADMINtST R ATIVE CHANGE:e (such ch.a tes 49 p.ylmt.ffste.

.ppropri rsom d.re, etc.) $E T FOR Tb (N IT EM 14. PU H$U Are T TO THC AU THO RIT Y OF F A R 4 3.103(t>).

C.1 H15 $UPet U.t L N 7 AL AG H L EMLt. T IS Ltd T 4.H t.O Ifd TO PUH SU AN T 10 AU1 HO Hl f Y OF :

8910040213 880929 O. O t H t H <scuex o p, or mos.ru.r...a..,a PDR CONTR NR C-Oh8_7_-121 PNU E. IMPO R TAN T: Contractor b is not. Ois,cquitcaio.isaini,eUcurnentomo,.iurn

- cop es to ine issuins civic.

i ls. O< sc H wi uON us A M t N OM eN rsuoOa IC A s s0N <O,,,,a,a s, ocF <<e>.n k<.senen.

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The purpose of this modification is to revise the natorial to be covered in the !!edical Uses of Byproduct !!aterial Course by deleting the topics of brachytherapy and telethorapy and 1 caving l diagnostic nucicar medicine and radiopharmaceutical therapy as the major course topics, and to i

increase the total amount of the contract by $23,040.00.

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The NRC hereby accepts the offer of the University of Texas Science Center at San Antonio dated Septenber 20, 1938 as revised by 1cteers dated September 23, 26, 27, and 28,1988, all I

incorporated herein by reference, to perform the work outlined horcin.

l Therefore, the subject contract is riodified as follows:

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ERC-05-87-121 liodification No. 3 Page 2 of 5 1.

SF26, Block 15G, Total Amount of Contract, is revised to read, "$6 5,280.00".

2.

Section B, Add a new paragraph, B.3 as follova:

"B.3 The price for the revisien (

5e course material and presentation of one course is $23,040.00."

3.

Add, under Section C, Description /Spect fications/ Work Statement, a new Part, C.1.3.6 to read as follows:

C.1.3.6 Course Modifications a.

Course Outline.

Attachment I shall replace the proposed course outline in the original statement of work.

b.

Course manual.

The Contractor shall modify the existing course manual to adequately cover the topics listed in i. The manual shall include copies of important viewgraphs or slides (visual aids) used during course presentations and copies of applicable case studies.

The contractor shall include in the revise manual a glossary of common terms relating to the course topics.

c.

Case Studies.

The Contractor shall revise case studies, where applicable, to supplement course lectures.

I d.

Instructor I.esson Plans.

The contractor shall revise the existing course lesson plans to reflect the topics identified in Attachment 1.

e.

Visual Aids.

(viewgraphs, slides, etc.) The contractor shall revise the course visual aids as necessary to support the revised course presentation.

f.

_ Lea rn i ng_Obj ec ti ve s.

Learning objectives shall be prepared for each course topic.

The intent of the objectives is to provide a means for the students to concentrate on key points and prepare for the course examination.

Copics of the learning objectives will be provided to the students.

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M[odificationNo.3 N C-05-87-121 Page 3 of 5 An approximate breakdown ~of time (in hours) to be spent on course topics is as follows:

(1) Introduction 1.5 (2) Radiology (a) Radiobiology / Glossary Familiarization 2.0 (b) Facilities, Equipment and Instrumentation 3.0 (c) Clinical, Research and In-Vitro Procedures 2.5 (d) Safe Handling of Patient 1.0 (e) Radiation Surveys 0.75 (f) Training and Retraining 0.5 (g) NRC Bulletins and Information Notices 0.5 (h) Responsibilt+.ies and Authority of Key Personnel 0.75 (1) ALARA Program 0.75 (j) Diagnostic Nuclear Medicine and P,adiopharmaceutical Misadministrations 2.0 (k) Transportation 0.5 (1) Emergency Procedures 0.5 (m) Records 0.75 (n) Quality Assurance Program 1.0 (o) Waste Disposal 1.0 (p) Hands-on-Experience 12.0 (NRC speaker, 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />)

(q) Observations 2.0 1

(3) Ex&mination 3.0 The NRC shall provide an instructor to cover the material discussed in l

topic I (Introduction) and topics II.Q.4 and II.Q.5 (Reviewing of license applications for limited and broad scope specific licenses and simulation of a nuclear medicine inspection).

l Delete, under Section C, Description / Specifications / Work Statement, 4,

Subsection C.1.3.2 in its entirety and replace it with the following:

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C.1.3.2 Course Description / Presentation i

The contractor shall furnish qualified personnel, classroom, laboratory and clinical facilities, materials, texts, and services to conduct a training course of approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> duration entitled "Medical Uses of Byproduct Material." A course outline is enclosed.

In particular, the course shall provide participants with the following:

A brief review of principles of radiation protection and elements a.

of a radiation protection program.

This shall include a

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familiarization with the radiation hazards incident to the use of byproduct material in nuclear medicine and research as follows:

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NRC-05-87-121

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Modification No. 3 Page 4 of 5 Radiation does likely to be received by the patient under going a medical procedure Radiation dose received by hospital personnel as a result of.

handling byproduct material and caring for the patient during and after the administration b.

Familiarization and demonstration of the types of instruments and equipment used for the medical use of byproduct material, e.g.,

survey instruments, dose calibrators, generator systems, shielding devises, well counters, liquid scintillation counters, lung ventilation units and associated monitoring systems, thyroid probes, gamma cameras, bone mineral analyzers, lixiscopes, or devices containing byproduct material such as appitcators and nylon ribbons, and in vitro facilities.

Ilands on experience in laboratory exercises including the c.

following:

clution of technettu'm-99m generator permissible molybdenum-99 breakthrough concentration drawing of doses kit preparation dose calibrator constancy, accuracy, linearity and geometry test

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wipe and leak test surveys of areas, equipment and packages d.

A brief review of the Federal Food and Drug Administration (FDA) regulatory authority over radiopharmaceutical containing byproduct material.

A brief review of NRC regulations, license conditions, NUREGs, e.

and regulatory guides applicable to medical licensees.

f.

Current research and development and future development trends in the medical use of byproduct material that may affect NRC's regulatory requirements.

Problems that may be experienced and things to look for during an g.

inspection.

5.

Delete, under Section C, Description / Specifications / Work Statement,

%bsection C.1.3.3 in its entirety and replace it with the following:

C.

Technical Qealifications Requirements The course shall be conducted at an NRC or NRC Agreement State licensed medica; institution by a contractor with brord experience in t1e medical uses of byproduct material are related teaching expertince. As a minimum, lecturers possesiang the following diverse areas of experience are required.

NRC-05-87-121 c.

Modificcticn No. 3 Page 5 of 5

'At least one board certified physician / lecturer shall be a.

from each of the following medical specialities:

Radiology Radiation Oncology Nuclear Medicine A physician lecturer may be certified in more than one of the above specialities.

b.

At least one graduate-level physicist / engineer shall be from each of the following areas a a lecturer:

4 American Board of Health Physics in Comprehensive llealth Physics Nuclear Medicine Instrumentation / Biomedical Engineering To satisfy this requirement, a physicist / engineer may be certified in one or more of the above areas.

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The physician / lecturer and the physicist / engineer must have i

c.

experience in providing instruction to an din supervising activities of individuals who have had no previous experience in handling the equipment and sources in thi I

course to ensure applicable NRC safety requirements are met.

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6.

Add the following sentence to Section F, paragraph F.1.2., Number of Courses /

Course Scheduling.

'i "Lesson plans for the revised course are to be delivered no later than Novenber 15, 1988."

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All other terms and conditions remain the same.

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i At(t.chment 1 MEDICAL USES_OF RADIGIS0 TOPES PR0 POSED TOPICS FOR OIAGNOSTIC NUCLEAR MEDICINE AND RADI0 PHARMACEUTICAL TliERAPY OBJECTIVE:

To acquaint students with facilities and equipment, clinical procedures, radiation safety procedures, and quality assurance (QA) programs pertaining to the medical uses of radioisotopes (diagnostic nuclear medicine and radiopharmaceutical therapy) and to provide them with hands on experience in safety techniques used in these specialities.

I.

INTRODUCTION Reasons for revising 10 CFR Part 35, implementation of 10 CFR Part 35, Regulatory Guide 10.8 "Guide for the Preparation of Applications for Licenses for Medical Teletherapy Programs," and quality assurance program (NRC speaker).

II.

RADIOLOGY A.

Radiobiology, 1.

Critical organ and dose calculations 2.

Risk-to-benefits ratio a.

Diagnostic exposures b.

Therapeutic exposures 3.

Late ef fects of radiation exposure B.

Familiarization with Glossary _(Classroom Olscussions}

1.

Hematopoiesis 2.

Pernicious anemia 3.

Vitamin B-12 4.

Detector sensitivity S.

Detector efficiency 6.

Chi-Square Test 7.

Minimum detectable activity (MDA) 8.

Action level 9.

Antigen

10. Antibody 11.

Pathogen 12.

Radioimmunoassy 13.

Sterility test

14. Monoclonal antibody L

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Facilities. Equipment and__Instrumenta' tion (Tour and Classroom Olscussions_1 1.

Gamma camera (s) and associated imagining equipment (e.g., computers, collimators) 2.. Rectilinear scanner 3.

SPECT 4.

Radionuclide generator systems a.

Theory of operation b.

Preparation of Tc-99m compounds c.

Mo-99 breakthrough test 5.

Vial Shields and labels 6.

Syringe shields and labels 7.

Oose calibrator a.

Theory of operation b.

Quality control 8.

Xe-133 ventilation equipment 9.

Bone Mineral analyzer 10.

Lixiscope

11. Mobile Nuclear Medicine Vans a.

Administrative requirements b.

Ordering of byproduct material c.

Client responsibilities d.

Written authorization by client's management e.

Quality control 12.

Survey meters a.

Calibration procedures b.

Quality control 13.

OTPA Aerosols j

D.

Cifnical Research and In-Vitro Procedur_est_(Classroon DiscussionsJ 1.

Types of diagnostic clinical, research, and in-vitro procedures performed in nuclear medicine, types and quantities of i

radiopharmaceuticals used for each procedure 2.

Types of radiopharmaceutical therapy procedures and types and l

quantities of radiopharmaceutials used (e.g., I-131, P-32 chromic l

phosphate, P-32 sodium phosphate) 3.

Usage of radioisotopes for which the Food and Drug Administration (FDA) has accepted a "Notice of Claimed Investigational Exception for a New Drug" (IND) or approved a "New Drug Application" (NOA).

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Safe Handlina of P it (Cl Assroom Discussions) 1.

Room preparat1.

'n applicable, e.g., for I-131 therapy patients) 2.

Visitor control 3.

Patient control 4.

Confirmation control 5.

Waste control 6.

Notification of the Radiation Safety Officer in case of a patient's death or other medical emergency.

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7.

Need for bioassays 8.

Release of patients containing radiopharmaceuticals i

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. F.

Radiation Survey _s_(Classroom Olscussions).

1.

Daily surveys of areas where radiopharmaceuticals are routinely prepared for use or administration 2.

Weekly surveys where radiopharmaceuticals or radiopharmaceutical waste is stored 3.

Weekly surveys for removable contamination 4.

Use of survey instruments capable of detecting contamination of 2000 disintegrations per minute 5.

Leak testing 6.

Surveys for I-131 therapy patients G.

Training _and Retaining _(Classroom Discussions) 1.

Training program (10 CFR parts 19, 20, and 35, as applicable) 2.

Retraining program, as required by $35.972 of 10 CFR Part 35 H.

NRC Bulletins and Information Notices _(Chssroom Discussions).

1.

Discussion of recent NRC bulletins and Information Notices applicable to nuclear medicino and radiopharmaceutical therapy (NRC speaker)

I.

Responsibilities and Authority of Key _ Personnel (Classroom Discussions) 1.

Radiation Safety Officer 2.

Authorized user 3.

Visiting authorized user 4

Radiation Safety Cormittee J.

ALARA_Pr_o,qrandCla ssroom Discussions) 1.

Develcpment of ALARA program for nuclear medicine and radiopharmaceutical therapy 2.

Implementation of an ALARA program for nuclear nedicine and radiopharmaceutical therapy 3.

Delegation of authority for implement.ing such a program K.

D_lagnostic Nuclear Medicine and Radiopharmaceutical Therapy.

Mi_sadministrations (_ Classroom Olscussions) 1.

Causes of misadministrations 2.

Examples of corrective action taken by hospitals to prevent future misadministrations 3.

Personnel involved in such misadministrations 4.

Notifications and reporting requirements for misadministrations t

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Transportation (Classroom Discussions) 1.

Use of authorized packages 2.

Proper' labeling of packages 3.

Shipping papers 4.

Radwaste brokers and common carriers M.

Emergency Procedures 1.

Minor spills and contamination 2.

Major spills 3.

Decontamination kit 4.

Personnel contamination N.

Records (Classroom Discussion 1 Record-keeping pursuant to 10 CFR Part 35 0.

Quality Assurance Program (QAl 1.

Voluntary QA program used by HRC and Agreement State licensees for a safe operation P.

Vaste Disposal (Classroom Discussions) 1.

Sanitary sewerage systems 2.

Landfill burial 3.

Calculation of MPC's in effluents 4.

Storage pending disposal Q.

Hands-on_-Experience 1.

Techniques for handling nuclear medicine and associated equipment (e.g.

syringe shleids, vial shicids, change of a collimator, Xe-133 ventilation equipment) 2.

Dose calibrator quality assurance tests as required by 535.50 4.

Constancy b.

Accuracy c.

Linearity (decay method and calicheck) d.

Geometry or position test 3.

Generator elution a.

No-99 breakthrough b.

Kit preparation c.

Drawing of doses d.

Assaying doses 4.

Reviewing of Itcense applications for limited and broad scope specific '

Itcenses(NRCspeaker)'

5.

Simulation of a nuclear medicine inspection (NRC speaker)'

6.

Measure of the flow rate through a fume hood 7.

Calculation of thyroid uptakes using a neck phantom

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Observations 1.

Operation of a gamma camera and rectilinear scanner 2.

Image acquisition of a radioactive source on gamma camera 3.

Operation of Xe-133 gas spirometry system with trap 4.

Operation of Lixiscope and bone mineral analyzer 5.

Aerosols 111. EXAMINATION

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