Chapter 4779-3 Definitions

4779-3-01 Definition of terms.

The following definitions shall apply to the language of Chapter 4779. of the Revised Code:

(A) “Board” means the state board of orthotics, prosthetics and pedorthics

(B) “Good moral character” as it is used in section 4779.09 and under division (A)(1)(3) in section 4779.18 of the Revised Code, means not having been convicted of a crime of moral turpitude; not having made misstatements or misrepresentation in connection with an application or examination for registration, certification or licensure; and not having willfully violated any of the sections related to conduct required of applicants or licensees and set forth in the statutes or rule.

(C) “License”, as it is used under division (A) of section 4779.20 of the Revised Code, means the license certificate or a notarized copy of the license certificate as issued by the board.

(D) “Licensee” means a person who holds a license issued under Chapter 4779. of the Revised Code.

(E) “Nationally accredited college or university in the U.S.” means colleges and universities accredited by an accreditation body recognized by the U.S. department of education, including regional accreditation bodies.

(F) “Physically present” as it is used under division (B) of section 4779.04 of the Revised Code means at the same building, location, or facility as the non-licensed practitioner and patient.

(G) “Temporary license” means a license issued under section 4779.18 of the Revised Code.

(H) “Under the direct supervision”, as it is used under division (B)(5) of section 4779.02 of the Revised Code, means the individual who provides orthotic, prosthetic, or pedorthics services under the supervision of an individual authorized to practice medicine or osteopathic medicine, must perform the evaluation, measurement, design, fitting, adjusting, servicing, or training in a location where the physician or osteopathic physician is present.

(I) “Under the supervision” as it is used under division (B) in section 4779.18 of the Revised Code means the individual who practices under the supervision of an individual who holds a license issued under section 4779.09 of the Revised Code may conduct the initial evaluation or all activities at a building, location, or facility where the supervising orthotist, prosthetist, or pedorthist is physically present or is readily available to the individual through some means of telecommunication and is in a location that under normal circumstances is not more than sixty minutes travel time away from the location where the non-licensed individual is practicing.

(J) “Residency program” approved by the board, as referenced in section 4779.10 of the Revised Code, section 4779.11 of the Revised Code, and section 4779.12 of the Revised Code means a residency requiring nineteen hundred hours under the direct supervision of a practitioner certified in the same discipline.

(K) “Custom fabricated or fitted medical device” as referenced in division (E) of section 4779.01 of the Revised Code means an orthotic, prosthetic or pedorthic device that is individually made (custom fabricated) or fitted (custom fitted) for a specific patient. No other patient would be able to use this item after fabrication or fitting.

(1) A custom fabricated item is defined as a device which is fabricated based on a clinically derived rectified casting, tracings, measurements, and/or other images (such as x-rays) of the body part. It may involve using calculations, templates, and components. The process starts with basic materials including, but not limited to plastic, metal, leather, or cloth in the form of uncut or unshaped sheets, bars, or other basic forms. It involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, and finishing prior to fitting on the patient.

(a) A molded-to-patient-model item is a particular type of custom fabricated device in which either:

(i) An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or

(ii) A digital image of the patient’s body part is made using computer-aided design-computer aided manufacture (CAD-CAM) systems software. This technology includes specialized probe/digitizers and scanners that create a computerized positive model and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.

(2) A custom fitted item is defined as a prefabricated device which is manufactured in quantity without a specific patient in mind. The device may be supplied as a kit of prefabricated parts that require some assembly and/or fitting and adjustment, or a device that must be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient.

(a) A custom fitted item/device as referenced in division (E) of section 4779.01 of the Revised Code does not include:

(i) Upper extremity adaptive equipment used to facilitate the activities of daily living;

(ii) Finger splints;

(iii) Wrist splints;

(iv) Prefabricated elastic or fabric abdominal supports with or without metal or plastic reinforcing stays;

(v) Other prefabricated soft goods requiring minimal fitting;

(vi) Nontherapeutic accomodative inlays;

(vii) Shoes that are not manufactured or modified for a particular individual;

(viii) Prefabricated foot care products;

(ix) Other durable medical equipment;

(x) Dental applicances;

(xi) Pedorthic devices;

(xii) Devices implanted into the body by a physician.

(L) The phrase “for use from the apex of the medial malleolus and below” as used in division (G) of section 4779.01 of the Revised Code means that the pedorthic device does not physically extend proximal to the apex of the medial malleolus, meaning not extending higher than the middle of the ankle bone.

Effective: 11/01/2008

R.C. 119.032 review dates: 01/02/2012

Promulgated Under: 119.03

Statutory Authority: 4779.08

Rule Amplifies: Chapter 4779

Prior Effective Dates: 08/09/02; 04/09/07