Ultrasound Accreditation and Regulatory Compliance from A to Z

Transcription

1 Jim Rickner presents: Ultrasound Accreditation and Regulatory Compliance from A to Z Sponsored by: Conquest Imaging

2 Wednesday, September 28, 2016, 2:00pm ET PRESENTER: JIM RICKNER, CONQUEST IMAGING Jim Rickner, Training Director for Conquest Imaging has over 20 years of experience working on variety of electronic equipment. His experience includes repairing and operating flight simulators, specialty aircraft avionics, destructive material testing instruments and a variety of ultrasound systems. He has worked for Conquest Imaging over ten years and was the Senior Field Service Engineer prior to becoming the Training Director. Jim has attended all courses offered at Conquest Imaging for GE, Philips, Siemens, and ATL and has repaired a variety of others. WEBINAR AGENDA: During this presentation Jim will demonstrate the various complex requirements and testing protocols for all the accreditation and regulatory organizations overseeing the ultrasound industry including the American Institute of Ultrasound in Medicine (AIUM), American College of Radiology (ACR), Intersocietal Accreditation Commission (IAC) as well as Centers for Medicare and Medicaid Services (CMS) and National Fire Protection Association 99 (NFPA 99). Objectives: 1. Describe the requirements of testing protocols used by various accreditation and regulatory organizations overseeing the ultrasound industry. 2. Applying the protocols in your facilities/departments. 3. Discuss the difficulties encountered at each facility trying to meet the various requirements. TechNation would like to thank our sponsor Conquest Imaging! TechNation would like to thank our sponsor Conquest Imaging! Conquest Imaging is the largest supplier of ultrasound parts, probes/transducers, probe/transducer repair, training, service and free, 24/7 technical support. For more information, visit

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4 YOUR VIP PASS TO New England Fall 2016 UNCASVILLE, CT MOHEGAN SUN CASINO & RESORT OCTOBER 4-6TH $100 VALUE VIPEngland INVITATION New Fall 2016 (FOR HOSPITAL EMPLOYEES ONLY) WHAT IT INCLUDES Over 30 hours of accredited CE education Over six hours of exhibit hall time to meet with over 100 world-class vendors! Lunch provided each day during exhibit hall hours. The industry s best networking events to connect and share best practices with other leading HTM professionals MD Expo annual awards presentation Joint Commission Keynote Address covering regulatory updates World-class exhibit hall featuring latest technology, products and services The opportunity to win great door prizes donated by exhibiting vendors. Industry-leading speakers covering hottest topics in HTM, compliance, IT, management and equipment service Admission to the Wrap-up Party at Margaritaville VIP Pass Compliments of: Because Quality Matters. ENTER PROMO CODE: 16MDE300 REGISTER ONLINE TODAY AT

5 Ultrasound Accreditation and Regulatory Compliance from A Z Regulatory Agencies Ultrasound Accreditations ACR American College of Radiology AIUM American Institute of Ultrasound in Medicine IAC Intersocietal Accreditation Commission CMS Centers for Medicare and Medicaid NFPA 99 National Fire Protection Association 1

6 AIUM Standards Partnered with ACR Proof of sufficient training is the pathway to musculoskeletal ultrasound practice accreditation. Other very important criteria include quality of care by the qualifications of sonographers and other nonphysicians who may perform the exams, the maintenance and calibration of the ultrasound machines, the content, accuracy, and timeliness of reports, the implementation of policies to protect patients and personnel, and regular quality assurance activities. AIUM Standards Display Standards o Verify Transducers Free of cracks Separations Discoloration o Transducer Uniformity Scan with Phantom Note dropouts and non uniformities AIUM Standards Maximum Depth of Visualization All transducers All frequencies Distance Measurement Accuracy Use Phantoms high contrast targets Evaluate horizontal and vertical accuracy Target Detection and Imaging (Optional) Use low contrast objects Evaluate target resolution 2

7 IAC Standards Record method and frequency of maintenance of ultrasound instrumentation Establish and adhere to a policy regarding routine safety inspections Establish and adhere to an instrument cleaning schedule that includes filters and transducers, according to OEM specifications CMS Standards Must Evaluate systems in accordance with OEM specifications OEM specifications change based on system model Refer to service manual to ensure compliance NFPA 99 Electric Safety Differ from OEM to OEM GE consistently requires NFPA 99 electrical safety Other OEMs don t specify what standard Also differ from model to model Philips HD11 and Envisor systems specify NFPA 99 iu22/ie33 doesn t specify standard 3

8 ACR Accreditation This accreditation program involves the following: Acquisition of clinical ultrasound images. Personnel qualifications must be met for both physicians and technologists. The submission of physician reports related to the ultrasound images. Quality Control Program must be in place for each ultrasound system in the facility. ACR Accreditation Changes ACR Accreditation Changes New as of 2014 Different forms New tests / verifications New mandatory frequency of testing 4

9 Sensitivity /Penetration Testing To perform system sensitivity/penetration test, the following parameters should be selected: Maximum transmit power. Proper gain and TGC (time gain control) to produce an image in the far field. Transmit focus set as deep as possible. The maximum depth of visualization represents system s penetration capability. Sensitivity/Penetration Testing Measure to the noise floor Image Uniformity Testing To perform image uniformity test, adjust TGC / DGC and gain settings to obtain an image as uniform as possible. Note on the QC/Preventative maintenance form any of the following: Dropouts Vertical or radial streaks Reduction in brightness near edges of the scan Brightness transitions between focal zones 5

10 Image Uniformity Testing Image artifact in near field of probe Probe array? Probe cable? Probe pins/connector? Connector board? Front end board? NEW: Geometric Accuracy Commonly involves use of the scanner calipers to measure known distances between test targets. Measurement is required only in the mechanically scanned directions The caliper readout of the distance between these two targets agrees to within 1.5 % or 1.5 mm, whichever is greater both axially (vertically) and laterally (horizontally) Geometric Accuracy 6

11 NEW: Scanner Electronic Image Display Performance Display characteristics that are evaluated may include gray scale response and luminance calibration, presence of pixel defects, and overall image quality o Completed o Not Completed NEW: Primary Interpretation Display Performance Display characteristics that are evaluated may include gray scale response and luminance calibration, presence of pixel defects, and overall image quality Completed Not Completed N/A (Only required if located at the facility where ultrasound is performed.) Luminance Many tests/testing methods ACR Technical Standards for Electronic Practice of Medical Imaging gives examples of tests and methods 7

12 Site: Facility UAP #: Facility BUAP #: System Manufacturer: System SN: Building/Room #: Medical Physicist (or designee): Signature: Test 1. Physical and Mechanical Inspection 2. Image Uniformity and Artifact Survey 3. Geometric Accuracy 4. System Sensitivity 5. Scanner Electronic Image Display Performance 6. Primary Interpretation Display Performance* 7. Contrast Resolution (Optional) 8. Spatial Resolution (Optional) * If located at the facility where ultrasound is performed Annual System Performance Evaluation Report Ultrasound/Breast Ultrasound Equipment Evaluation Summary Equipment Evaluation Tests Pass/Fail Medical Physicist's (or designee's) Recommendations for Quality Improvement: Model: System ID: You must send ACR the entire, most recent Annual System Performance Evaluation report. It must include: Equipment Evaluation Summary form, signed by the medical physicist (or designee) Evaluation of Site s Routine QC Program form, AND All data pages from the report (not just the summary forms) Report Date: Survey Date: Comments 9/26/2016 LCD Visual Inspection Brightness Details of the image should not be difficult to see or dull. Color clarity Colors should be brilliant and dissimilar. Dead pixels Dead pixels are acceptable around the outer perimeter of the screen out of the viewing area. General inspection Monitor should not have abnormalities in display area. Utilize grayscale bar to ensure all shades of gray are displayed. Whites should be white but not blooming. Assurance of Electrical/Mechanical Safety Make sure all cords and cables are intact Make sure all transducers are intact without cracks or delaminating Verify all transducers are being cleaned after each use Make sure the image monitors are clean Verify air filters are clean Make sure the wheel locks are in working condition Make sure the wheels are fastened securely to the US unit and they rotate easily Make sure all accessories (VCR, cameras, etc.) are fastened securely to the US unit New Forms for ACR Compliance Summary Page 8

13 New Forms for ACR Compliance ACR Worksheet Page 1 New Forms for ACR Compliance ACR Worksheet Page 2 Frequency Annual Surveys are complete tests performed once a year by the medical physicist or designee to assess the performance of the equipment. Although the Annual Surveys include all of the same tests conducted during routine QC testing, it is intended to be more extensive. In addition, Annual Surveys include an evaluation of the facility s routine QC program, if applicable. Routine QC testing is less extensive and is recommended to be performed semiannually by the facility s sonographer (or a service engineer). 9

14 Questions Thank you for joining us 10

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