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RULES AND REGULATIONS

STATE BOARD OF NURSING

[49 PA. CODE CH. 21]

Certified Registered Nurse Practitioners; General Revisions

[39 Pa.B. 6994]
[Saturday, December 12, 2009]

 The State Board of Nursing (Board) amends Chapter 21, Subchapter C (relating to certified registered nurse practitioners), to read as set forth in Annex A.

Effective Date

 The amendments will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.

Statutory Authority

 The amendments are authorized under sections 2.1(k) and (l) and 8.1—8.3 of The Professional Nursing Law (act) (63 P. S. §§ 212.1(k) and (l) and 218.1—218.3).

Background and Purpose

 The Board and the State Board of Medicine jointly promulgated regulations regarding certified registered nurse practitioner (CRNP) practice at 30 Pa.B. 5943 (November 18, 2000), under statutory provisions that provided for joint regulation of CRNPs by the Board and the State Board of Medicine. The act of December 9, 2002 (P. L. 1567, No. 206) (Act 206), amended the act to give the Board exclusive jurisdiction over the regulation of CRNPs. The act was further amended by the act of July 20, 2007 (P. L. 318, No. 48) (Act 48). The Board's proposed rulemaking implementing the 2002 and 2007 amendments to the act was published at 38 Pa.B. 6161 (November 8, 2008).

 During the 30-day public comment period, the Board received 218 letters from the general public and 471 letters from nurses supporting the proposed amendments. The Board received about 20 letters from nursing and hospital groups supporting the proposed rulemaking and about 53 letters from physicians and pharmacists supporting the proposed rulemaking. The Board also received about 23 letters from physicians and pharmacists opposed to the proposed rulemaking and letters from five physician groups opposed to the proposed rulemaking. In addition to considering all of the comments received from the public, the Board met with representatives from the Pennsylvania Coalition of Nurse Practitioners and the Pennsylvania Medical Society regarding amendments to the final-form rulemaking.

 The existing regulations prevented the effective use of CRNPs to the full extent of their education, skills and abilities, thereby depriving the citizens of this Commonwealth necessary, high quality care. More than half of states' laws permit CRNPs to practice with fewer restrictions on their ability to order diagnostic tests, treat illnesses and prescribe medications to patients. The Pearson Report, The American Journal for Nurse Practitioners, vol. 13, no. 2, February 2009. To the Board's knowledge, every study completed has concluded that CRNPs provide safe and effective care, even when practicing independently from physicians. Cochrane Database of Systematic Reviews 2004, Issue 4, Art. NO.: CD00127. DOI: 10.1002/14651858.CD00127.pub2. There is no evidence that expanded CRNP prescribing endangers the public. The Board's final-form rulemaking increases access to care while protecting the public.

Response to Comments

 Following the close of the public comment period, the Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC). The Senate Consumer Protection and Professional Licensure Committee did not comment. The following is a summary of the comments and the Board's response.

 Approximately 53 physicians and pharmacists wrote letters in support of the proposed rulemaking. Of this number, 49 noted that the proposed amendments would benefit patients and that the current regulations, specifically the limitations on CRNPs' prescription of controlled substances, create a financial hardship to patients and are unnecessary for patient safety. Thirteen physicians specifically noted that removing the physician—CRNP ratio will improve healthcare and allow more CRNPs to serve some of the neediest patients. Sixteen of the group noted that the education and training of CRNPs prepares CRNPs to complete medical examinations and to effectively diagnose and treat patients. These physicians practice successfully with CRNPs.

 About 20 nursing and health care organizations and facility groups wrote in support of the proposed rulemaking. The Hospital and Healthsystem Association of Pennsylvania (HAP) noted that the Board had substantially improved the existing regulations by reiterating that a CRNP can issue written and oral orders for medical, diagnostic and therapeutic measures. HAP also supported the deletion of the provisions related to CRNP identification and the Board's proposed revision on the restrictions on CRNPs prescribing controlled substances and dispensing professional drug samples.

 Several health systems wrote in support of the proposed rulemaking. The College of Health Professions at Temple University applauded the Board's deletion of the ratio of nurse practitioners to physicians, stating: ''Please eliminate false ratios that restrict the number of nurse practitioners that any one physician can collaborate with—these health teams must be unhindered in their work.'' The Safe Harbor Behavioral Health organization applauded the Board's elimination of the CRNP-physician ratio and the elimination of the 72-hour restriction on prescribing Schedule II controlled substances and 30-day restriction on Schedule III—IV controlled substances. This organization stated that the current restrictions on CRNPs negatively impacts children with ADHD who are prescribed Schedule II medications and patients with chronic anxiety disorders that are prescribed schedule IV medications.

 The Rothman Institute in Philadelphia wrote in support of the 30-day prescriptive privileges for Schedule II controlled substances, noting that CRNPs determine post-surgical discharge pain medications for patients based on the CRNPs frequent evaluation and adjustment of the medication during the hospital stay. Rothman Institute wrote that the current restriction on Schedule III and IV controlled substances are ''barriers [that] create an unnecessary burden on the patients.'' These views were echoed consistently throughout the comments received from members of the public.

 The Pennsylvania Medical Society (PMS) submitted comprehensive comments. The Board met with representatives from PMS twice to discuss their concerns and specific language in the regulation. Most of the issues raised by PMS were resolved through these meetings and amendments to the proposed rulemaking reflect these resolutions. PMS expressed to the Board its continuing concern with the provision related to the length of treatment with Schedule II controlled substances and the deletion of the ratio limiting the number of CRNPs with which a physician may collaborate. The Board's rationale in maintaining the rulemaking as proposed on these issues is discussed fully below.

 The comments submitted by the HPLC and IRRC reflect and summarize many of the comments made by physician groups in opposition to some provisions of the proposed rulemaking. The HPLC first commented that eliminating the regulatory restriction that requires that all collaborative agreements be in writing ''does not provide any consumer protection, cannot be proven if called into question, does not protect the physician or the CRNP, and could cause problems with discipline by the board.'' IRRC noted that while it did not question the Board's authority to allow oral collaborative agreements, it questioned the reasonableness of permitting oral collaborative agreements. The Board believes that the act requires a written collaborative agreement only for CRNPs who have prescriptive authority. Nevertheless, in light of the comments by the HPLC and IRRC, the Board has amended its proposed rulemaking to require that all collaborative agreements be in writing.

 The HPLC next urged the Board ''to continue to specify the minimum requirements for what needs to be contained within the non-prescriptive authority collaborative agreement'' by including the definition of ''collaborative agreement'' or specifying the terms in a separate section. The Board has repeated the statutory definition for ''collaboration'' and has added a definition for ''collaborative agreement,'' which references the minimum requirements of collaboration. IRRC suggested that the details found in section 8.3(a)(2)(i)—(iii) of the act (63 P. S. § 218.3(a)(2)(i)—(iii)) addressing minimum requirements for a prescriptive authority collaborative agreement, be repeated in the Board's regulations. The Board does not believe it is necessary to repeat these statutory provisions because CRNPs are required to submit their prescriptive authority collaborative agreements on a form provided by the Board and the form includes the three provisions found in section 8.3(a)(2)(i)—(iii) of the act, as well as additional information that must be submitted to the Board.

 The HPLC noted that § 21.261(c) (relating to use of title; authorization to practice) should refer to ''individuals'' rather than ''persons''. The Board amended its proposal to refer to an individual.

 Regarding § 21.282a (relating to CRNP practice), the HPLC suggested that the section be amended to specify that a CRNP may only perform the listed tasks if the CRNP is acting within the scope of the CRNP's specialty and collaborative agreement. Because section 8.2(a) and (b) of the act (63 P. S. § 218.2(a) and (b)) provide that CRNPs may only act in the expanded role in their specialties and in accordance with their collaborative agreements, the Board had thought it redundant to repeat these statutory provisions. Given the concerns raised by the commentators, the Board has amended § 21.282a(b) to repeat the statutory limitations, and apply the limitations to all of the enumerated functions of a CRNP.

 In addition, it was strongly suggested that the Board should repeat, in its regulation, the list of tasks that a CRNP may perform enumerated by the Legislature in section 8.2(c.1) of the act. Based on this urging, the Board reproduced the list from section 8.2(c.1) in § 21.282a(b)(8)—(15). After the Board added the list, the Department of Public Welfare suggested that the Board should mention in this preamble that Federal Medicaid or Medicare, or both, law currently only allows providers of home health and hospice care to receive reimbursement for patients whose initial order and recertification order was written by a physician. CRNPs and their collaborating physicians should consider whether these providers can obtain Federal reimbursement when writing these initial or recertification orders.

 Regarding § 21.284(e) (relating to prescribing and dispensing parameters), the HPLC asked if the changes in the length of time for which a CRNP may prescribe controlled substances is a change that must be submitted to the Drug Review Committee (DRC). IRRC asked why the changes proposed by the Board are not additions or deletions to the categories of drugs. Section 8.4 of the act (63 P. S. § 218.4), requires the Board to submit ''any proposed change to the categories of drugs that CRNPs were authorized to prescribe under the board regulations in effect on the effective date of this section. The board shall not change, by addition or deletion, the categories of authorized drugs without prior approval of the Drug Review Committee.'' The categories of drugs were identified in § 21.284(a) of the jointly promulgated regulations—the categories identified in the American Hospital Formulary Service Pharmacologic-Therapeutic Classification.

 In the fall of 2007, the Board proposed to the DRC to amend the regulations to provide for a negative formulary rather than a positive formulary, and to increase the treatment time periods for controlled substances. The proposal was deemed approved. The Board then decided to maintain the positive formulary and submitted the version published as proposed to the Department of Health (Department). Upon review by the Department, the Board was advised that the DRC approval was not required. The Office of Attorney General (OAG) was fully apprised of this matter by both the Board and the Department during its review of the proposed rulemaking, and the OAG approved the legality of the proposal.

 The HPLC asked about the current acceptable standards for prescribing controlled substances and the justifications the Board used to suggest the changes proposed in the proposed rulemaking. CRNPs possess the knowledge and skills to safely prescribe controlled substances for up to these longer time frames. Board research has found that every academic study that has been conducted has concluded that CRNPs prescribe safely. CRNPs have been prescribing for these longer periods without issue in many other states for years. The current restrictions are unnecessary and cause significant and unnecessary delays in treatment and expenses to the public.

 The HPLC next questioned the deletion of § 21.286(a) and (c) (relating to identification of the CRNP), and the changes to § 21.286(b). Section 21.286(a) provided that a patient must be informed at the time the patient makes an appointment that the patient will be seen by a CRNP. The Board is deleting this subsection. Clerical staff makes patient appointments; therefore, it would be unfair to discipline a CRNP for an inadvertent omission by a staff member employed by a facility or office. Similarly, the State Board of Medicine's regulations do not provide for disciplining a physician assistant for a misstatement by clerical staff.

 Section 21.286(b) provided that a CRNP wear a name tag with the title ''certified registered nurse practitioner.'' The title for a CRNP is ''CRNP.'' CRNPs working in pediatrics are unable to wear name tags because pediatric patients try to pull them off and can be injured by a name tag or its pin. In consultation with the PMS, the Board proposes to delete this provision and provide instead that CRNPs comply with State, Federal and facility regulations regarding identification of personnel to provide up-to-date provisions applicable to all personnel.

 Section 21.286(c) regarding identification of CRNPs who hold doctoral degrees. CRNPs are already required, under subsection (b) to be appropriately identified. The Board finds it unnecessary to have a second provision regarding the identification of CRNPs. The Board's proposed amendment is consistent with regulations of other healthcare practitioners, such as optometrists and podiatrists, which require the practitioners to use their title in addition to ''Dr.''

 The HPLC next commented on the Board's rescission of § 21.287 (relating to physician supervision). This section was promulgated under the old statutory scheme, wherein physicians supervised CRNPs. Section 21.287 provided that a physician could not supervise more than four CRNPs who prescribe and dispense drugs at any one time. In its December 2002 amendments to the act, the General Assembly deleted the physician supervision provisions. Under the new statutory scheme, CRNPs practice in the expanded role of an advanced practice nurse in collaboration with physicians. Section 21.287 is outdated and contrary to the statutory scheme enacted in December 2002.

 The HPLC stated that it ''believes [the § 21.287] restriction is necessary for patient safety and to ensure the quality of care.'' The HPLC did not explain the basis of this belief. Many nurses, physicians, group practices and organizations submitted comments to the contrary, and provided examples of ways that the § 21.287 restriction created a situation where patients were unable to receive the care that they needed and increased the risk of harm to patients. The Board is not aware of any research that has demonstrated that a limitation on the number of CRNPs collaborating with one physician increases patient safety or quality of care. No group or individual who submitted comments objecting to the proposed amendment cited evidence in any research that suggests that deleting this provision would compromise patient safety or quality of care. CRNPs practice in many other states without this arbitrary restriction, and there is no evidence that patients in these states receive a lower quality of care than patients in this Commonwealth. The Board respectfully rejects the HPLC's recommendation.

 The HPLC next addressed § 21.288 (relating to CRNP standards of conduct), and suggested that the section should specify that practice by a CRNP must be within the specifications of the CRNP's collaborative agreement. The Board has adopted the recommendation.

 The HPLC next questioned the rescission of §§ 21.291—21.294. These provisions purported to place requirements on health care facilities. Health care facilities are regulated by the Department of Health. The Board does not have any regulatory authority over health care facilities. The HPLC commented that ''[s]ince the statutory requirement on which these sections are based continues to apply, the Committee suggests retaining these sections.'' By Act 48 of 2007, the General Assembly provided that section 8.2(c.2) of the act could not be construed to ''[s]upersede the authority of the Department of Health and the Department of Public Welfare to regulate the types of health care professionals who are eligible for medical staff membership or clinical privileges'' or to ''[r]estrict the authority of a health care facility to determine the scope of practice and supervision or other oversight requirements for health care professionals practicing within the facility.'' (63 P. S. § 218.2(c.2)). The Board does not believe that these provisions give the Board the authority to direct the formation, composition, meeting dates or duties of committees that may operate within a health care facility to make determinations about staff within the facility. Finally, the Hospital and Healthsystem Association of Pennsylvania supports the deletion of these provisions. The Board respectfully declines the HPLC's suggestion.

 The HPLC noted that the Board used, in § 21.351(1) (relating to penalties for violation), both the abbreviation CRNP and the words certified registered nurse practitioner, and suggested that the Board be consistent. Although the Board submitted the proposed rulemaking to the HPLC using both the abbreviation and the words, the Legislative Reference Bureau corrected this error and only the abbreviation was used in the published version of the proposed rulemaking. The HPLC next noted that § 21.351 did not require CRNP practice to be consistent with the collaborative agreement. The Board has added a provision explaining that a CRNP may be subject to discipline if the Board finds that the CRNP practiced in violation of the collaborative agreement.

 Finally, the HPLC suggested that the Board require a CRNP to only form collaborative agreements with a physician who holds an unrestricted license. The Board understands the Committee's concern, and has added to § 21.282a(a) a provision that a CRNP may only collaborate with physicians who hold a current license. Physicians who hold a current license are authorized by the State Board of Medicine or State Board of Osteopathic Medicine to practice in this Commonwealth. At the meeting held by the Board on April 2, 2009, the PMS recommended that the Board prohibit CRNPs from collaborating with certain types of medical and osteopathic medical license holders, such as physicians participating in residency programs. The Board believes that the State Boards of Medicine and Osteopathic Medicine are in a better position to determine which of their licensee classes may enter into collaborative agreements with CRNPs.

 In addition to voicing some of the same concerns as the HPLC, IRRC asked why the definition of ''direction'' was being deleted from the Board's regulations. Act 206 amended the act by deleting the definition of ''direction'' and replacing that definition with the definition of ''collaboration.'' The amendment to the Board's regulations conforms the regulations to the statute.

 IRRC suggested that the Board specify in § 21.273(a) (relating to application for certification) the kinds of documents that a CRNP may submit to the Board with the application for certification as a CRNP to verify compliance with the statutory provision mandating liability insurance. CRNPs, like physicians, will not be required to submit any documents. When Act 48 of 2007 became effective, the Board added a verification statement to its application that was modeled after the verification statement used on the application for physicians.

 IRRC suggested that the Board list the eight activities set forth in section 8.2(c.1) of the act that a CRNP may perform in its list of permissible activities in § 21.282a(b). The Board has added the statutory provisions to its regulation. IRRC noted that it found the term ''other laws and regulations'' and ''pharmaceutical treatments'' vague terms. The Board has replaced the reference to other laws and regulations with a reference to the collaborative agreement. The Board has determined that it need not amend the term pharmaceutical treatments, that is, treatments utilizing pharmaceutical agents or drugs, because the term is not vague to health care practitioners.

 Regarding § 21.283, IRRC asked what was meant by the term ''oral orders'' and recommended that the term be defined. The term ''oral order'' is already defined in § 21.141 (relating to definitions) as a ''spoken order issued by a practitioner authorized by law and by facility policy to issue orders for medical and therapeutic measures.'' The definition was added to the regulations related to Licensed Practical Nurses (LPNs) when those regulations were amended at 33 Pa.B 6219 (December 20, 2008) because LPNs had not previously been permitted to take oral orders. Because professional nurses (RNs) have always been permitted to take oral orders, the term is not new to CRNPs and a definition is not required.

 IRRC recommended that the Board add a definition for the term ''categories of drugs'' to avoid further confusion if this section is amended in the future. Section 21.284(a) provides that the categories are those identified in the American Hospital Formulary Service Pharmacologic-Therapeutic Classification.

 IRRC next recommended that the Board retain the language in existing § 21.284(d), which mandates certain conduct by physicians. The Board does not believe that it has the statutory authority to mandate conduct by physicians. The Board's regulations already mandate that CRNPs act to safeguard patients. This mandate would, of course, require a CRNP to take action to safeguard a patient for whom a prescription was erroneously issued, regardless of whether the prescription was erroneously issued by the CRNP, another CRNP or a physician.

 Regarding the new time periods for which a CRNP is permitted to write a prescription for controlled substances, IRRC asked the Board to further explain why it was deleting the requirement that a CRNP notify the collaborating physician of the prescription and address why it believes CRNPs have the appropriate education and training to administer these provisions without the oversight of a physician.

 In considering the comments to § 21.284(d), specifically the notification provision, the Board held two meetings with representatives from PMS. After the first meeting, at which the representatives raised their concerns about the deletion of the provision, the Board agreed to include a provision requiring that CRNPs notify their collaborating physician within 24 hours when a CRNP prescribes a Schedule II drug for a 30-day period or a Schedule III—IV drug for a 90-day period. The PMS representatives then advised the Board that they objected to the notification provision because it might increase physician liability. At the second meeting held with the PMS representatives, the representatives and the Board agreed that the period of time for which a CRNP may prescribe controlled substances, subject to the 30-day and 90-day limitations, is a matter that could be addressed individually between CRNPs and physicians. Therefore, the Board added language to the revised subsection (d) to provide that the CRNP may prescribe controlled substances ''as identified in the collaborative agreement.'' When the regulation becomes final, the Board will amend the prescriptive authority collaborative agreement form consistent with this provision.

 IRRC asked what education was required for CRNPs. CRNPs must complete a minimum of a master's degree or post-master's degree certificate in nursing that prepared the nurse to practice as a CRNP. In addition, CRNPs must obtain and maintain National certification in their specialty by an organization that requires passing an examination. To maintain National certification requires significant continuing education in the specialty. CRNPs have expertise as clinicians and have an excellent record of providing effective and safe care to patients.

 In response to IRRC's inquiry whether CRNPs can safely administer these provisions ''without the oversight of a physician,'' the Board points out that CRNPs practice safely and effectively in most other states without the level of physician involvement as is in this Commonwealth. The qualifications met by CRNPs in this Commonwealth are similar to the qualifications to practice as a prescribing CRNP in the other 50 states, all of which, plus the District of Columbia and the United States Virgin Islands, have prescriptive authorization for CRNPs. The prescriptive authority granted to CRNPs varies from state to state. Seven states and this Commonwealth restrict CRNP prescribing to a formulary, 12 states authorize CRNPs to prescribe consistent with protocols, 27 states authorize CRNPs to prescribe consistent with their collaborative agreements, 16 states authorize CRNPs to prescribe independently within their specialty, and seven states authorize CRNPs to prescribe independently both within and outside their specialty. CRNPs were authorized to prescribe in 48 states prior to obtaining prescriptive authority authorization in this Commonwealth.

 A comprehensive study of disciplinary actions imposed on CRNPs, conducted over a 2-year period from data from 38 boards of nursing that license or certify 86,940 CRNPs, found that 0.12% of CRNPs were disciplined for exceeding their scope of practice. Hudspeth, R., (2007). Advanced Practice Registered Nurse Discipline 2003-2004. Institute of Regulatory Excellence, National Council of State Boards of Nursing. In this Commonwealth, CRNPs have held prescriptive authority since 2000. There are approximately 4,150 CRNPs with prescriptive authority in this Commonwealth. From 2000 to date, three CRNPs have been charged with improper prescribing and found guilty by the Board. Each case involved a single instance of improper prescribing as an accommodation to a relative or friend.

 The extremely low rate of improper prescribing cases brought in this Commonwealth echoes the findings of numerous research studies—that CRNPs practice—including prescribing—safely, and with virtually identical patient outcomes. According to a study published in the Journal of the American Medical Association in 2000, the data ''strongly supported the hypothesis that, using the traditional medical model of primary care, patient outcomes for nurse practitioner and physician delivery of primary care do not differ.'' Primary care outcomes in patients treated by nurse practitioners or physicians. JAMA 2000; 283(1):59-68. Other studies have reached a similar conclusion in particular fields. (For example, Prescribing patterns for gerontological nurse practitioners in the United States; Journal of the American Academy of Nurse Practitioners 20 (2008) 28-34; Quality of HIV care provided by nurse practitioners, physician assistants, and physicians; Annals of Internal Medicine 2005; 143(10):729-735; Improving the effectiveness of screening for colorectal cancer by involving nurse clinicians. Medical Care 1991; 29(1):1-5; and Pediatric trauma nurse practitioners provide excellent care with superior patient satisfaction for injured children; Journal of Pediatric Surgery (2006) 41, 277-281). A comprehensive survey of 4,253 articles related to nurse practitioner care, including nurse practitioner prescribing, concluded that ''appropriately trained nurses can produce as high quality care as primary doctors and achieve as good health outcomes for patients.'' Substitution of doctors by nurses in primary care. Cochrane Database of Systematic Reviews 2004, Issue 4, Art. NO.: CD00127. DOI: 10.1002/14651858.CD00127.pub2.

 IRRC asked the Board to consider alternative language offered by some of the commentators to this subsection, specifically the suggestion by PMS that CRNPs be permitted to write a prescription for a 7-day dosage, with proper notification to the physician and for 30-day dosage for ongoing therapy as approved by the collaborating physician. The Board considered the suggestions. In the face of the many comments from physicians, nurses and patients applauding the Board's proposal as necessary to ensure adequate access to safe and effective healthcare for this Commonwealth's citizens, the Board determined that it should not amend its proposal.

 IRRC noted that the preamble and proposed Annex were inconsistent regarding whether the prescription blanks of CRNPs must identify the collaborating physician. IRRC asked what was the Board's intention for § 21.284a(b)(1) and suggested that the name of the collaborating physician should be on the prescription as finally written. Section 21.284a(b)(1) requires prescriptions to bear the name, title and Pennsylvania CRNP certification number of the CRNP. Because CRNPs often collaborate with multiple physicians, it would be both impractical and confusing to patients and pharmacists for CRNPs to have multiple prescription pads. The Board has made available, on its public verification web site, information on the certification of CRNPs, including, where applicable, the identity of a CRNP's collaborating physician.

 IRRC next addressed § 21.285 (relating to prescriptive authority collaborative agreements) and expressed concern that the Board proposed to delete subsections (a)(4) and (6). IRRC asked the Board to further explain why it is in the public interest to delete these two sections. Section 21.285(a)(4) required physicians to attest to the physician's knowledge and experience with drugs that a CRNP may prescribe. The Board does not believe it is the appropriate body to require physicians to attest to their knowledge of drugs. Section 21.285(a)(6) provided that the collaborative agreement specify the conditions under which a CRNP could prescribe Schedule II controlled substances. A similar provision has been added to § 21.284(d).

 IRRC also noted that subsection (a)(6) is being amended to limit access to a prescriptive authority collaborative agreement to any license pharmacist or pharmacy and asked why the Board would not maintain the existing regulatory language to allow patients access to information they may need. The Board's proposed rulemaking required CRNPs to make the collaborative agreement available for inspection, including to patients. In addition, the Board's proposed rulemaking required CRNPs to provide a copy of the collaborative agreement to pharmacists and pharmacies at no charge. The Board has added additional language to clarify its original intent.

 The Board approved the final version of the rulemaking for promulgation at its meeting on May 5, 2009. On May 6, 2009, the Board received communication from the Pennsylvania Society of Anesthesiology (Society), expressing concern that § 21.17 (relating to anesthesia), which prohibits all nurses except Certified Registered Nurse Anesthetists (CRNAs) and certain nurse anesthesia students and graduates from administering anesthesia, might not be considered applicable to CRNPs in light of the deletion from § 21.284(b)(7) of the prior prohibition on CRNPs' prescribing general anesthetic drugs. Through discussions between representatives of the Board and representatives of the Society, it was determined that the Board and the Society agreed on the interaction of these sections of the regulations. It was also agreed that the preamble to this final-form rulemaking should further explain the role of CRNPs in the administration of general anesthetic drugs, but that the final rulemaking should not be amended. The Pennsylvania Coalition of Nurse Practitioners also provided input on this matter. The Board approved this addition to the preamble at its June 4, 2009, meeting.

 In accordance with sections 8.2(a), (b) and (c.2)(1) and (2), and 8.3(a)(2) of the act, CRNPs practice within their specialty, consistent with their collaborative agreements, subject to other statutes and regulations, and in accordance with the policies of health care facilities in which they practice. The amendment to § 21.284(b)(7) does not alter the § 21.17 provisions that limit the administration of anesthesia by licensed nurses to CRNAs. The amendment to § 21.284(b)(7) also does not affect the provisions of § 21.413(d) (relating to interpretations regarding the administration of drugs—statement of policy), which set forth the scope of practice of the professional nurse related to administering intravenous conscious sedation medications during minor therapeutic and diagnostic procedures.

 CRNPs may administer central nervous system agents classified as general anesthetics to intubated patients in a health care facility and, when credentialed by their employer, may administer central nervous system agents classified as general anesthetics for sedation in connection with procedures being performed in a health care facility in collaboration with a physician trained in airway management or with the immediate availability of a CRNA or anesthesiologist.

Fiscal Impact and Paperwork Requirements

 The amendments will have no adverse fiscal impact on the Commonwealth or its political subdivisions, because the costs of the Board's activities are supported by fees charged to licensees and others who benefit from specific activities of the Board. The amendments will impose no additional paperwork requirements upon the Commonwealth or political subdivisions.

Sunset Date

 The Board continuously monitors the effectiveness of its regulations. Therefore, no sunset date has been assigned.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Board submitted a copy of this proposed rulemaking, published at 38 Pa.B. 6161, to IRRC and the House Professional Licensure Committee (HPLC) and the Senate Consumer Protection and Professional Licensure Committee (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 Board 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 November 4, 2009, the final-form rulemaking was deemed approved by the HPLC and SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 5, 2009, 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 administrative amendments adopted by this order 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 (relating to notice of proposed rulemaking required; and adoption of regulations).

 (2) A public comment period was provided as required by law and all comments were considered in drafting this final-form rulemaking.

 (3) The amendments made to the final-form rulemaking do not enlarge the original purpose of the proposed rulemaking as published at 38 Pa.B. 6161.

 (4) These amendments to the regulations of the Board are necessary and appropriate for the regulation of the practice of CRNPs in this Commonwealth.

Order

 The Board therefore orders that:

 (a) The regulations of the Board, 49 Pa. Code Chapter 21, are amended by amending §§ 21.251, 21.261, 21.271, 21.283—21.286, 21.331, 21.332, 21.332a, 21.333, 21.334 and 21.351; by adding §§ 21.273, 21.282a, 21.284b and 21.288; and by deleting §§ 21.252, 21.272, 21.281, 21.282, 21.287, 21.291—21.294, 21.311 and 21.321 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) The regulations shall take effect immediately upon publication in the Pennsylvania Bulletin.

ANN L. O'SULLIVAN, PhD, FAAN, CRNP, 
Chairperson

(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 6705 (November 21, 2009).)

Fiscal Note: Fiscal Note 16A-5124 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 C. CERTIFIED REGISTERED NURSE PRACTITIONERS

GENERAL PROVISIONS

§ 21.251. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

Act—The Professional Nursing Law (63 P. S. §§ 211—225.5).

Board—The State Board of Nursing of the Commonwealth.

CRNPCertified Registered Nurse Practitioner—A professional nurse licensed in this Commonwealth who is certified by the Board in a specialty and who, while functioning in the expanded role as a professional nurse, performs acts of medical diagnosis or prescription of medical therapeutic or corrective measures in collaboration with a physician licensed to practice in this Commonwealth and in accordance with the act and this subchapter. Nothing in this subchapter is to be deemed to limit or prohibit a professional nurse from engaging in those activities which constitute the practice of professional nursing as defined in section 2 of the act (63 P. S. § 212).

Certification—The authorization granted by the Board to a professional nurse who has demonstrated the qualifications for recognition as a CRNP.

Collaboration—A process in which a CRNP works with one or more physicians to deliver health care services within the scope of the CRNP's expertise. The process includes the following:

 (i) Immediate availability of a licensed physician to a CRNP through direct communications or by radio, telephone or telecommunications.

 (ii) A predetermined plan for emergency services.

 (iii) A physician available to a CRNP on a regularly scheduled basis for referrals, review of the standards of medical practice incorporating consultation and chart review, drug and other medical protocols within the practice setting, periodic updating in medical diagnosis and therapeutics and cosigning records when necessary to document accountability by both parties.

Collaborative agreement—The written and signed agreement between a CRNP and a collaborating physician in which they agree to the details of their collaboration including the elements in the definition of collaboration.

Initial certification—The first certification or licensure as a nurse practitioner that an individual receives in any jurisdiction.

National certification—Certification by a Board-recognized National certification organization which required passing a nurse practitioner National certifying examination in a specialty.

Prescriptive authority collaborative agreement—The written and signed agreement between a CRNP with prescriptive authority and a collaborating physician in which they agree to the details of their collaboration.

Specialty—The area of practice or population in which a CRNP is certified by the Board.

§ 21.252. (Reserved).

LEGAL RECOGNITION

§ 21.261. Use of title; authorization to practice.

 (a) A professional nurse who has satisfactorily met the requirements set forth in the act and this subchapter and holds current certification as a CRNP or whose certification is maintained on inactive status may use the designation CRNP.

 (b) The Board will identify the specialty in which a CRNP is certified on the certification issued to the CRNP.

 (c) Only an individual who holds current active certification may practice or offer to practice as a CRNP in this Commonwealth.

 (d) A professional nurse may not practice or offer to practice as a CRNP in a specialty in this Commonwealth during the time the professional nurse's certification in that specialty or the professional nurse's RN license is inactive, lapsed or expired. A professional nurse may not practice or offer to practice as a CRNP in this Commonwealth if the professional nurse's certification or RN license is revoked or suspended.

CERTIFICATION REQUIREMENTS

§ 21.271. Certification requirements.

 (a) Initial certification. An applicant for initial certification shall meet the following requirements:

 (1) Registered nurse license. An applicant for certification shall hold a current, unrestricted license as a professional nurse in this Commonwealth.

 (2) Education. An applicant for certification shall have completed an accredited, Board-approved master's or postmaster's nurse practitioner program or other Board-approved program that awarded an advanced degree or a course of study considered by the Board to be equivalent to that required for certification in this Commonwealth at the time the course was completed.

 (3) National certification. An applicant for initial certification after February 7, 2005, shall hold current National certification in the specialty in which the professional nurse is seeking certification.

 (b) Certification by endorsement. An applicant for certification who holds a current, unrestricted license or certificate as a nurse practitioner from another state, territory or possession of the United States or a foreign country, shall meet the certification requirements that were effective at the time the applicant was licensed or certified as a nurse practitioner by the other jurisdiction. Applicants who were initially licensed or certified by another state, territory or possession of the United States or a foreign country after February 7, 2005, shall hold current National certification in the specialty in which the nurse is seeking certification. Nurse practitioners applying for certification from a jurisdiction that does not designate the nurse practitioner's specialty will be required to present evidence satisfactory to the Board to demonstrate the nurse practitioner's specialty.

 (c) Addition of a specialty. A CRNP who holds an unrestricted certification to practice may apply for certification in an additional specialty. To be granted certification in an additional specialty, the CRNP shall meet the educational and National certification requirements for the specialty in which the CRNP is applying for certification.

§ 21.272. (Reserved).

§ 21.273. Application for certification.

 (a) Applicants for certification shall pay a fee set forth in § 21.253 (relating to fees), and submit an application form provided by the Board to the Board for its review and approval. Applicants shall verify compliance with section 8.7 of the act (63 P. S. § 218.7) regarding professional liability coverage.

 (b) An applicant for initial certification shall include documentation satisfactory to the Board of the following:

 (1) Proof of completion of a Board-approved education program or proof of completion and official transcript from another course of study that meets the requirements of § 21.271(a)(2) (relating to certification requirements).

 (2) Proof of current National certification as set forth in § 21.271(a)(3).

 (c) An applicant for certification by endorsement shall include documentation satisfactory to the Board of the following:

 (1) Verification of current, unrestricted licensure or certification as a nurse practitioner issued by the proper licensing authority of another state, territory or possession of the United States or a foreign country.

 (2) Copy of the licensure or certification requirements at the time the applicant was initially licensed or certified by another jurisdiction and a copy of the criteria under which the applicant was initially licensed or certified, obtained from the jurisdiction's board of nursing or licensing authority.

 (3) Official transcript from the applicant's nurse practitioner program, including degree awarded.

 (4) Proof of current National certification in the specialty in which the nurse is seeking certification by the Board, if the applicant obtained initial certification or licensure after February 7, 2005.

 (5) Proof of specialty designation. for a nurse practitioner who obtained initial certification in a specialty before February 7, 2005, and who does not hold current National certification, the specialty designation shall be demonstrated by certification from the nurse practitioner's original state of certification. For a nurse practitioner whose certification is from a state that does not designate a specialty, the specialty designation shall be demonstrated by the nurse practitioner's educational program.

 (d) An applicant who holds certification who is applying for certification in another specialty shall submit documentation of the following:

 (1) Official transcript from the applicant's nurse practitioner program and any additional educational programs, including degree awarded, demonstrating a concentration in the specialty in which the applicant is seeking certification.

 (2) Proof of current National certification in the specialty in which the nurse is seeking certification by the Board.

 (e) Applicants shall remit the fee set forth in § 21.253.

 (f) Applicants shall submit additional information as identified on the application or as requested by the Board. Applications will remain on file for 12 months.

 (g) All forms are available on the Board's web site or by contacting the Board.

§ 21.281. (Reserved).

§ 21.282.  (Reserved).

CRNP PRACTICE

§ 21.282a. CRNP Practice.

 (a) A CRNP may collaborate only with physicians who hold a current license to practice in this Commonwealth.

 (b) When acting in collaboration with a physician as set forth in a collaborative agreement and within the CRNP's specialty, a CRNP may:

 (1) Perform comprehensive assessments of patients and establish medical diagnoses.

 (2) Order, perform and supervise diagnostic tests for patients and, to the extent the interpretation of diagnostic tests is within the scope of the CRNP's specialty and consistent with the collaborative agreement, may interpret diagnostic tests.

 (3) Initiate referrals to and consultations with other licensed professional health care providers, and consult with other licensed professional health care providers at their request.

 (4) Develop and implement treatment plans, including issuing orders to implement treatment plans. However, only a CRNP with current prescriptive authority approval may develop and implement treatment plans for pharmaceutical treatments.

 (5) Complete admission and discharge summaries.

 (6) Order blood and blood components for patients.

 (7) Order dietary plans for patients.

 (8) Order home health and hospice care.

 (9) Order durable medical equipment.

 (10) Issue oral orders to the extent permitted by the health care facilities' by-laws, rules, regulations or administrative policies and guidelines.

 (11) Make physical therapy and dietitian referrals.

 (12) Make respiratory and occupational therapy referrals.

 (13) Perform disability assessments for the program providing temporary assistance to needy families (TANF).

 (14) Issue homebound schooling certifications.

 (15) Perform and sign the initial assessment of methadone treatment evaluations, provided that any order for methadone treatment shall be made only by a physician.

 (c) The provisions of this section are subject to limitation as set forth in section 8.2(c.2) of the act (63 P. S. § 218.2(c.2)), regarding the authority of state agencies and health care facilities.

§ 21.283. Authority and qualifications for prescribing, dispensing and ordering drugs.

 (a) A CRNP with prescriptive authority approval may, when acting in collaboration with a physician as set forth in a prescriptive authority collaborative agreement and within the CRNP's specialty, prescribe and dispense drugs and give written or oral orders for drugs and other medical therapeutic or corrective measures. These orders may include:

 (1) Orders for drugs, total parenteral nutrition and lipids, in accordance with §§ 21.284 and 21.285 (relating to prescribing and dispensing parameters; and prescriptive authority collaborative agreements).

 (2) Disposables and devices adjunctive to a treatment plan.

 (b) To obtain prescriptive authority approval, a CRNP shall:

 (1) Successfully complete at least 45 hours of course work specific to advanced pharmacology in accordance with the following:

 (i) The course work in advanced pharmacology may be either part of the CRNP education program or, if completed outside of the CRNP education program, an additional course or courses taken from an educational program or programs approved by the Board.

 (ii) The course work shall be at an advanced level above a pharmacology course required by a professional nursing (RN) education program.

 (iii) The course work shall have been completed within 5 years immediately preceding the date the applicant applies for initial prescriptive authority approval.

 (2) Submit an application for prescriptive authority approval to the Board.

 (3) Pay the fee set forth in § 21.253 (relating to fees).

 (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 biennial renewal date of the certification. The CRNP shall verify completion of the continuing education when submitting a biennial renewal.

§ 21.284. Prescribing and dispensing parameters.

 (a) The Board adopts the American Hospital Formulary Service Pharmacologic-Therapeutic Classification to identify drugs which the CRNP may prescribe and dispense subject to the parameters identified in this section.

 (b) A CRNP with current prescriptive authority approval from the Board may prescribe, dispense and administer drugs and therapeutic or corrective measures consistent with the prescriptive authority collaborative agreement and relevant to the CRNP's specialty from the following categories:

 (1) Antihistamines.

 (2) Anti-infective agents.

 (3) Antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids.

 (4) Autonomic drugs.

 (5) Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.

 (6) Cardiovascular drugs.

 (7) Central nervous system agents.

 (8) Contraceptives including foams and devices.

 (9) Diagnostic agents.

 (10) Disinfectants for agents used on objects other than skin.

 (11) Electrolytic, caloric and water balance.

 (12) Enzymes.

 (13) Antitussive, expectorants and mucolytic agents.

 (14) Gastrointestinal drugs.

 (15) Local anesthetics.

 (16) Eye, ear, nose and throat preparations.

 (17) Serums, toxoids and vaccines.

 (18) Skin and mucous membrane agents.

 (19) Smooth muscle relaxants.

 (20) Vitamins.

 (21) Hormones and synthetic substitutes.

 (c) A CRNP may not prescribe or dispense a drug from the following categories:

 (1) Gold compounds.

 (2) Heavy metal antagonists.

 (3) Radioactive agents.

 (4) Oxytocics.

 (5) Schedule I controlled substances as defined by section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-104).

 (d) Restrictions on CRNP prescribing and dispensing practices are as follows:

 (1) A CRNP may write a prescription for a Schedule II controlled substance for up to a 30-day supply as identified in the collaborative agreement.

 (2) A CRNP may prescribe a Schedule III or IV controlled substance for up to a 90 day supply as identified in the collaborative agreement.

 (e) A CRNP may not delegate prescriptive authority.

§ 21.284a. Prescribing and dispensing drugs.

 (a) Professional samples. A CRNP who holds current prescriptive authority approval may request, receive and sign for professional samples and may dispense professional samples to patients.

 (b) Prescriptions.

 (1) Prescriptions must bear the name, title and Pennsylvania CRNP certification number of the CRNP.

 (2) When appropriate, the CRNP's National Provider Identifier (NPI) number must appear on the prescription.

 (3) Prescriptions may not be presigned.

 (c) Documentation requirements. When prescribing or dispensing a drug, the CRNP shall document in the patient's medical record the name, amount and dosage of the drug, instructions for taking the drug, the number of refills, the date and the CRNP's name.

 (d) Packaging. Prescription drugs shall be dispensed in accordance with Federal regulations pertaining to packaging. (See 16 CFR Part 1700 (relating to poison prevention packaging).)

 (e) Labeling of dispensed drugs.

 (1) The label on a dispensed drug container must include the name of the drug, using abbreviations if necessary; the quantity; and the name of the manufacturer if the drug is a generic drug. If a CRNP specifically indicates that the name of the drug may not appear on the label, the recognized National drug code number shall be placed on the label if the number is available for the product. The label shall also bear the name and address of the CRNP, the date dispensed, the name of the patient and the directions for use of the drug by the patient.

 (2) Drugs that, at the time of their dispensing, have full potency for less than 1 year, as determined by the expiration date placed on the original label by the manufacturer, may only be dispensed with a label that indicates the expiration date. The label must include the statement, ''Do not use after manufacturer's expiration date,'' or similar wording.

 (f) Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A CRNP shall comply with this section, § 21.284b (relating to prescribing, administering and dispensing controlled substances) and regulations of the Department of Health in 28 Pa. Code §§ 25.51—25.58, 25.61—25.63, 25.72, 25.81 and 25.91—25.95.

§ 21.284b. Prescribing, administering and dispensing controlled substances.

 (a) A CRNP authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration.

 (b) A CRNP shall carry out the following minimum standards when prescribing, administering or dispensing controlled substances:

 (1) Initial evaluation. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, an initial medical history shall be taken and an initial physical examination shall be conducted to the extent required by the Department of Health in 28 Pa. Code (relating to health and safety) or Department of Public Welfare in 55 Pa. Code (relating to public welfare) or the Federal government in appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, before commencing treatment that involves prescribing, administering or dispensing a controlled substance, an initial medical history shall be taken and an initial physical examination shall be conducted unless emergency circumstances justify otherwise. Alternatively, medical history and physical examination information recorded by another health care provider may be considered if the medical history was taken and the physical examination was conducted within the immediately preceding 30 days. The physical examination must include an evaluation of the heart, lungs, vital signs, pain level, and body functions that relate to the patient's specific complaint.

 (2) Reevaluations. Among the factors to be considered in determining the number and frequency of follow-up evaluations that should be recommended to the patient are the condition diagnosed, the controlled substance involved, expected results and possible side effects. For chronic conditions, periodic follow-up evaluations shall be recommended to monitor the effectiveness of the controlled substance in achieving the intended results.

 (3) Patient counseling. Appropriate counseling shall be given to the patient regarding the condition diagnosed and the controlled substance prescribed, administered or dispensed. Unless the patient is in an inpatient care setting, the patient shall be specifically counseled about dosage levels, instructions for use, frequency and duration of use and possible side effects.

 (4) Medical records. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, information pertaining to the prescription, administration or dispensation of a controlled substance shall be entered in the medical records of the patient and the health care facility under 28 Pa. Code or 55 Pa. Code or appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, certain information shall be recorded in the patient's medical record on each occasion when a controlled substance is prescribed, administered or dispensed. This information must include the name of the controlled substance, its strength, the quantity and the date it was prescribed, administered or dispensed. On the initial occasion when a controlled substance is prescribed, administered or dispensed to a patient, the medical record must also include a specification of the symptoms observed and reported, the diagnosis of the condition for which the controlled substance is being given and the directions given to the patient for the use of the controlled substance. If the same controlled substance continues to be prescribed, administered or dispensed, the medical record must reflect changes in the symptoms observed and reported, in the diagnosis of the condition for which the controlled substance is being given and in the directions given to the patient.

 (5) Emergency prescriptions. In the case of an emergency contact by a known patient, a prudent, short-term prescription for a controlled substance may be issued. Neither a refill nor a consecutive issuance of this emergency prescription may be given unless a physical examination and evaluation of the patient are first conducted. The results of this examination and evaluation must be set forth in the patient's medical record together with the diagnosis of the condition for which the controlled substance is being prescribed. An emergency oral prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the pharmacist within 72 hours. In certain health care facilities regulated by the Department of Health, the Department of Public Welfare and the Federal government, an order for the immediate, direct administration of a Schedule II controlled substance to a patient is not considered a prescription and is, therefore, not subject to the requirements in this paragraph. Further information regarding this exclusion can be found in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144) and 28 Pa. Code Chapter 25 (relating to controlled substances, drugs, devices, and cosmetics).

 (c) This section establishes minimum standards for the prescription, administration and dispensation of controlled substances by a CRNP. This section does not restrict or limit the application of The Controlled Substance, Drug, Device and Cosmetic Act or of another statute or regulation, and does not relieve a CRNP from complying with more stringent standards that may be imposed by another statute or regulation, or policy of the CRNP's employer or facility in which the CRNP is employed.

 (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.

§ 21.285. Prescriptive authority collaborative agree-ments.

 (a) The prescriptive authority collaborative agreement between a physician and a CRNP who will prescribe and dispense drugs and other medical therapeutic or corrective measures, as set forth in § 21.283(a) (relating to authority and qualifications for prescribing, dispensing and ordering drugs) must satisfy the following requirements. The agreement must:

 (1) Be in writing, identify the parties, including the collaborating physician, the CRNP, and at least one substitute physician who will provide collaboration if the collaborating physician is unavailable, include the signature of the CRNP and the collaborating physician, and contain the date that the agreement is signed and the date that the agreement is effective.

 (2) Identify the specialty in which the CRNP is certified.

 (3) Identify the categories of drugs from which the CRNP may prescribe or dispense in accordance with section 8.3 (a)(2)(ii) of the act (63 P. S. § 218.3(a)(2)(ii)).

 (4) Specify the circumstances and how often the collaborating physician will personally see the patient.

 (5) Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.

 (6) Be made available for inspection to anyone who requests it and be provided, without charge, to any licensed pharmacist or pharmacy upon request.

 (7) Be reviewed and updated by the parties at least once every 2 years or whenever the agreement is changed.

 (8) Specify the amount of professional liability insurance that covers the CRNP.

 (b) The CRNP shall notify the Board, in writing, whenever a prescriptive authority collaborative agreement is updated or terminated, and, when appropriate, shall file the ''Change Of Prescriptive Authority Collaborative Agreement'' form and the amended prescriptive authority collaborative agreement with the Board and pay the fee set forth in § 21.253 (relating to fees).

§ 21.286. Identification of the CRNP.

 (a) A CRNP shall comply with State, Federal and facility regulations regarding identification of personnel.

 (b) The listing of a CRNP in an advertisement or publicly displayed sign shall identify CRNPs who use the designation ''Dr.'' as CRNPs by using the title CRNP following the individual's name.

§ 21.287. (Reserved).

§ 21.288. CRNP standards of conduct.

 A CRNP shall undertake a specific practice or procedure only if the CRNP has the necessary knowledge, preparation, experience and competency to properly execute the practice or procedure and the practice is within the scope of the CRNP's specialty and consistent with the CRNP's collaborative agreement. A CRNP shall comply with § 21.18 (relating to standards of nursing conduct).

§ 21.291. (Reserved).

§ 21.292. (Reserved).

§ 21.293. (Reserved).

§ 21.294. (Reserved).

§ 21.311. (Reserved).

§ 21.321. (Reserved).

MAINTENANCE OF CERTIFICATION

§ 21.331. Biennial renewal of certification.

 (a) The certification, and prescriptive authority approval, if applicable, of a CRNP will expire at the same time as the CRNP's registered nurse license as provided in § 21.29 (relating to expiration and renewal of license).

 (b) Notice of application for renewal will be forwarded biennially to each active CRNP at the CRNP's address of record with the Board prior to the expiration date of the current biennial period.

 (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. As a condition of biennial renewal of prescriptive authority approval, a CRNP shall complete a minimum of 16 of the 30 hours of Board-approved continuing education in pharmacology in the 2 years prior to renewal.

 (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.

 (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.

§ 21.332. Requirement of continuing education.

 (a) A CRNP shall comply with this section and §§ 21.332a—21.337.

 (b) Continuing education requirements shall be completed each biennial renewal cycle.

 (1) A CRNP who does not meet the continuing education requirements for a biennial period will be subject to formal disciplinary action under section 14(a)(3) of the act (63 P. S. 244(a)(3)).

 (2) The Board may waive the requirements of continuing education in cases of illness or undue hardship. It is the duty of each CRNP who seeks a waiver to notify the Board in writing and request the waiver at least 90 days prior to the end of the renewal period. The Board will grant, deny or grant in part the request for waiver.

 (3) A CRNP who requests a waiver may not prescribe or dispense drugs after the expiration of his current prescriptive authority until the Board grants the waiver request or the prescriptive authority approval has been renewed.

§ 21.332a. Inactive status and reactivation.

 (a) A CRNP who places his certification on inactive status is not required to meet the continuing education requirements in section 8.1(c) of the act (63 P. S. § 218.1(c)) during the period the certification is on inactive status. Upon application for reactivation of certification, the CRNP shall show proof of meeting the continuing education requirements for the biennial period immediately preceding the request for reactivation, and, if the certification has been lapsed or on inactive status for 5 years or longer, the CRNP must have a current, active professional nurse license, reactivated in accordance with the continued competency requirements in § 21.30a (related to continued competency), and at least one of the following:

 (1) Proof of current National certification in the specialty in which the nurse is seeking reactivation, if the CRNP is subject to section 8.1(b) of the act.

 (2) Evidence that the applicant has practiced as a nurse practitioner in another jurisdiction at some period of time within the last 5 years under a current license or certification during that time.

 (b) A CRNP who places his prescriptive authority approval on inactive status for less than 3 years is not required to meet the continuing education requirements in § 21.332(b)(2) (relating to requirement of continuing education) during the period the prescriptive authority approval is on inactive status. Upon application for reactivation of prescriptive authority approval, the CRNP shall show proof of meeting the continuing education requirements for the biennial period immediately preceding the request for reactivation.

 (c) A CRNP who places his prescriptive authority approval on inactive status for 3 years or longer or whose prescriptive authority approval is lapsed for 3 years or longer, may reactivate the prescriptive authority approval by meeting one of the following conditions:

 (1) Complete the requirement in § 21.283(b)(1) (relating to authority and qualifications for prescribing, dispensing and ordering drugs) by taking at least 45 hours of course work in advanced pharmacology.

 (2) Provide evidence to the Board that:

 (i) The CRNP has practiced, for at least 1 of the last 3 years, as a CRNP with prescriptive authority in another jurisdiction.

 (ii) The scope of the prescriptive authority in the other jurisdiction is equivalent to prescriptive authority in this Commonwealth.

 (iii) The CRNP was required, as a condition for continued practice in the other jurisdiction, to complete continuing education that is substantially equivalent to the requirements of § 21.283(b)(1).

 (iv) The CRNP met the continuing education requirements of the other jurisdiction within 1 year of the request for reactivation of prescriptive authority.

 (d) A CRNP whose certification has been suspended for 5 years or longer shall meet the requirements in § 21.332(b), and any other requirements set forth by Board order. A CRNP whose prescriptive authority approval has been suspended for 3 years or longer shall, in addition to meeting the requirements to renew the CRNP certification, meet the requirements in subsection (c), and any other requirements set forth by Board order.

 (e) A CRNP whose certification has been revoked shall meet all of the requirements for certification in § 21.271(a) (relating to certification requirements), the requirements in § 21.332(b), and any other requirements set forth by Board order. A CRNP whose prescriptive authority approval has been revoked shall, in addition to meeting the requirements to reinstate the CRNP certification, meet the requirements in subsection (c), and any other requirements by Board order.

§ 21.333.  Continuing education content.

 (a) Continuing education activities must address the CRNP's specialty.

 (b) Pharmacology continuing education activities must provide the knowledge and skills to understand the pharmacokinetics and pharmacodynamics of broad categories of drugs or drugs used in the CRNP's specialty and to analyze the relationship between pharmacologic agents and physiologic/pathologic responses.

§ 21.334. Sources of continuing education.

 (a) The following providers of continuing education and credentialing organizations have currently met the standards for approval for continuing education. Therefore, all activities offered by these providers are approved for continuing education hours required for biennial license renewal.

 (1) Board-approved CRNP educational programs and CRNP educational programs approved by other state boards of nursing or that hold current accreditation issued by a National nursing accreditation organization.

 (2) National and international nursing organizations and their state and local affiliates.

 (3) National and international medical and osteopathic organizations and their state and local affiliates.

 (4) National pharmaceutical organizations and their state and local affiliates.

 (5) National nursing specialty organizations.

 (6) Continuing education programs approved by other state boards of nursing for advanced practice nurses or nurse practitioners.

 (b) CRNPs may obtain hours for continuing education activities offered by providers not indicated in subsection (a)(1)—(6) if the provider receives approval of the activity under § 21.336 (relating to continuing education course approval) prior to its implementation.

 (c) CRNPs may obtain credit for continuing education hours on an individual basis if the CRNP, prior to attendance at the course, obtains Board approval by submitting a request for course approval and supporting documentation listed in § 21.336(b).

 (d) CRNPs may obtain credit for correspondence courses, taped study courses and other independent study courses if the course is Board approved.

 (e) Up to 4 hours will be credited for service as a teacher, preceptor, lecturer or speaker and for publication in a refereed journal or other scholarly publication relating to pharmacology or the CRNP's area of practice. Application shall be made prior to the service or within 90 days of the publication to assure that the Board will approve the service or publication and to allow the Board to determine the number of contact hours that will be granted.

 (f) An hour for purposes of nurse practitioner continuing education is 50 minutes.

PENALTIES FOR VIOLATION

§ 21.351. Penalties for violation.

 Certification as a CRNP may be suspended, revoked or otherwise restricted or subjected to remedial measures when, after notice and opportunity to be heard, the Board finds that:

 (1) The CRNP has engaged in the performance of medical functions and tasks beyond the scope of practice permitted for a CRNP, beyond the scope of the CRNP's specialty, or in violation of the CRNP's collaborative agreement, as provided in the act and this subchapter.

 (2) The CRNP has performed a medical task or function which the CRNP does not have the necessary knowledge, preparation, experience and competency to perform properly or is not qualified under the act and this subchapter to perform.

 (3) The CRNP has violated the act or this subchapter, or engaged in any conduct prohibited for professional nurses.

[Pa.B. Doc. No. 09-2276. Filed for public inspection December 11, 2009, 9:00 a.m.]



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