WSR 98-18-065

PROPOSED RULES

DEPARTMENT OF HEALTH

(Orthotics and Prosthetics)

[Filed August 31, 1998, 4:16 p.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 97-22-025.

Title of Rule: WAC 246-850-010 Definitions, this section contains the definition of "maintenance of an orthosis or prosthesis."

WAC 246-850-020 Requirements for licensure, requires a bachelor degree in orthotics or prosthetics from an approved school, a residency of at least 1900 hours and successful completion of the required examination.

WAC 246-850-030 Application requirements, sets forth the documentation required to substantiate that the applicant meets the requirements for licensure.

WAC 246-850 [246-850-050] Approved internship or residency requirement, requires completion of at least 1900 hours for each discipline for which a license is sought. Training must be completed under qualified supervision in an established facility. RCW 18.200.050(5), 18.200.070 (1)(c).

WAC 246-850-080 Inactive credential, adoption by reference of chapter 246-12 WAC, Part 4.

WAC 246-850-090 Retired active credential, adoption by reference of chapter 246-12 WAC, Part 5.

WAC 246-850-100 Licensure without examination, sets for the experience and application requirements for licensure without examination.

WAC 246-850-110 Approval of orthotic and prosthetic educational programs, includes the approval and curriculum requirements for O&P programs.

WAC 246-850-120 Withdrawal of program approval, sets forth the circumstances that would result in withdrawal of program approval.

WAC 246-850-990 Orthotic and prosthetic fees, sets forth the fees for licensure, renewal or relicensure, inactive and retired status, duplicate credentials and certification.

Purpose: To implement chapter 18.200 RCW enacted by the legislature in 1997.

To protect the consumers of Washington from physical and financial harm by assuring that practitioners are qualified to provide orthotic and prosthetic services. The proposed rules set forth specific minimum requirements that must be met by applicants for licensure. These proposed rules also set forth the process by which a license may be renewed and set fees.

Statutory Authority for Adoption: RCW 18.200.050(1).

Statute Being Implemented: RCW 18.200.050 (1)(2)(5)(6)(8)(11), [18.200.]070, [18.200.]080, 43.70.250, [43.70.]280, [43.70.]320.

Summary: These rules are the initial rules to implement chapter 18.200 RCW. The rules set forth licensure and application requirements; provision for licensure without examination, education and internship requirements, administrative requirements and fees.

Reasons Supporting Proposal: Licensing requirements must be in rule form.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Judy Haenke, Program Manager, 1300 S.E. Quince Street, Olympia, WA 98504, (360) 753-4614.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rules are the initial rules developed to implement chapter 18.200 RCW which was enacted in 1997. These rules set forth licensure and application requirements; provisions for licensure without examination, education and internship requirements, administrative requirements and fees. The purpose of the rules is to set sufficient standards to ensure that applicants who qualify for licensure have adequate training and experience, thus safeguarding the public health, safety and welfare.

Proposal does not change existing rules.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

significant rules analysis

economic impact analysis and

small business economic impact statement

objective: To adopt rules necessary to implement chapter 18.200 RCW, the law relating to orthotic and prosthetic services, which was enacted by the legislature in 1997. All rules presented are new rules and focus on licensure and application requirements, the process of renewal of credentials and fees.

note: The term "O&P provider," "O&P practitioner," or "O&Ps" will be used to substitute for "orthotist and prosthetist" throughout this report. These are accepted substitutions among these professionals.

background: Chapter 18.200 RCW provides for the licensure of orthotists and prosthetists. An orthotist designs, fabricates, assembles and fits custom-braces or supports for patients who have a disease, injury or deformity that interferes with normal body functions. A prosthetist designs, fabricates and fits prostheses to replace limbs lost due to amputation, deformity or absences.

The following rules are proposed to implement the first phase of this chapter, the licensing of qualified applicants. These rules relate to licensure without examination (grandfathering), licensure and application requirements, the process of renewal of credentials and fees. The proposed rules include:

WAC 246-850-010 Definitions, this section contains the definition of "maintenance of an orthosis or prosthesis." Statutory authority: RCW 18.200.050(1).

WAC 246-850-020 Requirements for licensure, requires a bachelor degree in orthotics or prosthetics from an approved school, a residency of at least 1900 hours and successful completion of the required examination. Statutory authority: RCW 18.200.050 (5)(8)(11), 18.200.070 (1)(c).

WAC 246-850-030 Application requirements, sets forth the documentation required to substantiate that the applicant meets the requirements for licensure. Statutory authority: RCW 18.200.050 (1)(2).

WAC 246-850 [246-850-050] Approved internship or residency requirement, requires completion of at least 1900 hours for each discipline for which a license is sought. Training must be completed under qualified supervision in an established facility. RCW 18.200.050(5), 18.200.070 (1)(c).

WAC 246-850-080 Inactive credential, adoption by reference of chapter 246-12 WAC, Part 4. Statutory authority: RCW 43.70.280.

WAC 246-850-090 Retired active credential, adoption by reference of chapter 246-12 WAC, Part 5. Statutory authority: RCW 43.70.280.

WAC 246-850-100 Licensure without examination, sets forth the experience and application requirements for licensure without examination (grandfathering). Statutory authority: RCW 18.200.080.

WAC 246-850-110 Approval of orthotic and prosthetic educational programs, includes the approval and curriculum requirements for O&P programs. Statutory authority: RCW 18.200.050(5).

WAC 246-850-120 Withdrawal of program approval, sets forth the circumstances that would result in withdrawal of program approval. Statutory authority: RCW 18.200.050(6).

WAC 246-850-990 Orthotic and prosthetic fees, sets forth the fees for licensure, renewal or relicensure, inactive and retired status, duplicate credentials and certification. Statutory authority: RCW 43.70.250, 43.70.320.

goals and specific objectives of the statute: To protect the consumers of O&P care in Washington from physical, psychological and financial harm by assuring that practitioners are qualified to provide O&P services. The proposed rules set forth specific minimum requirements that must be met by applicants for licensure. These proposed rules also set forth the process by which a license may be renewed and set fees.

is the rule necessary to achieve these goals and objects? Rules are necessary because the proposed requirements or processes either establish qualifications or standards for the issuance of licenses or set forth the process requirements for making application for a license.

are the probable benefits of the rule greater than the probable cost? The proposed rules set educational requirements at a level that will help to ensure consumers of O&P services receive quality care. These standards and requirements for licensure are substantially equal to the standards commonly accepted in the fields of O&P. Currently, only three other states, Florida, New Jersey and Texas have laws regulating O&P practitioners. In these states, regulations are in various stages of development. The statutes for these states, seem to have similar provisions. The two primary national certifying bodies also have similar qualifications for certification, although the requirements for formal training and experience differs. By requiring minimum competency, the likelihood of harm by poorly designed O&P devices which compromise the function and safety of physically challenged consumers is greatly reduced.

Probable benefits: Improved quality of care - a decrease in the magnitude of risk to which consumers are subjected by the poor application of O&P devices or as a result of inadequate training of patients or maintenance of an orthosis or prosthesis. It is estimated that at least one hundred thirty-nine practitioners within Washington state will apply for licensure. It is also estimated that at least thirty out-of-state practitioners will apply for licensure.

A poorly fitting or improperly designed O&P device can result in deep ulcerations in patients who have no sensation which may necessitate additional surgery.

Improperly designed devices or inadequate patient training or follow-up may cause malalignment of a patient's skeleton and create deformity.

Progression of a deformity that could have been prevented by an appropriately fitted and maintained O&P device.

Improved consumer safety - catastrophic failure of an O&P device can result in permanent damage to the limb on which the device is worn or temporary bodily injury, or in the extreme, death. To the consumer of O&P services, whose device suddenly fails, there is a potential for a serious injury.

Public sense of well being - confidence that the practitioner has met standards for licensure and is competent to practice.

Competent O&P care as a key component of rehabilitation helps to mitigate the effects of injury and chronic disease, restores functional ability and helps patients cope.

Financial gain - the patient, his or her family and society in general sustain a financial cost when a member, who could otherwise be productive, is unemployable due to inadequate O&P care.

Significant financial cost is incurred if O&P care not only fails to restore function but instead, produces further complications. These increased costs are due, in part, to decreased productivity and function with resulting dependence on society.

Probable Costs to Regulated Parties:

Recordkeeping and reporting: None of the proposed rules would represent any additional recordkeeping or reporting costs to licensees.

Training and education: Applicants would be required to complete a bachelor degree program or certificate program in orthotics or prosthetics. Approved bachelor degree programs must include college level course work in the basic sciences: Biology, psychology, physics, chemistry, physiology, human anatomy, and algebra or higher math. These courses serve to provide a necessary basis of knowledge for formal O&P training. Advanced O&P training uses the foundation of the basic sciences and builds on that information to complete the education of an O&P provider.

The educational requirements for an O&P license were developed by practicing professional O&P providers, the Orthotics and Prosthetics Advisory Committee, and the Department of Health. The educational requirements were proposed and discussed in four public meetings held in 1998. The educational requirements in rule represent the consensus of this process.

The average cost of tuition for the bachelor degree or certificate from currently approved Washington schools is $6,538 per year. It should be noted that, in the absence of licensure, national certification is required for employment in the majority of positions. Currently, national certification requires a bachelor degree or certificate program as well as an experience requirement, however qualifying training or experience is considered. Therefore, a majority of potential licensees have already completed the training proposed by the rules as a means for national certification.

New Equipment Requirements: The proposed rules do not represent any requirements for equipment.

Inspections - Audits: The proposed rules do not represent any requirements for inspections or audits.

New Licenses/Fees: Proposed fees are incorporated in WAC 246-850-990. Proposed application fees are $600.00. The renewal is $575.00. RCW 43.70.250 and 43.70.280 require that the cost of licensing be fully supported by the licensees. Therefore, the amount of the fees reflect the estimated cost to operate the Orthotics and Prosthetics program divided by the anticipated number of licensees. Estimated costs include the expenses incurred to set up the program, the estimated administrative cost to issue the licenses, estimated disciplinary costs, estimated expert witness fees, and estimated attorney general fees. The department's fee study indicated that an application fee of $600 and a renewal fee of $575 were necessary to recover the estimated costs.

Administration Expenses and Professional Services: The proposed rules do not represent any requirements for administration expenses and professional services.

Reduced Production: The proposed rules will not affect production.

Probable Costs to DOH: Administration Costs: The total budget for this program is $137,506 for the biennium. It is estimated that licensing accounts for 60% of the total budget. This allotment includes start up costs, both direct and indirect. The proposed fees based on the current estimate of applicants and licensees would adequately support the program. Assuming the estimate is correct, the program should recover the start up costs after the second year. It is not anticipated that there would then be an excess of revenue.

cost/benefit summary: Given the intangible nature of the benefits of the proposed rules, i.e., improved quality of care, improved consumer safety, public sense of well being and financial gain, it is difficult to place an actual monetary value. However, when viewed against the costs to the regulated parties, the department concludes that the benefits exceed the costs. There is no disproportionate effect on small businesses.

alternatives to rule making: Considering the scope of the proposed rules, there is no alternative to rule making. All of the proposed rules are necessary to implement the statute. The rules as presented are meant to be the least burdensome alternative to meet the requirements of the chapter.

in violation of another federal or statute law? The proposed rules are not in violation of another federal or state law.

impose stricter performance requirements on private entities than public entities: Any proposed performance requirements would apply equally to both private or public entities.

rules differ from federal regulation or statute: There are no known federal regulations or statute that differ from the proposed rules.

coordinate rule with other federal, state and local laws on same activity: The program has maintained open contact with stockholders during the course of the rules development.

A copy of the statement may be obtained by writing to Judy Haenke, P.O. Box 47870, Olympia, WA 98504-7870.

RCW 34.05.328 applies to this rule adoption. It establishes qualifications for the issuance of licenses.

Hearing Location: Department of Health, 1102 S.E. Quince Street, Olympia, WA 98504, on October 7, 1998, at 1:00 p.m.

Assistance for Persons with Disabilities: Contact Judy Haenke by October 5, 1998, TDD (360) 753-2870, or (360) 664-0064.

Submit Written Comments to: Judy Haenke, P.O. Box 47870, Olympia, WA 98504-7870, fax (360) 586-0745, by October 5, 1998.

Date of Intended Adoption: October 8, 1998.

August 27, 1998

Kristine Van Gorkom

Deputy Secretary

OTS-2326.3

Chapter 246-850 WAC

ORTHOTICS AND PROSTHETICS RULES

NEW SECTION

WAC 246-850-010  Definitions. "Maintenance of an orthosis or prosthesis" includes replacement or repair of component parts that is equivalent to the original component and is required due to wear or failure. Maintenance of an orthosis or prosthesis does not include altering the original components or complete replacement of the orthosis or prosthesis.

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NEW SECTION

WAC 246-850-020  Requirements for licensure. To qualify for licensure as either an orthotist or prosthetist in this state, a candidate must:

(1) Possess a bachelor degree in orthotics or prosthetics from an approved orthotic or prosthetic educational program as provided in WAC 246-850-110; alternatively, a candidate may complete a certificate program in orthotics or prosthetics from an approved education program as provided in WAC 246-850-110;

(2) Complete a clinical internship or residency of 1900 hours as required in WAC 246-850-050; and

(3) Complete an examination as required in WAC 246-850-060.

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NEW SECTION

WAC 246-850-030  Application requirements. An applicant for licensure shall submit the following:

(1) A completed application and fee as required in chapter 246-12 WAC, Part 2;

(2) Official transcripts, certificate, or other documentation forwarded directly from the issuing agency where the applicant has earned a bachelor degree or completed a certificate program from an NCOPE or CAAHEP accredited program as set forth in WAC 246-850-110;

(3) Documentation of completion of an internship or residency of at least 1900 hours as provided in WAC 246-850-050;

(4) Documentation of successful completion of a licensing examination as approved by the secretary;

(5) Verification of four clock hours of AIDS education as required in chapter 246-12 WAC, Part 8.

(6) Verification from all states in which the applicant holds or has held a license, whether active or inactive, indicating that the applicant is or has not been subject to charges or disciplinary action for unprofessional conduct or impairment; and

(7) Additional documentation as required by the secretary to determine whether an applicant is eligible for licensure.

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NEW SECTION

WAC 246-850-040  Licensure without examination. (1) The secretary may grant a license to an applicant who has practiced full time for five of the six years prior to December 1, 1998, and who has provided comprehensive services in an established practice as determined by the secretary.

(2) Applications must be received no later than December 1, 1999.

(3) For the purposes of this section, the following terms have the following meanings:

(a) "Full time" means at least 30 hours per week.

(b) "Comprehensive services" includes the continuum of direct patient care utilizing primary diagnostic evaluation, assessment and follow up and measurable experience in initiating and providing independent measurement, design, fabrication, assembling, fitting, adjusting and servicing. Comprehensive services does not include the provision of incidental repairs, maintenance, or other services at the direction, or under the supervision of, a primary orthotic or prosthetic practitioner.

(c) "Established practice" means a recognized place of business with access to equipment essential to the provision of comprehensive orthotic and/or prosthetic services.

(4) An applicant for licensure without examination must provide the following:

(a) A completed application and fee as required in chapter 246-12 WAC, Part 2;

(b) Official certificates or transcripts sent directly from the issuing agency or institution documenting formal education, if any, including internships or residencies in the professional area for which a license is sought;

(c) Documentation of employment or work history in the professional area for which the license is sought, including the names and qualifications of individuals providing direction or supervision;

(d) A statement describing scope of practice of employment or work experience;

(e) Certification received directly from at least one supervisor describing the applicant's scope of practice and work experience and assessing the applicant's competence and skill level;

(f) Three letters of recommendation from employers or physicians from whom the applicant has received referrals;

(g) Verification of four clock hours of AIDS education as required in chapter 246-12 WAC, Part 8;

(h) Verification from all states in which the applicant holds or has held a health care practitioner license, whether active or inactive, indicating that the applicant has not been subject to charges or disciplinary action for unprofessional conduct or impairment; and

(i) Additional documentation as required by the secretary to determine whether an applicant is eligible for licensure.

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NEW SECTION

WAC 246-850-050  Approved internship or residency requirement. Applicants must complete an internship of at least 1900 hours in each area for which a license is sought. Individual internships must be completed within a minimum period of one year and a maximum period of two years unless extended by the secretary for good cause shown. The internship or residency must be completed under a supervisor qualified by training and experience in an established facility and incorporate patient management and clinical experience in rehabilitation, acute and chronic care in pediatrics and of adults. Applicants who submit evidence of completion of a 1900 hour internship or residency which is approved by the National Commission on Orthotic and Prosthetic Education (NCOPE) or Commission for Accreditation of Allied Health Education Programs (CAAHEP) are considered to have met the requirements of this section. The 1900 hours of internship training must be completed subsequent to graduation from an approved program.

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NEW SECTION

WAC 246-850-090  Inactive credential. A practitioner may obtain an inactive credential. Refer to the requirements of chapter 246-12 WAC, Part 4.

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NEW SECTION

WAC 246-850-100  Retired active credential. A practitioner may obtain a retired active credential. Refer to the requirements of chapter 246-12 WAC, Part 5.

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NEW SECTION

WAC 246-850-110  Approval of orthotic and prosthetic educational programs. (1) For purposes of WAC 246-850-020, the secretary recognizes as approved those orthotic and prosthetic programs that:

(a) Are approved by the National Commission on Orthotic and Prosthetic Education (NCOPE) or its successor, or the Commission on Accreditation of Allied Health Programs (CAAHEP) or its successor or other accrediting body with substantially equivalent requirements; and

(b) Meet the requirements of subsections (2) and (3) of this section.

(2) Approved baccalaureate degree programs or certificate programs must have as prerequisites the following college level coursework:

(a) Biology.

(b) Psychology.

(c) Physics.

(d) Chemistry.

(e) Physiology.

(f) Human anatomy.

(g) Algebra/higher math.

(3) Approved baccalaureate degree programs or certificate programs must include the following coursework within a minimum of three quarters or two semesters in each practice area for which a license is sought.

(a) Orthotics only:

(i) Lower extremity orthotics.

(ii) Upper extremity orthotics.

(iii) Spinal orthotics.

(iv) Pathophysiology.

(v) Biomechanics and kinesiology.

(vi) Radiographic interpretation.

(vii) Normal and pathological gait.

(viii) Clinical evaluation.

(ix) Clinical affiliation.

(x) Research methods.

(xi) Practice management.

(b) Prosthetics only:

(i) Lower extremity prosthetics.

(ii) Upper extremity prosthetics.

(iii) Pathophysiology.

(iv) Biomechanics and kinesiology.

(v) Radiographic interpretation.

(vi) Normal and pathological gait.

(vii) Clinical evaluation.

(viii) Clinical affiliation.

(ix) Research methods.

(x) Practice management.

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NEW SECTION

WAC 246-850-120  Withdrawal of program approval. Approval of educational programs may be withdrawn by the secretary, as provided in chapter 34.05 RCW and chapter 246-10 WAC, if:

(1) A program ceases to be approved by NCOPE or CAAHEP; or

(2) Fails to maintain the accreditation standards of NCOPE or CAAHEP; or

(3) Does not meet the minimum curriculum requirements as provided in WAC 246-850-110.

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NEW SECTION

WAC 246-850-990  Orthotic and prosthetic fees. (1) Licenses must be renewed every year on the practitioner's birthday as provided in chapter 246-12 WAC, Part 2.

(2) The following nonrefundable fees will be charged:

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