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PA Bulletin, Doc. No. 08-1544

NOTICES

Notice of Comments Issued

[38 Pa.B. 4695]
[Saturday, August 23, 2008]

   Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P. S. § 645.5b).

   The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.

Reg. No. Agency/TitleClose of the Public Comment PeriodIRRC Comments Issued
16A-5133 State Board of Nursing
Clinical Nurse Specialists
38 Pa.B. 3246
(June 14, 2008)
7/14/08 8/13/08
16A-6911 State Board of Social Workers, Marriage
and Family Therapists and Professional
Counselors
Code of Ethical Practice and Standards of
Professional Conduct
38 Pa.B. 3253
(June 14, 2008)
7/14/08 8/13/08

____

State Board of Nursing
Regulation #16A-5133 (IRRC #2700)

Clinical Nurse Specialists

August 13, 2008

   We submit for your consideration the following comments on the proposed rulemaking published in the June 14, 2008 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Nursing (Board) to respond to all comments received from us or any other source.

1.  General.--Consistency with statute; Implementation procedures; Reasonableness.

Consistency with statute

   The proposed regulation includes certain parts, verbatim, from Act 49 of 2007 (63 P. S. §§ 213, 216.2, 217, 218.5 and 218.6) (Act), while other provisions from the Act are not included. Several commentators, including the House Professional Licensure Committee, questioned whether Section 218.5(e) (relating to Clinical nurse specialist; qualifications) of the Act should be added to this regulation. Further, some commentators also assert that Section 218.6 (relating to Scope of practice for clinical nurse specialist) of the Act should be included.

   The final-form regulation should include all requirements from the Act or justify why certain provisions are being omitted.

Grandfather clause

   Several commentators have suggested that this regulation include a grandfather clause for those nurses that have a master's degree in Nursing and have previously ''demonstrated success'' and effectiveness in the role of clinical nurse specialist (CNS). The Board should consider adding a grandfather clause for a CNS in this situation. If the Board adds a grandfather clause, it should also specify the criteria that must be met for a nurse to be certified as a CNS under a grandfather clause.

2.  Section 21.801. Definitions.--Consistency with statute; Clarity.

   The definition of ''CNS--Clinical nurse specialist'' is not the same as the definition of ''clinical nurse specialist'' contained in the Act. For clarity, the language in these definitions should be the same.

3.  Section 21.805. Fees.--Statutory authority; Reasonableness.

   Subsection (b) states that ''a candidate for National certification will also pay an additional fee to the National certification organization'' and that ''a candidate for credentials review by a Board-recognized organization will also pay an additional fee to the credentialing organization.'' Does the Board intend to require the candidate to pay these additional fees to other organizations? If so, what is the Board's authority to do so? If this provision is merely acting as a notice that the candidate might have to pay fees to other organizations and is not a requirement of the Board, then this language should be deleted from the final-form regulation because it is not regulatory language. The Board also should add a provision directing CNSs to the Board's website for additional fee information.

4.  Section 21.811. Qualifications for initial certification.--Reasonableness; Clarity.

   This section discusses the qualifications necessary for initial certification as a CNS. We have two concerns.

   First, the opening sentence of this section contains the phrase ''. . . show evidence of. . . .'' Board staff has indicated that this evidence would consist of an official transcript and a certificate awarded by a national certification organization. This information should be set forth in the final-form regulation. A similar concern applies to Section 21.813(b).

   Second, commentators state that the reference to the National Council of State Boards of Nursing (NCSBN) under Subsection (1)(i) should be deleted because NCSBN has no authority as an accrediting body. Further, they recommend that NCSBN should be replaced with a reference to the National Organization of Competency Assurance (NOCA). The Board should explain why NCSBN is an appropriate body to recognize organizations for providing continuing education. Also, has the Board considered including NOCA as an accrediting body?

5.  Section 21.812. Qualifications for certification by endorsement or change of clinical specialty area.--Clarity.

   The title of Subsection (b) is ''Change of clinical specialty area.'' However the content of the subsection refers to ''additional specialty area.'' (Emphasis added.) The final-form regulation should clarify whether this subsection applies to changing a specialty, adding one, or both.

6.  Section 21.813. Application for certification.--Reasonableness; Clarity.

Subsection (b)

   This subsection contains the phrase ''An applicant . . . shall include documentation satisfactory to the Board . . . .'' What documentation is acceptable to the Board? How will the applicant know this when submitting the application? The final-form regulation should clarify these issues.

Subsection (d)(1)

   This subsection does not consider those applicants that do not have access to official transcripts. Commentators assert that this subsection should be amended to allow other documentation to be accepted by the Board when official transcripts are not available. The Board should consider allowing other documentation in these circumstances and should specify what other documentation is acceptable.

Subsection (f)

   This subsection allows 12 months for CNSs to meet compliance standards. How did the Board determine that this was an appropriate timeframe?

7.  Section 21.821. CNS standards of conduct.--Reasonableness; Clarity.

   It is unclear how the Board would determine whether a CNS has the ''necessary knowledge, preparation, experience and competency'' to properly execute a specific practice or procedure. The Board should specify if more is expected from CNSs than is already provided in the existing standards of nursing practice and this proposed regulation. If there is nothing additional, then this provision should be deleted.

8.  Section 21.822. Biennial renewal of certification.--Reasonableness; Clarity.

   We have four concerns with this section.

   First, Subsection (b) states that notice will be forwarded to each active CNS ''prior to the expiration date of the current biennial period.'' However, it does not establish how much notice will be given. The final-form regulation should clearly state when this notice will be given to each active CNS.

   Second, the final-form regulation should provide circumstances for when the Board would waive the 30 hours of Board-approved continuing education requirement in Subsection (d), or provide a cross-reference to Subsection 21.823(b), which mentions illness or undue hardship as instances requiring a waiver.

   Third, Subsection (d) requires a CNS to complete a minimum of 30 hours of Board-approved continuing education. How does the Board determine that an individual has met this requirement? The final-form regulation should clarify this issue.

   Finally, this section sets forth the requirements for the biennial renewal of certification. However, Subsection (f) establishes the requirements for written communication with the Board. Therefore, it should be moved to a more appropriate portion of the regulation.

9.  Section 21.823. CNS-level continuing education; waiver; sanctions.--Clarity.

   Under Subsection (b), the Board states that it will ''grant, deny or grant in part the request for waiver.'' The final-form regulation should specify what timeframe these actions will be taken in and how the CNS will be notified.

10.  Section 21.825. Sources of continuing education.--Implementation procedures; Reasonableness; Clarity.

Group or individual research

   This regulation is silent as to whether a CNS can get credit for group or individual research. However, commentators assert that the regulatory provisions for professional registered nurses allow this type of credit. Did the Board consider this option for CNSs?

Subsection (a)

   This subsection contains the phrase ''. . . and, provided that these providers and credentialing organizations agree to abide by §§ 21.826 and 21.827 . . . they are preapproved . . . .'' How does one know if the organizations have agreed to these particular sections and, therefore, would be preapproved?

Subsection (b)

   Under this subsection, what circumstances would result in a reevaluation of an approval given to providers and credentialing organizations? What circumstances would warrant a rescission of approval?

Subsection (c)

   Under this subsection, a CNS can get Board approval for a course given by a provider not on the pre-approved list. The request for approval must be submitted at least 60 days prior to the course. However, a request for approval by a professional registered nurse must be submitted at least 90 days prior to the course. Why is the timeframe different?

Subsection (e)

   How did the Board determine that 15 credit hours were sufficient for providing the various types of services listed in this subsection?

11.  Section 21.826. Requirements for continuing education courses.--Clarity.

   The term ''adequate'' in Subsection (2) is non-regulatory language. To be clear what is expected of a facility, the term ''adequate facility'' should be defined or this term should be deleted.

12.  Section 21.827. Continuing education course approval.--Reasonableness; Clarity.

   Subsection (b) sets forth the items that one must submit when requesting Board approval for continuing education. Subsection (b)(12) states ''Other information requested by the Board.'' It is impossible for the applicant to know what ''other information'' the Board would want at the time of the initial submittal of this information. However, we recognize that it is reasonable for the Board to have the ability to request additional information when necessary. Therefore, Subsection (b)(12) should be deleted and a new subsection (e.g. Subsection (e)) should be added that states that the Board may request additional information.

   ____

State Board of Social Workers, Marriage and Family Therapists and Professional Counselors Regulation #16A-6911 (IRRC #2701)

Code of Ethical Practice and Standards of Professional Conduct

August 13, 2008

   We submit for your consideration the following comments on the proposed rulemaking published in the June 14, 2008 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Social Workers, Marriage and Family Therapists and Professional Counselors (Board) to respond to all comments received from us or any other source.

Sections 47.71, 48.71 and 49.71. Code of ethical practice and professional conduct.--Fiscal impact; Public health and safety; Reasonableness; Feasibility; Implementation procedure; Clarity.

Format

   This proposed regulation consists of one new section which is added to each of the three separate chapters (49 Pa. Code Chapters 47, 48 and 49) governing the three different professions licensed by the Board. The new section is practically identical in each of the three chapters. In each chapter, the new section contains ten subsections. Some of the subsections are lengthy and contain a variety of topics. It is unclear why all these topics and provisions are grouped together into one section. To improve clarity and ease implementation, some subject areas should be set forth separately. The following paragraphs provide examples.

   The first example is Subsection (b)(4), relating to confidentiality and privacy. It should be placed in a separate section since these subjects involve licensees following the requirements of pertinent statutes and related regulations and is not limited to professional codes of conduct and practice. Hence, it would be an ideal provision as a separate section that stands alone and is not lost or obscured within a larger group of provisions.

   A second area that could be moved to a separate section or an existing section is Subsection (b)(6), relating to sexual harassment. All three chapters already contain provisions related to sexual misconduct (Sections 47.61--47.65, 48.21--48.25 and 49.21--49.25). These existing provisions prohibit ''sexual intimacies'' between a licensee and a client/patient or an immediate family member of a client/patient. Two commentators stated that such a prohibition should be added to this proposed regulation. This is unnecessary since it is addressed in the existing regulations. However, the comments demonstrate the confusion generated by separating sexual misconduct and harassment into separate and unrelated sections.

   A third area that would benefit from separate treatment is Subsection (g), relating to recordkeeping. Examples of similar provisions that other boards promulgated as separate sections include 49 Pa. Code §§ 16.95, 23.71, 27.405, 31.22 and 32.209.

   A fourth example is Subsection (j), relating to advertising. Other boards have similar provisions in separate sections. The Board should review the existing regulations at 49 Pa. Code §§ 11.33, 23.31, 25.212 and 29.31.

   If Board opts to retain the ''single section'' approach, it should explain why provisions involving such variety and length need to be set forth in one section.

Nonregulatory language

   Another problem with the proposed regulation is the use of the word ''should'' in different provisions. This word is found in Subsections (b)(4)(ii) and (b)(4)(iii), (c)(1) and (c)(2), (f)(4), (g)(5) and (g)(7). The use of ''should'' is inappropriate because it is nonregulatory language that indicates that the provisions are optional. Regulations establish binding norms of general applicability and future effect. If the Board decides that it will retain the word ''should'' and the provisions are to remain optional, then these provisions need to be deleted from this regulation and placed in a policy statement or guidance document.

   The use of the word ''should'' in Subsection (g)(5) is especially troublesome because it allows the protection of client/patient privacy and confidentiality to become discretionary. This provision needs to be revised to replace the term ''should'' with ''shall.'' The Board should also include references to applicable federal and state laws and regulations.

Subsection (a) Application.

   Subsection (a)(3) appears to be one of the few provisions that is unique in each of the three chapters. Each chapter contains references to the codes of ethics and conduct of various organizations for the different professions. The Pennsylvania Association for Marriage and Family Therapy (PAMFT) does not see the need for the extensive list of organizations in Section 48.71(a)(3). In its comments, PAMFT contended that the only group that should be listed is the code of the American Association for Marriage and Family Therapy. The other groups are professional counseling groups, and the PAMFT requests that these other groups be deleted from this section. The Board needs to explain the need for the other organizations being included or delete them from Section 48.71 in the final-form regulation.

   In its comments, the Pennsylvania Counseling Association (PCA) suggests the addition of the ''Code of Ethics of the American Counseling Association'' to Section 49.71(a)(3). The Board should consider this suggestion in the final-form regulation or explain why this national code is not included with the others already listed in the regulation.

Subsection (b) Responsibility to clients/patients.

   Subsection (b)(1)(i) reads:

   Licensees may not misrepresent directly, indirectly or by implication their professional qualifications such as education, specialized training, experience or area or areas of competence.

   Similar language is also found in Subsection (j)(2), which includes a requirement that licensees ''accurately represent their competencies, education, training and experience . . . .'' The Board should combine these directives to avoid duplication in the final-form regulation.

   Subsection (b)(1)(iii) refers to ''appropriate standards of care.'' It reads:

   The appropriate standard of care is defined as what an ordinary, reasonable professional with similar training would have done in a similar circumstance.

   One commentator referred to this language as ''weak'' and stated that it ''permits quite a bit of latitude.'' The House Professional Licensure Committee (House Committee), in its comments dated June 25, 2008, also expressed concerns with this language. The PCA notes that there is nothing in the proposed regulation that addresses whether a licensee provided ''effective'' care, therapy or treatment. Should the definition of the ''appropriate standard of care'' also involve a review of the effectiveness of the care or treatment and the licensee's effort to ascertain an effective strategy? In addition, we note that in its existing regulations at 49 Pa. Code § 41.61. Principle 2, relating to competency, the State Board of Psychology includes the following statement:

   In areas in which recognized standards do not yet exist, psychologists take whatever precautions are necessary to protect the welfare of their clients. They maintain knowledge of current scientific and professional information related to the services they render.

   How will this proposed regulation address situations or areas when recognized standards may not apply?

   A related concern is the term ''reasonable professional'' in describing ''appropriate standard of care.'' The Board includes two public members who are not licensees. Both the Pennsylvania Chapter of the National Association of Social Workers and Pennsylvania Society for Clinical Social Work (PSCSW) expressed concerns with the review of violations of this section by unlicensed individuals who have not been trained in the same code of ethical practice and professional conduct. In determining whether a violation has occurred, who will make the determination regarding what a ''reasonable professional'' would have done in similar circumstances?

   In its comments, the House Committee expressed concern with the phrase ''in a timely manner'' in Subsection (b)(1)(iv). We agree that it is ambiguous. The Board needs to provide licensees with a specific rule for a minimum time period for referrals in the final-form regulation.

Subsection (b)(2) Informed consent.

   The House Committee questioned the practicality of the disclosure requirement in Subsection (b)(2)(i). Both Subsections (b)(2)(i) and (ii) contain substantive requirements for disclosures to patients/clients. In order to provide for consistent implementation of the disclosure requirements, the Board should consider providing a written disclosure form for licensees to use in discussing services and other issues with the patient/client. To document that the discussion occurred, the licensee could have the patient/client sign or initial the form. This form could also include a statement, as suggested by PSCSW, informing the patient/client that a collection agency may be used in cases of nonpayment for services rendered.

   This subsection also includes the words: ''client/patient's parent, guardian or court-appointed representative.'' What about a spouse, domestic partner or adult child? Could one of these people be a legal representative if the client/patient is unable to read or understand a document or is receiving services involuntarily?

Subsection (b)(4) Confidentiality and privacy.

   We identified four concerns in this subsection.

   First, the House Committee requested that the Board specifically cite the ''other laws'' mentioned in this Subsection (b)(4)(i). We agree. For example, does the Health Insurance Portability and Accountability Act apply to these licensees and their patients/clients?

   Second, PCA mentioned the confidentiality protections in federal regulations at 42 CFR Part 2 (§§ 2.1--2.67), relating to confidentiality of alcohol and drug abuse patient records. The Board should review the pertinent statutes and regulations and identify specific requirements that will protect patient/client privacy and confidentiality.

   The third issue is the use of the term ''legally authorized person'' or ''person legally authorized.'' In Subsections (b)(2)(iii) and (iv), the proposed regulation refers to the ''client/patient's parent, guardian or court-appointed representative'' when discussing issues related to someone giving consent for the client/patient. However, the term ''legally authorized person'' is used for a similar purpose in Subsections (b)(4) and (e)(2)(v). The final-form regulation should be consistent in how it describes who may represent the client/patient. The Board should consider developing a definition for this term and be consistent in its use in the final-form regulation.

   Fourth, PAMFT noted a concern with counseling families and protecting confidentiality. It asked for specific language requiring written authorization from each member of the family group before a therapist could disclose information outside the treatment situation. The Board should amend the regulation to ensure that each family member's confidentiality is protected.

Subsection (b)(5) Termination.

   There are two concerns with this subsection.

   First, PCA suggested that licensees should be allowed to terminate or discharge a patient/client for nonpayment of fees. This issue does not appear to be addressed in this subsection or Subsection (f), relating to payment for services. The Board should address this concern in the final-form regulation.

   Second, this subsection includes a reference to ''appropriate referral for continued services'' and ''reasonable notification'' but includes no directive regarding what constitutes ''reasonable notification.'' To assist with continuity of care, the Board should consider establishing a specific minimum time period, such as 30 days, for advance notice of termination to provide time for referrals and the search for a new provider.

Subsection (b)(6) Sexual harassment.

   Subsection (b)(6)(iii) of this proposed regulation states: ''Sexual harassment includes unwanted sexual advances, sexual solicitation, requests for sexual favors and other verbal, visual or physical conduct of a sexual nature.'' These are broad terms. The term ''sexual intimacies'' is defined in the existing ''definitions'' section of each chapter. This existing definition includes specific language describing this type of conduct. The Board should consider using a reference to this existing definition in its provisions prohibiting sexual harassment. The Board should also include a definition of ''sexual harassment'' in the existing ''definitions'' sections of each chapter (Sections 47.1, 48.1 and 49.1).

Subsection (b)(7) Discrimination.

   There are numerous State and Federal laws barring discrimination. The Board should reference existing anti-discrimination laws and regulations rather than designing a new anti-discrimination rule. If the Board opts to proceed with this provision as proposed, it should explain why existing laws and regulations are insufficient.

Subsection (c) Dual or multiple relationships affecting the licensee's judgment.

   We agree with the House Committee's concerns about terms and phrases in this subsection that it described as vague or ambiguous. In addition to amending the subsection in response to the points raised by the House Committee, the Board needs to provide specific examples of the situations that this provision seeks to address.

Subsection (e) Research and publication.

   Subsection (e)(1) refers to ''Federal and State laws.'' The Board needs to cite the pertinent federal and state laws. In addition, the House Committee raised several questions and points of clarification about implementation and enforcement of this subsection. The Board should address these concerns with the final-form regulation.

ARTHUR COCCODRILLI,   
Chairperson

[Pa.B. Doc. No. 08-1544. Filed for public inspection August 22, 2008, 9:00 a.m.]



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