PROPOSED RULES
(Podiatric Medical Board)
Original Notice.
Preproposal statement of inquiry was filed as WSR 98-08-115.
Title of Rule: WAC 246-922-010 Definitions, 246-922-100 Acts that may be delegated to an unlicensed person, and 246-922-090 Delegation of acts to unlicensed persons.
Purpose: Clarification of the definitions of orthotic devices and procedures that can be performed by unlicensed persons under the supervision of a podiatric physician.
Statutory Authority for Adoption: RCW 18.22.015, 18.130.050.
Statute Being Implemented: Chapter 18.22 RCW.
Summary: The definition rule is being modified to include descriptions of the various kinds of orthotic devices. The other two rules pertaining to procedures being performed by unlicensed personnel are being combined for clarification. The areas being clarified include debridement of tissues instead of lesions and removing physical therapy but permitting mechanical, manipulative and electrical treatments to be delegated to unlicensed personnel.
Reasons Supporting Proposal: Some products have been misrepresented by podiatric physicians which has resulted in excessive charging to consumers. It was noted that unlicensed personnel should not be debriding lesions, a medical procedure; and physical therapists had concerns about the reference of unlicensed personnel being able to provide physical therapy.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Arlene Robertson, Program Manager, 1300 Quince Street, Olympia, WA, (360) 236-4945.
Name of Proponent: Podiatric Medical Board, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The rules identify exactly what types of services are being provided to consumers. These changes will give the board a mechanism to take action against practitioners who misrepresent their products.
The delegation of acts to unlicensed personnel is clarified so that it is clear they may not perform procedures that require a license.
Proposal Changes the Following Existing Rules: A new definition section is added pertaining to orthotic devices. The two rules pertaining to unlicensed personnel are being combined and also provide clarification of specific procedures to be performed by those individuals.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
An estimated 220 credentialed providers will have to comply with the requirements of these rules.
Public involvement was solicited through mailings to interested parties and board meetings.
Opportunity for written comments was provided during different stages of the development of the rules. Comments were received from FootMaxx Corporation; Ted Carlson, DPM, Executive Director, Washington State Podiatric Medical Association; Bernard Hewey, WOPA; Chris Smith, DPM, NW Podiatric Lab; and Alan Woodle, DPM.
Alternate: Continue with the definitions in policy. The board considered the options of leaving the definitions in policy but determined that policies are not enforceable. Since several complaints are received each pertaining to the types of orthotics prescribed and/or dispensed, it was determined the public would be better served by having an enforcement mechanism.
II. Financial Impact on Regulated Parties: No additional record-keeping and reporting requirements.
No additional training and education requirements.
No additional new equipment requirements.
Inspections--Audits: These rules may increase the number of complaints against podiatric physicians. The cost to the practitioner is unknown. The cost would be determined by the type of action taken and the extent to which the practitioner's practice might be limited. Fewer patients might go to a practitioner whose license has been disciplined.
No additional new licenses/fees requirements.
No additional administration expenses and professional services requirements.
No additional reduced production requirements.
Summary: It is anticipated that the rules would not impact a practitioner's way of practicing. The rules provide clarification for both providers and consumers.
III. Cost to DOH:
Administration Costs: The rules may increase the number of complaints that are received by the board. Administrative costs would vary from a minimal review, investigation of a complaint, informal disposition or disciplinary action. An estimated average cost for an informal disposition is $1,000; disciplinary action averages from $5,000-$10,000. Some costs may be recovered through reimbursements and fines.
A copy of the statement may be obtained by writing to Arlene Robertson, Program Manager, P.O. Box 47870, Olympia, WA 98504-7870, phone (360) 236-4945, fax (360) 586-0745.
Section 201, chapter 403, Laws of 1995, applies to this rule adoption. The rules will adopt new or make significant amendments to a policy or regulatory program. The agency has conducted the additional analysis required under RCW 34.05.328.
Hearing Location: SeaTac Hilton, 17620 Pacific Highway South, Seattle, WA 98188-4001, on May 14, 1999, at 9:30 a.m.
Assistance for Persons with Disabilities: Contact (360) 236-4945 by May 3, 1999, TDD 1-800-236-4945.
Submit Written Comments to: Arlene Robertson, Podiatric Medical Board, P.O. Box 47870, Olympia, WA 98504-7870, fax (360) 586-0745, by May 10, 1999.
Date of Intended Adoption: May 14, 1999.
March 18, 1999
Robert J. Nicoloff
Executive Director
OTS-2415.2
AMENDATORY SECTION(Amending Order 158B, filed 4/25/91, effective 5/26/91)
WAC 246-922-010
Definitions.
(1) Chiropody, podiatry, and podiatric medicine and surgery shall be synonymous.
(2) "Board" shall mean the Washington state podiatric medical board.
(3) "Secretary" shall mean the secretary of the department of health.
(4) "Supervision" shall mean that a licensed podiatric physician and surgeon whose patient is being treated has personally diagnosed the condition to be treated and has personally authorized and directed the procedures to be performed. A podiatric physician and surgeon shall be physically present in the treatment facility while the procedures are performed.
(5) "Treatment facility" means a podiatric medical office or connecting suite of offices, podiatric medical clinic, room or area with equipment to provide podiatric medical treatment, or the immediately adjacent rooms or areas. A treatment facility does not extend to any other area of a building in which the treatment facility is located.
(6) "Unlicensed person" means a person who is not a podiatric physician and surgeon duly licensed pursuant to the provisions of chapter 18.22 RCW.
(7) Orthotic devices defined:
(a) Prefabricated or off-the-shelf orthotics, are devices that are manufactured as commercially available stock items for no specific patient. It is appropriate to dispense prefabricated orthotic devices for some conditions.
(b) Direct-formed orthotics are devices formed or shaped during the molding process directly on the patient's foot.
(c) Custom-fabricated orthotics, also known as custom-made orthotics, are devices designed and fabricated, in turn, from raw materials for a specific patient, and require the generation of an image, form, or mold that replicates the patient's foot, and, in turn, involves the rectification of dimensions, contours, and volumes to achieve proper fit, comfort, and function for that specific patient.
Prefabricated orthotic devices that have been adjusted or modified may not be dispensed and sold to consumers as custom fabricated or custom-made orthotics. All orthotic devices must be correctly represented and charged to the patient.
[Statutory Authority: RCW 18.22.015. 91-10-041 (Order 158B), § 246-922-010, filed 4/25/91, effective 5/26/91; 91-03-095 (Order 118B), recodified as § 246-922-010, filed 1/18/91, effective 2/18/91; 84-02-077 (Order PL 450), § 308-31-020, filed 1/4/84; Order PL 128, § 308-31-020, filed 7/7/72.]
A podiatric physician and surgeon may authorize the delegation of certain duties to nonpodiatric personnel and prohibit the delegation of certain other duties. The licensed podiatric physician and surgeon is ultimately responsible for all treatments performed at his or her direction. Duties that may be delegated to a person not licensed to practice podiatric medicine and surgery may be performed only under the supervision of a licensed podiatric physician and surgeon. The degree of supervision required to assure that treatment is appropriate and does not jeopardize the systemic or pedal health of the patient varies with, among other considerations, the nature of the procedure and the qualifications of the person to whom the duty is delegated. A podiatric physician and surgeon may allow an unlicensed person to perform the following acts under the podiatric physician and surgeon's supervision limited to the following:
(1) Patient education in foot hygiene.
(2) Deliver a sedative drug in an oral dosage form to patient.
(3) Give preoperative and postoperative instructions.
(4) Assist in administration of nitrous oxide analgesia or sedation, but the unlicensed person shall not start the administration of the gases and shall not adjust the flow of the gases unless instructed to do so by the podiatric physician and surgeon. Patients must never be left unattended while nitrous oxide analgesia or sedation is administered to them. This regulation shall not be construed to prevent any person from taking appropriate action in the event of a medical emergency.
(5) Take health histories.
(6) Determine rate and quality of patient's radial pulses.
(7) Measure the patient's blood pressure.
(8) Perform a plethysmographic or doppler study.
(9) Observe the nature of the patient's shoes and hose.
(10) Observe and report wearing patterns on the patient's shoes.
(11) Assist in obtaining material for a culture-sensitivity test.
(12) Take scrapings from the skin or nails of the feet, prepare them for microscopic and culture examination.
(13) Perform weightbearing and nonweightbearing x-rays.
(14) Photograph patient's foot disorder.
(15) Debride hyperkeratotic ((lesions)) tissues of the foot.
(16) Remove and apply dressing and/or padding.
(17) Make necessary adjustments to the biomechanical device.
(18) Produce impression casting of the foot.
(19) Produce the following:
(a) Removable impression insoles and modifications.
(b) Protective devices for alleviating or dispersing pressure on certain deformities or skin lesions such as ulcers, corns, calluses, digital amputation stumps (e.g., latex shields).
(20) Apply strap and/or pad to the foot and/or leg.
(21) Prepare the foot for anesthesia as needed.
(22) Know the indications for and application of cardiopulmonary resuscitation (CPR).
(23) Prepare and maintain a surgically sterile field.
(24) Apply flexible cast (e.g., Unna Boot).
(25) Apply cast material for immobilization of the foot and leg.
(26) Remove sutures.
(27) Debride nails.
(28) Administer ((physical therapy)) mechanical, manipulative and electrical treatment as
directed by the podiatric physician and surgeon.
(29) Counsel and instruct patients in the basics of:
(a) Their examination, treatment regimen and prophylaxis for a problem.
(b) Patient and family foot health promotion practices.
(c) Patient and family care of specific diseases affecting the foot (e.g., diabetes, cerebrovascular accident, arthritis).
(d) Performing certain exercises and their importance.
(30) Give patient or family supplementary health education materials.
[Statutory Authority: RCW 18.22.015. 94-05-051, § 246-922-100, filed 2/10/94, effective 3/13/94; 91-10-041 (Order 158B), § 246-922-100, filed 4/25/91, effective 5/26/91; 91-03-095 (Order 118B), recodified as § 246-922-100, filed 1/18/91, effective 2/18/91; 84-02-077 (Order PL 450), § 308-31-110, filed 1/4/84.]
The following section of the Washington Administrative Code is repealed:
| WAC 246-922-090 | Delegation of acts to unlicensed persons. |