ML20050D886
| ML20050D886 | |
| Person / Time | |
|---|---|
| Issue date: | 07/01/1980 |
| From: | Adam W, Davis A, Lovendale P, Oberg C, Paperiello C, Reichhold W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| 30-14386-80-01, 30-14386-80-1, NUDOCS 8204120414 | |
| Download: ML20050D886 (22) | |
Text
1 U.S. NUCLEAR REGULATORY COMMISSION E OF INSPECTION AND ENFORCEMEN" 0F.
PEGION III Report No. 80-01 Docket No. 03014386 Category B License No. 12-18044-01MD Priority 1 Nuclear Pharmacy, Inc.
Licensee:
319 West Ontario Street Chicago, IL 60610 F cility Name: Nuclear Pharmacy Inspection At: Elmhurst and Chicago, IL
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Inspection Conducted: January 21, February 27, 28, 29, 1980 Inspectors:
C. T. Oberg4V
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- b William Adam, Ph.D.
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WI
.. t LW M S[, / f /1 William Re,ichhold 9 e shu(M
~/!Z!/f80 Paul Lovendale YO [O C
Pa P.D.
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'7///70 Approved By:
A. B. Davis, Chief Fuel Facility and Materials Safety Branch 27, 28, 29, 1980 (Report No. 30-14386/80-01 Inspection on January 22, FebruarySpecial inspection to follow-up on inspection cond Areas Inspected:
Organization; Audits; Training; Retraining January 31 and February 2, 1979.
il and Instructions to Workers; Radiological Protection Procedures; M External Exposures; internal Exposures and Airborne Effluents; Posting, Labe Facilities and Equipment; lletin and Control; Leak Tests and Instrument Calibration; Waste Disposal - Bu Survey of No. 79-19; Notifications and Reports; Quality Assurance; Close-OutThis inspection invo Water Tower Place; and Independent Measurements. A representative of the NRC inspector-hours on site by five NRC inspectors.
licensing office was also present.
items of noncompliance or
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Of the sixteen areas inspected, no apparent items of noncompli-Aesults:
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~ deviations were identified in nine areas; fourteen apparentInfraction (inf.) - failure to 6.b.; inf.
ance were identified in seven areas.
surveys - para.
surveys - para. 6.a.; inf. - failure to perform direct v y all
- failure to perform personnel surveys - para. 6.c.; inf. - failure to sur e secured -
incoming packages - para. 8; inf. - material in unrestricted area not 10.a; Para. 9.b.; deficiency (def.) - failure to maintain valid Form NRC par 11.a.; inf.
inf. - extremity overexposure - para.
10.c.; inf. - failure to monitor iodine-131 effluents - para.11.b.; inf. - failure to repor para.
- failure to perform thyroid bioassay - para,*** lef. - failure to submit exposure sunmary - p 15; overexposure - para.
rol on dose calibrator - para.
16.
inf. - inn e -
0204120414 020407 01MD PDR t
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DETAILS 1.
Persons Contacted I
- Mr. Robert L. Sanchez, President, Nuclear Pharmacy, Inc.
- Mr. Nunzio DeSantis, District Manager, Nuclear Pharmacy, Inc.
- Mr. Roy Storey, Managing Pharmacist, Nuclear Pharmacy, Inc.
- Mr. Stan Huber, Consultant, Stan Huber Consultants, Inc.
Mr. Gary Klockow, Pharmacist, Nuclear Pharmacy, Inc.
In addition to the above, several other licensee employees were interviewed during this inspection.
- Denotes individuals attending the exit interview on February 29, 1980.
Licensee Action on Previous Inspection Findings 2.
Use of bulk xenon-133 from unauthor-(Closed) Noncompliance (79-01): Licensee records indicate material is being rece ized supplier.
from approved suppliers.
(Closed) Noncompliance (79-01): Unauthorized users. The inspector found no evidence to indicate that operations were being conducted without an authorized user available since the last inspection.
(Open) Noncompliance (79-01): Failure to perform thyroid bioassay with sufficient sensitivity to demonstrate compliance with 10 CFR The Licensee is not conducting thyroid bioassay in accord-The system used remains unchanged since the 20.103.
ance with his license.
last inspection. See Paragraph 11.b.
Failure to perform airborne monitoring (Open) Noncompliance (79-01):The Licensee's xenon-133 detection system is in restricted area.
For iodine-131 the proper performance of thyroid bioas-acceptable.
say along with the monitoring of hood air to identify abno See Paragraph 11.b.
This has not been accomplished.
(Open) Noncompliance (79-01): Surveys to determine compliance with The Licensee has installed an todine 10 CFR.106, Airborne Effluents.
air sampling system but has conducted no air sampling.
(Closed) Noncompliance (79-01): Performance of thyroid bionssay in-The Licensee is now author-house instead of at authorized location.
ized to perform thyroid bioassay in-house.
(Closed) Noncompliance (79-01): Transfer of material without ade-quate verification of transferee's authorization to possess material.
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l A review of a sampling of the Licensee's customers shows that the Licensee has a copy of a current license for each customer.
3.
Organization NuclearPharmacy, Incorporated,operatesanumberofnuclea$ phar-macies in the United States. Each location has a separate NRC or 2
Agreement State License. The president of Nuclear Pharmacy is Mr. Robert L. Sanchez. The present manager of the Chicago facility is Mr. Roy Storey, who reports to Mr. Nunzio DeSantis, District Manager, who in turn reports to Mr. Sanchez. At the previous inspection Dr. Michael Zinsner was the Regional Manager and manager of the Chicago area facilities. The licensee has moved his activi-ties from his Elmhurst and Water Tower Place locations used in 1979 Water to his current address on West Ontario Street in Chicago.
Tower Place was used until the end of 1979. The Elmhurst facility was used until the end of January, 1980. These facilitics operated a usual five day week.
License amendment 6 lists Mr. Robert L. Sanchez, Mr. Jon Michael Reavis, Mr. Richard Sheriff, Mr. Gary R. Klockow and Mr. Nunzio DeSantis as authorized users.
Mr. Gary R. Klockow is named as Radiation Safety Officer.
Of the current authorized users only Mr. Gary R. Klockow is per-manently assigned to the Chicago office. Since the licensee oper-ates more than one shift per day there is no assurance there will be an authorized user alway:; on site. However, since the user is in the area there appears to be no noncompliance with License Condition No. 12.
No items of noncompliance were identified.
4.
Licensee Audits The licensee, in a letter dated March 21, 1978, stated that a con-sultant would spend a minimum of one full day at each facility quarterly. There are no other license requirements for formal cor-porate audits or a radiation safety committee although this is a I
A review of the consultant's reports major distribution license.
f showed that he was at each facility more often thau stated above.
l The licensee apparently has no formal system to review the consul-tant's findings to ensure that internally identified deficiencies are corrected.
The company president stated that a corporate health physicist had This been being hired and would audit company branch facilities.
individual would have the authority to correct deficiencies.
No items of noncompliance were identified.
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Training, Retraining and Instruction to Workers g
5 The training of the licensee's radiation workers is r g
12, 1978. Records of training a license application dated JanuaryThe inspectors interviewed two licensee The employees demonstrated provided are not required.
employees working in the restricted area.
12 with a working knowledge in the areas enumerated in 10 CFR 19.They said they t
respect to the byproduct material they were handling. They were not I
were looking at the posted monthly exposure reports. This information
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sure of the 10 CFR 20.101 external exposure limits.The inspectors concluded the il was provided by the inspectors.
interviewed had sufficient knowledge commensurate with potent a radiological health protection problems in the restricted area.
No items of noncompliance were identified.
Radiological Protection Procedures 6.
The I.icensee's radiation protection procedures are described in lications and attachments to the license application, amendment appThe implementa-several letters referenced in license condition 15 d during the in-tion of a sampling of these procedures was reviewe spection.
Contamination Surveys a.
21, 1977, that The licensee states in a letter dated November wipe surveys will be performed in the laboratory and storage The inspec-areas on a daily basis and the results recorded.
979 and tors reviewed contamination surveys for the year 1 through February 28, 1980.
The surveys were recorded on pages that had been torn l
spiral notebook.since they were out of order and in many cases illegib e.
The survey records for the Water Tower Place location indicate l 40 dates that contamination surveys had been performed on on y 28, 1980, on the average from February 9, 1979 through JanuaryThe swipe survey records for the Elmburst location indicated that contamination surveys had been of once every nine days.
performed on only 41 dates from January 4, 1979 through or again an average of once every nine days.
Independent swipe surveys (see Paragraph 18) by the NRC January 28, 1980, This failure to contamination to be present in the facility.
itutes perform and record swipe surveys on a daily basi by b
21, reference the commitment made in the letter dated Novem 1977.
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b.
Direct Radiation Surveys
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In a letter dated March 21, 1978, in response to questions from the Radioisotopes Licensing Branch, the Licensee stated that the restricted area would be monitored using a low level survey meter and the readings recorded.
It was stated that this would be done along with the daily wipe surveys stated in the letter dated November 21, 1977. A review of direct survey records for January and Febraury,1980 showed that on January 15 and 18, 1979, at the Elmhurst location and on February 25,1980, at the Ontario Street location this monitoring was not performed and This constitutes noncompliance with License Condi-recorded.
tion 15 which incorporates the above by reference.
Contamination Monitoring of Personnel c.
The Licensee stated in the license application dated November 21, 1977, that all entrances to the radiation controlled area will be controlled by limited accessibility, a monitor will be placed at all access entrances and exits for hand and shoe monitoring, all access to the laboratory will be controlled through and procedures for monitoring on entering and exiting the laboratory In a letter dated March 21, 1978, in by all the individuals.
response to questions from the Radioisotopes Licensing Branch, the Licensee stated that all personnel will be required to moni-tor hands, shoes and clothes prior to leaving the restricted The license had placed a monitor, a copy of the survey procedure and a data sheet at the front entrance to the restrict-area.
ed area.
During the inspection the inspectors observed clerical employees who did not survey themselves before leaving the restricted area through the entrance from the office area in the front of the Furthermore, although shipments leave through the facility.
rear of the building, no monitor or data sheet was available to perform or record personnel monitoring for contamination by individuals exiting the laboratory through the rear.
Indepen-dent measurements by the NRC inspectors showed floor contamina-tion in the rear shipping area of the facility (see Paragraph 18). This constitutes noncompliance with License Condition No._
i 15 which incorporates the above procedures by reference._
Three items of noncompliance were identified.
f 7.
Materials, Facilities and Equipment Receipt and Transfer of Materials t
i s.
The Licensee is required to keep records of receipt and transfer of materials by 10 CFR 30.51.
In addition, the application l
dated November 21, 1977, states that all radionuclides received from outside sources shall be entered in the Radionuclide Log Book. The Radionuclide Log Book will contain the following information: wipe test, ites, manufacturer, assay and as.say date, volume, lot or control number, date received, expiration date, and disposal date. The inspector reviewed a sampling of the Radionuclide Log Book for the months of January, February, March, and December 1979, and January and February,1980. For the period reviewed the isotopes received were those authorized by the license and within the quantities specified.
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 Administra-tion New Drug Application (NDA) or in accordance with an ac-cepted Investigatory New Drug authorization. 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 menon-133. Technetium-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's 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 com-pliance with 10 CFR 30.41.
b.
Facilities License Amendment 6, issued January 30, 1980, authorized the licensee to open a facility at 319 West Ontario Street, Chicago, Illinois. During the inspection, the inspector found that all operations had ceased at the other authorized locations in Elmhurst, IL and at the Water Tower Place in Chicago, IL.
The inspector conducted a tour of the Ontario Street facility.
The Mo-99/Tc-99m generators, waste material and all other by-product 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 foot 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. -
e During the inspection all byproduct material, except that a-waiting shipment, was inside of the restricted area. The rooms and containers were posted as required by 10 CFR 20.203.
c.
Equipment E5 In the application dated November 21, 1977, the Licensee states the following:
(1) All dispensing and preparation of radiopharmaceuticals
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will be done behind lead drawing sheilds.
(2) Personnel will at all times wear disposable gloves while handling and dispensing radiopharmaceuticals.
(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.
(5) No smoking or eating vill be allowed in the pharmacy area, except 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) Radiopharmaceutical containers will be appropriately labeled.
(8) In the transportation and handling of the radioisotopes, careful manipulation will be stressed. Unbreakable contain-ers 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 observations of several inspectors over a period of three days the licensee appears to be meeting the above requirements.
In the case of item (2) above, with respect to the use of dis-posable gloves, the inspector noted that although gloves were being worn they were not always effective. The licensee's radiation survey records show that during the month of January, 1980, there were 37 instances of contaminated hands ranging between 0.05 to 4.0 mR/hr. In addition, employees were seen bandling paperwork, including shipping papers, with gloved hands which had also been observed handling radioisotope containers.
In one instance a pharmacist was observed answering a telephone with a gloved hand. Although these practices are not contrary to a license requirement, they can result in the unnecessary spread of contamination.
I, No items of noncompliance with NRC requirements were identified.
8.
Receipt and Transfer of Materials - Shipping Procedures Receipt and transfer records have been discussed in Paragraph 7.
The licensee, in the application dated November 21, 1977, stated that all incoming shipments of radiopharmaceuticals will be moni-tored. The monitoring will be accomplished by taking a wipe test of both the outside and inside of the packing container. Results of this survey will be kept for a permanent record. The inspector reviewed the licensee's records of surveys of incoming packages, and found that only packages requiring contamination surveys by 10 CFR 20.205 were wipe tested.
Instructions in the record book stated that packages not meeting 10 CFR 20.205 levels requiring a survey limits would not be surveyed. For the period February 1, 1980, through February 15, 1980, of the 64 packages received, two were wipe tested for contamination. This is in noncompliance with license Condition No. 15 which requires activities to be conducted in accordance with the license application. At the exit meeting, the inspector explained that 10 CFR 20.205 was intended to set limits te protect carriers of packages and that the NRC's require-ment was intended to protect the Licensee from the spread of con-tamination in his own facility.
Most Licensee shipments are in the form of individual unit doses drawn in disposable syringes. Syringes are sealed in plastic and placed in lead containers as described in the license application.
A prescription form described in the license application is also en-closed. The lead containers are placed in metal containers (surplus army ammunition containers) which are marked as meeting DOT specifica-tion 7A requirements. The licensee measures the external radiation with a GM counter and puts on the appropriate Department of Trans-portation labels as requird by 49 CFR 172.403.
The Licensee does not perform smear surveys on the external surf 6ces of packages prior to shipment to ensure compliance with DOT contami-nation limits. However, there are no requirements in DOT regulations or NRC regulations to perform this measurement.
License Condition 17 authorizes the licensee to pick up from the Licensee's customers used vials and syringes in which material was. _ _
originally shipped by the licensee to the customer. These materials are stored by the Licensee for decay. The Licensee is monitoring the external surfaces of shipping containers returned after use from customers.
One apparent item of noncompliance was identified.
9.
Shipping Incidents Package Discovered in Telephone Booth - February 6, 1980.
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a.
At 12:30 p.m. on February 6, 1980, the Region III Office re-ceived a call stating that a package marked with a radioactive symbol was in a telephone booth on Roosevelt Road in Glen Ellyn, An Illinois, about one-half mile from the Region III office.
inspector was dispatched to the site to perform surveys and inspect the package. No radiation readings above background were measured.
The package included the Licensee's name. The Glen Ellyn, Illinois police department and the Licensee were notified. A representative of the Licensee's organization responded to the incident and identified the package at the police facilities.
The package seal was intact and the package had not been tam-pered with. He opened the container to identify the contents.
Packing slips indicated original assay values of 219 millicuries of technetium-99 in four vials. The package was then released to the Licensee's representative at about 5:30 p.m. on February 6, 1980.
The Licensee's representative stated that the package was dis-covered missing in Barrington, Illinois by a Nuclear Pharmacy truck driver at about 8:00 a.m. on February 6,1980.
Since the application dated November 21, 1977, states that in the event of an emergency due to theft of radioactive material the pharmacist in charge will immediately notify the Nuclear Regulatory Commis-sion, the inspector asked during this inspection why the NRC had not been notified of the loss until the licensee was called by the NRC on February 6.
The Licensee's representative stated that they were not sure it was stolen. He stated that they thought it may have been delivered to another hospital by mis-take and were still in the process of contacting hospitals on the driver's route when the NRC called.
In response to the inspector's question, the Licensee stated that vehicles are kept locked. They did not know how entry was made to the vehicle. They noted that the material was taken over 20 miles from the NRC office and placed in a telephone booth near the NRC of fice where it was very likely to be found.
The Licensee suggested that someone had made a deliberate at-tempt to embarrass Nuclear Pharmacy, Incorporated.
The inspector stated that the Licensee should have a low thresh-Much hold for reporting this type of information to the NRC.
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trouble and much of the public excitement would have been a-voided if the NRC had known that NP1 was missing a package when the call came in reporting the package in the telephong booth.
-2 The inspector had no additional questions on this mattsr.
Material Placed on Front Step of Elmhurst Facility b.
On January 22, 1980, an inspector observed licensed material in an unrestricted area and not controlled at the Elmhurst Facility.
Upon arrival at the Facility the inspector parked his car in the two-aisle (4 rows of parked vehicles) parking lot in front of the As the inspector parked the vehicle an Licensee's building.
employee came out of the front door of the Facility carrying two packages (ammunition cases) labeled with Department of Transpor-This took tation lables as containing radioactive material.
place directly in front of the inspector's vehicle.
This individual deposited the packages on the front step of the The Facility and walked away leaving the packages unattended.
inspector got out of his car, walked past the packages on the front step and entered the front entry, reception area, of the Facility; no other Licensee personnel were in the immediate From this reception area, the inspector area of the packages.
watched through the window while the Licensee's employee walked across to the far side of the parking lot to a vehicle which The inspector proceeded into the office he opened and entered.
area of the Facility where he waited for a considerable period of time (about 10 to 15 minutes) to talk to a licensee represen-An individual, apparently a secretary and/or clerk, tative.
was quite busy answering the telephone and traveling back and forth between the laboratory and office areas handling paper During this period the inspector observed the individual work.
outside, his vehicle parked behind the inspector's car, loading the packages into his vehicle. Subsequently during discussions with the Licensee, the inspector told them of his observations Their response was that they had recently as outlined above.
discussed this type of situation with their personnel explaining that they are not to leave radioactive materials unattended.
Leaving licensed material unattended and not under the immediate control of the license in an unrestricted area is in noncom-pliance with 10 CFR 20.207(a).
- 10. Exposure Control - External External Exposure Evaluation s.
The Licensee is required by License Condition 15, which re-ferences license applications dated November 21, 1977, and._
Janua ry 12, 1978, to provide whole body and ring personnel dosimeters to personnel working in the restricted area of the facility. Title 10, Code of Federal Regulations, Part 20.202(a)(2) requires each licensee provide appropriate per-sonnel 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
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applicable value specified in 10 CFR 20.101(a).
The inspector reviewed the Licensee's reports from the dosimeter vendors.
In August, 1979, the Licensee changed his dosimeter vendor. The forms on which these reports come from the vendors contain spaces for all the information required by the Form NRC-5. Form NRC-5 requires a running total for the calendar quarter exposure to be maintained. When the Licensee changed vendors in August, the exposures for July, the first month of the calendar quarter, were not added to the running total calen-dar quarter column of the new vendor's form. The Licensee maintained no other type of Form NRC-5 record. Therefore, for the quarter ending in September, 1979, the licensee failed to maintain a valid Form NRC-5A or its equivalent, as required by 10 CFR 20.401(a).
The data presented to the inspector on the dosimeter report forms showed numerous cases of apparent missing dosiceters and damaged dosimeters for which no evaluation of exposures had been performed. There was no dosimeter report for the month of March, 1979. A total of twenty-eight whole body, wrist and ring dosimeters appeared missing. These dosimeters were as-signed to 15 individuals of whom at least 10 apparently worked in the restricted area according to job title or the readings on badges assigned prior to or subsequent to March, 1979.
These ten individuals are listed in Attachment A to this report.
No evaluation of exposures had been made for these individuals for the March, 1979, dosimeter period. The Licensee's repte-sentative called the dosimeter vendor and asked for a copy of the dosimeter report for March, 1979 during the inspection.
The Licensee's representative told the inspector that the vendor stated that the badges for March, 1979, had never been returned for read out.
1979, the Licensee's dosimeter report shows that For August, nine whole body badges were damaged and could not be evaluated by the dosimeter vendor. No evaluation was made by the Licensee for the whole body exposures for these individuals for this badging period. These nine individuals are listed in Attachment B..
A review of the licensee's ring dosimeter records for hand exposure shows six individuals receiving hand exposures at dose rates which indicate they are likely to have received hand exposures in excess of 25 percent of the 10 CFR 20.101(a) limit. These individuals are listed in Attachment C..For these six individuals a total of twelve ring dosimeterf were missing for 1979. This includes six for March, 1979..One in-dividual, who received an apparent hand overexposure in the last quarter of 1979, had no ring dosimeter report for January, 1980, siso. No evaluation had F en performed for individual hand doses for periods for which. ad dosimeter results were missing.
The failure of the licensee to evaluate whole body and hand doses for the periods for which personnel dosimetry data is not available is noncompliance with 10 CFR 20.201(b).
b.
Personnel Exposures Dn January 22, 1980, on his visit to the Elmhurst Faciltiy the inspector noted from the dosimeter records posted on the bul-letin board that an individual's right hand ring dosimeters had an exposure of 20,083 millirems for the period from October 11, 1979 to December 1, 1979. This exposure was brought to the attention of the assistant manager of the facility, a pharmacist, by the inspector. During the inspection of the week of February 27, 1980, a review of Licensee vendor dosimeter re-ports showed that the same individual received an additional right-hand ring dosimeter exposure of 1738 millirems giving a fourth quarter 1979 total of 21,821 millirems.
The inspectors interviewed the exposed individual during this inspection. The individual stated that he did not know how the high exposure had occurred. He stated that he had contaminated his left thumb and forefinger on October 19, 1979, and had removed his ring badge on his right forefinger with his left hand prior to scrubbing his hands.
The licensee, in his report (Attachment D) of this overexposure states that part of the high ring badge reading may be due to contamination of the badge during this incident. As presented in Attachment E, it appears that this contamination would have contributed at most 130 millirems to the 21821 millirens quar-terly exposure of this individual's ring dosimeter, assuming that the contamination transferred to the ring dosimeter was as high as the highest amount measured on his left hand and assuming that it remained on the badge until it decayed away.
Attachment C shows that three other individuals working at this facility received hand exposures of 14034, 13879, and 17266.
millirems, respectively, during the fourth quarter of 1979.
In the absence of any other reasonable explanation for the above individual's exposure and since other individuals' exposures in this same facility with the same job title show comparable ex-posures, it can be concluded that the ring dosimeter assigned to this individual for the purpose of measuring hand exposure did measure the actual dose of 21,821 millirems less perhaps 130 millirems due to contamination. This hand dose is in non-I_
compliance with 10 CFR 20.101(a) which limits the dose to the bands to 18,750 millirems per quarter.
The highest recorded whole body exposure for 1979 was 1144 mil-lirems. However, doses received for periods when badges were missing is not included. This is less than the 1250 millirems quarterly limit in 10 CFR 20.101(a).
c.
Badging of Drivers In the letter dated November 21, 1977, the licensee stated that,
" drivers will wear wrist badges or equivalent and be processed on a monthly basis, the results being recorded and becoming a matter of record." A review of the licensee's employment re-cords and vendor dosimeter badge records showed 29 individuals, identified in Attachment H, who were drivers and who had no assigned dosimeters. A number of other drivers did have as-signed dosimeters. The use of dosimeters by these drivers was erratic with records of a number of dosimeter periods missing.
Exposures for drivers for periods when monitoring was provided ranged from less than detectable to about 30 millirems per month. Failure of the licensee to provide dosimeters to all drivers is in noncompliance with License Condition 15 which requires the licensee to distribute material in accordance with the statements in the letter dated November 21, 1977.
d.
Inspector's Observations The inspector noted that Licensee employees he observed were wearing ring and whole body dosimeters. One pharmacist eluting a generator was observed wearing a lead apron with his whole body badge underneath the apron. The inspector told the Li-censee's representative that this provided an inaccurate evalua-tion of eye and head dose since the apron did not shield these parts of the body and the 10 CFR 20.101(a) limit of 1,250 mil-lirems per quarter applied to the eyes and head as well as the trunk and the whole body. The Licensee's employee then placed the badge on his collar but with the rear of the badge facing fo rwa rd.
The inspector pointed out this would face the energy discriminating shields in the badge towards the body and not the source of radiation and give a higher than normal dose response.
The employee then put his badge on his collar in the proper i
position.
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Three items of noncompliance were identified.
II.
Exposure Controls - Internal and Airborne Effluents a.
Airborne Monitoring
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TheLicenseeisrequiredby10CFR20.103andhislice3seto monitor for iodine-131 and xenon-133 and perform thyroid bioas-say for iodine-131.
lodine-131 is generally ordered by the Licensee as needed by a customer and in the exact quantity required for therapy. The Licensee representative stated that therapeutic liquid doses of iodine-131 are opened and prepared only a few times each month. The inspector was shown the hood in which iodine-131 was dispensed and xenon-133 in unit doses was stored. The hood in the Ontario Street facility was equipped with a xenon-133 detector and an alarm. For iodine-131 it was equipped with a charcoal filter sampling system. The inspector was told by the licensee that the system had just been installed and no iodine-131 monitoring data was available for either this facility or the former facilities. Although this facility is new, the licensee in 1979 had operated at the Elmhurst and Water Tower Place locations. Licensee records for that period showed iodine-131 in liquid therapeutic quantities had been received and the licensee's representative stated that they had been dispensed. This failure to monitor the iodine-131 air-borne releases to assure compliance with 10 CFR 20.106 is in noncompliance with 10 CFR 20.201(b). This item of noncompliance was also identified during the previous inspection of this li-The real time monitor for xenon-133 appeared adequate.
cense.
b.
Bioassay for Iodine-131 Uptake When handling liquid iodine-131, the two major uptake paths are skin absorption and inhalation of oxidized iodine. The licensee is required by his license application and additional amendment application letters to perform thyroid bioassay on a monthly basis. The licensee's letter dated July 5, 1979 states in part i
that bioassays will be performed in-house using a multichannel analyzer with a shielded; collimated 2 x 2 inch NaI(TI) detector.
I Instrument efficiency will be determined by using a known activ-ity iodine-131 source and counting that source in a commercially f
available thyroid uptake phantom in the same geometry as count-ing the personnel. The inspector examined the Licensee's thy-roid counting system and was shown a 2 x 2 inch NaI(TI) well detector system connected to a pair of single channel analyzers.
The Licensee's representative stated that they did not own a thyroid uptake phantom. For thyroid monitoring records, the inspector was shown pages torn from a notebook with names of individuals, dates, gross counts and the results obtained by.
counting a decayed iodine-131 seed. The detector in a shield was capped with a lead plug with about a 2 en diameter hole in it.
A review of calibration data showed that the instrument efficiency had to have been obtained by placing an iodine-131 source inside the well counter itself and not outside the counter in a position about 12 cm from the detector surface as stated in the licensee's letter. Furthermore, no results were obtained for total activity (uCi) contained in the thy-
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roid as stated would be done in the licensee's letter dated July 5, 1979. Because the licensee's counting efficiency data could not be related to the actual counting efficiency for an individual's thyroid, the inspector could not calculate actual thyroid levels from the licensee's gross counting data to deter-mine compliance with 10 CFR 20.103. This failure to properly conduct thyroid bioassay is in noncompliance with License Condi-tion 15 and is a repeat item from the last inspection. Further-10 CFR 20.103(a)(3) requires the Licensee to perform air-
- more, borne monitoring for iodine-131 and, as appropriate, perform bioassay to determine compliance with 10 CFR 20.103(a)(1).
Since the Licensee performed neither airborne monitoring nor bioassay measurements for iodine-131, this represents noncom-pliance with 10 CFR 20.103(a)(3).
- 12. Posting, Labeling and Control Posting and labeling, as required by 10 CFR 20.203(b) thru (f),
appeared to be done as required. No high radiation or radia-tion areas were detected. Localized radiation areas existed only around containers of Tc-99m. These areas were all shield-ed with respect to a worker's whole body.
Posting required by 10 CFR 19.11 was performed.
No items of noncompliance were observed.
- 13. Leak Tests and Instrument Calibration A review of licensee records for 1979 showed that the licensee's consultant had performed the leak tests on the licensee's sealed sources and had calibrated the licensee's survey instruments as required by the license application.
No items of noncompliance were identified.
- 14. Vaste Disposal - Bulletin No. 79-19 The Licensee does not use much long lived radioactive isotopes and waste disposal is not a major problem. The Licensee's customers
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This is return used vials and syringes for disposal after use.
authorized by License Condition No. 17. Waste is stored in drums Radiation levels around in a vault with 12 foot thick brick walls.
these drums were about 1-2 milliroentgens/ hour during this inspection.
Long-lived Most vaste is held for decay, then discarded as trash.
waste is picked-up by the Atomic Disposal Company.
The licensee responded to Bulletin No. 79-19 in a letter dated With respect to items 1, 2, 3, and 9 in that September 6, 1979.
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With respect to Bulletin, the Licensee's actions are acceptable.
item 4 the Licensee is using procedures supplied by its waste con-These procedures are generally acceptable, but do not re-quire the Licensee to smear survey the outside of its waste packa tractor.
prior to shipment. training and for items 7 and 8 the Licensee has not submitted a policy for management-controlled audits of transportation activities.
No waste drums were closed and ready for shipment.
After a review of the above area the inspector had no additional questions.
- 15. Notifications and Reports The Licensee was required by 10 CFR 20.405 to report in writing theThe Licensee's overexposure discussed in Paragraph 10 within 30 days.
copy of the dosimeter vendor report reviewed by the inspector, was 22, 1980. As of the received by the dosimeter Licensee by January 27-29, 1980, no report had been dates of this inspection on FebruaryThe Licensee's report was not sent until the received by the NRC.
The lack of a report was brought to his attention in February.
This failure to report the over-report was sent on March 7, 1980.
exposure with an evaluation of its cause and actions to prevent re-currence within 30 days is in noncompliance with 10 CFR 20.405(a).
The personnel monitoring report required by 10 CFR 20.407 was filed for calendar year 1978 but as of May 9, 1980, had not been received for calendar year 1979 by the Director of Management and Program Analysis, U. S.
Nuclear Regulatory Commission. Since this report must be submitted within the first quarter of each calendar year this failure to report on time is an item of noncompliance.
IVo items of noncompliance were identified.
- 16. Quality Assurance In a letter dated March 21, 1978, the Licensee stated that the dose calibrators would be calibrated in accordance with the procedures set forth or defined in Appendix D, Section 2 of the November 1977 Draf t NRC Licensing Guide for Medical Programs entitled " Methods for Cali-The Licensee further stated that daily bration of Dose Calibrator". ~
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calibration checks of the dose calibrators would also be made. A review of the calibration records showed that the annual calibration had been performed as required.
i The above licensing guide in Section 2, Item E, Test of Instrument Linearity states that the linearity of a dose calibrator should be
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ascertained over the entire range of activities employed. The pro-cedure set forth requires a vial of Tc-99m to be counted over a decay period of 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> with assay times at 0, 6, 24, 30 and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after the start of the procedure. This test is required quarterly. The Licensee performed this test more often than re-quired but not for the required 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> period. A review of Li-censee records for the period f rom January,1979, thru April,1979, and for October,1979, show linearity tests were usually run for 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> and occasionally run for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. No record of a test run for 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> could be found for this period of time.
A review of records for daily constancy checks for January,1979, thru April, 1979, and for the end of August, 1979, thru September 1979, showed that these checks were not always made.
In particular checks were not made on January 24 and 31; February 1, 13, 16, 18, 22 and 27; March 16; April 4, 5, 9, 16, 17, and 20; August 29, 30 and 31; and September 3, 4, 6, 10, 11, 12, 13, and 14.
Examination of the available daily constancy records shows variations up to the 5% limit in the licensing guide. The licensee felt this was due to chamber contamination, and not to variation in the dose calibrator. Since the dose calibrators are close to dispensinq stations there could also be variations in instrument background due to external radiation which cause this.
Failure to calibrate the dose calibrator for linearity in accordance with the licensing guide procedure and to perform all daily checks as required is noncompliance with License Condition 15 and the referenced letter dated March 21, 1978.
One item of noncompliance was identified.
17.
Close-Out Survey - Water Tower Place On February 28, 1980, the inspectors surveyed the licensee's former facility at the Water Tower Place, 845 N. Michigan Avenue, Suite 991W. Area surveys were conducted using a GM Survey Meter Eberline E-530, NRC No. 507, and a Victoreen Thyrac II, NRC No. 706, Scintilla-tion counters. Contamination levels were measured by direct beta counting using a minisolar, Eberline MS-1, with an Eberline HP-210 pancake probe and smear surveys. No activity was detected by any survey and all levels appeared to be within the Draft " Guidelines for Decontamination". Attachment F presents the detailed results of the l
NRC survey.
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No items of noncompliance were identified.
18.
Independent Measurements A contamination survey was conducted at the Ontario Street Eac'131cy by the NRC inspector to determine the extent of contaminatinn pre-These results are presented in Attachment G.
Wipe surveys sent.
were conducted in the laboratory area and show removeable contamina-Slight contamination was found on the floor in the laboratory tion.
area with most found around dispensing stations. The most significant contamination was found by direct surveys of the carpeted floor in the shipping area.
While performing surveys the inspectors found an iodine-131 capsule on the floor in an area where licensee employees were surveying returned shipping containers. The licensee's representative stated that he did not know how the capsule got on the floor. He speculated that it was not used by a customer hospital, left in the shipping container and fell out as an employee was starting a survey of the container.
The above findings are significant because the licensee has not always performed the required surveys of his facility as discussed in Paragraph 6.
No additional items of noncompliance were identified.
19.
Depleted Uranium Shields The licensee uses Union Carbide Mo-99/Tc-99m generators with depleted uranium shields. The licensee has no license to possess depleted The State of New York granted Union Carbide, Tuxedo, New uranium.
York, a license which authorized them to send these shields to cus-tomers as long as they were returned for reuse. This New York li-cense treats these shields as New York licensed material owned by Union Carbide. The question of New York's authority to grant such a license is being evaluated.
20.
Exit Meeting The exit meeting was held at the conclusion of the inspection on February 29, 1980. Licensee attendance is denoted in Paragraph I The NRC was represented by Mr. A. B. Davis, Chief, of this report.
Tuel Facility and Materials Safety Branch, Dr. John Cooper, Chief, Regional Materials Licensing Section, as well as the inspectors performing the inspection.
The findings of this inspection presented in this report were discussed. --
The licensee stated that they were aware they had some problems.
They said these problems were due to a former manager of the faci-lity who no longer worked for the company. They stated that they had hired a corporate health physicist to audit their entire program and empowered him to make the necessary changes to bring them 'into compliance with NRC regulations.
Mr. Davis stated that with the number of items identified and the fact that a year earlier an enforcement conference had been held, strong enforcement was likely. He presented the enforcement options available to the NRC.
Attachments: A through H _ _ _ _
ATTACHKENT A The individuals listed below are missing dosimeter reports for Marc,b, 1979. They were assigned badges prior to and subsequent to March, 1979, and who appeared to work in the restricted area.
4 Wane Title Dosimeter Missing Clerical Whole Body, Ring TLD Pharmacist Whole Body, Ring TLD Pharmacist Whole Body, Ring TLD Whole Body - Beta Technician Whole Body, Ring TLD Pharmacist -
Whole Body, Ring TLD Intern Pharmacist Whole Body, Ring TLD Pharmacist Whole Body, Ring TLD Technician Whole Body, Ring TLD Whole Body - Beta Unknown Whole Body, Ring TLD Pharmacist Whole Body Naces of parties and certain other Identifying details have been removed in order to prevent a clearly unwarranted Invasion of the personal privacy of the Individuals involved.
1 ATTACHMENT B For the individuals listed below evaluations of whole body exposure was not made for the period in August, 1979, for which whole body dosimeters yere damaged and could not be evaluated:
Nares of parties and certain other Identifying details have been removed in order to prevent a clearly unwarranted invasion of the personal privacy of the Individuals involved.
ATTACHMENT C The licensee is missing ring dosimeter reports for individuals listed below who have received exposures in excess of 25 percent of the.10 CFR 20.101(a) for periods when data is available. For each quarter lhe re-torded dose is listed along with number of months for which monitoring
,results were recorded. The number of badges missing per quarter are also poted.
Quarterly Exposure (arems) - 1979 Ware 1st 2nd 3rd 4th 1980 (2 mo.)
4050 (1 mo.)
6717(3 mo.)
14034 (3 mo.)
(1 missing)
(2 missing) 9630 (2 mo.)
9390 (3 mo.)
7112 (2 mo.)
13879 (3 mo.)
(1 missing)
(1 missing)
Hired 6/18/79 5231 (2 mo.)
21821 (3 mo.)
(1 missing) 2730 (1 mo.)
13150 (3 mo.) 8791 (3 mo.)
Terminated 9/26/79 (2 missing) 5750 (2 mo.)
13310 (3 mo.) 8616 (3 mo.)
4010 (3 mo.)
(1 missing) 0 (1 mo.)
5710 (3 sio.)
9854 (3 mo.)
17266 (3 me.)
(2 missing) i Mares of parties and certain other Identifying details have been removed in order to prevent a clearly unwarranted Invasion of the personal privacy of the Individuals involved.
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