ML20050D594
| ML20050D594 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1982 |
| From: | Adam W, Mccarter J, Warnick R, Weideman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| 30-12831-80-01, 30-12831-80-1, NUDOCS 8204120348 | |
| Download: ML20050D594 (10) | |
Text
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4 U.S. NUCLEAR REGULATORY COMMISSION REGION III Report No. 33-12831/80-01 Priority I Category B Docket No. 30-12831 License No 48-17466-01MD Licensee: Nuclear Pharmacy, Inc.
933 N. Mayfair Road Wauwatosa, WI 53226 Facility Name: Nuclear Pharmacy, Inc.
Inspection / Investigation At: Wauwatosa, WI Inspection / Investigation Conducted: September 3, 4, 5, 1980 Inspector: O 3 A6 N W. J.QAdam, Ph.D.
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Investigator:
/2/'M!rwurl'/Ov YehtI"T.
J. B. McCarten Date 3N Reviewed By:
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D.G.VWiedeman,ActinpChief date '
Materials Radiation Protection Section 1 l
2 E R.h-b shk D' ate R. F. Warnick, Director Enforcement and Investigation Staff Inspection Summary Inspection on September 3, 4, 5, 1980 (Report No. 30-12831/80-01)
Areas Inspected: Special inspection and investigation into allegations regarding the laboratory radiation safety program including: Organization; Audits; Training, Retraining, and Instruction to Workers; Radiological Protection Procedures; Facilities and Equipment; Receipt and Transfer of Materials; Exposure Controls - External; Exposure Controls - Internal; Leak Tests, Instrument Calibration, and Quality Assurance; Surveys; and Waste Disposal. This inspection / investigation involved 40 onsite hours i
by two NRC representatives.
Results: Of the eleven areas inspected, no apparent items of noncompliance were identified in ten areas, one apparent item of noncompliance was identi-fled in one area.
Infraction - failure to perform bioassays - Section 10.b.
i O2041203y 820407 1
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1 DETAILS 1.
Persons Contacted
- Mr. J. M. Reavis, Managing Pharmacist
- Mr. K. Barat, Radiation Safety Technician Ms. C. Casey, Radiation Safety Surveyor
- Mr. R. Petosky, Head Driver Mr. W. R. Fast, Registered Pharmacist In addition to the above, several other licensee employees were interviewed during the inspection / investigation.
- Denotes individuals attending the exit interview conducted on September 5, 1980.
2.
Licensee Action on Previous Inspection Findings Noncompliance 79-01; Procurement of non-human use Xenon-133 for distri-bution to medical licensees for human use.
Noncompliance 79-01: Transfer of non-human use xenon to licensees not authorized to possess this form of material.
The licensee has instituted corrective actions in that bulk, non-human use xenon is no longer being procured or distributed.
3.
Organization Nuclear Pharmacy, Incorporated, operates a number of centralized radio-pharmacies in the United States.
Each facility has a separate NRC or Agreement State license. The president of Nuclear Pharmacy is Mr. Robert L. Sanchez. The present branch manager of the Milwaukee facility is Mr. Jon M. Reavis who reports to Mr. S. Dessel, District Manager, who, in turn, reports to Mr. N. DeSantis. The licensee has moved his activities from 1024 North Sixth Street, Milwaukee, to 933 North Mayfair Road, Wauwatosa, as authorized by amendment No. 6.
The licensee's close-out survey of the Sixth Street facilities was sub-mitted to Mr. Joseph De1 Medico, Material Licensing Branch, Division of Fuel Cycle and Material Safety.
Amendment No. 6 of this license amends License Condition 12.A and 12.B l
to name R. L. Sanchez, A. C. Solomon, W. Guthrey, J. M. Reavis or l
N. M. DeSantis as authorized users and designates Mr. J. M. Reavis as l
the Radiation Safety Officer. A letter from the licensee dated April 2, 1980, established the positions of Radiation Safety Technician and Radiation Safety Surveyor. Both positions are supervised by the cor-l porate Radiation Safety Officer.
No items of noncompliance were identified.
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4.
License Audits The licensee's letter dated April 2, 1980, states that the cors porate Radiation Safety Officer would visit the Milwaukee facility on a quarterly basis for the purpose of management audits of the radiation safety program. The Radiation Safety Technician, who is based at the Chicago facility, is to spend an average of one day per week at the Milwaukee facility.
A review of audit records indicated that the required frequency of audits has been met or exceeded by the licensee and that the audits
- l consisted of a review of records, contamination surveys, safety procedures and laboratory facilities. Results of these audits are forwarded to corporate headquarters. The Radiation Safety Technician and Surveyor perform unscheduled contamination surveys of areas not routinely surveyed.
Both the corporate Radiation Safety Officer and the Radiation Safety Technician institute corrective actions as required.
No items of noncompliance were identified.
5.
Training, Retraining and Instruction to Workers The licensee's letter dated April 28, 1975, outlines the training requirements of 10 CFR 19.12 and specifies a minimum of one hour of training for each individual who frequents any portion of a restricted area. Review instructions are to be given at three month intervals to the drivers.
F At present, the drivers are receiving formal training at least monthly.
A number of the drivers were interviewed, and it was determined that while training was received by all of them, the drivers knowledge of emergency procedures, in the event of an accident was limited to calling NPI.
Documentation of training consisted of signoff sheets on varicus NRC handouts, driver training sessions, safety changes and the radiation safety manual review.
No items of noncompliance were identified.
6.
Radiological Protection Procedures Operating procedures for the radiopharmaceutical lab have been out-lined by the licensee in a letter dated April 16, 1975. Dispensing of radiopharmaceuticals was performed in a vertical laminar flow hood provided with a lead glass L-block. The dose calibrator was also provided with lead foil and lead glass shielding. Personnel handling radiopharmaceuticals were observed wearing disposable gloves and using syringe shields. Smoking, eating, drinking and mouth pipetting were not observed in the lab area. Working surfaces in the lab were covered i
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Storage areas, including refrigera-tors, as well as various containers appeared to be appropriately labeled.
Emergency procedures described actions to be taken in the event of a radioactive spill and were posted in the lab.
Procedures for receiv-ing and opening packages were also posted.
No items of noncompliance were identified.
7.
Materials, Facilities and Equipment a.
Use of Licensed Material The licensee's possession limit for molybdenum-99/ technetium-99m generators is 20 Ci.
At the present time, the licensee is receiv-ing one 9.5 Ci Union Carbide generator and one 2.5 Ci Squibb generator per week.
Xenon-133 is supplied in unit dose form as a gas from Diagnostic Isotopes and New England Nuclear.
1 The licensee is authorized to receive and distribute byproduct j
material listed in Groups I, II, IV and V, of Schedule A, Section 1
35.100 of 10 CFR Part 35.
From review of receipt records it appeared that no material was received which was not authorized by the licensee. No unauthorized uses or forms of material were apparent.
b.
Facilities The physical layout of the facility is as described in the licensees' letter dated January 20, 1980, with the exception of some minor changes in placement of a fume hood and colloid preparation area.
Generators are stored and cluted along an outside wall in the isotope storage room.
In addition to the generator manufacturer's shielding, additional lead sheeting was placed at the periphery of the generator station.
Localized radiation areas existed only in the immediate vicinity of the generators.
i Waste is stored in the lower level of the building within a l
locked steel mesh cage. This area is discussed in more detail in Section 13.
I c.
Security Entrance to the radiopharmaceutical lab can be made by one of two ways, either through the drivers entrance or from the secretary's office.
In both cases, access is controlled by intercom systems I
and electric strike locks controlled by a button within the general pharmacy area.
Anyone who enters the general laboratory area must be ide ntified prior to entering. The generator and isotope storage room is secured by a separate lock which is not keyed to the master i
l key and hence is not accessible to cleaning personnel. The waste storage area in the lower level of the building is secured by a locked solid steel door. The steel cage within which the waste is I
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1 kept is also locked and requires a second key.
Visitors to the lab are required to wear dosimeters and the visitor's name and dosimeter readings are registered in a Icg.
d.
Caution Signs and Labels Rooms and containers appeared appropriately labeled as required by 10 CFR 20.203(a) through (f). No high radiation or radiation areas were encountered within the facility.
Posting requirements of 10 CFR 19.11(a) through (e) were met.
Equipment e.
The licensee's letter dated April 2, 1980, outlines some of the equipment in use at this facility as well as room ventilation capabilities. A lead-shielded, vertical laminar-flow hood is provided for drawing doses. A second conventional hood, located in the isotope storage room, is used to store and process xenon-133 and iodine. This hood is vented to the outside and the flowrate at the hood sash is monitored on a weekly basis using an Alnor Jr. velometer. Radiation monitoring equipment includes:
a Ludlum 2600 well counter, a Davidson Multichannel analyzer, a Nuclear Associates Xen-Alert and a number of pancake, thin-window, G-M survey meters. The multichannel analyzer is used to perform thyroid bioassays. The iodine sampling system is described in Section 10a.
No items of noncompliance were identified.
8.
Receipt and Transfer of Material The licensee is required to keep records of receipt and transfer of materials by 10 CFR 30.51.
In addition, the application dated i
March 18, 1975, requires the use of a "Radionuclide Log Book" for recording: package wipe test results, item, manufacturer, assay and assay date, volume, lot or control number, date received, expiration date, disposal date and the initial of the pharmacist. The inspector noted that the information required by the Radionuclide Log Book is, in fact, kept on the manufacturers packing slips or other loose sheets and filed by radionuclide. The licensee is required by 10 CFR 20.205(a) through (d) to monitor certain incoming packages of radionuclides. A record of the results of these surveys is required by 10 CFR 20.401(b).
10 CFR 20.205 also requires the licensee to establish and maintain procedures for safely opening packages of licensed material.
l The inspector reviewed a selected sample of package survey results.
It appeared that all incoming packages from manufacturers containing byproduct material were being surveyed.
Procedures for opening packages of licensed material were posted.
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The inspector also confirmed that, for the customers sampled, the licensee had current copies of the customer's NRC license to ensure compliance with 10 CFR 30.41.
The licensee is required by License Condition No. 21 to procure radio-pharmaceuticals distributed for human use from suppliers that provide material under either a Food and Drug Administration New Drug Application (NDA) or in accordance with an accepted " Notice of Claimed Investigational Exemption for a New Drug" (IND). For xenon-133 the licensee's suppliers have been, since mid-January 1979; General Electric, Medi Physics and New England Nuclear, all of whom have NDA's for xenon-133. Technetium-99m i
generators come from either Union Carbide or Squibb. Other material in millicurie quantities is supplied by Squibb, Amersham, Mallinckrodt, 3M, Diagnostic Isotopes, and CIS Radioisotopes, Inc. These suppliers have NDA's for the products received by the licensee.
Most licensee shipments are in the form of individual unit doses drawn in disposable syringes.
Syringes are placed in lead containers as described in the license application. Each lead container is then sealed in shrink wrap. A prescription form described in the license application is also enclosed. The lead containers are placed in metal containers (surplus army ammunition containers) which are marked as meeting DOT specifications 7A requirements. A plastic security seal is placed over the latch of the ammunition box before it leaves the lab. The licensee measures the external radiation with a GM counter and attaches the appropriate Department of Transportation labels as required by 49 CFR 172.403.
No items of noncompliance were identified.
9.
Exposure Controls - External External Exposure Evaluation The licensee's March 18, 1975, application specifies the use of film badge personnel dosimeters as well as TLD ring dosimeters for all persons working in the radiopharmacy.
10 CFR 20.202(a)(2) requires each licensee provide appropriate per-sonnel monitoring equipment and to require the use of such equipment by each individual who enters a restricted area under such circum-stances that he receives, or is likely to receive, a dose in any calendar quarter in excess of 25 percent of the applicable value specified in 10 CFR 20.101(a).
A review of the licensee's personnel dosimetry records showed the i
following maximum yearly total exposures for 1978, 1979 and eight months of 1980, (recorded in millirens):
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4 1980 (8 mo.)
1979 1978 Extremity 7710 13,584*
8,519 Whole Body 350 3,170 1,100 None of the quarterly exposure limits in 10 CFR 20.101 were ex-ceeded during this inspection period, except the apparent exposure to a film badge during the 4th quarter of 1979 which is summarized in the investigation report accompaning this report.
The format of the vendor's personnel monitoring reports fulfills the requirements of NRC Form 5.
Evaluations were available for those individuals who appeared to have not turned in a personnel monitoring device for processing.
No items of noncompliance were identified.
10.
Exposure Controls - Internal i
Title 10, CFR 20.103(a)(3) requires the licensee to use suitable measurements of concentrations of radioactive materials in air for detecting and evaluating airborne radioactivity in restricted areas and in addition, as appropriate, to use measurements of radioactivity excreted from the body in order to make a timely detection and assess-ment of individual intakes by exposed individuals.
In a letter dated April 16, 1975, the licensee stated that thyroid bioassays would be performed on each individual on a monthly basis, a.
Airborne Monitoring The inspector examined the licensee's xenon and iodine storage hood. The iodine sampling system consisted of a Gast Model l
1047-075 air pump drawing on a 47 mm charcoal impregnated filter paper which was con.iected to the hood via Tygon tubing. The pump ran continuously and the charcoal impregnated filter was changed and counted on a multichannel analyzer on a weekly basis. This system is of limited sensitivity in that the small absorptive capacity of the charcoal filter limits the filters usefull life-time to an average of fifteen minutes. A review of iodine monitoring records showed an approximate average concentration of I-131 at the uptake port of IE-10 microcuries/cc air.
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Monitoring of xenon concentrations in the restricted area is performed by a Nuclear Associates Xen-Alert. The monitor is located in a low-background area of the lab and samples the air about the storage hood through the flexible hose with the intake located at the face of the hood.
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- cxcludes 25 rem overexposure of the December 1979 monitoring period.
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b.
Bioassays Iodine bioassays are performed with a NaI (T1) crystal and a multichannel analyzer. The system is calibrated using a lucite thyroid phantom and a 0.2 micrccurie mock fodine source. An examination of bioassay monitoring data for June 1977 to June 1980 listed the following information for each individual: name, date of bioassay, background counts per minute and thyroid counts per minute. No information relating to the efficiency of the counting system was available nor was any conversion made of counts per minute to microcuries/cc air or MPC hours. Without this information, an evaluation to determine compliance with 10 CFR 20.103(a)(1) could not be made. This is in noncompliance with 10 CFR 20.103(a)(3) which requires the licensee to evaluate airborne radioactivity. As of June 1980, the licensee has identi-fled and corrected this problem by determining the efficiency of their counting system.
One item of noncompliance was identified.
11.
Equipment Calibration Leak Tests and Quality Assurance The licensee's March 18, 1975, application specifies a daily "cali-bration" using cesium and radium sources. At present, a more elabor-ate calibration protocol is being maintained including a daily accuracy test, and a quarterly linearity test.
Since the accuracy test is being performed on a daily basis, this also serves as the constancy check. The accuracy test is performed with Cs-137, Co-57 and Ba-133 sealed source, NBS-traceable standards.
License Condition No. 14 requires the leak testing of all sealed sources of an activity of 100 microcuries or greater at six month intervals. From a review of leak test certificates it was determined that the licensee has employed a consultant authorized by the NRC to perform leak tests and that the tests have been completed on a timely basis. Results indicated no removable contamination in excess of 0.005 microcuries.
License Condition No. 19 requires a six month physical inventory to account for all sealed sources received and possessed under the license. The information required by this condition is being main-tained as part of the six month leak test certificates.
i License Condition No. 20 requires the licensee:
(1) to perform a test to detect and quantify the activity of molybdenum-99 contamination in each clution of technetium-99m from a molybdenum-99/ technetium-99m generator and maintain records for each test for two years; (2) estab-lish written procedures for personnel performing tests to detect and quantify molybdenum-99 contamination; and, (3) give personnel per-forming the tests specific training.
Molybdenum-99/ technetium-99m elution records reviewed by the inspector indicated molybdenum-99 contamination well below the 1 microcurie of l
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molybdenum-99 per millicurie of technetium-99m limit. Written proce-dures have been established for quantifying the molybdenum-99 contam-ination and personnel responsible for elution of the generators have been trained in these procedures.
The license's March 18, 1975 application specifies a six month calibra-tion period for radiation monitors and survey meters. Certificates examined by the inspector indicated that the calibrations were being performed by the licensee's consultant on a timely basis.
No items of noncompliance were identified.
12.
Surveys Various commitments for performing surveys have been incorporated into this license via License Condition No. 17.
These commitments include:
a.
Weekly surveys of the waste storage room. Results of these surveys are required to be recorded. The results of these surveys reviewed by the inspector indicated radiation levels at or near background except when in close proximity to the waste storage bins. A personnel monitoring badge is placed on the ceiling above the east storage area to act as an environmental monitor and is exchanged monthly along with the other personnel monitors. The radiation levels detected by this device are in reasonable agree-ment with the licensee's survey results and the independent mea-surements made by the inspector. The hallway immediately adjacent to this storage room and accessible to members of the general public was surveyed by the inspector.
Levels were well below the 2 mR/hr limit for an unrestricted area.
b.
Personnel contamination surveys upon exiting the restricted area.
Monitoring stations are provided at the entrances to the restricted area and all personnel exiting the area monitor their hands and clothing for contamination. A record of these surveys is not re-quired; however, the licensee has had all personnel record the result of their final survey each day since July 28, 1980.
The results reviewed by the inspector did not reveal any cases of excessive contamination, however, some of the licensee's employees were not recording the results of their final surveys on a regular basis.
c.
Incoming packages. The licensee's March 18, 1975, application states that all incoming packages will be wipe tested for con-tamination and the results of these surveys will be recorded.
A review of receipt records indicated this was being carried out for all packages arriving from manufacturers. The date and results of these surveys were recorded in the receipt records.
No apparent cases of gross contamination were noted.
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d.
Daily wipe tests. Daily wipe tests are performed in designated areas of the lab and storage area. The results of these tests are recorded.
Decontamination procedures are to be performed on any area indicated to be over background in excess of 500 cpm.
Significant contamination occurred infrequently in the areas of heavy use, i.e.,
the dose drawing station, dose calibrator, and various work surfaces. Records documented corrective actions taken in such cases - usually cleaning and recount-ing the area. From a review of a sample of wipe test forms, it appeared that the locations of sampling areas were logically placed. Such areas as work surfaces, storage areas, the dose calibration station, storage refrigerator surfaces, exits, and surfaces in the unrestricted areas (halls and stairways) which may be traversed by delivery personnel were tested.
In addition to the above mentioned required surveys, supplemental crea surveys and wipe tests have been performed, as of June 1980, as part of a routine radiation safety audit conducted on a weekly basis by the Radiation Safety Technician. The licensee has also positioned per-sonnel monitoring devices in the entrance used by the delivery per-sonnel and on the ceiling of the waste storage room to monitor ambient exposure levels.
No items of noncompliance were identified.
13.
Radioactive Effluents and Waste Disposal On April 27, 1978, this license was amended to allow the licensee to retrieve waste from its customers and dispose of it in accordance with procedures,
statements and representations in letters dated December 23, 1977, and February 28, 1979.
The bulk of the waste collected has been spent, contaminated syringes or multidose vials. The waste is returned to the licensee in the original DOT Type A containers (ammo boxes) segregated into long and short half-lived (less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) material, allowed to decay to background, surveyed, and disposed of as normal trash.
A waste storage room is maintained in the basement of the building and consists of five concrete bins located against a wall which is below ground level. The bins have lead-sheilded plywood covers and are used for storage and decay of long and short half-lived material. Long half-life waste will be transferred to a commercial disposal firm if the amounts of material approach the storage capacity of the facility.
No items of noncomplicace were identified.
14 Exit Interview On September 5, 1980, an exit meeting was held with licensee representatives listed in Section 1 of this report at the conclusion of this inspection /
investigation. The scope and findings of this inspection / investigation were summarized and management was informed of the item of noncompliance.
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