ML20210U161
| ML20210U161 | |
| Person / Time | |
|---|---|
| Issue date: | 02/07/1997 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Siegel J COOPER HOSP./UNIV. MEDICAL CENTER, CAMDEN, NJ |
| Shared Package | |
| ML20210U065 | List: |
| References | |
| FOIA-97-273 NUDOCS 9709170230 | |
| Download: ML20210U161 (17) | |
Text
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UNITED STATES s
y NUCLEAR REGULATORY COMMISSION 2
WASHINGTON. D.C. 20656-0001 February 7, 1997 Cooper Hospital /Univers e y Medical Center Department of Continuing Medical Education ATTN: Jeffrey A. Siegel. Ph.D.
Program Director One Cooper Plaza Sarah Cooper Building. Room 116 j
Camden. New Jersey 08103-1489
Dear Dr. Siegel:
I am responding to your letter dated October 7,1996, a facsimile dated November 12. 1996, and an electronic transmission (E-mail) dated December 23. 1996, that conveyed your revised course schedule the topics covered, and sample homework assignments.
We have reviewed the course material provided, and find that the topics you plan to include appear to focus on the subject matter described in 10 CFR 35.920(b)(1).
Although the syllabus still contains minimal instruction in subjects that are not included in Part 35, the requirement for "200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:
[ specific topics listed]." has been met.
Additionally, you describe expanding your course from 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> to 130 hours0.0015 days <br />0.0361 hours <br />2.149471e-4 weeks <br />4.9465e-5 months <br /> of contact hours, and reducing the homework component from 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> to 78 hours9.027778e-4 days <br />0.0217 hours <br />1.289683e-4 weeks <br />2.9679e-5 months <br />, for a total of 208 hours0.00241 days <br />0.0578 hours <br />3.439153e-4 weeks <br />7.9144e-5 months <br />.
As stated in my letter dated September-26, 1996 (enclosed). NRC will consider alternative methods of training, consistent with current approaches to formal collegiate level training and available information technology to meet the requirements in-10 CFR 35.920(b). e.g.. video lectures, workbooks, tutoring, computerized disks. and other off-site training modalities.
In addition, we agreed there may be circumstances in which homework could be an appropriate alternative for parts of the required classroom and laboratory training.
The program you described, consisting of 130 hours0.0015 days <br />0.0361 hours <br />2.149471e-4 weeks <br />4.9465e-5 months <br /> of contact hours and 78 hours9.027778e-4 days <br />0.0217 hours <br />1.289683e-4 weeks <br />2.9679e-5 months <br />
-of homework appears to satisfy the requirements in 10 CFR 35.920(b)(1), In view of the fact that your program contains a homework component, you will need to ensure and document that your attendees actually complete this component of your program.
Please note that graduates of your program will be reviewed on a case-by-case basis at the time they request to be designated as an authorized user on an NRC medical-use license.
In addition. to be approved as an authorized user, these anlicants must also provide documentation to satisfy the requirements in 10 C 1 35.920(b)(2) and (3).
n s
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-9709170230 970911 f
PDR 7 /t/71 ni v'
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4 Jeffrey A. Siegel, Ph.D.
2 February 7, 1997 If there are any additional questions, please direct them to:
U. S. Nuclear Regulatory Commission ATTN: Sally Merchant MS T8F5 Washington. DC 20555 Telephone:
(301) 415-7874 or Facsimile:
(301) 415-5369 Electronic mail (E-mail):
SLM2@NRC. gov Sincerely, l
//W fff!'Y Donald A. Cool. Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
Ltr dtd 9/26/96
Participants in review of trainina oroarams:
4 1.
Sally L. Merchant, Health Physicist NRC Headquarters TWFN, MS T 8-F-5 Washington, DC 20555 2.
Neetam Bhalla, Ph.D., inspector NRC, Region i Office 475 Allendale Road King of Prussia, Pennsylvania 19406-1415 Under the supervision of; Larry W. Camper, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, l
Office of Nuclear Material Safety and Safeguards NRC Headquarters, TWFN, MS T-8-F-5 Washington, DC 20555 i~ ll 1
OUW f)1 TWT REVIEW 0F AVAILABLE TRAINING llackaround:
NRC is preparing to make a major revision af 10 CFR Part 35, " Medical Use of Byproduct Material." As part of this effort, the staff will deterairie the adequacy of its current training and experience criteria as described in 10 CFR Part 35, Subpart J, " Training Requirements."
Currently, Subpart J includes training and experience criteria for radiation safety officers, physicists, and physicians for each type of medical use authorized. Various training pathways are recognized in Subpart J including certification by one of the identified professional boards or equivalent training and experience provided outside of a formal integrated training program, such as programs offered by private enterprise organizations.
The purpose of this project is to review training programs provided by private enterprise organizations that are designed to meet the training regt.aements described in section 10 CFR 35.920, item (b)(1).
Specifically, private enterprise training programs that are designed to provide the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and didactic training in basic radioisotope handling techniques as required in the rule. The required classroom and didactic training, in combination with 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> of supervised experience as described in 10 CFR 35.920(b)(2)&(3),
constitutes the training and experience criteria for physicians who request authorization to use byproduct material for imaging and localization studies, pursuant to 10 CFR 35.200, " Imaging and localization studies."
Methodqlagy:
Two members of the NRC staff, Sally L. Merchant, Headquarters, and Neelum Bhalla, RI, visited and reviewed five private enterprise training programs that are intended to provide the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and didactic training in basic radioisotope handling techniques that is described in 10 CFR 35.920 (b)(1).
Since two of the programs were located in Agreement States, the NRC Office of State Programs assisted in the coordination of the visits with the appropriate State Agencies.
In one case, the State Agency chose to accompany the NRC team on the visit.
NRC has agreed to provide both States with a copy of the final report.
In an attempt to ensure consistency in the reviews, the staff developed a set of specific questions that would be asked of each program director.
Each of the two NRC staff members independently recorded each answer, she heard, to each question. The two met after each visit to compile their answers into one form. A final meeting was held in Region I to compile all five forms into this Draft report.
'n
pNb REVIEW OF AVAILABLE TRAINING Facilities Visited:
1.
Health Physics Services. Inc.
1350 Piccard Drive Rockville, Maryland CE0: Joseph Mount Telephone:
(301) 670-1818 2.
NMA Medical Physics Consultation / Mallinkrodt Medical. Inc. (NMA) 9457 Midwest Avenue Cleveland, Ohio 44125-2419 Program Director: David Close Telephone: (216) 663-7000 This orocram has been discontinued.
This program was affiliated with Hallincrodt Medical, Inc. and provided services such as license and amendment preparation and basic health physics services.
3.
National Physics Consultants. LTD. (NPCl l
1591 Trotter Lane Painesville, Ohio 44077 Course coordinator (no title): David Close Telephone:
(216) 350-1242 This program is new (1995).
It was developed by David Close, the program director for the, now defunct NMA program.
Except for some minor changes, the program remains the same.
In addition to training, NPC offers license and amendment preparation and health physics services.
The course was provided for the first time in Spring, 1995.
-4.
Institute for Nuclear Medicirie Education. Inc. (Rose) and American Association of Nuclear Cardiology 5171 Eldorado Springs Drive Boulder, Colorado 80303 Program Director:
Charles H. Rose, MA, MSPH, D(ABSNM)
Telephone:
(303) 499-4099 FAX:
(303) 499-3999 9
5.
-Coooer Hosoital/ University Medical Center Department of Continuing Medical Education One Cooper Plaza, Sarah Cooper Building, Room 116 Camden, New Jersey 08103-1489 Program Director: Jeffry A. Siegel, Ph.D.
Telephone: (609) 342-3260
$.,,h f. 0 FAX (609) 541-4762 Course Manaaement:
1.
Has your course been approved or accredited? By Whom?
H/SI: No NMA: ACCME, ACFE NPC: No Rose: ACE, Accreliiting Conslission of the Accrediting Council for Continuing Education and Training (ACCET), ACCHE, State of (.olorado, Dept of Higher Education Cooper: ACCME 1.
What courses do you offer te meet NRC or Agreement State training and l
experience requirements?
HPSI: Basics of Radioisotopes Handling - 200 hrs.
NMA:
Basics of Radioisotopes Handling - 200 hrs.
40 hrs.
Technologist training RSO Training 24 hrs.
NPC:
Basics of Radioisotopes Handling - 200 hrs.
RSO Training
- 24 hrs.
Rose: Basics of Radioisotopes Handling - 200 hrs.
80 hrs.
24 hrs.
RSO Training (not often given)
Cooper: Basics of Radioisotopes Handling - 200 hrs.
2.
Do you offer radiation safety officer training?
HPSI: No HMA:
Yes NPC:
Yes Rose: Yes Cooper: No 3.
Is your training program affiliated in any way with another entity (e.g., college or university, medical facility, or business)?
J
DRAFT 3
HPSI: No.
(Offers health physics services to some graduates)
NMA: Were affiliated with Hallincrodt Radiopharmacy.
NPC:
No (Offers health physics services to some graduates)
Rose: Yes, is associated with NC Systems, an equipment company that provides " turn key" imaging setups. According to Mr. Rose, the two entitles share employees and are financially affiliated.
However, Mr. Roses stated that, in so far as students are concerned, the two entities are completely separate.
Further, Mr.
Rose stated that he would lose his accreditation if he tied the training to the purchase of equipment.
Cooper: Yes. Affliated with University of Medicine and Dentistry of New
- Jersey, 4.
Do you have reciprocity with any other training programs?
All stated "No" 5.
Are attendees always ohysicians?
HPSI: Yes NMA:
No, Physicians, Piii.:icists and Technologists.
NPC:
No, Physicians, Physicists and Technologists.
Rose: No, Physicians, Physicists and Technologists.
Cooper: Yes 6.
How often is each course offered?
HPSI: 3 times per year NMA:
2 times per year NPC:
1 time per year Rose: 6 times per year Cooper: 1 time per year 7.
Where are courses held?
HPSI: Office in Rockville, Maryland I
4 (includes " hot" lab)
NMA: Holiday Inn Hotel, Cleveland (Labs at Picker Camera Co. and Syncor Radiopharmacy)
NPC:
Next course: Charleston W.V.
Previous course: Cleveland, Ohio (labs arranged with local radiopharmacies and/or hospitals)
Rose: Hotels in various cities, nationwide
(" dry" labs are performed at hotels)
Cooper: The Mansion on Main Street, Voorheese, New Jersey 8.
How are the number of contact hours segmented over the duration of tne course? Hours? Days? Weeks? Months?
HPSI: 4 50-hour modules 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> over 5 days (Thursday through Monday)
NMA:
4 50-hour modules 50-hours over 5 days (Monday through Friday)
NPC:
4 50-hour modules 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> over 4 days (Thursday through Sunday)
Rose: 4 50-hour modules 2 50-hour module over 9 days (Saturday through Sunday)
Cooper: One day per week for 11 consecutive weeks { 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> )
9.
Must all program elements be obtained sequentially?
All responded "No" 10.
Is student attendance taken?
How often?
HPSI: Yes, student attendance is documented by taking the required examinations (3 per module).
.NMA:
At the beginning of each day.
NPC:
At the beginning of each day.
Rose: Beginning of each morning, afternoon, and e'vening session (2 to 3 times per day, total of 10 times per session).
If the instructor suspects a discrepancy (one individual signing in for other(s)), a roll call is taken. We were shown evidence of this having happened.
Cooper: At the begining of each day.
4
DRAFT 5
11.
Do you maintain records of student attendance?
All responded "yes" If yes, may we have an example?
HPSI:
Maintains student folders containing tests (We reviewed student completed tests, they were not graded)
NMA: Maintains records of attendance.
(We were not able to review).
l -.-
NPC: Maintains records of attendance.
(We were not able to review).
Rose: Maintains records of attendance.
(We reviewed samples, and were provided an example).
Cooper:
Maintains records of attendance.
(We reviewed samples).
l 12.
How are absences accounted for in generating the total number of contact hours?
All stated that absences were rare. However, when pressed, each answered as follows:
HPSI: If test is missed, student cannot take later.
Student must retake that complete session (at no cost).
HPSI would excuse an hour or two if there was a " good" reason.
HMA: Up to "a day or two" may be excused. Would make up with assigned reading.
NPC:
(New Program) Somewhat the same as NMA.
Rose: If I hour missed, the student is responsible for the material; several hours (with good reason), student is tutored.
If a day is missed, must make up the next time session is offered (at no cost)
Cooper: If not signed in by 8.20 a.m., half day is missed and not signed in by noon, ntire day is marked absent. Upto one day of absence is acceptable.
13.
What credentials do those teaching the course possess?
HPSI: 95% Ph.D. or M.D. in-the pertinent _ subject.'
HMA:' All instructors are consultants-in health physics.
All have, at least, a BS and experience.in the pertinent field.
NPC:
Same as NMA
h!
6 Rose: See description of written policies (below).
Cooper: One M. D. and 3 Ph.D.s and 1 technologist.
16.
What are the minimum credentials required for an individual to present course material?
Must the individual have expertise in the subject area being presented?
HPSI: Must have expertise in subject area presented.
However, no minimum credentials stated.
HMA: Must have expertise in subject area presented.
However, no minimum credentials stated.
l NPC: Must have expertise in subject area presented.
However, no minimum credentials stated.
Rose: Mr. Rose procedure manual contained the requirements for instructor qualifications: Experience in topic presented, licensure by NRC or Agreement State as licensee, authorized user, RSO, or radiopharmacist.
l Cooper: Must have expertise in subject area presented.
However, no minimum credentials stated.
20.
What teaching methods, other than lecture, does your program utilize?
HPSI: Reading, video tape, computer programs (to analyze heart studies and to work out problems), student observation, hands-on labs.
NMA:
Reading, video tape, overheads, slides.
NPC: Same as NMA Rose: Slides, overheads, electronic bulletin board,demonstation, study guides, and video tapes.
Cooper: Slides.
Course Content:
21.
What is the course content (hours) for each of the subjects areas?
All of the training providers followed the following breakdown (previously required by NRC; still required by some Agreement States):
Radiation Physics 1
o
DRAPT 7
and Instrumentation 100 Radiation Protection 30 Mathematics 20 4
Radiopharmaceutical Chemistry 30 Radiation Biology 20
- Cooper provides 100 contact hours (classroom) plus 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> homework.
22.
How many hours of classroom versus laboratory training does your course provide for each of the following:
None of the courses could provide a breakdown of classroom vs lab.
23.
What supplemental material is provided to the stude..cs?
HPSI: 1. Books: An organized binder of handouts, 4 textbooks:
" Practical Nuclear Pharmacy," by Phan and Ling, " Physics in Nuclear Medicine," by Saunders, " Radiobiology for the Radiologist," by Hall, and one other.
NMA:
1.
Books:
" Practical Nuclear Pharmacy," by Phan and Ling, the "Early/Sodee" textbook, and an organized binder of handouts.
NPC:
Same as NMA.
. Rose: 1.
Books: A book containing the chart of the nuclides, an organized binder of handouts, and a booklist.
Cooper:
Book: " Physics in Nuclear Medicine," by Sorenson and Phelps, and an organized binder of handouts.
24.
Are there individual work assignments? How is the student's understanding of the course material evaluated?
HPSI: Yes, there are assignments for between sessions.
However, they are not enforced (Dr. Mounts words).
NMA:
No NPC:
No Rose: Yes, to be completed afterhours, but not collected.
Cc,oper: Yes, mandates take home exercises to complete the 200 hour0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> program. Take home exercises are graded.
25.
Are students tested in each subject?
DRAFT 8
HPSI, NMA, NPC, and Rose - yes, test are given.
Cooper, no tests are given.
26.
How often are students tested in each subject?
HPSI: 3 times, each subject (grade not recorded)
NMA:
1 test per session, (grade not recorded)
NPC:
1 test per session (grade not recorded)
Rose: Pre-test for each subject (to be able to demonstate that learning has occurred) and 1 final in each subject that is graded.
Cooper:
No test.
27.
What is a passing grade?
It was the consensus of those interviewed that 10 CFR 920(b)(1) requires applicants for A.U. status to have attended a 200 hr course.
No demonstration of competency is necessary.
The following are the grades required of each course:
NMA and Rose 70%
However, if 70% is not achieved, a certificate of 200 hour0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> attendance is still provided. Mr. Rose provides two different certificates, one for completion and competency and the other for completion.
HPSI, NPC No passing grade is required.
The certificate provides proof of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> attendance.
Cooper:
No passing is required.
A certificate of completion is given.
28.
Do you maintain records of test results for your previous students?
HPSI, NMA, NPC, and Rose - yes, Cooper, no tests are given, however, graded home assignments are maintained in student files.
30.
Where is laboratory training provided?
HPSI:
In " hot" lab within HPSI facility.
NMA:
At the Cleveland "Syncor" radiopharmacy facility.
NPC:
At contracted radiopharmacy or hospital (may be different each time).
Rose: A " dry" lab is conducted at each hotel where training is held, 1
o
r DRAFT 9
Cnoper: At Cooper Hospital, Dept. of Nuclear Medicine.
31.
What equipment is used in the student training?
HPSI:
Dose Calibrator?
Survey Instruments?
Personal dosimetry?
Spectrometer?
Other:
NMA:
Dose Calibrator?
Survey Instruments?
Personal dosimetry?
Spectrometer?
Other:
NPC:
Dose Calibrator?
Survey Instruments?
Personal dosimetry?
Spectrometer?
Other:
Rose:
Dose Calibrator?
Survey Instruments?
Personal dosimetry?
Spectrometer?
Other:
Cooper:
Dose Calibrator?
Survey Instruments?
Personal dosimetry?
Other:
Gamma Camera, both planar and SPECT 32.
How is proficiency in using radiation safety equipment measured?
None of the programs measured proficiency.
33.
What laboratory procedures are either demonstrate'd to or performed by the students?
HPSI:
NMA:
" DRAFT 10 NPC:
Rose:-
Cooper:
34.
Does course address the authorized user's supervision responsibilities regarding the delegation of the above described tasks?
They describe the requirements, however, it appeared that none of the reviewed programs adequately addressed supervision responsibilities.
Ceneral:
35.
How long have you been conducting your training program?
HPSI: 15 yrs NMA:
15 yrs NPC:
6 months Rose: 12 yrs (previously taught in other businesses and programs, since 1966)
Cooper:
3 years 36.
How many individuals have successfully completed your 200 hour0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> program?
HPSI: 500 NMA:
450
.NPC:
-12
~ Rose:
2000 Cooper:
54-37.
In 1994, how many students attended-your course?
HPSI: 60 students NMA:
30 students
~
NPC:
12 students 1
Rose:
150 students Cooper:
1994: 20, 1995: 16 g
' DRAFT 11 38.
Of those that attended in 1994, how many students successfully completed your program?
NMA, NPC 100%
HPS!
97% (3X = failure to attend for 200 hrs)
Rose 92% (8% did not achieve competency certificate)
Cooper:
100%
39.
Is the number of individuals (physicians and others) completing your course increasing or decreasing? What is the degree of change?
HPS!: Increasing NMA: Decreasing (program was discontinued)
NPC:
(new program)
Rose: Increasing Cooper:
No change 40.
How many graduates of your programs have successfully achieved liccaaure as an authorized user on an NRC or Agreement State license?
All responded; " unknown" 41.
Is information regarding the various medical specialties of your students available?
HPSI: Cardiologists only NMA: Cardiologists, Endocrinologists, NPC:
Cardiologists Rose: Cardiologists, Endocrinologists, Oncologists, Neurologists, Pharmacists.
Cooper:
Cardiologists j
43.
Do you provide related services for your graduates such as preparation of licensing docuents or ongoing consulting services?
HPSI, NMA, NPC, and Rose provided license or amendment preparation.
HPSI, NMA, and NPC provide on-going health physics consulting services.
Cooper provides no services 44.
What is the level of student understanding of basic radiation safety before they take your course?
DRM:T 12 All said "very little" 45.
What have you observed to be the most difficult subject areas for students to comprehend?
HPSI: Statisticsi HPSI plans to " cut back" on statistics, since "it is not required and thsy are not learning."
NMA: None in particular NPC:
None in particular l
l Rose Instrumentation, Cardiologists are least interested in the topic.
Statistics Cooper:
Physics 46.
In your experience, how many hours, in each subject (in Subpart J or otherwise), are necessary to assure student comprehension?
HPSI: The hours are correct if you include reading scans and computer t.nalysis.
NMA:
NPC:
- Rose: 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> work best, if-the number of hours was cut, the quality -
of education would go down. However, if subject matter was more closely regulated, it might be passible to do in 100 hrs.
Cooper:
200 contact hours are too many. However, they stated that 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of contact and 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of enforced homework was the proper mix.
47; What do you believe are the strengths of your program?
HPS!: "Our faculty, we use the best in the field."
Nm:
NPC:
Rose: 1.
" Accreditation, which ensures that we hold to ethical and moral standards that are examined by third parties."
2.
"An-academic program, providing college credits, with graded tests."
Cooper:
The one day per week couse attendance.
Because: 1. saturation is not-as great as in more compressed classes, and physicians did not have to leave their practices for h>ng.
48.
Based'on your experience, what changes to 10 CFR Part 35, Subpart J
' DRAFT 13 would you suggest?
Are there subject areas you would add or delete?
If so, why?
HPSI:
NMA:
NPC:
Rose:
Cooper:
The regulation should provide standardization of curriculum for training courses.
Should require a pre and post test, should include more formal requirements regarding tests, grades, and course contents.
For sealed source therapy, Cardiologists would need only 1 or 2 weeks of additional training (over the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />).
i
.