IR 05000291/2014001
| ML20217D664 | |
| Person / Time | |
|---|---|
| Site: | 05000291, 03034496 |
| Issue date: | 09/19/1997 |
| From: | Prange B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| References | |
| 50-29114-01, 50-29114-1, 572521, NUDOCS 9710060053 | |
| Download: ML20217D664 (84) | |
Text
September 30, 2007
SUBJECT:
Application dated 06-07 97 for a new Byproduct Materials License
Dear Ms. Prange:
This is in response to your letter dated July 30,1997 requesting additional Information needed in order to complete the review of our recent application for a new materials license. The numbers listed below correspond directly with the numbered requests in your letter:
1. Dr. Thomas Hathaway, the RSO obtained training on the use of the blood irradiator from the manufacturer's representative on July 23,1997 (Certificates of training, Attachments A 1 and A 2). Maureen Pedigo, MT (SBB) will receive training specific to the operation of the blood irradiator from the manufacturer's representative when the unit is installed. Dr. Hathaway will receive additional training on the irradiator at the same timo. Dr. Hathaway has had previous operator training by a similar Irradiator company in January 1990 (Certificate of Training, Attachment B). The manufacturer's representative anticipates such training will be .
of approximately two (2) days in duration. Dr Hathaway will be present for this training also.
2. A. Also attached are Certificates of Training (Attachments C 1 through C 3) for Dr. Hathaway relative to Radiation Safety Training. The training consisted of a total of 41 hours4.74537e-4 days <br />0.0114 hours <br />6.779101e-5 weeks <br />1.56005e-5 months <br />, as specified below:
C-1 Health Physics Aspects of Radioisotype Use Nov. 26 30,1973 (17 Hrs)
C2 - Principles of Radiation Protection July 1819,1990 (16 Hrs)
C3 Radiation Safety Training July 23,1997 (8 Hrs)
B, Maureen Pedigo will receive three days of Safety Training by the RSO prior to operation of the new irradiator.
MEMBER OF AMERICAN ASSOCIATION OF BLOOD BANKS MEMBER OF COUNCIL OF COMMUNITY BLOOD CENTERS Sb .
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3. Attached are coples of the following tests, with answer keys, and the training checklist:
Attachment D 1 Radiation Safety At%chment D 2 Irradiator Operation Attachment D 3 Irradiator Training Checklist The tests and checklist represent samples of what we will be using. We may add, delete, or change some of the questions In the future if we find there are areas / subjects that we may wish to emphasize.
l 4. Although it is highly improbable that the occupational radiation exposure dose level for any employee will exceed .5 rem during a year, the Blood Bank of Alaska shall comply with the requirements of Section 20.1208 of 10 CFR Part 20 * Dose to Embryo / fetus". This requires that we ensure that the dose to an embryo / fetus does not exceed 0.5 rem during the entire course of the pregnancy, and that there is no substantial variation above a uniform monthly dose exposure rate to a pregnant employee. In order to ensure that the requirements are met, the following will occur:
Instruction concerning prenatal radiation exposure and its risks to the embryo / fetus will be provided to workers before they are allowed to work with the irradiator, Information on the specifics of our policy, and the option of completing a Declaration of Pregnancy will also be provided, if a pregnant female employee chooses to fill out a * Declaration of Pregnancy" form (Attachment E), the Blood Bank of Alaska will prohibit that n individual from operating or being in the irradiator room during the operation of the blood irradiator during her pregnancy.
Minors (people under 18 years of age) will not be permitted to operate the irradiator (a State of Alaska Department of Labor regulation prohibits minors from engaging in activilles where occupational exposure to radioactive material may occur, regardless of the exposure level: see attached State of Alaska Regulation).
5. Dr. Hathaway, the RSO, will be collecting the sample that we will send to the commercial firm who will perform the leak test measurement.
6. The blood irradiator will be returned to the manufacturer or transferred to another licensed recipient when it is no longer needed at the Blood Bank of Alaska, Inc.
In our original submission as part of item 9, Facilities and Equipment, we included a diagram of the building indicating the location of the irradiator. On the advice of the
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Irradiator manufacturer, we would like to change the location to the opposite wall at the extreme end of the room. We are including a revised diagram with this new location marked (Attachment F 1 and F 2) and a Fax from the engineering firm stating that there are five (5) acceptable locations for the irradiator (Attachment G). This new locPLn is the engineering firm's location No. 4 on their diagram.
We hope the above Information is satisfactory. If you have any questions or need additional Information, please contact me.
Very truly yours, BLOOD BANK OF ALASKA,INC.
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Thomas K. Hathaway, PhD Executive Director TKH:gh Attachments
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CIS-US IHL 437 IRRADIATOR TRAINING OUTLINE Operation of the Irradiator controlled by the IDL Control Panel A. Power on using the key switch 1. Description of the illuminated lamps H. Description of and how to load the canister C. Preparing the Irradiator for a cycle 1. Properly position the canister in the chambt 2. Closing the door properly 3. Ilow to program time on the counter D. Description of the complete cycle run 1. Starting a cycle with the cycle start switch 2. Movement of the canister during the cycle 3. Canister rotating indication 4. Irradiation position indication 5. Door interlock during a cycle 6. Counter counts down 7. Cycle terminates on 7ero time E. Demonstration of repetitive cycle runs 1. Unloading the canister, reloading the canister 2. Time automatically reset on the counter F. Reprogramming the timer for a new time 1. Resetting the counter to zero 2. F.ntering the new time G. Operation of the cycle brake function
1. Reasons for using the cycle brake switch ! 2. Canister operation after pressing the cycle brake suitch
- 3. Resetting the cycle brake 4. Resuming the cycle after the brake i ...
cis m ine. 10 de ongolo drive bedford. rna 01730 __._
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Description of the illuminated lamps indicating a main power failure 2. Operation of the canister during the battery backup 3. Products may be returned to storage 4. Irradiator is in a holding state until main power is restored
$. Completion of the interrupted cycle after the power is restored I. Operation of the emergency switch 1. Why the emergency switch is used 2. Canister operation after the emergency switch is activated 3. Mariual rotation of the drum rotation to retrieve products 4. Resetting the emergency sv itch 5. Reprogramming the timer is necessary after an emergency off situation 6.
Alternate method of tracking irradiation time of the products during an ernergency off function 7. Products left in the irradiation position during an emergency off situation must be discarded 8. Resuming normal operations after an emergency off situation cis us,inc. 10 de ongelo drivo . bedford. mo 01730 . 1e1. (617) 275 7120 I fox (6573 275-265
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CIS-US DOSEWRITER$ COMPUTER SYSTEM TRAINING OUTLINE
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, Operation of the Irradiator with the DoseWriter* Cornputer Systern (optional).
A. File 1. Printer Setup 2. Login (Security Levels 15) 3. Exit B. Tables i 1. Users 2. Customers 3. Blood Products 4. Blood Types 5. Mixed Barcodes 6. Systern Infonnation 7. Registration 8. Cycle Data a. Review Cycle b. Review Product C. Irradiate 1. Irradiation Setup 2. Irradiation Processing 3. Irradiated Product Data D. Reports 1. Cycles a. Dy Date or Cycle b. By Technician Single Technician All Technicians 2. Products a. By Date or Cycle b. Unit Search c. By Customer I cis-us, Inc. . 10 de ongolo drive . bedford. rna 01730 . tel. (617) 275 7120 . fo[(617) 2752634
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CIS-US, Inc.
Subsidiary of CIS bio intomotional Single Customer All Customers d. By Tecimician Single Technician All Tecimicians 3. Users 4. Blood Products 5. Customers 6. System Reports a. System Setup b. System Log e. System Error Log d. QC Report e. Customer Report #1 (#2, #3, #4, #5) E.. Utilities 1. Backup / Restore Create Backup Restore Backup 2. Data Export 3. Database Archive Create Archive Archive RAD System Examine Archive Review Cycle Review Product 4. Repair Database 5. Compact Database 6. Calculator 7. Notepad 's,
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THis CERTIFICATE HAf_ JEEN PRESENTED TO x 11 Col. Thomas K. Hathaway T ? FOR
Y COMPLETION OF A TRAINING PROGRAM IN OPERATION OF Tile 3. L. SHEPHERD & ASSOCIATES MODEL 143-45A BLOOD PRODUCT IRRADIATOR , ps '% ,
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WAa a to ce>by, aat . Thomas K. llathaway, ILT, MSC, M
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. ilealth Physics Aspects of Radioisotope Use" (26-30 November 1973) (Basic Ccurse) 17 hours h tttejg g [ *
11 alter Reed Army Medical Center h'ashington, DC 20012 enew / VERNON R. BURCli, MAJ, MSC c v'f ADCOCK, LTC, MSC Director, Force Development il Ith Physics Officer IVRN1C h?#1C ."., ..t.c..o., ............... .. ..<.,. <
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l l Le J e. , t iw 1d i ' j 23 July,1997 Susan J.$ngelhardt ! .
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SAMPLE EXAMINATION FOR RADIATION SAFETY )
STATE WHETHER TRUE (T) OR FALSE (F) ANSWER F 1. X-rays are a form on non lonizing radiation.
F 2. Radiation exposure is directly proportional to the square of the - distance between the source of radiation and the point of exposure.
, F 3. The GM meter is generally used for personnel dosimetry.
T 4. Beta particles are a form of ionizing radiation.
T 5. Cs 137 is a source of Bett and Gamma rays. . T 6. Part 19 of Title 10 of the Code of Federal Regulations deals with the " notices, instructions and reports to radiation workers and inspection j of radiation facilities.
F 7. The IBL 437C Irradiator uses Co 60 as a source of radiation.
i F 8. In case of a radiation emergency involving the irradiator you should call the NRC immediately.
T 9. Only individuals who have prior radiation safety training and approval
- of authorized user may use the irradiator.
T 10. Past and present exposure history of each radiation worker has to be maintained by the licensee.
F 11. Battery check on the survey meter has to be performed only once a . week or whenever the battery is changed.
N F 12. If a sample gets stuck in the irradiator, try to pry it loose with a screw driver before initiating emergency procedure.
F 13. Lead aprons have to be worn by individuals working within 1' of the irradiator.
T 14. The law of Bergonie and Tribondeau states that the sensitivity of a cell is dependent on the reproductive activity, the length of mitotic activity and the degree of cellular differentiation.
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CHOOSE THE CORRECT ANSWER i
-d 15.. For personnel dosimetry, one may use:
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a. TLD badges b. Film badges t c. Pocket dosimeters i
- d. All of the above l e. None of the above ;
-t d~ 10. Consumer products that result in an annual dose of radiation include:
I a. TV sets and luminous watches
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b. Airport x rays and smoke detectors c. Incandescent mantles and tobacco products ! d.. All of the above j d 17.. The GM meter is used to detect:
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a. Alpha particles b. Neutrons c. Coins buried in the sand
- d. Beta and gamma rays c 18. The maximum permissible whole body dose for radiation workers per t calendar quarter is: !
a.- < 50 mSV b. 3000 mrem .
. c. 12.5 mSV - - d, 50 mrem ;
d 19. Natural background radiation can be received from: , a. Air *
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b.. Water ' l c. Ground minerals d. 'Allof the above
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- 'd 20. Low levels (less than 10 rad) of radiation may cause
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: e. All of the above f. None of the above i
e: . 21. Proper operation of survey meter has to be checked: i
- a. _ Once a week )
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b. Once a month c. Once a quarter ,
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, d 22. The average American receives a dose of about mrem i each year due to background radiation. ! . . a. .5 mrem ,
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b. 5 mrem c. 50 mrem i
!- d. 500 mrem 1 a _ 23.- The IBL 437C irradiator contains:
a. Cs.137
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i Ir 192 ' e. - X-ray , i' e- 24, Nuc! ele acids respond.to radiation in the following ways: , a. C,$ange in base deamination and base loss ' b. H liand breakage between strands and single strand breakage (DNA/RNA) .
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c. Double strand breakage and cross linking within the helix.
- d. Cross linking with another DNA molecule and cross linking with
' a protein e. All of the above
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c 25. The quantity of isotope in the IBL 437C Irradiator is approximately (Note: 1-2 3 Source): a. 1700 mCl per source b. 700 Cl per source c. 1700 Ci per source d. 1700 Bq per source ! -d 26. If the exposwa rate at i meter from a radioactive source is 16 mR/h at 10 cm the exposure rate is: l a. 1.6 mR/h , b, 160 mR/h c. 0.16 mR/h d. -1.6 R/h e. 2 mR/h b 27. - Which of the following options is most effective in reducing exposure from rad allen: l a. Insert i HVL of shielding material between you and the source b. Double your distance from the source , c. Reduce your time near the source by one third ' e 28. With a dose _of 100,000 rads in one hour, you would expect which
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acute radiation syndrom? a. Hematopoeter b. Gastrointestinal c. Central nervous system d. Molecular death' e. Allof the above a- 29. - A Peisor n 31 dosimeter: a. Monitors exposure to radiation b. Provides protection against radiation c. Is required to be worn only by pregnant workers , d. Is required to be worn only by workers less than 18 years old
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d 30. Man made radiation sources include: !
a. Medical exposure
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b. Building materials
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c. Weapons fall-out i d. Allof the above
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a 31. If you think you were over-exposed to radiation from the Cs Irradiator, j you could determine how much exposure you received by: ! a. Checknig your personal dosimeter reading
! b. Usl.ng a GM meter to survey yourself
- c. Having an x-ray of yourself taken d. Determining how much you glow in the dark
. ' b 32. Isotopes are: a. All radioactive b. Both stable and unstable
c. Radioactive elements with low risk of damage d. All of the same e. Radioactivity for the same element -
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j d - 33. The ernission of particles and energy from the nucleus is called: ' ' a. Activity b. lonization c. Exposure . d. Radioactivity L
.b 34. . The separation of electrons from their atoms by the passage of radiation through matter is called:
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c. Exposure , d. Dose c' The blood irradiator emits which type of radiation?
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a. Alpha particles b. . Beta particles c. Gamma rays and beta particles d. Neutrons
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, b 36. The time regulied for the amount of radioisotope to decrease to one-
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half its original amount is: l a. Half value b. Half-life ! c. Activity l d. Dose equivalent
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a 37 The amount of radioactive material, measured by the number of decays per second is: '
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a. Activity . _.
b.. Dose equivalent - c. Exposure
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l d. Dose I l i c 38 'he measure of the ionization produced in air by gamma rays or x-rafs is called: e. Activity ! b. Dose equivalent c. Exposure d .- Dose b 39. The quantity that takes into account the different biologic effects of different radiation is: a. _ Activity b. Dose equivalent c.- Exposure d. Dose c 40. With increased exposure time, the radiation dose is: , a. Decreased be Unaffected c. Increased-d 41. The unit of energy used in radiation physics is: , i a. Rad' , b. Rem c. Curie d. Kiloelectron volt (kev) . , I I
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c 42. The unit of measure for radiation activity is: i
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a. Rad b. Rem c. Curie d. Kiloelectron volt (kev) d 43. The half life of cesium 137 is: a. 3 days b. 3 months c. 30 months d. 30 years b 44. The unit of dose equivalent is: a. Rad b. Rem c. Curie d. Kiloelectron volt (kev) a 45. The principle that describes the relationship of distances and radiation dose is known as: a. Inverse square law b. Law of direct prcportions c. Ohms law d. Theory of relativity d 46. A twofold increase in distance from the radiation source results in a decrease in dose by a factor of: a. % b. 1/6 c. Two d. Four c 47. The prenatal radiation exposure policy of the Blood Bank of Alaska is: a. All pregnant females must be monitored b. Only declared pregnant females must be monitored c. Declared pregnant females will be removed from exposure risks d. All pregnant females will be removed from exposure risk _
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a S 48. Given slabs of the same thickness, the material that has the greatest shielding effect for cesium 137 is: a. Air b. Lead c. Water d. Aluminum b 49. The amount of particular material that reduces the radiation exposure by one half is: a. Helf.'ife b. Half valuelayer c. 15 inches of water d. Unaffected by the type of material c 50. A dosimeter: I a. Protects personnel from radiation exposure b. Absorbs all the radiation from the atmosphere c. Measures the radiation dose deposited on its sensitive volume d. Allof the above a 51. The type of dosimeter issued to personnel is: a. Film badge b. Area monitor c. Geiger Mueller counter d. All of the above d 52. A limitation of an area film badge as a monitor is: I a. It measures the dose in a representative location on the body b. It does not absolutely indicate the dose a person has received c, None of the above d. Both a and b-c 53. The change in direction of subatomic particles or photons as a result , of a collision or interaction is called: l l a, lonization b. Attenuation c. Scatter radiation d. Leakage radiation i D-/ ,
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i a. lonization b. Attenuation c. Scatter radiation
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d. Leakage radiation . a 55. Section 20.1208 of 10 CFR, Part 20 * Standards for Protection Against Radiation", requires licensees to ensure that the dose to an - embryo / fetus during the entire pregnancy, due to occupational , exposure "of a declared pregnant woman", does not exceed rem, l
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a. .5 b. .05 ' c. 5 d. 50 l d 56. The purpose of the blood bank area monitor is to: a. Detect scatter radiation - b. Detect alpha and beta particles c. Provide a permanent record of radiation levels d. Determine if a radiation level exceeds a preset level-d 57. The use of radioactive materials at _ is regulated or monitored by: a. Radiation Safety Service
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c. Radiation Policy Committee d. Allof the above ,
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, FILL IN THE BLANKS one - 58. For radiation protection _ purposes 1R of x rays equal' rem.
, -_ Emergency . : 59, in case of Emergency push in switch.
Stop , 500 60. The maximum occupational recommended fetal dose during 9 months , [ , of pregnancyis- mrem.
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[' 50 62. The maximum permissible dose to the extremities for radiation workers is . rem / quarter. ;
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As Low as 63. ALARA stands for . Reasonably >
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months. , 2.5 65. The exposure rate at a point A from a radioactive source is 10 mR/h.
Two HVL's of shielding material, inserted between the source "nd i point A will reduce exposure at point A to mR/h.
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DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST NAME: DATE: , POSITION: ANSWER TRUE OR FALSE: 1. It is necessary to enter the irradiation exposure dosage time for each irradiation cycle performed.
2. - It is acceptable to irradiate platelets and whole blood simultaneourly.
3. As soon as the loaded cylinder is placed into the irradiation chamber and
- the door is closed, irradiation exposure begins.
4. If CYCLE START is depressed while the timer displays zero, no irradiation will occur.
l 5. The expiration date of allirradiated blood products will be 28 days after the date Irradiation is performed.
6. The Rad Sure Irradiation labels should not be applied to products stored below -50' C.
7. The CANISTER ROTATION Indicator light will flash only when the canister , is actually making the 180* rotation back to the irradiation source or the return to the loading / unloading position.
8. If the "NOT" portion of the Rad Sure Irradiation indicator is still visible after the irradiation cycle is complete, it is acceptable to irradiate the product again.
9. It is acceptable to re-program the exposure time to a longer dose if the cylinder is exceptionally full.
10. Platelets should be promptly returned to the rotator following irradiation.
11. The product license should be stricken from the label of all irradiated blood products.
12. Frozen blood : cts and room temperature blood products can be , irradiated sirr .iieously provided that the maximum cylinder capacity is not exceeded.
-. . . . M-A
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DRAFT CIS US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST 13. Pressing the EMERGENCY STOP switch willinterrupt the irradiation cycle i and cause the drum to begin rotating to the load / unload position; irradiation
- exposure will cease until cycle is resumed, t
14. It is acceptable to irradiate hematopoletic progenitor cell preparations.
15. The Blood Bank of Alaska will routinely keep irradiated blood in its inventory.
10. The door to the CIS US IBL 437 C Blood Irradiator can be opened at My time during the liradiation cycle.
17. Irradiated blood products can be stored at room temperature indefinitely.
18. Graft Versus Host Disease (GVHD) occurs when transfused white blood cells engraft within the bone marrow of the recipient and begin to reject the i blood cells of the recipient, i
; 19. The plasma potassium levelincreases at a slower rate after irradiation.
20. The CIS-US IBL 437 C Blood Irradiator's radiation source is Cobalt 60.
21. Prior to irradiation, the Rad Sure Irradiation Indicator should read "NOT - Irradiated."
TWO PART QUESTION: 22a. Pressing the CYCLE BREAK switch will interrupt the irradiation cycle and
'
cause the drum to begin rotating t3 the load / unload position.
22b. Pressing CYCLE BREAK again will ceuse the irradiation cycle to resume.
MULTIPLE C TICE Circle the correct answer or answers:
.
1. The AA J recommends using irradiated blood products to treat: a. Recipients of donor units known'to be from a blood relative b. Recipients of HLA selected platelets or platelets known to be HLA homorygous c. Fetuses receiving intrauterine transfusions , d. Selected immunoincompetent or immurocompromised recipients e. Recipients who have undergone bone marrow or peripheral blood progenitor cell transplantation f. All of the above.
p.7
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DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST MULTIPLE CHolCE CONTINUED - Circle the correct answer or answers:
.
2. The dose of irradiation delivered to any blood product should be: a. 1000 cGy targeted, with a minimum of 500 cGy delivered to any point in the canister.
b. 2500 cGy targeted, with a minimum of 1500 cGy delivered to any point in the ca;ister, ' c. 2000 cGy targeted, with a minimum of 1000 cGy delivered to any point in , the canister.
3. It is acceptable for which of the following personnel to operate the CIS-US IBL 43 C Blood Irradiator:
a. Pregnant wome, b. Employees under the age of 18 c. Neither of the aoove t
THIS SECTION TO BE COMPLETED BY TRAINER
# question correct = PASS RE-TRAIN .(Minimum passing score = 80% correct = minimum 20 correct answers)
EVALUATED BY: DATE:
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3 -2
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DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST
*** ANSWER KEY *** ANSWER KEY *** ANSWER KEY ***
TRUE OR FALSE: 1. It is necessary to enter the irradiation exposure dosage time for each irradiation cycle performed.
1. False. The CIS-US IBL 437 C BloodIrradiator should be pre-programmed. Technicians should never alter the exposure dosage time without expIIcit instructions from the Radiation Safety Officer.
The exposure dosage will be adjusted on an annual basis to account for the naturaldeterioration of the Ceslum source.
2. lt is acceptable to irradiate platelets and whole blood simultaneously.
l 2. Falso. It is acceptable to Irradiate multiplo types of blood products simultaneously only if theirstorage environments are the same.
' _3. As soon as the loaded cylinder is placed into the irradiation chamber and the door is closed, irradiation exposure begins.
3. False. When the dooris closed, the cylinder begins a 180" rotation. The products are not exposed to radiation until the rotation is complete.
4. If CYCLE START is depressed while the timer displays zero, no irradiation will occur.
4. False. If CYCLE STARTis depressed whils the timer displays zero, Irradiation will continue indefinitelyll 5. The expiration date o' all irradiated blood products will be 28 days after the date irradiation is performed.
5. False. The expiration date of bloodproducts with a normalshelf life less than 28 days (such as platelets) will not change, but blood products with a shelflife greater than 28 days (such as whole blood) will now expire 28 days after irradiation.
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DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST
*** ANSWER KEY *** ANSWER KEY *** ANSWER KEY ***
6. The Rad Sure Irradiation labels should not be applied to products stored below -50' C.
6. True.
7. The CANISTER ROTATION indicator light will flash only when the canister is actually making the 180* rotation back to the irradiation source or the return to the loading / unloading position.
7, False. The CANISTER ROTATIONIndicatorIlght flashes ths oughout the Irradiation cycle. It begins flashing when the drum beg!ns rotating into irradiation position, it flashes throughout the actu IIrradiation time, and it stops flashing when the canister has rotated back to the unloadposition.
l ' 8. If the "NOT" portion of the Rad-Sure Irradiation indicator is still visible after , the irradiation cycle is complete, it is acceptable to irradiate the product l again.
8. False. Bloodproducts should never be irradiated more than once.
\ Any bloodproduct irradiated more than once (or suspected to have received irradiation more than once) should be discarded.
, 9. It is acceptable to re-program the exposure time to a longer dose if the cylinder is exceptionally full.
9. False. The exposure time will be pre-programmed and adjusted annually by supervisory personnel. It should never be adjusted without the express consent of the Radiation Safety Officer.
Maximum cylinder capacity is specified within the Irradiator Operation SOP and should never be excesded.
10. Platelets should be promptly returned to the rotator following irradiation.
10. True. Platelets should be returned to the rotator within ten minutes of removal.
11. The product license should be stricken from the label of all irradiated blood products.
' 11. True. '
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DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TEST
*** ANSWER KEY *** ANSWER KEY *** ANSWER KEY ***
12. Frozen blood products and room temperature blood products can be irradiated simultaneously provided that the maximum cylinder capacity is not exceeded.
12. False. Only blood products with similar storage conditions should be Irradiated simultaneously.
13. Pressing the EMERGENCY STOP sv. itch will interrupt the irradiation cycle and cause the drum to begin rotating to the load / unload position; irradiation exposure will cease until cycle is resumed.
13. False. Pressing the EMERGENCY STOP switch will disconnect allpower to the Irradiator. Therefore, the cylinder WILL NOT automatically rotate out of the irradiation exposure position.
Pressing the CYCLE BREAK switch will return the cylinder to the loading / unloading position.
14. It is acceptable to irradiate hematopoietic progenitor cell preparations.
14. False. Hematopoietic progenitor celipreparations should NOT receive irradiation. Irradiation willprevent them from engrafting in the recipient.
15. The Blood Bank of Alaska will routinely keep irradiated blood in its inventory.
15. False. BBA willirradiate blood products ONLY upon the specific request of a hospital transfusion service.
16. The door to the CIS-US IBL 437 C Blood Irradiator can be opened at any time during the irradiation cycle.
c 16. False. The door automaticallylocks when " CYCLE START"is pressed.
17. Irradiated blood products can be stored at room temperature indefinitely.
17. False. Irradiated bloodproducts should be returned to a proper storage or transportation environment as soon as possible; the irradiation technician will document the total time each product was at room temperature and verify that this is within acceptable limits.
])J
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, DRAFT CIS-US IBL 437 C BLOOD IRRADIATOR OPERATIONAL TECT
*** ANSWER KEY *** ANSWER KEY *** ANSWER KEY ***
18. Graft Versus Host Disease (GVHD) occurs when transfused white blood cells engraft within the bone marrow of the recipient and begin to reject the blood cells of the recipient.
18. True.
19. The plasma potassium levelincreases at a slower rate after irradiation.
19. False. The plasma potassium levelincreases at a faster rate after irradiation. That is why the expiration date may be shortened to 28 days.
20. The CIS-US IBL 437 C Blood Irradiator's radiation source is Cobalt 60.
20. False. The CIS-US IBL 437 C BloodIrradiato*'s radiation source is Cesium 137.
21. Prior to irradiation, the Rad-Sure Irradiation Indicator should read "NOT Irradiated."
21. True. After radiation, the Rad-Sure Irradiation Indicator should read " Irradiated."
TWO-PART QUESTION: 22a. Pressing the CYCLE BREAK switch will interrupt the irradiation cycle and cause the drum to begin rotating to the load / unload position.
22a. True.
22b. Pressing CYCLE BREAK again will cause the irradiation cycle to resume.
22b. False. The CYCLE BREAK switch illuminates when it is originally pressed to interrupt a cycle in progress. Pressing CYCLE BREAK again causes the CYCLE BREAK Indicatorlight to extinguish, and the CYCLE STARTlight to illuminate. To resume the cycle and the timer countdown, it is necessary to press the CYCLE START switch at this point.
L -2
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... UK /ar l CIS-US IBL 437 C BLOOD lRRADIATOR OPERATIONAL TEST
*** ANSWER KEY *** ANSWER KEY *** ANSWER KEY ***
MULTIPLE CHOICE - Circle the correct answer or answers: 1. The AABB recommends using irradiated blood products to treat: a. Recipients of donor units known to be from a blood relative b. Recipients of HLA-selected platelets or platelets known to be HLA homozygous c. Fetuses receiving intrauterine transfusions d.
Selected immunoincompetent or immunocompromised recipients e.
Recipients who have undergone bone marrow or peripheral blood progenitor cell transplantation f. All of the above, f. AH of the above 2. The dose of irradiation delivered to any blood product should be: a.
1500 cGy targeted, with a minimum of 500 cGy delivered to any point in the canister.
b.
2500 cGy targeted, with a minimum oi 1500 cGy delivered to any point in the canister, c.
2000 cGy targeted, with a minimum of 1000 cGy delivered to any point in the canister.
b.
2500 cGy targeted, with a minimum of 1500 cGy delivered to any point in the canister.
3.
It is acceptable for which of the following personnel to operate the CIS-US IBL 437 C Blood irradiator: a. Pregnant women b. Employees under the age of 18 c. Neither of the above b. Employees under the age of18. Pregnant women may operate the CIS-US IBL 437C Blood Irradiatorif they have signed a declaration of pregnancy and are individually badged.
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- .o CIS-US IBL 437 0 BLOOD IRRADIATOR OPERATIONAL TRAINING CHECKLIST TRAINEE NAME:
POSITION: DATE: DATE IRRADIATION SAFETY TRAINING COMPLETED:
(NOTE: IRRADIATION SAFETY TRAINING MUST BE COMPLETED PRIOR TO OPERATIONAL TRAINING)
OBSERVED BY: SATISFACTORY UNSATISFACTORY PRE-IRRADIATION PROCEDURE Prepare product (s) to be irradiated; verify irradiation instructions Document date, unit number, unit weight, time removect from storage Apply irradiator indicator (Rad-Sure) INITIATE IRRADIATION CYCLE insert key and turn key switch to ON position. Verify illumination of the following: Timer Display Screen, Mains, Battery, No Canister Press " Test Lamps." All indicator lights illuminate.
Place products into canister and replace lid.
Open chamber door and slide canister onto stand.
Rotate canister 1/4 turn clockwise and lock into place.
Close door.
Verify that the timer displays correct exposure time.
Record time setting on irradiated Products Log.
Press the CYCLE START switch.
. p -3
_ _ . _ .. . ._ _ _ _ _ _ _ DRAFT CIS-US IBL 437 C BLOOD 1RRADIATOR OPERATIONAL TRAINING CHECKLIST Verify CANISTER ROTATION light is flashing.
Verify the timer display is counting down from preset time.
Verify IRRADIATION indicator light illuminates when canister has rotated into exposure position.
When Irradiation cycle is complete, verify timer reads zero and IRRADIATION light will extinguish.
Drum has completed rotation to unload position, it will stop and automatically unlock.
Open chamber door. NO CANISTER light willilluminate.
Rotate canister clockwise to release it from holder.
! Remove canister from chamber.
l Remove products from canister.
! POST IRRADIATION PROCEDURE ( Verify Rad-Sure Irradiation indicator now reads " Irradiated" Re-label irradiated products.
Complete Irradiated Products Log documentation.
Have a second irradiation Technician perform review.
ADDITIONAL IRRADIATION TRAINING Discuss Troubleshooting for the CIS-US IBL 437 C Blood Irradiator Discuss Safety Precautions COMMENTS: , RE-TRAINING NECESSARY? YES NO kk--_ _j
__ l j DECLARATION OF PREGNANCY
:
10 CFR 20.1003 DEFINITIONS - DEFINES A DECLARED PREGNANT WOMAN AS FOLLOWS:
- A " declared pregnant woman means a woman who has voluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception".
10 CFR 20.1208 DOSE TO AN EMHRYO/ FETUS - STATES" (a.) The licensee shall ensure that the dose to an embryo / fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv).
(b,) ne licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.
(c.) The dose to an embryo / fetus shall be taken as the sum of -
(1) ne deep-dose equivalent to the declared pregnant woman: and
-
(2) The dose to the embryo / fetus from radionuclides in the embryo / fetus and radionuclides in the declared pregnant woman.
(d.) If the doce to the embryo / fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to ihe licensee, the licensee shall be deemed to be in compliance with the paragraph (a) of this section if the additional dose to the embryo / fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
I, . (Print Last Name, First Name, MI) have read the above Nuclear Regulatory Commission definition of a " DECLARED PREGNANT WOMAN" and section 10 CFR 20.1208 on the dose to an embryc! fetus and understand them and that by declaring my pregnancy in writing I have reduced my maximum permissible deep-dose equivalent exposure to 0.5 rem (5 mSv) during the entire gestation period from that of a non-pregnant. With this understanding I am vohintarily informing that I meet the NRC definition and request that a fetal monitor be issued to me. I estimate that the date of conception to be on or about (Date).
Date: Signature of the applicant Identification Number: Code: Date: Signature of the Radiation Safety Officer or designee E
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LIVINGSTON SLONE,INC.
$ tol(907)562 2058 3900 Arctic BNd., Suite 301, Anchorage, Alaska 19503 5790 fax (907)561-4528 RECIPIENT:_ BOP hrM% mm e<eewi j Attents: _ $Ol(d Date: 4-1-41 Ew5ca Fax No; _ Project Nuntec __361-1471 Project Name:
,_
__ No. of pagesincludog tNs cover; 2- HARD COPY: , _ TbhpAOWFCk.,
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- UNITED STATES 3[m j
e,t NUCLEAR REGULATORY COMMISSION
- REGION IV = }e % .,. ..[ Walnut Creek Field Office 1450 Maria Lane Walnut Creek, Califomia 94506-5368
, MUL 3 01157 Blood Bank of Alaska, Inc.
- ATTN: Thomas K. Hathaway, Ph.D.
Executive Director 4000 Laurel Street Anchorage, Alaska 99508 i-SUBJECT: REQUEST FOR A NEW LICENSE
-
, This is in reference to your application dated June 7,1997, for a byproduct material - license. The content of this letter was discussed with Ms. Gaye Hurley, Director of Quality
- Assurance, on July 30,1997. In order to complete our review, we need the following additional information:
l 1. You should specify that both Dr. Hathaway and Ms. Pedigo will receive training specific to the operation of your irradiator from the manufacturer's representative when the unit is installed. Submit such a commitment in.your reply.
. 2.- A. You should specify the number of hours of training which Dr. Hathaway has completed relative to radiation safety. (Reier to item 7 of your application, - which lists classes completed but does not indicate their duration).
B. ' You should describe the radiation' training which Ms. Pedigo will complete prior to delivery of the irradiator. The radiation safety portion of this training should-be at least three days in length. (Refer to item 7 of your application, and to item 7 of Regulatory Guide 10.9, copy enclosed.)
- In your reply, you should submit this information.
3. Your irradiator training program indicates that two written tests and one operational checklist will be used to test the understanding of employees prior to authorizing them to use the irradiator. You should submit sample tests, with answer keys, to < demonstrate the types of questions which will be posed to your students. The guide
, -(Refer to item 8., item 2.) suggests that the tests include at least 25 questions involving r'adiation safety, the use of radiation detection instruments, and the design
- and operation of the irradiator. You should submit sample examinations and answer keys.
0 m , _ , . ,
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! - # * " : Blood Bank of Alaska, Inc.
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, 4-'. , ' 4. -- 10 CFR_20.1502 states that personnel monitoring,is required for minors and declared
~
. pregnant women likely to receive 50 millirem per year. You should specify how you
-
--will assure that this requirement is satisfied. 0:,-'at of Regulatory Guide 8.13, i
- Revision 2 and of Proposed Revision 3 to Regulatory 7ulde 8.15 are enclosed for j reference.-- Please submit information to demonstrate hev you will satisfy this i
- requirement.
i E . 5. -- Ms. Hurley indicated that leak tests will be conducted by the Rau. Jv., Gafety Officer ; according to the' manufacturer's instructions and submitted to a licensed contractor
'
i ~
' - .for analysis. You should submit a statement to this effect.' Refer to item 10.3 of ,
Regulatory Guide 10.9.
6.1 - The blood irradiator can only be transferred to an authorized recipient, as described in 110 CFR 30.41. You should specify that the irradiator will be either returned to the - manufacturer or transferred to another licensed recipient when it is no longer needed.
. We will continue the review of your request for a new. license upon receipt of this :
- information. In order to continue prompt teview of your application, we request that you submit your response to this letter within 30 days form the date of this ' 'er, Please reply ' in. duplicate, and refer to Mail Control 572521.
Sincerely, - 78* G'. &
~ Beth A.- Prange Sr. Health Physicist (Licensing)
Materials Branch Docket: 030-04496 Control: 572521
.
Enclosures:
As Stated h _
, -
. .. .. - _ _. .. _ __. _. ._ ._ . _ _ . . . . . . . _ . _ -. _ . . _ .
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Blood Bank of Alaska, Inc. 3- ,
- bec:
LFARB, T 9 E10 ~ - WCFO Inspection File
,
, Docket File * ,
'
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; DOCUMENT NAME: G:\beth\bba.def -
- To receive copy of document, Irdcate in box: "C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy MB - M BPrange #F 0780/97 07/-/97 07/ /97 07/ /97- 07/ = /97 OFFICIAL RECORD COPY
. _
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g/ % UNITED STATES
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t NUCLEAR REGULATORY COMMISSION g
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REGION IV
,
l' Walnut Creek Field Office
'o * " * , # 1450 Maria Lane Walnut Creek, Californ!a 94596-5368 JUL 0 71937 Blood Bank of Alaska, Inc.
ATTN: Thomas K. Hathaway, Ph.D.
Executive Director 4000 Laurel Street Anchorage, Alaska 99508 SUBJECT: ACKNOWLEDGMENT OF REQUEST FOR NEW LICENSE ' REFERENCE: Letter dated June 17 and Application dated June 7,1997 We have completed the administrative review and initial processing of your application for a new license.
Please note that the technical review may identify additional omissions in the submitted Information or technical issues that require additional information.
Applications for a new license are normally processed within 90 days, unless the technical review identifies:
* Major technical deficiencies *
Policy issues that require input and coordination with other NRC Regional offices, Agreement State offices, or NRC's Office of Nuclear Materials and Safeguards A copy of your correspondence has been forwarded to our License Fee and A
REGION 9 U S NUCLEAR REOULATORY COMMISSOM REGON V 101 MARIETTA STREET, NW, SUITE 2900 1450 MARIA LANE j ATLANTA, GA 3032S0199 W ALNUT CREEK, CA 94596 S368
PE7. SONS LOCATED IN AOREEMENT STATES SEND APPUCATONS TO THE U S NUCLEAR REQULATORY COMMISSON ONLY IF THEY WISH TO POSSESS AND USE LICENbED MATEZlAL IN STATES SUEUECT TO U.S NUCLEAR REGULATORY COMMIS$40N (JRISOCTV)NS.
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t THis is AN ApetCATON FOR 4Checa ,roenete nom) 2 NAME AND MAluNG ADDRESS OF APPLCANT (hchase ZW code) A. NEW LICENSE
_,X blood Bank of 7.laska, Inc.
a AMENDMENT TO LCENSE NUMBER 4000 Laugg1 Styggt C RENEW AL OF UCENSE NUMBEN Anchorage, AK 99508
- 3 ADDRESS (ES) WHERE UCENSED MATERIAL WILL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THIS Blood Bank of Alaska, Inc. APPLCATON l 4000 Laurel Street Thomas K. hathaway, Ph.D.
Anchorage, AK 99508 TELEPHONE NUMBER 907/563-3110 SUBMIT ITEMS S THROUGH 11 ON S.1/2 X 11* PAPER THE TYPE AND SCOPE OF INFORMATON TO BE PROVOED is DESCRIBED IN THE LCENSE APPLCATION OulDE.
5' R ADOACTIVE MATERIAL.
S Elemeat and mass aurnter b chemmat andror physcallorm, and c mammum amount e PURPOSE (S) FOR WHICH LICENCED MATERIAL WILL BE USED wNcm wil be possessed at any one time 7 IHOVOUAL(S) RESPONSIBLE FOR RADATON SAFETY PROGR AM AND THEIR 8 TRANING FOR N0lVOUALS WORKING N OR FREQUENTNO RESTRCTED AREAS TRANING EXPERIENCE.
S FAClUTIES AND EQUIPMENT 10 RADATON SAFETY PROGRAM 11 LEENSEE FEES (See f0 CFR f 70 and Sechon 170..Tf) , 11 W ASTE MANAGEMENT. AMOUNT FEE CATEGORY 3E l ENCtOsED s 1,200.00 13 CERTIFCATON. (Must se compeled by appacen0 THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPUCATON ARE BINDNG UPON THE APPLCANT.
THE APPLCANT AND ANY OFFICIAL EXECUTNG THis CERTIFCATION ON BEHALF OF THE APPUCANT, NAMEC IN ITEM 2, CERTIFY THAT TH4S APPUCATION IS PREPARED N CONFC4MITY WTTH TfTLE 10 CODE OF FEDERAL REGULATIONS PARTS 30,32,33,34,4 30,39 AND 40, AND THAT ALL NFORMAflON CONT ANED HEREW IS TRUE AND CORRECT TO THE BEST OF THEIR KNOVVLEDGE A ND BEUEF WARNNG 16 U S C SECTION 1001 ACT OFJUNE 25,1946 62 ST AT 749 MAKES IT A CRIM NAL OFFENSE TO MAKE A WILLFULLY F ALSE STATEMENT OR REPRESENT ATON T3 ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WTTHIN ITS JURISDICTION CERTIFYNO OFFICER = TYPED / PRINTED NAME AND TITLE SIGNATUR DATE
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Thomas K. Hathaway, Ph.D. Executive Director ser *> 4 A*%- Nw417 FOR NRC USE ONLY F V TYPE OF FEE FEE LOG FEE CATEGORY AMOUNT RECEIVED CHECK NUMBER COMMENTS S APPROVED BY DATE NRC FORM 313 (6 93) PRINTED ON RECYCLED PAPER
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, item No. 5 Submitted by Blood Bank of Alaska,Inc.
i ' item No. 5, Radioactive Material: a. Element and Mass Numb 1r: Isotope: Cs-137 b. Chemical and or physical form: Sealed sources - ' ORIS/CBI Model CSL-15 In a Model IBL 437C Blood irradiator
' c, Maximum amcunt in possession at any one time: Maximum of 1870 curies .
(One source 1700 curies 10% in the
' Oris CBI Model IBL 437C Blood Irradiator) !
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, ftem No. 6
. Submitted by Blood Bank of Alaska, Inc. {
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Item No. 6, Purpose (s) For Which Licensed Material Will Be Used: 1 The irradiator will be used for the irradiation of blood, blood products,
cells and tissues.
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, Item No. 7 Submitted by Blood Bank of Alaska,Inc.
Item No. 7, Individual (s) Responsible for Radiation Safety Program and Their Training Experience: SEE ITEM 7a. FOR C.V. OF THE INDIVIDUALS LISTED BELOW
- 1. Radiation Safety Off!cer
Thomas K. Hathaway, Ph.D., MT (ASCP) SBB Training: " Health Physics Aspects of Radioisotope Use" Walter Reed Army Medical Center ,
" Health Physics / Radioisotopes" Walter Reed Army Institute of Research " Training Program in Operation of J.L. Shepherd & Assoc.
Model 143-45A Blood Product Irradiator" J.L. Shepherd & Assoc.
. Radiation Safety Refresher Course Engelhardt & Associates, Inc.
Experience' Over 25 years training and experience through US Army Health Services Command and irradiator usage at Walter Reed Army Medical Center.
1 2. Authorized User and Staff Trainer in Use of Irradiator: The following individual will be responsible for tr6;ning personnel in the use of the irradiator: ' Maureen Pedigo, MT (ASCP) SBB, Director of Technical Services . Training: Radiation Safety Program to be completed prior to the delivery of the irradiator.
Training in use of the irradiator to be provided by the manufacturer representative upon delivery of the irradiator.
Experience: No formal training.
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l l ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, item No. 7 : Submitted by Blood Bank of Alaska,Inc.
Item No. 7a, C.V. of Individual (s) Responsible for Radiation Safety Program and Their Training Experience:
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CURRICULUM VITAE: THOMAS K. HATHAWAY, Ph.D.
' NAME: nomas K. llathaway , PRESENT ADDRESS: ACADEMIC TRAINING and DEGREES: 1987 Bowling Green State University Bowling Green, Ohio Degree: PhD in Biology (Immunology /Inununohematology) 1981 Bowling Green State University Bowling Green, Ohio Degree: Specialist in Applied Biology (Immunohematology) Post , Masters Degree 1977 Central Michigan University Mt. Pleasant, Michigan Degree: M.A. Management and Supervision: Health Care Administration 1970 Bowling Green State University Bowling Green, Ohio Degree; BS in Biology CERTIFICATIONS: 1986 National Certi5 cation Agency for Medical Personnel (NCA) Certification: Clinical 12boratory Scientist (CLS) No. 0930944 1986 National Certification Agency For Medical Personnel (NCA) Certification: Blood Banking CLSP (IH) No. 0930944
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1981 Walter Reed Army Medical Center Blood Bank Fellowship, Washington, D.C.
Certification: Specialist in Blood Banking SBB(ASCP) No. 002264 1974 Walter Reed Army Medical Center School of MedicalTechnology Washington, D.C.
Certification: MT(ASCP) No. 095320 PROFESSIONAL EXPERIENCE: 1996-Present Executive Director Blood Bank of Alaska,Inc.
Anchorage Alaska 99508
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1994-1996 Director, Laixtatory Seryn s & llealth Information System Administrator
- Scott General llospital/ Columbia liCA Georgetown, Ka,atucky 40324 1991 1993 Director TechnicalServices Sylvan N. Goldman Center Oklahcana Blood Institute OklahomaCity, Oklahoma 73104 1989-1991 Executive Director Blood Center
. Waher Reed Army Medical Center Washington, D.C. 20307 5001 l Program Director , Blood Bank Fellowship Program (SBB) Walter Reed Army Medical Center Washington, D.C, 20307 5001 1987 1989 Chief of Research and Education - Department of Pathology & ALS Walter Reed Army Medical Center Washington, D.C. 20307 5001 l 1984-1987 Doctoral Candidate Bowling Green State University - Bowling Green, Ohio 43416 1983-1984 Commander / Director U.S. Army Europe Blood ~ Bank Landstuhl ArmyMedicalCenter Landstuhl, Germany _- Director, USAREUR Dlood Program IlQ,7th Medical Command lleidelberg, Germany ' 1981-1983 Technical Director US Army Europe Blood Bank landstuhl ArmyMedicalC:nter Landstuhl, Germany 1979 1980 - Quality Control Ofncer Dept. of Pathology and Area Laboratory Services-Walter Reed Army Medical Center Washington, D.C. 20307 1974-1978_ Administrative Oiticer/ Quality Control Officer Department of Pathology Fitzsimons Army Medical Center Denver, Colorado
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PROFESSIONAL EXPERIENCE CONT: . 1971 1973 Chief MedicalMaterial first US Army Medical Laboratory Fort Meade, Maryland PROFESSIONAL APPOINTMENTS: 1983-Present inspector Blood Bank Inspection and Accreditation Program American Association of Blood Banks 1993 1994 Member, legislative Committee Oklahoma Association ofIlome llealth Care 1989 1991 Member, Board of Directors Society of Armed Forces Medical Laboratory Scientists 1989 1991 Editor Journal of Military Medical Laboratory Science !' 1985 1987 Member Advisory Board 4 American Red Cross Bowling Green, Ohio 1985 1991 Member Department of Defense Blocxl Program Technical Advisory Panel The Pentagon, Washington, D.C.
MEMBERSHIPS: 1979-Present American Association of Blood Bankt.
1973 Present American Society of Clinical Pathologists 1985-Present Beta, Beta, Beta Biological lionorary , , 199.1 Present Clinical Laboratory Management Association 1996-Present Northwest Assoc!ation of Blotv] Banks 1996-Present Anchorage East Rotary
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MAUREEN JENNIFER PEDIGO, MT(ASCP)SBB m llomc 6 Work:(907)S63 3110
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PROFESSIONAL EXPERIENCE Director of Technical Services (August 1995 Present) Blood Bank of Alaska,Inc.,4000 Laurel Street, Anchorage, AK 99508
* Supenise and schedule staff * Perform staffevaluations * Write and maintain updated standard operating procedures * Assistin training of staff * Review quality control and perfonn lot release for the laboratory, components, and distribution * Assist with the planning and implementation of new procedures and equipment * Supenise on-call staff who perform distribution and laboratory duties after hours * Supenise distribution staff and oversee the blood bank's inventory of blood products * Perform quarantine andlookback ,
Laboratory Supervisor (Processing and Components) (March 1993 July 1995) Central California Blood Center,3445 North First Street, Fresno, CA 93726
* Supenised sad scheduled staff of twenty-one * Perfortned staff evaluations * Wrote and maintained updated standard operating procedures * Assistedin training of staff
. * Verified testing and quality control parameters were within acceptable range
* Coordinated product production with the Product Management Group
. * Filled in as needed to perform testing when staffmg shortages occurred
* Performed Beta testing and validation of Ortho Diagnostics' LOMS system Specialist in Blood Banking - Student (January 1992 -January 1993)
Sacramento Medical Foundation,1625 Stockton Bh'd., Sacramento, CA 95816 Medical Technologist - Generalist (April 1988 February 1993) Fremont Medical Center,970 Plumas Street, Yuba City, CA 95991
* Performed patient testing, quality control, and preventathe maintenance in chemistry, blood bank, urinalysis, hematology, special chemistry, scrology, and microbiology * Assistedin trammg new staff Medical Technologist - Per Diem Generalist (March 1991 -December 1991)
Enloc Hospital, West Fifth Street, Chico, CA 95926
* Performed patient testing and quality control in chemistry, blood bank, urinalysis, hematology,
. special chemistry, and scrology , o Gained some experience in a trauma level hospital
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MAUREEN JENNIFER PEDIGO, MT(ASCP)SBB Medical Technologist - Generalist (March 1989 August 1989) Marysville Medical Group,800 Third Street, Marysville, CA 95901
* Perfonned patient testing, quality control, and preventative maintenance in chemistry, blood bank, urinalysis, hematology, and microbiology Medical Technologist - Generalist (March 1987 April 1988)
Colusa Community Ilospital,199 East Webster, Colusa, CA 95932
* Perfonned patient testing, quality control, and preventatiw maintenance in chemistry, blood bank, urinalysis, hematology, and microbioloFy * Took call on weckends and during the week Medical Technologist - Generalist (December 1986 - March 1987)
Paufs Valley Gcaeral llospital,100 Paul's Valley Drive, Paul's Valley, OK 73075
* Performed patient testing, quality control, and preventative maintenance in chemistry, blood bank, urinalysis, and hematology *- Took callduring the week Medical Technologist - Student and Lab Assistant (August 1985 - December 1986)
Valley View Ilospital,405 Monta Vista, Ada, OK 74820
* Performed patient testing, quality contml, and preventative maintenance in chemistry, blood bank, hematology, microbiology, special chemistry, and urinalysis * Completed Medical Technology internship and worked on wcckends
> EDUCATION University of Alaska Anchorage, Anchorage, AK (1996 present)
* Completing final courses for Master of Public Ilealth Administration degree California State University Fresno, Fresno,CA (1993 - present) * Master of Public lica';h Administration, projected graduation June 1998
, Sacramento Medical Foundation, Sacramento, CA (1992 - 1993)
* Specialist in Illood Banking internship Valley View Hospital School of Medical Technology, Ada, OK (1985 - 1986)
, * Medical Technologist Internship Oral Roberts University, Tulsa, OK (1982 - 1986)
* Bachelor of Science ( Cum Laude), Medical Technology
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EUREEN JENNIFEM PEDIGO, MT(ASCP)SHH i PROFESSIONAL CERTIFICATION l l /.tnerican Society of Clinicall'athologists (ASCP) i blical Technologist #170954 (1986) 1)kud llands.g MKil881 (1992) t' ! Specidial in likxxl llanking M26743 (1993) ' Califonia S'aie ikpartancut ofilcalth Clinkal Medical Technologist #33636 (1987) i ' Nationaf Certification Apowy(NCA) l Medical 1ochnologis: M932387 (1986) Aie ne snber of Anwrican Annoeistion oflikxxl llanka and California likxxl llank Society i
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ATTACHMENT TO APPLICA~ ION FOR MATERIAL LICENSE, item No. 8
- Submitted by Blood Bank of Alaska, Inc.
f item No. 8, Training for Individuals Working in or Frequenting Restricted Areas: I a. Outline of Training Program: Ses item 8.a., attached b. On the job training: See item 8.b. attached c. Records documenting the training for Radiation Safety and Irradiator Use will be maintained for each Individual operating the irradiator.
d. The Training course instructors will be as follows:
' * Thomas K. Hathaway, Ph.D., the Blood Bank of Ak. Radiation Safety Officer, will provide Radiation Safety Training to all employees using the irradiator. Such training will occur prior to any on the job training and/or use of the irradiator. A qualified trainer from Health Physics Northwest or other commercially available quallfled trainer may also provide Radiation Safety Training to the staff prior to using the irradir. tor.
- The Manufacturar's representative will provide on the-job training for all employees operating the Irradiator when the irradiator is installed.
Maureen Pedigo, MT(ASCP),SBB will provide training in the use of the irradiator to employees who will be using the irradiator that may be subsequent to the manufacturer's initial training.
- The Blood Bank Radiation Safety Officer, or a quallfled trainer from Health Physics Northwest or other commercially available quallfled trainer, will perform annual Radiation Safety Training.
- The names and certification of other qualified trainers that may be used will be maintained as part of the employee training records.
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, Itetn No. 8 Submitted by Blood Bank of Alaska,Inc.
Item No. 8a, TRAINING OUTLINE 1. Basic terminology and physics a. lonizing and non lonizing radiation b. Types of ionizing radiation 2. Sources of radiation a. Natural b. Man made 3. Units of Radiation Measurement a. Exposure: roentgen (R); C/kg b. Absorbed dose: rad, gray (Gy) c. Dose equivalent: rem, sievert (Sv) ' 4. Radiation Detection and Measurement a. Gm counter b. lon chamber c. Personnel dosimeters: film, TLD, pocket chamber 5 Biological effects of radiation l a. Somatic / genetic l b. Prompt / delayed c. Stochastic /non stochastic 6. Standard for Radiation Protection a. 10 CFR 19, and 10 CFR 20 , t 7. Radiation Safety Practices I a. Time l b. Distance j c. Shielding 8. Radiation risks versus other risks i 9. ALARA 10. Design and Operation of the Irradiator 5-The Training Program for items 1 through. 9 will be 4 hours in length. A test will be given _ after the training, and the passing grade will be 80%. Training on item 10 will not be
performed until a satisfactory grade has been obtained for the test on items 1 through 9.
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The Training ior item No.10 will be a minimum of one hour, but will vary according to the needs of the Individual. A Standard Operating Procedure (SOP) for use of the irradiator i will be located next to the irradiator. Each employee using the irradiator must read the SOP, and complete a test on the design and operation of the IBL4370 Irradiator. The passing acore will be 90% After successful complsilon of the test, each employee must use the Irradiator while being observed by a quellflod trainer who will evaluate the employee against a Training Checkilot. Ea9h employee must perform a successful irradiation cycle while under observation priot to using the irradiator unsupervised.
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. ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, ftem No. 8 Submitted by Blood Bank of Alaska,Inc.
Item No. 8b, ON THE-JOB TRAINING IRRADIATOR OPERATION: A representative from the Irradiator manufacturer, CIS.
US, Inc., will instruct all staff who will be using the irradiator in the actual operational functions. The amount of time spent will be customized to meet the needs of each individual.
The Director of Technical Services, Maureen Pedigo, MT(ASCP)SBB, will assure that prior to using the irradiator each employee has satisfactorily passed a test on its use. Additionally, she will observe each employee perform an irradiation procedure and assess their competence against a Training Checklist. An employee will not be allowed to use the irradiator unless the test and hands on competency checklict have been satisfactorily completed.
RADIATION SAFETY: The Radiation Safety Officer, Thomas K. Hathaway, Ph.D., MT(ASCP)SBB, will Instruct employees in radiation safety in general terms, as well as specifics to the IBL 4370 Blood Irradiator. The training will be a minimum of 4 hours. An annual Radiation Safety meeting will be conducted by either the RSO, or another quallfled individual or firm.
ON THE-JOB TRAINING: Maureen Pedigo, MT(ASCP)SBB, the Director of Technical Services, will provide on the job retraining in the use of the irradiator, as needed. Sb3 will also train any new employees in the operation of the irradiator.
. . ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, item No. 9 Submitted by Blood Bank of Alaska,Inc.
Item No. 9, FACILITIES AND EQUIPMENT NOTE: Attachment 9a shows the location of the intended room in which the irradiator will be placed.
The irradiator will be installed at the Blood Bank of Alaska's main facility located at 4000 Laurel Street, Anchorage, Alaska. Installation will be performed by the manuf acturer's representative who will test the irradiator for proper operation and safety. The Blood Bank of Alaska's facility has an alarm system for fire and unauthorized access, which is monitored off site 24 hours a day. The building is installed with an automatic sprinkler system. The facility also has an emergency back up 150 Kw generator in case of power failure.
The irradiator will be located in a room that can be locked when a user is not present to prevent access by unauthorized person. The room has no exterior walls and the only access to the irradiator will be through the lockable door.
A survey meter will be available to persons using the irradiator.
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, ftem No 10 Submitted bv Blood Bank of Alaska,Inc.
Item No.10, RADIATION SAFETY PROGRAM PERSONNEL MONlTORING EQUIPMENT: A TLD will be installed in an appropriate location to ensure doses to all personnel will be betw regulatory requirements. A second dosimeter will be placed in the OA Director's office on the 2d floor to serve as a negative control. This badge will be changed monthly.
Health Physics Northwest (State of Oregon License number 90361), or another quallfled firm, will be providing the badges and the exposure information.
RADIATION DETECTION INSTRUMENT: A radiation survey meter selected and maintained by the RSO will be located nearby. A calibrated survey meter that can measure up to 1 R/hr will be available for use at all times.
The meter will be calibrated so that the readings are 120% of the actual values over the range of the instrument. The results of the calibration, the date of the last calibration, and the due date for the next calibration will be affixed to the survey meter. The meter will be calibrated annually and after servicing and/or repairs. Calibration records will be kept for 5 years after each calibration. Calibrations will be performed by Health Physics Northwest (State of Oregon License number 90361), or another quallfled firm, and reviewed by the RSO.
! LEAK TESTING: The leak test will be performed every six months by Health Physics Northwest (State of Oregon License number 90361), or another quallfled firm, using established procedures and equipment sufficiently sensitive to detect 0.005uCl of radioactivity. The leak test results will be reviewed by the RSO.
OPERATING. MAINTENANCE. AND EMERGENCY PROCEDURES: A Standard Operating Procedure (SOP) will ba ocated near the irradiator. All staff using . the irradiator will be trained in the SOP through tests, observation and competency assessments prior to using the irradiator unsupervised. See item 10a for an abbreviated outline of the operating procedure and inspection and maintenance instructions. See 10b for a copy of the Irradiator Safety Instructions.
Emergency procedures (see 100) will be provided to each user and will be located near the irradiator. Health Physics Northwest (State of Oregon License number 90301) or another qualified firm, will be used for emergency radiation consultants on a 24-hour a day basis.
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ATTACHMEN T TO APPLICATION FOR MATERIAL LICENSE, item No.10 Submitted by Blood Bank of Alaska,Inc.
' Item No.10s, OPERATING PROCEDURES, AND INSPECTION AND MAINTENANCE INSTRUCTIONS Abbreviated Operating Procedures: 1. Turn key switch to "on".
2. Pre select time 3. Open door 4. Load container holding units of blood into irradiator with its lid in place and lock.
5. Close the door.
6. Push " Start cycle" 7. Timer counts down to zero.
8. Open door.
9. Unload the container holding blood units and remove units from the container, inspection and Maintenance Instructions: 1. The irradiator shall be operated as described in the Operator's Manual which is incorporated into the SOP, and according to the requirements of the facility's NRC license.
2. No individual shall undertake repair, perform any maintenance, or make any changes on or in the IBL 437C Irradiator without prior approval of the RSO.
3. Relocation of the irradiator is prohibited without prior approval from the NRC.
4. - Leak tests, radiation protection surveys, and periodic inspections will be conducted and reviewed by the RSO.
5. A comprehensive annual maintenance survey will be performed by the manufactuier's representative. Periodic maintenance, as specified in the operator's manual, will be performed by quallfled staff. Maintenance records are maintained q by the Facilities Agent.
6. A simple functions check will be performed each day of use following Standard Operating Procedures as specified in the operator's manual. Any suspected malfunctions will promptly be reported to tha RSO.
7. An annual validation of the irradiator dosimetry calibration of both the central region and minimum dose locations within the irradiator's canister is performed and analyzed by the manufacturer's representative, reporting an accuracy compared to the manufacturer's original dose rate calibration to within 5% and i9%. 8. On a quarterly basis, the count down tabulator / timer will be checked for accuracy against a certified chronometer by Blood Bank personnel.
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, l tem No.10 Submitted by Blood Bank of Alaska,Inc.
item No.10b, IRRADIATOR SAFETY INSTRUCTIONS 1. Only authorized users and supervised trainees will be able to use the irradiator. A TLD badge located by the irradiator will monitor exposure.
2. The TLD badge will be exchanged on a monthly basis. Records of dosimetry will be kept in accordance with applicable regulations. All records are reviewed by the RSO.
3. Key control access of the irradiator will be maintained by the principal authorized user when qualified staff are not in the area to prevent unauthorized access to the irradiator. Only authorized users will have access to the keys.
4. All authorized users of the irradiator will receive an annual radiation safety class from the RSO or Health Physics Northwest, or other quallfled firm. Documentation of the annual training will be kept.
5. Any modification of the safety control system or removal of the radiation source is strictly prohibited, unless done by an authorized individual licensed by the NRC.
6. Under no circumstances shall explosive material be Irradiated in the blood ' irradiator.
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ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, ftem No.10 Submitted by Blood Bank of Alaska,Inc.
Item No.10c, EMERGENCY PROCEDURES IMPORTANT: IN THE EVENT OF AN EMERGENCY, MALFUNCTION, OR OTHER UNUSUAL OCCURRENCE INVOLVING THE IRRADIATOR, THE FOLLOWING INDIVIDUALS SHOULD BE NOTIFIED IMMEDIATELY AFTER THE IBL-437C IRRADIATOR HAS BEEN TURNED OFF: Firo Department (if appropriate)- Telephone 911 Radiation Safety Officer Thomas K. Hathaway, Ph.D.
Home telephone 344-0262 Cellular phone 242 9505 Pager 275-0717 Director of Tech Services - Maureen Pedigo, MT (ASCP)SBB Home telephone 337-0741 Pager 275-0636 Health Physics Northwest -(800) 762 8444 or (503) 620-6617 After hours Emergency for Health Physics North West (800) 762-8444 1. In case of improper operation: a. Push " Cycle Break" switch, b. To restart, press " Cycle Break" switch again to clear the cycle break, the start cycle light will illuminate, press the " Start Cycle" t,.vitch to continue the cycle.
2. In case of power failure: ' a. The battery power in the irradiator allows immediato return of the drum to the unloading position. The timer maintains the elapsed time. The building's emergency generator will restore power within 15 seconds. On return of power, to restart the irradiation cycle, push the " Start Cycle" switch.
3. In case of an EMERGENCY: (unrelated to the irradiator), i.e., building, fire alarm, etc.
a. Push in the " Emergency Stop" switch b. After the fault has been corrected, the irradiator may be restarted by resetting " Emergency Stop" switch with (Emergency) key and the original selected time will appear on the timer.
c. Product should be discarded if the elapsed time of the emergency is not of a short duration.
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.* 4. In case of EMERGENCY (related to the irradiator) 1.e. Irradiator malfunction and/or unusual event: a. Push in the " Emergency Stop" switch, b. Leave the room and lock the door, c. The senior individuals at the Blood Bank shall clear the area of personnel and restrict access to the irradiator room until relieved by competent authority. The Irradiator will not be operated until an inspection and radiation safety survey has been conducted by the RSO.
d. The RSO or other quallfled individual will conduct a survey as soon as possible with a radiation survey meter outside the irradiator room to determine if further restriction of the area is necessary to ensure that no one can enter the area if the radiation levels exceed 2 milliroentgen per hour.
ADDITIONAL TELEPHONIC POINTS OF CONTACT: a. IBL 437C Irradiator Manufacturer's representative: Paul Tyree, RSO, CIS-US. Telephone 1 800 221 7554 ;
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b. Nuclear Regulatory Commission, Emergency Operations Center, Washington DC. Telephone 1 301 816 5100
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4 i i ATTACHMENT TO APPLICATION FOR MATERIAL LICENSE, item No.11 J Submitted by Blood Bank of Alaska,Inc.
, item No.11. WASTE MANAGEMENT l Not applicable. No radioactive waste is generated.
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