ML20050D631
| ML20050D631 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1980 |
| From: | Glenn J, Remaklus L, Galen Smith NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20050D559 | List: |
| References | |
| 30-15125-80-02, 30-15125-80-2, NUDOCS 8204120378 | |
| Download: ML20050D631 (23) | |
Text
DRAFT i
E' U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION I Report tio. 30-15125/80-02 Docket No.
30-15125 License No. 37-18461-01MD Priority 4
Category E
Licensee:
Elfreth Alley Apothecary Nuclear Pharmacy, Incorporated 31-33 North 2nd Street Philadelphia, Pennsylvania 19106 Facility Name:
Elfreth Alley Apothecary Investigation At:
Philadelphia, Pennsylvania Investigation Conducted:
May 1, 1980 through May 15, 1980-Investigators:
L. P. Remaklus, Investigation Specialist 7/31/80 date
'If3/kO
/
n
~
. G. Glenn, Radiation Specialist date f
date Reviewed by:
tus
. -[n 7[5/[Id G. H. Smi,tn, t'hief, Fuel Facility and
' cate Mat ials Safety Branch Investigation Summa y:
/
Investigation from May 1, 1980 through May 15, 1980 (Investigation Resort No.
30-15125/80-02)
_ Areas Investigated:
Unannounced investigation of nine (9) allegations related to radiation safety and radiopharmaceutical quality control at Elfreth Alley Apothecary.
The inv'estigation involved 80 investigator-hours on-site by two NRC regional-based investigators.
Results:
Of the nine (9) allegations investigated, four (4) were found to be in part substantiated and five (5) were found not to be substantiated.
During the course of the investigation, three (3) items of noncompliance were identified:
- 1. Intraction - mislabeling of radiopharmaceuti-cals delivered to hospitals, Paragraph D.3; 2.' Infraction - f ailure to survey ir. coming shipments of licensed materials from customers, Paragraph D.2; 3.
Infraction - f ailure to calibrate pocket dosimeters at six month intervals, Paragraph F.4 poninn T r e-ic7 8204120378 820407 NMS LIC30 Exhibit D 12-18044-01MD PDR
\\
=
r e
I.
Background
A.
Reason for Investigation A former employee of Elfreth Alley Apothecary contacted the Nuclear Regu-latory Commission and requested a meeting to discuss problems observed while an employee.
In a statement, the former employee (referred to as Individual A in this Report) alleged several deficiencies in the radiation safety and quality assurance programs.
In addition, Individual A alleged that certain records had been falsified.
NRC initiated an investigation into these allegations on May 1, 1980.
B.
Identification of NRC Licensees Contacted 1.
Elfreth Alley Apothecary Nuclear Pharmacy, Incorporated Philadelphia, Pennsylvania 2.
Montgomery Hospital Norristown, Pennsylvania 3.
Abington Memorial Hospital Abington, Pennsylvania 4.
Albert Einstein Medical Center Philadelphia, Pennsylvania 5.
Germantown Dis 3ensary and Hospital Philadelphia,
?ennsylvania 6.
Medical College of Pennsylvania Philadelphia, Pennsylvania 7.
Temple University Hospital Philadelphia, Pennsylvania 8.
Metropolitan Hospital l
Philadelphia, Pennsylvania e
II.
Summary of Findings A.
Allegations NOTE:
The allegations below have been summarized for clarity.
The actual allegations are cited in detail in Section III of this investigation report.
1.
The training given to employees was inadequate.
The NRC identified and cited noncompliance with respect to instruc-tion of employees during Inspection 30-15125/80-01.
The NRC investi-gation found evidence that instruction has been given to employees since January 1980.
(Details, Paragraph D.1) 2.
Prior to and after the January 1980 inspection, wipe tests have not becn made on incoming shipments.
Records have been falsified to show surveys have been made.
The NRC investigation found evidence that wipe surveys have been made on incoming shipments from commercial suppliers.
The NRC investigation determined that no wipe surveys have been made on incoming shipments from customers.
The NRC investigation found no additional evidence or information to substantiate that records have been falsified to show that wipe surveys on incaming shipments were made.
(Details, Paragraph D.2) 3.
Mislabeled radiopharmaceuticals have been transferred to hospitals.
In at least three instances, misadministrations to patients have occurred.
The NRC investigation found evidence that mislabeled radiopharmaceu-ticals had been sent to two hospitals.
In one instance an apparent misadministration resulted from the mislabeling.
(Details, Paragraph D.3) 4.
There was a lack of decontamination procedures and facilities.
Safety related devices were not provided.
The NRC investigation found no evidence or information to substantiate this allegation.
(Details,ParagraphD.4) 5.
Outgoing containers of radioactive materials were not monitored or wiped for removable contamination.
Hospitals reported receiving con-taminated shipping containers.
The NRC investigation determined that prior to March 21, 1980 outgoing shipping containers were not wiped for removable contamination.
The NRC investigation found evidence that two hospitals had detected con-tamination on the external surfaces of shipping containers.
None of
4 the apparently contaminated containers exceeded applicable NRC or 00T limits.
(Details, Paragraph D.5) 6.
A pharmacist, with no experience or training in radiation safety, was frequently on duty alone in the afternoon.
The NRC investigation determined that a pharmacist without previous radiation safety experience was frequently on duty alone in the phar-macy in the afternoon.
The NRC investigation found evidence that the pharmacist had been instructed in radiation hazards and precautions.
(Details, Paragraph D.6) 7.
Delivery vehicles were never monitored.
The NRC investigation found no evidence or information to substantiate this allegation.
(Details, Paragraph D.7) 8.
Drivers removed radioactive columns from molybdenum-99/ technetium-99m generators without adequate training and under unsafe conditions.
The NRC investigation identified two drivers who had removed columns from generators.
No evidence or information was found to substan-tiate that instruction was not given or that the operation was unsafe.
(Details, Paragraph D.8) 9.
Daily laboratory surveys were not made for a three week period during December 1979.
Employees, at management's request, falsified records to show that surveys had been made.
The NRC investigation found no additional evidence or information to substantiate this allegation.
(Details, Paragraph D.9)
B.
Items of Noncompliance During the course of the investigation, three (3) apparent items of noncom-i pliance were identified.
1.
Condition 20 of License No. 37-18461-01MD requires that licensed material be possessed, used, packaged, labeled, and distributed in accordance with statements, representations, and procedures contained in application dated November 6, 1978 and letters dated February 14, 1979, February 19,1979, March 12,1979, March 15,1979, July 11,1979, August 6, 1979, September 10, 1979, and January 25, 1980.
l
5 Contrary to item I.A.2 attached to the application dated November 6, a.
1978, on August 17, 1979, October 2, 1979, and December 10, 1979 radiopharmaceuticals were dispensed bearing labels with the incor-rect radiopharmaceutical named.
(Details,ParagraphD.3) b.
Contrary to items B.2, B.3, and B.6 of the document titled,
" Radiation Protection Program", attached to the application dated November 6, 1980, the licensee failed to monitor or wipe incoming packages from customers for radiation levels and remov-able contamination.
(Details,ParagraphD.2) c.
Contrary to item 7 of the letter dated February 14, 1979, the licensee failed to have pocket dosimeters calibrated on a six month basis.
(Details,ParagraphF.4) 6
I III.
Details A.
Introduction This investigation was initiated as a result of NRC receiving various allegations from a former employee of Elfreth Alley Apothecary concerning practices believed to be in noncompliance with NRC requirements.
A state-ment of these allegations was given to NRC investigators by the former employee on April 1, 1930.
B.
Scope of Investigation This investigation included an examination of pertinent records at Elfreth Alley, Apothecary and at several hospitals; interviews with pharmacy employ-ees; interviews with employees of hospitals receiving radiopharmaceuticals from Elfreth Alley Apothecary; and observations by the investigators.
Since Civil Monetary Penalties had been imposed on Elfreth Alley Apothecary following a January 3, 1980 inspection, the investigators reviewed correc-tive actions taken by the licensee since that inspection.
C.
Persons Directly Interviewed or Contacted During the NRC Investigation During the course of this investigation, the pharmacy manager, district manager, and the corporate director of radiation safety were interviewed and contacted to set up interviews with their employees.
Licensee repre-sentatives were informed that the hospitals listed in Section II-B of this report would be contacted during this investigation.
Dne additional pharmacist, two technical employees, and two drivers were interviewed by the NRC investigators.
Additional employees were contacted while the NRC. investigators viewed acutal operations.
All employees inter-viewed were notified of the voluntary nature of the interview.
Persons i
making sworn statements were informed of their right to refuse to make such sworn statements.
I D.
NRC Investigation Eindings and Conclusions Related to Allegations
(
1.
Allegation No. 1 a.
Allegation During his employment at Elfreth's Alley Apothecary, Individual A never received any formal or informal training with respect to the pharmacy's NRC license, safety practices, or procedures with l
one exception. The exception being that after the January 1980 t
inspection, Individual A was shown how to do a check in proce-dure of products.
It was not until after the January 1980 inspection that management took any steps toward educating in materials, employees in established procedures for checkingious contamina-such as external monitoring of packages, the var tion, DOT labeling, and mandatory use of syringe shields.
During
7 February 1980, Individual A was refused access to a copy of the NRC license by the Radiation Safety Officer.
b.
NRC Investigation Findings NRC investigators interviewed four individuals who routinely dispense radiopharmaceuticals.
Each individual stated that instruction to use syringe shields had been received since the.",
January 1980 inspection.
NRC investigators observed that on May 6,1980 syringe shields were used by every individual dispensing radiopharmaceuticals and that a sign requiring the use of syringe shields was posted in the vicinity of each dispensing araa.
NRC investigators interviewed the two individuals assigned the responsibility of checking-in and surveying incoming packages of radioactive material.
Both individuals stated that they had received additional instruction since the January 1980 inspec-tion in package survey and recording requirements.
One indivi-dual noted that incoming package surveys had resulted in the identification of a Xenon-133 shipment from a supplier with excessive external radiation levels.
Nuclear Pharmacy, Incorpo-rated identified the high radiation levels in a survey on August 25, 1979 and reported the results to Region I as required by 10 CFR 20.205. This occurrence is documented in Inspection Report 30-15125/79-02.
NRC investigators noted documents specifying training received l
since January 3, 1980.
Documented training included giving every employee a copy of the Radiation Safety Manual, on January 24, 1
1980; instructing professional. employees of required surveys and I
records on January 28, 1980; a health physics lecture for two laboratory technicians, one pharmacist, and two typists on March 19, 1980; a lecture for seven drivers on March 20, 1980; and training for one maintenance employee on April 30, 1980.
In addition, a newly hired driver was given instruction on May 5, l
1980 during the investigation.
Seventeen individuals, including Individual A, acknowledged receipt of the Radiation Safety Manual.
I Five individuals, including Individual A, acknowledged reading the memorandum on required surveys and record keeping.
NRC investigators did not interview the individual who served as Radiation Safety Officer during February 1980.
This indivi-dual is no longer employed by Nuclear Pharmacy, Incorporated.
None of the employees interviewed had ever been refused access to the NRC license.
Management representatives stated that the license was available for review by employees.
A notice telling employees of the license and its availability was observed to be posted in the dispensing area.
8 i
Several employees stated during in';erviews that instruction and emphasis on following procedures had been stressed to a greater degree after the January 1980 inspection.
These individuals noted an improvement in awareness of hazards as a result of the company acquiring a radiation protection officer at the end of January 1980.
c.
NRC Conclusion The NRC found evidence to substantiate this allegation prior to January 1980.
Noncompliance has been identified and documented in Inspection Report 80-01.
The NRC found no evidence or infor-mation to substantiate this allegation after January 1980.
2.
Allegation No. 2 a.
Allegation Prior to January 1980, no wipes for removable contamination of incoming shipm ats were performed although the radionuclide log book reflected that such testing had been performed.
This prac-tice was known to management.
This practice continued even after the January 3, 1980 NRC inspection.
b.
NRC Investigation Findings NRC investigators reviewed records showing wipes for removable contamination had been performed on the external surfaces of incoming packages of radiopharmaceuticals since December 3,1979.
Prior to this date such wipes had not been taken.
This was documented in NRC Inspection Report 30-15125/79-03.
No records were available showing the results of wipes for removable con-tamination on incoming shipments from pharmacy customers.
Man-agement representatives confirmed radiation and wipe surveys were not made of incoming shipments from customers.
The pharmacy manager and district manager signed sworn state-ments testifying that to the best of their knowledge all records f
of wipes for removable contamination on incoming packages were accurate and that the surveys had been performed.
The two individuals responsible for performing wipe tests made sworn statements testifying that all recorded wipe tests had been performed.
c.
NRC Conclusion The NRC found no evidence or information to substantiate the specific allegation. The NRC identified noncompliance with the i
conditions of License No. 37-18461-01MD requiring radiation and t
i
9 contamination surveys of incoming shipments of radioactive mate-rials from customers.
3.
Allegation No. 3 a.
Allegation A shortage of personnel resulted in mistakes being made relative to prescriptions, including mislabeling of radiopharmaceuticals.
Specifically, mislabeled doses were administered to patients at three named hospitals.
b.
NRC Investigation Findings NRC investigators interviewed employees and reviewed records at seven hospitals who had received radiopharmaceuticals from the Elfreth Alley Apothecary.
At one hospital, a radiopharmaceutical labeled technetium-99m/
sulfur colloid was administered to a patient on December 10, 1979. The radiopharmaceutical was intended for a liver image.
The resulting scan showed a lung image.
The hospital staff concluded that the radiopharmaceutical labeled sulfur colloid was in fact macroaggregated human serum albumin, an agent used for lung imaging.
The pharmacy supplied sulfur colloid as a replacement and a successful liver scan was obtained the next day.
The hospital has had no other problems with mislabeled l
radiopharmaceuticals.
At a second hospital, radioiodinated human serum albumin (RISA) was, received on two occasions with labels indicating on isotope of iodine other than ordered.
On August 17, 1979, RISA labeled "I-123" was received when iodine-131 (I-131) was ordered.
On l
October 2, 1979, RISA labeled "I-125 was received when iodine-131 was ordered.
In both cases, the radiopharmaceutical was not used for patient studies.
A nuclear medicine technologist at the hospital believed that on one other occasion two correctly labeled syringes containing radiopharmaceuticals had been received in shielded containers with the wrong labels.
The labels on each of the two shielded containers correctly described the contents of the syringe in the other of the two containers.
No records could be found to substantiate that this did occur.
At a third hospital, an in-vivo tagging with technetium-99m l
labeled sodium pertechnetate failed to produce the desired image.
The hospital initially concluded a renal scanning agent had been sent rather than sodium pertechnetate.
An investigation by the hospital, Nuclear Pharmacy, Incorporated, and the manufacturer l
l
i 10 of the imaging agent revealed that the tagging failed because the patient was on heparin therapy.
The physician in charge of Nuclear Medicine at the hospital agreed with this explanation and concluded that the administered radiopharmaceutical was correctly described on the label.
The physician and chief tech-nologist stated there had been no instances of mislabeled radio-pharmaceuticals from the Elfreth Alley Apothecary.
Item I.A.2, "Radiopharmaceutical Log Control Sheet," attached to the application dated November 5, 1978 and referenced by License Condition 20 requires that radiopharmaceuticals bear a proper label including the radiopharmaceutical dispensed.
The investigators visited four other hospitals during the investigation.
Representatives at each hospital were asked if any mislabeled radiopharmaceuticals had been received.
Each representative stated that to the best of their knowledge there had been no mislabeling.
c.
NRC Conclusion The NRC found the allegation to be partially substantiated.
The finding that, in one instance, a mislabeled radiopharmaceutical was administered to a patient represents noncompliance with Condition 20 of License No.
37-18461-01MD.
4.
Allegation No. 4 a.
Allegation There was a lack of decontamination procedures and facilities.
Showers, sinks with closed water systems for disposing of con-taminated water, goggles, and other safety related items were not provided.
b.
NRC Investigation Finding A shower is located in the manager's office.
Five individuals told the NRC investigators the location of the shower during interviews.
The shower was stated to have been in this location since the opening of the pharmacy and is shown in drawings sub-mitted by Nuclear Pharmacy Incorporated with a letter dated February 14, 1979.
A sink has been designated for decontamination of hands.
The sink is located in the dispensing area and commercial cleaning agents designed to remove radioactive contamination were observed
11 to be placed at this location.
The sink empties directly into the sanitary sewer system.
A licensee representative stated that only submicrocurie quantities of technetium-99m or other radioactive materials have ever been detected on any employee's hands.
During interviews,, employee's acknowledged detectable but minor levels of contamination on hands.
The licensee is permitted by 10 CFR 20.302 to dispose of more than one milli-curie (1000 microcuries) of technetium-99m to the sanitary sewer each day.
On the basis of employee statements concerning levels of personnel contamination, there would be no requirement for a closed water system for the decontamination sink.
NRC investigators observed that goggles were not worn by employ-ees handling radioactive materials.
The Elfreth Alley Apothecary license does not require that goggles be worn.
The NRC investi-gators observed that lead shields with lead glass viewing windows, lead vial shields, lead syringe shields, and tongs were available and used at each of three dispensing stations.
c.
NRC Conclusion The NRC found no evidence or information to substantiate this allegation.
5.
Allegation No. 5 a.
Allegation Outgoing containers of radioactive materials were not monitored orwipedforremovablecontaminationinthemajorityofcases.
On several occasions, hospitals reported receiving contaminated boxis from the Elfreth Alley Apothecary.
Four hospitals were specifically identified as receiving contaminated boxes.
b.
NRC Investigation Findings Elreth Alley Apothecary management and employees stated that routine wipes for removable contamination on all outgoing pack-ages did not begin until March 21, 1980.
A log reviewed by NRC investigators showed records of outgoing package wipes beginning March 21, 1980.
During the early morning of May 6, 1980, NRC investigators observed employees monitoring the surface and three In addition, an foot radiation levels of outgoing packages.
individual was observed to wipe the outside surface of each out-going package, including handles, with a small piece of dry, absorbent paper.
Each wipe was observed to be counted with a Geiger-Meuller pancake probe with a digital readout.
The employ-ee making wipe surveys stated that he was to report any package showing removable contamination in excess of 100 counts per minute
12 above background.
This employee stated that previous to two months ago wipes had been taken only on outgoing packages with Department of Transportation Yellow-III labels.
NRC investigators visited seven hospitals who had received pack-ages from the Elfreth Alley.
Employees at four hospitals stated no high levels of removable contamination had been detected or reported.
Employees at three hospitals stated contamination had been detected on either the inside or outside surfaces of pack-ages received from the Elfreth Alley Apothecary.
At one hospital, records showed wipes indicating contamination levels on the outside surface of packages from the Elfreth Alley Apothecary of 63,628 counts per minute (cpm) on November 9, 1979, 62,349 cpm on February 7, 1980, and 2,847 cpm on February 28, 1980.
In addition, the inner containers were recorded to have removable contamination on October 10, 1979 and November 11, 1979. The hospital's records indicated contaminated packages had also been received from three radiopharmaceutical manufacturers.
In two instances the results in counts per minute for wipes taken of inner and outer surfaces were nearly identical.
The investigators inquired whether surveys were made to assure that wipes were not accidentally contaminated by laboratory employees wiping the incoming packages.
Hospital employees indicated no surveys had been made to assure that the results truly reflected package rather than laboratory contamination.
Based on the measured efficiency of the sodium iodide well counter used for counting wipe samples, none of the recorded results were in excess of D0T contamination limits of 220 decays per minute per square centimeter when averaged over the package surface.
A hospital representative stated that the hospital did cancel its orders froni the Elfreth Alley Apothecary, in part, because of contami-nation problems.
i At a second hospital, records showed wipes taken of the inside surface of packages from the Elfreth Alley Apothecary had exceeded twice background levels on thirteen occasions since April 1979.
Licensee representatives stated no wipe tests of external pack-age surfaces had been made.
A licensee representative noted that during April of 1980 a radiation level survey of a package showed a " hot spot" on the package.
Elfreth Alley Apothecary was informed and a radiation safety technician came to the hospital. Wipe tests and radiation level survey's demonstrated the package was not con-taminated.
The " hot s)ot was due to a properly labeled container of iodine-131 within tie package.
Hospital employees acknowledged the package was not contaminated and had been properly labeled.
At a third hospital, records showed a wipe of a package taken on the external surface of a package received from the Elfreth Alley
13 Apothecary on April 23, 1980 read 18,000 cpm of technetium-99m.
Hospital representatives stated no other instances of external contamination had been noted.
Based on the measured efficiency of the sodium iodide well counter used to evaluate wipes, the hospital concluded no levels of removable contamina. tion exceeded NRC or DDT limits.
Hospital employees had detected contamina-tion on the inside of boxes several times according to a hospital representative.
During interviews with Elfreth Alley Apothecary employees, employ-ees were aware some hospitals had complained about -, Minated packages.
One employee estimated complaints are rece..ed on an average of once every two weeks.
The radiation safety technician acknowledged that inner surfaces of the packages were sometimes contaminated when returned from customers.
The radiation safety technician now surveys each empty returned package for contamina-tion and decontaminates any packages found to be contaminated.
c.
NRC Conclusion The NRC found information to substantiate that wipes for contami-nation were not performed on each outgoing package of licensed material prior to March 21, 1980 and, that three hospitals did measure levels of removable contamination on or in packages received from the Elfreth Alley Apothecary.
No evidence or information was found to indicate any NRC or DDT requirements had been violated.
6.
Allegation No. 6 a.
Allegation A pharmacist, frecuently the only pharmacist on duty during the afternoon, hac no experience or training in working with radiopharmaceuticals.
b.
NRC Investigation Findings The pharmacy manager stated that individuals not named on the license to use or supervise the use of licensed materials were sometimes alone on duty at the pharmacy from three to five in the afternoon and on Saturdays.
The pharmacy manager is named on License No. 37-18461-01MD to use and supervise the use of licensed material.
The pharmacy manager can be reached at all times through a telephone " beeper".
Two laboratory technicians stated they had been alone on duty at the pharmacy on Saturdays.
Both technicians stated the phar-macy manager was usually in the front office and could always
14 I
be rearhed by the " beeper".
Both individuals stated they had received instruction in the radiation safety practices for the dispensing laboratory and had been instructed to contact the pharmacy manager in any emergency situation.
A pharmacist stated he was routinely on duty at Elfreth Alley g
He was most often the only Apothecary during the afternoons.
professional employee on duty from three to five in the after-The pharmacist and the pharmacy manager stated that the noon.
pharmacist has eluted generators and drawn doses of radiopharma-ceuticals in the phsyical absence of the authorized users named on the license. The pharmacist stated he had received instruc-tion in the form of manuals, specific procedures to be followed, and individual supervision and training.
He described to the investigators the requirements to wear protective clothing, to use syringe shields, to perform tests for molybdenum-99 in genera-tor elutions, to follow emergency procedures in case of a spill, and to notify the pharmacy manager by " beeper" if he needed assistance while on duty alone.
In addition, the pharmacist had been on duty alone on Saturdays.
He stated that on such occasions he made checks of the dose calibrator and made the required labora-Records of daily laboratory surveys had been signed tory surveys.
by the pharmacist for two Saturdays.
c.
NRC Conclusion NRC investigators determined that one pharmacist and two labora-tory technicians not named on the license to use or supervise the use of licensed materials had used licensed materials in the The NRC investigators physical absence of such named users.
found evidence that each individual had received training in the hazards and precautions to be taken when handling licensed materials..These individuals appear to have been using licensed materials under the supervision of the pharmacy manager and in 37-18461-OlMD.
compliance with Condition 12 of License No.
7.
Allegation No. 7 a.
Allegation Delivery vehicles were never monitored.
b.
NRC Investigation Findings NRC and Department of Transportation Regulations do not require vehicle surveys for shipments of properly packaged radioactive materials which do not exceed the radiation dose limits as spe-cified in Paragraph 173.393(i), Title 49, Code of Federal Regu-lations.
Item 2, page 3 of the section entitled:
" Radiation
15 Protection Program" attached to the application dated November 6, 1978 states the vehicles will be monitored on a routine basis.
Statements made in this application are incorporated as require-ments by Condition 20 of License No. 37-18461-01MD.
No statement specifies the frequency or the methods for vehicle monitoring.
The NRC investigators were shown a log book containing entries at approximately monthly intervals for vehicle surveys.
A labc-ratory technician stated that he had made monthly surveys of vehicles for contamination using a Geiger-Mueller survey instru-ment with a pancake probe.
One driver stated he sometimes sur-veyed vehicles but kept no records of these surveys.
c.
NRC Conclusions The NRC investigators found evidence that vehicle surveys had been performed on a monthly basis.
8.
Allegation No. 8 a.
Allegation Drivers sometimes removed columns from molybdenum-99/ technetium-99m generators for the purpose of recovering lead for resale.
Drivers were merely shown how to open generators and remove the components and not how to provide themselves with adequate shielding or how to safely handle molybdenum-99 columns.
Not all the generators were at a safe level.
b.
NRC Investigation Findings A driver stated that in early March of 1980 he had helped to recover lead from decayed molybdenum-99/ technetium-99m generators.
He stated that the district manager, a laboratory technician, and a pharmacist were also involved in this operation.
He stated that a pharmacist demonstrated how to dismantle the generator and remove the column.
He stated that he wore gloves, that some generators had been surveyed with a survey instrument, and that he had draped a lead apron over his lap.
Records show this driver is assigned both whole body and extremity dosimeters.
The district manager stated that on one occasion he and a driver had recovered lead from generators.
He demonstrated to the driver the methods and precautions to be taken.
He stated that to the best of his knowledge there is no documentation of this operation.
The pharmacy manager stated that the district manager, a labora-tory technician, and a driver did recover lead from decayed generators some weekend about the middle of March 1980.
~
16 A laboratory techniciaa stated that he remembered one weekend in March 1980 when he, the district manager, and a driver had recovered lead from generators. The technician stated that generators were normally allowed to decay for about 60 days before the columns were removed.
The technician recalled that surface radiation levels had been measured with a survey instru-ment at some time.
A second driver stated he had been employed for four months and had once reclaimed lead and bottles from generators.
This driver could not remember a date but stated it was on a Saturday.
The driver stated he was shown how to dist:antle generators by another driver.
He stated he was instructed to:
wear gloves, watch out for needles, make sure columns were separated from other waste, and handle columns quickly because they were " hotter than normal".
He stated that most of the work was done by the two drivers but they were assisted by a laboratory technician and observed by the district manager.
He stated he wore a film badge to measure whole body exposure only and that a survey instrument was in the area.
He did not remember if the survey meter was used.
He stated he had received instruction in the hazards of handling radioactive materials and specifically mentioned time, distance, and shielding as protection factors to be used.
Records reviewed by the inspectors indicated the last generator which would have been reclaimed was received on February 13, 1980.
Af ter that date, all generators received were required to be returned to the manufacturer. The activity of the reclaimed generators was stated as 2.5 curies at the time of the shippers calibration.
From the statements of individuals interviewed, it appears that generators were reclaimed on either March 8 or 15, 1980.
The investigators were unable to determine the spe-cific date on which generators were reclaimed or the date of calibration of the generators reclaimed.
Based on records reviewed and statements made, the highest pos-sible activity in a column removed from a generator by a driver would have been 10.625 millicuries (2500 mil 11 curies decayed for 22 days or 7.88 half-lifes).
Exposure rates from a 10.625 milli-curie molybdenum-99 source would be 1.9 milliRoentgens per hour at 1 meter and 319 milliRoentgens per minute at I centimeter (contact).
From the records of receipt, only one column could have contained this much activity.
All other columns would contain orders of magnitude less activity.
From the description of procedures followed, it appears that no individual would have been in immediate contact with any generator column for more than one minute.
Film badge records for the two drivers did not indicate any unusual exposures during early March.
17 c.
NRC Conclusion The NRC determined that Elfreth Alley Apothecary's drivers had sometimes removed columns from molybdenum-99/ technetium-99m gene-rators.
The NRC found evidence that drivers had received instruc-tion in how to safety handle molybdenum-99 columns under the con-ditions described.
Tha NEC cou?d not detemine the radiation levels associated with the molybdenum-59 columns.
However, it appears that in the worst case, no it.dividual was likely to have been exposed in excess of any NRC limit.
9.
Allegation No. 9 a.
Allegation Daily area laboratory survey records were falsified for a three week period in December 1979.
Specifically, the pharmacy manager and the district manager reportedly informed Individual A that laboratory area surveys, which were supposed to be conducted daily, had not been performed for a three week period in December 1979.
Because of this, the district manager was said to have told Individual A it was his responsibility to see that the daily surveys were conducted and directed Individual A to
" correct the situation" by making up the missing daily survey records.
Individual A claims that after this conversation with the district manager, he checked and confirmed that daily survey sheets for a three period in December 1979 were in fact missing.
Individual A reported he then met with lab technicians A and B, apprised them of the situation, and directed them to ensure that daily laboratory records to cover the missing three week period were completed.
Individual A said he subsequently asked labora-tory technician B if had completed the task of making up the missing records, and after being told that the task had been completed, personally checked the survey records and verified that no survey record was missing for the month of December 1979.
b.
NRC Investiga' tion Findings Items 5 and 9 of the section entitled " Radiation Protection Pro-gram" attached to Efireth's Alley Apothecary application dated November 6, 1978 states that daily laboratory surveys will be performed and a permanent record of such surveys will be main-tained.
This application statement is incorporated as a require-ment by condition 20 of license number 37-18461-01MD.
Review of the pharmacy's daily laboratory survey records revealed a completed survey record for each work day of December 1979.
No apparent discrepancies were noted on any of the December 1979 l
s 18 records, which were determined to have been completed by labora-tory technician B.
Laboratory technician B assumed responsibility for taking the daily surveys on November 19, 1979, from laboratory technician A.
Prior to December 1979, the following number of survey records th t earliest dated April 9,1979, were found to be missing in the months indicated:
April 8, May 1, June -0, July 1, August 4, September 6, October 6, November 6.
After December 1979 to the date of the record review, May 1, 1980, no survey sheets were found to be missing for any month.
It was l
further noted that beginning Jar.uary 26, 1980 area laboratory l
surveys were found to be taken on almost every Saturday, and on one Sunday, while prior to January 26 no surveys were found to have been taken on a weekend.
The pharmacy manager explained that area surveys were not taken on weekends prior to January 1980 because little, if any, pharmaceutical preparation for dispensing was done on a weekend.
However, he continued, in a January 1980 NRC inspection.it was called te his attention that area surveys should be conducted anytime the laboratory is open, so he then required such surveys to be conducted.
Laboratory technician B was interviewed and provided a sworn statement claiming that he conducted the December 1979 labora-tory area surveys on a daily basis as required, and that the survey records were completed on the same date that the survey was performed.
The pharmacy manager, district manager, and laboratory technician A, were also interviewed, and all provided a sworn statement claiming that they had no knowledge of daily laboratory area surveys not being conducted for a 3 week period in December 1979, and that to the best of their knowledge all December 1979 surveys had been performed, and records of such surveys completed, as required.
The Radiation Safety Technologist stated that since his hiring in April 1980, he had made area radiation level and contamination surveys three times daily in the restricted areas in addition to the recorded surveys, c.
NRC Conclusion No evidence to substantiate this allegation was found.
E.
Licensee Action on Previous Inspection Findings (30-15125/79-03 and 30-15125/80-01)
(Closed) Noncompliance (30-15125/80-01 and 30-15125/79-03):
Failure to limit exposures to extremities of persons handling licensed materials to the levels listed in 10 CFR 20.101.
Employee exposure records for the first calendar quarter of 1980 show no employee received an extremity dose in excess of 3.55 rems or approximately 20 per cent of the maximum permis-sible dose listed in 10 CFR 20.101.
19 (Closed) Noncompliance (30-15125/80-01):
Failure to instruct employees in the license requirement to use syringe shields when drawing doses and pre-paring kits.
All employees authorized to draw doses and prepare kits stated that instruction had been given requiring the use of syringe shields.
(Closed) Noncompliance (30-15125/80-01):
Failure to use syringe shields during dispensing operations.
The investigators observed employees using syringe shields during dispensing operations and while preparing kits.
All employees who dispense or prepare radiopharmaceuticals stated that syringe shields have been used for these operations since the last inspection.
(Closed) Noncompliance (30-15125/79-03):
Failure to report exposure in excess of any applicable limit in Part 20.
The exposure noted in Inspec-tion 80-01 was reported to the Commission and to the individual who received the exposure.
Exposure records maintained by the licensee indicate that no additional overexposures have occurred.
(Closed) Noncompliance (30-15125/79-03):
Failure to evaluate concentra-tions of iodine-131 in effluent air discharged from a hood.
The licensee has installed sampling equipment to draw effluent air through a charcoal impregnated filter to trap iodine-131.
Records of evaluations of iodine-131 in effluent air are maintained and indicate aireborne concentrations of iodine-131 less than ten percent of valves listed in Part 20, Appendix B, Table II, Column 1.
(0 pen) Nencompliance (30-15125/79-03):
Failure to wipe the external sur-faces of packages received for removable contamination.
The licensee main-tains records showing that wipes for removable contamination have been made on all packages received from commercial distributors since December 3, 1979.
Licensee employees stated that wipe tests are performed on incoming packages from distributors but are not performed on incoming packages from customers.
(Closed) Noncompliance (30-15125/79-03):
Failure to include proper ship-ping papers with each shipment of radioactive material.
The investigators reviewed completed shipping papers showing the radionuclide, shipping name, form, transport label, and activity.
Licensee employees stated a properly completed shipping paper as included with each shipment.
(Closed) Noncompliance (30-15125/79-03):
Failure to provide information on DOT radioactive labels.
The investigators observed packages being pre-pared for shipment with DOT radioactive labels including information on the radionuclides, activity, and transport index (if appropriate).
Licens-ee employees stated each package leaving the facility is properly labeled.
The investigators observed that a slip-lock plastic security seal was attached through the latching mechanism of each package.
(Closed) Noncompliance (30-15125/79-03):
Failure to placard vehicles on four sides when transporting a package bearing a Radioactive Yellow-III
20 label. The investigators did not observe any packages bearing a Radio-active Yellow-III label being prepared for shipment.
Licensee employees stated vehicles now bear placards on all four sides when transporting packages bearing a Radioactive Yellow III label.
F.
Findings in Other Areas Reviewed by the Investigators 1.
Organization Elfreth Alley Apothecary is owned and operated by Nuclear Pharmacy, Incorporated with corporate offices in Albuquerque, New Mexico.
A district manager has responsibility to oversee the financial, person-nel, and regulatory aspects of this and other pharmacies operated by Nuclear Pharmacy, Inc.
Daily operations are managed by a pharmacist designated as the pharmacy manager.
Pharmacists and nuclear medicine technologists are employed for preparation and dispensing of radio-pharmaceuticals.
The company hires drivers to transport and deliver radiopharmaceuticals to local medical institutions.
Since the last inspection, a Corporate Director, Radiation Safety and Regulatory Affairs has been hired.
This individual is responsible for auditing the radiation safety programs at Nuclear Pharmacy, Incor-porated's pharmacies throughout the United States.
A radiation safety technologist has been hired full time to oversee the radiation safety program at Elfreth Alley Apothecary.
Many of the radiation safety functions formerly assigned to pharmacists and dispensing technicians have been assigned to the radiation safety technologist.
2.
Use of Materials The investigators observed technicians assaying individual and multi-dose vials on a dose calibrator.
The results were decayed to a pre-set time and recorded on the pharmacy form transmitted to the custo-The investigators observed that an elution from a molybdenum-99/
mers.
technetium-99m generator was assayed for both molybdenum-99 and technetium-99m activity.
Employees stated that every dose is assayed and that every elution is assayed for molybdenum-99 and technetium-99m activity.
Records reviewed by the investigators showed that dose calibrators had been checked daily, since the last inspection, except Sundays, against cobalt-57, cesium-137, and barium-133 sources.
Measured activities were compared with the predicted activity of the sources and found to be within 15%.
Dose calibrator linearity had been last checked on March 21, 1980 and found to be within 15%.
The previous linearity check had been made during the previous calendar quarter on October 21, 1979.
Leak tests of the calibration sources were last done on December 17, 1979 a date within six months of investigation.
All leak test results indicated less than 0.005 microcuries of removable contamination.
~
21 3.
Storace of Materials All licensed materials were observed to be stored in the restricted dispensing laboratory, generator elution room, and basement.
The investigators observed that entry to each area is controlled by the licensee.
Visitors are required to register and are assigned self reading dosimeters.
Visitors are escorted through the restricted areas.
The investigators observed shielded storage bins for returned radio-active materials.
Licensee representatives stated that wastes were placed in bins according to half-life.
Drivers stated that they periodically remove decayed waste from the bins, survey the waste for radiation levels, and transfer the waste to the basement storage area for further decay if the waste reads less than 5 mR/hr. licensee representatives stated that no decayed waste had been disposed of as normal trash as of May 6,1980.
Records showed that non-radioactive waste formerly stored in what is now the Radiation Safety Office had been surveyed and found free of contamination prior to disposal as normal waste.
No items of noncompliance or deviations were identified.
4.
Instruments The investigators observed five Geiger-Mueller survey instruments being used during the investigation.
Two portable instruments had been purchased prior to the last inspection and records showed they were last calibrated on November 23, 1979.
Three new survey instru-ments were purchased to be used at permanent check stations and were received on February 14, 1980.
These instruments were calibrated by the manufacturer prior to shipment as indicated by certificates main-
~
tained by the licensee.
22 The investigators observed that the licensee had a multichannel ana-lyzer which was used to'look for isotopic contaminants in generator elutions.
A technician was observed using the analyzer.
In addition, the technician tested elutions for alumina content.
Licensee representatives stated that all handling of volatile compounds was done inside a hood observed by the investigators.
Records reviewed showed that the hood flow was last checked on February 26, 1980 and showed greater than 120 linear feet per minute face velocity.
The investigators were issued a self-reading, digital, pocket dosi-meter before each entry into the restricted areas.
Item 7 of a letter dated February 14, 1979, referenced by License Condition 20, requires that pocket dosimeters be calibrated on a six month basis.
A licens-ee representative stated that pocket dosimeters had not been calibrated for a period in excess of eight months.
This finding represent noncompliance with the licensed is calibration procedures for pocket dosimeters referenced by License Condition 20, 5.
Personnel Monitoring Since the last inspection the licensee has changed film badge process-ing companies and increased the frequency of. film badge monitoring from monthly to weekly.
Records showed results of finger dosimetry on both hands, wrist dosimetry on both hands, and a badge worn on the trunk of the whole body for all dispensing personnel.
Drivers and clerical employees were assigned whole body film badges only.
These records of personnel dosimetry indicated no overexposures since the last inspection.
A consultant makes monthly determinations of possible uptake of licensed material in the thyroids of laboratory personnel.
Records show that a sodium iodide probe is used in the integral mode with a single channel analyzer on a monthly basis.
The system is calibrated each time against a 0.32 microcurie mock iodine-131 standard.
No employee was recorded as having more than 30 nanocuries of licensed material in the thyroid gland.
l No items of noncompliance or deviations were identified.
23 4
i
_nclosures G.
E i
Enclosed with this report are typed copies of the original handwritten statements of:
1.
Steven Dessel 2.
Nunzio DeSantis 3.
Barry Crecenzi 4.
Frank Schweitzer, with attachments
\\
1 I
I i
J e
I i
l i
l 1
t'
, _ _ _ _ _ _ _ _ _. _ _ _ _ _ _ _. _ _. _ _ _