ML20050D579
| ML20050D579 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1982 |
| From: | Adam W, Mccarter R, Warnick R, Weideman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| NUDOCS 8204120337 | |
| Download: ML20050D579 (11) | |
Text
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7 U.S. NUCLEAR REGULATORY CO.T11SSION REGION III Report No. 30-14386/80-02 Priority I Category B Docket No. 30-14386 License No. 12-18044-01MD Licensee: Nuclear Pharmacy, Inc.
319 W Ontario St.
Chicago, IL 60610 Facility Name: Nuclear Pharmacy, Inc.
Inspection / Investigation At: Chicago, Illinois Inspection / Investigation Conducted: September 23-25, 1980 Inspector: M.k. b
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W. J() Adam, Ph.D Date#
Investigator:
F?Fubv.wh h 3494'.:
J. B. McCarten Date Reviewed By: h.A.
3,24 L-h D. G.Wiedeman, Acting! Chief Date /
Materials Radiation Protection Section 1 R FlC m.k R. F. Warnick, Director date Enforcement and Investigation Staff l
l Inspection Summary 4
I Inspection on September 23-25, 19E0 (Report No. 30-14386/80-02)
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 Instruction to Workers; Radiological Protection Procedures; Facilities and Equipment; Receipt and Transfer of Materials; Exposure Controls-External; Exposure Con-trols-Internal; Leak Tests. Instrument Calibrations, and Quality Assurance; Waste Disposal; and Surveys. This inspection / investigation involved 40 onsite hours by two NRC representatives.
Results: Of the eleven areas inspected, no items of noncompliance were identified in nine areas, two apparent items were identified in two areas:
Deficiency; failure to maintain a valid NRC Form 5 or its equivalent, Section 9 Infraction; failure to train employees frequenting a restricted area, Section 5.
7 Exhibit A PUN 01
b o DETAILS 1.
Persons Contacted
- Mr. Robert L. McClintock, Corporate Radiation Safety Officer
- Mr. Kenneth Barat, Radiation Safety Officer
- Mr. Roy Storey, Pharmacy Manager
- Mr. Steven Wilkerson, Coordinator of Pharmacies In addition to the above, several other licensee employees were interviewed during the inspection.
- Denotes individuals attending the exit meeting conducted on September 25, 1980.
2.
Licensee Action on Previous Inspection Findings (Closed) Noncompliance (80-01):
Failure to perform and record swipe surveys on a daily basis. These surveys have been performed in a timely manner since March 1,1980, and have been recorded.
(Closed) Noncompliance (80-01):
Failure to perform direct area surveys on a daily basis. Direct area surveys are being performed and recorded on a daily basis as of March 1, 1980.
(Closed) Noncompliance (80-01): Failure to perform personal contamina-tion surveys upon exiting a restricted area. Monitoring equipment has been placed at both exits and personnel were observed using it upon exiting the restricted area.
(Closed) Noncompliance (80-01): Failure to wipe test incoming packages for surface contamination. All incoming packages are now held and surveyed before opening.
(Closed) Noncompliance (80-01): Leaving licensed material unattended and not under the immediate control of the licensee in an unrestricted Delivery personnel have been instructed to maintain immediate area.
control over licensed material.
(0 pen) Noncompliance (80-01): Failure to maintain a valid NRC Form S or its equivalent.
See paragraph 9.
(Closed) Noncompliance (80-01): Failure to evaluate whole body and hand doses for periods during which personnel dosimetry data was not available. Evaulations have been made for periods during which dosimetry data is missing.
(Closed) Noncompliance (80-01): Dose to extremity in excess of 10 CFR 20.101(a) limits. No extremity overexposures have occurred since the previous inspection.
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(Closed) Noncompliance (80-01): Failure to provide dosimeters to all drivers. All drivers have been provided with film badges to evaluate whole body e -
- res.
(Closed) Noncompliance (80-01): Failure to monitor iodine-131 air-borne releases to assure compliance with 10 CFR 20.106.
An air sampling system has been installed to monitor I-131 storage hood exhaust.
(Closed) Noncompliance (80-01): Failure to properly conduct thyroid bioassays. A bioassay program has been instituted which appears capable of accurately assessing I-131 uptake.
(Closed) Noncompliance (80-01): Failure to perform airborne monitoring and bioassays to determine compliance with 10 CFR 20.103(a)(1). Air-borne monitoring and bioassays have been instituted for I-131.
l (Closed) Noncompliance (80-01): Failure to report an overexposure within 30 days. No reportable exposures have occurred since the previous inspection.
(Closed) Noncompliance (80-01): Failure to perform linearity and accuracy tests as required. These tests are being performed on a timely basis and are being recorded.
3.
Organization Nuclear Pharmacy, Incorporated, operates a number of nuclear pharmacies in the United States.
Each location has a separate NRC or Agreement State License. The president of Nuclear Pharmacy is Mr. Robert L. Sanchez.
The present manager of the Chicago f acility is Mr. Roy Storey, who reports to Mr. Steven Dessel, District Manager, who in turn reports to Mr. Nunzio DeSantis. The licensee has moved his activities from his Elmhurst and Water Tower Place locations used in 1979 to his current address on West Ontario Street in Chicago. Water Tower Place was used until the end of 1979. The Elmhurst facility was used until the end of January 1980.
The radiation safety program of the Chicago facility is carried out under the supervision of Mr. Ken Barat, Radiation Safety Officer, who reports to Mr. Robert McClintock, Corporate Radiation Safety Officer.
License Condition No. 12 lists R. L. Sanchez, J. M. Reavis, R. Sherif, G. R. Klockow, N. DeSantis, K. Barat, R. A. Storey and P. J. Horvat as authorized users.
Mr. K. L. Barat is also designated Radiation Safety Officer.
No items of noncompliance were identified.
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4.
License Audits The licensee, in a letter dated March 21, 1978, stated that a consul-tant would spend a minimum of one full day at each facility quarterly.
There are no other license requirements for formal corporate audits j
or a radiation safety committee although this is a major distribution license.
t As of March 1980, the Corporate Radiation Safety Officer is fulfilling j
this function by either visiting the Chicago facility or through the audits of the facilities' Radiation Safety Officer. These audits consist of spot checks of records, observations of personnel, and radiation surveys above those performed as part of a daily or weekly routine.
I No items of noncompliance were identified.
5.
Training, Retraining and Instruction to Workers i
The training of the licensee's radiation workers is required by 10 CFR 19.12 and License Condition No. 15, which incorporates by reference a license application dated January 12, 1978. Records of training provided are not required. The inspectors interviewed several licensee employees working in the restricted area. With the exception of the cleaning crew, the employees demonstrated a working knowledge in the areas enumerated in 10 CFR 19.12 with respect to the byproduct material they were handling. The cleaning crew, who entered the restricted area on a routine basis, was not provided with training in the health and safety aspects of working in an area in which byproduct material is used. This item is covered in detail in the investigation report.
One apparent item of noncompliance was identified.
6.
Radiological Protection Procedures In the application dated November 21, 1977, the licensee states the following:
(1) All dispensing and preparation of radiopharmaceuticals will be done behind lead drawing shields.
(2) Personnel will at all times wear disposable gloves while handling and dispensing radiopharmaceuticals.
l (3) - Syringe and vial shields will be utilized while preparing kits and/or eluting generators.
(4) All pipetting of radiopharmaceuticals will be done via pipette bulbs and pipettes.
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(5) No smoking or eating will be allowed in the pharmacy area, except
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In office areas.
(6) All working surfaces where radioactive material is handled will be made of non-absorbing material and will be topped with a replaceable absorbent paper with waterproof backing.
(7) Radiopharmaceuticals containers will be appropriately labeled.
(8) In the transportation and handling of the radioisotopes, careful i
manipulation will be stressed. Unbreakable containers should minimize possible spills. Protective coverings should be used, particularly so when radioactive compounds are transferred.
(9) Refrigerators used to store radioactive compounds will be labeled.
No food will be stored within.
(10) All radiation areas will be posted as required by the NRC.
From the inspector's observations over a period of three days, the licensee appears to be meeting the above requirements.
Dispensing of radiopharmaceuticals was performed in a vertical laminar flow hood provided with a lead glass L-block. The dose calibration st(tion is also shielded.
Personnel handling radiopharmaceuticals were observed wearing disposable gloves and using syringe shields.
There was no evidence of smoking, eating, drinking, or mouth pipett-Ing in the lab. Working surfaces in the lab were covered with plastic-backed absorbent paper. Storage areas, including refriger-ators and various containers appeared to be appropriately labeled.
Emergency procedures describing actions to be taken in the event of a radioactive spill were posted in the lab.
Personnel frequenting the lab were observed monitoring themselves before exiting the restricted area and wearing appropriate personal dosimetry. Visitors to the restricted area are provided with continuous read-out, digital pocket dosimeters, No apparent items of noncompliance were identified.
I 7.
Materials Facilities and Equipment a.
Use of Licensed Material
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The licensee is required by License Condition No. 19 to procure radiopharmaceuticals 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 generators come from either Union Carbide or Mallinckrodt.
Other material in 5
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O millicurie quantities is supplied by Squibb, Amersham, Mallinckrodt, 3M, Diagnostic Isotopes or CIS Radioisotopes, Inc. These suppliers also have a NDA/IND for the products received by the licensee.
The inspector reviewed a sampling of the licensee's transfer records and noted that for customers sampled, the licensee had current copies of the customer's NRC license to ensure compliance with 10 CFR 30.41.
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 Radionuclide 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.
At the time of this inspection, this facility was producing 300-340 doses per day. Typically the licensee receives one 16.6 Ci and one 9.9 Ci molybdenum-99/ technetium-99m Union Carbide generator per week.
Most licensee shipments are in the form of individual unit doses drawn in disposable syringes. Syringes are sealed in lead con-tainers 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 laboratory. The 11-censee measures the external radiation with a GM counter and applies the appropriate Department of Transportation labels as required by 49 CFR 172.403.
b.
Facilities The physical layout of the facility is as described in the licensee's June 13, 1980 letter.
The inspector conducted a tour of the Ontario Street facility.
The Mo-99/Tc-99m generators, some waste material and all other byproduct material not in current use are locked in a walk-in vault. The facility was previously used by a wholesale jeweler.
Material in the vault is secured by 12 inch thick brick walls and a steel vault door.
Material in use in the laboratory portion of the facility is under the constant observation of licensee employees. Visitors to the facility must pass through a narrow gate by a receptionist to gain access to the laboratory.
Waste collected from the licensee's clientele is stored in a separate room dedicated for this purpose and is provided with lead-lined bins which are used as decay areas for the waste.
Handling of waste is discussed in Section 13.
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c.
Security Entrance to the radiopharmaceutical lab is made through one of two entrances. At the rear entryway, access is controlled by an intercom system and an electric strike lock operated by an individual within the lab. Anyone who wishes to enter the restricted area must identify himself before being allowed to enter. Visitors to the lab are required to register at the front desk, and to wear dosimeters before entering the restricted areas.
Anyone who enters the facility through the main entrance must pass by the receptionist.
d.
Labeling and Posting Posting and labeling, as required by 10 CFR 20.203(b) through (1),
appeared to be properly performed. No high radiation or radiation areas were detected.
Localized radiation areas existed only around containers of Tc-99m.
These areas were all shielded to a minemize whole body exposure.
c.
Equipment The licensee's application dated November 21, 1977, 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 lodine-131. Radiation monitoring equipment includes:
a multichannel analyzer used for performing bioassays and detecting isotopic contaminants in generator elutions, a single channel analyzer, a Nuclear Associates Xen-Alert and a number of pancake, thin window GM survey instruments used for contamination monitor-ing of personnel, packages and surfaces.
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 in accordance with 10 CFR 30.51.
In addition, the applica-tion dated November 21, 1977, 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, j
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 j
i of these surveys is required by 10 CFR 20.401(b).
also requires the licensee to establish and maintain procedures for safely opening packages of licensed material.
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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.
No items of nonco9yllance were identified.
9.
Exposure Control-External The licensee is required by License Condition No. 15, which references license application dated November 21, 1977, and January 12, 1978, to provide whole body and ring personnel dosimeters to personnel working in the restricted area of the facility.
10 CFR 20.202(a)(2) requires each licensee provide appropriate personnel monitoring equipment 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 following maximum totals for eight months of 1980 were obtained (recorded in millirem): Extremity - 13,390, Whole Body - 300.
10 CFR 20.401 requires each licensee to maintain records showing the radiation exposures of all individuals for whom personnel monitoring is required under 20.201, and that such records be kept on Form NRC-5 or on a form containing all the information required by Form NRC-5.
During the period October 11, 1979, to December 1, 1979, an individual received a 21,821 millirem overexposure to an extremity. This matter was reviewed during the February 1980 inspection of this facility and it was concluded that the ring dosimeter assigned to this individual did measure the actual dose to the extremity.
The licensee was cited for the overexposure in that report's accompanying Notice of Violation.
This dose is not reflected in the licensee's current dosimetry records as part of the individuals permanent total. This is in noncompliance with 10 CFR 20.401(a).
The format of the vendor's personnel monitoring reports provides the information required by Form NRC-5.
One item of noncompliance was identified.
i 10.
Exposure Control-Internal a.
Bioassays When handling liquid iodine-131, the two major uptake paths are 1
skin absorption and inhalation of oxidized iodine. The licensee is required by his license application and amendment letters to perform thyroid bioassay on a monthly basis. The licensee's letter dated July 5, 1979, states in part that bioassays will be i
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performed in-house using a multichannel analyzer with a shielded, collimated 2 x 2 inch NaI (TI) detector.
Instrument efficiency will be determined by using a known activity iodine-131 source and counting the source in a commercially available thyroid uptake phantom using the same geometry as when counting the individual.
The inspector reviewed bioassay records from April 16, 1980, to the date of the inspection. The data recorded included date, name of individual, gross cpm, and counts of the iodine standard.
Results were uot recorded as either activity or MPC hours.
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 NaI scintillator. This system is of limited sensitivity in that the small absorption capacity of the charcoal limits the filter's useful lifetime to an average of fifteen minutes. An alternative method of effluent sampling was discussed with the licensee.
No items of noncompliance were identified.
11.
Equipment Calibration, Leak Tests and Quality Assurance The licensee is committed to performing daily constancy checks, quarterly linearity tests and semi-annual accuracy tests on all dose calibrators.
Constancy and linearity tests have been performed in a timely manner from January 1980 to the date of this inspection.
Accuracy tests have been performed on a daily basis since July 1980.
4 Results appeared to be within 15 percent.
Leak tests of the licensee's Cs-137, Co-60 and Ba-133 sealed sources were reviewed from June 1979 to the date of this inspection. The tests had been performed on a timely basis and all indicated less than 0.005 a microcuries of removable contamination.
l, Survey meters are required by License Condition No. 15 to be calibrated on a six-month basis. The calibration certificates were examined from i
April 1980 to the date of this inspection. The calibrations are being l
performed by an NRC approved consultant. The results indicated that the instruments were within i 10 percent of expected values.
i License Condition No. 18 requires the licensee to:
(1) perform a test to detect and quantify the activity of molybdenum-99 contamination in i
each elution of technetium-99m generator and maintain records for each test for two years; (2) establish written procedures for personnel j
performing tests to detect and quantify molybdenum-99 contamination; and, (3) give personnel performing the tests specific training.
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4 Molybdenum-99/ technetium-99m elution records reviewed from March 30, i
1980, to the date of this inspection, indicated molybdenum-99 contam-ination well below the one microcurie of molybdenum-99 per millicurie of technetium-99m limit. Written procedures have been established for quantifying the molybednum-99 contamination and were submitted with the licensee's November 21, 1977 application.
Personnel respons-ible for elution of the generators have been trained in these procedures.
4 No items of noncompliance were identified.
12.
Surveys I
Daily Wipe Tests and Area Surveys a.
Records were reviewed from February 15, 1980, to the date of this inspection. The tests were being performed regularly and indi-cated low level contamination in such areas as dose drawing stations, dose calibrators and other work surfaces.
It appeared 4
that the locations of sampling areas were logically placed and included various work stations, dose calibrators, calculators, and storage refrigerators, hood surfaces, floors and exits. The results of the area surveys were in agreement with the inspectors independent measurements.
b.
Personnel Contamination Surveys Monitoring stations are placed at the entrance to the restricted area and outside the entrance to the delivery / waste storage room.
Personnel were observed monitoring themselves upon exiting the restricted area. A record of the results is being maintained.
Occasional contamination of hands was noted and corrective action was documented.
c.
Vehicle Surveys Delivery vehicles are required to be surveyed for contamination, however, no frequency has been specified. Since April 1980, these surveys have been performed on a weekly basis. No excessive contamination has been noted.
i d.
Unrestricted Areas These surveys have been performed on a weekly basis since June 2, 1980, and involve GM surveys of such areas as the main entryway, building periphery and loading dock. Exposure rates in excess of background levels have not been noted.
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No items of noncompliance were identified.
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0 13.
Waste Disposal License Condition No. 17 allows the licensee to transfer waste from its customer's 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 DOT Type A container (ammunition 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 area is maintained as part of this facility and con-sists of several cinder block bins provided with lead-shielded plywood Long half-life wastes will be transferred to a commercial covers.
disposal firm if the amount of material approaches storage capacity of the facility.
No transfers of waste to a commercial disposal firm have occurred since the previous inspection.
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This licensee does not dispose of amounts of liquid waste to the sanitary sewer systems in excess of Part 20 limits.
Airborne effluents are monitored as described in Section 10.B.
No items of noncompliance were identified.
14.
Exit Interview On September 25, 1980, an exit meeting was held with the licensee representatives listed in Section 1 of this inspection / investigation.
The scope and findings of this inspection / investigation were summarized and management was informed of the items of noncompliance.
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