ML20206C964
| ML20206C964 | |
| Person / Time | |
|---|---|
| Issue date: | 10/25/1988 |
| From: | Glenn J, Oberg C, John Pelchat NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20206C956 | List: |
| References | |
| 30-18966-88-01, 30-18966-88-1, NUDOCS 8811160486 | |
| Download: ML20206C964 (12) | |
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U.S. NUCLEAR REGULATORY COMMISSION f
REGION I l
Report No. 030-18966/88-001 Docket No. 030-18966 License No. 29-19608-01MD Priority 2
Category G-1 Licensee:
Syncor Corporation 19A Gardner Road Fairfield, New Jersey 07006 i
Facility.3me:
Syncor Corporation Inspection At:
Fairfield, New Jersey 27006 Inspection Conducted: August 11 and 12, and October 5, 1988 Inspectors:
h.
M
/0 TS/
C. T. Oberg, T3t # ys icist trSaf{et)Section A da'te (igned Nuclear Mat,er
/k>r A
sebsb3 John M. Pelchat, health Physicist dite/ signed Nuclear ateria)s Sa,f tygection A f
((
/0/
ff Approved by:
go hn E. Glenn, Ph.D.,
Mef date signed uclear Materials Safety action A Inspection Summary:
Inspection on August 11, 12, and October 5, 1988 k
(Report No. 030-18966784-0'01) i Areas _ Inspected:
Unannounced routine inspection to review:
record of apparent diagnostic misadministrations caused by mislabeling; organization; inspection history; audits; training; radiological protection; materials and equipment; receipt and transfer of material; personnel protection - external and internal; effluent control and waste disposal; notifications and reports; i
posting and labeling; confirmatory measurements; transportation; and quality assurance.
Resiits:
in the areas inspected, four apparent violations were identified:
fUsla5eled radiopharmaceutical doses on four separate occasions over a seven month period were shipped to client hospitals and administered to patients.
The mislabeling resulted in misadministrations of the wrong chemical form of the radiopharmaceuticals.
$$0$If & 001102 29-19600-ojND PNU i
,e OETAiLS 1.0 Persons Centacted
- Vincent M. Immerso, Manager and Site RSO Wayne Wong, Assistant Manager Christopher Mayo, Pharmacist Peter Mongleve Pharmacist Garcia Simon, Pharmacist
- Attended both the entrance and exit interviews During this inspection, other individuals were also interviewed.
2.0 Scope of Operations and Purpose of Inspection 2.1 Scope of Licensed Operations NRC License No. 29-19608-01MD authorizes Syncor Corporation to dispense and distribute radiopharmaceuticals, and to redistribute unopened generators, sealed :ources and prepared radiopharmaceuticals to authorized recipients.
2.2 Purpose and Scope
of the_In!pection Inspection No. 030-18966/88-001 w:: conducted as a routine inspection and included a review of the misadministrations resulting from mislabeling that occurred between September 1987 and March 1988.
3.0 Review of Multiple Diagnostic Misadmin'strations During the period from September 18, 1987, through March 25, 1988, a series of five diagnostic misadministrations occurred due to errors by the Syncor Corporation, Fairfield, New Jersey facility (Syncor).
The following is a summary of these misadministrations.
3.1 On September 18, 1987, a unit dose 'abeled tha11tum-201 (T1-201) was delivered to a client hospital and auministered to a patient after the activity was verified with their dose calibrator.
The patient was scanned and the images were observed to be of poor quality.
Residue material in the syringe was radioassayed and determined to be g3111um-67 (Ga-67).
The syringe and residue were returned to Syncor where they verified that the syringe had contained 3 mci of Ga-67 and no; T1-201.
The dose was incorrectly labeled by Syncor parsonnel, Individual A.
Neither of these radiot>otooes are byproduct materials and are therefort not subject to NRC regulations.
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3 Until shown the gamma ray spectrum of the residue material, Individual A did not believe such a mistake had been made. Apparent human error and lack of attention caused this incident.
Contributing factors included the presence of two radiopharmaceuticals in the same area and recent changes in the configuration of the gallium shield. The shield change resulted from a switch from M.P.I. to E.I. du Pont as the supplier of gallium.
The du Pont g.111um shield closely resembles the shield in which the pharmacy receives thallium.
The only apparent differences are the color of and thr. information listed on the shield.
This error occurred between 7:00 a.m. and 6:00 p.m.
3.2 On September 21, 1987, a prescription for 15 millicuries (mC1) of technetium-99m (Tc-99m) pyrophosphate was filled using sodium pertechnetate (NaTc04) containing 16.5 mci of Tc-99m, delivered to a client hospital, and administered to a patient.
The subsequent scan of the patient showed only abdominal, salivary and thyroid activity.
j Syncor was advised and they ascertained that the material dispensed I
was NaTc0. with Tc-99n., and not Tc-99m pyrophosphate as stated on the label.
The drug or chemical form of the radiopharmaceutical was incorrectly labeled by Syncor personnel, Individual B.
This incident was attributed to carelessness on the part of Individual B.
Contributing factors included the presence of two different radio-l pharmaceuticals in the same work area.
The error occurred between l
9:00 a.m. and 6:00 p.m..
No further misadministrations have been attributed to Individual B.
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3.3 On January 5,1988, a prescription for Tc-99m in sulfur colloid for l
GI bleeding was filled as required, but the label was processed for l
Tc-99m in NaTc0. for GI bleeding.
The assayed amount of 10.2 mci of Tc-99m was changed by hand on the label, but the identification of the contained drug as sulfur colloid for GI bleeding was not written in place of the NaTc0..
The dose was shipped to a client hospital and administered to the designated patient along with nonradioactive pyrophosphate as required to be used with the NaTc0. for the study.
T h, subsequent scan showed the activity to be concentrated in the l
patient's liver and spleen.
This indicated that the dose actually l
contained sulfur colloid and not NaTc0. as specified.
The chemical i
form (drug) of the radiop5armaceutical was incorrectly labeled by Syncor personnel, Individual C.
This error occurred between 6:00 p.m.
and 6:30 p.m.
Investigations of this incident could not identify a specific problem except for human error.
No further misadministrations have been attributed to Individual C.
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4 3.4 On March 17, 1988, an incident similar to that of September 21, 1987 occurred. A prescription for Tc-99m in DTPA was ordered and NaTc0 with 15.1 mci of Tc-99m was dispensed and subsequently administered to a patient at a client hospital. Again, the scan showed that the wrong drug was administered.
Syncor verified that the chemical form of the dose was irtorrectly labeled by Syncor personnel, Individual 0.
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This incident was also attributed to human error and carelessness by the ir.dividual. Contributing factors included the presence of two radiopharmaceuticals in the same area.
The error occurred between 12:00 noon and 1:00 p.m.
No further misadministratons have been attributed to Individual D.
3.5 On March 25, 1988, a unit dose of Tc-99m MAA was delivered to a client hospital and administered to a patient for a lung scan.
The scan showed the activity to be concentrated in the liver and spleen instead of the lungs.
Syncor was notified and they verified that the dose was sulfur colloid with Tc-99m instead of the Tc-99m labeled MAA.
i The chemical form of the dose was incorrectly labeled by Syncor I
personnel, Individual A.
This was a repeat error by individual A.
Thi error occurred just one week af ter the individual's six-month probationary period (for causing the September 18, 1987 misadministration) had ended.
The investigation into this incident identified personal problems that created inatten-tion on the job as the root cause for the error. The individual offered to resign but this was not accepted by Syncor.
This error occurred l
at 9:00 a.m.
1 The inspectors noted that all these errors occurred after the peak of pharmacy activity, which occurs between midnight and 6:00 a.m.
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3.6 A licensee representative stated that the occurrence of five misadmin-l 1strations occur over a seven-month period was very disconcerting.
l These errors, and resulting misadministrations, were caused by human error and carelessness and by inattention to the task because of personal problems. The presence of more than one radiopharmaceutical in a work area and reduced vigilance during non peak periods could have contributed to these errors.
The licensee believes that they have established control over these errors by their corrective actions.
No further incidents have i
occurred since March 1988.
T.ketr corrective actions have been:
3.6.1 Inmediate 6 month probation for employees causing misicbelings and if any other incidents occur in this period, immediate dismissal.
3.6.2 Written reprimand to the employee.
5 3.6.3 During the probationary period the empluyee is to work directly unter the supervision of senior personnel.
3.6.4 The licensee has established a dual verification system for all preparations and doses.
Labels are checked by the individual compounding the material (both vial and shield labels) and checked again by a second individual when dispensing the dose or making up the vial for delivery to the customer.
3.6.5 In addition, to have help r(duce pharmacy staff fatique, a staggered shift rotation has been adopted, previously staff rotated between the 12:30 a.m. - 8:30 a.m. and the 8:30 a.m.
to 6:30 p.m. shifts every two weeks.
The staff now rotates incrementally every two weeks to the fo' lowing shifts:
Midnight t.o 8:30 a.m.; 3:00 a.m. to 11r30 a.m.; 8:30 a.m.
to 5:00 p.m.; and 10:00 a.m. to 6:30 p.m.
Staff response to the new shift system is reported to be very good.
A total of four apparent violations were identified.
Four misadministrations of byproduct materials were the result of incorrectly labeled unit dosos that were administered to patients.
Incorrectly labeling of radiopharmaceutical products is an apparent violation of the requirements of Condition 23 of Syncor Corporation's License No. 29-18608-01MD.
4.0 Organization Mr. Vincent M. Immerso is the Manager and the Radiation Safety Officer (RS0), Mr. Immerso reports to the Corporate Office Staff of the Syncor Corporatten and is responsible for the licensed program and operations at the Fairfield, New Jersey (NJ) location.
Mr. Wayne Wong, pharmacist, is the Assistant Manager for the Fairfield, New Jersey facility and is rwsponsible for the program when Mr. Immerso is not present.
Mr. Wong and three other pharmacists report to Mr. Immerso and to the Syncor Corporate offices if necessary.
In addition, the licensee employs fou,' technologists and several drivers who perform pack ( a, transporting and delh sry functions of the licensed material.
l Syncor Corporate personnel provide program iverview, support and audit functions to the Fairfield, New Jersey location and other Syncor sites.
Commur.ications between the Syncor sites and the Corporate, Regional and Zone Offices are always oper ar.d continuous, personnel from these offices, as well as those from other Syncor sites, frequently conduct unannounced radiation safety and otl.tr types of audits or inspections of the Syncor sites.
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y No violations were identified.
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5.0 Inspection History r
During the previous inspection on February 10, 1986, no violations were identified. The violations toentified prior to that inspection had been adequately corrected and were cinsed.
The previous inspector, however, expressed concern about the adequacy of 3
P space in the Fairfield, 9ew Jersey facility. The licensee addressed this issue in their letter dated August 20, 1986. They have expanded their facility and now bave twice the space that was previously available.
No violations were identified.
6.0 Audits Internal audits and inspections are conducted.in cordance and compliance with the documents incorporated by reference in L.ense Condition No. 23.
The audits and internal inspections are condteted and records are maintained.
No violations were identified.
7.0 Training The trt.ining program specified by reference in License Condition No. 23 was reviewed. Both training and retrair*ng has been implemented by the t
licensee.
Instructions to workers are provided in compliance with 10 CFR 19.12.
The licensee has recently instituted a dual verification program to mitigate misadministrations. The do.
and form are checked by the individual who prepves it and by the indis.uaal drawing and packaging the radiopharmaceutical.
Th(..censee nas implemented actions in compliance with requirements for medical licensees in 10 CFR 35.33 subsequent to the identification of misadministrations. A rev12w of the misadministrations that occurred between September 1987 and March 1968 :ndicated that appropriate actions were taken in attempts to prevent recurrence. All personnel at thit facility and those at the corporate level were made aware of the occurrences and the preventive actions taken, No violations were identified.
8.0 Radiological Protection A review of the licensee's program tr.dtcoted that no changes have bleen made in the radiation :afety program and that licensed materials are used in accordance with current procedures.
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Based en discussions with the licensee's employees it was determined that underst.anding of the licensee's procedures ranged from adequate to very good.
No vio'iations were identified.
9.0 Mat tals and Equipment Based on a review by the inspectors, and with the exception of incorrect labeling causing the misadministratioct it'entified, radioisotopes, chemical form, quantity and use were as authorized; syringes and vials were properly
'abeled and shielded; the required dose calibrator tests and leak tests have been performed; calibration sources have been inventoried; storage areas and materials are secured to prevent unauthorized entry or removal; and operable ;urvey instruments are provided, are adequate for the program and are calibrated in accordance with requirements.
No violations were identified.
10.0 Receipt and Transfer of Material Based on discussions with the licensee, the inspectors learned that materials received during off-duty hours were deposited in a locked foyer area.
The delivery company driver has a key to the exterior door, the material is deposited within the foyer and the exterior door is again locked.
All incoming packages are surveyed within the required time period and records are maintained.
Established procedures for opening packages are followed.
Records of receipt and transfer are maintained.
No violations were identified.
11.0 Personnel Protection - External and Internal 11.1 External Monthly whole body ard weekly extremity (ring) badges are supplied by R.S. Lendauer, Jr. and Co., Inc.,
Pro.essing reports are reviewed by the site RSO as received. The reports are also forwarded to the corporate RSO fcr his review.
The inspectors reviewed the personnel monitorie.3 records for the years 1986, 1987 and through June and July of 1988 as available.
Maximum exposure levels for a calenda. year were 560 mren whole body #nd 32,940 nrem extremities, Maximum quarterly exposures were about 100 mrem whole body and 7,700 mrem for extremities.
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I The licensee has implemented an ALARA p. an and established action E
levels at 50*4 of the regulatory limits in 10 CFR 20.101(a).
Ambient radiation surveys of restricted and unrestricted areas are conducted and records are maintained.
11.2 Internal Potantial exposure to airborne radioactive materials exists in the i
Iodine Room, where iodine-131 solutions (1-131) and xenon-133 (Xe-133) gas are stored in a continuously operating fume hood.
l Ef fluent and breathing zone air monitoring for I-131 is conducted in restricted and unrestricted areas.
Results of radioassays performed on the air samples show a concentration range of 1xE-12 to 1xE-11 microcuries (uC1)/mi ef air.
For individuals preparing I-131 doses, bah thyroid it oring and j
urinalysis bioassays are performed.
Results of these bioassays show I
personal I-131 burden levels of <0.0) uCi for the thyroid and background concentrations for the urinalysis.
No violations were identified, 12.0 Effluent Control and Waste Disposal Effluent air to unrestricted areas is monitored and controlled as discussed in Section 10.2 of this report.
Releases are within ragulatory limits.
3 No other effluents were identified.
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t In accordance with License Condition No. 22, the licensee holds material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash.
This waste is held for a minimum of 10 half-lives, is surveyed to verify background activity levels and labels are removed or defaced prior to disposal.
l Waste materials with half-lives innger than 65 days are deposited in drums for disposal through a waste handling company by burial at a licensed burial site.
The licensee har disposed of only one 55 gallon drum of waste material in the past three years.
l The licensee does not generate any liquid waste for disposal, i
i Records of surveys of waste prior to disposal and the records of the disposals are maintained and w re reviewed by the inspectors.
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No violations were identified.
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13.0 Notifications and Reports The licensee P in compliance with the requirements of 10 CFR 19.13, 10 CFR 20.402, 10 CFR 20.403 and 10 CFR 20.405 for notifications and reports to individuals and to the NRC. As described in 10 CFR 35.33, the licensee has reported their involvement with diagnostic misadmin-istrations between September 1987 and March 1988 et various hospitals.
These misadministrations are discussed in Section 3.0 of this report.
No violations were identified.
14.0 Posting and Labeling Notices to workers have been posted in compliance with 10 CFR 19.11.
The licensee is in compliance with the posting and labeling requirements of 10 CFR 20,203.
No violations were identified.
15.0 Confirmatory Measurements Heasurements made by the inspectors during this inspection were conducted using (during the August 11-12 portion of the inspections) a Ludlum Model 14C G.M. survey instrument, NRC No. 9662, due for calibration on September 1, 1988, and (during the October 5 portion of the inspection) an Eberline Model E-120 G.M. survey instrument, NRC No. 899, due for calibration on December 15, 1988.
The results of the ambient survey measurements made by the inspectors were not significantly different from those by the licensee.
For example, the Transportation incex (TI) on packages being shipped were measured to be 0.1 by the licensee. Measurements indicating between 0.1 and 0.15 were made by the inspectors.
No violations were identified.
16.0 Transportation In the capacity of a radiopharmacy, the licensee makes shipments of radioactive materials. These shipments consist of radiopharmaceuticals, sources and preparations, and radwaste.
The licensee was determined by the inspectors to be aware of the radwaste requirements of 10 CFR 61 and 10 CFR 20.311(d).
The licensee was authorized packages in compliance with 49 CFR 173.415 for DOT specification 7A. Type A packaging.
They have performed the required QC testing of the packages and the records are maintained.
Packages are properly labeled and marked.
Shipping papers are prepared for each package, e
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t 10 On October 4, 1988, the licensen reported that a radiopharmaceutical delivery vehicle was involved in an automobile accident in Jersey City, New Jersey (PNO-I-88-100 attached).
The accident occurred October 3, 1988.
The vehicle was carrying 40 mci of Tc-99m. The radioactive material packages remained braced and suffr ed no damage.
There was no release of radioactive material.
The licensee's response to this incident appears to have been prompt and appropriate.
No violations were identified.
17.0 Quality Assurance Program Severa' elements of the licensee's radiopharmaceutical quality assurance prcgram were reviewed in accordance with the NRC's September 20, 1988, Temporary Instruction issued for the expanded examination of nuclear pharmacy quality assurance programs.
Dose calibrator constancy checks were observed to be performed at the beginning of the work day before the dose calibrators were used for the assay of radioactive materials.
Review of dose calibrator constancy test records confirmed that these tests wtre performed each day that radiopharmaceuticals were prepared.
Assay of generator eluant to determine the concentration of molybdenum-99 was observed.
Interviews of licensee staff revealed that they were knowledgeable in correct assay procedures and the maximum permissible concentration of molybdenum.
Review of molybdenum assay records and generator elution records indicated that the concentration of molybdenum was determined for each elution of the generators. All assay results were less than 0.15 microcuries of molybdenum-99 per millicurie of technetium-99m.
The RSO stated that radiopharmaceutical kits had never been pooled inte "superkits". The RSO cited personal concerns over compounding errors as the primary reason he had prohibited the practice.
The licensee's radiopharmaceutical quality assurance procedures were observed. A sample from each batch of compounded radiopharmaceutical was drawn and set aside in a lead vial labeled with the pharmaceutical name and batch identification numbar. A technician or pharmacist then used thin layer chromatography to determine the percentage of technetium-99m tagged to the particular material.
The paper strips were assayed with a Ne.t England Applied Research, Inc. Quality Assurance Analyzer, which simultaneously measured the amount of radioactive material at the "origin" and at the "front" of the chromatography strip. The device was equipped with a digital display which presented the result expressed in percent of the total technetium-99m bound.
The RSO stated that the use of this device was not provided for in Syncor's Standard Operating Procedures and that a extensive set of trials was performed and documented before Syncor's corporate staff permitted routine use of the device for radiopharmaceutical quality assurance testing.
The RSO stated that the results of percent of
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technetium-99m tagged determined with the device ran slightly but consis-l tently lower than the results using the thin layer chromatography test l
dascribed in Syncor's Standard Operating Procedures.
The RSO added that i
this resulted in more conservatism in the examination of quality assurance l
tests results.
The performance of alumina contamination testing of generator eluant was observed. A review of alumina contamination test records indicates that each elution of technetium-99m was assayed for alumina as required.
The inspectors observed that the licensee's staff performed quality assurance testing and confirmed satisfactory results prior to the shipment of any radiopharmaceutical. The RSO stated no radioactive material was shipped prior to completion of required quality assurance testing. A review of quality assurance testing records indicated that these tests were performed on each batch of radiopharmaceutical repared.
As a result of the recent experience of a Syncor nuclear pharmacy in Blue Ash, Ohio, the manager /RSO or assistant manager review the results of these tests on a daily basis.
The RSO stated that the maximum permissible percent of unbound technetium-99m is ten percent.
The RSO also stated that he had instructed his staff to contact him immedia bly any time the percent of unbound technetium-99m exceeded 5 percent.
Interviews of the licensee's staff indicated that they were very knowledgeable in the required test procedures and acceptance criteria.
All radioactive materials used in the preparation, dispensing, and the testing of radiopharmaceuticals were properly labeled.
Vials used for the compounding of radiopharmaceuticals were prepackaged and prelabeled by the manufacturer. Because of several misadministrations that had occurred in the past due to failure to properly read radiopharmaceutical labels, the licensee instructed all staff preparing and dispensing radioactive material to confirm that the labels of both the inner kit container and the shield match the identity of the ordered material.
One indhidual compounds the particular material, confirms its identity, and signs a log sheet indicating that the material in the vial matches the material described on the order.
The individual dispensing the material picks up the vial, confirms that the inner and outer labels match the order, and then countersigns the same log sheet entry prior to moving the material to the dispensing area.
The persons compounding and dispensing radiopharmaceuticals work with one particular material at a time during "rush" periods to reduce the likelihood of confusing the different pharmaceuticals.
Radiopharmaceuticals are placed into prelabeled vial shields as soon as they are dispensed.
The shields are then sealed using a heat-activated plastic shrink wrap.
No violations were identified.
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12 18.0 Exit Interview On October 5,1988, an exit interview by the inspectors was conducted with the individual identified in Section 1.0 of this report.
The inspection findings were originally reviewed with the licensee on August 12, 1988 and no apparent violations were identified for the licensee's ongoing program as it existed at that time. Upon review at the Regional Office, it was concluded that the mislabelings which caused four misadministrations were apparent violations.
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