ML20050D568
| ML20050D568 | |
| Person / Time | |
|---|---|
| Issue date: | 03/26/1982 |
| From: | Adam W, Mccarter J, Warnick R, Wiedeman D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| 30-12831-80-02, 30-12831-80-2, 30-14386-80-03, 30-14386-80-3, 30-15125-80-04, 30-15125-80-4, NUDOCS 8204120327 | |
| Download: ML20050D568 (41) | |
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~4' U.S. NUCLEAR REGULATORY COMMISSION REGION III Reports No. 30-12831/80-02; 30-15125/80-04; 30-14386/80-03 Docket No. 30-14386 License No. 12-18044-01MD-Chicago, IL Docket No. 30-12831 License No. 48-17466-01MD-Wauwatosa, WI Docket No. 30-15125 License No. 37-18461-01MD-Philadelphia, PA Licensee: Nuclear Pharmacy Incorporated Post Office Box 25141 Albuquerque, NM 87125 Facility Name: Nuclear Pharmacy Incorporated Investigation At: Chicago, Illinois; Wauwatosa, Wisconsin; Philadelphia Pennsylvania; and Albuquerque, New Mexico Period of Investigation:
September 3, 1980 - October 19, 1981 Investigator:
((Ub mN /~y 3bMl?
James B. McCarten Dste '
Inspector:
k.
5k(,/ F2-Willibb J. Adam, Ph.D.
Dade Reviewed By:
M d.i d b d t u t J Ic R//' y'/hi' Robert F. Warnick, Director Ddte Enforcement and Investigation Staff M.
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Darrel G. Wiedeman, Acting C ief Date' Radiological Protection Section 1 Investigation Summary Investigation on September 3, 1980 - October 19, 1981 (Reports No. 30-14386/80-03; 30-12831/80-02; 30-15125/80-04)
Areas Investigated: This investigation was initiated at the request of Headquarters Office of Inspection and Enforcement after allegations were made that NPI was improperly implementing its radiation safety and radio-pharmaceutical quality control programs at its Chicago, Illinois; Wauwatosa, 8204120327 820407 NMS LIC30 12-18044-01MD PDR
Wisconsin; and Philadelphia, Pennsylvania laboratories. This investigation included a total of 125 man-hours onsite by two NRC representatives.
Results: Of the twenty-two allegations investigated, six allegations were substantiated, one of which had been previously identified during other inspections. TWo allegations were substantiated but did not violate any NRC requirements. The remaining fourteen allegations were unsubstantiated.
Five items of noncompliance were identified:
Infraction-(Chicago and Philadelphia) failure to train cleaning personnel in radiation safety, ParagraphH3.5; Infraction-(Chicago and Philadelphia) failure to evaluate exposures of cleaning personnel, Paragraph 3.5; Infraction (Philadelphia) failure to establish current employee exposure history, Paragraph 3.10; Infraction (Philadelphia) failure to perform bioassays, Paragraph 3.11; Infraction (Philadelphia) mislabelling of radiopharmaceuticals delivered to hospital, Paragraph 3.17.
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TABLE OF CONTENTS Reason for Investigation Summary of Facts Details 1.
Personnel Contacted 2.
Background Information 3.
Allegations 3.1 Violation of Possession Limit 3.2 Laboratory Manager's Failure to Wear Dosimetry 3.3 Driver Training 3.4 Improper Film Badge Exchange 3.5 Cleaning Crew Training 3.6 Survey Irregularities 3.7 Irregularities In Customer License Files 3.8 Transfer of Radioactive Waste 3.9 Shipment of Contaminated Containers 3.10 Failure to Correlate Occupational Exposure 3.11 Failure to Perform Bioassays 3.12 Posting of NRC License 3.13 Pre-Natal Exposure Training 3.14 Inadequate Training 3.15 Unauthorized Waste Storage Facility 3.16 Vehicle Surveys 3.17 Mislabeling and Misadministration of Radiopharmaceuticals 3.18 Inadequate Xenon-133 Dispensing Hood 3.19 Reuse of Glass Ampules and Doses of Xenon-133 3
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j 3.20 Unsafe Generator Dismantling Procedure 3.21 Survey Instrument Calibration i
3.22 Sealed Source Inventory 4.
Interviews of Management / Consultants 5.
Exit Meeting Exhibits:
(A) IE Inspection Report No. 30-14386/80 Chicago (B)
IE Inspection Report No. 30-12831/80 k'auwatosa (C) IE Inspection Report No. 30-15125/80 Philadelphia j
(D) IE Investigation Report No. 30-15125/80 Philadelphia j
(E) IE Inspection Report No. 30-14386/80 Chicago i
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REASON FOR INVESTIGATION On April 1, 1980, a former employee at NPI's Philadelphia, PA Pharmacy made allegations concerning irregularities in NPI's radiation safety program.
From May 1, 1980 through May 15, 1980, the Region I, Office of Inspection and Enforcement, (IE) conducted an investigation into these allegations and documented this effort in Investigation Report No. 30-15125/80-02. This report is enclosed as Attachment D.
During the period May 13-17, 1980, the NRC Headquarters Investigation Staff interviewed two former Radiation Safety Officers (RS0) who made additional allegations concerning NPI's radiation safety program at its Chicago, Illinois; Wauwatosa, Wisconsin; and Philadelphia, Pennsylvania laboratories.
Region III was directed by IE Headquarters to initiate an investigation into all of these matters and to incorporate Region I's findings in the final report.
SUMMARY
OF FACTS This investigation was initiated after former employees made allegations of irregularities in NPI's radiation safety and radiopharmaceutical quality control programs at its Chicago, Illinois; Wauwatosa, Wisconsin; and Phila-delphia, Pennsylvania Pharmacies. The allegations and the results of an earlier Region I investigation into some of these allegations were reviewed.
This review identified twenty-two alleged areas of concern covering all aspects of the licensee's program. The investigation team also conducted a routine inspection at each of the three laboratories during September 1980.
Noncompliance with NRC requirements was found in the following areas:
(a) cleaning personnel at NPIs Chicago and Philadelphia pharmacies who entered a restricted area were not provided with film badges and exposures were not evaluated (3.5); (b) cleaning personnel at NPI's Chicago and Philadelphia facilities were not trained in the hazards associated with radioactive material (3.5); (c) a part-time employee at the Philadelphia laboratory was also employed as a full-time radiation worker at another facility, yet NPI made no correlation of her total exposure to radiation (3.10); (d) at the Philadelphia laboratory bioassays for individual uptake of I-131 and I-125 were not performed in accordance with Regulatory Guide 8.20 (3.11); (e) NPI's Philadelphia laboratory mislabeled radiopharmaceuticals which resulted in one misadministration (3.17).
Some of the allegations were found to be true; however, either the licensee had been previously cited for these violations or the conduct did not violate any NRC requirements. The previously cited items are:
failure of Chicago and Philadelphia drivers to wear film badges and deficiences in Philadelphia drivers training (3.3); and failure to perform laboratory and personnel contamination surveys at the Chicago Pharmacy (3.6).
At NPI's Chicago and Philadelphia Pharmacies, female employees were not trained in the hazards of pre-natal exposure to radiation (3.13); however, this is not required by NRC regulations. Also at NPI's Philadelphia laboratory, wipe tests of outgoing shipments were not performed, which resulted in hospitals receiving 5
contaminated shipping containers; however, the contamination levels did not exceed NRC/ DOT limits, nor violate any NRC requirements (3.9).
The allegations concerning the remaining 14 areas were not substantiated.
They are for the Philadelphia laboratory:
(a) violation of 15 curie pos-session limit (3.1); (b) providing radiopharmaceuticals to customers without verification of the customer's NRC or State license authorizing possession of the material (3.7); (c) NRC license not posted or shown to employees upon request (3.12); (d) inadequate training of pharmacists (3.14); (e) Improper storage of radioactive waste (3.15); (f) failure to survey delivery vehicles (3.16); (g) unauthorized use and maintenance of NPI's Xenon-133 dispensing (h) re-use of glass ampules and doses of Xenon-133 gas (3.19);
hood (3.18);
(1) Pharmacy employees unsafely dismantling and removing the resaleable lead components of Tc-99m generators (3.20); (j) survey instruments calibrated by an unauthorized calibration service (3.21); and (k) failure to inventory sealed sources (3.22).
The unsubstantiated allegations at the Chicago (a) Pharmacy manager's failure to wear dosimetry (3.2);
Pharmacy are:
(b) improper weekly film badge exchange resulted in laboratory personnel not wearing film badges (3.4); and (c) radioactive waste was improperly transferred between NPI's Wauwatosa, Wisconsin and Chicago, Illinois Pharmacies (3.8).
The Region I investigation and the three Region III inspections conducted concurrently with this investigation identified other items of noncompliance which are not documented in the body of this report. They are as follows:
One item of noncompliance with NRC requirements was identified at NPI's failure to maintain an NRC Form 5 or its equivalent.
Chicago Pharmacy:
Three items of noncompliance were identified at NPI's Philadelphia Pharmacy:
(a) failure to survey incoming shipments of licensed materials from customers; (b) failure to calibrate pocket dosimeters at six month intervals; and (c)
One item of noncompliance failure to perform dose calibrator linearity tests.
was identified at the Wauwatosa pharmacy:
inadequate evaluation to determine compliance with 10 CFR 20.103.
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DETAILS 1.
Personnel Contacted Nuclear Pharmacy Incorporated
- Robert L. Sanchez, President
- Nunzio DeSantis, Vice President, former Northeast-Midwest District Manager Stephen Dessel, Northeast District Manager and former Pharmacy Manager, Philadelphia Robert L. McClintock, Corporate Radiation Safety Officer (RS0)
Kenneth Barat, RSO, Chicago and Wauwatosa James Fulton, RST Philadelphia Garry Crescenzi, Assistant Laboratory Manager, Philadelphia 4
j Jon M. Reavis, Pharmacy Manager, Wauwatosa i
Roy Storey, Pharmacy Manager, Chicago I
Curtis Blaum, former Pharmacist, Chicago George Jeresko, former Pharmacist and RSO, Chicago Jeffrey Lee, former Pharmacist, Chicago Gary Klockow, Pharmacist, Chicago Mobin Sohel, Pharmacist, Chicago Wilbur Zipperlen, Pharmacist, Philadelphia Colleen Casey, Radiation Safety Surveyor, Wauwatosa Elaine Tonasuto, Nuclear Medicine Technician, Philadelphia Naomi Toi, former Sales Representative, Chicago Jeanette Swanson, former Office Manager, Chicago Julie Friebus, former Of fice Manager, Chicago Linda Norten, Secretary, Chicago Darkus Candle, Secretary, Chicago Lottie McGill, Secretary, Chicago Sylvia Jackson, Secretary, Chicago Victoria Ostema, Secretary, Chicago Michael Caprara, Driver, Chicago Larry Riggs, former Driver, Chicago David Collier, Driver, Chicago William M. Bradshaw, Driver, Philadelphia Edward Burgos, Driver, Chicago Dominic Perri, Driver, Chicago Ivan Muniz, Driver, Chicago i
Paul Kaupla, Driver, Wauwatosa Scott Weissbrodt, Driver, Wauwatosa l
R. Petosky, Driver, Wauwatosa Individual "A",
former Pharmacist, Wauwatosa Mario Edney, Driver, Philadelphia Charles Dale, Driver, Philadelphia l
Moses Greene, Driver, Philadelphia i
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Stan Huber and Associates Stanley A. Huber, President
- Denotes those attending Exit Meeting on December 16, 1980.
===2.
Background===
The NRC licenses Nuclear Pharmacy, Incorporated (NPI) to operate a number of radiopharmacies throughout the United States. NPI provides hospitals with prepackaged, precalibrated, radiopharmaceuticals for use in various nuclear medicine procedures. NPI services approximately fifty hospitals from its Chicago Pharmacy, thirty from Wauwatosa, Wisconsin, and fifty from Philadelphia, Pennsylvania.
During May 1-15, 1980, Region I, conducted an investigation into nine allegations regarding irregularities in the licensee's radiation safety and radiopharmaceutical quality control program at its Philadelphia Pharmacy. While this investigation was in progress, two other individ-uals contacted the NRC and made additional allegations about safety programs at the Philadelphia, Chicago, and Wauwatosa Pharmacies. The Director of the NRC's Office of Inspection and Enforcement requested Region III to conduct an investigation into all of these allegations.
This investigation report documents that effort as well as Region I's findings. The report also documents the results of an inspection at each of the three NPI Pharmacies conducted during September of 1980.
3.
Allegations From April 1, 1980 to May 16, 1980, three individuals were interviewed by the NRC's Office of Inspection and Enforcement Investigation Staff regarding the licensee's radiation safety and radiopharmaceutical quality control programs. The results of these interviews were forwarded to Region III.
This material and the NPI license files were reviewed and twenty-two allegations concerning the licensee's radiation safety program were identified. The balance of this report documents each of the 22 allegations, the investigation of each allegation, the findings and conclusions regarding each allegation, and the items of noncompliance associated with each allegation.
3.1 Violation of Possession Limit 3.1.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy the possession limit (15 Ci) for technetium-99m (Tc-99m) generators was exceeded. The alleger stated that in February and March 1980, NPI began purchasing 15 Ci and 5 Ci Tc-99m generators, and exceeded their possession limit when in possession of two or more of the 15 Ci generators.
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3.1.2 Investigation 3.1.2.1 Review of License File A review of the NPI Philadelphia license file shows that on January 25, 1980, NPI requested their possession limit for molybedenum-99/
technetium-99m generators be increased from their current authorization of 15 Ci to 25 Ci.
NRC approved this request on March 21, 1980.
3.1.2.2 Review of Radionuclide Log Book On September 16, 1980, the NPI Philadelphia Radionuclide Log Book was reviewed.
It reported NPI was shipped a 16.6 Ci generator assayed for 12 p.m.,
EST on January 30, 1980.
Considering the sixty-seven hour half life of Mo-99 this amount would have decayed to 13.5 Ci by the time it arrived at NPI at 8 a.m. the following morning.
Similarly, it was found on February 1, 15, and 20, 1980, 16.6 Ci generators were ordered, but they also decayed significantly by the time they arrived at NPI. NRC personnel reviewed the log and made independent calculations which showed that NPI had not exceeded the 15 Ci possession limit.
3.1.3 Findings and Conclusions NPI had ordered 16.6 Ci Tc-99m generators, however, by the time they arrived at the Philadelphia Pharmacy they had decayed to within the 15 Ci possession limit. Record reviews and independent calculations by NRC personnel found that when receiving these Tc-99m generators at the rate of one per week, the possession limit had not been exceeded.
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3.1.4 Items of Noncompliance No items of noncompliance were identified.
3.2 Laboratory Manager's Failure to Wear Dosimetry l
3.2.1 Allegation It was alleged that in December 1979 and January 1980, i
the Chicago NPI Pharmacy Manager, Roy Storey, drew doses of radiopharmaceuticals but did not wear a ring or wrist badge and did not use syringe shields or lead-lined gloves.
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3.2.2 Investigation 3.2.2.1 Interview of Curtis Blaum On September 25, 1980, Curtis Blaum, former Pharmacist, NPI, Chicago, was interviewed by the NRC. Blaum said during the period in question, Roy Storey always wore a film badge but did not wear a ring badge or use syringe shields when drawing doses in the laboratory.
Blaum stated that Storey once told him the syringe shields were too cumbersome and so he did not use them. According to Blaum, Storey once said that to avoid a fine against NPI, he did not wear a ring badge because he did not want an overexposure reported on it.
3.2.2.2 Interview of George Jeresko On October 10, 1980, George Jeresko, former Pharmacist and RSO, NPI, Chicago, was inter-viewed by the NRC. He said that in January 1980, Storey did not use syringe shields when drawing doses in the laboratory even though licensee procedures required they be used when drawing doses in excess of 10 mci. Jeresko was not sure if Storey wore a ring badge in the laboratory but recalled Storey was concerned about fines for overexposures.
3.2.2.3 Interview of Roy Storey On September 25, 1980, Roy Storey, Pharmacy Manager, NPI, Chicago was interviewed by the NRC. He stated he always wore a film and ring badge and used syringe shields when drawing doses in the Pharmacy.
Storey stated he re-called commenting to the former RSO, Mark Shaffer, that a way to keep overexposures down was to not wear dosimetry. He said this comment was mis-construed if Shaffer thought he said laboratory
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personnel should not wear dosimetry.
3.2.2.4 Interview of Kenneth Barat On September 30, 1981, Kenneth Barat, RSO, Chicago was interviewed by the NRC. He stated Roy Storey worked at the Chicago laboratory from late December 1979, to the present date. He reviewed NPI film badge records which reported Storey received exposures to both his ring and 10
body badge which are consistent with exposures other employees received during this period.
Barat stated the records reflect Storey received i
the following exposures for the first quarter of 1980 and the first month of the second quarter of 1980.
Ring Badge Whole Body January 1550 mr 597 mr February 1090 mr 50 mr March 1440 mr 90 mr April 520 mr Minimum 3.2.3 Findings and Conclusions The licensee procedures require that pharmacists wear a body badge and a ring badge and use syringe shields when drawing doses in excess of 10 mci. Lead-lined gloves and
" wrist dosimetry" are not required. The alleger and two other employees stated that they observed Roy Storey not using syringe shields when drawing doses in the lab.
Storey stated he wore a film badge and utilized syringe shields. Dosimetry data showed Storey received exposures which were consistent with other exposure data. We are unable to confirm this allegation because of conflicting statements and the dosimetry data.
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3.2.4 Items of Noncompliance No items of noncompliance were identified.
3.3 Driver Training 3.3.1 Allegation It was alleged that NPI's Chicago and Philadelphia delivery drivers were not properly trained or issued film badges prior to their handling radiopharmaceuticals.
3.3.2 Investigation 3.3.2.1 Interview of Michael Caprara On September 24, 1980, Michael Caprara, Driver, NPI, Chicago, was interviewed by the NRC.
He stated the training given drivers previously was not as adequate as it is now.
He also stated that in September 1979, during his first week of employment he made deliveries and handled radio-pharmaceuticals but was not issued a film badge.
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l 3.3.2.2 Interview of Larry Riggs On September 25, 1980, Larry Riggs, former Driver, NPI, Chicago, was interviewed by the NRC. He said he was employed by NPI from January 4 to February 28, 1980, and during this period he routinely delivered radiopharmaceuticals but was not issued, nor did he wear a film badge or pocket dosimeter. He said during the January 1980 NRC inspection, Roy Storey, Pharmacy Manager, gave him a film badge assigned to Stephen Lounds, and told him to wear it during the inspection.
3.3.2.3 Interview of William Bradshaw On September 15, 1980, William Bradshaw, Driver, NPI, Philadelphia was interviewed by the NRC. He said he had been employed as a driver since August 1980, and always wore a film badge at work.
Bradshaw stated he was given a radiation safety manual and signed a form stating he had read it.
However, he was not formally instructed in the hazards of handling radioactive material.
He said he did not know the material he was delivering was potentially hazardous. He also said he was not given any training in decontamination procedures but was told if the container opens during an accident he was to call the office and evacuate the area.
(INVESTIGATOR'S NOTE: On the date of the interview Bradshaw had only been employed by NPI for about three weeks.)
3.3.2.4 Interview of Paul Kaupla On September 4, 1980, Paul Kaupla, Driver _, NPI, Wauwatosa, Wisconsin was interviewed by tae NRC.
He stated on his first day at work at LPI, the RSO briefly discussed with him radiation safety practices and gave him some pamphlets on this subject.
He said he periodically attended driver training meetings where radiation safety was dis-cussed but he had never been instructed in accident procedures; however, he said there is an accident procedure notice in the delivery vehicle window.
He said he knew he was to call the office in case of an accident or radioactive spill.
3.3.2.5 Interview of Mario Edney On September 15, 1980, Mario Edney, Driver, Philadelphia, Pennsylvania, was interviewed by
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the NRC. He said he had been employed by NPI l
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3.3.2.6 Interview of James Fulton On September 15, 1980, James Fulton, Radiation Safety Technician (RST), Philadelphia, Pennsyl-vania, was interviewed by the NRC. He said in May 1980 he was employed by NPI and found there was no formal driver training program. He said that some of the drivers were aware of radiation safety practices and accident procedures. He said the drivers have now been trained in accident procedures, use of film badges, and the ALARA program.
3.3.2.7' Interview of Scott Weissbrodt On September 4, 1980, Scott Weissbrodt, Driver, Wauwatosa, Wisconsin, was interviewed by the NRC. Weissbrodt stated that between July 1978 and July 1980, he did not receive any training in radiation safety practices or accident pro-cedures. Weissbrodt stated he knew that in case of an accident he was to call the office. He also stated that during his first 10 days of employement he delivered radiopharmaceuticals but was not issued a film badge.
3.3.2.8 Interview of Jon Reavis On September 3, 1980, Jon M. Reavis, Pharmacy Manager, Wauwatosa, Wisconsin was interviewed by the NRC. He said NPI's Wauwatosa Pharmacy employed six fulltime drivers, all hired in the previous six months. Reavis said Kenneth Barat, RSO, Chicago, visited the Wauwatosa Pharmacy twice weekly and in the previous four months had given inservice training to all delivery personnel.
i 3.3.2.9 Interviews of Delivery Drivers On September 23-24, 1980, the following delivery personnel at NPI's Chicago Pharmacy were inter-l viewed by the NRC. All of these individuals stated they had received inservice training while l
employed at NPI:
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David Collier Edward Burgos Dominic Perri Ivan Muniz.
3.3.2.10 Interview of Kenneth Barat On September 24, 1980, Kenneth Barat, RSO, NPI, j
Chicago was interviewed by the NRC. Barat stated informal training sessions have been conducted for delivery personnel since March 1980. He said currently no formal training program was required therefore, no records of these training sessions were maintained by NPI. He added that the high turnover for delivery personnel has caused problems in the training area. He stated that currently he was expanding the existing informal training program into a formal program which must be com-pleted by each driver prior to his making any deliveries of radiopharmaceuticals.
3.3.2.11 Interview of Individual "A"
On September 5, 1980, Individual "A" former Pharmacist, Wauwatosa, was interviewed by the NRC.
He said drivers were adequately trained at the Wauwatosa laboratory.
3.3.3 Findings and Conclusions NRC inspectors found no records of driver training at NPI's Wauwatosa, Chicago, or Philadelphia Pharmacies. NRC regula-tions do not require records be maintained. The RSO at NPI's Philadelphia Pharmacy stated that prior to May 1980 there l
was no driver training program at the Philadelphia Pharmacy.
Interviews of delivery drivers at the Chicago and Wauwatosa Pharmacies indicated that some driver training had been given; however, apparently some personnel did not attend this training. Two drivers stated they were not issued a film badge or dosimeter during their first week of employ-ment, and a third driver stated he had no film badge for a 30 day period.
3.3.4 Items of Noncompliance The Philadelphia Pharmacy was previously cited in Inspection Report No. 37-18461-01MD/79-01 for training deficiences and for failure to wear film badges. The Chicago Pharmacy was also previously cited in Inspection Report No. 30-14386/80-01 (Exhibit E) for drivers failing to wear film badges. The licensees corrective action was documented in their response to the Notice of Violation accompanying these reports. No new items of noncompliance were identified.
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3.4 Improper Film Badge Exchange i
3.4.1 Allegation It was alleged that in February 1980 at NPI's Chicago Pharmacy, Julie Friebus did not properly conduct the weekly exchange of employee film badges. The result was some employees wore the previous week's badge or no badge at all for a two hour period.
3.4.2 Investigation 3.4.2.1 Interview of Julie Friebus On September 23, 1980, Julie Friebus, former Secretary, NPI, Chicago, was interviewed by the NRC.
She stated she was responsible for the weekly exchange of film badges and on Friday i
evenings she would exchange the badges of the off-duty employees.
If an employee was wearing i
a badge she said it would be exchanged later in the evening.
She recalled on one occasion badges were exchanged on a Saturday morning so some l
employees wore the previous week's badge for a few more hours than usual. She said that in this instance all of the employees were properly badged.
3.4.3 Findings and Conclusions It was found that on one occasion film badges which are routinely exchanged on Friday evening were not exchanged until Saturday morning. This resulted in employees wearing the previous week's film badge for a longer period, however, all the employees were badged in accordance with NRC regulations.
3.4.4 Items of Noncompliance No items of noncompliance were identified.
3.5 Cleaning Crew Training 3.5.1 Allegation It was alleged that at NPI's Chicago and Philadelphia
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Pharmacies the cleaning crews routinely entered restricted areas without film badges or dosimeters and were not l
trained in the hazards associated with entering a restricted area.
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3.5.2 Investigation 3.5.2.1 Interview of Stephen Dessel On September 16, 1980, Stephen Dessel, Northeast District Manager and former Pharmacy Manager, NPI, Philadelphia was interviewed by the NRC.
He said the janitors at the Philadelphia facility were not badged when entering the restricted area.
Dessel stated that in January 1980, the former RSO Charles Stephens brought this to his attention and he directed Stephens to badge the cleaning crew. Dessel said Stephens left NPI shortly afterwards and never followed up to see if the crews were badged. From a review of personnel monitoring records it was apparent that other personnel entering the restricted area were receiving exposures in excess of 25 percent of the limits, therefore, it is not unre-asonable to assume that the cleaning personnel could have received similar exposures.
He said the cleaning crew recently received training in the hazards associated with working in a restricted area. Dessel added that a female in her early teens is also employed by the janitorial service to clean other areas of the same building. However, she does not enter the restricted area.
1 3.5.2.2 Interview of James Fulton On September 16, 1980, James Fulton, RST, Philadelphia, was interviewed by the NRC. He said in June 1980, he trained the cleaning crew in the hazards associated with working in a restricted area. He said the cleaning crew was not badged when entering this area.
3.5.2.3 Interview of Kenneth Barat On September 23, 1980, Kenn'th Barat, RSO, i
Chicago, was interviewed by the NRC.
He said prior to September 22, 1980, the cleaning crew the Chicago Pharmacy entered the restricted at i
area but crew members were not issued film badges or trained in the hazards associated with l
entering the area.
Barat said in March 1980 he informally briefed the cleaning crew on the precautions to be taken when entering and exiting this area.
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3.5.3 Findings and Conclusions It was found that the cleaning crew at NPI's Chicago and Philadelphia Pharmacies were not issued dosimetry or given training in the hazards associated with entering a restricted area.
3.5.4 Items of Noncompliance TWo items of noncompliance were identified for both the Chicago and Philadelphia facilities:
(1) 10 CFR 19:12; failure to train cleaning personnel in the precautions and procedures to minimize exposure to radioactive material and the health protection problems associated with exposure to radioactive material, (2) 10 CFR 20.201(b) failure to evaluate exposures of cleaning personnel who entered a restricted area (failure to wear film badges and evaluate exposures).
3.6 Survey Irregularities 3.6.1 Allegations It was alleged that at NPI's Chicago and Philadelphia Pharmacies, surveys for personnel and laboratory contamina-tion were not performed or were performed sporadically.
It was specifically alleged that in December 1980 the survey log books at these facilities were falsified, after it was found that surveys had not been performed that month.
3.6.2 Background Information The licensee's procedures submitted in support of the license application requires the licensee to perform daily swipe surveys to determine if radiocctive con-tamination is present in a laboratory.
In addition, any personnel entering and exiting the laboratory must survey themselves with a portable survey instrument.
3.6.3 Investigation 3.6.3.1 Review of Region III Inspection Report No. 30-14386/80-01 Region III Inspection Report No. 30-14386/80-01 (Exhibit E), dated July 2, 1980, reports in Paragraph 6.a, Contamination Surveys, that from February 9, 1979, to January 28, 1980, daily surveys of the laboratory were not always performed as required.
Inspectors found con-taminated areas in the laboratory.
Inspectors also observed Pharmacy personnel did not survey 17
i themselves before exiting the lab and personnel monitoring devices were not available at the 7
rear exit of the laboratory used by delivery drivers.
The licensee was previously cited in Inspection Report No. 30-14386/80-01 for three items of noncompliance regarding surveys. They were cited for failure to perform and record daily swipe surveys, failure to perform daily area surveys, and failure to perform personal monitoring surveys when exiting a restricted area.
3.6.3.2 Review of Region I Inspection Report No. 30-15125/80-02 Region I Inspection Report No. 30-15125/80-02, dated July 31, 1980, reports in Paragraph D.9.b that in December 1979, daily surveys of NPI's Philadelphia Pharmacy were performed and a record of said surveys was maintained. A copy of the Region I report is appended to this report as Exhibit D.
4 3.6.3.3 Review of Survey Records-Philadelphia On September 16, 1980, Region III inspectors reviewed the license's daily area survey and weekly area and swipe test logs. The inspectors found that the records indicated that the re-quired surveys were being performed. See Inspection Report No. 30-15125/80-03 (Exhibit C).
3.6.3.4 Review of Survey Records-Chicago On September 24, 1980, Region III inspectors i
reviewed the licensee's daily area and swipe survey log books. The inspectors found that the records indicated that the daily area and swipe surveys had been performed since March 1, 1980.
Inspectors also observed that personnel monitoring equipment has been placed at both exits of the laboratory and personnel used the equipment when exiting the laboratory.
See Inspection Report No. 30-14386/80-02 (Exhibit A).
3.6.3.5 Interview of Jeanette Swanson On September 30, 1980, Jeanette Swanson, former Office Manager, NPI, Chicago, was interviewed by the NRC.
She stated prior to January 1980 at NPI's Elmhurst Pharmacy, she routinely entered the lab, but did not survey herself for radio-active contamination when exiting.
She said a 18 4
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survey meter was available for use by laboratory technicians and drivers, but a meter was not available at the exit used by the clerical staff.
Swanson added that in January 1980 a survey meter was put at both exits.
3.6.3.6 Interview of Jeffrey Lee On October 2, 1980, Jeffrey Lee, former Pharmacist, NPI, Chicago was interviewed by the NPC. He stated that from June 1979 to January 1980, laboratory and clerical employees routinely did not survey them-selves for radioactive contamination when exiting the laboratory.
He said that on one occasion he brought this to the attention of the RSO, George Jeresko, but Jeresko did nothing about it.
3.6.3.7 Interview of Gary Klockow On September 24, 1980, Gary Klockow, Pharmacist, NPI, Chicago, was interviewed by the NRC. He stated that during November 1979 to January 1980 while working at NPI's Elmhurst Pharmacy, he noted that the clerical staff did not survey themselves when exiting the laboratory. He said during this period he and other employees frequently did not j
survey themselves; however, he added that all NPI employees have recently been instructed to survey t
themselves when exiting the lab.
3.6.3.8 Interview of Naomi Toi
)
On September 25, 1980, Naomi Toi, former Sales Representative, NPI, Chicago, was interviewed by the NRC.
She stated that while employed at NPI from January 1979 to March 14, 1980, she noted that some employees, mostly drivers and the clerical staff, did not survey themselves l
when exiting the laboratory.
She said a survey meter was available for the professional staff's i
use, however, others were not aware of its availability.
3.6.3.9 Interview of Larry Riggs i
On September 25, 1980, Larry Riggs, former Driver, NPI, Chicago was interviewed by the NRC. He stated that while employed by NPI from January 4 to February 29, 1980, he did not survey himself when exiting the laboratory.
f 19
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3.6.3.10 Interview of Julie Friebus On September 23, 1980, Julie Friebus, former Of fice "a:>ager, NPI, Chicago was interviewed by the NRC.
She stated that in November 1980 after Laboratory Manager Dr. William Zimmer left NPI, she noted that the laboratory and clerical staff did not survey themselves when exiting the laboratory. She also noted swipe surveys in the laboratory area were not performed as often as in the past.
She attributed this lack of concern about radiation safety to the attitudes of the new Laboratory Manager, Nunzio DeSantis.
3.6.3.11 Interview of Curtis Blaum On September 25, 1980, Curtis Blaum, former Pharmacist, NPI, Chicago, was interviewed by the NRC. He stated that while employed at NPI from January 1, 1980 to February 11, 1980, a survey meter was not available for use at the laboratory exit, and consequently employees did not survey themselves for radioactive contamination.
I 3.6.3.12 Interview of Mobin Schel On September 24, 1980, Mobin Sohel, Pharmacist, NPI, Chicago was interviewed by the NRC. He stated that he had been employed by NPI since November 1978, and recalled that from November 1979 to January 1980 a survey meter was avail-able, but employees were not routinely surveying themselves when exiting the laboratory. He attributed this to confusion resulting from NPI's acquisition of a large number of new clients i
during this period, and NPI's consolidation move from two locations to their present facility.
3.6.3.13 Interview of George Jeresko On October 10, 1980, George Jeresko, former Pharmacist and RSO, NPI, Chicago, was interviewed l
l by the NRC. He stated he was employed at NPI from November 1978 to January 19, 1980, and was RSO at NPI's Elmhurst Pharmacy from November 1979 to January 19, 1980. He stated that when he be-l came RSO, contamination surveys of the NPI lab and l
of personnel exiting the lab were not always performed. He said the new Pharmacy Manager, Nunzio DeSantis, did not support radiation safety practices and in one instance laughed when shown i
20
a survey instrument which was used to monitor one's hands and feet for contamination.
Jeresko also stated that, as RSO, he frequently failed to perform the required contamination surveys.
During December 1979 and January 1980, NPI was audited by an outside consultant who found the survey records incomplete. Jeresko stated the RSO for NPI's Atlanta office visited Chicago following these audits and asked him to falsify entries in the log for December 1980 by filling in entries for those days when a survey had not been performed. He said he refused to do so and that he was unsure whether the other RSO went ahead and made the entries in the log.
INVESTIGATORS NOTE:
It is evident from IE Inspection Report No 30-14386/80-01 dated July 2, 1980, Paragraph 6a, that falsifi-cation of these survey records was unlikely.
Region III inspectors found that the records were grossly incomplete. Specifically, the information was recorded on pages torn from a spiral notebook, and was present for only 40 dates from February 9, 1979 to January 28, 1980, an average of once every nine days.
The Chicago Pharmacy was previously cited by the NRC for failure to properly perform and record these surveys.
(See Exhibit E, Para-graph 6a) 3.6.4 Findings and Conclusions NRC inspectors found evidence that the required surveys had been performed at NPI's Philadelphia Pharmacy.
Region III inspectors found during the January and February 1980 inspections of NPI's Chicago Pharmacy that the daily swipe and area surveys were performed sporadically or not at all.
Inspectors also observed that the clerical staff did not survey themselves when exiting the laboratory.
This was subsequently confirmed through interviews of NPI 3
employees.
l There was no evidence that the December 1980 survey records at either NPI's Chicago or Philadelphia Pharmacies were falsified.
f l
l 21 y
- + -. - -,.
o NPI's Chicago laboratory was previously cited in Region III Inspection Report No. 30-14386/80-01, dated July 2, 1980, for failure to perform surveys and failure to record results of surveys (see Exhibit E).
3 3.6.5 Items of Noncompliance 4
No new items of noncompliance were identified.
3.7 Irregularities in Custemer License Files 3.7.1 Allegation It was alleged that NPI's Philadelphia Pharmacy was provid-ing radiopharmaceuticals to customers without maintaining a copy of the customer's NRC or State Byproduct Materials license on file.
t 3.7.2 Background Information To ensure that customers do not receive unauthorized material, NPI is required to maintain a copy of the customer's NRC or State Byproduct Materials license.
I If the license has expired submission of a renewal I
application is sufficient, since possession of material is permitted if a renewal application has been received
~
by materials licensing prior to expiration of the license.
3.7.3 Investigation 3.7.3.1 Record Reviews l
On September 16, 1980, NPI's Philadelphia license files were reviewed. Current copies of NRC or i
State Byproduct Material Licenses were on file, or if the customer's license had expired, a letter, or renewal application was on file.
3.7.3.2 Interview of James Fulton t
On September 16, 1980, James Fulton, RST, NPI, Philadelphia was interviewed by the NRC. Fulton stated in June 1980 he audited NPI's customer i
license files and found about 1/4 of the customer licenses were not on file. He said he corrected this and obtained copies of all the missing licenses, or in the case of expired licenses a copy of the customer's renewal application.
He said to the best of his knowledge this did not result in the unauthorized shipment of byproduct material.
s 1
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3.7.3.3 Interview of Stephen Dessel On September 16, 1980, Stephen Dessel, Northeast District and former Pharmacy Manager, NPI, Philadelphia, was interviewed by the NRC. He stated that between March and April 1979, NPI's Philadelphia Pharmacy expanded from 6 to 39 customera. He said during this rapid expansion there may have been shortcomings in the main-tenance of the customer's license files, however, this did not result in the unauthorized shipment of byproduct material. He said in each case NPI's sales representatives reviewed the customer's license prior to authorizing shipment of the material.
3.7.4 Findings and Conclusions NRC inspectors found the licensee was properly maintaining copies of customer's NRC or State byproduct materials licenses.
It was also established that prior to June 1980, NPI had not properly maintained copies of customer's NRC or State Byproduct Material licenses. However, the licensee identified and corrected this problem.
3.7.5 Items of Noncompliance No items of noncompliance were identified.
3.8 Transfer of Radioactive Waste 3.8.1 Allegation It was alleged that NPI had transported radioactive waste from its Wauwatosa Pharmacy to its Chicago Pharmacy.
3.8.2 Investigation 3.8.2.1 Interview of Kenneth Barat On September 23, 1980, Kenneth Barat, RSO, Chicago was interviewed by the NRC. He stated that at one time NPI planned to r.ip decayed low 5
level radioactive waste from the Wauwatosa Pharmacy to its Chicago Pharmacy. He said due to concern over regulatory requirements this transfer was not made.
23
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3.8.2.2 Interviews of Laboratory Personnel Between September 3, 1980 and September 25, 1980, the following current and former employees of NPI's Chicago and Wauwatosa Pharmacies were in-terviewed by the NRC.
All denied that NPI transferred low level radioactive waste between the Wauwatosa and Chicago Pharmacies.
John M. Reavis, Pharmacy Manager, Wauwatosa Colleen Casey, Radiation Safety Surveyer, Wauwatosa Michael Caprara, Driver, Chicago Larry Riggs, former Driver, Chicago William Bradshaw, Driver, Philadelphia Paul Kaupla, Driver, Wauwatosa Scott Weissbrodt, Driver, Wauwatosa R. Petosky, Driver, Wauwatosa 3.8.3 Findings and Conclusions Eight current and former NPI employees were interviewed and all stated that decayed low level radioactive waste was not transferred between the two subject NPI Pharmacies.
3.8.4 Items of Noncompliance 3
No items of noncompliance were identified.
3.9 Shipment of Contaminated Containers 3.9.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy, wipe tests for surface radioactive contamination on outgoing containers were not performed and, as a result, Albington Memorial Hospital in Philadelphia reported receiving contaminated shipping containers from NPI on six to eight occasions.
3.9.2 Review of Region I Investigation Report No. 30-15125/80-02 Region I Investigation Report No. 30-15125/80-02 dated l
July 31, 1980, reports in Paragraph Sb that on nineteen occasions between April 1979, and April 23, 1980, three hospitals, including Albington Hospital, reported that they had received contaminated shipping containers from NPI. Region I inspectors found that prior to March 21, 1980, wipe tests of shipping containers for surface radio-active contamination were not performed. Region I reported that the levels of contamination found on the containers did not exceed NRC or DOT limits.
(See Exhibit D) i 24
3.9.3 Findings and Conclusions Prior to March 21, 1980, outgoing packages were not wipe tested for surface radioactive contamination. This resulted in three Philadelphia area hospitals, including Albington Hospital, receiving contaminated shipping con-tainers from NPI; however, the contamination did not exceed NRC or DOT limits. As of the date of the investigation, all outgoing packages were being wipe tested for contamination.
3.9.4 Items of Noncompliance No items of noncompliance with any NRC or Department of Transportation (DOT) requirements were identified.
3.10 Failure to Correlate Occupational Exposure 3.10.1 Allegation It was alleged that a correlation of total radiation exposure was not made for Elaine Tonasuto, a part-time employee at NPI's Philadelphia Pharmacy, while she worked as a full-time radiation worker at Temple University.
3.10.2 Background Information The NRC requires that any individual who enters a restricted area where he is likely to receive a quarterly occupational dose in excess of 25*4 of 10 CFR 20.101(a) limits (312.5 mr),
disclose in a written statement that they have had no prior occupational dose during the current quarter, or the nature and the source or amount of any occupational dose which the A cor-individual may have received during that quarter.
relation of these exposures should be made by each licensee.
3.10.3 Investigation 3.10.3.1 Interview of Elaine Tonasuto On September 15, 1980, Elaine Tonasuto, Nuclear Medicine Technician, NPI, Philadelphia was inter-viewed by the NRC. She said that from October to December 1979, she was employed full-time at Temple University and part-time at NPI.
She said during this period she wore two film badges; one at each location, but no correlation of her total exposure was made. She said that during this period she was aware of the probability for increased exposure and made an extra effort not to exceed the exposure Ifmits.
25 i
L
Tonasuto stated that in March of 1980, Charles Stephens, RSO, NPI, Philadelphia, discussed this matter with her and he said he would obtain the required data and correlate her exposures from both facilities. She added that Stephens left NPI shortly af terwards, and she was not sure if he obtained the necessary data to determine if she had exceeded her exposure limit for the calendar quarter.
3.10.3.2 Interview of Stephen Dessel On September 16, 1980, Stephen Dessel, Northeast District Manager and former Pharmacy Manager, NPI, Philadelphia, was interviewed by the NRC. He said he was aware that from October to December 1979, Elaine Tonasuto, part-time radiation worker at NPI was also a full-time radiation worker at Temple University. He said he was not aware a correlation of her total exposure should have been made during the period. He said Charles Stephens later informed him that one should be made to ensure she had not exceeded her quarterly exposure limits. Dessel told Stephens to write a memo to Temple University to obtain the necessary exposure data; however, Dessel said Stephens left NPI shortly afterwards. Dessel said he never followed up to see if the data was sent or that the required correlation was made. Dessel said a correlation of Tonasuto's exposure was yet to be made.
3.10.3.3 Interview of James Fulton On October 19, 1981, James Fulton, RST, Philadelphia, was interviewed by the NRC. He stated he reviewed Ms. Tonasuto's exposure history at NPI and Temple University for the last quarter of 1979. Fulton stated these records showed that Tonasuto received the following exposures:
Temple University Ring Badge Exposures Whole Body Exposures October 1979 200 mr 50 mr November 1979 170 mr 40 mr December 1979 220 mr 70 mr 26
r Nuclear Pharmacy Incorporated Ring Badge Exposures Whole Body Exposures October 1979 180 mr 47 mr November 1979 283 mr (right hand) 35 mr 10 mr (left hand)
December 1979 114 mr (right hand) 23 mr 74 mr (left hand)
Combined exposures did not exceed NRC Limits.
3.10.4 Findings and Conclusions It was determined that a correlation of Ms. Tonasuto's radiation exposure was not made while she was employed part-time by NPI and full-time at Temple University.
An after-the-fact correlation was made by NPI and it was determined that her exposures at both facilities did not exceed NRC limits.
3.10.5 Items of Noncompliance One item of noncompliance was identified - failure to cor-relate exposures received by a part-time employee who worked full-time with byproduct material at another facility.
3.11 Failure to Perform Bloassays 3.11.1 Allegations It was alleged that at NPI's, Chicago and Philadelphia Pharmacies, bioassays for individual uptakes of iodine-131 l
and iodine-125 were not performed in accordance with NRC Regulatory Guide 8.20.
3.11.2 Investigation On September 18, 1980, during a routine inspection of the Philadelphia Pharmacy conducted concurrently with this investigation, NRC inspectors found that NPI was in non-compliance with NRC requirements.
Bioassays were not being performed in accordance with Regulatory Guide 8.20 as required by a license condition. These findings are reported in Region III Investigation Report No. 30-15125/80-03, a copy of which is appended to this report as Exhibit C.
NRC inspectors also found, on January 22, 1980, during a routine inspection of NPI's Chicago laboratory that bioassays were also not being performed 11. accordance with the above re-ferenced Regulatory Guide. NPI was previously cited for this item of noncompliance in Inspection Report 27
No. 30-14386/80-01, a copy of which is appended to this report as Exhibit E.
In September 1980, NRC inspectors found that NPI's Chicago and Wauwatosa laboratories were properly performing bioassays.
3.11.3 Findings and Conclusions License Condition requires that bioassays for individual uptake of I-131 and I-125 be performed in accordance with NRC Regulatory Guide 8.20.
In January 1980, inspectors found that NPI's Chicago Pharmacy had not properly performed the required bioassays. This same condition was found in September 1980, at NPI's Philadelphia laboratory. NP! was cited in both instances.
In September 1980, NRC inspectors found that the bioassay programs at NPI's Chicago and Wauwatosa Pharmacies were corrected and were in compliance with NRC requirements. The licensee committed to correcting the deficiencies at its Philadelphia Pharmacy.
3.11.4 Items of Noncompliance One item of noncompliance was identified and is reported in Inspection Report No. 30-15125/80-03 Exhibit (C).
3.12 Posting of NRC License 3.12.1 Allegation It was alleged that a copy of the NRC license was not posted at NPI's Philadelphia Pharmacy, and employees were not pro-vided access to the license.
3.12.2 Investigation 3.12.2.1 Interview of Barry Crescenzi On September 16, 1980, Barry Crescenzi, Assistant Laboratory Manager, NPI, Philadelphia, was inter-viewed by the NRC. Crescenzi stated he began working at NPI in April 1979, and at that time a j'
copy of the NRC license was not posted. He was not sure if a notice was posted stating where y
the license was filed. He stated that in April l
1979, he was given a copy of the license to read for familiarization, and he also reviewed the license in training sessions given in February 1980, by the RSO, Charles Stephens.
28
3.12.2.2 Interview of Stephen Dessel On September 16, 1980, Stephen Dessel, Northeast District Manager and former Pharmacy Manager, NPI, Philadelphia was interviewed by the NRC. He stated that when the Philadelphia Pharmacy first began operation, a copy of the NRC license was posted on the Bulletin Board. He said after a week, the license was removed and a notice of where the license was filed was put in its place.
Dessel recalled on one occasion, Pharmacist Mark Browning requested he be shown the license.
Dessel told the RSO, Charles Stephens, to show Browning the license and have Browning sign a form indicating he had seen the license. Dessel stated Stephens attempted to show Browning the license but Browning refused to sign the form. Dessel said in i
this instance he was not sure if Stephens eventually showed the license to Browning.
INVESTIGATOR'S NOTE: Charles Stephens, Radiation Safety Officer, NPI, Philadelphia, was no longer employed at NPI and was not available for comment, j
3.12.2.3 NRC Observations i
Region I Inspection Reports No. 30-15125/79-01 and No. 30-15125/80-01 report that during inspections conducted on June 18, 1979, and January 3, 1980, a copy of NPI's NRC license, or a notice of where the license was filed, was posted in the Pharmacy. On September 17, 1980, Region III personnel also observed the aforementioned notice was posted.
3.12.3 Findings and Conclusions During three unannounced inspections conducted during 1979 and 1980, NRC personnel observed that a notice of where the license was filed was posted.
It was found that on one occasion an employee asked to be shown the license, but he refused to sign a form attesting he had been shown the i
license, and it could not be determined if the individual ever saw the license.
3.12.4 Items of Noncompliance No items of noncompliance were identified.
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3.13 Pre-natal Exposure Training 3.13.1 Allegation It was alleged that at NPI's Chicago and Philadelphia Pharmacies, female employees were not treined in the hazards of pre-natal exposure to radiation.
3.13.2 Background Information There are no specific NRC requirements to instruct employees regarding pre-natal exposure hazards. NRC Regulatory Guide 8.29 does suggest some training be provided to female employees regarding pre-natal exposure hazards, but it is not a specific NRC requirement for this licensee.
3.13.3 Investigation 3.13.3.1 Interview of Jeanette Swanson On September 30, 1980, Jeanette Swanson, former Office Manager, NPI, Chicago, was interviewed by the NRC.
She said at NPI she routinely entered the laboratory radiation area. Swanson said in February 1980, Mark Schaffer, RSO, trained some of the female staff in the hazards of pre-natal exposure to radiation. She said prior to February 1980, she did not receive any training on this subject.
3.13.3.2 Interview of Naomi Toi On September 28, 1980, Naomi Toi, former Sales Representative, NPI, Chicago, was interviewed by the NRC.
She stated while employed at NPI from January 1, 1979 to March 14, 1980, she did not receive any training in the hazards of pre-natal exposure to radiation. Toi stated that she is a registered Nuclear Medicine Techologist and is well aware of these hazards.
3.13.3.3 Interview of Elaine Tonasuto On September 15, 1980, Elaine Tonasuto, Nuclear Medicine Technologist, NPI, Philadelphia, was interviewed by the NRC. Tonasuto stated prior to February 1980, she did not receive any training in the hazards of pre-natal exposure to radiation.
She said in February 1980, Charles Stephens, RSO, and the current RSO discussed this matter with her and gave her literature on this subject. Tonasuto said she was made aware of these hazards as part of her Nuclear Medicine Technology training.
30
3.13.3.4 Other Interviews The secretaries listed below, who were employed by NPI since February 1980, were interviewed and stated they received training in the hazards of pre-natal exposure to radiation:
Linda Norton Darkus Candle Lottie McGill Sylvia Jackson Victoria Ostema.
3.13.4 Findings and Conclusions There is no regulatory requirement-for NPI to instruct l
its female employees in the hazards of pre-natal exposure to radiation.
Prior to February 1980, female employees had not received training in the hazards of pre-natal exposure to radiation.
Since February 1980, NPI has instituted a program in which female employees are trained in the pro-cedures recommended in Regulatory Guide 8.29.
3.13.5 Items of Noncompliance No items of noncompliance were identified.
3.14 Inadequate Training i
3.14.1 Allegation It was alleged that employees at NPI's Philadelphia Pharmacy were improperly trained in radiation safety practices, as evidenced by the discovery of surface contamination on laboratory instruments and office equipment.
3.14.2 Investigation 3.14.2.1 Interview of Wilbur Zipperlen On September 16, 1980, Wilbur Zipperlen, Pharmacist, NPI, Philadelphia, was interviewed by the NRC.
He stated he had never worked as a 4
radiopharmacist until employed by NPI. He stated his initial training consisted of cbserving other pharmacists draw doses and reading some literature on decontamination procedures. He stated in February 1980, he was trained by Charles Stephens, RSO.
The training consisted of classroom work and practical exercises in decontamination and survey i
31
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i.
procedures.
Zipperlen said in hindsight he did not understand nuclear pharmacy practices and procedures as well as he should have during the first month he worked at NPI. He cited an example where he was asked to perform a vehicle survey, yet he did not know how to use a survey instru-ment.
He stated he did not recall an instance where laboratory personnel found surface con-tamination on phones, typewriters and other instruments.
3.14.2.2 Interview of Barry Crescenzi and Elaine Tonasuto On September 16, 1980, Barry Crescenzi, Assistant Laboratory Manager, and Elaine Tonasuto, Nuclear 4
i Medicine Technologist, NPI, Philadelphia, were interviewed by the NRC. They stated prior to February 1980, they did not receive any formal training in radiation safety practices or pro-cedures. They said they were familiar with these practices and procedures because of previous training required to obtain certification as Nuclear Medicine Technologists.
3.14.3 Findings and Conclusions One employee at NPI's Philadelphia Pharmacy, who had no i
l previous experience in radiopharmaceutical practices, questioned the adequacy of his initial training. Other I
laboratory personnel were interviewed and stated they did not receive any formal training from NPI, but the training they received as licensed Pharmacists or Nuclear Medicine Technologists was sufficient to implement NPI's radiation safety procedures.
I Interviews of laboratory personnel indicated sufficient knowledge of licensed activities to satisfy the require-ments of 10 CFR 19.12.
Formal training of laboratory personnel to supplement 10 CFR 19.12 requirements is not required by license condition.
i l
3.14.4 Items of Noncompliance i
No items of noncompliance were identified.
3.15 Unauthorized Waste Storage Facility 3.15.1 Allegation It was alleged that radioactive waste was being improperly stored in the basement of NPI's Philadelphia laboratory and that the material was not segregated into long and short-i 32
. ~
lived material, that radioactive material labels were not defaced and that there was no procedure for the final disposal of the waste.
3.15.2 Background Information On December 13, 1979, the NRC approved a license amendment authorizing NPI to temporarily store radioactive waste in the basement of its Philadelphia laboratory until transfer could be made to an authorized disposal service. The waste is currently stored in plastic bags which are placed in a locked bin in a secure area of the basement in the Philadelphia laboratory.
3.15.3 Examination and Surveys of Philadelphia Waste Disposal Area On September 17, 1980, NRC inspectors surveyed NPI's Philadelphia Pharmacy waste disposal area with a GM survey instrument. Radiation levels were found to be consistent with existing posting. A sample of the waste was examined and inspectors observed that the radioactive material labels were removed or defaced on empty vials, containers, etc.
Inspectors also noted that the long-lived isotopes were segregated from the short-lived isotopes required by the licensee's procedures.
as 3.15.4 Findings and Conclusions The NRC authorized storage of radioactive waste in the basement of NPI's Philadelphia Pharmacy. This area was surveyed and radiation levels were found to be consistent with existing posting. The material was properly grouped for storage, and radioactive material labels were removed or defaced.
3.15.5 Items of Noncompliance No items of noncompliance were identified.
3.16 Vehicle Surveys 3.16.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy, surveys of exclusive use delivery vehicles were performed on a monthly basis instead of after each use.
3.16.2 Background Information The NRC requires NPI to' adhere to procedures outlined in its application for Byproduct Material License dated November 6, 1978. Section C, Paragraph 2, of this 33
application entitled " Procedures for Shipment of Packages Containing Radioactive Material," states:
" Delivery vehicles will be monitored on a routine basis and the results will be recorded as a matter of record."
3.16.3 Investigation 3.16.3.1 Interview of Stephen Dessel On September 16, 1980, Stephen Dessel, Northeast District Manager and former Pharmacy Manager,. NPI, Philadelphia was interviewed by the NRC. Dessel stated his interpretation of this license re-quirement is that NPI is required to perform surveys for radioactive contamination of delivery vehicles on a monthly basis. Dessel states since the labs inception, he or one of his assistants has performed the monthly vehicle surveys.
3.16.3.2 Review of Vehicle Survey Records On September 16, 1980, Region III inspectors reviewed the licensee's vehicle survey log. The j
inspectors found that monthly vehicle surveys were being performed.
t 3.16.4 Findings and Conclusions It was found that at NPI's Philadelphia Pharmacy surveys of exclusive use delivery vehicles were being performed as required. Surveys of these vehicles after each use are not required by NRC or DOT regulations.
3.16.5 Items of Noncompliance No items of noncompliance were identified.
3.17 Mislabeling and Misadministration of Radiopharmaceuticals 4
3.17.1 Allegation It was alleged that NPI's Philadelphia Pharmacy had provided three hospitals with mislabeled radiophar-t i
maceuticals and in one instance this resulted in a misadministration of a radiopharmaceutical.
3.17.2 Review of Region I Inspection Report No. 30-15125/80-02 Region I Inspection Report No. 30-15125/80-02, dated July 31, 1980, (Exhibit D) reports in Paragraph d.3 that on one occasion mislabeled radiopharmaceuticals 34
. - - -- -. -... ~ -
were delivered to a NPI client hospitial, and this re-sulted in the misadministration of a radiopharmaceutical.
3.17.3 Findings and Conclusions The Region I Investigators found that on one occasion NPI had delivered mislabeled radiopharmaceuticals to a client hospital, which resulted in a misadminstration of a radiopharmaceutical. Details supporting this item can be found in Region I Investigation Report No.
30-15125/80-02.
3.17.4 Items of Noncompliance One Item of noncompliance was identified.
3.18 Inadequatn Xenon-133 Dispensing Hood 3.18.1 Allegation It was alleged that the xenon-133 (Xe-133) dispensing hood at NPI's Philadelphia laboratory was improperly operated and maintained.
It was specifically alleged that the glass ports on the assembly were missing or not used and the hood was located within thirty feet of the driver's lounge, an unrestricted area.
It was also alleged that weekly surveys and filter determinations were not performed, filters were not changed monthly, and hood pulling capacity was not evaluated at the required six month intervals.
3.18.2 NRC Examination of Xenon Filtering Hood On September 18, 1980, NRC inspectors examined the xenon-133 filtering hood assembly located in NPI's Philadelphia Pharmacy.
Inspectors observed that the driver's lounge was located within thirty feet of the hood; however, the lounge was contro led as part of the restricted area. The glass port in question was intact on the date of the inspection.
Flow rate for the xenon-133 hood was adequate with or without glass ports.
It was aisc noted that surveys and filter efficiency determinations were not required because the xenon-133 hood was equipped with a continuous effluent sampling system which was being monitored as required.
Filter changes were not required, because the xenon-133 release evaluation submitted as part of NPI's license application assumes no uptake of xenon-133 by the filtering system.
Inspectors found that the air flow rate of the hood was being properly monitored as required by License Conditions.
35
3.18.3 Findings and Conclusions NRC inspectors examined the xenon-133 hood at NPI's Philadelphia laboratory and found it was being properly maintained, operated, and monitored.
3.18.4 Items of Noncompliance No items of noncompliance were identified.
3.19 Reuse of Glass Ampules and Doses of Xenon-133 3.19.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy personnel were reusing glass ampules and partially used doses of xenon-133 Gas which had remained in the ampules after their initial use.
3.19.2 Background Information Xenon-133 is distributed as a gas contained in a glass vial with a rubber septum. The septum is punctured when the dose is prepared for use.
Once punctured, the vial's rubber septum is no longer useable and if the septum is punctured several times any gas remaining in the vial will escape making reuse of these vials impractical.
3.19.3 Interview of Barry Crescenzi On September 17, 1980, Barry Crescenzi, Assistant Laboratory Manager, NPI, Philadelphia, was interviewed by the NRC. He stated he drew doses of xenon-133 for distribution to NPI client hospitals. He stated he never reused a xenon-133 vial because once the rubber septum is punctured, the gas escapes. He also stated there was an ample supply of unused vials on hand at NPI.
Crescenzi also stated that following a December 1979 overexposure to a pharmacist who was dispensing xenon-133, SPI has since ordered prepackaged doses of xenon-133 from another radiopharmaceutical supplier.
3.19.4 Findings and Conclusions NRC inspectors found personnel at NPI's Philadelphia Pharmacy were not reusing doses of xenon-133 gas.
These doses are now provided in prepacked individual doses by another radiopharmaceutical distributor to NPI.
3.19.5 Items of Noncompliance No items of noncompliance were identified.
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3.20 Unsafe Generator Dismantling Procedure 3.20.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy employees were unnecessarily exposed to radiation when dismantling technetium generators.
3.20.2 Background Information Technetium-99m generators generally consist of a resinous column containing the mother and daughter isotopes -
surrounded by lead shielding, Routinely, a generator is allowed to decay over 10 to 15 i
half lives, dismantled, surveyed to ensure safe background radiation levels and then segregated into its reuseable and non-rcuseable components.
3.20.3 Investigation 3.20.3.1 Interview of Barry Crescenzi l
On September 16, 1980, Barry Crescenzi, Assistant Laboratory Manager, NPI, Philadelphia, was inter-viewed by the NRC.
He stated in March 1980, he supervised drivers who disassembled about 100 Tc-99m generators which had been in storage at NPI for about two months. He said the generators, prior to being dismantled, were surveyed to ensure the radiation levels were safe. He said l
the drivers wore glove and film badges during the dismantling process.
3.20.3.2 Interview of Charles Dale On September 15, 1980, Charles Dale, Driver, NPI, Philadelphia was interviewed by the NRC. He stated in March 1980, he dismantled Tc-99m generators to extract the lead components for resale.
He stated Barry Crescenzi supervised this process and each generator was surveyed prior to its dismantling. Dale stated he wore gloves and a dosimeter during this procedure.
l 3.20.3.3 Interview of Moses Greene On September 15, 1980, Moses Greene, Driver, NPI, Philadelphia, was interviewed by the NRC.
He stated in March 1980, he d'.mentled Tc-99m generators with Charles Dale.
Greune stated during the procedure he wore gloves and a film badge.
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3.20.3.4 Review of Film Badge Records On September 16, 1980, Region III inspectors reviewed the licensee's film badge records.
It was found that none of the personnel who par-ticipated in the dismantling of the Tc-99m gen-erators exceeded or/even approached 10 CFR 20.101 radiation exposure quarterly limits.
3.20.4 Findings and Conclusions It was determined that NPI personnel dismantled Tc-99m generators to remove the lead components for resale.
However, the process was monitored and the radiation exposure received by the involved personnel were within regulatory limits.
3.20.5 Items of Noncompliance No items of noncompliance were identified.
3.21 Survey Instrument Calibration 3.21.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy survey instruments were being calibrated by a local firm which had no formal or written procedures for instrument calibration.
3.21.2 Background Information On January 25, 1980, NPI submitted a request to amend their NRC license to authorize the RSO at Temple University to calibrate the survey instruments. The NRC denied NPI's request on March 21, 1980, because Temple University was not licensed by the NRC to calibrate survey instruments.
I 3.21.3 Review of Survey Instrument Calibration Records On September 16, 1980, Region III inspectors reviewed the Philadelphia Pharmacy survey instrument calibration records.
Inspectors found that the survey instruments and dose calibrators were calibrated at the proper intervals by Stan Huber and Associates, a company authorized by the NRC to provide this service.
3.21.4 Findings and Conclusions It was found that survey meters at NPI's Philadelphia Pharmacy were properly calibrated and that the calibrations had been performed by a company authorized by the NRC to perform the calibration service.
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3.21.5 Items of Noncompliance No items of noncompliance were identified.
3.22 Scaled Source Inventory 3.22.1 Allegation It was alleged that at NPI's Philadelphia Pharmacy, inventories of the scaled sources and leak tests of the sealed sources were not being performed.
3.22.2 Record Reviews Region I Investigation Report No. 30-15125/80-02 (Exhibit D, Paragraph F.2) reports that semi-annual physical inventories and leak tests of scaled sources were performed as required. On September 16, 1980, Region III inspectors reviewed the licensee's sealed source inventory, and leak test records.
It was found that the leak tests and scaled source inventories had been performed as required.
3.22.3 Findings and Conclusions It was determined that inventories and leak tests of sealed sources had been performed as required.
3.22.4 Items of Noncompliance No items of noncompliance were identified.
4.
Management / Consultant Interviews 4.1 Interview of Nunzio DeSantis On December 16, 1980, Nunzio DeSantis, Vice President, NPI, was interviewed by the NRC.
He stated that in November 1980, he re-placed Dr. William Zimmerman as Laboratory Manager at NPI Chicago after Zimmerman quit to accept employment elsewhere. DeSantis stated from November 1980 to March 1980, there were numerous problems with the radiation safety programs at NPI's Chicago and Philadelphia laboratories which were identified by NPI or the NRC.
He said upon his arrival in Chicago, he found that the laboratories were not centralized, records were poorly kept, and in hindsight NPI was poorly served by their Consultant, Stan Huber and Associates (SHA) who was responsible for advising NPI on radiation safety matters.
He said SHA reports repeatedly indicated that NPI's film badge records, bioassay program, and survey records were acceptable, yet the NRC later identified major deficiencies in these areas. DeSantis said SHA did not inform him that the cleaning crew and drivers at 39 L
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NPI should be badged and trained, or that wipe tests of incoming In addition, shipments of radiopharmaceuticals should be performed.
DeSantis claimed SHA failed to report a December 1980 extremity (18 rem) to an NPI employee after he had directed them overexposure to report the incident to the NRC.
DeSantis confirmed that a copy of NPI's NRC license for the Chicago Pharmacy was maintained in Albuquerque, NM, and was not available for himself or the consultant to read. He also stated he recalled verbally directing pharmacy employees to survey themselves when exiting the laboratory, but a formal system for this was not instituted until January 1980.
DeSantis said he was not aware that airborne monitoring for iodine-131 was required at NPI's Philadelphia laboratory until Robert McClintock, then an employee of the NRC, told i
him one was required.
DeSantis commented that during this period, there were serious shortcomings in NPI's radiation safety program at both the Chicago l
and Philadelphia Pharmacies. NPI has now hired a fulltime corporate RSO and individual RS0s at each laboratory. They have implemented a radiation safety program to ensure NPI meets all regulatory require-He said since implementing this program, overexposures to i
ments.
NPI employees and noncompliances with State and NRC requirements j
have decreased dramatically. He said NPI is committed to the safe operation of all of its pharmarles.
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4.2 Interview of Stanley A. Huber On January 23, 1981, Stanley A. Huber, President, Stan A. Huber and i
Associates, was interviewed by the NRC. He stated prior to March 1980 he was consultant to NPI's Chicago Pharmacy on NRC licensing f
matters and that he provided equipment calibration services and monthly audits of NPI's operation. He stated he was seldom asked to consult on management of NPI's radiation safety program.
Huber stated he was aware the NRC identified deficiencies in NPI's program and stated some of the NRC findings had been previously identified during his audits yet not corrected by NPI.
He said he had advised NPI earlier that bioassays should be performed monthly on all personnel, that surveys should be performed, and that records of the surveys should be maintained. He said he also advised NPI that the delivery drivers and cleaning crew personnel should be j
badged and trained in the hazards associated with handling radio-active material and that female employees of NPI should be instructed in accordance with Regulatory Guide 8.29 concerning pre-natal exposure to radiation.
Huber stated in his opinion the shortcomings in NPI's radiation l
safety program stemmed from frequent changes in upper management personnel, and the physical decentralization of NPI's Chicago 1
l He said to properly manage the program, he asked for 2
operation.
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a copy of NPI's NRC license in November 1978. Neither he nor NPI's Chicago laboratory manager received a license until January 1980. Huber also stated he never saw, nor could he evaluate NPI's personnel monitoring (film badge) records in total because they were filed at as many as three different locations. Also records of daily area and weekly swipe surveys were recorded in spiral notebooks and lacked sufficient data to determine if the survey had been properly performed. He added that he provided NPI with the proper survey forms, yet they were not used. Huber said the NRC later found that these records were e
unacceptable. As an example of NPI's poor organization Huber i
cited loss of all leak tests records. Huber said he had retained a copy of these tests in his files and was able to reconstruct i
the records for NPI.
Huber stated in March 1980, NPI hired a corporate RSO and fulltime staff RSO at the Chicago laboratory. He and NPI agreed to terminate their contract at that time.
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Exit Interview 4
On December 16, 1980, an exit meeting was held with licensee repre-l sentatives at the conclusion of this investigation. The scope and findings of the investigation and the inspections at all three NPI pharmacies were summarized, management was informed of the items of noncompliance and enforcement options available to the Commission and they were advised that escalated enforcement action may be considered in this case.
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