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XR 29: NEMA White Paper Clarifies Aftermarket Add-ons, RDSR, and More

Posted by David Harns

May 22, 2015 12:49:00 PM

is-my-ct-xr-29-compliantThe discussion surrounding NEMA Standard XR-29 is about a year old at this point. We've tackled the subject in this blog on several occassions, talking about what it means, what is included in the law, what is not, and even tips to check for compliance on your own but, there are still many questions remaining. Fortunately, some new information has been released that might help answer some of them.

If you are in the CT industry, you know that providers, hospitals, OEMs, third-party companies – anyone that owns a CT, really – has been waiting for clear direction from the Centers for Medicare & Medicaid Services (CMS) ever since XR-29 was passed in to law. While we expect that direction to come in the next few months, we did receive a clue yesterday as to which direction CMS might lean regarding a few questions that have been ambiguous to date.

That clue was in the form of a white paper written by the MITA CT Group and released by NEMA yesterday. In the release, NEMA stated that their purpose in releasing the document was to:

“…clarify with CT users and hospital administrative staff how to determine whether their CT equipment conforms to the Smart Dose Standard and outline important considerations for assessing system modifications marketed to obtain Smart Dose Standard conformance.” 

In writing this white paper, MITA confirmed that – under the XR-29 law – healthcare providers will be required to report when a CT scan is performed that uses equipment that does not comply with the Smart Dose Standard (the common name for the four XR-29 requirements). To answer the question that has been circulating around the CT industry for months – How will compliance be determined? – MITA writes:

“We believe that at minimum, healthcare providers will be required to provide documentation from the manufacturer of their CT system identifying whether or not their system meets the four attributes. CT manufacturers (OEMs) have committed to provide a certification, based on their knowledge of individual system configurations, when the four required attributes have been integrated on a particular piece of equipment.”

MITA’s white paper went on to describe the four attributes with specific considerations to help determine compliance.

First up was DICOM RDSR, arguably the most misunderstood one of the four – and the one that has caused the most difficulty in determining if a CT would be compliant or not. Here’s what MITA (and NEMA) had to say:

“DICOM RDSR is available on new model CT Scanners. Prior to the industry adoption of RDSR, many CT systems stored an image containing a screen capture of a dose report, listing CTDIvol and DLP values for each CT series. The reports contained much less information than the RDSR, and the values could not be directly processed. Commercial and open-source software attempt to perform optical character recognition and text parsing – but this is only capable of partially populating an RDSR, and does not achieve compliance.”

This is very important information to keep in mind if you are considering purchasing an after-market “add-on” from a company that is marketing their solution as NEMA XR-29 compliant. While this white paper doesn’t carry the force of law, it should be considered a clue as to what CMS might do when it makes its decision as to if the products that these companies are selling will make the CT compliant. MITA’s opinion: no, they will not.

The second attribute, CT Dose Check, is also somewhat misunderstood. MITA points out that this attribute will notify and alert the operating personnel PRIOR to starting a scan that the estimated dose index is above a previously-defined value.

“Dose Check is incorporated into the firmware of a CT system by the manufacturer and dose related notification and alert messages must appear on the operating console of the CT scanner prior to starting a scan in order for the system to be compliant. To continue scanning, a compliant system must prompt the user to enter their name, diagnostic reason for exceeding the predetermined threshold, reconfirm the chosen protocol, and in some cases provide a password before proceeding to the scan. An accessory or external software application not integrated into the firmware of the CT system cannot meet the Dose Check requirements.”

This white paper makes it clear that MITA’s opinion is that after-market “add-ons” will not meet the requirements of the Dose Check attribute because it does not alert the operator to the high dose BEFORE the scan takes place. This is very important to consider when you are determining if the purchase of an accessory or external software application that isn’t integrated into the CT’s firmware is a good idea or not.

The third attribute, automatic exposure control (AEC), is fairly clear, is more common and doesn’t usually hold a CT system back from being XR-29 compliant. AEC is incorporated into CT systems and tailors the radiation output to the body regions which are being scanned in order to minimize the radiation delivered to the patient. In the white paper, here’s what MITA said:

“AEC is incorporated into newer CT machines as a part of the system design and firmware, relying on patient specific parameters obtained during the scan setup process and/or continuously during the scan to modulate the X-Ray tube output. If you are not familiar with this attribute on your system, check your equipment guide and other labelling. If you’re still unsure, contact the service line for the applicable manufacturer.”

The fourth – and last – of the XR-29 attributes are pediatric and adult reference protocols. This attribute has also not been controversial as it pretty clear and is easy for most systems to incorporate. In the white paper, here’s what MITA had to say if you want to make sure your system is compliant:

“Manufacturers develop reference protocols through detailed knowledge of the system’s specific performance characteristics and input from clinical collaborators. Reference protocols may be in the format defined in NEMA XR 28-2013, explained within section 2.4 and appendix C and found in the system’s user manuals. The XR 28 standard is free for electronic download. If you are unsure whether your system meets the reference protocols attribute, contact the service line for the applicable manufacturer.”

MITA suggests carefully evaluating upgrades of non-compliant equipment. It might not make fiscal sense for certain facilities to upgrade at this time. There is no one-size fits-all answer for XR-29 compliance. From the white paper:

“A decision to upgrade non-compliant CT equipment should take into consideration many factors such as the complexity of your equipment, your clinical usage, and ultimately the cost/benefit of upgrading.”

MITA recommends considering how the four attributes are INTEGRATED into the CT equipment before you decide upon a solution:

“Many of the required features are integral to the system design/firmware and a third party software tool or bolt-on accessory likely will not achieve compliance. Additionally, you should consider whether the level of invasive integration into the OEM system and software required to incorporate these features would void any OEM warranty and/or require the third party vendor to obtain and maintain their own regulatory registration to design and perform such modifications.”

MITA’s white paper is also very clear about the scope of XR-29 and what does and does not constitute compliance:

“The Smart Dose Standard (XR-29) compliance requires these four, and only these four, attributes. There are no substitutes (e.g. iterative reconstruction) for any one or all of them that can make your equipment compliant or render any one or more of these four attributes unnecessary.” 

Before you make your facility’s decision on how you will become XR-29 compliant, feel free to schedule a phone consultation with us here at Block Imaging. We have the resources to help you wade through the XR-29 confusion and come up with a plan to make your CT system compliant. Check back often or subscribe in the right column of this page to get more news on XR-29 as details emerge.

Read the XR-29 Self-Check Guide

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Written by David Harns 

harns-david David Harns is the CT Product Specialist at Block Imaging. His goal is to provide people with service that makes the experience of purchasing imaging equipment worry-free. Outside the office, David follows Michigan State University athletics closely. He also loves to travel with his wife and four sons -- including to their favorite destination: Camp Arcadia on Lake Michigan.

 

Written by David Harns

author of blog post

Topics: Medical Imaging Compliance

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