Part A: Structure and Organization
Radioactive Materials License
NRC (or State) radioactive materials license present Y / N
Personnel Medical Director
Meets Medical Director responsibility requirements Y/ N Meets Medical Director training and experience Y / N Current medical license for geographic area of lab Y / N Copy of current board certification (other than CBNC certificate) Y / N
Is the Medical Director certified by the CBNC Y / N Copy of current CBNC (if applicable) Y / N Listed as authorized user for diagnostic use of medical isotopes on the radioactive materials license Y/ N
Does this physician personally supervise stress testing? Y/N Is current BLS/ACLS certification present if physician personally supervises stress testing? Y / N
Does this physician have 15 hours of AMA Category I CME within the past three years Y/N Meets one of the CME exemptions within past three years: completion of an ACGME approved relevant
residency or fellowship; initial certification by relevant board, recertification by ABR, ABNM or CBNC
Y/N Attestation with signature submitted Y / N
Technical Director
Meets Technical Director responsibility requirements Y/ N Technical Director works in the lab on a full time basis Y / N Technical Director present in lab 20% of normal business hours Y / N Is an appropriately credential technologist designated in writing to assume Technical Director duties in
Technical Director's absence
Y / N Copy of current license / certification submitted Y / N Copy of current BLS/ACLS included Y / N At least 15 hours of accredited CE relevant to nuclear medicine in the past three years Y / N Meets one of the CE exemptions within past three years: Completion of an accredited nuclear medicine
training program; attainment of appropriate nuclear medicine credential; attainment of advanced technical credential
Y / N
Attestation with signature submitted Y / N
Interpreting Medical Staff
Meets Medical Staff training and experience Y / N Current medical license for geographic area of lab Y / N Copy of current board certification (other than CBNC certificate) Y / N
Is this physician certified by the CBNC Y / N Copy of current CBNC (if applicable) Y / N Listed as authorized user for diagnostic use of medical isotopes on the radioactive materials license Y/ N
Does this physician personally supervise stress testing? Y/N Is current BLS/ACLS certification present if physician personally supervises stress testing? Y / N
Does this physician have 15 hours of AMA Category I CME within the past three years Y/N Meets one of the CME exemptions within past three years: completion of an ACGME approved relevant
residency or fellowship; initial certification by relevant board, recertification by ABR, ABNM or CBNC
Y/N Attestation with signature submitted Y / N
Technical Staff
Copy of current license / certification submitted Y / N Copy of current BLS/ACLS included Y / N At least 15 hours of accredited CE relevant to nuclear medicine in the past three years Y / N Meets one of the CE exemptions within past three years: Completion of an accredited nuclear medicine
training program; attainment of appropriate nuclear medicine credential; attainment of advanced technical credential
Y / N
Direct Patient Care Personnel
Are all personnel supervising cardiac stress procedures certified in BLS or ACLS? Y / N / NA Are there at least two qualified people in attendance at the time of radionuclide injection during stress testing? Y / N
Is a person who is certified in ACLS always on site in site during all cardiac stress procedures? Y / N Attestation with signature submitted Y / N
Part B: Protocols
Laboratory-specific protocols written for all clinical procedures performed in the laboratory and performed under conditions that ensure patient and staff safety?
Y / N
Radiation Safety Protocols
Written radiation safety and radioactive materials handling protocols specific for the laboratory?
Y / N
Patient Identification Policy:
A patient identification policy is present that accurately identifies the patient prior to initiating the procedure
Y / N The policy indicates that patients are identified using two independent patient identifiers Y / N Pregnancy Screening/ Risk to Fetus:
A patient screening policy is present that assures that patients who could be pregnant are identified.
Y / N Does the policy contain the necessary provisions for:
written documentation Y / N appropriate signatures (patient and/or technologist) Y / N explanation of steps to be taken if patient may be or is pregnant. Y / N Breast Feeding:
A breast feeding screening policy is present that assures that patients who are breast feeding are identified
Y / N Does the policy contain the necessary provisions for:
written documentation Y / N appropriate signatures (patient and/or technologist) Y / N explanation of steps to be taken (isotope specific), including timing of temporary
discontinuation or cessation for breast feeding patients
Y / N
Administration of Radiopharmaceuticals to Patients:
Protocol for the administration of radiopharmaceuticals to patients submitted Y / N Determination of patient dosages using standardized protocols approved by Medical Director
or by individually written prescriptions
Y / N Determination of doses for pediatric patients prior to administration Y / N / NA Assay of patient dosages of radiopharmaceuticals in dose calibrator or mathematical
calculation of dose prior to administration
Y / N Verification immediately prior to administration of:
Radiopharmaceutical identity Y / N Dosage Y / N Route of administration Y / N Verification of radiopharmaceutical expiration date/time Y / N
Written documentation of:
Radiopharmaceutical identity Y / N Dosage Y / N Route of administration Y / N Site of administration Y / N Date Y / N Time Y / N Identity of person administering Y / N
Administrative and Other Protocols:
Written administrative and other protocols are in place Y / N Reporting:
Lab indicates that studies are reviewed promptly upon completion and transmitted to referring physician within 4 business days
Y / N Lab indicates that less than 20% of final reports are transmitted over 4 business days Y / N Lab indicates that signatures on final reports are either handwritten or electronic, password
protected
Y / N
Imaging Equipment Quality Control (Gamma Cameras) Intrinsic or Extrinsic Uniformity:
Site specific protocol for the performance of intrinsic or extrinsic uniformity submitted Y / N Protocol indicates that uniformity is done daily or prior to use Y / N Protocol includes acceptable range (or tolerance limit) Y / N Protocol contains instructions/corrective action for out-of-tolerance results Y / N Protocol contains instructions for record retention and/or comparison with previous result Y / N Recent Uniformity image/documentation submitted Y / N Submitted uniformity images acceptable Y / N Spatial resolution/Spatial linearity (Bars):
Site specific protocol for the performance of spatial resolution/spatial linearity submitted Y / N / NA Protocol indicates that resolution is done weekly Y / N Protocol includes acceptable range (or tolerance limit) Y / N Protocol contains instructions/corrective action for out-of-tolerance results Y / N Protocol contains instructions for record retention and/or comparison with previous result Y / N Recent Resolution (Bars) image/documentation submitted Y / N Submitted resolution images acceptable Y / N Center-of-Rotation (COR):
Site specific protocol for the performance of center-of-rotation submitted Y / N / NA Protocol indicates that center-of-rotation is done monthly Y / N
Protocol includes acceptable range (or tolerance limit) Y / N Protocol contains instructions/corrective action for out-of-tolerance results Y / N Protocol contains instructions for record retention and/or comparison with previous result Y / N Recent Center of Rotation image/documentation submitted Y / N Submitted center-of-rotation results acceptable Y / N Preventive Maintenance:
Gamma camera preventive maintenance report submitted Y / N Preventive maintenance within past 12 months Y / N
Imaging Equipment Quality Control (PET Cameras) Blank Scan:
Site specific protocol for the performance of blank scan submitted Y / N Protocol indicates that blank scan is done daily or prior to use Y / N Protocol includes acceptable range (or tolerance limit) Y / N Protocol contains instructions/corrective action for out-of-tolerance results Y / N Protocol contains instructions for record retention and/or comparison with previous result Y / N Preventive Maintenance:
PET camera preventive maintenance report submitted Y / N Preventive maintenance within past 12 months Y / N
Quality Improvement Quality Improvement:
The plan contains administrative quality improvement measures (e.g. patient satisfaction, Y / N The plan contains technical quality improvement measures (e.g. image quality, correct
patient preparation, reproducibility of processed images) Y / N The plan contains physician performance quality improvement measures (e.g. interobserver
variability, intraobserver variability, correlation of interpretation to other diagnostic studies) Y / N Minutes document at least one measure from each of the three areas (administrative,
Part C: Diagnostic Imaging Protocols and Case Studies
Diagnostic protocols include, as appropriate:
Clinical indications Y / N Contraindications Y / N Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of
medications)
Y / N / NA Does the protocol list:
Radiopharmaceutical identity Y / N dosage Y / N and route of administration Y / N If weight based dosing is used, is the method of calculation included in the protocol? Y / N / NA
Does camera setup include:
type of collimator Y / N Energy peak and window percentage Y / N Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Y / N Patient position (e.g. supine, prone, posterior, anterior, head in, head out, arms up, arms down) Y / N Camera positions (e.g. starting angle, detector configuration, caudal tilt, detector to patient distance) Y / N
Camera/computer specific acquisition instructions including:
Injection to imaging time Y / N Number of views (stops) Y / N Time/counts per view (stop) Y / N Gating (frames/cycle, R - R window) Y / N /NA
Attenuation correction Y / N / NA Camera/computer specific processing protocols include:
Step-by-step instructions Y / N Type of reconstruction stated (e.g. filtered back projection, iterative) Y / N
Filters (cut-off, order) Y / N / NA
Exercise
Does the protocol include:
Name of the exercise protocol(s) (e.g. Bruce, Naughton) Y / N Instructions/timing for stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood pressure Y / N Electrocardiographic tracings Y / N Criteria for tracer injection Y / N Does the protocol indicate that exercise stress tests should be symptom-limited? Y / N Reasons for early termination of exercise stress Y / N Instructions/timing for post-stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood Pressure Y / N Electrocardiographic tracings Y / N Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable
reasons for stopping)
Y / N Identification and treatment of common adverse effects of exercise stress (e.g. hypertension, chest pain) Y / N
Diagnostic Imaging Protocol: Myocardial Perfusion
Adenosine
Does the protocol(s) include:
Pharmacologic stress agent dose Y / N Infusion duration/details (description or chart) Y / N If applicable, instructions for low-level exercise included in protocol:
Speed and elevation of treadmill Y / N / NA Exercise duration Y / N / NA Instructions/timing for stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood pressure Y / N Electrocardiographic tracings Y / N Timing of tracer injection Y / N Reasons for early termination of pharmacologic stress Y / N Instructions/timing for post-stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood Pressure Y / N Electrocardiographic tracings Y / N Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable
reasons for stopping)
Y / N Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Y / N Regadenoson
Does the protocol(s) include:
Pharmacologic stress agent dose Y / N Injection duration of 10 seconds Y / N If applicable, instructions for low-level exercise included in protocol:
Speed and elevation of treadmill Y / N / NA Exercise duration Y / N / NA Instructions/timing for stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood pressure Y / N Electrocardiographic tracings Y / N
Timing of tracer injection Y / N Reason for reversal of regadenoson Y / N Instructions/timing for post-stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood Pressure Y / N Electrocardiographic tracings Y / N Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable
reasons for stopping)
Y / N Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Y / N Dipyridamole
Does the protocol(s) include:
Pharmacologic stress agent dose Y / N Infusion duration/details (description or chart) Y / N If applicable, instructions for low-level exercise included in protocol:
Speed and elevation of treadmill Y / N / NA Exercise duration Y / N / NA Instructions/timing for stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood pressure Y / N Electrocardiographic tracings Y / N Timing of tracer injection Y / N
Reasons for early termination of pharmacologic stress Y / N Instructions/timing for post-stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood Pressure Y / N Electrocardiographic tracings Y / N Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable
reasons for stopping)
Y / N Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Y / N Dobutamine
Does the protocol(s) include:
Pharmacologic stress agent dose Y / N Infusion duration/details (description or chart) Y / N Instructions/timing for stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood pressure Y / N Electrocardiographic tracings Y / N Timing of tracer injection Y / N Reasons for early termination of pharmacologic stress Y / N Instructions/timing for post-stress monitoring including:
Symptoms Y / N Heart rate Y / N Blood Pressure Y / N Electrocardiographic tracings Y / N Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable
reasons for stopping)
Y / N Identification and treatment of common adverse effects of pharmaceutical stress (e.g. tachycardia) Y / N
Report Items The report includes:
Facility identification: name Y / N Facility identification: address Y / N Facility identification: phone number Y / N Patient gender Y / N Age or date of birth Y / N Requesting health care provider's name Y / N Interpreting physician name Y / N Name of the procedure (type of procedure e.g. Exercise myocardial perfusion imaging, myocardial viability) Y / N Date of the procedure Y / N Date report approved and signed by interpreting physician (Date of report) Y / N Clinical indication Y / N Description of the imaging procedure (e.g. stress/rest, rest/stress, two-day, SPECT, gated) Y / N Radiopharmaceutical(s): name (Tc99m sestamibi or Tc99m tetrofosmin, Thallium-201) Y / N Radiopharmaceutical(s): exact amount administered Y / N Radiopharmaceutical(s): route of administration Y / N
Pharmacologic agent(s): name Y / N / NA Pharmacologic agent(s): exact amount administered Y / N / NA Pharmacologic agent(s): route of administration Y / N / NA Manual or electronic signature of responsible physician (Stamps not acceptable) Y / N
Approved within 4 working days Y / N Image Quality
Excessive motion noted on raw cine data Y / N / NA Artifact present (e.g. attenuation, subdiaphragmatic activity, normalization error, metal, flickering) Y / N
Adequate count density Y / N
Conventional Slice Display Y / N Stress and rest slices aligned Y / N
Time-volume curve (EF) without artifact (e.g. frame drop-off, gated on T-wave) Y / N Interpretation
Stress Test Findings
Stress protocol (e.g. Bruce, Modified Bruce, Naughton) Y / N / NA Exercise stress duration Y / N / NA Reason for termination of exercise stress Y / N / NA Rest and peak stress heart rate Y / N Rest and peak stress blood pressure Y / N Percent of maximum predicted HR or other adequate stress measure (e.g. pressure-rate product) Y / N / NA
Presence or absence of symptoms during stress Y / N Rest and peak stress (infusion) ECG finding Y / N Pharmaceutical administration duration (e.g. 6 minute, 4 minute, 10 seconds) Y / N / NA Image findings reported
Defect location(s) (e.g. Basal anteroseptal, apical inferior) Y / N / NA Defect size/extent (Small, medium, large) Y / N / NA Defect severity/intensity (Mild, moderate, severe) Y / N / NA Defect type (e.g. reversible, persistent, mixed) Y / N / NA EF Y / N / NA Regional/global wall motion Y / N / NA Other pertinent findings (e.g. TID, lung uptake, LV dilatation) Y / N / NA Impression:
Summary of LV perfusion (i.e. normal, equivocal, abnormal: ischemia, infarct) Y / N Summary of LV function (normal, abnormal, equivocal) Y / N Reviewer agrees with interpretation Y / N Case Study: Myocardial Perfusion Imaging
Protocols reviewed:
Rest ERNA
Exercise ERNA Gated SPECT ERNA Other:
Diagnostic protocols include, as appropriate:
Clinical indications Y / N Contraindications Y / N / NA Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of
medications)
Y / N / NA Does the protocol list:
Radiopharmaceutical identity Y / N dosage Y / N and route of administration Y / N If weight based dosing is used, is the method of calculation included in the protocol? Y / N / NA
Does the protocol include:
Red cell labeling method identified (in vivo, in vitro, Ultratag™) Y / N Precautions to insure that the correct blood is administered to the correct patient, if applicable Y / N / NA
Non-radioactive drug identity Y / N / NA Dosage Y / N / NA Timing of administration Y / N / NA Route of administration Y / N / NA Patient instruction, monitoring and/or precautions Y / N / NA
Does camera setup include:
type of collimator Y / N Energy peak and window percentage Y / N Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Y / N Patient position (e.g. supine, prone, head in, head out, arms up, arms down) Y / N Camera position (e.g. anterior, posterior, starting angle, detector configuration, caudal tilt, detector to patient
distance)
Y / N Camera/computer specific acquisition instructions including:
Injection to imaging time Y / N Number of views/stops Y / N Time/counts per view/stop Y / N Gating (frames/cycle, R - R window) Y / N Camera/computer specific processing protocols include:
Step-by-step instructions (e.g. ROI and background placement) Y / N Filters (cut-off, order) Y / N Diagnostic Imaging Protocols: Equilibrium Radionuclide Angiography
Report Items: The report includes:
Facility identification: name Y / N Facility identification: address Y / N Facility identification: phone number Y / N Patient gender Y / N Age or date of birth Y / N Requesting health care provider's name Y / N Interpreting physician name Y / N Name of the procedure Y / N Date of the procedure Y / N Date report approved and signed by interpreting physician (Date of report) Y / N Clinical indication Y / N Description of the imaging procedure (e.g. views, SPECT, 1st pass) Y / N Radiopharmaceutical(s): name (e.g. Tc99m label red blood cells) Y / N Radiopharmaceutical(s): exact amount administered Y / N Radiopharmaceutical(s): route of administration Y / N Red blood cell labeling method (in vivo, in vitro, Ultratag™) Y / N
Pharmacologic agent(s): name (e.g. Cold PYP) Y / N / NA Pharmacologic agent(s): route of administration Y / N / NA Manual or electronic signature of responsible physician (Stamps not acceptable) Y / N
Approved within 4 working days Y / N Image Quality
Adequate count density Y / N Images acquired in three views: LAO, Ant, LAO 70 or Left Lat Y / N Adequate positioning (e.g. LAO septal separation) Y / N Processing/Filtering (e.g. Regions of interest, background, SPECT) Y / N Time-activity curve (EF) without artifact (e.g. frame drop-off, gated on T-wave) Y / N Image Display/Labeling Y / N Artifact present (e.g. motion, attenuation, metal, free Tc99m) Y / N Interpretation
Image findings reported
Description of the results of the examination including:
Ventricular size Y / N Ventricular wall motion, regional or global Y / N Reporting of quantitative data (EF) Y / N Other pertinent findings Y / N / NA For quantitative data, are normal values reported Y / N Identification of suboptimal or limited examinations Y / N / NA Impression:
Succinct impression (normal, abnormal, equivocal, stable) Y / N Reviewer agrees with interpretation Y / N Case Study: Equilibrium Radionuclide Angiography
Protocols reviewed:
Cardiac shunt First pass radionuclide ventriculography
Nuclear venogram/thrombus localization Myocardial infarct avid Cardiac molecular imaging
Other
Diagnostic protocols include, as appropriate:
Clinical indications Y / N Contraindications Y / N / NA Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of
medications)
Y / N / NA Does the protocol list:
Radiopharmaceutical identity Y / N dosage Y / N and route of administration Y / N
Does the protocol include:
Non-radioactive drug identity Y / N / NA Dosage Y / N / NA Timing of administration Y / N / NA Route of administration Y / N / NA Patient instruction, monitoring and/or precautions Y / N / NA
Does camera setup include:
type of collimator Y / N Energy peak and window percentage Y / N Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Y / N Patient position (e.g. supine, prone, head in, head out, arms up, arms down) Y / N Camera position (e.g. anterior, posterior, starting angle, detector configuration, detector to patient distance) Y / N
Camera/computer specific acquisition instructions including:
Injection to imaging time Y / N Number of views (stops) Y / N Time/counts per view (stop) Y / N Gating (frames/cycle, R - R window) Y / N / NA Camera/computer specific processing protocols include:
Step-by-step instructions Y / N / NA Filters (cut-off, order) Y / N / NA Diagnostic Imaging Protocols: Other Cardiovascular
Report Items: The report includes:
Facility identification: name Y / N Facility identification: address Y / N Facility identification: phone number Y / N Patient gender Y / N Age or date of birth Y / N Requesting health care provider's name Y / N Interpreting physician name Y / N Name of the procedure (e.g. First Pass Ventriculography) Y / N Date of the procedure Y / N Date report approved and signed by interpreting physician (Date of report) Y / N Clinical indication Y / N Description of the imaging procedure (e.g. views, timing, SPECT) Y / N Radiopharmaceutical(s): name (e.g. Tc99m DTPA, Tc99m Pertechnetate ) Y / N Radiopharmaceutical(s): exact amount administered Y / N Radiopharmaceutical(s): route of administration Y / N
Pharmacologic agent(s): name Y / N / NA Pharmacologic agent(s): exact amount administered Y / N / NA Pharmacologic agent(s): route of administration Y / N / NA Pharmacologic agent time of administration Y / N / NA Manual or electronic signature of responsible physician (Stamps not acceptable) Y / N
Approved within 4 working days Y / N Image Quality
Adequate count density Y / N Processing/Filtering (e.g. Regions of interest, SPECT) Y / N / NA
Quantitative data correctly calculated Y / N / NA Image Display/Labeling Y / N Artifact present (e.g. motion, attenuation, metal, free Tc99m) Y / N Interpretation
Image findings reported
Description of the results of the examination including:
Pertinent positive finding (including location and type) Y / N / NA Pertinent negative findings Y / N / NA Reporting of quantitative data if applicable (e.g. right to left shunt, EF) Y / N / NA If quantitative data is used, are normal values reported Y / N / NA Identification of suboptimal or limited examinations Y / N / NA Impression:
Succinct impression (normal, abnormal, equivocal, stable finding) Y / N Reviewer agrees with interpretation Y / N Case Study: Other Cardiovascular