PROPOSED RULEMAKING
STATE BOARD OF NURSING
[49 PA. CODE CH. 21]
Opioid Prescription and Education and Organ Donation Education
[53 Pa.B. 5776]
[Saturday, September 16, 2023]The State Board of Nursing (Board) proposes to amend §§ 21.131, 21.133, 21.134, 21.283, 21.284b, 21.289, 21.331, 21.605 and 21.822 to read as set forth in Annex A.
Effective Date
This proposed rulemaking will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
Section 2.1(k) of The Professional Nursing Law (63 P.S. § 212.1(k)) sets forth the Board's general rulemaking authority. Under section 9.1 of the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act (35 P.S. § 872.9a) and 20 Pa.C.S. § 8628 (relating to requirements for physician and nurse training relative to organ and tissue donation and recovery), the Board is required to implement the mandatory education requirements.
Background and Purpose
In 2016, the Legislature amended the ABC-MAP Act (35 P.S. §§ 872.1—872.40), including the requirement imposed by section 9.1(a) of the act of November 2, 2016 (P.L. 980, No. 124) (Act 124 of 2016) on all prescribers and dispensers to obtain 2 hours of mandatory education regarding pain management or the identification of addiction, 2 hours of education in the practices of prescribing or dispensing of opioids (collectively, ''opioid education'') within 1 year of obtaining prescriptive authority, and an additional 2 hours of education in any of the three topics per biennium as a condition of prescriptive authority biennial renewal. At the same time, the Legislature enacted the Safe Emergency Prescribing Act (35 P.S. §§ 873.1—873.9), the act of November 2, 2016 (P.L. 976, No. 122) (Act 122 of 2016), which imposed restrictions on certified registered nurse practitioners' (CRNP) prescription of opioid drug products to individuals seeking treatment in an emergency department, urgent care center or in observation status in a hospital. Violation of the Safe Emergency Prescribing Act subjects CRNPs to discipline.
The Board implemented Act 124 of 2016, and since January 1, 2017, the Board has required CRNPs with prescriptive authority to verify completion of the 2 hours of education in any of the three topics per biennium as a condition of prescriptive authority biennial renewal. Generally, CRNP nursing education programs verify completion of the opioid education at the time of application. If a prescriptive authority is issued without a verification of completion, the Board sends a letter to the CRNP reminding the CRNP that the education must be completed, and the verification submitted within 1 year from issuance of the prescriptive authority and that failure to do so may result in disciplinary action. Shortly after enactment, representatives of the Bureau of Professional and Occupational Affairs, on behalf of the impacted licensing boards, met with representatives of the Department of Health (DOH) to discuss curricula required by Act 124 of 2016. Because the opioid education required was readily available from multiple Board-approved providers and is incorporated into many CRNP nursing education programs' advanced pharmacology courses, a decision was made not to mandate a specific curriculum like what is required for the organ and tissue donation and recovery process (collectively, ''organ donation''), discussed as follows. Nonetheless, for guidance, DOH has posted seven modules that fit within the mandated education on its webpage at www.health.pa.gov/topics/programs/PDMP/Pages/education.aspx.
In addition, the Legislature amended 20 Pa.C.S. §§ 8610—8632 (relating to express anatomical gifts), including the requirement imposed under 20 Pa.C.S. § 8628, added under the act of October 23, 2018 (P.L. 594, No. 90) (Act 90 of 2018), that registered nurses (RN) complete at least 2 hours of Board-approved continuing education in organ donation one time within 5 years of initial licensure or within 5 years of licensure renewal, whichever occurs first. In drafting organ donation regulations, the Board has worked with the DOH and other agencies regarding the development of an approved curriculum for continuing education in organ donation. Representatives from the DOH's Division of Nutrition and Physical Activity, Bureau of Health Promotion & Risk Reduction, Center for Organ Recovery and Education (CORE), Donate Life PA (Donate PA) and Gift of Life Donor Program (Gift of Life), organ procurement organizations (OPO) designated for the region by the United States Secretary of Health and Human Services, and Counsel for the State Board of Medicine, State Board of Osteopathic Medicine and State Board of Nursing formed a workgroup to discuss implementation of Act 90 of 2018 and the development of the required curriculum by the OPOs. Because the OPOs expect that the curriculum will be available for providers when this regulation is published as a final-form rulemaking, the Board has tied the implementation date for Act 90 of 2018 to the publication date of this regulation.
The proposed amendments are required to update the Board's existing regulations on both subjects to be consistent with the aforementioned acts.
Description of the Proposed Amendments
The Board is proposing to add §§ 21.131(a.1), 21.331(c)(6), 21.605(b) and 21.822(f) to include the requirement from Act 90 of 2018 that RNs complete at least 2 hours of Board-approved continuing education in organ and tissue donation and recovery (organ donation) one time within 5 years of initial licensure or within 5 years of licensure renewal, whichever occurs first. Specifically, under section 8 of Act 90 of 2018, RNs must complete a 2-hour course on organ donation designed to address the clinical aspects of the donation and recovery process as a condition of license renewal. The course may include information about donation of hands, facial tissue and limbs and other vascularized composite allografts. 20 Pa.C.S. § 8628. Act 90 of 2018 applies to RNs, CRNPs, registered nurse volunteer licensees (RN-volunteer) and clinical nurse specialists (CNS). Because licensed practical nurses are not required to complete continuing education, aside from child abuse education, they were not included in Act 90 of 2018. In the future, when section 8.8 of The Professional Nursing Law (63 P.S. § 218.8) regarding licensure and regulation of certified registered nurse anesthetists (CRNA) is implemented, they too will be required to comply with this requirement. The Board is currently drafting CRNA regulations.
Proposed § 21.131(a.1)(1) (relating to continuing education) would apply to existing licensees at the time the regulation is published as a final-form rulemaking and therefore would sunset 5 years from that publication. Paragraph (2) would apply to licensees who obtain their licenses on or after the effective date and paragraph (3) would apply to licensees who reactivate expired or inactive licenses on or after the effective date.
Concomitantly, the Board proposes to add § 21.133(a.1) (relating to continuing education content) which delineates the mandatory organ donation curriculum. Unlike the opioid curriculum which is established and in use by CRNP nursing education programs, there is no established organ donation curriculum. In light of the statutory mandate and the lack of an established curriculum, the Board decided that a specific pre-approved curriculum was needed. The curriculum was jointly developed by CORE, Donate PA and Gift of Life and approved by the Board at its March 6, 2023, meeting. The curriculum is composed of six parts: an overview of the organ donation and transplantation system, the tissue donation process, the organ donation process, determining death and family communication, caring for families and organ donor management. The first part describes the National, State and local systems for organ and tissue donation. Organ transplant waiting lists will be discussed as well as transplantable organs and tissues, including vascularized composite allografts. The second part describes common applications for transplantable tissue and a framework for an effective hospital process. The third part describes commonly transplantable organs and the entire organ donation process from the initial referral to the recovery of organs. It also defines the role of the OPO and the healthcare ream, including optimal practices for communication and collaboration. The fourth part describes a historical perspective for determining death and effective communication techniques to aid in family conversations. The fifth part addresses considerations for providing compassionate end of life care for families and assessing readiness for the donation conversation. It also addresses information and techniques for debunking common myths and misconceptions. The last part describes the organ donation pathways, medical assessment for eligibility and clinical management strategies for optimizing end organ function, the surgical recovery phase, and coroner/medical examiner communication. It also highlights practices for maintaining optimal communication and collaboration. Like all other providers of education, a provider of organ donation education must follow existing regulations regarding continuing education. Under subsection (a.1), a copy of the Board-approved organ donation curriculum will be posted on the Board's web site. Like with other continuing education aside from child abuse, licensees/certificate holders will only be required to submit certificates of attendance upon audit under § 21.131(c) but will be required to verify completion on their biennial renewal applications under § 21.331(c)(2) (relating to biennial renewal of certification).
Because the organ donation education is relevant to patient care and professional nursing generally, as required by § 21.131(a), the Board proposes to add organ donation content to the list of approved content in § 21.133(c)(7). Also, since this education may be required by facilities for licensees/certificate holders who work in emergency and operating rooms, the Board has not limited the amount of organ donation education that may be taken for continuing education credit so long as the mandatory 2 hours be taken within 5 years of licensure/certification for new licensees/certificate holders and within 5 years of licensure renewal for existing licensees/certificate holders as indicated in proposed §§ 21.131(a), 21.331(c)(6), 21.605(b) and 21.822(f).
Proposed § 21.134(a)(11) (relating to continuing education sources) would add the activities sponsored by OPOs designated for the region by the United States Secretary of Health and Human Services as an organ procurement organization to the list of pre-approved continuing education activities. Approved OPOs are listed on the DOH web site at https://www.health.pa.gov/topics/programs/Organ%20Donation/Pages/Organ%20Donation.aspx, and the United States Department of Health and Human Services Resources & Services Administration at organdonor.gov.
In connection with opioid prescription by CRNPs, the Board is also proposing to amend § 21.283(b) (relating to authority and qualification for prescribing, dispensing and ordering drugs) to include the requirement from the ABC-MAP Act in proposed paragraph (4) that CRNPs who hold prescriptive authority authorizations complete 2 hours of mandatory education regarding pain management or the identification of addiction and 2 hours of education in the practices of prescribing or dispensing of opioids within 1 year of obtaining prescriptive authority. Proposed subparagraph (i) would clarify that the specified opioid education may be taken as part of a Board-approved CRNP Program, a stand-alone course from a Board-approved CRNP advanced pharmacology course provider or as part of a continuing education course from a CRNP continuing education provider. Subparagraph (ii) also clarifies that only CRNPs who hold a current Drug Enforcement Administration (DEA) registration number or utilize the DEA registration number of another person or entity are required to comply with proposed paragraph (4).
The Board is also proposing to amend § 21.283(c) by removing the biennial renewal requirements for prescriptive authority holders and replacing them with a reference to those requirements in § 21.331(c)(2) thereby eliminating the current redundancy in §§ 21.283(c) and 21.331(c). In addition to the current requirement in § 21.331(c)(2)(i) that these holders complete at least 16 hours of Board-approved continuing education in pharmacology, the Board proposes to add § 21.331(c)(2)(ii) to incorporate the mandatory 2 hours of continuing education in opioid education per biennium as a condition of prescriptive authority biennial renewal for CRNPs who hold a DEA registration or use the DEA number of another. The additional hours can be included within the mandatory 30 hours required by § 21.131(a). In recognition that CRNPs hold multiple prescriptive authorities, proposed paragraph (2)(ii) also clarifies that the opioid education need only be completed one time per biennium regardless of the number of prescriptive authority approvals being renewed.
Finally, in connection with the Safe Emergency Prescribing Act, the Board is proposing to amend CRNP prescription requirements for controlled substances in § 21.284b (relating to prescribing, administering and dispensing controlled substances) to incorporate by reference this act's prescribing restrictions on opioid drug products for individuals seeking treatment in an emergency department, urgent care center or in observation status in a hospital by adding proposed subsection (e). In addition, the Board is proposing to add § 21.289 (relating to additional grounds for discipline) to notify CRNPs that in addition to the grounds for discipline in section 14(a) of The Professional Nursing Law (63 P.S. § 224(a)), a violation of the Safe Emergency Prescribing Act subjects a CRNP to discipline.
Fiscal Impact and Paperwork Requirements
The Board does not anticipate any significant fiscal impact or paperwork requirements relating to these amendments. RNs, CRNPs, CNSs and RN-volunteer license holders are already required to complete mandatory continuing education, and as these hours are incorporated in the existing requirement, there would be no increased burden. Also, like with other continuing education, aside from the mandatory child abuse education, licensees and certificate holders are required to keep copies of their continuing education certificates in the event of an audit.
There are no significant fiscal impact or paperwork requirements associated with the Safe Emergency Prescribing Act.
Sunset Date
The Board continuously monitors the effectiveness of its regulations on a fiscal year and biennial basis. Therefore, except for § 21.131(a.1)(1), no sunset date has been assigned.
For § 21.131(a.1)(1), this provision expires 5 years from the effective date of the regulation.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on August 30, 2023, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) which have not been met. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the rulemaking by the Board, the General Assembly and the Governor of comments.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Counsel, State Board of Nursing, P.O. Box 69523, Harrisburg, PA 17106-9523, RA-STRegulatoryCounsel@pa.gov within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference 16A-5146 (Additional Continuing Education) when submitting comments.
LINDA L. KMETZ, PhD, RN,
ChairFiscal Note: 16A-5146. No fiscal impact; recommends adoption.
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
CONTINUING EDUCATION § 21.131. Continuing education.
(a) Requirement of continuing education. A registered nurse seeking licensure renewal shall complete 30 hours of continuing education approved by the Board during the biennial renewal period immediately preceding the application for renewal in accordance with section 12.1 of the act (63 P.S. § 222) and this subchapter. At least 2 of the 30 hours shall be completed in approved continuing education in child abuse recognition and reporting requirements in accordance with § 21.508(b) (relating to child abuse recognition and reporting—mandatory training requirement). The Board will not renew a license of a registered nurse who fails to verify compliance with the continuing education requirement. A registered nurse whose license is not renewed by the expiration of the biennial renewal period may not engage in the practice of professional nursing until the continuing education requirements are satisfied and the license has been renewed, reinstated or reactivated.
(Editor's Note: The blanks in subsection (a.1) refer to the date of publication of the final-form rulemaking in the Pennsylvania Bulletin. Subsection (a.1)(1) expires 5 years from the effective date.)
(a.1) Additional continuing education requirement.
(1) Effective ______ a registered nurse shall complete at least 2 of the 30 hours in Board-approved continuing education in organ and tissue donation and recovery process in accordance with § 21.133(a.1) (relating to continuing education content) from the sources identified in § 21.134(a)(11) (relating to continuing education sources) one time within 5 years of licensure renewal.
(2) Licensees who obtain a license on or after ______ shall verify completion of the 2 hours one time within 5 years of initial licensure.
(3) Licensees who reactivate expired or inactive licenses on or after ______ shall verify completion of the 2 hours one time within 5 years of reactivation.
(b) Exception. An applicant applying for initial licensure in this Commonwealth will not be required to meet the continuing education requirement on the first renewal immediately following licensure, except for the mandatory continuing education in child abuse recognition and reporting required under § 21.508(b).
* * * * * § 21.133. Continuing education content.
(a) Continuing education must be relevant to patient care or professional nursing in a general or specialty area and enhance the knowledge and application of the physical, social, biological and behavioral sciences.
(a.1) The continuing education required to satisfy the organ and tissue donation and recovery process in § 21.131(a.1) (relating to continuing education) consists of the following Board-approved curriculum, which is posted on the Board's web site:
(1) Overview of the Organ Donation and Transplantation System.
(2) Tissue Donation Process.
(3) Organ Donation Process.
(4) Determining Death and Family Communication.
(5) Caring for Families.
(6) Organ Donor Management.
(b) The Board may, for any given biennial license period and with adequate notice to registered nurses, require that up to 4 hours of continuing education be completed in designated topics.
(c) Courses in areas related to the practice of professional nursing such as the following are acceptable:
* * * * * (6) Pharmacology.
(7) Organ and tissue donation and recovery.
(d) Courses in areas impacting the practice of professional nursing, such as nursing administration, management, education, and diagnostic and procedural coding are acceptable.
* * * * * § 21.134. Continuing education sources.
(a) The following continuing education activities that meet the requirements of § 21.133 (relating to continuing education content) for registered nurses are approved:
* * * * * (10) Activities approved by a Board in another jurisdiction.
(11) Activities sponsored by an organ procurement organization as defined in 20 Pa.C.S. § 8601 (relating to definitions).
(b) The Board may approve other sources of continuing education on a case-by-case basis after the provider or registered nurse seeking approval submits the following:
* * * * *
Subchapter C. CERTIFIED REGISTERED NURSE PRACTITIONERS
CRNP PRACTICE § 21.283. Authority and qualifications for prescribing, dispensing and ordering drugs.
* * * * * (b) To obtain prescriptive authority approval, a CRNP shall:
* * * * * (3) Pay the fee set forth in § 21.253 (relating to fees).
(4) Complete at least 2 hours of Board-approved education in pain management or the identification of addiction and 2 hours of Board-approved education in the practices of prescribing or dispensing of opioids within 1 year of obtaining prescriptive authority approval. The following apply:
(i) The education may be taken as part of a Board-approved CRNP program posted on the Board's web site under § 21.362(d) (relating to annual report and compliance reviews; list of approved programs), a stand-alone course from a Board-approved CRNP advanced pharmacology course provider authorized under subsection (b)(1) or a continuing education course from a CRNP continuing education provider listed in § 21.334(a) (relating to sources of continuing education).
(ii) This requirement only applies to CRNPs who hold a current Drug Enforcement Administration (DEA) registration or utilize the DEA registration number of another person or entity, as permitted by law, to prescribe controlled substances in any manner.
(c) A CRNP who has prescriptive authority shall complete [at least 16 hours of Board-approved continuing education in pharmacology in the 2 years prior to the] the continuing education set forth in § 21.331(c)(2) (relating to biennial renewal of certification) as a condition of biennial renewal [date of the certification. The CRNP shall verify completion of the continuing education when submitting a biennial renewal].
§ 21.284b. Prescribing, administering and dispensing controlled substances.
* * * * * (d) Compliance with this section will not be treated as compliance with the standards of acceptable and prevailing practice as a CRNP when medical circumstances require that the CRNP exceed the requirements of this section.
(e) A CRNP shall comply with the prescribing requirements for opioid drug products for individuals seeking treatment in an emergency department, urgent care center or in observation status in a hospital under the Safe Emergency Prescribing Act (35 P.S. §§ 873.1—873.9).
(Editor's Note: The following section is proposed to be added and is printed in regular type to enhance readability.)
§ 21.289. Additional grounds for discipline.
In addition to the grounds set forth in section 14(a) of the act (63 P.S. § 224(a)), a CRNP who fails to comply with the Safe Emergency Prescribing Act (35 P.S. §§ 873.1—873.9) shall be subject to disciplinary action.
MAINTENANCE OF CERTIFICATION § 21.331. Biennial renewal of certification.
* * * * * (c) As a condition of biennial renewal, a CRNP shall:
(1) Renew the CRNP's registered nurse license.
(2) Verify completion of a minimum of 30 hours of Board-approved continuing education in the 2 years prior to renewal, including at least 2 hours of approved training in child abuse recognition and reporting in accordance with § 21.508(b) (relating to child abuse recognition and reporting—mandatory training requirement). As a condition of biennial renewal of prescriptive authority approval, in the 2 years prior to the biennial renewal date of the certification, a CRNP shall [complete a minimum of] also verify completion of:
(i) At least 16 [of the 30] hours of Board-approved continuing education in pharmacology [in the 2 years prior to renewal].
(ii) At least 2 hours of Board-approved continuing education in pain management, the identification of addiction or the practices of prescribing or dispensing opioids, in the 2 years prior to renewal if the licensee is renewing a prescriptive authority approval and holds a current Drug Enforcement Administration (DEA) registration or is utilizing the DEA registration of another. If required, this education shall be completed once per renewal regardless of the number of prescriptive authority approvals being renewed.
(3) Demonstrate current National certification, if the CRNP was certified by the Board after February 7, 2005.
(4) Pay the required biennial renewal fee set forth in § 21.253 (relating to fees).
(5) Verify compliance with section 8.7 of the act (63 P.S. § 218.7) regarding liability coverage.
(Editor's Note: The blank in paragraph (6) refers to the date of publication of the final-form rulemaking in the Pennsylvania Bulletin.)
(6) Effective ______ , verify completion of at least 2 of the 30 hours in Board-approved continuing education in organ and tissue donation and recovery process in accordance with § 21.131(a.1) (relating to continuing education) within 5 years of certification renewal. Certificate holders who obtain certification on or after the effective date shall verify completion of the 2 hours within 5 years of initial certification.
(d) Any written communication with the Board must be typed or printed and include the CRNP's full name, including former names, the current address and certification number.
Subchapter F. VOLUNTEER LICENSES § 21.605. Biennial renewal.
(a) A volunteer license shall be renewed biennially on forms provided by the Board. In accordance with section 6(c) of the Volunteer Health Services Act (35 P.S. § 449.46(c)), a volunteer license holder shall comply with the applicable continuing education requirements imposed by the Board, including at least 2 hours of training in approved child abuse recognition and reporting in accordance with § 21.508(b) (relating to child abuse recognition and reporting—mandatory training requirement)[.], and if the licensee is renewing a prescriptive authority approval and holds a current Drug Enforcement Administration (DEA) registration or is utilizing the DEA registration of another, at least 2 hours of Board-approved continuing education in pain management, the identification of addiction or the practices of prescribing or dispensing opioids, in the 2 years prior to renewal. If required, this education shall be completed once per renewal regardless of the number of prescriptive authority approvals being renewed. The applicant shall be exempt from payment of the biennial renewal fee of § 21.5, § 21.147 or § 21.253 (relating to fees), as applicable.
(Editor's Note: The blank in subsection (b) refers to the date of publication of the final-form rulemaking in the Pennsylvania Bulletin.)
(b) Effective ______ , verify completion of at least 2 of the 30 hours in Board-approved continuing education in organ and tissue donation and recovery process in accordance with § 21.131(a.1) (relating to continuing education) within 5 years of licensure renewal. Licensees who obtain licensure on or after the effective date shall verify completion of the 2 hours within 5 years of initial licensure.
Subchapter H. CLINICAL NURSE SPECIALISTS
MAINTENANCE OF CERTIFICATION § 21.822. Biennial renewal of certification.
* * * * * (e) The applicant shall remit the required renewal fee in § 21.805 (relating to fees) with the applicant's renewal application forms. Upon approval of the renewal application, the CNS will receive a certification for the current renewal period.
(Editor's Note: The blank in subsection (f) refers to the date of publication of the final-form rulemaking in the Pennsylvania Bulletin.)
(f) Effective ______ , verify completion of at least 2 of the 30 hours in Board-approved continuing education in organ and tissue donation and recovery process in accordance with § 21.131(a.1) (relating to continuing education) within 5 years of certification renewal. Certificate holders who obtain certification on or after the effective date shall verify completion of the 2 hours within 5 years of initial certification.
[Pa.B. Doc. No. 23-1248. Filed for public inspection September 15, 2023, 9:00 a.m.]
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