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PA Bulletin, Doc. No. 05-2201

RULES AND REGULATIONS

STATE BOARD OF NURSING

[49 PA. CODE CH. 21]

Approval of Diploma Programs in Transition to Degree-Granting Status

[35 Pa.B. 6527]

   The State Board of Nursing (Board) amends § 21.51 (relating to establishment) governing the establishment of approved programs of nursing for professional nurses (registered nurses (RNs)) to read as set forth in Annex A.

   Notice of proposed rulemaking was published at 34 Pa.B. 851 (February 14, 2004). Publication was followed by a 30-day public comment period. The Board received seven comments from the public. On March 16, 2004, the House Professional Licensure Committee (HPLC) submitted comments. The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) made no comments. On April 14, 2004, the Independent Regulatory Review Commission (IRRC) submitted comments to the proposed rulemaking.

Statutory Authority

   Under section 2.1(k) of the Professional Nursing Law (act) (63 P. S. § 212.1(k)), the Board is authorized to establish rules and regulations for the practice of professional nursing and the administration of the act. Section 6.1 of the act (63 P. S. § 216.1) requires the Board to establish standards for the operation and approval of nursing education programs. Section 5 of the act of June 28, 2002 (P. L. 651, No. 99) amended section 6 of the act (63 P. S. § 216) to include ''programs in transition from approved diploma to degree granting programs'' in the category of programs of professional nursing that may be approved by the Board.

Summary of Comments and Responses to Proposed Rulemaking

Public Comments

   The Lancaster Institute for Health Education commented that the Board's proposed rulemaking was ''realistic and reasonable'' and would allow the Board to ''continue to protect the quality of educational curricula within our Commonwealth.''

   The Pennsylvania Osteopathic Medical Association (POMA) commented that there were two osteopathic medicine colleges in this Commonwealth that could qualify to develop a nursing program. The POMA suggested that the Board allow hospital programs accredited by the American Osteopathic Association's Healthcare Facilities Accreditation Program (HFAP), in addition to the Joint Commission on Accreditation of Healthcare Organizations, an independent organization, to develop nursing education programs. No osteopathic hospitals in this Commonwealth conduct a diploma nursing education program. This final-form rulemaking relates to the transition of an existing hospital-based nursing education program to a degree-granting nursing education program. Adding a new hospital accreditation organization, which would only serve to make it possible for an osteopathic hospital to open a diploma nursing education program, exceeds the scope of the proposed rulemaking. The Board will invite the POMA to provide additional information related to HFAP and separately consider whether HFAP accredited hospitals should be permitted to open a diploma nursing education program.

   Mount Aloysius College (College) commented that ''[t]here are substantive questions about the hospital-based program's capacity to provide the comprehensive education that is the hallmark of the associate or bachelor's degree in nursing.'' The College recommended ''that diploma programs seek creative ways in which to partner over the long term with degree-granting institutions in order to afford their students the advantages that accrue to affiliation with such institutions.''

   The Pennsylvania Medical Society expressed it support for the proposed rulemaking.

   The Hospital and Healthsystem Association of Pennsylvania (HAP) noted that it fully supports the proposed rulemaking as written. HAP did suggest additional details be provided, outside of the rulemaking, such as whether the Board would send the Department of Education (Department) a statement that a diploma program wishing to transition to a degree-granting program had been on full approval status for 3 years prior to the transition. HAP suggested that the Board and the Department consider hosting an educational program to provide these details. The Board has a checklist of requirements for program approval, which is provided to persons who contact the Board for information. The checklist will instruct interested parties how to obtain verification of full approval status.

   Carol Gisselquist, Higher Education Specialist with the Department, wrote to clarify the role of the Department and noted that regional accreditation is different than the certificate of authority to operate granted by the Department. Carol Gisselquist noted that the rulemaking appeared to incorrectly identify the Department as the agency that granted accreditation. The Board revised the final-form rulemaking to correctly identify the role of the Department and the accrediting body.

   The Accrediting Council for Independent Colleges and Schools (ACICS) commented that it should be considered an accrediting body for purposes of the rulemaking. The United States Department of Education recognizes the Middle States Association of Colleges and Schools (Middle States) as the regional accrediting body for institutions of higher learning in this Commonwealth. The United States Department of Education recognizes ACICS as an accrediting body for independent colleges and schools training in business careers. Currently, all colleges and universities in this Commonwealth with Board-approved schools of nursing are accredited by Middle States. The Board does not believe that ACICS accreditation is comparable to Middle States accreditation and declines to make the proposed amendment.

HPLC Comments

   The HPLC submitted two comments. First, the HPLC sought clarification under subsection (a)(2)(iv) and asked what would happen to a nursing education program if the program did not obtain full approval from the Department and has been in existence more than 6 years. The question is similar to one raised by IRRC.

   Second, the HPLC asked whether the Board intended to make an exception for programs in transition to the rule that a nursing education program be developed under the leadership of an RN. The Board did not intend this and believes the renumbered, redrafted final-form rulemaking addresses this issue.

IRRC Comments

   First, IRRC commented that the phrase ''under the leadership of a registered nurse'' already existed in §§ 21.71(b) and 21.74(b) (relating to faculty and staff requirements for baccalaureate and associate degree programs; and faculty and staff requirements for diploma programs), and suggested that the phrase may be duplicative. The phrase is already part of existing § 21.51(a). It has not been added by the proposed rulemaking. This provision has been in existence since the regulation was part of the Board's Handbook for Schools of Nursing from 1952. The provision remained in existence through two regulatory amendments, published at October 23, 1976 (6 Pa.B. 2677) and September 17, 1983 (13 Pa.B. 2829). Throughout this time, the phrase has not caused any confusion among universities, colleges or hospitals as to the requirements for establishment of an approved nursing education program. The Board therefore declines to remove the phrase.

   Second, IRRC noted that a commentator had suggested that HFAP be added as an approval body for hospitals. As previously discussed, the Board will further examine this issue, which is distinct from the purposes of this final-form rulemaking.

   Third, IRRC suggested that subsection (a)(1)(iii) be amended to require a diploma program contemplating transition to a degree-granting program to have 3 years of full approval status before the program applies to the Board to start the transition process. The Board agrees that subsection (a)(1)(iii) is unclear as drafted because the date of transition is unspecified. To clarify this subsection, the Board has added language to indicate that a program must have been on full approval status for at least 3 years prior to the admission of students to the degree-granting program. In addition, the Board has amended subsection (a)(2)(i) to list the other Board regulations with which a program in transition must comply. A program in transition must comply with § 21.51(b). The amendment to this section will clarify that an intent to transition begins with a feasibility study, a process already familiar to all nursing education programs.

   Fourth, IRRC submitted two comments on subsection (a)(2)(ii) and (iii) regarding transition requirements. IRRC questioned whether the requirement that a program in transition submit an annual report was duplicative because that requirement exists in § 21.124 (relating to records to be filed with Board). The annual report submitted by nursing education programs under § 21.124 is a brief demographical report of enrollment and graduation dates. The report envisioned by the Board under subsection (a)(2)(ii) is a report on the progress of the transition. The Board has amended subsection (a)(2)(ii), which has been renumbered § 21.51(g)(1), to make this clarification. IRRC also commented that subsection (a)(2)(iii) states that the program in transition will be subject to a site review, but does not identify what entity will perform the review. The reviewer is identified in § 21.51(e) as a nursing education advisor to the Board. The Board's amendment of subsection (a)(2)(i) to include compliance with § 21.51(e) will clarify the identity of the reviewer.

   Fifth, both the HPLC and IRRC commented on subsection (a)(2)(iv) regarding the time period for transition. The HPLC queried whether it was necessary to use 6 years as a time limit, and expressed concern that retaining the 6-year time frame could force the Board to close an educational program that was on the verge of receiving full accreditation. IRRC asked what would happen after 6 years if the program does not obtain full approval from the Department and asked the Board to clarify the consequences of not meeting the 6-year time limit. In addition, IRRC noted that the preamble to the proposed rulemaking indicated that it may take up to 6 years for a college or university to obtain full regional accreditation.

   The proposed rulemaking confused the certificate of authority to operate issued by the Department and regional accreditation by a United States Department of Education-approved body, as noted in Carol Gisselquist's comments, previously addressed. Thus, the question is what will happen to a nursing education program that fails to obtain full regional accreditation (§ 21.51(g)(3)).

   The Board has removed the 6-year time limit for obtaining full regional accreditation. A program that submits annual progress reports evidencing satisfactory progress toward full accreditation under § 21.51(g)(1) may remain on initial approval status longer than 6 years. A program that fails to progress will be placed on provisional approval status under § 21.33(c) (relating to types of approval).

   Sixth, IRRC submitted comments on subsections (a)--(e), existing regulations regarding nursing education programs, procedures and requirements. IRRC expressed three concerns. First, IRRC noted that subsection (a)(1) should not be an exception to § 21.51. The Board agrees, and has amended the language. Second, IRRC noted that subsection (a)(1) is lengthy and complex and might be better renumbered. The Board agrees and has renumbered the final-form rulemaking for simplicity. Third, IRRC noted that it is unclear whether existing requirements in subsections (b)--(e) will apply to programs in transition. The Board's renumbering and inclusion of specific regulatory references in what had been subsection (a)(2)(i) addresses this concern.

   Seventh, IRRC noted that the Board uses both the terms ''nursing program'' and ''nursing education program'' in § 21.51. The final-form rulemaking has been amended to use only the term ''nursing education program.''

   Eighth, IRRC noted that the term ''wishing'' was not standard regulatory language. The wording has been amended.

   Ninth, IRRC requested that any references to types of approval status reference the appropriate section of the Board's regulations explaining that status. Thus, full approval status would reference § 21.33(b) and initial approval status would reference § 21.33(a). The Board has made these amendments.

   Tenth, IRRC noted that subsection (a)(2)(i) may be unnecessary if a program in transition is considered another type of approved program. The Board believes its renumbering of the regulation addresses this concern.

Additional Amendments

   The Board has made several amendments in the final-form rulemaking which delete obsolete requirements from § 21.51. Specifically, the Board deleted references to the regional health planning agency, which has not existed for many years. Second, the Board increased the number of copies of the feasibility study required from 15 to 18 to provide adequate copies for the Board members and staff to review.

Fiscal Impact and Paperwork Requirements

   The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions. Programs in transition will be required to follow the same rules regarding the program proposal and feasibility study as new nursing education programs and will be charged the same fee for service as new programs. This fee is being promulgated in a separate rulemaking package regarding fees. The final-form rulemaking will not impose significant paperwork requirements upon programs in addition to those for new programs or upon the Board, and none upon any political subdivisions. The private sector will not incur additional costs in submitting information to the Board.

Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 14, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 851, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.

   Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.

   Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on October 18, 2005, the final-form rulemaking was approved by the HPLC. On November 2, 2005, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 3, 2005, and approved the final-form rulemaking.

Additional Information

   Additional information may be obtained by writing to Ann Steffanic, Board Administrator, State Board of Nursing, P. O. Box 2649, Harrisburg, PA 17105-2649.

Findings

   The Board finds that:

   (1)  Public notice of intention to adopt the amendment was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.

   (2)  A public comment period was provided as required by law and all comments were considered.

   (3)  This final-form rulemaking is necessary and appropriate for the regulation of diploma nursing education programs in transition to degree-granting nursing education programs in this Commonwealth.

   (4)  This final-form rulemaking does not enlarge the original purpose of the proposed rulemaking at 34 Pa.B. 851.

Order

   The Board orders that:

   (a)  The regulations of the Board, 49 Pa. Code Chapter 21, are amended by amending § 21.51 to read as set forth in Annex A.

   (b)  The Board shall submit a copy of this order and Annex A to the Office of the Attorney General and the Office of General Counsel for approval as required by law.

   (c)  The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

   (d)  This order shall take effect upon publication in the Pennsylvania Bulletin.

JANET HUNTER SHIELDS, MSN, CRNP, CS,   
Chairperson

   (Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 35 Pa.B. 6390 (November 19, 2005).)

   Fiscal Note: Fiscal Note 16A-5118 remains valid for the final adoption of the subject regulations.

Annex A

TITLE 49.  PROFESSIONAL AND VOCATIONAL STANDARDS

PART I.  DEPARTMENT OF STATE

Subpart A.  PROFESSIONAL AND OCCUPATIONAL AFFAIRS

CHAPTER 21.  STATE BOARD OF NURSING

Subchapter A.  REGISTERED NURSES

APPROVED PROGRAMS OF NURSING

§ 21.51. Establishment.

   (a)  A nursing education program shall be developed under the leadership of a registered nurse as follows:

   (1)  A nursing education program may be developed under the authority of a regionally accredited university or college and will be known as a degree-granting nursing education program.

   (2)  A nursing education program may be developed under the authority of a hospital approved by the Joint Commission on Accreditation of Hospitals and will be known as a diploma nursing education program.

   (3)  A Board-approved diploma nursing education program may transition to a degree-granting nursing education program under the authority of a university or college pursuing regional accreditation and will be known as a program in transition.

   (b)  A nursing education program may be developed only if there is an adequate faculty and adequate clinical facilities and the philosophy of the parent institution encompasses dual programs of education.

   (c)  Prior to establishment or transition, a nursing education program shall:

   (1)  Complete a feasibility study which includes:

   (i)  Sufficient statistical data to support the need for a program within the community and to assure availability of an adequate supply and flow of interested candidates.

   (ii)  Identification of available clinical recourses for program implementation based on the projected enrollment and faculty. In viewing the clinical resources, the study must speak to other nursing education programs that share the teaching facilities identified in the study.

   (iii)  Letters of intent from the cooperating agencies indicating positive commitment to the nursing education program and the availability of sufficient clinical resources to meet the educational requirements of the program.

   (iv)  Actual cost of the program including faculty needed, clinical teaching resources, education supplies, office supplies, and the like, and sufficient evidence of stable financial support.

   (2)  Submit 18 copies of the feasibility study to the Board for approval.

   (3)  Employ the nurse administrator of the educational unit at least 12 months prior to the intended admission date of students. Board approval of the nurse administrator's credentials shall be obtained prior to the appointment. For a program in transition, the nurse administrator may serve as administrator of both the degree-granting and diploma nursing education program during the transition period.

   (4)  Submit 18 copies of the tentative planned education program to the Board. For degree-granting and diploma nursing education programs, the submission shall be made at least 8 months prior to the intended admission date of students. For a program in transition, the submission shall be made at least 3 months prior to the intended admission date of students.

   (5)  Employ the teaching faculty at least 1 semester before the initiation of their teaching responsibilities.

   (d)  Change of ownership shall be processed as the establishment of a new program.

   (e)  The planned educational program must include:

   (1)  Organization and administrative policies of the controlling institution.

   (2)  Administrative structure and functions of the nursing school.

   (3)  Educational preparation and nursing experience of faculty members employed.

   (4)  Statement of the philosophy, purposes and objectives of the program.

   (5)  Proposed curriculum design based on sound educational concepts and including detailed course descriptions and identification of clinical practice.

   (6)  Admission policies.

   (7)  Educational standards.

   (8)  Copy of proposed budget projected for a minimum of 5 years.

   (9)  Copies of written agreements with cooperating agencies and facilities to be used in the program.

   (f)  A program in transition shall submit the following to the Board with the program's feasibility study:

   (1)  A copy of the certificate of authority to operate a degree-granting institution from the Department of Education.

   (2)  Documentation of the university or college's pursuit of regional accreditation.

   (3)  Documentation that the diploma program has maintained full approval status under § 21.33 (relating to types of approval) for at least 3 years prior to the intended date for admission of students.

   (g)  A program in transition shall:

   (1)  Submit an annual report detailing the progress of the transition to the Board. If requested by the Board's educational advisor, a program in transition shall appear before the Board to respond to questions or concerns that arise from the annual progress report.

   (2)  Be subject to a site review by the Board's education advisor after the first class has been awarded degrees and the results of the licensing examination taken by the first class are available.

   (3)  Continue on initial approval under § 21.33(a) until the university or college has obtained full regional accreditation.

   (h)  Following the review of the program and before final Board action is taken to grant permission to recruit students, an initial faculty and nursing education program survey will be made by a nursing educational advisor of the Board.

[Pa.B. Doc. No. 05-2201. Filed for public inspection December 2, 2005, 9:00 a.m.]



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