The University of New Mexico THE UNIVERSITY OF NEW MEXICO COLLEGE OF PHARMACY ALBUQUERQUE, NEW MEXICO Correspondence Continuing Education Courses for Nuclear Pharmacists and Nuclear Medicine Professionals VOLUMEII, NUMBER 4 How to Prepare for and Successfully Complete an NRC Inspection: A Review for Nuclear Pharmacists by: Mark H. Rotman, M. S., R. Ph. Co-sponsored by: mpi @armcy services inc an Amersham company M The University of New Mexico College of Pharmacy is approved by the American Council on Pharmaceutical Education as a provider ofcon~inuing pharmaceutical educalion. Program No. 180-039-93-006. 2.5 Contact @ Hours or .25 CEU’S
Transcript
The University of New Mexico
THE UNIVERSITY OF NEW MEXICO
COLLEGE OF PHARMACYALBUQUERQUE, NEW MEXICO
Correspondence Continuing Education Coursesfor
Nuclear Pharmacists and Nuclear Medicine Professionals
VOLUMEII, NUMBER 4
How to Prepare for and Successfully Completean NRC Inspection:
A Review for Nuclear Pharmacists
by:
Mark H. Rotman, M. S., R. Ph.
Co-sponsored by: mpi
@armcy services incan Amersham company
M The University of New Mexico College of Pharmacy is approved by the American Council on PharmaceuticalEducation as a provider ofcon~inuing pharmaceutical educalion. Program No. 180-039-93-006. 2.5 Contact
@ Hours or .25 CEU’S
9
b
Editor
and
Director of Phrmacy Coti”nuing Education
William B. Hladik III, M.S., R.Ph.College of Pharmacy
University of New Mexico
Associute Miter
and
Production Spectiist
Sharon I. Ramirez, Staff AssistantCollege of Pharmacy
University of New Mexico
While the.advice and informationin thispublicationarcbelievedto betrueandaccurateat presstime,neithertheauthor(s)northeeditornor thepublishercanacceptanylegalresponsibilityforanyerrorsor omissionsthatmaybe made. Thepublishermakesnowarranty,expressor implied,withrespectto the materialcontainedherein.
Copyright 1993Universityof New Mexico
PharmacyContinuingEducationAlbuquerque,New Mexico
HOW TO PREPARE FOR ANDSUCWSFULLY COMPLETEANNRC mSPECTION
A REWW FOR NUCLEARPHARMACISTS
STATEMENTOF OBJECTIVES
Theprimarygoalsof this correspondencecourseare to a) describeand list for the readerthe NRCNuclearPharmacyinspectionprocessandb) identifyandexplainthe requirementsagainstwhichtheNRCwillinspect.Thisinformationwillprovidethereaderwiththenecessaryelementsto successfullyprepare for, and learn from, an NRCinspection.
Uponsuccessfulcompletionof this coursethe readershodd be able to:
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OB20.
Knowthe feeschargedby the NRC for inspections.
Knowthe importanceof the conditionof the physicalplantto the overallinspectionprocess.
Trainemployeesto work naturallywhilebeing inspected.
Maintainand organizethe recordsmostcommonlyinspectedby the NRC.
Understandwhy it is usefuland necessaryto periodicallyreviewradiationsafetyrecords.
HOW To PREPARE FOR AND SUCCESSl?ULLYCOMPLETE AN NRC INSPECTION:
● A REVIEW FOR NUCLEAR PHARMACISTS
by
Mark Rotman, Pharm.D., M.S., BCNPChief Radiopharmacist
Department of Nuclear MedicineNational Institutes of HealthBethesda, Maryland 20892
andPast Visiting Medical Fellow
United States Nuclear Regulatory Commission
Editor’s Note: me text of this CE lesson was based on current(1993) regulations. However, some of the regulations referredto in this lesson will soon under-go change. Spect~cally, thenew 10 CFR 20 will take effect in January 1994 and theproposed, so-called “Radiophamacy Rule” (published for
comment in 58 FR 33396, June 17, 1993) will likely beimplemented sometime in ]994. ~erefore, the reader shouldbe miltiful of impending regularo~ changes (and any futurechanges) as they impact upon the recommendations made inthis publication.
m NTRODUCTION
There are several types of US Nuclear RegulatoryCornraission (NRC) inspections. Categories ofinspection listed on the NRC inspection field notesinclude announced or unannounced: routine or special,initial or reinspection. The most cornrnon type ofinspections are routine and unannounced, usually doneat two year intervals dependenting on the type of license.Special inspections generally are done in addition toroutine inspections, and often immediate y follow anincident or misadministration. Initial inspections areSometimes a pre-1icensing site visit or a post-licensingpre-start up inspection. The fee charged by the NRC tothe licensee for the inspection process ranges from$1500.00 for a routine inspection to $2000.00 for a non+routine inspection. The principles of inspectionpreparation are the same for all types of NRCinspections.
The best advice for inspection preparation and thebest formula for violation-free inspections is to a) knowthe NRC regulations and your license conditions, b) keepneat, complete, and easily accessible records, and c)
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dhere to the concept of ALARA (as low as iseasonably achievable; 10 CFR 35.20) at all times. The
best time to prepare for an inspection is as far inadvance of the inspector’s arrival as possible.
PREINSPECTION RECOMMENDATIONS
Physical PlantStart by carefully looking over the building or
physical plant within which your nuclear pharmacyoperates. Is the building neat, clean, and of soundconstruction? Is your business name and address clearlyannounced? Are the entrances and exits clear]y marked,solidly constructed and secure? Inside the building, inwhat condition are the floors, walls, and ceilings? Is thesite a safe workplace, free of electrical, mechanical,chemical and environmental hazards? Is it properlyventilated, heated, cooled, and lighted? Is thereadequate workspace and storage space? Are the workareas delineated by radiation levels? Are you aware ofthe occupancy rates in the areas surrounding yournuclear pharmacy? Is there adequate and secure parkingspace for the delivery vehicles? Can the deliveryemployees load and unload their vehicles with aminimum of exposure, while maintaining the security ofRAM packages?
Inspectors, like anyone else, are positively ornegatively impactd by appearances. A well-markedbusiness is easier to find, and a clean, spacious, neat,well-1ighted, and properly ventilated facility is morepleasant to inspect. Inspectors are often very busy mdhave many inspections of various licensees to perform.Inspectors may, in the course of a week, inspect a widevariety of 1icensees in one particular area of theirterritory for which they are responsible (e.g., a typicalweek’s work may consist of inspecting three or fourhospitals, a nuclear pharmacy, and several commercialsealed source users such as pipeline radiographers,moisture/density gauge users, and gas chromatographyusers). Inspectors, most likely, are traveling while inyour city and often have a tight schdule to follow, somaking the inspection proceed quickly through the useof better organization benefits everyone.
PersonnelThere are basic regulatory and license requirements
for personnel and these requirements will be discussedlater in this lesson. The basic, universal, good businesspractices of employing individuals who know the rulesand regulations of the business, who know their jobresponsibilities and the lines of authority, and who arepolite and courteous apply to nuclear pharmacy as well.Your nuclear pharmacy should be secure, so that theNRC inspector (or anyone else) cannot enter anyrestricted area without being screened by your personnel,When the inspector arrives, an introduction will bemade, identification provided and a request to seesomwne Iisted on the license, usual]y the RadiationSafety Officer (RSO). This first line of contact willoften shape the inspector’s first impression of the
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pharmacy. This person (usually a secretary orreceptionist) should be polite and cheerful, but firm instating the nuclear pharmacy’s policy on non-staffentering into the restricted area without an escort. Ifyour policy is to ask the insp~tor to wait while the RSOis pagd, then do so; if the RSO is unavailable, thenimmediately find sommne else (an authorized user, AU)to escort the inspector. The inspector should not beprevented from entering the facility while waiting for therequmted person. It is important for the inspector to seethat access to restricted ar- is controlled. Once theinspector has contactd the RSO or AU and inspectionhas begun, quietly notify all the employees that aninspection is in progress and ask them to cooperate fullywith the inspector. Show the inspector to a suitablework area and ask if he/she would first like to tour thefacility, observe workers, or review records. If recordreview is first, resign one person to bring the inspectorthe necessary records, or allow the inspector to browsethrough the records once their location has beenidentified.
It is advisable to have practice {simulated)inspectionand, in fact, a large number of commercial nuclearpharmacies have corporate inspections. During thesepractice inspections the staff will learn to operate in arelaxed, eff~cientmanner while being observed. This isa good time to refine radioactive material (RAM)handling skills to maintain exposure ALARA. Thoughconversation and humor in the workplace certairdy canbe a morale booster, it should be discouraged during aninspection. The staff should be trained to do everythingright all the time and to continue to do the daily routineduring an inspection. The inspector will quickly noticeprocedures and practices that appear put on, forced, ordone solely for his/her benefit. ~
TECHNICAL, PROFESSIONAL, AND RECORD-KEEPING REQUIREMENTS
The recordkeeping requirements for your nuclearpharmacy will be dependent on the regulations and yourRAM license. Before beginning an in-house recordreview, first examine your RAM license and supportingcommunication to insure that there are no additionalrecordkeeping commitments that may have beenoverlooked. Since these requirements vary, only themost common ones will be discussed in this lesson.
The RAM license, and any amendments, letters,communications, and procedures described in the licenseshould be kept together and easily retrievable. Previousinspection reports, and any other NRC or AgreementState Information Notices (IN), Bulletins, RegulatoryGuides (Reg Guides), or dirwtives should also be keptwith the RAM license.
In-house or corporate inspection findings should be
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cataloged in a separate binder, but in the same locationas the RAM license. It is important to document anynegative findings, along with the corrective action taken. ●
Also, document any additional training which resultdfrom self-identified violations and the subsequent ocorrective action.
A generally efficient method for recordkeeping is tohave preprinted on the form all the necessaryinformation that is not variable. For instate, the formsshould have the name of the nuclear pharmacy, the RAMlicense number, and the name of the record being keptor type of information contained therein. Additionally,if appropriate, it should include the name of theinstrument being tested or being used to conduct the test,model number, serial number, trigger level, andprocedure if trigger level is achieved. Some surveyforms will have scale drawings and factors forconverting cpm to dpm; thus the areas surveyed or wipe-tested along with the findings can be seen and reviewd“at a glance. ”
Dose CalibratorThe linearity, accuracy, and geometry tests must be
done after installation or repair, and prior to any patientdosage measurements. Testing frequency varies for eachof the four tests depending on Iicence conditions (seeindividual test descriptions below). The daily constancytest must be done prior to patient dosage administrationas well. Keep these records for a minimum of three ●years (or whatever your State or RAM license requires).It is interesting to note that for the linearity, accuracy,and geometry twts, the RSO need only to sign thedocument which shows test results. Although approvalis implied in 10 CFR 35.21 as a duty of the RSO, thereis no regulatory requirement for the RSO to approvethese tests.
The dose calibrator is probably the single biggestgenerator of important records for an NRC inspector.Documentation which indicates that the dose calibratoris functioning properly is critical to insuring that patientdoses are correct. Generally speaking, dose calibratorsare very reliable, needing little, if any, maintenance orrepair. Because of this reliability and accuracy, there isa tendency to place daily dose calibrator quality controlin a low priority position, and forget or neglect this veryimportant daily duty.
Daily ConstancyThe daily constancy test is a measure of the
reproducibility of assay of a constant activity over a longperiod of time. The constant activity measured must beassayed at all the commonly used radionuclide settings. oThe non-variable information that can be preprinted onrecord keeping forms for the dose calibrator constancytest includes the pharmacy name and RAM license
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number; the test name; - the make, model, and serialnumber of the dose calibrator; the sealed radionuclide
8 source as well as the manufacturer/supplier, model
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number, serial number, and thmretical activity of thesource; the allowable range of activity within which testresults should fall; the potentiometer radionuclidesettings; the trigger level; and the person to contact ifthe trigger level is achieved. The variables to berecorded include the date of test; initials of person doingthe test; and the measured activity. The NRCregulations allow an error of up to 10%. Although somehave adopted even more restrictive conditions, mostlicensees set their trigger level at 5% to 7%.Additionally, this test should be done before first use ofthe dose calibrator on each day that it will be used tomeasure radiopharmaceutical doses for administration topatients. Should your dose calibrator not demonstrateconstancy it must be repaired or replaced, andsubsequently retested before use. A commonly observederror is failure to do this test on weekends and holidays.There should also be space for notes should a triggerlevel be reached or approached, or should the tester wishto record something related to dose calibrator constancychecks. (See 10 CFR 35.50 and Reference 1 and 2.)
Linearity TestLinearity means that the dose calibrator is able to
● measure radioactivity linearity over the range of activityfor which it is normally used. The linearity test requiresquarterly testing, or testing afier repair, over the rangeof patient doses from the highest dosage (don’t forgettherapy doses) a patient might receive down to 10microcuries. The non-variable information that can bepreprinted on recordkeeping forms for the dosecalibrator linearity test (decay method) include thepharmacy name and RAM license number; the testname; make, model, and serial number of the dosecalibrator; the test radionuclide; the initial measuredactivity; the potentiometer radionuclide setting; thecalculated activity for the period of time that the linearitytest will be performed; the range of deviation fromlinearity allowed; the trigger level; and the person tocontact if the trigger level is achieved. The non-variableinformation that can be pre-printed on recordkeepingforms for the dose calibrator linearity test (shieldmethod) include the pharmacy name and RAM licensenumber; the test name; make, model, and serial numberof the dose calibrator; the name of the shield test plusmodel number and serial number (if applicable); the testradionuclide name and initial measured activity; thetrigger level; and the person to contact if the trigger
●J evel is achieved. Additional documentation required forthe shielded method are the measurements andcalculations that determined the “equivalent decay time”for each thickness of sleeve (shield). This determination
need only be done once; the numbers should be constantfrom then on, and the only number used for thatinstrument. The variables to be recordd are the date oftest; initials of person doing the test; and the measuredactivity for each point in time, or for each sleeve. TheRSO must sign the linearity test records, NRCregulations allow an error of up to 10%, but mostlicensees set their trigger level at 5% to 7%. Shouldyour dose calibrator not be linear throughout the entirerange of dosage measurements, a mathematical correc-tion factor must be used to compensate; otherwise, repairor replace and then retest the dose calibrator before use.The most common mistakes observed are a) failure tocarry the test out to 10 microcuries or below, b) whennon-linear, failure to determine and use correctionfactors, and c) failure to test quarterly, or after repair.(See 10 CFR 35.50 and Reference 1 and 2.)
Accuracy T=tAccuracy m- that for a given standwd reference
source, the assay is equal to, or within preset limits of,the assay of the source manufacturer. The accuracy t~tis done annually or after repair using, at a minimum,two different sources of different activities and principalphoton energies. The non-variable information that canbe preprinted on recordkeeping forms for the dosecalibrator accuracy test include the pharmacy name andRAM license number; the test name; make, model andserial number of the dose calibrator; the sealedradionuclide source name, model number, serial number,and tharetical activity; the potentiometer radionuclidesettings usd to measure the sources; the allowable rangeof activity within which test results should fall; thetrigger level; and the person to contact if the triggerlevel is achieved. The variables to be recorded includethe date of test; initials of person doing the test; themeasured activity for each source; and the percentdeviation of measured activity from thmretical activity.The RSO must sign the accuracy test records. NRCregulations allow an error of up to 10%, while mostlicensees set their trigger level at 5% to 7% (althoughsome have adopted even more restrictive conditions).Should your dose calibrator not be accurate it must berepaired or replaced, and subsequently retested beforeuse. (See 10 CFR 35.50 and Reference 1 and 2.)
Geometry T=tThe gwmetry tmt is performed to document that dose
assays are independent of geometric variation for therange of volumes used in both syringes and vials. Thistest is done before first use, and after repair. The non-variable information that can be preprinted onrecordkeeping forms for the dose calibrator geometrytest include the pharmacy name and RAM licensenumber; the test name; make, model, and serial number
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of the dose calibrator; the test radionuclide; the initialmeasured activity; the potentiometer radionuclide setting;the range of deviation allowed for gmmetry; the triggerlevel; and the person to contact if tie trigger level isachieved. The variables to be recorded include the dateof test; initials of person doing the test; and themeasurd activity for each volume change for bothsyringes and vials. The RSOmust sign the geometry testrecords. Again, the NRC regulations allow an error ofup to 10%, but most licensees set their trigger level at2% (this lower number is found in the NRC licensingguidance and subsequently has found its way into mostlicensm). Should your dose calibrator not havegametric variation independence throughout the entirerange of dosage measurement configurations, amafiematical correction factor must be used tocompensate; othewise repair or replace and then retestthe dose calibrator before use. A word o~cautz’on: Asmdiophannaceutical therapy with monoclinalantibodies (or any other non-con ve~”onal dosageforms) becomes more popdar, the volumes dispensedhave a much higher likelihood of exceeding thevolumes traditionally used or dispensed; thus, they maynot have been tested for geomettic independence. (See10 CFR 35.50 and Reference 1 and 2.)
Survey InstrumentsThe recordkeeping requirements for survey
instruments will vary depending on whether theinstrument calibration is done in-house, or contractedout. In either case the instrument must a) be calibratedin dose rate (mR/hour) from O to 1000 mR/hour, b)provide measurements within 20% of the calculatedexposure rate, and c) be calibrated before first use, afterrepair and yearly. In-house calibration requires acomplete record of each survey meter calibration, whilecontracting out for calibration services only requires thata licensee maintain a” certificate” of calibration from theservice. For in-house calibration, the requird recordsinclude a description of the calibration procedure; thedate of calibration; a description of the source and thecertified exposure rates; the rates indicated by theinstrument; any correction factors deduced fromcalibration; and the signature of the person doing thecalibration. Keep these calibration records for threeyears or whatever your RAM license conditions or Staterequires. Beware, however, that not all calibrationservices calibrate survey instruments to NRCspecifications. The two most common failings are usingelectronic calibration and/or orIly using one source. Besure to place a sticker or tag on the survey instrumentdenoting its calibration specifications. date of calibration,date next calibration is due, and name (signature) ofperson doing the calibration. Although no recordkeepingis required for this, the survey instrument must be
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checked for proper operation daily before use with adedicated check source. Most nuclear pharmacies willhave several survey instruments. Typically, at least one iwill be an ion chamber designed to measure dose rate?primarily, and have a low efficiency at finding ocontamination. Another will be a classic end window orpancake probe “geiger” counter for finding low levelcontamination. Some “geiger” counters are calibratedfor measuring dose rate, although most are not, and acommon mistake is to use the contamination surveyinstrument to look for contamination, and then recorddose rates into the daily survey log using the readingsfrom this meter. It is best to first look for, locate, andremove contamination, then return with the dose ratemeter for recording the radiation levels on the dailysurvey. (See 10 CFR 35.51 and Reference 3 and 4.)
Dosage AssayIn general, commercial nuclear pharmacies are
required to measure tie dosage of radiopharmaceuticalsprior to dispensing. This is not a regulatory requirement,but almost always is a license condition. The licensingguidance is sufficiently vague so that the details of therecordkeeping cannot be determined without examiningthe issue on a license by license basis. Nuclearpharmacies based in nuclear medicine departments arerequired to assay patient radiopharmaceutical doses asdescribed in 10 CFR 35.53. Part 35.53 requires th[following records be kept for three years: the name of o
the radiopharmaceutical (including tie radionuclide plusthe generic or trade name or abbreviation); lot number(prescription number); expiration date (time); patient’sname and identification number, if appropriate;prescribed dosage; measured dosage and date (time) ofmeasurement, or a notation that the dosage is less than10 uCi; and initials of person measuring the dose. Itwould appear logical to attach these records to theradiopharmaceutical preparation record from which theassayed dose was drawn. Where possible, it would beadvisable for all nuclear pharmacies to keep such recordsof dosages dispensed. There are situations where anindividual patient’s name will not be known, and then itis sufficient to dispense to the AU who ordered theradiopharmaceutical (depending on State board ofpharmacy regulations). (See 10 CFR 35.53 andReference 5 and 6.)
Radiopharmaceutical PreparationsFor commercial nuclear pharmacies there does not
appear to be any regulatory requirement or licensingguidance that mandates radiopharmaceutical preparationrecords. To some extent, however, the recordkeeping is ●required through an indirect means. 10 CFR 30.34 ~)requires a ‘Mo assay, and sets limits for ‘Mo per mCiof ‘Tc. In addition, in 10 CFR 30.51, there is a
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requirement to maintain records of receipt, transfer anddisposal of byproduct material, i.e., a “perpe~a]
7 inventory” requirement. Since these regulations require
e
that inventory be maintained and tracked, and that ‘Mo~levels in each patient dose be measured and recorded,radiopharmaceutical preparation records may be a criticalcomponent in helping to fulfill these regulatoryrequirements. These records must be retained for threeyears. There is specific guidance on radiopharm-aceutical preparation recordkeeping for nuclewpharmacies based in nuclear medicine departments. (SeeReference 6.)
‘Mo breakthrough tat rards must also be retainedfor three years. The non-variable information that canbe preprinted on recordkeeping forms for the ‘Mo assayinclude the pharmacy name and RAM license number,and the test name. The variables to be recorded includethe date of test; initials of person doing the test; themeasured activity of ‘Mo in uCi; the measured activityof *Tc in mCi; the ratio of uci of ‘Mo to mci of‘Tc; if more than one dose calibrator is used, the dosecalibrator identity; the date and time of measurement;and initials of person making the measurement. Theupper limit ratio of uCi of ‘Mo to mCi of ‘“Tc that canbe administered to a patient is 0.15. Through licensingguidance (and thus license conditions) most nuclearpharmacies have a limit of 0.07 (ratio of uCi ‘Mo to
emCi of *Tc) at the time of kit preparation. This is toinsure that the radiopharmaceut ical can be used until itsusual expiration time (six hours). This approach issomewhat simplistic and does not work for *Tc SodiumPertechnetate (expiration time = 12 hours), or anyradiopharmaceutical with a “shelf” life in excess of sixhours. A reasonable recommendation would be toestablish an in-house policy that would limit acceptable‘Mo breakthrough levels to a quantity which insures thatthe ‘Mo to ‘mTc ratio never exceeds 0.15 for anyradiopharmaceutical dose dispensed. It then follows thatthe upper limit of ‘Mo to ‘mTc ratio would be based onthe expiration time of the radiopharmaceutical with thelongest shelf life. If you have developed a ‘Mo triggerlevel, post it near the dose calibrator, and have itpreprinted onto the dosage assay forms. (See 10 CFR30.34(g), 35.204 and Reference 5 and 6.)
The ‘Mo breakthrough test requires a special lead-shield container (pig) that is designed to be used with thedose calibrator. If you choose to use a lead pig of yourown design for the breakthrough test, you must have thedocumentation to show that it is functionally equal to theone provided by the dose calibration manufacturer.
—-The record keeping requirements for sealed sources
apply mainly to calibration sources used for the qualitycontrol of the dose calibrator. Some nuclear pharmacies
do distribute sealed sources for other nuclear m~icinepurposes; those sealed sources that remain on the nuclearpharmacy license must have appropriate recordsmaintained on them. New sealed sources must be smemwiped to test for leakage, or have a certificate from thesupplier a) stating that the source was leak tested withinthe last six months and b) the results of that test. Afterinitial tests, sealed sources must be tested every sixmonths (or more often in some license conditions) toinsure detected leakage is less than 0.005 uCi. Therecords must be kept for five years and must contain themake, model and serial number of each scald source;the radionuclide name and activity (in uCi); the type oftest (describe wipe test); test date; and signature of RSO.(See 10 CFR 35.59 and Reference 5 and 7.)
In addition, nearly every license has inventoryconditions that call for a physical inventory every sixmonths to account for sources received and possessed.The records, kept for two years (some licenses requirethree, or five years), must contain the kind and quantityof byproduct material contained in the sealed source;name of the source manufacturer; model numbers andlocation of sources; and the date of inventory.Interestingly enough, there does not appear to be myrequirement that this inventory be signed by the RSOorby the person maintaining the inventory.
Daily Surveys and Weekly Wipe THtsThe rards of daily dose rate surveys and the wwkly
contamination smear wipe tests are kept for three years.The daily survey must be done with an instrumentsensitive to O.lmR/hour, and the weekly smear wipescounted in an instrument capable of accurately countingbelow 2000 dpm/wipe sample. Although wipe sample isundefined in the regulations, licensing guidance suggestsa limit of 220 dpm/wipe, where sample covers 100cm2.The areas that must be surveyed include any areas whereRAM was used routinely. Areas where very smallquantities are used can be surveyed month]y, and wastestorage areas can be surveyed weekly. Your RAMlicense may have slightly different requirements for areasand frequency of survey. Both daily and weekly surveysmust have trigger levels established; the RSO must benotified if the trigger level is reached. The non-variableinformation that can be preprinted on recordkeepingforms for the daily dose rate survey and weekly smearwipe test include the pharmacy name and RAM licensenumber; the test name; make, model, and serial numberof survey instrument; a list of sites to be surveyed/wiptiand/or a drawing of the areas; the trigger level; and theperson to contact if the trigger level is achieved. Thevariables to be recorded include the date of test; initialsof person conducting the test; and the measured doserate or counts/wipe for each area. There should also bespace for notes should a trigger level be reached or
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approached, or should the tester wish to recordsomething related to these surveys. In addition, thereshould be documentation on the counting efficiency ofthe instrument used to count the smear wipw. This isnecessary as the data must be recorded in dpm units, andthus the results must be Convertti from cpm to dpm.
Using forms for recordkeeping that have the areas tobe surveyed/wiped drawn on them facilitate visualizationof areas potentially contaminate, and help spot trends,or sloppy work habits. “(See 10 CFR 20.401, 35.70 andReference 8 and 9.)
Decay in Storage (DIS) for Disposal of RAMRecords for RAM held in storage until decayed to
background (and then disposed of as ordinary trash) arerequird to be retained for three years. The non-variableinformation that can be preprinted on recordkeepingforms for the DIS method of RAM disposal include thepharmacy name and RAM license number; the recordname; make, model, and serial number of the surveyinstrument used to measure the dose rate of the waste.The variables to be recorded include the wasteradionuclide; the date the waste was entered into storage;the date of waste disposal; the name of personresponsible for the disposal; the measured dose rate ofeach item to be disposed ofi the area in which the surveywas done; and the background reading in the survey areaat the time of the survey. There are some additionalconstraints on DIS; the material to be disposed of musta) have a physical half life of less than 65 days (thuslonger-lived waste must be disposed of by anothermeans), b) be held in storage for a minimum of 10 halflives, and c) found to have a reading (with no shieldinginterposti) that cannot be distinguished from backgroundwith the survey instrument on its most sensitive setting.The most common violations reported by NRCinspectors relate to a) not waiting the full 10 half 1ivesbefore surveying and disposal b) not surveying in a lowor normal background area, thus not detecting low levelcontamination or rmidual activity and c) not fullydefacing the radiation symbols and product labels. Theradiation symbols and labels must be defaced prior todisposal as ordinary trash. (See 10 CFR 20.401, 35.92and Reference 10.)
Inventory and Possmsion Limits of RAMAlthough there does not appear to be any specific
regulation requiring that an inventory of RAM be kept,it is required indirectly. Each license will have specific“maximum amount(s) that the licensee may possess atany one time. ” In order not to violate license conditions(which vary, depending on the scope of the program), aperpetual, or running inventory must be kept. This isgenerally a duty assigned to the RSO, but in nuclearpharmacies is done by the computer (electronically).
This electronic inventory must match a physicalinventory. It may be necessary to demonstrate to theinspector how your inventory control system works, andto document that electronic and physical inventoriesmatch. T’he major source of violations in this area isrelated to radioiodine inventory. This usually occurswhen several Na1311therapies are ordered, preparti, anddispensd on a single day. On these occasions, it issometimes noted that possession limits of *3110dineneedto be raised. (See 10 CFR parts 20, 30, 35 andReference 4 and 6.)
Compounding (Pharmacy- or Physician-DirectedDepartur=)
From August 23, 1990 to October 2, 1992, allradioactive drugs prepared in ways not listed in thepackage insert pursuant to a written directive(prescription) required certain records be kept. Whenfirst published in the Federal Register (55 FR 34513) thisrequirement was called the “Immediately EffectiveInterim Final Rule. ” It was put in place in response to apetition (PRM 35-9) from the American College ofNuclear Physicians and the Society of Nuclear Medicineto address certain restrictions in the regulations that mighthinder tie practice of medicine and pharmacy. ~IsInterim Final Rule gave physicians and pharmacists theflexibility to compound (deviate from the manufacturer’sinstructions when preparing radiopharmaceuticals)provided certain records were kept. On October 2, 1992,the NRC ended the recordkeeping portion of the InterimFinal Rule (57 FR 45568). The Interim Final Rule wasscheduled to terminate on August 23, 1993; however, theNRC has extended the Interim Final Rule (without therecordkeeping requirements) until December 30, 1994 (58FR 26938). This extension is necessary, so that theplanned revision of 10 CFR part 35, also known as theRadiopharmacy Rule, can be made final. This proposedrule will allow a qualified nuclear pharmacist (AuthorizedNuclear Pharmacist [ANP]) to prepare, or an AUphysician to use, any byproduct material for any medicaluse. This, in essence, will make the practice of nuclearpharmacy the same as the traditional practice of pharmacywith respect to compounding.
When preparing for an inspection, keep in mind thatcertain records were required to be retained during theinitial phase of the Interim Final Rule (8/23/90 through10/2/92). Specifically, the required information includesa written directive giving a specific departure for a patient(or patients) or radiopharmaceutical, the mture of thedeparture, a description of the departure, and thereason(s) why the departure from the package insert ismedical]y necessary. These records must be kept in anauditable form for a period of five years. (See 10 CFR30.34(i)(l), 35.200(c)(1), 55 FR 34513, 57 FR 45568,and 58 FR 26938.)
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Radiogases and RadioaerosolsNo specific records are required with regard to
? radiogases ad radioaerosols, and most license conditions
o
call forlimiting possession to unit doses. A related setof records and documents are those required by 10 CFRpart 20 regarding radioactive air concentrations. Theserecords and calculations must be maintained for theentire period the RAM license is active and include themeasurement and calculations used to determine the timenecessary to reduce room air concentration to levelsprescribed by 20.103 and/or 20.106 and any additionallicense conditions. These clearance times andemergency procedures must be posted in the appropriateareas. Common violations notd are a failure to post thearea, or to recalculate clearance times after remodeling.(See 10 CFR 20.103,20.106, and Reference 11.)
ALARA
The licensee shall have a written radiation protectionprogram which incorporates the philosophy of ALARA.Although this program is submitted as part of thelicense, it is expected, whenever there are significantchanges in the operation, that the ALARA program willbe updated as well. These program changes should bedocumented. Usually the changes that occur here arepart of the duties of the RSO to routinely evaluate the
o-adiation safety of the nuclear pharmacy and to updateprocdures as they are refined or changed. Sometimesprevious violations, and their corrective action, result inchanges in the ALARA program. (See 10 CFR 20.1(c),35.2, Regulatory Guides 8.10 or 8.18, NUREG-0267,and Reference 12.)
Training and SupervisionThe regulations require two types of training and
supervision of the workers by an AU. The initialtraining is somewhat generic and is directed atinstructing the workers on the regulations and 1icenseconditions that apply to them, and to instruct them inbasics, such as, which areas are restricted, who tocontact in an emergency, and what rights they have asradiation workers. The licensee is responsible for thisbasic training. The second type of training is morejob/profession specific and is related to the tasks forwhich the worker is responsible. This also includes allin-house policies and procedures. The supervisor (AU)is responsible for this second type of training, and forthe actions of the supervised individuals. The records oftraining must be kept for the length of the license andinclude the name of the person conducting the training,
e e attendees, date of training, and the topics covered.(See 10 CFR 19.12, 35, NUREG 1134, and Reference2 and
MlsadministrationsEmployees of centralized nuclear pharmacies do not
administer radioactive drugs to patients; rather, theydispense radiopharmaceuticals to AU physicians whopractice with RAM licenses issud under 10 CFR part35. Therefore, nuclear pharmacies cannot be solelyresponsible for a misadministration, and cannot be thereporting licensee. However, occasionally a dispensingerror by a nuclear pharmacist is the reason amisadministration occurs. Nuclear pharmaciw soinvolved in a misadministration should carefullydocument the event and any corrective actions(s) taken,should the misadministration trigger an inspection.
The triggering factors for a misadministration werechanged fairly dramatically when the QualityManagement Rule became final in January of 1992 (10CFR 35.2, and 35.32). The good news is that thetrigger level for diagnostic radiopharmaceutical (otherthan radioiodine) misadministrations increased from 5rem to 50 rem dose equivalent for any individual organ.This will eliminate nearly all diagnosticmisadministrations (except radioiodine). With thepolitical fallout from the recent print media articles inthe Cleveland Plain Dealer (December 13,14,15,16,17,1992), and the lethal brachytherapy misadministration inIndiana, PA (November 16, 1992) the NRC, under closescmtiny by the U,S. Congress, has taken a much moreaggressive and serious stance on misadministrations.Regulatory Guide 8.33 is an excellent tool for learningthe “ins and outs” of the Quality Management Rule.
RAM Receiving RecordsGenerally the conditions and records required for
receiving RAM are linked to RAM package openingprocedures, and are license conditions. The regulationsrequire recordkeeping in a general sense (again, linkedto inventory and possession limits), monitoring of thepackages receivd to assure compliance with shippingexposure rate limits, and testing for leakage. Thereceiving area must be located so as to keep radiationlevels in unrestricted areas at or below levels in 10 CFR20. 105(b)(l and 2). The regulations simply state thatrecords of receipt of RAM must be kept for three yearspast transfer or disposal of the material. 10 CFR 20.205requires smear wiping of packages (NRC notification isrequired if levels are in excess of O.OluCi or 22,000dpm/100cm2) and surveying them to confirm that thedose rate is less than 200 mR/hour at the surface or lessthan 10 mR/hour at three feet (NRC notification isrequired if levels exceed these limits). These tests mustbe done within three hours if received during workinghours, and within 18 hours if received after work hours,and records must be kept on these procedures. 10 CFR20.401 (b) and (c) require records of the results of thesurveying be kept in the same units as the surveys, and
8
3.)
be kept for two years. However, should contaminationor dose rate violation be detected the licensee is requiredto notify the shipper and the NRC. The implication isthat documentation of the finding of a violation isnecessary. Noting on the invoice that the package wassurveyed and that it was in compliance with theapplicable regulations (along with the name of surveyorand the date the survey was due) is suficient todocument complimce with the regulations. Packageopening is a license condition procedure, and is anextension of the receiving procedure. Package openingprocedurm may lead to discovery of other shippingviolations, and this is discussed in the section onShipping. [See 10 CFR 20.205, 20.401(b) and (c),30.51, 35.23 and Reference 12 and 14-16.]
Shipping Records and RequirementsShipping papers shall include a description of the
hazardous material being shipped. [See 49 CFR 172.101and 172.200 (a).] All RAM used in nuclear pharmaciesare considered hazardous material. The description mustbe legible and printd, may not contain any codes orabbreviations, and must contain an emergency responsephone number (49 CFR 172.600). In addition, otherrequirements include the proper shipping name (technicaland chemical group names may be entered in parenthesesdirectly after proper shipping name), the hazard class(may be contained in the proper shipping name), theidentification number, the total quantity by weight orvolume (including units of measure), the packaging typeand destination marks md, if a limited quantity, thismust be so stated. Moreover, for RAM, there are otherspecial regulations [see 49 CFR 172.203(d)]. Theshipping paper requirements for RAM include: the nameof each radionuclide (abbreviations are acceptable butmust come from the table in 49 CFR 172.435), adescription of the physical and chemical forms, theactivity in each package, the category of shipping label,and the transport index (TI). (The TI is a dimensionlessnumber found by rounding up the highest dose rate (inmR/hour) at 1 meter from the package[173.403 (bb)(l)].)
Package markings shall include the words “Type A“at least 1/2” in height and plainly marked on the outsideof the package (see 172.310). The package must also bemarked with a Radioactive label, properly completed,b~ed on the requirements in 49 CFR 172.403.
For RAM used in nuclear medicine a dose rate(highest reading) at package surface of less than 0.5mR/hour would require a “white I” Department ofTransportation (DOT) label (49 CFR 172.436); a doserate of greater than 0.5 mR/hour but less than 50mR/hour with TI of 1.0 or less require the use of a“yellow II” label (CFR 172.438); and a dose rate greaterthan 50 mR/hour with a TI greater than 1.0 require the
9
use of a “yellow 111”(49 CFR 172.440), [SW 49 CFR172.403(b)]. ‘f’hwe Radioactive labels must be on twosidm of the package (opposite each other), [see172.406(e)(3)]. The radioactive labels must alsocontain, in legible writing of a durable nature, the nameof the radionuclide (from 49 CFR 172.435), the activity,and the TI. Additional design requirements for Type Apackages are described in 49 CFR 173.412. The mostimportant feature, for nuclear pharmacies is the securityseal. The security seal shall not be readily breakableand, if intact, it provides evidence that the RAM has notbeen previously opend. In the case of exclusive usevehicle shipping, the cargo area may be sealed in lieu ofthe individual package. Absorbent packing in shippingcontainers is required when shipping liquids, and mustbe capable of absorbing twice the volume of liquidcontained in the package [49 CFR 172.412(n)(2)].
Package surveys for shipping packages have spwificlimits. The normal limit is 200mR/hour on the surface(highest reading) and a TI not exceeding 10.0. Apackage in excess of these readings can be transported inan “exclusive use shipment only“ vehicle. This vehiclemust be marked. Additional requirements include thefollowing: the dose rate of the package surface must bebetween 200 and 1000 mR/hour; the package must besecured to remain motionless while being transported;there must be no loading or unloading betweenbeginning and ending of shipment; the dose rate on theouter surface (any place) of the transportation vehiclemust not exceed 200 mR/hour; the dose rate at 2 metersfrom the outer surface (any place) of the transpofiationvehicle must not exceed 10 mR/hour; and the dose ratein any normally occupied space (e.g., drivers seat) mustnot exceed 2 mR/hour. This 2 mR/hour limit does notapply to private carriers if the driver (or other exposedpersonnel) are under control of shipper (employees whoare operating under a RAM license) and wear dosimetrydevices (49 CFR 173.441).
Shipping boxes and containers (e.g., ammunitioncans, specially designed attach~ cases) shall be designedso that each package can be easily handld and properlysecured for transportation. Packages from 22 to 110pounds shall be designed to be manually handled, witha minimum safety factor of three built into the design, sothat if a failure does occur, it does not impose an unsafestress on the structure of the package, or impair theability of the package to meet all the other requirementsfor shipping containers. The outer surface must beeasily decontaminated, and designed so as to not collectwater. Any feature(s) added to this container at the timeof transportation must not reduce the safety of thepackage (49 CFR 173.41 1).
Most nuclear pharmacies will use type A packaging,which must meet DOT 7A specifications (49 CFR178.350). You must have on file the documentation of
*
.
0
0
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certification for any Type A packaging you use, for aperiod of one year past latest shipment (49 CFR 173.415).
3
●,Delivery vehicle
The RAM license will require written procedures fordelivery of RAM which address requirements of 49 CFRparts 170 through 189, and describe procedures used toprovide security of the RAM (prevention of loss ofcontrol to a non-RAM license holder). Each vehicleshould have documentation describing a) contents of thevehicle in general, b) persons (with phone numbers) tonotify in case of emergency (traffic accident), c) generalradiation safety directions for drivers or personnelresponding in an emergency. These documents shouldbe reviewed and updated when necessary with eachchange documented.
CustomersNuclear pharmacy licensees are required to have on
file copies of current RAM licenses for all recipients ofRAM shipped. The RAM can only be transferred toanother RAM license holder. The recipient must havea current RAM license from the NRC or an agreementstate, and the nuclear pharmacy must have thedocumentation to support the validation of the recipient’sRAM license (10 CFR 30.41). Records for transfers ofRAM must be ker)t for three Years ~ast transfer as
program must require “film” and/or “TLD” badging forall employees who enter restricted areas. Somepersonnel may only be required to have whole bodybadging, while most RAM handlers will be required towear extremity badges as well. Exposure records mustbe monitored and compared to ALARA program triggerlevels, and this review must be documented. Anyabnormality in the exposure record must be investigated,and the investigation documented. Commonabnormalities are “lost” film badges, or badges whichare unreadable (washed in the laundry). In both cases,a “reconstruction” of work done during that time periodshould be used to estimate the exposure. This also mustbe documented, and entered into the permanent recordof that individual (10 CFR 20.201).
The film badge contractor who processes and assignsa dose to each film badge must be accredited by theNational Voluntary Laboratory Accreditation Program(NVLAP) (10 CFR 20.202). If the dosimetry reportprovided by the contractor does not state “NVLAP
oP-accredited” then such a statement should be obtainedfrom the contractor and file it with the dosimetryrecords.
Also, dosimetry from prior employment must be
obtained and maintained for each employee. This can bea signed statement from an employee new to radiationwork, or an NRC-4 form from a veteran radiationworker. In addition, for a previous radiation worker allof hislher previous exposures must be summed to insurethat his/her future exposures are not limited by previousexposures in excess of the limits (10 CFR 20.101).
GENERAL PHI~SOPHY
Without a doubt, the best mechanism to have asuccessful NRC inspection is to have well trained,ALARA-conscious, competent RAM handlers; to followall the rules, regulations, license conditions; and keepwell organized, retrievable, and complete records. It isalso very important to practice radiation safety everyday, just as you would if the NRC inspector waswatching. This means filling out forms, performing thesurveys, and filing the records daily. Routinely reviewthe files to insure proper placement, completeness, andclear organization. The manager or RSO should observeemployees and make radiation safety (ALARA) anumber one priority.
Although an insp~ion by any regulatory agencycanbe an uncomfortable and tense situation, it need notalways be that way. Try being upbeat and interested inthe inspector/inspection process. Act like the inspectionis a college midterm exam in a course for which youwere well prepared. Try to make “aceing” theinspection your goal.
Consider the impector as a friend who will audit yourprogram and clearly indicate areas that are notacceptable. Inform the inspector of your wish to have aperfect operation. Ask the inspector about arem in theregulations/recordkeeping that are unclear. Askspecifically if there are any areas in your practice thatcould be tweakedlfinetuned and if he/she has seenanother facility that perhaps does a certain functionbetter or safer. If so, ask the inspector for the name ofthat facility so you can contact the RSO or manager foradvice.
Specifically, you should ask the inspector during theexit interview what he/she thinks of the pharmacyoperation. How does it compare to the many otiers thatthe inspector has seen? Does the inspector have anyspecific or general recommendations to improve thepharmacy?
An obsewatz”on:Inspectom oflen work long houm,alone, and usually have to travel forpefiods of a weekmore. Inspection work can be lonely and, o~en becauseof the nature of their job, the iwpectom are treated asd they had a communicable dtieue. Yet, in reality, then.specter is probably a fellow “rad&on” worker, ofienwith some fom of patient care experience, and yourabsolute best source of info--on about the
10
regdations, the recotikeeping requirements, licensingactions, regufato~ gutince, and any upcomingchanges in the regultim. Tiy to make the inspe&”ona positive experience for both the iwpector ad theinspectee.
Shotid the insp-or find some flaws in your programthat will likely become violations, resist the temptationto become defensive and argumentative. First of all, theinspector has guidance and directives from managementthat do not allow much flexibility with respect toviolations. The inspector’s job rating is linked toinspections, and how they are handled. Secondly,should a violation be overlooked by one inspector andfound by another, especially if the overlooked violationis linked to a spill, source loss, or misadministration, itmay have a negative impact on the career of theinspector who did not document the violation. Lastly,finding violations means a great deal more paperworkand a large time commitment for the inspector, thusdecreasing his/her ability to fulfill the overall inspectionrequirements of the involved NRC regional inspectionprogram.
Take a positive approach when the inspector finds aviolation. Ask to be shown the details, how thisviolation can be rerndied for the next inspection, and ifthe inspector requires any additional information on theviolation. Now is a good time to provide the inspectorwith any additional information you may have, orextenuating circumstances that surround the violation.
Sometimm extenuating circumstance and additionalinformation can mitigate the finding of a violation. Aclassic example of this was a hospital that had aRadiation Safety Committee (RSC) violation, i.e., themembers were not promptly receiving copies of theminutw, and the committee was not, itself, retaining acopy of the minutes. During a subsequent inspection thesame violation was found, thus becoming a “repeat”violation, and the hospital was facing escalatedenforcement action. During the exit interviewmanagement was informed of the repeat violation andvery skillful] y informed the inspector of the “unusual”circumstances. Previously, the hospital had an employeewho had released privileged information to the press andas a result, the hospital had established very tightcontrols on documents. In fact, all the members hadread and initialed the RSC minutes, but then the onlycopy was filed in a controlled access file in the hospitaladministrator’s office, Thus the “intent” of theregulation was met. The inspector then added theadditional information to the report, and regional NRCmanagement decided that this was not a violation. Therationale was that each member did get a copy of theminutes to review and sign, and the minutes of themeeting were available for review, but had to berequested from the hospital administrator. This
11
additional information, plus the statement (and history)of the hospital’s policy were sufficient to mitigate awaya repeat violation.
~
This brings us to, perhaps, the most misunderstoodaspect of inspectors. Inspectors, generally, are not ●encouraged to make discretionary judgments, They areencouraged to write up all apparent violations, and thenlet regional NCR management and the licensee work outmitigation. This gives regional management the decisionmaking responsibility, because they have a broader viewof the violation with respect to the mission of the NRCto protecting the public health and safety.
A common complaint is that some inspectors findviolations where previous inspectors found none. Thishappens routinely and is, in fact, to be expected. Eachinspector has his/her own style, and areas of concern.Moreover, for many reasons (lack of time, or adiversion of allocated time to investigate a perceivdsafety problem), a given inspector may not thorough] yinspect every aspect of the operation. It is unreasonableto expect each and every inspector to be exactly thesame. My personal experiences with fellow pharmacistsis that each of us compounds and handles paperworkdifferently, some more carefully and completely thanothers. Therefore, give the inspector the sameprofessional latitude you would a fellow nuclearpharmacist,
If a violation is found by the inspector which wasmissed on a previous inspection, calmly state that sincethe area of concern was not cited on a previousinspection, you were unaware it was a problem. Thenask how to address the underlying problem. Listen, askquestions and make the required changes to be incompliance.
So, in summary, do encourage the inspector to askquestions, then provide the specific information and anyother information that may bear on the topic. Don’tpressure the inspector to mitigate in the field; rather,provide the facts and let the decision be made elsewhere.Remember the inspector is coming into your facilitywithout any “inside” knowledge specific to youroperation, so what appears clear and logical to you may,in fact, not be so to the inspector. Take the advice ofthe inspector and make the necessary changes.
Encourage the inspector to take field notes of theinspection and share those observations with you. Usethis interaction to get constructive criticism that will helpyou maintain regulatory compliance.
Many complaints have been voiced about inspectorsranging from incompetent, uninformed, attitudeproblems, to unprofessional conduct. The NRC has,within itself, an independent investigative branch, theInspector General (IG). It is the duty of the IG, amongothers, to investigate all allegations made against anyNRC employee. The lG answers directly to the
Commissioners, and is highly respected by all NRCemployees. If you feel that an inspector has actedimproper]y, you may describe, in writing, the offendingact(s), and notify the IG, or call the Office of theinspector General at 1-800-233-3497.
INSPECTION FREQUENCY
Although there are some exceptions, centralizednuclear pharmacies are usually inspected every otheryear, community hospitals every third year (heightenedinterest in medical use of byproduct material has pushedthis to every other year), and licenses of broad scope areinspected yearly. Variations from the schedules givenabove may be based on past inspection history or arecent misadministration.
Generally each inspection will be only for the periodof time from the last inspection to the present. Theexception would be if a violation is discovered, theinspector may proceed back through the records todetermine the duration of time the noted problem hasbeen occurring. Clearly note, on tie records, the dateof the last inspection. This will lessen the burden of theinspector in finding the starting date for records reviewfor the present.
THE INSPECTION
Introductory CommentsOccasionally, the inspectorwill observe the operation
of the nuclear pharmacy from a distance, prior toannouncing himself. The NRC is encouraging inspectorsto do more direct observation of radiation workers andless record review. In a business that is done indoors,observation at a distance is limited to viewing loadingand unloading of delivery vehicles. Therefore, it isadvisable to properly train the drivers on topics such asbasic radiation protection and security. Also, make suredelivery vehicles are properly placarded and have met allDOT requirements for manifests, invoices, andemergency notification instructions. Recently, securityof the packages in delivery vehicles and in nuclearpharmacies within nuclear medicine departments hasbeen a topic of increased inspection vigilance. It wouldseem advisable to reinforce the concept of locking doorsin areas where RAM is held when those areas are notattended by a radiation worker.
Following these initialobservations, the inspectorwillwalk into the nuclear pharmacy and announces his/herintentions. This is not a good time to panic or try tocatch-up on those records you have been meaning to
gb palate or file. Instead, the inspector should beintroduced to the pharmacy manager and/or RSO andgiven a business card from each of these individuals; inreturn, a business card should be requested from the
inspector.Shodd the insp~r arrive at a critically busy time,
briefly explain this to the inspector and ask if he wouldlike to take this time to either observe work in progressor start reviewing records. Give the inspector anestimate of the duration of time for this “busy” period.If the inspector wishes to observe, show himher thebasic layout of the facility md suggest a few placeswhere an observation can be made without impeding theflow of traffic. If records review is the inspector’s firstchoice, then ask an employee who is “nonessential” tothis critical time to show the inspector to an area suitablefor records review. Then instruct the employee to bringany records the inspector might want.
Once the critical period is over, introduce each ofthe employees to the inspector, inform them what theinspector is there to do, and ask them to attend the exitconference. If the employees have any questions theinspector might be able to answer, they should beencouraged to ask them as time permits. Ask theinspector to accompany you on an orientation tour sothat the physical plant may be briefly examined. Thenawait instructions on what part of the inspection processwill be next.
Each inspector will have differentpreference for theorder of inspection. All areas on the inspector’s fieldnotes will eventually be covered. The major inspectionsubject headings are:1.2.3.4.5.
6.7.8.9.10.11.12.13.14.15.16.17.18.19.
OrganizationScope of ProgramInspwtion HistoryInternal Audits or InspectionsTraining, Refresher Training, and WorkerInstructionFacilities and EquipmentRadiological Protection ProceduresRadioactive MaterialsReceipt and Transfer of RAMArea SurveysPersonnel Radiation Protection - ExternalPersonnel Radiation Protection - InternalRadioactive Waste DisposalNotification and Reports and MisadministrationsRadiation Safety OfficerTransportationIndependent MeasurementsBulletins ad Information NoticesSpecial Procedures
The following information describes what theinspector is likely to ask or observe with regard to eachof the 19 areas of emphasis (subject headings). Theinspector will have reviewed, before arrival, your RAMlicense and all correspondence, previous inspectionreports, previous violations and corrective action, if any.
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OrganizationThe inspector will quwtion workers about the duties
of various employees, their functional roles, and theirjob titles, in order to insure that the organizationalstructure in the RAM license is displayed/representedaccurately in the nuclear pharmacy. Two major areas ofinterest will be to determine if a) the AUS are listed onthe RAM license and if they are qualified, and b) theRSO is performing hislher duties and if he/she hassufficient authority to enforce the ALARA program andcorresponding radiation safety endeavors. Also, theinspector may want to see organizational charts, chainsof command, lines of authority, and job descriptions.
Scope of ProgramThis is a helpful indicator to gauge the amount and
types of activities in which the licensee engages. Sinceinspection frequency is approxirnatel y every two years,an operation can grow and change significantly in thatperiod of time. As a result the inspector will want toknow the number of a) current employees, b) dosesdispensed at the present time per day and a year ago (orat last inspection), c) generators received per week, d)delivery vehicles presently in use, and e) drawingstations. He/she will also desire to know any changes ininternal procedures or policies which occurred since thelast inspection, For example, has there been a change inRAM waste disposal procedures?
Inspection HistoryInspection history will contain the findings and
observations of previous inspectors. Any areas ofconcern to previous inspectors will be given top priorityin the present inspection. The first thing which will belooked at and verified is the corrective action taken onprevious violations. Second, any areas or fimctionsthought to be weak by a previbus inspector will berevisited by the present inspector. This might be a goodtime to explain previous violations or programweaknesses found and the corrective actions taken (alongwith the documentation of the corrective action). Theinspector will want to determine if there are anyuncorrected violations. Some corrective actions willinvolve equipment purchases which can be observed.Others will involve changes in procedures and practiceswhich can be verified through observation andinterviewing.
Internal Audits and InspectionsThe inspector will want to know if internal audits
(inspections) are done, the frequency with which theyare done, the person who performs the audit, and ifrecords of these audits are retained. An importantconcern or principle which the NRC purports is self-identifscation of, and correction of, violations by the
r
licensee. Some consider these actions to be consistentwith continuous quality improvement (CQI), a processthat, when applied to radiation safety, has been very “successful y employed in nuclear power facilities. It i’a policy being adopted by many major medical providers ●to improve patient care. If such a program exists in thenuclear pharmacy (internal inspections and/or CQI),whether it consists of a “hired gun” or an in-houseprogram, make certain that the inspector is aware of it.Give the inspector some examples of how it has workdto improve the pharmacy. Some licenses haveindependent audits as a license condition and, if so, theinspector will want to review those records as well.
Training, Refresher Training, and WorkerInstruction
As required in 10 CFR 19.12, worker training(instruction) is commensurate with potential radiologicalhealth protection problems in the restricted areas that theworker frequents. This training consists of informationon basic radiation protwtion, principal licenseconditions, and NRC regulations. The worker is giventhe training necessary to protect himself/herself fromunnecessary exposure and to comply with the licenseconditions and regulations. Strictly speaking, there areno recordkeeping requirements for this training, butfrom a practical standpoint, documenting workerinstruction makes good sense. This can be accomplished”by having the instructed worker sign and date a note ●which outlines the subjects on which they wereinstructd and which contains the name of the instructor.
Employee training is quite variable and is usuallyfound as a license condition. If the pharmacy has alicense-mandated training program, then be prepard toshow the inspector documentation of its implementation.Generally, this will be initial training for new employeesand refresher training for existing employees. Training,if not license-mandated, is the responsibility of thesupervising AU or the RSO, depending on the type oftraining. Records of initial and refresher training mustinclude date of training, subject matter, instructor andinstructed. Some types of training are related to job dutyand the supervising AU is usually responsible for thistype of training. Some training covers general radiationsafety or is refresher in nature, and it is the duty of theRSO to provide this type of training. Required trainingwhich includes generic radiation protection andregulatory requirements is outlined in 10 CFR 19.12.As long as the topics listd in 10 CFR 19.12 arecovered, job-specific training can fulftil bothrequirements. The inspector will review these trainingdocuments to verify compliance. m
Refresher training is done yearly, or as often as alicense condition requires. The topics may vary but, ata minimum, should contain a review of the basics of
13
i
radiation Protection ad NRC regulations. Document thistraining ‘by keeping records- of topics, attendees,
~instructor, and dates taught.
● ’ The inspector may interview certain workors to‘ascertain their”knowledg~ of the regulations that impacttheir duties as a test of the training program. It is likelythe inspector will ask staff about 10 CFR 19.12 trainingand the RAM license, the shippers and drivers aboutDOT requirements, female workers (with obvious childbearing potential) about Regulatory Guide 8.13~nstruction Concerning Prenatal Radiation Exposure),and nuclear pharmacists and technologists about ‘Mobreakthrough testing and limits.
Facilitiw and EquipmentThis part of the inspection is often done
simultanwusly with another part of the inspection, whilethe inspector is observing or taking independentmeasurements. The size, the state of maintenance(lighting, paint and floor condition), layout, andequipment will be noted and evaluated. The RAMlicense will have described the facility, and theinspector, at a minimum, will insure that the licenseconditions are fulfilled. Some of the questions theinspector will consider during the facility inspection arethe following: Is the facility designed with ALARA inmind? Is it a safe workplace for tie workers? Is theemployee lounge clearly separate from the work areas?Is the RAM refrigerator clearly marked “No Food orDrink?” Are there any obvious OSHA or EPAviolations? Is the RAM area secured from unauthorizedentry? Are the RAMs secured from theft? Is thephysical plant clean, well ventilated (heated and/orcooled), and conducive to preparing and dispensingradioactive drugs? Are there signs of an adequateALARA program? Is there adequate shielding andposting? If decay in storage is used for radioactivewaste disposal, is the storage area well shielded,separated from work areas, and secure?
Posting and Labeling. Is the NRC-3 “Notice toWorkers” posted in each work area? Is the RAM licenseposted in a worker-accessible area along with theapplicable parts of 10 CFR 19, 20, and 21?
Are the restricted areas clearly delineated? Are theymarked as a radiation area or posted with a RAM sign?Is the pharmacy permit (license) current and displayed?(A current pharmacy permit is a licensing condition.)Are the emergency procedures clearly posted?
.Equipmeti. The inspector will look to confirm that
●k quipment listed on the license is present and operatingproperly. At a minimum, this includes a dose calibrator,survey instruments (both a “geiger” type and anionization chamber type), and syringe and vial shields.
It may also include biological safety cabineti, fumehoods, multichannel analyzers, HPLC, autoclavw, anda host of other items. The role that these additionalitems play in radiation safety will determine theirimportance to the inspection process.
It maybe helpful to affix labels to the dose calibratornoting that the instrument is linear, accurate,gwmetrically independent, and constant, and indicatingthe retmt due date for each test. The calibration labelfor the survey instruments should also note when thenext calibration is due. For any instrument notoperating properly and requiring a mathematicalcorrection, a clear, prominent, label should be afflxdnoting that a correction factor is requird. Anyinstrument not currently in use (e.g., in storage orawaiting repair) should be so noted with a label in orderto prevent inadvertent use.
Equipment must be quality control (QC) checkedpostrepair (battery changes are not considerd repair).Survey meters need to be recalibrated post repair andprior to use, then recalibrated yearly thereafter (or.sooner if license conditions so require). Dose calibratorconstancy checks should be performed at the beginningof each day. Dose calibrators require a complete QCcheck post repair and prior to use. This meansaccuracy, geometry, linearity, and constancy testingbefore first use and post repair. Neither the regulationsin 10 CFR 35.50 nor the guidelines in Reference 1require retesting post relocation, but Reference 2 doesrequire this procedure. Check your license on thispoint, and ask the inspector what constitutes a relocation.Is it a move within a room, a move within the samefacility, or a move to an entirely new facility?
The inspector will look for vials and containers to beproperly labeled with the radiation symbol, radionuclidecompound name, date/time of assay, radioactivityconcentration, and volume. Some licenses will havecolor-coding conditions which will also be confirmed.
Radiological Protection Procedur6To determine the adequacy of the radiological
protection program, the inspector will initially observethe equipment and instrumentation and then proceduresand practices (document review and direct observation).1s the use of RAM in accordance with the license? Thiscan be determined by observation and interviewingworkers. Do the workers understand the general rulesfor safe use of RAM? Were the workers given part 10CFR 19.12 training? Is there an “emergency plan, ” anddo the workers understand it? The inspector willobserve workers to determine if proper lab attire isworn, if gloves are used (and frequently changed whilehandling RAM), and if hand monitoring is performdpost RAM use. Are the workers using vial and syringeshields? Are hands, feet, containers, and syringe shields
14
routinely monitored for contamination? Are the workareas covered with absorbent material which is changedroutinely or after positive survey findings? Are areasoutside the facility (or non-radiation areas within thefacility) surveyed?
Surveys. The wipe tests which are done to determine ifremovable contamination is present (usually doneweekly) must be countd using suitable instrumentation.Is the counting instrument sensitive enough to detectcontamination below the trigger level? What is thecounting eff~ciency of the instrument? A determinationof counting efficiency is necessary to display smear wipedata in disintegrations per minute (dpm). Data collectedin counts per minute (cpm) must be converted into dpm.Is the staff trained to make area smear wipes covering aminimum of 100 cmz? When contamination is found, isit documented and corrective action taken? Was theRSO notified? Are follow up smears taken to confirmthat the contamination is either below trigger level ornon-removable?
Radioactive MaterialsThe inspector will survey the scope of use of RAM
by the licensee, and compare it to the RAM license. Isthere any inventory control mechanism/procedure to as-sure that the quantity of RAM possessed is below licenselimits? Is the licensee knowledgeable of the licensepossession limits? Are there written directives fordeviations from the package insert for the period of timerecords were required? Has a ‘Mo breakthrough testbeen done for each generator elution, and the appropriaterecords retained? Have the sealed sources beeninventoried and wipe tested? Are gasmus and volatileRAMs stored in a chemical fume hood or glove box?
Radiopbtmaceutl”cal Preparation. Most nuclearpharmacies have license conditions that requireradiopharmaceutical preparation in accordance with thepackage insert instructions. Even those nuclearpharmacies which have obtained license amendments forfuture unspecified departures have procedure manualrequirements, record keeping requirements, and/or QCrequirements. Thus, the inspector may want to reviewradiopharmaceutical preparation records to determine if“deviations” from the package insert instructions haveoccurred without a written directive from the prescriber.
Radiophamceti”cd Quality Control. Some nuclearpharmacies have QC license conditions. Generally agood place to keep these records is with the records forRAM. Usually records will he retained that describeeach elution of the generator and disposition of each mCiof the eluate. The ‘Mo breakthrough records aretypically kept along with elution records. If your license
also requires aluminum ion testing or radiochemicalpurity testing, then records of this procedure should alsobe kept in this same location. For eachradiopharmaceutical prepared, similar records need to bpon file. The inspector will confirm compliance witillicense requirements by reviewing records.
Receipt and Transfer of Radioactive MaterialThe inspector will exarnineby observation, interview,
and records review, the procedures for package receiptand opening. Is this done with the concept of ALARA(radiation safety) and security in mind? Are theseprocedures compatible with the license conditions and 10CFR part 20? Are the packages surveyed and wipetested as required? Are the records in order? Is theprocedure for after-hours receipt of packages current andadequate?
Tmnsfer (Shipping) of RAM. Preparation of RAM fortransportation is obviously a large part of the work in anuclear pharmacy. Has each outgoing package beensurveyed and wipe tested? Is the shipping areasufflcientl y large and does it have a low background forproper TI determination? Are the shipping papers filledout properly? Are DOT labels and security sealsaffixed? Are all liquids shipped with absorbent material?Are the delivery cases secure and do they contain therequired information? Are DOT 7A shipping containerused, and used as tested? Is the DOT 7A certificationon file? Do the drivers have a manual containing therequired material? If containers are being returned inaccordance with the DOT definition of “empty,” are theoriginal DOT labels covered (with a label that reads“empty”) or defaced (to be unreadable)?
A wod of caution: Drivem am o~en a weak link ina chin of radtion safety. They should be carefldlyinstructed in radiation safety pn”nciples and pmcticespertaining to shipping and delivering. Inti trainingshould be followed up with refresher tmining asneeded. me dn”vefl will likely be observed (o@en at adistance, and unannounced) and interviewed.
Delivery Vehicles. The inspector may examine thedelivery cars for compliance with DOT shippingregulations by checking on items such as bracingcapabilities for packages containing RAM, emergencynotifications, signs and procedures, placarding,emergency equipment, security (working locks),operational seat belts, and driver procedures forreporting accidents or contamination.
Arw SurveysSurvey records will be reviewd by the inspector to
determine if surveys are done, and to determine whichareas are routinely surveyed. On occasion, the inspector
:
P..
0
●
15
?
will observe surveys in progress and try to determine ifthe surveyor is using the instrument appropriately. Was
3a (turn on) battery check and a check source test
ouerformed?Are the areas surveved reflective of work areas? Are
the surveys done at ‘times most like]y to detectcontamination? Is the survey instrument appropriate forits intendti use? The inspector will confirm thatambient exposure rate surveys are done daily [10 CFR35.70(a)@)(c)], that contamination surveys are doneweekly [35.70(e)(f)], and that the counting instrumentfor the smear wipes is operational, calibratd, andappropriate for its intended use. The inspector willexamine trigger levels for each survey. Are theexposure rate surveys recorded in mR/hour? Are thecontamination survey data recorded in dpm?
men the insptir will compare daily dose calibratorconstancy checks and daily surveys to determine if workwith RAM was done (or doses dispensed). Theinspector will look for a mismatch, a day, usually aweekend or holiday, when doses were prepared andassayed without dose calibrator quality control and/or asurvey being done. A large number of violations arefound, especially on weekends and holidays, doing thiskind of comparison. It is important to remember that,if you work with RAM, even on a weekend or holiday,you must survey. If you prepare a patient dose, you~ust also do dose calibrator quality control (constancycheck) prior to dose assay.
Personnel Radiation Protection - ExternalThe inspector will observe workers and confirm
that dosimetry devices are being worn by all requiredworkers. Also, the inspector will review thedosimetry reports for completeness and for dosereported. The inspector will confirm that dosimetryis done by a NVLAP-certified lab, that the repofis arereviewed by all appropriate personnel, and that anyexposures reaching a trigger level were investigated.He will review these investigations, corrective actiontaken, and follow up to insure ALARA is maintained.
Any unreported exposures will require aninvestigation, and a “reconstruction” of the activitiesof that employee to estimate an exposure for themissing period of time. This should include aninterview with the employee. Estimated exposuremust then be permanently entered into the dosimetryrecord, and the estimation process documented by thelicensee.
●1
Were there any overexposures? Were they‘leported to the NRC (10 CFR 20.403). and a writtenreport made (10 CFR 20.405)? Are personneldosimetry records kept (on proper NRC forms)?Were they retained for the required time?
Personnel Radiation Prot&tion - InternalInternal dosimetry assessment and recordkeeping is
more complicated depending on license conditions.Generally, there are two acceptable routes to take: urinecounting, and thyroid counting. Whichever method isincluded as a license condition, the inspector willconfirm its use, and assure that the method is sensitiveto below the minimum detectable level as given in theRAM license. Procedures for bioassay equipment shouldinclude adequate QC to insure accuracy. In areas wherevolatilization of radioiodine is possible, are breathingzone and room air monitors used? Is the air monitortested to insure sensitivity to the levels stated in thelicense?
For protection against exposure to radioactive gas=,safety procedures and room clearance times for the gasesshould be posted in appropriate work areas, Recordedinformation should include hood flow rates, negativeroom pressure determinations, and ventilation rates(room air exchanges). The inspector will review recordsto confirm that this information is on file and mayobserve if minimum hood door closing is followed, Aneasy way to encourage compliance is to affix a label oneach hood which lists measured flow rate, the date thenext measurement is due, and the valu~ for theminimum door opening required to maintain theminimum acceptable flow rate.
Radioactive Waste DisposalAssuming that most waste disposal in nuclear
pharmacies will be handled by DIS, the inspector willreview the current waste disposaJ program and compareit to the license conditions and the regulatoryrequirements. The inspector will look for segregation ofwaste by liquid versus solid, and by half life. Also, theinspector will look at records of radioactive wastedisposal. Is the radioiodine waste stored in sealedcontainers or in the hood? Is activated charcoal used totrap volatile radioiodine? Are radioiodine-containingsyringes stored in the hood as well? Is radioactive wastestored for 10 half lives, and then surveyed in a lowbackground area? Was all shielding removal fromgenerators prior to surveying? Were all the radioactivelabels obliterated prior to disposal in ordinary trash?
Notification, Reports and MisadrninistrationsThe inspector will review the records to insure that
the workers are informal of their exposure records(routine - 10 CFR 19.13; overexposures - 10 CFR20.405), and that any thefts or losses (10 CFR 20.402)have been reported to the NRC. Any incidents or spillsthat exced tie routine contamination-resulting from day-to-day work must be reported [10 CFR 20.403 andInformation Notice (IN) 91-86]. Although, in thmry, anuclear pharmacy would not be directly responsible for
16
.
a misadministration, mistakes in nuclear pharmacies dooccur (although rarely), and these mistakes often resultin a misadministration (or sometimes multiplemisadministration stemming from a single nuclearpharmacy mistake). Since the medical licensee maymention in its misadministration report that the dosewhich was misadministered was obtained from acentralized nuclear pharmacy, that nuclear pharmacyshould have a written report of the incident and thecorrective action taken on file. Discussion among NRCstaffers has raised the question of whether nuclearpharmacies should have reporting requirements fornuclear pharmacy-generated misadministrations sinceeach incident can affect several patients. The sum of thedoses to the affected patients could easily trigger thenew, higher (single patient) misadministration triggerlevels.
Radiation Safety Officerme performance of duties by, and management
support of, the RSO are, in the eyes of the NRC, criticalto the success of any radiation safety program. Theinspector will want to interview the RSO to determine ifhe/she takes an active role in the ALARA program, andin the day-today radiation safety of the nuclearpharmacy. The inspector will be particular y interestedin any regulatory or internal radiation safety audits anddocumentation; content and records of training providedby the RSO; the RSO’S knowledge of the license andregulations; and evidence of support for the RSO frommanagement.
Transportationme inspector will check for compliance with the
requirements in 10 CFR parts 61, 71, and 49 CFR parts171 through 189. A license to dispose of radioactivewaste is required in 10 CFR part 61, so the licensee willhave waste disposal as a license condition. Additionally,the nuclear pharmacy may be disposing of returned spentradiopharmaceuticals, and assuming responsibility fortheir shipping requirements. 10 CFR Part 71 describesrequirements for transportation of licensed material,which includes the DOT requirements of 49 CFR parts171 through 189 (labeling, placarding, marking,packaging, monitoring, recordkeeping, and accidentreporting).
Independent MeasurementsThe inspector may measure dose rata at various sitm
within your facility and compare them withmeasurements made with in-house meters. This is doneto confirm reported dose rates and proper operation ofsurvey instruments. Also, some inspectors will look forcontamination in areas supposedly free of contamination,such as, ordinary waste cans, or door knobs in
>.unrestricted areas. Another often-used procedure is tosurvey ordinary trash containers (dumpsters) to check for ~improper disposal of RAM.
Bulletins and Information Noti~Besidw licensing correspondence, the NRC sends out –
Bulletins and Information Notices ON), publishes noticesin the Federal Register (FR), and has a newsletter(NMSS Licensee Newsletter). The inspector will look tosee if these have been received and complied with,where appropriate. The NRC has published 16 INs onnuclear medicine subjects from 1981 to present.
INs of the past 13 years are:
Nuclear Medicine Subjects
IN 81-32
IN 84-27
IN 85-61
IN 88-53
IN 89-12IN 89-85
IN 90-58
IN 90-59
IN 90-71
IN 91-03
IN 91-71
IN 91-86
IN 93-04
IN 93-07
IN 93-10IN 93-14
IN 93-36
17
Transfer and/or Disposal of SpentGeneratorsRecent Serious Violations of NRCRequirements by Medical LicenseesMisadministrations to PatientsUndergoing Thyroid ScansLicensee Violations of NRC RegulationsWhich Led to Medical DiagnosticMisadministrationsDose Calibrator Quality ControlEPA’s Interim Final Rule on Medics’Waste Tracking and Management o
Improper Handling of OphthalmicStrontium-90 Beta Radiation ApplicatorsErrors in the Use of Radioactive Iodine-131Effective Use of Radiation SafetyCommittees to Exercise Control OverMedical Use ProgramsManagement of Wastes Contaminatedwith Radioactive Materials (“Red Bag”Waste and Ordinary Trash)Training and Supervision of. .IndividualsSupervised by an Authorized UserNew Reporting Requirements forContamination Events at MedicalFacilities (10 CFR 30.50)Investigating and Reporting ofMisadministrations by the RadiationSafety OfficerClassification of TransportationEmergenciesDose Calibrator Quality ControlClarification of 10 CFR 40.22, SmallQuantities of Source Material oNotifications, Reports, and Records ofMisadministrations
i
Other INs that may be of interest to nuclear pharmacists
eWanagemeti Control
IN 88-10
IN 88-100
IN 89-25
lN 89-35
IN 90-01
IN 90-14
IN 92-37
IN 88-15
IN 90-44
@?ranspoti&ion
IN 80-32
IN 87-31
IN 91-35
MaterialsManagementPrograms
Licensees: Lack ofControls over Licensed
Memorandum of Understanding BetweenNRC and OSHA Relating to NRCLicensed FacilitiesUnauthorized Transfer of Ownership orControl of Licensed ActivitiesLoss and Theft of Unsecured LicensedMaterialImportance of Proper Response to Self-Identified Violations by LicenseesAccidental Disposal of RadioactiveMaterialsImplementation of the DeliberateMisconduct Rule Radiation ProtectionAvailability of US FDA Approved KIfor Use in Emergencies InvolvingRadioactive IodineDose-Rate Instruments Underrespondingto the True Radiation Fields
Clarification of Certain Requirementsfor Exclusive Use Shipments ofRadioactive MaterialsBlocking, Bracing, and Securing ofRadioactive Materials Packages inTransportationLabeling Requirements for TransportingMulti-Hmard Radioactive Materials
Other NRC publications that may be of interest tonuclear pharmacies, beside the ones previouslyreferenced in this course are:
NRC Regul&oty Guides
7.3”
8.7
8.10
●w,.158.18
Procedures for Picking Up and ReceivingPackages of Radioactive MaterialInstructions for Recording and ReportingOccupational Radiation Exposure DataOperating Philosophy for MaintainingOccupational Radiation Exposures as Low asReasonably AchievableAcceptable Programs for Respiratory ProtectionInformation Relevant to Ensuring that Occupa-tional Radiation Exposures at Medical Institu-tions Will Be as Low as Reasonably Achievable
8.20 Applications of Bioassay for 1-125 and 1-1318.23 Radiation Safety Surveys at Medical Institutions
NUREGS
1400 Air Sampling in the Workplace1446 Standards for Protection Against Radiation 10
CFR Part 20, A Compariso~of the Existing andRevised Rules
1460 Guide to NRC Reporting and RecordingRequirements
There are numerous other NRC documents that may beof use to nuclear pharmacy but are beyond the scope ofthis course to list. They are Bulletins, Policy andGuidance Directives, and notices in the FR.
NUREGS and Regulatory Guides can be purchasedfrom:
US Government Printing OffIceSupervisor of DocumentsP.0, BOX 37082Washington, DC 20013-7082(202) 512-2249
IN and Bulletins can be obtained from:
Linda Stevenson, P-370USNRCWashington, DC 20555(301) 492-9531
Special ProceduresSome licenses may have certain radiophannaceutids
or certain radiolabeled agents that require some specialprecautions and procedures. If possible, the inspector
will want to observe these ~rocedures. If this is notpossible, the inspector may ~eview the procedures andequipment used. The inspector is also likely to requestan interview with the workers most familiar with thesespecial procedures. An example of this might becompounding of 1-131 capsules from bulk radioiodine.Another example is cell labeling. This procedure oftenresults in bioh=ardous/mixed radioactive waste issues,and it requires special precautions to help insure thatradiolabeled blood is properly labeled, thus facilitatingreinfection of the product into the correct patient.
Exit InterviewThe exit interview signals the end of the inspection.
At this time, the inspector will usually insist on briefingmanagement of his/her findings. He/she will take thisopportunity to stress the importance of a) supportingradiation safety initiatives and policies of the pharmacy,
18
and b) fulfilling the regulatory and license requirementsof the NRC. Any programmatic weaknesses orviolations will be mentioned at this time, and any actionsto follow will also be described. If a violation is found,the inspector will mention that a Notice of Violation(NOV) will be delivered by mail following theinspection, and it will require a written response. Moreserious violations may require an enforcementconference or civil penalties, depending on the severitylevel of the violation. Generally, an exit interview is anappropriate time for the inspector to mention strong andweak points in the inspection. This exit interview timeis also ideal for the licensee to ask questions of theinspector.
SUMMARY
Although what may have seemed along, tedious, andconvoluted process, this CE lesson has reviewed therecordkeeping requirements of the NRC for nuclearpharmacies. Also reviewed were the hems which aremost likely to be assessed with regard to each of themajor subject headings listed on the NRC inspector’sfield notes. This review, when used as a guide for selfevaluation, prior to an NRC inspection, will be atemplate for a successful inspection. The most commonviolations found in nuclear pharmacies have beendiscussed to provide the nuclear pharmacist with areasthat might need additional vigilance. A strategy forinspector relations, derived from interviews withinspectors that will insure minimum anxiety during theinspection process has been proposed. Remember thatthere is no substitute for thorough preparation, completerecords, and safe work habits.
REFERENCES
1. Appendix E, “Procedures for Calibratio~lof DoseCalibrators” of Task FC 410-4, “Guide for thePreparation of Applications for Nuclear PharmacyLicenses,”
2. AppendixC, “Model Procedure for Calibrating DoseCalibrator” of Regulatory Guide 10.8, “Guide for thePreparation of Applications for Medical Use Programs. ”
3. Appendix D, “Proceduresfor Calibrationof SurveyInstruments” of Task FC 410-4, “Guide for thePreparation of Applications for Nuclear PharmacyLicenses. ”
4. Appendix B, “Model Procedure for Calibrating SurveyInstruments” of Regulatory Guide 10.8, “Guide for thePreparation of Applications for Medical Use Programs. ”
5.
6.
7.
8.
9.
10.
11.
12.
13,
14.
15,
16.
19
v
Appendix H, “General Rules for Safe Use ofRadioactive Material” of Task FC 4104, “Guide for mePreparation of Applications for Nuclear Pharmacy *Licenses. ” /
Appendix M, “Records of Byproduct Material Use” ot@
Regulatory Guide 10.8, “Guide for the Preparation ofApplications for Medical Use Programs. ”
Exhibit B (Numbers 13 and 14) of Task FC 410-4,“Guide for the Preparation of Applications for NuclearPharmacy Licenses. ”
Appendix J, ‘Area Survey Procedures” of Task FC 410-4, “Guide for the Preparation of Applications forNuclear Pharmacy Licenses. ”
Appendix N, “Model Procedure for Area Survey” ofRegulatory Guide 10.8, ”Guide for the Preparation ofApplications for Medical Use Programs. ”
Appendix R, “Model Procedure for Waste Disposal” ofRegulatory Guide 10.S, “Guide for the Preparation ofApplications for Medical Use Programs. ”
Appendix 0, “Model Procedure for Monitoring,Calculating, and Controlling Air Concentrations” ofRegulatory Guide 10,8, “Guide for the Preparation ofApplications for Medical Use Programs. ”
Appendix G, “Model Program for Maintainin~OccupationalRadiationExposureatMedicalInstitutio~ALARA”of RegulatoryGuide 10,8, ‘Guide for the
oPreparation of Applications for Medical Use Programs. ”
Appendix A, “Training and Experience for AuthorizedUsers and Day-to-Day Radiation Safety Officer” of TaskFC 410-4, “Guide for the Preparation of Applicationsfor Nuclear Pharmacy Licenses” and Appendix A,“Model Training Program” of Regulatory Guide 10. S,“Guide for the Preparation of Applications for MedicalUse Programs. ”
Appendix F, “Procedures for Ordering and ReceivingRadioactive Material” of Task FC 410-4, “Guide for thePreparation of Applications for Nuclear PharmacyLicenses. ”
Appendix K, ‘Model Guidance for Ordering andReceiving Radioactive Material” of Regulatory Guide10.8, “Guide for the preparation of Applications forMedical Use Programs. ”
Appendix L, “Model Procedure for Safely OpeningPackages Containing Radioactive Material” ofRegulatory Guide 10.8, “Guide for he preparation ofApplications for Medical Use Programs. ”
*
QU~TIONS
r
●1. The fee charged
inspection is:
A. $150.00B. $1OOO.OOc. $1500.00D. $2000.00
by the NRC for a routine
2. NRC inspectors, in the course of a week, mayinspect all of the following except:
A. pipe radiographersB. coal moisture densityc.. nuclear power plantsD. nuclear pharmacies
gauge users
3. The recordkeeping requirements which the NRCwill inspect stem from all of the following except:
A. 10 CFR parts 20, 30, 32 (NRC)B. RAM License conditions and amendmentsc. 49 CFR parts 170- 1S9 (DOT)D. 21 CFR parts O-1200 (FDA)
4. Which dose calibrator quality control test
o done quarterly?
A. constancyB. geomet~c. accuracyD. linearity
must be
5. Survey instruments must be calibrated before firstuse and
A. quarterly and post repairB. yearly and post repairc. every three years and post repairD. post repair andlor battery replacement
6. The limiting ratio of uCi %0 to mCi *Tc thatmay be administered to a patient is:
A. 0.015B. 0.15c. 1.5D. 5.0
7. Sealed sources require a wipe test and a physicalinventory every:
8. Daily dose rate surveys and weekly wipe testrecords must be kept in units of and
9respectively.
A. MIUhour and dpmB. mlUhour and cpmc. m~our and dpmD. MR50ur and cpm
9. For decay in storage, the half life of theradionuclidesmustbe less than , andthe RAM stored for half lives.
A. 65 hours and 10B. 65 days and 100c. 65 hours and 100D. 65 days and 10
10. Which radionuclide is most likely to musepossession limit violations?
A. WcB. %0c. 131ID. rnlTl
11. Compounding, .on a limited basis, pursuant to awritten directive, is allowed by which ride?
A. Quality ManagementRuleB. The RadiopharmacyRulec. The Immediately Effective Interim Final
RuleD. The Nuclear Pharmacy Guideline (1984
Lavender Report)
12. With respect to radiation safety, the acronymALAR4 means:
A. As Low As Reality AllowsB. At Lowest Assay Reason Allowsc. As Low as is Reasonably AchievableD. A Little or Almost no Radiation is Allowed
13. In January 1992, the definition of misadministrationchanged, and the trigger level increased toREM for dose equivalent for any individual organ.
A. 5B. 15C. 25D. 50
Ow A. quarterB. six monthsc. yearD. three years
20
14. RAM packages received duting normal workinghours must be formally receivedaccordingto licenseprocedures within:
A. three hoursB. six hoursc. twelve hoursD. eighteen hours
15. The absorbent material used in packing liquid RAMshipments must be able to absorbthe volume being shipped.
A. 1/2B. 2 timesc. 3 timesD. 5 times
16. The highest dose rate at the surface of a package,and the highest TI allowed for shipping other thanexclusive use shipments are:
A. 2000m~our and 10.0B. 200mR/hour and 1.0c. 20mR/hour and 0.1D. 200mMour and 10.0
17. You must have valid documentationof which of thefollowingbefore shipping RAM?
A. the medical license of the recipientB. the HCFA registration of the receiving
hospitalc. the RAM license of the recipient
D. the JCAHO certification for the recipient
18. If an NRC inspector finds a violation, you should:
A. argue loudly and try to change his mind
then threaten to call the NRC’s InspectorGeneral.
B. calmly explain the circumstancessurrounding the violation and present anyadditional information that might be useful.
c. state, “The last inspector didn’t cite us forthat!”
D. say, “We have always done it that way.What’s wrong with that?”
19. Which NRC office should you contact if you havea significant problem involving behavior or conductof an NRC employee?
A. Office of State ProgramsB. Office of Nuclear Materials Safety and
Safegaurdsc. Office of the General CounselD. Office of Inspector General
20. Nuclear pharmacies are uswlly inspected every: .
A. yearB. two yearsc. three yearsD. five years
21. During an inspection, the inspector will beespecially interested in records becausethey may be helpful in identi~ing past and presentprogram weaknesses,
A. area surveys and dosimetryB. training and equipmentc. inspection histo~ and internal auditD. radioactive waste disposal and shipping
22. Which topic has been of considerable concern toNRC inspectors within recent years?
A. state of the art equipmentB. compoundingc. security of RAMD. qualification of nuclear pharmacists
23. Dosimetry services (“film” badge readers) must becertified by:
A. MYLARB. KEVLARc. NVLAPD. LORAN
24. For the Decay in Storage method of radioactivewaste disposal, after 10 half lives you must:
A. survey the waste and find itindistinguishable from background beforeplacing in ordimry trash
B. obliterate any radiation signslsymbolsbefore placing in ordinary trash
c. crush in a trash compactorD. answers A and B
25. The inspector is most likely your best source ofinformation on:
A. professional consultantsB. regulatory requirementsc. NRC policiesD. answers B and C
