Section 6 INSTRUMENTATION (MR 1)

MRI Equipment Forms

Fill out and submit this form if your facility is requesting a change in equipment or adding or replacing a unit to a current accreditation.

Section 1B: Instrumentation and Equipment

STANDARD – Instrumentation

Magnetic resonance imaging (MRI) system information (complete for each MRI unit):

Manufacturer: Model: Serial number: Year manufactured: Software version:

Magnetic field strength (check one): Date of installation:

1 2 3 4 0.064 T 0.2 T 0.3 T 0.35 T

5 6 7 99 0.5 T 1.0 T 1.5 T Other specify:

1.1B Is an FDA approved MRI device available for imaging?

Yes No

1.1.2B Does the MRI equipment specifications and performance must meet all state, federal and local requirements?

Yes No

STANDARD – Equipment Quality Control

1.2B Does the QI Program consist of MRI system installation acceptance testing and major upgrade acceptance testing?

Yes No

If no, please provide an explanation:

Was an acceptance test performed at installation and prior to clinical use?

Yes No

Complete the following table for the quality control of the MRI system:

QUALITY CONTROL TESTS PERFORMED HOW OFTEN BY WHICH PERSONNEL SNR (for all coils) Center frequency (CF) Gradient and RF calibration Magnetic field homogeneity Image quality Slice thickness Slice accuracy

MRI Equipment Forms 1 Reviewed 11/2014 Spatial resolution Artifact assessment Monitor/processor QC Image uniformity RF coil cables/connectors RF shielding Function of safety equipment (audible and visual) Other (please list):

1.2.1B Are the quality control tests being performed according to the manufacturer’s performance standards by the MRI technologist, service engineer, medical physicist or qualified expert?

Yes No

1.2.2B Are the system parameters compared to the manufacturer’s system specifications or industry standards?

Yes No

Are the results reviewed by the QI Committee?

Yes No

Does the acceptance testing include:

1.2.2.1B Magnetic field homogeneity

Yes No

1.2.2.2B Gradient and RF calibration

Yes No

1.2.2.3B Resonance frequency

Yes No

1.2.2.4B Slice thickness

Yes No

1.2.2.5B Slice accuracy

Yes No

1.2.2.6B Image quality (including signal-to-noise ratio (SNR) evaluation for all coils, spatial resolution and artifact assessment)?

Yes No

1.2.2.7B Image uniformity

Yes No

MRI Equipment Forms 2 Reviewed 11/2014 1.2.2.8B Image linearity (geometric distortion)

Yes No

1.2.2.9B Monitor/Processor QC

Yes No

If no answered, please provide an explanation.

Attach, behind this page, a copy of the latest acceptance test results for each MRI scanner at the facility.

1.3.2B Are deviations from established thresholds documented and corrective action taken where appropriate?

Yes No

1.4B Is preventative maintenance (PM) performed for each MRI scanner at the facility?

Yes No

Indicate the frequency:

Indicate who performs the preventive maintenance:

Service engineer MRI site representative MRI technologist

1.4.2B Is a general equipment inspection (e.g., RF coil cables, RF shielding, scan table manipulation, etc.) included in the PM?

Yes No

Are the all of the following tests included in the PM?

1.4.2.1B Signal to noise (SNR) ratio? Yes No 1.4.2.2B Magnetic field homogeneity? Yes No 1.4.2.3B RF of calibration for all coils? Yes No 1.4.2.4B Spatial resolution tests? Yes No 1.4.2.5B Artifact assessment? Yes No

If no answered, please provide an explanation:

STANDARD – Quality Control Documentation

1.5B Are the QI documents (policies, reports, records, etc.) maintained at the MRI facility and made available to all personnel?

Yes No

1.5.1B Are the quality control tests, standards, thresholds, timelines and results reviewed and discussed on a regular basis by the QI Committee?

Yes No Indicate timeframe:

Are written report of the acceptance tests maintained at the MRI facility?

Yes No

MRI Equipment Forms 3 Reviewed 11/2014 Does the report include the QC tests performed, the results as compared to manufacturer’s or industry guidelines and recommendations to the facility (if any)?

Yes No

Are the reports signed and dated by the person performing the tests?

Yes No

Are the tests performed archived on the system or separate device for future reference?

Yes No

1.5.2B Does the facility maintain complete report of PM, quality control tests and service records?

Yes No

The reports must be signed and dated by the person(s) performing the tests?

Yes No

1.5.3B Does the MRI facility maintain a complete service record for all ancillary MRI equipment?

Yes No

Are the reports signed and dated by the person(s) performing the tests?

Yes No

In the table below, please list all ancillary equipment (patient monitors, cameras/processors, etc.) used as part of the MRI procedures, how often quality control tests are performed for each device and by which personnel (service engineer, technologist, etc.).

ANCILLARY DEVICE FREQUENCY OF QC TEST BY WHICH PERSONNEL

Attach, behind this page, a copy of the quality improvement tests that were performed by the technologists during a two-month period for each MRI scanner at the facility.

Attach, behind this page, the latest PM service performed for each MRI system in the facility to include the test performed, the results and any, recommendations and corrective actions, if applicable. The PM must have been conducted within six months prior to the submission of the application. The report must be signed and dated by the person performing the tests.

MRI Equipment Forms 4 Reviewed 11/2014 Section 1C: Quality Improvement (QI)

STANDARD – Quality Improvement (QI) Program

1.1C Is there a QI Program in the MRI facility?

Yes No

1.1.2C Is ancillary equipment used in the MRI procedures part of the quality assurance program?

Yes No

1.1.3C Indicate the members of the QI Committee:

Technical Director Clinical MRI Director Service Engineer Medical Physicist Qualified Expert Other (specify):

The QI Committee should determine the appropriate personnel and timeline for the QI evaluation of ancillary MRI equipment. This includes monitoring equipment, injectors, cameras/processors, workstations, PACS, etc.

STANDARD – Quality Improvement (QI) Measures

2.1.2C Does the QI Program include a process for evaluating indicators such as backlog for scheduled examinations, late reporting and long patient waiting times?

Yes No

MRI Equipment Forms 5 Reviewed 11/2014