Radiopharmacy Operation: Regulatory Issues

I. RADIATION SAFETY

A. LICENSURE OF INSTITUTION REQUIRED BY IDNS/NRC OR A "TIMELY FILED NOTICE"

B. RADIATION SAFETY RULES (e.g., NO SMOKING, EATING), MUST BE POSTED IN EACH LABORATORY IN WHICH RADIOACTIVE MATERIALS ARE USED.

C. IDNS/NRC REGULATIONS AND TELEPHONE NUMBERS MUST BE POSTED IN EACH LABORATORY IN WHICH RADIOACTIVE MATERIALS ARE USED. CHART SUPPLIED BY THE REGULATORY AGENCY

D. RING/WHOLE BODY BADGE MONTHLY REPORTS MUST BE POSTED ON BULLETIN BOARD ON A MONTHLY BASIS. EMPLOYER IS RESPONSIBLE FOR INFORMING EACH EMPLOYEE ON AN ANNUAL BASIS OF HIS CUMULATIVE RADIATION DOSE.

E. THYROID MONITORING LOGBOOK

1. ALL NUCLEAR MEDICINE PERSONNEL INVOLVED IN USE OF I-131 SODIUM IODIDE IN QUANTITIES >1 mCi MUST HAVE A ROUTINE THYROID COUNT PERFORMED EVERY 6 MONTHS; IN ADDITION, 24 HOURS AFTER AN IODINATION PROCEDURE OR ADMINISTRATION OF I-131 SODIUM IODIDE IN LIQUID FORM THE THYROID MUST BE COUNTED.

F. LEAK TESTING OF SEALED SOURCES LOGBOOK

1. ALL SEALED SOURCES (GAMMA COUNTER CALIBRATION SOURCES, DOSE CALIBRATOR STANDARDS, ETC) MUST BE LEAK-TESTED EVERY 6 MONTHS AND RESULTS OF THIS TESTING RECORDED IN THE APPROPRIATE LOGBOOK.

G. AREA ROOM MONITORING LOG BOOK

1. ON A DAILY BASIS, EVERY ROOM IN WHICH RADIOISOTOPES ARE USED MUST BE SURVEYED WITH A PROPERLY CALIBRATED GM COUNTER. IT IS IMPORTANT TO SPECIFY IN THE LOGBOOK EXACTLY WHICH METER WAS USED, WHETHER THE READINGS ARE IN UNITS OF CPM OR MR/HR, WHAT THE NORMAL BACKGROUND READING FOR EACH ROOM IS AND WHAT IS THE "ACTION LEVEL" (HOW MANY TIMES BKG REQUIRED BEFORE IMMEDIATE ACTION MUST BE TAKEN).

2. ON A WEEKLY BASIS, A WIPE TEST MUST BE PERFORMED IN EVERY ROOM IN WHICH RADIOISOTOPES ARE USED. AN ACCURATE AREA MAP MUST BE DRAWN AND 5-7 WIPES ARE TAKEN IN EACH ROOM. RESULTS OF THE COUNTING PROCEDURE ARE CORRELATED WITH THE AREA MAP TO IDENTIFY AREAS WITH COUNT RATES HIGHER THAN NORMAL ROOM BACKGROUND. THESE AREAS MUST BE DECONTAMINATED TO BACKGROUND AND NEW READINGS RECORDED IN THE LOGBOOK.

H. PERSONNEL MONITORING LOG BOOK

1. AT THE END OF THE DAY, EACH TECHNOLOGIST IS OBLIGATED TO MONITOR HIS/HER HANDS WITH A GEIGER COUNTER TO DETECT INADVERTANT CONTAMINATION. RESULTS OF THIS SURVEY ARE RECORDED IN THE APPROPRIATE LOGBOOK ON A DAILY BASIS. IF HANDS ARE "HOT", THEY MUST BE DECONTAMINATED TO BACKGROUND AND NEW READINGS RECORDED IN THE LOGBOOK.

I. INCOMING PACKAGE LOGBOOK

1. EVERY PACKAGE CONTAINING RADIOISOTOPES MUST BE LOGGED IN APPROPRIATELY. THIS INCLUDES RECORDING THE PRODUCT NAME, LOT NUMBER, CALIBRATED ACTIVITY AND DATE, RECEIVED ACTIVITY AND DATE, SHIPPER'S PACKAGE NUMBER, AND INITIALS OF PERSON RECEIVING THE PACKAGE. IN ADDITION, IF YOUR LICENSE REQUIRES YOU TO MONITOR EVERY PACKAGE RECEIVED BY YOUR DEPARTMENT, RESULTS OF THIS MONITORING MUST BE RECORDED IN THIS LOGBOOK.

J. HOT SINK LOG BOOK

1. ONE SINK IN EACH LABORATORY MAY BE DESIGNATED AS A "HOT SINK". THIS IS THE ONLY PERMISSIBLE LOCATION FOR DISPOSING OF RADIOACTIVE LIQUID WASTE IN YOUR DEPARTMENT. THE LOG BOOK SHOULD BE SET UP SO EACH LIQUID WASTE DISPOSAL IS DOCUMENTED BY THE RADIOISOTOPE, AMOUNT, DATE, AND INITIALS OF PERSON INVOLVED. THE USUAL LIMIT FOR HOSPITALS IS 1 CURIE PER YEAR (ALL RADIOISOTOPES) FOR ALL LIQUID WASTE FOR THE ENTIRE INSTITUTION.

K. TREADMILL MONITORING LOGBOOK

1. ASSUMING YOUR INSTITUTION MONITORS THE TREADMILL ON A DAILY BASIS (OR WITH ANY OTHER FREQUENCY), RESULTS OF THESE SURVEYS MUST BE RECORDED IN AN APPROPRIATE LOGBOOK.

L. RADIOPHARMACEUTICAL MANUFACTURING LOG BOOK

1. GENERATOR ELUTION DATA

a. Mo-99 BREAKTHROUGH

b. Al³⁺ ION BREAKTHROUGH

c. HYDROLYZED REDUCED Tc

2. RADIOPHARMACEUTICAL DISPOSITION

3. PATIENT DOSE SHEET

4. RADIOPHARMACEUTICAL QUALITY CONTROL

M. DOSE CALIBRATOR QC TEST LOGBOOK

1. ACCURACY TEST

2. CONSTANCY TEST

3. LINEARITY TEST

4. GEOMETRY TEST

N. EQUIPMENT (GENERAL AND RIA) LOGBOOK

1. EQUIPMENT REPAIR LOGBOOK

2. HOOD CERTIFICATION LOGBOOK

3. TEMPERATURE MONITORING LOGBOOK

4. CENTRIFUGE CALIBRATION LOGBOOK

O. MISCELLANEOUS

1. ANNUAL SUMMARY REPORTS FOR IND PRODUCTS

2. INDIVIDUAL FOLDER FOR EACH PATIENT

3. CONTINUING MEDICAL EDUCATION REQUIREMENTS (12 HR/YEAR FOR TECHNOLOGISTS

4. ANNUAL SUMMARY REPORT FOR RADIOACTIVE DRUG RESEARCH COMMITTEE

III. MISADMINISTRATIONS: DIAGNOSTIC

A. OLD DEFINITIONS

1. ADMINISTER RADIOPHARMACEUTICAL TO INCORRECT PATIENT

2. DIAGNOSTIC DOSE DIFFERING FROM PRESCRIBED DOSE BY > 50%

3. ADMINISTRATION BY AN UNPRESCRIBED ROUTE

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B. NEW DEFINITIONS

1. (1) OR (2) OR (3) FROM ABOVE AND A WHOLE BODY DOSE OF 5 R OR AN ORGAN DOSE OF 50 R.

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IV: MISADMINISTRATIONS: THERAPEUTIC

A. OLD DEFINITION

1. THERAPEUTIC DOSE DIFFERING FROM PRESCRIBED DOSE BY >10%

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B. NEW DEFINITION

1. THERAPEUTIC DOSE DIFFERING FROM PRESCRIBED DOSE BY >20%

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ACTION REQUIRED

1. DOCUMENT DETAILS OF MISADMINISTRATION

2. NOTIFY THE NRC/STATE IN WRITING OF THE MISADMINISTRATION, GIVING PERTINENT DETAILS.

FREQUENCY

PRIOR TO THE NEW RULES, IT HAS BEEN ESTIMATED BY THE FDA THAT IN THE UNITED STATES, 1 IN EVERY 10,000 INJECTIONS QUALIFIES AS A MISADMINISTRATION