Part A: Structure and Organization

Transcription

1 Part A: Structure and Organization Radioactive Materials License NRC (or State) radioactive materials license present Personnel Medical Director Meets Medical Director responsibility requirements Meets Medical Director training and experience Current medical license for geographic area of lab Copy of current board certification (other than CBNC certificate) Is the Medical Director certified by the CBNC Copy of current CBNC (if applicable) Listed as authorized user for diagnostic use of medical isotopes on the radioactive materials license Does this physician personally supervise stress testing? Is current BLS/ACLS certification present if physician personally supervises stress testing? Does this physician have 15 hours of AMA Category I CME within the past three years 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 Attestation with signature submitted Y/ N Y/ N Y/N Y/N Y/N Technical Director Meets Technical Director responsibility requirements Technical Director works in the lab on a full time basis Technical Director present in lab 20% of normal business hours Is an appropriately credential technologist designated in writing to assume Technical Director duties in Technical Director's absence Copy of current license / certification submitted Copy of current BLS/ACLS included At least 15 hours of accredited CE relevant to nuclear medicine in the past three years 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 Attestation with signature submitted Y/ N Interpreting Medical Staff Meets Medical Staff training and experience Current medical license for geographic area of lab Copy of current board certification (other than CBNC certificate) Is this physician certified by the CBNC Copy of current CBNC (if applicable) Listed as authorized user for diagnostic use of medical isotopes on the radioactive materials license Does this physician personally supervise stress testing? Is current BLS/ACLS certification present if physician personally supervises stress testing? Does this physician have 15 hours of AMA Category I CME within the past three years 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 Attestation with signature submitted Y/ N Y/N Y/N Y/N

2 Technical Staff Copy of current license / certification submitted Copy of current BLS/ACLS included At least 15 hours of accredited CE relevant to nuclear medicine in the past three years 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 Direct Patient Care Personnel Are all personnel supervising cardiac stress procedures certified in BLS or ACLS? Are there at least two qualified people in attendance at the time of radionuclide injection during stress testing? Is a person who is certified in ACLS always on site in site during all cardiac stress procedures? Attestation with signature submitted / NA

3 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? Radiation Safety Protocols Written radiation safety and radioactive materials handling protocols specific for the laboratory? Patient Identification Policy: A patient identification policy is present that accurately identifies the patient prior to initiating the procedure The policy indicates that patients are identified using two independent patient identifiers Pregnancy Screening/ Risk to Fetus: A patient screening policy is present that assures that patients who could be pregnant are identified. Does the policy contain the necessary provisions for: written documentation appropriate signatures (patient and/or technologist) explanation of steps to be taken if patient may be or is pregnant. Breast Feeding: A breast feeding screening policy is present that assures that patients who are breast feeding are identified Does the policy contain the necessary provisions for: written documentation appropriate signatures (patient and/or technologist) explanation of steps to be taken (isotope specific), including timing of temporary discontinuation or cessation for breast feeding patients Administration of Radiopharmaceuticals to Patients: Protocol for the administration of radiopharmaceuticals to patients submitted Determination of patient dosages using standardized protocols approved by Medical Director or by individually written prescriptions Determination of doses for pediatric patients prior to administration / NA Assay of patient dosages of radiopharmaceuticals in dose calibrator or mathematical calculation of dose prior to administration Verification immediately prior to administration of: Radiopharmaceutical identity Dosage Route of administration Verification of radiopharmaceutical expiration date/time Written documentation of: Radiopharmaceutical identity Dosage Route of administration Site of administration Date Time Identity of person administering

4 Administrative and Other Protocols: Written administrative and other protocols are in place Reporting: Lab indicates that studies are reviewed promptly upon completion and transmitted to referring physician within 4 business days Lab indicates that less than 20% of final reports are transmitted over 4 business days Lab indicates that signatures on final reports are either handwritten or electronic, password protected Imaging Equipment Quality Control (Gamma Cameras) Intrinsic or Extrinsic Uniformity: Site specific protocol for the performance of intrinsic or extrinsic uniformity submitted Protocol indicates that uniformity is done daily or prior to use Protocol includes acceptable range (or tolerance limit) Protocol contains instructions/corrective action for out-of-tolerance results Protocol contains instructions for record retention and/or comparison with previous result Recent Uniformity image/documentation submitted Submitted uniformity images acceptable Spatial resolution/spatial linearity (Bars): Site specific protocol for the performance of spatial resolution/spatial linearity submitted / NA Protocol indicates that resolution is done weekly Protocol includes acceptable range (or tolerance limit) Protocol contains instructions/corrective action for out-of-tolerance results Protocol contains instructions for record retention and/or comparison with previous result Recent Resolution (Bars) image/documentation submitted Submitted resolution images acceptable Center-of-Rotation (COR): Site specific protocol for the performance of center-of-rotation submitted Protocol indicates that center-of-rotation is done monthly Protocol includes acceptable range (or tolerance limit) Protocol contains instructions/corrective action for out-of-tolerance results Protocol contains instructions for record retention and/or comparison with previous result Recent Center of Rotation image/documentation submitted Submitted center-of-rotation results acceptable / NA Preventive Maintenance: Gamma camera preventive maintenance report submitted Preventive maintenance within past 12 months Imaging Equipment Quality Control (PET Cameras) Blank Scan: Site specific protocol for the performance of blank scan submitted Protocol indicates that blank scan is done daily or prior to use Protocol includes acceptable range (or tolerance limit) Protocol contains instructions/corrective action for out-of-tolerance results Protocol contains instructions for record retention and/or comparison with previous result Preventive Maintenance: PET camera preventive maintenance report submitted Preventive maintenance within past 12 months

5 Quality Improvement Quality Improvement: The plan contains administrative quality improvement measures (e.g. patient satisfaction, The plan contains technical quality improvement measures (e.g. image quality, correct patient preparation, reproducibility of processed images) The plan contains physician performance quality improvement measures (e.g. interobserver variability, intraobserver variability, correlation of interpretation to other diagnostic studies) Minutes document at least one measure from each of the three areas (administrative, technical, physician performance) annually

6 Part C: Diagnostic Imaging Protocols and Case Studies Diagnostic Imaging Protocol: Myocardial Perfusion Diagnostic protocols include, as appropriate: Clinical indications Contraindications Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of / NA medications) Does the protocol list: Radiopharmaceutical identity dosage and route of administration If weight based dosing is used, is the method of calculation included in the protocol? / NA Does camera setup include: type of collimator Energy peak and window percentage Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Patient position (e.g. supine, prone, posterior, anterior, head in, head out, arms up, arms down) Camera positions (e.g. starting angle, detector configuration, caudal tilt, detector to patient distance) Camera/computer specific acquisition instructions including: Injection to imaging time Number of views (stops) Time/counts per view (stop) Gating (frames/cycle, R - R window) /NA Attenuation correction / NA Camera/computer specific processing protocols include: Step-by-step instructions Type of reconstruction stated (e.g. filtered back projection, iterative) Filters (cut-off, order) / NA Exercise and /or Pharmacologic Stress Testing Protocols Exercise Does the protocol include: Name of the exercise protocol(s) (e.g. Bruce, Naughton) Instructions/timing for stress monitoring including: Symptoms Heart rate Blood pressure Electrocardiographic tracings Criteria for tracer injection Does the protocol indicate that exercise stress tests should be symptom-limited? Reasons for early termination of exercise stress Instructions/timing for post-stress monitoring including: Symptoms Heart rate Blood Pressure Electrocardiographic tracings Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable reasons for stopping) Identification and treatment of common adverse effects of exercise stress (e.g. hypertension, chest pain)

7 Adenosine Does the protocol(s) include: Pharmacologic stress agent dose Infusion duration/details (description or chart) If applicable, instructions for low-level exercise included in protocol: Speed and elevation of treadmill / NA Exercise duration / NA Instructions/timing for stress monitoring including: Symptoms Heart rate Blood pressure Electrocardiographic tracings Timing of tracer injection Reasons for early termination of pharmacologic stress Instructions/timing for post-stress monitoring including: Symptoms Heart rate Blood Pressure Electrocardiographic tracings Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable reasons for stopping) Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Regadenoson Does the protocol(s) include: Pharmacologic stress agent dose Injection duration of 10 seconds If applicable, instructions for low-level exercise included in protocol: Speed and elevation of treadmill / NA Exercise duration / NA Instructions/timing for stress monitoring including: Symptoms Heart rate Blood pressure Electrocardiographic tracings Timing of tracer injection Reason for reversal of regadenoson Instructions/timing for post-stress monitoring including: Symptoms Heart rate Blood Pressure Electrocardiographic tracings Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable reasons for stopping) Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Dipyridamole Does the protocol(s) include: Pharmacologic stress agent dose Infusion duration/details (description or chart) If applicable, instructions for low-level exercise included in protocol: Speed and elevation of treadmill / NA Exercise duration / NA Instructions/timing for stress monitoring including: Symptoms Heart rate Blood pressure Electrocardiographic tracings Timing of tracer injection

8 Reasons for early termination of pharmacologic stress Instructions/timing for post-stress monitoring including: Symptoms Heart rate Blood Pressure Electrocardiographic tracings Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable reasons for stopping) Identification and treatment of common adverse effects of pharmaceutical stress (e.g. headache, wheezing) Dobutamine Does the protocol(s) include: Pharmacologic stress agent dose Infusion duration/details (description or chart) Instructions/timing for stress monitoring including: Symptoms Heart rate Blood pressure Electrocardiographic tracings Timing of tracer injection Reasons for early termination of pharmacologic stress Instructions/timing for post-stress monitoring including: Symptoms Heart rate Blood Pressure Electrocardiographic tracings Criteria for terminating post stress monitoring (i.e. minimum duration of post stress monitoring and acceptable reasons for stopping) Identification and treatment of common adverse effects of pharmaceutical stress (e.g. tachycardia)

9 Case Study: Myocardial Perfusion Imaging Report Items The report includes: Facility identification: name Facility identification: address Facility identification: phone number Patient gender Age or date of birth Requesting health care provider's name Interpreting physician name Name of the procedure (type of procedure e.g. Exercise myocardial perfusion imaging, myocardial viability) Date of the procedure Date report approved and signed by interpreting physician (Date of report) Clinical indication Description of the imaging procedure (e.g. stress/rest, rest/stress, two-day, SPECT, gated) Radiopharmaceutical(s): name (Tc99m sestamibi or Tc99m tetrofosmin, Thallium-201) Radiopharmaceutical(s): exact amount administered Radiopharmaceutical(s): route of administration Pharmacologic agent(s): name Pharmacologic agent(s): exact amount administered Pharmacologic agent(s): route of administration Manual or electronic signature of responsible physician (Stamps not acceptable) Approved within 4 working days / NA / NA / NA Image Quality Excessive motion noted on raw cine data / NA Artifact present (e.g. attenuation, subdiaphragmatic activity, normalization error, metal, flickering) Adequate count density Conventional Slice Display Stress and rest slices aligned Time-volume curve (EF) without artifact (e.g. frame drop-off, gated on T-wave) Interpretation Stress Test Findings Stress protocol (e.g. Bruce, Modified Bruce, Naughton) / NA Exercise stress duration / NA Reason for termination of exercise stress / NA Rest and peak stress heart rate Rest and peak stress blood pressure Percent of maximum predicted HR or other adequate stress measure (e.g. pressure-rate product) / NA Presence or absence of symptoms during stress Rest and peak stress (infusion) ECG finding Pharmaceutical administration duration (e.g. 6 minute, 4 minute, 10 seconds) / NA Image findings reported Defect location(s) (e.g. Basal anteroseptal, apical inferior) / NA Defect size/extent (Small, medium, large) / NA Defect severity/intensity (Mild, moderate, severe) / NA Defect type (e.g. reversible, persistent, mixed) / NA EF / NA Regional/global wall motion / NA Other pertinent findings (e.g. TID, lung uptake, LV dilatation) / NA Impression: Summary of LV perfusion (i.e. normal, equivocal, abnormal: ischemia, infarct) Summary of LV function (normal, abnormal, equivocal) Reviewer agrees with interpretation

10 Diagnostic Imaging Protocols: Equilibrium Radionuclide Angiography Protocols reviewed: Rest ERNA Exercise ERNA Gated SPECT ERNA Other: Diagnostic protocols include, as appropriate: Clinical indications Contraindications / NA Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of / NA medications) Does the protocol list: Radiopharmaceutical identity dosage and route of administration If weight based dosing is used, is the method of calculation included in the protocol? / NA Does the protocol include: Red cell labeling method identified (in vivo, in vitro, Ultratag ) Precautions to insure that the correct blood is administered to the correct patient, if applicable / NA Non-radioactive drug identity / NA Dosage / NA Timing of administration / NA Route of administration / NA Patient instruction, monitoring and/or precautions / NA Does camera setup include: type of collimator Energy peak and window percentage Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Patient position (e.g. supine, prone, head in, head out, arms up, arms down) Camera position (e.g. anterior, posterior, starting angle, detector configuration, caudal tilt, detector to patient distance) Camera/computer specific acquisition instructions including: Injection to imaging time Number of views/stops Time/counts per view/stop Gating (frames/cycle, R - R window) Camera/computer specific processing protocols include: Step-by-step instructions (e.g. ROI and background placement) Filters (cut-off, order)

11 Case Study: Equilibrium Radionuclide Angiography Report Items: The report includes: Image Quality Interpretation Image findings reported Impression: Facility identification: name Facility identification: address Facility identification: phone number Patient gender Age or date of birth Requesting health care provider's name Interpreting physician name Name of the procedure Date of the procedure Date report approved and signed by interpreting physician (Date of report) Clinical indication Description of the imaging procedure (e.g. views, SPECT, 1st pass) Radiopharmaceutical(s): name (e.g. Tc99m label red blood cells) Radiopharmaceutical(s): exact amount administered Radiopharmaceutical(s): route of administration Red blood cell labeling method (in vivo, in vitro, Ultratag ) Pharmacologic agent(s): name (e.g. Cold PYP) / NA Pharmacologic agent(s): route of administration / NA Manual or electronic signature of responsible physician (Stamps not acceptable) Approved within 4 working days Adequate count density Images acquired in three views: LAO, Ant, LAO 70 or Left Lat Adequate positioning (e.g. LAO septal separation) Processing/Filtering (e.g. Regions of interest, background, SPECT) Time-activity curve (EF) without artifact (e.g. frame drop-off, gated on T-wave) Image Display/Labeling Artifact present (e.g. motion, attenuation, metal, free Tc99m) Description of the results of the examination including: Ventricular size Ventricular wall motion, regional or global Reporting of quantitative data (EF) Other pertinent findings / NA For quantitative data, are normal values reported Identification of suboptimal or limited examinations / NA Succinct impression (normal, abnormal, equivocal, stable) Reviewer agrees with interpretation

12 Diagnostic Imaging Protocols: Other Cardiovascular 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 Contraindications / NA Patient preparation and education/instructions (food/diet restrictions, withholding or non-withholding of / NA medications) Does the protocol list: Radiopharmaceutical identity dosage and route of administration Does the protocol include: Non-radioactive drug identity / NA Dosage / NA Timing of administration / NA Route of administration / NA Patient instruction, monitoring and/or precautions / NA Does camera setup include: type of collimator Energy peak and window percentage Other parameters (e.g. orbit, acquisition type, matrix, zoom, etc) Patient position (e.g. supine, prone, head in, head out, arms up, arms down) Camera position (e.g. anterior, posterior, starting angle, detector configuration, detector to patient distance) Camera/computer specific acquisition instructions including: Injection to imaging time Number of views (stops) Time/counts per view (stop) Gating (frames/cycle, R - R window) / NA Camera/computer specific processing protocols include: Step-by-step instructions / NA Filters (cut-off, order) / NA

13 Case Study: Other Cardiovascular Report Items: The report includes: Image Quality Interpretation Image findings reported Impression: Facility identification: name Facility identification: address Facility identification: phone number Patient gender Age or date of birth Requesting health care provider's name Interpreting physician name Name of the procedure (e.g. First Pass Ventriculography) Date of the procedure Date report approved and signed by interpreting physician (Date of report) Clinical indication Description of the imaging procedure (e.g. views, timing, SPECT) Radiopharmaceutical(s): name (e.g. Tc99m DTPA, Tc99m Pertechnetate) Radiopharmaceutical(s): exact amount administered Radiopharmaceutical(s): route of administration Pharmacologic agent(s): name Pharmacologic agent(s): exact amount administered Pharmacologic agent(s): route of administration Pharmacologic agent time of administration Manual or electronic signature of responsible physician (Stamps not acceptable) Approved within 4 working days / NA / NA / NA / NA Adequate count density Processing/Filtering (e.g. Regions of interest, SPECT) / NA Quantitative data correctly calculated / NA Image Display/Labeling Artifact present (e.g. motion, attenuation, metal, free Tc99m) Description of the results of the examination including: Pertinent positive finding (including location and type) / NA Pertinent negative findings / NA Reporting of quantitative data if applicable (e.g. right to left shunt, EF) / NA If quantitative data is used, are normal values reported / NA Identification of suboptimal or limited examinations / NA Succinct impression (normal, abnormal, equivocal, stable finding) Reviewer agrees with interpretation