Information Notice No. 91-71: Training and Supervision of Individuals Supervised by an Authorized User

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

                             November 12, 1991 


NRC INFORMATION NOTICE 91-71:  TRAINING AND SUPERVISION OF INDIVIDUALS 
                               SUPERVISED BY AN AUTHORIZED USER


Addressees 

All U.S. Nuclear Regulatory Commission (NRC) medical licensees. 

Purpose 

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information 
notice to remind licensees of the importance of providing adequate 
instruction and supervision to individuals working under the supervision of 
an authorized user.  Supervised individuals who infrequently use radioactive 
materials, such as part-time or cross-trained technologists, and 
technologists whose services are used under contract of a temporary 
employment service are of particular concern.  It is expected that licensees 
will review this information for applicability to their own procedures, 
distribute this notice to those responsible for radiation safety, all 
authorized users, and facility management, and consider actions, as 
appropriate, to preclude situations similar to the ones described in this 
notice from occurring at their facilities.  However, suggestions contained 
in this information notice are not NRC requirements; therefore, no specific 
action or written response is required. 

Description of Circumstances 

Reports received by NRC of recent events that led to misadministrations or 
violations indicate that some licensees are not providing individuals 
working under the supervision of authorized users with adequate instruction 
or supervision.  In the six recent cases described below, lack of adequate 
instruction and/or supervision were major contributing factors that led to:  
(1) a significant diagnostic misadministration by a cross-trained 
technologist; (2) the alteration of patient nuclear medicine films and 
significant violations of NRC requirements by a contract temporary 
technologist; (3) unauthorized transfer of radioactive material to a patient 
and nearby facility; (4) a significant therapy misadministration during a 
brachytherapy implant and unnecessary extremity exposure to a nurse's hands; 
(5) a diagnostic misadministration of iodine-131; and (6) failure of the 
licensee to have a trained operator present during patient treatment on a 
High Dose Rate (HDR) Afterloader on two occasions. 

Case 1:  An X-ray technologist, cross-trained to perform emergency nuclear 
medicine scans on an on-call basis, erroneously prepared and administered 
approximately 175 millicuries of a technetium-99m labeled radiopharmaceu- 
tical 


9111060255
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instead of the prescribed dosage of 8 millicuries.  This misadministration 
resulted in the patient receiving excess dose for an estimated whole body 
dose of 3 rad and an estimated bladder dose of 36 rad. 

NRC inspection of events surrounding the misadministration revealed that the 
X-ray technologist had not been adequately trained by the licensee.  
Specifically, the technologist was not familiar with the correct procedures 
for generator elution or the preparation of the radiopharmaceutical, nor was 
the individual familiar with any of the procedures established by the 
Radiation Safety Officer (RSO) or authorized users, or applicable NRC 
regulations governing the facility's operations.  Further review of this 
case also revealed that the licensee, through the RSO, was not exercising 
effective oversight of the medical use program.  

Case 2:  A nuclear medicine technologist, on temporary assignment from a 
contracted medical personnel service, apparently presented fraudulent 
nuclear medicine films for physician interpretation.  An investigation 
performed by the licensee revealed that the films presented for 
interpretation were films from patients previously imaged at the hospital.  
The licensee's conclusion was based upon two observations:  1) the names of 
previously imaged patients appeared to be partially erased on the films and 
covered up by the names of patients scheduled to be imaged by the contract 
technologist; and 2) some of the films the licensee had reviewed had 
computer generated patient names that were different from the names of the 
scheduled patients.  The prescribed dosages or radiopharmaceuticals actually 
administered to those patients cannot be determined due to poor 
recordkeeping.  The licensee had not familiarized the contract technologist 
with the instructions of the supervising authorized users, procedures 
established by the RSO, and NRC regulations and license requirements.  Also, 
the licensee did not provide adequate supervision of the contract employee's 
activities to ensure that proper radiopharmaceuticals were ordered, 
received, administered, and disposed of.  The licensee relied heavily on the 
individual's credentials, including professional certifications by 
technologist registries and a favorable employment history. 

Case 3:  A physician requested an X-ray technologist, cross-trained to 
perform emergency nuclear medicine scans on an on-call basis, to perform a 
patient lung scan.  The technologist incorrectly prepared the technetium-99m 
labeled radiopharmaceutical and infiltrated the patient dosage.  As a result 
of these mistakes and the patient's medical condition, the primary care 
physician decided to consult with a nearby facility to see if that facility 
could perform the procedure.  The X-ray technologist transferred a vial of 
technetium-99m to the patient's spouse for transport to the nearby hospital 
since that facility did not have a sufficient amount of technetium-99m but 
did have the radiopharmaceutical kit available.  Upon arrival at the nearby 
hospital, radiation surveys indicated that contamination was present on both 
the patient, the patient's spouse, and the lead shield.  A survey of the 
patient's automobile did not detect radiation levels above background. 

After notification by both hospitals, the NRC performed an inspection of the 
licensee responsible for the unauthorized transfer of radioactive material.  
The inspection revealed a number of violations associated with this 
incident, including the failure to record the results of radiation and 
contamination 
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surveys, and to prepare shipping papers.  The licensee had failed to 
adequately instruct the cross-trained technologist to perform nuclear 
medicine procedures.  In addition, if the technologist had been adequately 
supervised during the training period, it might have become apparent that 
the technologist was not capable of performing these procedures 
independently. 

Case 4:  A catheter containing iridium-192 seeds encased in ribbon was 
inserted through a patient's nasal cavity.  According to a representative of 
the nursing staff, the catheter appeared to be in place at the time of 
implant.  Subsequently, during the 11 p.m. to 7 a.m. shift, a second nurse 
noted that the implanted catheter was located outside of the patient's nose 
at approximately 12 midnight and 2 a.m.  Not recognizing that the 
radioactive seeds were located within the dislodged portion of the catheter, 
she handled it with her bare hands and taped it to the patient's face.  This 
resulted in a misadministration with a significant dose contribution to the 
patient's face, and unnecessary radiation exposure to the nurse's hands.  At 
approximately 5 a.m., another nurse removed the ribbon from the patient's 
face and placed it in a lead container in the patient's room.  The RSO and 
radiation oncologist were notified, the catheter was reimplanted and the 
treatment continued as prescribed.  NRC inspection revealed that the 
individual nurse assigned to care for the brachytherapy implant patient on 
the midnight shift had not been adequately trained in radiation safety 
precautions associated with implant patient care.  

Case 5:  A 37 year old female patient, 2 days post partum, was administered 
5.0 millicuries iodine-131 instead of the intended dosage of 50 microcuries 
iodine-131.  The patient was diagnosed to have a mediastinal mass and was 
referred for a thyroid scan to rule out a possible substernal goiter.  In 
this medical facility, this procedure normally involves a dosage of 50 
microcuries iodine-131.  The Physician's Assistant (PA), who is permitted by 
the licensee to write orders for procedures at the request of a physician, 
gave the order for the scan to the floor nurse for processing.  The floor 
nurse placed the order with the Nuclear Medicine department.  The nuclear 
medicine technologist contacted the PA to arrange a time for the scan.  
During this conversation, the appropriateness of the study ordered was 
questioned by the technologist based on the patient information supplied by 
the PA.  The PA agreed to change the order from a thyroid scan, which 
required a dosage of 50 microcuries of iodine-131, to a whole body scan 
requiring the administration of 5.0 millicuries of iodine-131.  At no time 
during this decision making process was the authorized user consulted.  The 
licensee had not established quality assurance procedures regarding the 
ordering and administering of radiopharmaceuticals, nor had instruction to 
the technologist been provided to prohibit the changing of the referring 
physician's orders without authorized user approval.  This is clearly a 
violation of 10 CFR 35.25(a)(1) in that the licensee failed to provide the 
supervised individual with adequate instruction to prohibit changing or 
disregarding the prescribed procedure without the permission of an 
authorized user or the referring physician. 

Case 6:  NRC conducted an announced inspection of a High Dose Rate (HDR) 
Afterloading Brachytherapy program to review the circumstances surrounding 
two reported therapy misadministrations.  The license application contained 
operating procedures, reviewed and approved by the radiation safety 
committee, that required a trained operator to be present during any use of 
the HDR unit.  
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During the inspection, licensee representatives informed NRC inspectors that 
only their physicists are considered to be trained operators.  However, on 
two occasions a nurse and a dosimetrist were left to control the treatment 
console during patient treatment when the trained operator was not 
physically present.  The licensee did not provide adequate supervision to 
ensure that the unit was not operated by untrained individuals in the 
absence of the trained operators.  

Discussion 

The regulatory requirements for supervision of individuals who use byproduct 
material under the supervision of an authorized user are described in 10 CFR 
Part 35, Section 35.25, "Supervision."  This section provides as follows: 

(a)  A licensee that permits the receipt, possession, use, or transfer of 
     byproduct material by an individual under the supervision of an 
     authorized user as allowed by 35.11(b) of this part shall: 

     (1)  Instruct the supervised individual in the principles of radiation 
          safety appropriate to that individual's use of byproduct material; 
          
     (2)  Require the supervised individual to follow the instructions of 
          the supervising authorized user, follow the procedures established 
          by the Radiation Safety Officer, and comply with the regulations 
          of this chapter and the license conditions with respect to the use 
          of byproduct material; and

     (3)  Periodically review the supervised individual's use of byproduct 
          material and the records kept to reflect this use.

(b)  A licensee that supervises an individual is responsible for the acts 
     and omissions of the supervised individual. 

Additional requirements for the instruction of workers are described in 10 
CFR 19.12, "Instructions to workers."  Personnel training programs must be 
described as part of each licensee's radiation safety program submitted as 
supporting documentation when applying for an NRC license.  

The terms "instruction" and "supervision" are not defined in 10 CFR Part 35; 
however, the Statements of Consideration (SOC) for revised Part 35 
(effective April 1, 1987) discusses these terms in the context of responding 
to comments on the proposed rule.  The following discussion is based on the 
SOC.  With respect to the term "instruction," NRC recognizes that 
instruction may be in the form of lectures, audiovisual packages, printed 
handouts, laboratory exercises, preceptorials, or apprenticeships.  The 
format of the instruction is not important, but it must be presented in a 
manner that is appropriate for each individual's use of or exposure to 
byproduct material.  An opportunity for questions and answers should be an 
integral part of each instruction module.  The NRC recognizes that the 
authorized user physician identified on the license is responsible for 
providing quality medical care and the practice of medicine is regulated 
differently in each state.  Therefore, a prescriptive definition of 
supervision that describes tasks that may be delegated, time requirements 
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for the availability of the supervising authorized user, and training 
requirements may not be appropriate for all licensees.  The purpose of 
adequate supervision is to ensure that technologists and supervised 
physicians do not use byproduct material in a manner that is contrary to the 
requirements of the license or the regulations, or that is otherwise 
hazardous to public health and safety.  Adequate supervision must encompass 
a system of checks and balances whereby the authorized user is responsible 
for:  (1) creating and implementing procedures and protocols for the 
administration of byproduct material; (2) instructing the workers or 
individuals under the supervision of the user to ensure comprehension and 
compliance; (3) monitoring their performance to detect deficiencies and to 
develop corrective measures, and to provide feedback to these individuals.  

Licensees should review the aforementioned regulations on the instruction 
and supervision of their staff to ensure that all procedures and 
requirements are adequately addressed and implemented, and that sufficient 
safeguards are in effect to preclude events similar to the ones described in 
this notice from occurring at their own facilities.  

This information notice requires no specific action or written response.  If 
you have any questions about the information in this notice, please contact 
one of the technical contacts listed below or the appropriate NRC regional 
office. 




                                   Richard E. Cunningham, Director 
                                   Division of Industrial and 
                                     Medical Nuclear Safety 
                                   Office of Nuclear Material Safety 
                                     and Safeguards 

Technical contacts:  Janet R. Schlueter, NMSS 
                     (301) 492-0633

                     Roy Caniano, RIII
                     (312) 790-5721


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