United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 94-74: Facility Management Responsibilities for Purchased or Contracted Services for Radiation Therapy Programs

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                           WASHINGTON, D.C.   20555


                               October 13, 1994


NRC INFORMATION NOTICE 94-74:  FACILITY MANAGEMENT RESPONSIBILITIES FOR
                               PURCHASED OR CONTRACTED SERVICES FOR
                               RADIATION THERAPY PROGRAMS


Addressees

All U.S. Nuclear Regulatory Commission Medical Licensees.

Purpose

This information notice is provided to remind licensees of their
responsibilities regarding management of radiation therapy programs (involving
byproduct material) for which all or part of the services is purchased or
contracted.  It is expected that licensee management will review this
information for applicability to their programs, and consider this
information, in the future, when planning to purchase or contract services. 
However, suggestions contained in this information notice are not new NRC
requirements; therefore, no specific actions nor written response is required.

Description of Circumstances

The following incidents are examples of licensees who contracted for radiation
therapy services, and failed to maintain management oversight of the
contracted program.

Incident 1.  An NRC licensee (community hospital) contracted with a large
teaching institution to provide brachytherapy services at the licensee's
facility.  The contractual services provided all oversight of the program
including the radiation safety and medical physics support, the dosimetrist,
and the physician authorized user, who also performed brachytherapy at the
teaching institution.  The managers of the licensee's facility delegated
management of the brachytherapy program to the contractor.  Additionally, the
licensee's Radiation Safety Officer had little knowledge or contact with the
brachytherapy program.

On June 21, 1994,  a patient was scheduled to receive a transperineal prostate
iodine-125 seed implant.  The written directive, sent to the facility by the
contractor via facsimile, prescribed 112 iodine-125 seeds, with an activity of
16 - 17 MBq (0.43 - 0.46 mCi) per seed.  The order for the seeds was placed by
the licensee's chief nuclear medicine technologist.  However, there was an
apparent miscommunication between the licensee and the supplier regarding the
seed activity.  The packing slip shipped with the order listed the actual
activity of the seeds as 166 MBq (4.49 mCi) per seed.  When the order was


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received at the licensee's facility, the seeds were logged in by a nuclear 
medicine technologist using the actual activity as recorded on the packing
slip.  The order was not checked against the written directive prepared by the
authorized user.  Subsequently, the (contracted) dosimetrist removed the seeds
from storage for the implant, but did not verify that the activity of the
seeds was as specified in the written directive.

After the seeds were implanted, the (contracted) dosimetrist discovered that
the activity of the implanted seeds was actually 166 MBq (4.49 mCi) per seed,
or approximately 10 times the intended activity.  The initial planned
peripheral tumor dose (PTD) was 16,000 cGy (16,000 rad).  The factor of 10
error in seed strength implied that the PTD, if the seeds were left in place,
would have been 160,000 cGy (160,000 rad) to decay.

Within 5 hours of the implant, the patient underwent a radical prostatectomy
which resulted in the removal of 69 of the 112 seeds.  During this surgery,
one of the seeds was inadvertently cut, resulting in a dose to the patient's
thyroid.  The patient was later transferred to the contractor's facility.  A
second surgery, 6 days following the initial implant, recovered 15 additional
seeds.  A total of 28 seeds were left in place (scattered throughout the
perineum, perirectal area and left sacrum) with a total activity of 4651 MBq
(125.7 mCi).

The licensee did not have a quality management program (QMP) that addressed
brachytherapy.  The contractor's facility had implemented a QMP that required,
among other things, that the activity of the seeds be assayed prior to
implantation.  The licensee did not adopt the contractor's program nor ensure
that the contractor followed the same QMP procedure described in the QMP
implemented at the contractor's facility.

Incident 2.  Two NRC Licensees jointly finance a non-NRC licensed cancer
treatment center.  Both licensees utilize a computerized treatment planning
system, located at the cancer center.  Sometime between July and September
1992, the linear source data files, in the computer planning system,
apparently were deleted and an incorrect data file was created.  Both
licensees failed to adequately validate data used in the computer planning
system.  Consequently, the radiation dose administered to 11 patients was
calculated to be in excess of the dose prescribed by the authorized users, by
5 to 30 percent.

Both licensees had written QMPs at their facilities.  Because the treatment
planning was done at the cancer center, neither licensee had directly
addressed treatment planning as part of their QMP.  The cancer center was not
an NRC licensee, and was not required to establish a QMP.  The licensee's
managers assumed that the authorized users had responsibility for oversight of
all aspects of the patients' treatments and that the licensees need only be
aware of those aspects of the treatment actually conducted at the licensee's
facility.




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Discussion

Licensees may contract for patient services for which they do not have         
in-house expertise.  In those instances where the contracted service is
regulated by the NRC, the licensee should be aware that the licensee remains 
responsible for regulatory compliance and implementation of the radiation
safety program and QMP.  The licensee should not assume that by hiring a
contractor to perform certain tasks that it has fully satisfied all regulatory
requirements or that it has somehow transferred responsibility for the
licensed program to a contractor.  Licensee management should ensure that
adequate mechanisms for oversight are in place to determine that the
licensee's QMP is effectively implemented by the appropriate individuals, to
provide high confidence that byproduct material is administered as directed by
the authorized user.

This information notice requires no specific action nor written response.  If
you have questions about the information in this notice, please contact the
technical contact listed below, or the appropriate regional office.

                                    /S/'D BY CJPAPERIELLO


                                    Carl J. Paperiello, Director
                                    Division of Industrial and
                                      Medical Nuclear Safety
                                    Office of Nuclear Material Safety
                                      and Safeguards

Technical contacts:  Sally L. Merchant, NMSS
                     (301) 415-7874

                     Patricia K. Holahan
                     (301) 415-7847

Attachments:
1.  List of Recently Issued NMSS Information Notices
2.  List of Recently Issued NRC Information Notices

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