PROPOSED RULEMAKING
STATE BOARD
OF MEDICINE
[ 49 PA. CODE CHS. 16 AND 18 ]
Perfusionist
[40 Pa.B. 2652]
[Saturday, May 22, 2010]The State Board of Medicine (Board) proposes to amend §§ 16.11 and 16.13 (relating to licenses, certificates and registrations; and licensure, certification, examination and registration fees) and to add Subchapter J (relating to perfusionists) to read as set forth in Annex A.
Effective Date
The proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The proposed rulemaking is authorized under sections 8 and 13.3 of the Medical Practice Act of 1985 (act) (63 P. S. §§ 422.8 and 422.13c).
Background and Need for the Proposed Rulemaking
The act of June 11, 2008 (P. L. 154, No. 19) (Act 19) amended the act to provide for licensure of perfusionists. Section 2 of the act (63 P. S. § 422.2) now defines the term ''perfusion'' as ''the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular system or other organs, or a combination of those functions, and for ensuring the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under the supervision of a physician. . . .'' This proposed rulemaking is intended to implement licensure of perfusionists under the act as amended by Act 19. Practice of profusion in this Commonwealth without a license from the Board will be prohibited after August 10, 2010. This proposed rulemaking is also designed to provide to prospective licensees adequate notice of the requirements for licensure as a perfusionist.
Description of the Proposed Rulemaking
The Board's current regulation in § 16.11(b) identifies licenses that the Board issues. The proposed rulemaking adds licensure as a perfusionist. Similarly, § 16.11(c) identifies registrations that the Board issues and the proposed rulemaking adds biennial registration of perfusionist licenses. The proposed rulemaking also adds § 16.13(k) setting forth the fees associated with perfusionist licensure to be charged by the Board, as authorized under section 13.3(l) of the act. To recover the costs of providing those services, the fee for applications for perfusionist license, reactivation of perfusionist license and temporary graduate perfusionist license would each be $50 and the fee for application for temporary provisional perfusionist license would be $40. Because the Board believes that the cost to provide the service would be minimal and does not want to delay application, the Board has not set any fee for notification of emergency practice as a perfusionist. To provide for an appropriate share of the general costs of operating the Board, the biennial renewal fee for a perfusionist would be $50.
The proposed rulemaking amends Chapter 18 by adding Subchapter J. Proposed § 18.531 (relating to purpose) identifies the purpose of the subchapter as providing for licensure of perfusionists. Proposed § 18.532 (relating to definitions) provides necessary definitions. These include the statutory definitions of ''extracorporeal circulation,'' ''perfusion,'' ''perfusionist'' and ''ventricular assist device'' as are used in the subchapter. Additionally, the Board defines ''ABCP'' as the American Board of Cardiovascular Perfusion (ABCP), the National body that both accredits perfusion education programs and certifies perfusionists. The Board proposes to define ''accredited perfusion program approved by the Board'' as a perfusion program accredited by a Nationally-recognized accrediting agency approved by the Board. The Board would further define ''Nationally-recognized accrediting agency approved by the Board'' as the ABCP or another organization for which the Board publishes notice that the organization is approved by the Board as an accrediting agency for perfusionist programs. The Board also defines ''Nationally-recognized certifying agency approved by the Board'' as the ABCP or another organization for which the Board publishes notice that the organization is approved by the Board as a certifying agency for perfusionists. Finally, the Board proposes to define an ''hour of continuing education'' to consist of at least 50 minutes of instruction (including question and answer sessions) in an approved course of continuing education or an equivalent time that an on-line or correspondence course would be presented live. This time is consistent with the standards for continuing education that is required by the ABCP for recertification.
Under proposed § 18.533(a) (relating to application for perfusionist license), an applicant shall submit a completed application form, including necessary supporting documents, and pay the required application fee. Section 13.3(f) of the act sets five criteria for licensure as a perfusionist: The applicant must be at least 18 years of age, be of good moral character, have graduated from an accredited perfusion program approved by the Board and be certified by a certifying agency approved by a Nationally-recognized accrediting agency approved by the Board. Accordingly, proposed § 18.533(b)(1) provides that the Board will license as a perfusionist an applicant who demonstrates that the applicant satisfies the requirements of section 13.3(f) of the act for licensure as a perfusionist. Because section 13.3(k) of the act requires a perfusionist to carry a minimum level of professional liability insurance, proposed § 18.533(b)(2) requires that an applicant provide proof of liability insurance. Because, as discussed as follows, the Board is also setting forth in this proposed rulemaking grounds for disciplinary action, proposed § 18.533(c) would provide that the Board may, in its discretion, deny an application for perfusionist licensure upon those grounds for disciplinary action in § 18.539 (relating to disciplinary action for licensed perfusionists).
The Board has not proposed a rulemaking to incorporate the grandfather provision of section 13.3(g) of the act, which, during the first 2 years after the effective date of Act 20, permits a person who was not a graduate of an accredited program prior to 1981, but who met the then-current eligibility requirements for certification as a certified clinical perfusionist and subsequently was certified, to become licensed if the person otherwise complies with the requirements for licensure. Not only is this statutory provision self-executing, but the opportunity to take advantage of it will expire August 10, 2010, not long after final promulgation of the rulemaking.
Proposed § 18.534 (relating to application for temporary graduate perfusionist license) addresses the application for temporary graduate perfusionist license, as provided in section 13.3(h) of the act. Under proposed § 18.534(a), an applicant shall submit a completed application form, including necessary supporting documents, and pay the required application fee. Section 13.3(h)(1)(i) of the act provides that an individual who has graduated from an educational program in compliance with the education requirements and is eligible for and has applied for the examination may receive a temporary graduate license. These criteria, along with good moral character and being at least 18 years of age, would be in proposed § 18.534(b)(1) as the basic requirements for a temporary graduate license. Because section 13.3(k) of the act requires a perfusionist to carry a minimum level of professional liability insurance, proposed § 18.534(b)(2) requires that an applicant provide proof of liability insurance. Because, as discussed as follows, the Board is also setting forth in this proposed rulemaking grounds for disciplinary action, proposed § 18.534(c) provides that the Board may, in its discretion, deny an application for temporary graduate perfusionist license upon those grounds for disciplinary action in § 18.539. Because section 13.3(h)(1)(iii) of the act provides that a temporary graduate license is to be issued for 2 years but not be renewable, proposed § 18.534(d) provides that a temporary graduate perfusionist license will expire 2 years after the date of issuance and may not be renewed. Because section 13.3(h)(1)(iv) of the act provides that a temporary graduate license is to expire upon notice of failing the required examination, proposed § 18.534(e) provides that a temporary graduate perfusionist license will expire upon notice to the Board that the holder failed the Nationally-recognized certifying agency's certification examination.
Proposed § 18.535 (relating to application for temporary provisional perfusionist license) would address the application for temporary provisional perfusionist license, as provided under section 13.3(i) of the act. Under proposed § 18.535(a), an applicant must submit a completed application form, including necessary supporting documents, and pay the required application fee. Section 13.3(i)(1) of the act provides that an individual who holds a current license in good standing under the laws of another state, which includes certification by a certifying agency approved by a Nationally-recognized accrediting agency, may receive a temporary provisional license if the applicant meets the requirements of section 13.3(f) of the act that the applicant is at least 18 years of age and of good moral character and has graduated from an accredited perfusion program approved by the Board. These criteria are in proposed § 18.535(b)(1) as the basic requirements for a temporary provisional license. Because section 13.3(k) of the act requires a perfusionist to carry a minimum level of professional liability insurance, proposed § 18.535(b)(2) would require that an applicant provide proof of liability insurance. Because, as discussed as follows, the Board is also setting forth in this proposed rulemaking grounds for disciplinary action, proposed § 18.535(c) provides that the Board may, in its discretion, deny an application for perfusionist temporary provisional license upon those grounds for disciplinary action in § 18.539. Because section 13.3(i)(2) of the act provides that a temporary provisional license is to be issued for 1 year but not be renewable, proposed § 18.535(d) provides that a temporary provisional perfusionist license will expire 1 year after the date of issuance and may not be renewed thereafter.
Section 13.3(j) of the act provides an exemption to the general prohibition against unlicensed practice for one-time temporary emergency services by an out-of-State licensed perfusionist when the licensed perfusionist that would normally have provided the services is unavailable or incapable of providing services and no other licensed perfusionist is available or capable of providing services. Section 13.3(j) of the act requires the out-of-State perfusionist to provide to the Board electronic notice of the emergency and acknowledgment that the out-of-State perfusionist is subject to jurisdiction of the Board as if licensed by the Board and requires the healthcare facility to provide to the Board electronic notice that services were provided and the grounds for the exemption. Proposed § 18.536(a) (relating to registration of temporary emergency perfusionist service) requires the out-of-State perfusionist to register with the Board in accordance with section 13.3(j) of the act prior to providing emergency services. Under proposed § 18.536(b), the out-of-State perfusionist or other person acting on behalf of the out-of-State perfusionist (such as healthcare facility staff) shall submit a completed registration on forms provided by the Board. It is anticipated that this registration will be done almost exclusively from the Board's web site. Because ''one-time emergency perfusionist service'' is not defined in section 13.3(j) of the act, proposed § 18.536(c) provides that although the services are not limited to a single procedure or patient or group of related patients, the out-of-State perfusionist may not provide emergency services for a period longer than 72 hours. However, section 13.3(j)(3) of the act prohibits the out-of-State perfusionist from providing services other than emergency services. Consistent with section 13.3(j)(2) of the act, proposed § 18.536(d) provides that the out-of-State perfusionist may not provide further perfusionist service in this Commonwealth without being licensed as a perfusionist or holding a temporary graduate license or temporary provisional license.
Because licenses issued by the Board must be registered biennially as a condition of continued practice in accordance with § 16.15 (relating to biennial registration; inactive status and unregistered status), proposed § 18.537 (relating to biennial registration of perfusionist license) addresses biennial registration of perfusionist licenses. Proposed § 18.537(a) provides that licensed perfusionists shall register biennially by December 31 of each even-numbered year. Under proposed § 18.537(b), a licensed perfusionist is required to complete and submit an application for biennial registration, including the required fee, disclose a license to practice as a perfusionist in another jurisdiction, disclose a disciplinary action pending before or taken by the appropriate healthcare licensing authority in another state, disclose pending criminal charges and convictions, verify that the licensee has complied with the continuing education requirements, and verify that, if practicing as a perfusionist in this Commonwealth, the licensed perfusionist maintains professional liability insurance coverage as required under section 13.3(k) of the act. Because the ABCP requires a perfusionist to complete a minimum number of procedures each year to maintain certification, the Board has chosen not to require continued National certification as a condition of renewal.
Proposed § 18.538 (relating to inactive status of perfusionist license; reactivation of inactive license) addresses inactive status of perfusionist licenses. Proposed § 18.538(a) provides that the license may become inactive either by the licensee's request or by expiration at the end of the biennial registration period. To minimize the opportunity or consequence of a license being incorrectly placed on inactive status at what appears to be the request of the licensee, proposed § 18.538(a)(1) provides that the Board will forward written confirmation of inactive statues to the licensee. Proposed § 18.538(b) provides that a perfusionist whose license is inactive may not practice as a perfusionist in this Commonwealth until the license has been reactivated. Proposed § 18.538(c) provides the general requirement for reactivation of an inactive perfusionist license that the licensee shall apply on forms supplied by the Board, answer questions fully, provide documentation of completion of the required amount of continuing education for the preceding biennium, as required under section 13.3(n)(5) of the act, pay the current biennial registration fee and the reactivation fee specified in § 16.13(k) and verify that the licensee did not practice as a perfusionist in this Commonwealth while the license was inactive. If the licensee cannot verify that the licensee did not practice during the period of lapse, the license may be reactivated under proposed § 18.538(d). Under that proposed section, in addition to the requirements of subsection (c), the licensee shall pay the biennial registration fee for past registration periods and a late fee of $5 per month. This late fee is the standard late fee of section 225 of the Bureau of Professional and Occupational Affairs Fee Act (63 P. S. § 1401-225). However, as provided in proposed § 18.538(d), payment of late fees will not preclude the Board from taking disciplinary action for practicing while the license was inactive.
Proposed § 18.539 next addresses disciplinary action. Although section 13.3 of the act does not specifically authorize the Board to take disciplinary action against a licensed perfusionist, section 13.3(m) of the act provides that disciplinary action taken by the Board against a perfusionist shall be enforceable by the State Board of Osteopathic Medicine if the perfusionist seeks licensure by that board. Section 41 of the act (63 P. S. § 422.41) authorizes the Board ''to impose disciplinary or corrective measures on a board-regulated practitioner'' for a variety of grounds. Accordingly, proposed § 18.539(a) provides that a licensed perfusionist, including one holding a temporary graduate license or temporary provisional license, is subject to disciplinary action under the grounds of section 41 of the act and that the Board may impose a corrective action in section 42 of the act (63 P. S. § 422.42). Because section 41(8) of the act authorizes the Board to take disciplinary action for immoral or unprofessional conduct, proposed § 18.539(b) defines unprofessional conduct and proposed § 18.539(c) defines immoral conduct. Modeled upon §§ 16.61 and 18.181 (relating to unprofessional and immoral conduct; and disciplinary and corrective measures), unprofessional conduct includes the following: performing acts in a healthcare profession in a fraudulent or incompetent or negligent manner; performing acts in the practice of a healthcare profession in violation of statute or regulation in this Commonwealth or another state; violating a provision of the act or regulation of the Board setting a standard of professional conduct; engaging in healthcare practice beyond the licensee's authority to practice; representing oneself to be a licensed physician or other healthcare provider; practicing while the licensee's ability to do so is impaired by alcohol or drugs or disability; and revealing personally identifiable facts obtained as the result of the practitioner-patient relationship. Immoral conduct includes the following: misrepresenting or concealing a material fact in obtaining a license or reactivating or renewing the biennial registration of the license; being convicted of a crime involving moral turpitude; or committing an act involving moral turpitude or dishonesty or corruption. Additionally, unprofessional conduct includes engaging in conduct prohibited under § 16.110 (relating to sexual misconduct). Section 13.3(e)(2) of the act exempts from the general prohibition against practicing perfusion without a license a perfusion student who, among other requirements, is performing under the direct supervision of a perfusionist who is assigned to supervise the student. Section 13.3(e)(3) of the act exempts a perfusion graduate who, among other requirements, is performing under the supervision and responsibility of a perfusionist. Accordingly, proposed § 18.539(b)(9) includes as unprofessional conduct failing to provide supervision as required under section 13.3(e)(2) of the act of a perfusion student or failing to provide supervision as required under section 13.3(e)(3) of the act of a perfusion graduate who is not otherwise licensed by the Board to practice perfusion.
Section 13.3(n) of the act provides for required continuing education and proposed § 18.540 (relating to continuing education for licensed perfusionists) addresses that topic. Proposed § 18.540(a) sets forth the general credit hour requirements. As required under section 13.3(n)(2) of the act, proposed § 18.540(a)(1) requires each licensed perfusionist to complete at least 30 hours of continuing education—including at least 10 hours in category I continuing education—applicable to the practice of perfusion during each biennial registration period. Consistent with section 13.3(n)(3) of the act, a licensee would not be required to complete continuing education during the biennial registration period in which the licensee was first licensed. Although a licensee would not be permitted to carry over continuing education credit into a subsequent renewal period, proposed § 18.540(a)(2) recognizes that a licensee may need to make up deficient continuing education credit to reactivate an inactive license or if otherwise ordered by the Board. However, a particular hour of continuing education taken in a given biennial registration period may not be used to satisfy the requirement both for that period and to make up a deficiency for a prior period. Proposed § 18.540(a)(3) identifies that a licensee who failed to complete the required continuing education is subject to disciplinary action. Section 13.3(n)(4) of the act permits a licensee to submit a written request for waiver of the continuing education requirement due to serious illness, military service or other demonstrated hardship. Proposed § 18.540(a)(4) requires that the request be submitted at least 90 days before the end of the biennial registration period so that the Board could address the request and, if it is denied, give the licensee adequate opportunity to complete the required continuing education before the end of the period. Additionally, this proposed section explicitly notes that waiver may include extending the deadline, rather than simply relieving the licensee of the obligation to take continuing education. Proposed § 18.540(b) sets forth the standards for documentation of continuing education. Under proposed § 18.540(b)(1), a licensee shall receive a record of completion from the continuing education provider, setting forth the participant's name, the provider's name, the date of the course, the name of the course and the number of hours of continuing education. Proposed § 18.540(b)(2) requires the licensee to retain the record for at least 5 years after completion of the continuing education course or biennial registration period for which the continuing education was required, whichever is later. Because records of continuing education will not be sent to the Board and the Board will not track licensees' completion of required continuing education, the Board will conduct postrenewal audits of licensees to verify compliance. Proposed § 18.540(c) sets forth the types of activities for which continuing education credit may be earned. To better facilitate compliance with the requirements, these standards are modeled upon those of the ABCP. Under proposed § 18.540(c)(1), category I continuing education (which must provide at least 10 of the required 30 hours) could be earned by attendance at perfusion meetings, publication of a perfusion-related book, chapter or paper in a professional journal, presentation at a perfusion meeting, participation in a site visitor workshop or as a site visitor for perfusion program accreditation or completion of an ABCP-approved self-directed continuing education course for which the licensee scores at least 80% on an examination. Under proposed § 18.540(c)(2), other continuing education to reach the required total could be earned by reading journals or other educational materials, participating in electronic forums or journal clubs, participation in degree-oriented professional-related course work, presentation of perfusion topics at a nonperfusion meeting or working as a clinical or didactic instructor in an accredited school of perfusion. However, as noted in section 13.3(n)(6) of the act, proposed § 18.540(c)(3) prohibits continuing education credit for a course in office management.
Section 13.3(k) of the act provides for required professional liability insurance for perfusionists and proposed § 18.541(a) (relating to professional liability insurance coverage for licensed perfusionist) requires a licensed perfusionist to maintain a level of professional liability insurance as required under section 13.3(k) of the act. Conversely, proposed § 18.541(d) prohibits a perfusionist who does not have the required amount of liability insurance from practicing as a perfusionist in this Commonwealth. Section 13.3(k)(2) of the act requires an applicant to provide proof that the applicant has obtained the liability insurance. Proposed § 18.541(b) sets forth the general requirement that proof of liability insurance consists of a certificate of insurance or a copy of the declarations page from the insurance policy setting forth the effective and expiration dates and the dollar amounts of coverage. However, section 13.3(k)(2) of the act permits an applicant to file with the application a letter from an insurance carrier stating that the applicant will be covered in the required amounts effective upon issuance of the license, but the applicant must then submit the certificate of insurance or copy of the declaration page within 30 days after issuance of the license. To effectuate this provision, proposed § 18.541(c) provides that a license issued in reliance upon the insurance carrier's letter will become inactive as a matter of law 30 days after the license is issued if the licensee has not submitted proof of insurance. The license will be inactivated and not suspended, because it is not a disciplinary action, as insurance is required only if practicing as a perfusionist in this Commonwealth.
Fiscal Impact and Paperwork Requirements
The proposed rulemaking will not have adverse fiscal impact on the Commonwealth or its political subdivisions. Perfusionists who wish to become licensed to practice in this Commonwealth will bear the fiscal impact of the proposed rulemaking in the form of required fees and costs associated with obtaining the required continuing education. The Board will be required to develop forms required to implement the proposed rulemaking. The proposed rulemaking will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
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)), on May 11, 2010, 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 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 must specify the regulatory review criteria 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, recommendations or objections raised.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to the Regulatory Unit Counsel, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649, st-medicine@state.pa.us within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference No. 16A-4931 (perfusionist) when submitting comments.
CAROL E. ROSE, M.D.,
ChairpersonFiscal Note: 16A-4931. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE—GENERAL PROVISIONS
Subchapter B. GENERAL LICENSE, CERTIFICATION AND REGISTRATION PROVISIONS § 16.11. Licenses, certificates and registrations.
* * * * * (b) The following nonmedical doctor licenses and certificates are issued by the Board:
* * * * * (6) Perfusionist license.
(c) The following registrations are issued by the Board:
* * * * * (10) Biennial registration of a perfusionist license.
§ 16.13. Licensure, certification, examination and registration fees.
* * * * * (k) Perfusionist license.
Application for perfusionist license $50
Biennial renewal of perfusionist license $50
Application for reactivation of perfusionist license $50
Application for temporary graduate perfusionist license $50
Application for temporary provisional perfusionist license $40
CHAPTER 18. STATE BOARD OF MEDICINE—PRACTITIONERS OTHER THAN MEDICAL DOCTORS (Editor's Note: The following subchapter is new and printed in regular type to enhance readability.)
Subchapter J. PERFUSIONISTS Sec.
18.531. Purpose. 18.532. Definitions. 18.533. Application for perfusionist license. 18.534. Application for temporary graduate perfusionist license. 18.535. Application for temporary provisional perfusionist license. 18.536. Registration of temporary emergency perfusionist service. 18.537. Biennial registration of perfusionist license. 18.538. Inactive status of perfusionist license; reactivation of inactive license. 18.539. Disciplinary action for licensed perfusionists. 18.540. Continuing education for licensed perfusionists. 18.541. Professional liability insurance coverage for licensed perfusionist. § 18.531. Purpose.
This subchapter implements section 13.3 of the act (63 P. S. § 422.13c) pertaining to perfusionists, which was added by the act of June 11, 2008 (P. L. 154, No. 19), effective August 10, 2008.
§ 18.532. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
ABCP—American Board of Cardiovascular Perfusion.
Board—The State Board of Medicine.
Accredited perfusion program approved by the Board—A perfusion program accredited by a Nationally-recognized accrediting agency approved by the Board.
Extracorporeal circulation—As defined in section 2 of the act (63 P. S. § 422.2), the diversion of a patient's blood through a heart-lung machine or similar device that assumes the functions of the patient's heart, lungs, kidneys, liver or other organs.
Hour of continuing education—At least 50 minutes of instruction (including relevant question and answer sessions) in an approved course of continuing education or an equivalent time that an on-line or correspondence course would be presented live.
Nationally-recognized accrediting agency approved by the Board—ABCP, or any other organization for which the Board publishes notice that the organization is approved by the Board as an accrediting agency for perfusionist programs.
Nationally-recognized certifying agency approved by the Board—ABCP, or any other organization for which the Board publishes notice that the organization is approved by the Board as a certifying agency for perfusionists.
Perfusion—As defined in section 2 of the act, the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular system or other organs, or a combination of those functions, and for ensuring the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under the supervision of a physician licensed under the act or the Osteopathic Medical Practice Act (63 P. S. §§ 271.1—271.18).
Perfusionist—As defined in section 2 of the act, an individual who is licensed to practice perfusion by the Board or the State Board of Osteopathic Medicine.
Ventricular assist device—
(i) As defined in section 2 of the act, a mechanical device used to partially or completely replace the function of a failing heart through connections to the heart and great vessels that may be located intracorporeally or extracorporeally.
(ii) The term includes a device that is placed intravascularly or extravascularly and provides support through direct means or via counterpulsation.
§ 18.533. Application for perfusionist license.
(a) An applicant for a license to practice as a perfusionist shall submit, on forms supplied by the Board, a completed application, including all necessary supporting documents, for license to practice as a perfusionist and pay the fee set forth in § 16.13(k) (relating to licensure, certification, examination and registration fees) for application for a perfusionist license.
(b) Except as otherwise provided in subsection (c), the Board will license to practice as a perfusionist an applicant who:
(1) Demonstrates that the applicant satisfies the requirements of section 13.3(f) of the act (63 P. S. § 422.13c(f)) for licensure to practice as a perfusionist, including the following:
(i) The applicant holds a current certification by a certifying agency approved by a Nationally-recognized accrediting agency approved by the Board.
(ii) The applicant has graduated from an accredited perfusion program approved by the Board.
(iii) The applicant is at least 18 years of age and of good moral character.
(2) Provides proof as set forth in § 18.541 (relating to professional liability insurance coverage for licensed perfusionist) that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act.
(3) Otherwise complies with this subchapter.
(c) The Board may deny an application for licensure as a perfusionist upon the grounds for disciplinary action set forth in § 18.539 (relating to disciplinary action for licensed perfusionists).
§ 18.534. Application for temporary graduate perfusionist license.
(a) An applicant for a temporary graduate perfusionist license shall submit, on forms supplied by the Board, a completed application, including all necessary supporting documents, and pay the fee in § 16.13(k) (relating to licensure, certification, examination and registration fees) for application for a temporary graduate perfusionist license.
(b) Except as otherwise provided in subsection (c), the Board will grant a temporary graduate perfusionist license to an applicant who:
(1) Demonstrates that the applicant satisfies the requirements of section 13.3(h)(1)(i) of the act (63 P. S. § 422.13c(h)(1)(i)) for temporary graduate licensure to practice as a perfusionist, including all of the following:
(i) The applicant is qualified and has applied to sit for the examination of a certifying agency approved by a Nationally-recognized accrediting agency approved by the Board.
(ii) The applicant has graduated from an accredited perfusion program approved by the Board.
(iii) The applicant is at least 18 years of age and of good moral character.
(2) Provides proof as set forth in § 18.541 (relating to professional liability insurance coverage for licensed perfusionist) that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act.
(3) Otherwise complies with this subchapter.
(c) The Board may deny an application for a temporary graduate perfusionist license upon the grounds for disciplinary action set forth in § 18.539 (relating to disciplinary action for licensed perfusionists).
(d) A temporary graduate perfusionist license will expire 2 years after the date of issuance and may not be renewed.
(e) A temporary graduate perfusionist license will expire upon notice to the Board that the holder has failed the Nationally-recognized certifying agency's certification examination.
§ 18.535. Application for temporary provisional perfusionist license.
(a) An applicant for a temporary provisional perfusionist license shall submit, on forms supplied by the Board, a completed application, including all necessary supporting documents, and pay the fee in § 16.13(k) (relating to licensure, certification, examination and registration fees) for application for a temporary graduate perfusionist license.
(b) Except as otherwise provided in subsection (c), the Board will grant a temporary provisional perfusionist license to an applicant who:
(1) Demonstrates that the applicant satisfies the requirements of section 13.3(i) of the act (63 P. S. § 422.13c(i)) for temporary provisional licensure to practice as a perfusionist, including the following:
(i) The applicant holds a current license in good standing under the laws of another state, the District of Columbia or a territory of the United States that includes certification by a certifying agency approved by a Nationally-recognized accrediting agency.
(ii) The applicant has graduated from an accredited perfusion program approved by the Board.
(iii) The applicant is at least 18 years of age and of good moral character.
(2) Provides proof as set forth in § 18.541 (relating to professional liability insurance coverage for licensed perfusionist) that the applicant has obtained professional liability insurance as required under section 13.3(k) of the act.
(3) Otherwise complies with this subchapter.
(c) The Board may deny an application for certification as a perfusionist upon the grounds for disciplinary action set forth in § 18.539 (relating to disciplinary action for licensed perfusionists).
(d) A temporary provisional perfusionist license will expire 1 year after the date of issuance and may not be renewed.
§ 18.536. Registration of temporary emergency perfusionist service.
(a) An out-of-State perfusionist shall register with the Board in accordance with this section prior to providing temporary emergency perfusionist service in this Commonwealth in accordance with section 13.3(j) of the act (63 P. S. § 422.13c(j)).
(b) The out-of-State perfusionist or another person acting on behalf of the out-of-State perfusionist shall submit, on forms supplied by the Board, a completed registration form, fully answering all questions.
(c) Although not limited to a single procedure or single patient or group of related patients, an out-of-State perfusionist may provide temporary emergency perfusionist services in this Commonwealth for not longer than a period of 72 hours.
(d) An out-of-State perfusionist may not provide temporary emergency perfusionist service in this Commonwealth more than once without being licensed in accordance with § 18.533, § 18.534 or § 18.535 (relating to application for perfusionist license; application for temporary graduate perfusionist license; and application for temporary provisional perfusionist license).
§ 18.537. Biennial registration of perfusionist license.
(a) A licensed perfusionist shall register biennially by December 31 of each even-numbered year, in accordance with § 16.15 (relating to biennial registration; inactive status and unregistered status).
(b) A licensee applying for biennial registration of a perfusionist license shall submit a completed application, including payment of the biennial registration fee set forth in § 16.13(k) (relating to licensure, certification, examination and registration fees) for application for biennial registration of perfusionist license. On the biennial registration application, the licensed perfusionist shall:
(1) Disclose any license to practice as a perfusionist in another state, territory, possession, or country.
(2) Disclose any disciplinary action pending before or taken by the appropriate healthcare licensing authority in any other jurisdiction since the most recent application for biennial registration, whether or not licensed to practice in that other jurisdiction.
(3) Disclose any pending criminal charges and any finding or verdict of guilt, admission of guilt, plea of nolo contendere, probation without verdict, disposition in lieu of trail or accelerated rehabilitative disposition in any criminal matter since the most recent application for biennial registration.
(4) Verify that the licensed perfusionist has complied with the continuing education requirements mandated under section 13.3(n) of the act (63 P. S. § 422.13c(n)) during the biennial period immediately preceding the period for which registration is sought in accordance with § 18.540 (relating to continuing education for licensed perfusionists).
(5) Verify that, if practicing as a perfusionist in this Commonwealth, the licensee maintains professional liability insurance coverage in accordance with section 13.3(k) of the act.
§ 18.538. Inactive status of perfusionist license; reactivation of inactive license.
(a) A perfusionist license will become inactive upon either of the following:
(1) The licensee requests in writing the Board to place the license on inactive status. Written confirmation of inactive status will be forwarded to the licensee.
(2) The licensee fails to register the license by the expiration of the biennial registration period, that is, by December 31 of each even-numbered year.
(b) A perfusionist whose license has expired or been placed on inactive status may not practice as a perfusionist in this Commonwealth until the license has been reactivated.
(c) To reactivate an inactive license, the licensee shall apply on forms supplied by the Board, answering all questions fully. The licensee shall:
(1) Include the documentation required under § 18.540(b) (relating to continuing education for licensed perfusionists) for the immediately preceding biennium, which may be completed during the current biennium. Unless waived by the Board under section 13.3(n)(4) of the act (63 P. S. § 422.13c(n)(4)), the Board will not reactivate any license until the required continuing education for the preceding biennium has been successfully completed.
(2) Pay the current biennial registration fee and the reactivation application fee specified in § 16.13(k) (relating to licensure, certification, examination and registration fees).
(3) Except as provided in subsection (d), verify that the licensee did not practice as a perfusionist in this Commonwealth while the license was inactive.
(d) A licensee who has practiced with an inactive license, and who cannot make the verification required by subsection (c)(3) shall also pay the fees required by this subsection. Payment of a late fee does not preclude the Board from taking disciplinary action for practicing as a perfusionist without a currently registered license.
(1) A licensee whose license was active at the end of the immediately preceding biennial registration period and who practiced after the license became inactive shall pay a late fee of $5 for each month or part of a month from the beginning of the current biennium until the date the reactivation application is filed.
(2) A licensee whose license has been inactive since before the beginning of the current biennium shall pay the biennial registration fee for each biennial registration period during which the licensee practiced and shall pay a late fee of $5 for each month or part of a month from the first date the licensee practiced as a perfusionist in this Commonwealth after the license became inactive until the date the reactivation application is filed.
§ 18.539. Disciplinary action for licensed perfusionists.
(a) A licensed perfusionist, including a perfusionist holding a temporary graduate license or a temporary provisional license, is subject to disciplinary action under the grounds of section 41 of the act (63 P. S. § 422.41). Following a final determination subject to the right of notice, hearing and adjudication and the right of appeal therefrom in accordance with 2 Pa.C.S. (relating to administrative law and procedure), the Board may impose any of the corrective actions of section 42 of the act (63 P. S. § 422.42).
(b) Unprofessional conduct includes:
(1) Engaging in any conduct prohibited under § 16.110 (relating to sexual misconduct).
(2) Performing acts in a healthcare profession in a fraudulent, incompetent or negligent manner.
(3) Performing acts in the practice of a healthcare profession in violation of a statute or regulation of the Commonwealth, another state of the United States, or another country.
(4) Violating a provision of the act or this chapter setting a standard of professional conduct.
(5) Engaging in healthcare practice beyond the licensee's authority to practice.
(6) Representing oneself to be a physician, physician assistant, certified registered nurse practitioner or other healthcare practitioner whose profession the perfusionist is not licensed to practice.
(7) Practicing while the licensee's ability to do so is impaired by alcohol, drugs, physical disability or mental instability.
(8) Revealing personally identifiable facts obtained as the result of a practitioner-patient relationship without the prior consent of the patient, except as authorized or required by statute or regulation.
(9) Failing to provide supervision as required under section 13.3(e)(2) of the act (63 P. S. § 422.13c(e)(2)) of a perfusion student or failing to provide supervision as required under section 13.3(e)(3) of the act of a perfusion graduate who is not otherwise licensed by the Board to perform perfusion in this Commonwealth.
(c) Immoral conduct includes:
(1) Misrepresenting or concealing a material fact in obtaining a license issued by the Board or renewal, reactivation or reinstatement thereof.
(2) Being convicted of a crime involving moral turpitude, dishonesty or corruption in the courts of the Commonwealth, the United States, or another state, territory or county.
(3) Committing an act involving moral turpitude, dishonesty or corruption.
§ 18.540. Continuing education for licensed perfusionists.
(a) Credit hour requirements. A licensed perfusionist shall satisfy the following continuing education credit hour requirements.
(1) During each biennial registration period, a licensee shall complete 30 hours of continuing education applicable to the practice of perfusion, including at least 10 hours of category I continuing education. A licensee is not required to complete continuing education during the biennium in which the licensee was first licensed.
(2) Except as permitted in § 18.538(c)(1) (relating to inactive status of perfusionist license; reactivation of inactive license), paragraph (4), or as directed by the Board, continuing education may satisfy the requirement of paragraph (1) only for the biennium during which it was completed. No hour of continuing education may be used to satisfy the requirement of paragraph (1) for more than one biennium.
(3) Unless otherwise excused by the act or this subchapter, failure to complete the minimum required amount of continuing education during the applicable biennial registration period as required under section 13.3(n) of the act (63 P. S. § 422.13c(n)) and this section will subject the licensee to discipline under section 41(6) of the act (63 P. S. § 422.41(6)).
(4) A licensee seeking waiver of the continuing education requirements under section 13.3(n)(4) of the act shall submit the request with all supporting documentation to the Board at least 90 days prior to the end of the biennial registration period for which waiver is sought. Waiver may include extending the deadline by which the required continuing education must be completed.
(b) Documentation of continuing education. Continuing education shall be documented in the following manner.
(1) Proof of completion of continuing education must consist of a certified record issued by the provider, including:
(i) The name of the participant.
(ii) The name of the provider.
(iii) The date or dates of the course.
(iv) The name of the course.
(v) The number of hours of continuing education credit.
(2) A licensee shall retain proof of completion of continuing education for 5 years after completion of the continuing education or after the completion of the biennial registration period for which the continuing education was required, whichever is later.
(3) The Board will audit licensees to verify compliance with continuing education requirements.
(c) Continuing education activities. Credit for continuing education may be earned in the following activities.
(1) Category I continuing education may be earned by:
(i) Attendance at an international, National, regional or state perfusion meeting.
(ii) Publication of a perfusion-related book, chapter or paper in a professional journal.
(iii) Presentation at an international, National, regional, state or local perfusion meeting.
(iv) Participation in a site visitors workshop or as a site visitor for perfusion program accreditation.
(v) Completion of ABCP-approved self-directed continuing education for which the licensee scored at least 80% on an examination.
(2) In addition to category I, continuing education may also be earning by:
(i) Reading or viewing medical journals, audio-visual, or other educational materials.
(ii) Participation in electronic forums.
(iii) Participation in a journal club.
(iv) Participation in degree-oriented, professionally-related course work.
(v) Presentation of perfusion topic at a nonperfusion meeting.
(vi) Working as a clinical or didactic instructor in an accredited school of perfusion.
(3) Continuing education credit may not be earned in any course in office management.
§ 18.541. Professional liability insurance coverage for licensed perfusionist.
(a) A licensed perfusionist shall maintain a level of professional liability insurance coverage as required under section 13.3(k) of the act (63 P. S. § 422.13c(k)).
(b) Proof of professional liability insurance coverage shall consist of a certificate of insurance or copy of the declaration page from the insurance policy setting forth the effective date, expiration date, and dollar amounts of coverage.
(c) A license that was issued in reliance upon a letter from the applicant's insurance carrier indicating that the applicant will be covered against professional liability effective upon the issuance of the applicant's license as permitted under section 13.3(k)(2) of the act will become inactive as a matter of law 30 days after the date of issuance on the license if the licensee has not provided proof of professional liability insurance coverage and will remain inactive until the licensee provides proof of insurance coverage.
(d) A licensee who does not have professional liability insurance coverage as required under section 13.3(k) of the act may not practice as a perfusionist in this Commonwealth.
[Pa.B. Doc. No. 10-938. Filed for public inspection May 21, 2010, 9:00 a.m.]
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