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Quality Management Program f ' 'j i || I Nuclear Medicine ''| : Brachytherapy \

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- | | ' , Lewis J. Garrotto, M.D. i Medical Director I | Diagnostic Imaging Department and ' ' - Chairman, Radiation Safety Committee m jb, x --- ) (/# 'I ,' |

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* ; , Keith A. Hickey, Ph.D. , ' Radiation Safety Officer

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/ Columbia Recional Hosoital (cpH) Quality Manacement Procram

/ 1.. Introduction In accordance with paragraph 35.32, " Quality Management . Program", of 10CFR Part 35, " Medical Use of Byproduct Material" as part of the CRH NRC Radioactive Materials License, CRH has established a set of Quality Management (QM) procedures consistent with the intent and the spirit of , the NRC guidelines as outlined in NRC Regulatory Guide 8.33. !

, In general, this set of procedures requires that;

* The authorized user must date and sign a written directive prior to the administration of therapeutic quantities of byproduct materials or quantities of I-125 or I-131 radiopharmaceuticals greater than 30 microcuries.

' * The patient must be identified by more than one method to prevent a possible misadministration.

* The plans of treatment must be verified to be in accordance with the written directive. * : * Prior to administration, the person responsible for the treatment modality will check the specific details of the written directive.

* The radiopharmaceutical dosage or radiation dose actually administered must be recorded.

It should be noted that CRH maintains responsibility for the

, Nuclear Medicine Quality Management Program for all ' radiopharmaceutical procedures, while the adjacent Regional Radiation Therapy Center (RRTC) maintains responsibility for the Brachytherapy Quality Management Program for brachytherapy procedures. Brachytherapy procedures are performed at CRH using materials maintained under the RRTC NRC materials license and transferred in accordance with the ,! licenses of the respective institutions. The brachytherapy procedures and RRTC Brachytherapy QM Program are also reviewed by the CRH Radiation Safety Committee and CRH RSO. ,

; 2. Nuclear Medicine QM Procram j \ a. i Oral and written Directives l It is a CRH Nuclear Medicine policy to have the 1 authorized user (physician) date and sign a written directive | | prior to the administration of any therapeutic dosage of a i radiopharmaceutical or any dosage of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131 i radiopharmaceuticals. In accordance with NRC Regulatory | Position 5, the following procedures for oral directives and revisions to written directives are permitted. ;

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' ' ' "If ecause of the patient's ical condition, a delay in order to provide a ritten ' revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the ' patient's record and a revised written directive is dated and signed by the authorized user within 48 hours of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by the authorized user prior to the administration of the radiopharmaceutical dosage.

' If, because of the emergent nature of the patient's medical condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the o,ral, directive is documented immediately in the patient's record and a written directive is prepared within 24 hours of the oral directive."

The attached Radiopharmaceutical Therapy form must be filled . out consistent with these procedures (Purchase Order and Prescription Information Section),

b. Pre-Dosinc Patient Identification 1 The identity of the patient as the individual named in the written directive must be verified by more then one method. The patient shall be asked his/her name and that result shall be confirmed against the written directive. In addition, a comparison of at least one of the following with corresponding information in the patient's records shall be made; birth date, address; social security number, signature, the name on the patient's ID bracelet or Hospital ID card, or the name on the patient's medical insurance card. The attached Radiopharmaceutical Therapy form must be filled out consistent with those procedures. (Pre-Dosing Section)

c. Dosinc Verification and Administration Prior to administration of the radiopharmaceutical, the person administering the byproduct material must verify that the specific details of the administration are in accordance with the written directive. The ; radiopharmaceutical, dosage, and route of administration must i be confirmed with the written directive. The dosage shall be measured in the dose calibrator and the results compared with the prescribed dosage.

| The attached Radiopharmaceutical Therapy form must be filled out and initialed consistent with these procedures (Dosing Section).

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d. Discrocancies and/or Uncertainty in Radioisotope Administration Procedures In all CRH Medical procedures including the administration of radioisotopes, all workers shall seek guidance if they do not understand how to carry out the / medical directives or if they have not been properly trained to perform a procedure. All workers shall seek instructions from the authorized user or RSO, if they do not understand the instructions and/or if there are discrepancies in the written directive and any aspect of the radioisotope administration process. The attached Radiopharmaceutical Therapy form provides a reminder of that requirement to the worker performing the radioisotope administration.

e. Recordinc the Radioisotope Administration Following the administration of the l radiopharmaceutical, the authorized user or a qualified person under the supervision of an authorized user (Nuclear Medicine physician, physicist or technologist) shall date, and sign or initial a written record that documents the administered dosage in the patient's chart or other . appropriate record. | The attached Radiopharmaceutical Therapy form must be filled out and initialed consistent with the procedures. (Dosing Section)

f. Periodic Reviews of the QH Erecram The policy of QM Program Review is required by 10CFR 35.32(b) and is described by NRC Regulatory Position 6. Periodic reviews of the Nuclear Medicine QM Program for radiopharmaceuticals shall be performed by the CRH RSO and the CRH Radiation Safety Committee during the quarterly RSC meeting. All radiopharmaceutical therapeutic procedures or any dosages greater than 30 microcuries of either sodium iodide I-125 or I-131 shall be reviewed by the RSO and reported to the RSC. For each patient's case, a comparison shall be made between what was administered versus what was prescribed in the written directive. This comparison will include radiopharmaceutical, dosage and route of Deviations from the written directive, the administration.cause of each deviation, and the action required to prevent recurrence shall be noted in the QM review. The recommended actions may include new or re'rised policies, new or revised procedures, additional trai: ro, or increased supervisory f review of work.

t k During the quarterly QM program reviews, the QM | ' program's policies and procedures will be re-evaluated to determine whether the program is still effective or to identify actions required to make the program more effective.

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e . & w Program review results must be documented and key t readily available for NRC inspectors. The program review reports will be distributed within the institution to appropriate management and departments. Corrective actions for deficient conditions shall be implemented and documented within a reasonable time after identification of the deficiency.

3. Brachytherapy QM Procram As described in the introduction, Brachytherapy procedures are performed at CRH using byproduct materials maintained undertransferred the RRTC in accordance NRC materials with license the licenses (24-20475-01) of the andrespective institutions. The Brachytherapy procedures and RRTC Brachytherapy QM Program shall be reviewed quarterly by the CRH Radiation Safety Committee and the CRH RSO. Tne attached RRTC Brachytherapy QM Program is the Brachytherapy QM Program for CRH.

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Radiopharmaceutical_ Theraov

Purchase Order

Patient Name Date

Isotope Form Route __

Dosage mci uCi

Calibration Date Time Approved User Signature M.D.

Pre-Dosinc Ask patient's name and confirm the name by comparison with corresponding information in patient's records. Circle one of the following methods used to verify patient identity. Birth Date, Address, Social Security , Number, Signature, ID Bracelet, ID Card, Medical . ! Insurance Card. Dosine Dosage and Form - route of administration agrees with written directive. Dose measured in Dose Calibrator and agrees with dose prescribed. Technologist Init. Date, f I If you do not understand above instructions or there ' are any discrepancies. see approved user and/or RSO. 1 Patient Name Date Time | 1 Isotope _ Form Route | Dosage mci uCi Calibration Date Time

Approved User present yes no | Hospital Consent signed Init. -

Bioassay

Bioassay completed: Date Time Tech Init