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Quality standards | KevinRoot Medical

Quality standards


  • A previous bulletin raised a new term for most reading this bulletin, “Quality Standards Appendix C” 

    What exactly is the “Quality Standards, Appendix C”? 

    The Quality Standards apply both to the supplier and the vendor supplying the device.

    Physicians are exempt from most of the Quality Standards. This document primarily addresses facility licensing and operations. The Medicare Improvement Act which addressed Facility Accreditation and Surety Bonding requirements for most suppliers, exempted physicians treating their own patients from those requirements. However, Appendix C is one area which is still appliable, but as you read its summary below, you will find that you have been following Appendix C all along.

     

     

    The Appendix C stipulates the following requirements:

    Suppliers must get training in a broad range of treatment options to ensure the best items for the patient’s condition. 

    Offering custom-fabricated or custom-fitted devices requires facility access to provide follow-up treatment, including modification, adjustment, maintenance, and item repair, except off-the-shelf (OTS) items. See previous articles in this column for more information. 

    What the Quality Standards also requires is a proper intake and assessment of the patient by the provider. Your medical documentation must also provide a treatment plan consistent with your prescription and provide a prediction of what the device will do for the patient. 

    The second portion of the Quality Standards requires the chart to document the patient was provided instructions for use (IFU), which include information on inspection and maintenance of the DMEPOS you provided. If necessary, should the patient require further assistance beyond your level of expertise, that information should be conveyed in the chart.  Examples include referring patients to a pedorthist for a shoe to fit the AFO or to a physical therapist for follow up gait training with use of the AFO.

    The last portion of the Quality Standards addresses follow up care. How many DMEPOS providers provide patients with follow up appointments on a routine basis to mark their progress with the dispensed device? This is mandatory even for a replacement device. 

    It should become very apparent that most physicians already providing custom fabricated or custom fitted orthoses, are already providing documentation which exceed the Quality Standard requirements. 

    The Quality Standards Appendix C may be found on this link.



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