ML20050D607
| ML20050D607 | |
| 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 | |
| 30-15125-80-03, 30-15125-80-3, NUDOCS 8204120359 | |
| Download: ML20050D607 (10) | |
Text
Os U.S. NUCLEAR REGULATION COMMISSION REGION III Report No. 30-15125/80-03 Priority:
I Category: B Docket No. 30-15125 License No. 37-18461-01MD Licensee: Elfreth Alley Apothecary Nuclear Pharmacy, Inc.
31-33 North 2nd Street Philadelphia, PA 19106 Facility Name: Elfreth Alley Apothecary Inspection / Investigation At:
Philadelphia, Pennsylvania Inspection / Investigation Conducted: September 16-18, 1980 Inspector:
E FL W. J.V Adam, Ph. II.'
'Dat e' Inyestigator:
NTfis, o.,, w0: th 3 ?Wl"?
J. B. McCarten
' D6te 3
fL-Reviewed By:
D. G. Viedeman, Acting qdief Ifate /
Materials Radiation Protection Section 1
~(( /0a r yL.4 A-3 2&I'?l' R. F. Warnick, Director Date Enforcement and Investigation Staff Inspection Summary Inspection on September 16, 17, and 18, 1980 (Report No. 30-15125/80-03)
Areas Inspected:
Special inspection and investigation initiated as a result of receiving several allegations regarding the laboratory radiation safety program including: Organization; Audits; Training, Retraining, and Instruc-tion to Workers; Radiological Protection Procedures; Facilities and Equipment; Receipt and Transfer of Materials; Exposure Controls - External; Exposure Controls - Internal; Leak Tests, Instrument Calibrations, and Quality Assurance; Surveys; and Waste Disposal. This inspection / investigation involved 48 onsite hours by two NRC representatives.
Results: Of the eleven areas inspected, four apparent items of noncompliance were identified in four areas:
Infraction - training of cleaning personnel, Section 5; Infraction - failure to establish current employee exposure history, Section 9; Infraction - failure to perform bioassays, Section 10a.;
Infraction - failure to perform dose calibrator linearity test, Section 11.
8204120359 820407 NMS LIC30 Exhibit C 12-18044 -01 MD PDR
DETAILS i
1.
Persons Contacted
- Robert L. McClintock, Corporate Radiation Safety Officer Steven Dessel, District Manager
- James Fulton, Radiation Safety Technician In addition to the above, several other licensee employees were interviewed during the inspection / investigation.
- Denotes individuals attending the exit interview conducted on September 18, 1980.
l 2.
Licensee Action on Previous Inspection Findings Licensee action on previous items of nonrompliance has been summarized in Region I Report 30-15125/80-02.
Of the nine items listed, one remains open; f ailure to wipe exterr.a1 surf aces of packages received for removable contamination, see paragraph D.2 and E of Region I Inspection Report No. 80-02.
3.
Organization Organization is covered in detail in paragarph F.1. of Region I Inspection Report No. 80-02.
Amendment No. 4 dated March 21, 1980 designates Mr. Steven Dessel as Radiation Safety Officer.
Mr. Robert L. Sanchez, Mr. Arthur C. Solomon, Mr. William Guthrey, Mr. Nunzio M. DeSantis, Mr. Steven G. Wilkerson, Mr. Steven Dessel, and Mr. Mark W. Brovning are designated by the same i
amendment as authorized users.
No apparent items of noncompliance were identified.
4.
Licensee Audits While internal audits have not been incorporated by licensee condition, an informal audit system does exist. This consists mostly of the Radiation Safety Technician performing spot checks of records, observa-tion of personnel and radiation surveys above those performed as part of a daily or weekly routine. The operation is also frequently observed j
by the Corporate Radiation Safety Officer.
i 5.
Training, Retraining, And Instruction to Workers The training program at this facility is oriented primarily towards delivery personnel. Prior to February of 1980 no formal program existed other than on-the-job training. Drivers had been given a radiation safety manual and some instruction regarding emergency procedures.
However, the degree of understanding of these procedures, as well as 7
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the nature of and precautions required when handling byproduct material varied from person to person, Delivery vehicles are posted with emer-gency procedures to be followed in the event of an accident. Receipt of the radiation safety manual by the drivers was documented. To date, training beyond the contents of the radiation safety manual has included the ALARA program and the proper use of film badges.
From interviews with the Radiation Safety Officer and the District Manager it was determined that, prior to June 1980, cleaning personnel frequenting a restricted area were not trained in the health protection problems associated with exposure to radioactive materials or in the precautions and procedures used to minimize exposure. This is in noncompliance with 10 CFR 19.12.
From interviews with licensee personnel other than drivers, it appeared that these individuals have at least a working knowledge of the arees 1
which require training by 10 CFR 19.12.
One item of noncompliance was identified.
6.
Radiological Protection Procedures The licensee's radiological protection procedures are outlined in the November 6, 1976 application. Dispensing of radiopharmaceuticals was performed in a vertical laminar flow hood provided with a lead-glass L-block. The dose calibration station is also shielded.
Personnel handling radiopharmaceuticals were observed wearing disposable gloves i
and using syringe shields. There was no evidence of smoking, eating, I
drinking, or mouth pipetting in the lab. Working surfaces in the lab i
were covered with plastic-backed absorbent paper. Storage areas, in-cluding refrigerators and various containers appeared to be appropriately labeled. The emergency procedures described actions to be taken in the event of a radioactive spill and were posted in the lab.
Personnel l
frequenting the lab were observed monitoring themselves before exiting the restricted area and wearing appropriate personnel dosimetry.
Visitors to the retricted area were provided with continuous readout, i
digital pocket dosimeters.
No apparent items of noncompliance were identified.
7.
Materials, Facilities, and Equipment 1
a.
Use of Licensed Material l
In accordance with the licensee's letter dated January 25, 1980, s
Amendment No. 4, dated March 21, 1980, was issued. This amend-ment increased the licensee's possession limit for molybdenum-99/
technetium-99m generators from 15 curies to 25 curies. From a review of the "Radionuclide Log Book" it appeared that on several I
occasions, notably February 1, 8, 15, and 20, 1980, the 15 curie l
possession limit for molybdenum-99 was not approached because of l
delayed receipt times. The spent generators which were in the i
possession of the licensee, had decayed to insignificant amounts.
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Xenon-133 is supplied in unit dose form as a gas from Diagnostic Isotopes, New England Nuclear, and General Electric.
The licensee is authorized to receive and distribute byproduct material listed in Groups I, II, IV, and V of Schedule A Section 35.100 of 10 CFR Part 35.
From a review of the Radio-nuclide Log Book it appeared that since at least December 1979, no material had been received which was not authorized by the license. No unauthorized uses or forms of material were apparent.
b.
Facilities The physical layout of the f acility is as described in the licensee's February 14, 1979 letter. Generators are stored and eluted in the generator room.
In addition to the manufacturer's shielding, addi-tional lead foil has been ir. stalled around the generator tables.
With the exception of some localized radiation areas in the immediate vicinity of the generators, ambient exposure rates are on the order of 0.2 to 0.3 mR/hr. The reception area and various offices are separated from the restricted area by the managers office. Addi-tional office space and the employees room are located at the opposite end of the facility sharing one wall with the decay room and the generator room.
Exposure rates in the employee's room and in the additional office space are at background levels.
Waste is stored in a separate room dedicated for this purpose.
Currently, waste is being stored in large sealed cardboard boxes which are kept within a locked wire-mesh cage.
Handling of waste is discussed in Section 13.
c.
Security Entrance to the radiopharmaceutical lab is made through one main entrance. Access is controlled by an intercom system and an electric strike lock operated by the receptionist. Access to the restricted area is again controlled by a strike lock / intercom arrangement which can be activated by an individual within the radiopharmacy lab.
Any-one who enters the restricted area must identify himself before being l
allowed to enter. Visitors to the lab are required to register at the front desk, and to wear dosimeters before entering the restricted
- area, 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.
I Posting requirements of 10 CFR 19.11 (a) through (e) were met.
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e.
Equipment The licensee's application dated November 6, 1978, outlines some of the equipment in use at this facility. A vertical laminar flow hood is provided for drawing doses. A second conventional hood, vented to the roof, is used to store and process xenon-133 and iodine-131. Flow rate at the hood sash is monitored weekly with a velometer. Radiation monitoring equipment includes:
a multichannel analyzer used for detecting isotopic contaminants in generator elutions, a Nuclear Associates Xen-Alert and a number of pancake, thin window G-M survey instruments used for l
contamination monitoring of personnel, packages and surfaces.
No items of noncompliance were identified.
i 8.
Receipt and Transfer of Material The licensee is required to keep records of receipt and transfer of materials in accordance with 10 CFR 30.51.
In addition, the applica-tion dated November 6, 1978, requires the use of a "Radionuclide Log Book" for recording package wipe test results, item, manufactu:er, assay and assay date, volume, lot or control number, date received, expiration date, disposal date, and the initial of the pharmacist.
The inspector observed that the required information is kept in the Radionuclide Log Book as well as on elution records / assay sheets.
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). Title 10 CFR 20.205 also requires the licensee to establish and maintain procedures for safely opening packages of licensed material.
The inspector reviewed a selected sample of package survey results.
It appeared that all incoming packages from manufacturers containing byproduct material were being surveyed. No excessively contaminated packages were noted. The inspector also confirmed that, for the customers sampled, the licensee had current copies of their customers NRC license to ensure compliance with 10 CFR 30,.41.
The licensee is required by License Condition No. 19 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/IND's for xenon-133. Techne-tium-99m generators come from either Union Carbide or Mallinckrodt.
Other material in millicurie quantities is supplied by Squibb, Amersham, Mallinckrodt. 3M, Diagnostic Isotopes or CIS Radioisotopes, Inc. These suppliers also appear to have NDA/IND's for the products received by the licensee.
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Most licensee shipments are in the form of individual unit doses drawn 4
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 DDT specification 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 The licensee's November 6, 1978 application specifies the use of the film badge personnel monitors for all persons working in the radio-pharamacy as well as TLD ring dosimeters for those individuals perform-ing elutions and dose preparations.
i 10 CFR 20.202(a)(2) requires each licensee provide appropriate personnel monitoring equipmant to, and require the use of such equipment by each individual who enters a restricted area under such circumstances 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).
From a review of the licensee's personnel dosimetry records the follow-ing maximum yearly totals for 1979 and eight months of 1980 were obtained (recorded in millirem):
1980 1979 Extremity 6,350 27,903 Whole Body 1,160 872 10 CFR 20.102(a) requires each licensee to disclose for each individual who enters a restricted area, a written, signed statement either:
(1) that the individual had no prior occupational dose during the current calendar quarter, or (2) the nature and amount of any occupa-tional dose which the individual may have received during the specifi-cally identified current calendar quarter from sources of radiation possessed or controlled by other persons. During the investigation, i
it was determined that a part time laboratory employee was allowed to work in a restricted area without a current exposure history being established from the employee's personnel monitoring data collected l
at another licensed facility. This is in noncompliance with 20.102(a).
The format of the vendor's personnel monitoring reports provides the j
information required by NRC Form 5.
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One item of noncompliance was identified.
10.
Exposure Controls - Internal 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 assessment of individual intakes by exposed individuals.
In a letter dated February 14, 1979, the licensee stated that the guidelines of NRC Regulatory Guide 8.20 would be followed with regard to parforming bioassays for I-131 and I-125.
Since the licensee does not use any unbound forms of I-125, assay results are assumed to indicate only the presence of I-131.
a a.
Bioassayg I
Regulatory Guide 8.20 recommends a bi-weekly sampling frequency for an employee's initial 3 month period and a quarterly sampling frequency thereafter if the average thyroid burden for each individual falls below 0.04 microcuries of I-131 for that initial three month period. A review of bioassay records for May 1979 to the date of the inspection, showed that the highest body burden for any individual was 0.046 microcuries or approximately 18 MPC hours.
Before March 1980, bioassays were performed on a monthly basis by a consultant. From October 30, 1979 to January 17, 1980, no bioassays were performed on three individuals, nor for seven 9
individuals during the period November 29, 1979 - January 17, 1980.
Biweekly sampling frequencies were not used during an l
employee's initial three months of employment. This is in noncom-pliance with License Condition No. 20 which references the 11-censee's February 14, 1979 letter.
b.
Airborne Monitoring The inspector examined the licensee's xenon and iodine storage hood. The iodine sampling system consisted of Gast Model 1047-075 air pump drawing on a 47 mm charcoal impregnated filter paper which was connected to the hood via tygon tubing. The pump runs continuously and the charcoal impregnated filter is changed on a weekly basis and counted with a Nal scintillator. This system is of limited sensitivity in that the small absorptive capacity
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of the charcoal limits the filter's useful lifetime to an average I
of fifteen minutes.
One item of noncompliance was identified.
t 11.
Equipment Calibration, Leak Tests, and Quality Assurance The licensee's November 6, 1978 application specifies quarterly linearity 4
tests, annual accuracy tests and daily constancy checks for the dose calibrators. From a review of dose calibrator records, it was determined
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4 that no linearity test had been performed between May 30, 1980 to the date of the inspection, a period greater than one calendar quarter.
This is in noncompliance with License Condition No. 20 which references the November 6, 1978 application. Leak tests results were reviewed for the 255 microcurie Ba-133 source. The tests have been performed on i
a timely basis and showed results less then 0.005 microcuries of removable contamination.
The licensee's November 6, 1979 application specifies annual calibration of survey instruments by an NRC approved consultant. The consultant is licensed by the NRC to perform this function.
Instrument caliarationn I
j appeared to be performed on a timely basis and were within i 207. of expected readings.
License Condition No. 17 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 maintained as part of the licensee's six month leak test certificates.
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License Condition No. 18 requires the licensee to:
(1) perform a test to detect and quantify the activity of molybdenum-99 contamination in each elution of technetium-99m generator and maintain records of each test for two years; (2) establish written procedures for personnel performing tests to detect and quantify molybdenum-99 contamination; and, (3) give personnel performing the tests specific training.
Molybdenum-99/ technetium-99m elution records indicated molybdenum-99 contamination well below the one microcurie of molybdenum-99 per millicurie of technetium-99m limit. Written procedures have been established for quantifying the molybdenum-99 contamination and were submitted with the licensee's November 6, 1978 application.
Personnel responsible for elution of the generators have been trained in these procedures, i
One item of noncompliance was identified.
12.
Surveys Varlors commitments for performing surveys have been incorporated into this license via License Condition No. 20.
These commitments include:
f a.
Daily Area Surveys of All Elution and Preparation Areas Results of the surveys are to be recorded. The results of these surveys indicated levels of 0.3 to 1.0 mR/hr in most of the dose preparation areas and 0.5 to 2.0 mR/hr in the vicinity of the laminar flow hood and dose calibrator. The licensee's results were in reasonable agreement with the inspector's independent measurements.
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b.
Weekly Area Surveys _and Wipe Tests Areas other than the dose preparation and elution areas are surveyed on a weekly basis. This includes the waste storage area. Results of these surveys, with the exception of the waste storage area, were rarely above background levels. Wipe tests are performed on a weekly basis to determine levels of removable contamination. An action level of 100 dpm/100cm has been established as the action level for deccntamination. Significiant 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 recounting the area.
From a review of a sample of wipe test records, it appeared that the locations of sampling areas were logically placed. Such areas as work surfaces, storage areas, the dose calibrator station, storage refrigerator surfaces, floors, bood surfaces and exits were tested.
c.
Personnel Contamination Surveys Monitoring stations are placed at the entrance to the restricted area and outside the entrance to the employees room.
Personnel were observed monitoring themselves upon exiting the restricted area.
No record of the results is required.
d.
Incoming Packages This is discussed in Section 8, " Receipt and Transfer of Material.
No items of noncompliance were identified.
13.
Radioactive Effluents and Waste Disposal License Condition No. 23 allows the licensee to transfer waste from its customers to its own facility for storage and disposal. This transfer is restricted to waste generated by the use of radiophar-maceuticals purchased from the licensee. The bulk of the collected waste has been spent syringes or multi-dose vials. The waste is returned to the licensee in the original DDT Type A container (ammuni-tion boxes) segregated into long half-life (greater than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) and short half-life material, allowed to decay to background, surveyed, and disposed of in normal trash.
A waste storage room is maintained as part of this facility and consists of a locked, fenced-in area of the basement for holding the cardboard storage cartons.
Long half-life waste will be transferred to a commer-cial disposal firm if the amount of material approaches the storage capacity of the facility.
This licensee does not dispose of amounts of liquid waste to the sanitary sewer system in excess of release limits of Part 20.
Airborne effluents are monitored as described in Section 10.B.
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No items of noncompliance were identified.
14.
Exit Interview An exit interview was conducted on September 18, 1980, with the individuals listed in Section 1 of this report. The scope and findings of this inspection / investigation were summarized and management was informed of the items of noncompliance.
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