Specific reasons underlying the finding of necessity:
The proposed amendments to the Regulations of the Commissioner of Education are necessary to establish a process and standards for the approval of international medical schools to place students in long-term clinical clerkships in New York.
Emergency action is necessary for the preservation of the public health and general welfare in order to enable the Advisory Committee on Long-Term Clinical Clerkships to evaluate pending applications by international medical schools to place students in long-term clinical clerkships in New York State in a timely manner. Such applications have been on hold pending a review of the process and standards used to approve such applications, and it is now necessary to formally approve the new process and standards, which are designed both to protect the health and safety of patients in the facilities in which the clinical clerkships will be conducted and to assure that the students in the international medical schools placing students in such clerkships are receiving an appropriate medical education before and during their participation in such clerkships.
It is anticipated that the proposed amendment will be presented for adoption as a permanent rule at the June 2012 Regents meeting, after publication in the State Register and expiration of the 45-day public comment period on proposed rule makings required by the State Administrative Procedure Act.
Subject:
Establish the approval standards and procedures for international medical schools.
Purpose:
Establish the approval standards and procedures for international medical schools to place students in long term clerkships in NY.
Substance of emergency/proposed rule (Full text is posted at the following State website:www.op.nysed.gov):
The Commissioner of Education proposes to add a new section, 60.10, related to the standards and process for the approval of international medical schools to place students in long-term clinical clerkships in New York State. The following is a summary of the substance of the regulations:
(a) General requirements. To meet the requirements for approval to place students in long-term clinical clerkships in New York State, an international medical school shall meet the requirements in this section.
(b) Duration of approval. Initial and subsequent approvals of a school shall be for a term of 7 years unless otherwise limited to a lesser period for good cause, and such approvals may be subject to certain limitations and restrictions as determined by the Board of Regents. The term of approval may be extended by the Board of Regents on one or more occasions for a period not to exceed 12 months on each occasion for good cause.
(c) Approval standards. In addition to any applicable requirements in section 60.2 of this Part, in order to be approved to place students in long-term clinical clerkships in New York State, the institution shall meet the following requirements:
(1) Recognition by appropriate authorities of country. The international medical school shall be recognized by the appropriate civil authorities of the country in which the school is located as an acceptable educational program for physicians, and graduates of the program shall be eligible to pursue licensure or other authorization to practice medicine in such country.
(2) Institutional mission and objective.
(i) The medical school shall be organized and have in place a planning process that sets forth the responsibilities of all sectors of the school community and that sets the direction for its program and results in measurable outcomes.
(ii) The medical school shall have in place a system with central oversight to define the objectives of its program in outcome-based terms that facilitate assessment of student progress in developing essential physician competencies.
(3) Faculty. The medical school shall have a sufficient number of appropriately qualified faculty members to meet the needs and missions of the program.
(4) Curriculum.
(i) The medical education program shall provide at least 130 weeks of instruction, and the curriculum of the medical school shall provide a general professional education and prepare medical students for entry into graduate medical education in any discipline.
(ii) The curriculum of the medical school shall incorporate the fundamental principles of medicine and its underlying scientific concepts; promote the development of skills of critical judgment based on evidence and experience; and develop medical students' abilities to use such principles and skills in solving problems of health and disease.
(iii) The medical school curriculum shall include didactic and clinical instruction necessary for students to become competent practitioners of contemporary medicine, including communication skills as they relate to physician responsibilities.
(iv) The medical school curriculum shall include clinical experience in a broad cross-section of areas, including, but not limited to, primary care.
(v) The medical school shall provide instruction in medical ethics and human values, including, but not limited to, ethical principles in caring for patients and in relating to patients' families and to others involved in patient care.
(vi) The medical school shall demonstrate that there is integrated institutional responsibility for the overall design, management, and evaluation of a coherent and coordinated curriculum.
(vii) The medical school shall demonstrate that it provides comparable educational experiences and equivalent methods of assessment across all instructional sites within a given discipline.
(5) Assessment of student performance. The medical school shall have a system in place for the effective assessment of medical student performance throughout the program.
6) Administration.
(i) Responsibilities.
(a) The chief academic officer of the medical school shall be responsible for the conduct and quality of the educational program and for ensuring the adequacy of resources, including faculty, at all instructional sites, and shall be given explicit authority to facilitate change in the medical program and to otherwise carry out his or her responsibilities for management and evaluation of the curriculum.
(b) The medical school shall collect and use a variety of outcome data, including accepted norms of accomplishment, to demonstrate the extent to which its educational objectives are being met, and shall engage in an ongoing systematic process to assess student achievement, program effectiveness, and opportunities for improvement.
(c) At least every other year, the medical school shall publish, either in print or online, information on policies and procedures on academic standards, grading, attendance, tuition and fees, refund policy, student promotion, retention, graduation, academic freedom, students' rights and responsibilities.
(d) The medical school shall provide clinical clerkships in accordance with affiliation agreements that define the responsibilities of each party related to the educational program for medical students and section 60.2(d) of this Part. Such clerkships shall be conducted at health care settings in which there is appropriate oversight and supervision. The medical school shall inform the Department of the clinical facilities with which it has affiliation agreements and of anticipated changes in its affiliation agreements or the affiliation status the clinical facilities.
(ii) The chief official of the medical school and the other members of the school administration shall be qualified by education and experience to provide leadership in medical education, scholarly activity, and patient care and shall have a sufficient number of appropriately qualified administrators.
(7) The medical school shall develop criteria, policies, and procedures for the selection of medical students that are readily available to potential and current applicants and their collegiate advisors.
(8) The medical school shall have an effective system of academic advising and personal and career counseling for medical students that integrates the efforts of faculty members, course directors, and student affairs officers with its counseling and tutorial services.
(9) (i) The medical school shall establish, and make available to all sectors of the school community, policies regarding the standards of conduct for the faculty-student relationship, the standards and procedures for the assessment, advancement, and graduation of its medical students, and the standards and procedures for disciplinary action.
(ii) Medical student educational records shall be confidential and shall be maintained in a manner that will ensure confidentiality as well as the accuracy of such records. A medical student enrolled in the medical school shall be allowed to review the content and challenge information contained in his or her records if he or she considers the information contained therein to be inaccurate, misleading, or inappropriate.
(10) Resources. The medical school shall have sufficient resources to achieve its educational and other goals.
(d) Procedures for approval.
(1) Application.
(i) In order to obtain approval by the Board of Regents to place students in long-term clinical clerkships in New York State, an international medical school shall submit an application, on a form prescribed by the Department. Applications shall remain in active status for three years from the date of receipt of such application.
(ii) Self-study. A school shall be required to conduct and submit with its application for approval a self-study, substantiating compliance with the standards for approval set forth in this section and plans for improvements pertinent to such standards.
(2) Site visit.
(i) When the Advisory Committee has made a preliminary determination that the application has adequately addressed the standards for approval set forth in this section, a site visit will be scheduled, and the Advisory Committee will designate a site visit team of no less than three members, selected from a list of qualified medical education program evaluators developed and maintained by the Department.
(ii) During the site visit, the medical school and its program will be reviewed to verify, clarify and update the representations contained within the application and any supporting documents. The medical school will bear the burden of demonstrating satisfactory compliance with the approval standards set forth in this section.
(3) Site visit report and recommendation. The site visit team shall prepare a site visit report and recommendation and provide a copy to the medical school prior to review by the Advisory Committee. The school shall be provided with an opportunity to respond to such report and recommendation.
(4) Advisory Committee.
(i) The Advisory Committee shall review the site review team's report and recommendation and any written submission by the school and the record upon which the site review team made its recommendation, including, but not limited to, the institution's self-study, the institution's application for approval, and any additional documentation submitted by the institution in support of the application. The Advisory Committee shall base its determination only upon the record before it.
(ii) Upon completion of its review, the Advisory Committee shall forward a report and recommendation to the Board of Regents. The report shall include a recommendation to approve or deny the authority of the school to place students in long-term clinical clerkships in New York State and provide the rationale for the recommendation, reflecting majority and minority opinions.
(6) Board of Regents.
(i) The Board of Regents may review:
(a) the report and recommendation of the Advisory Committee;
(b) the record upon which the Advisory Committee made its recommendation, including, but not limited to, the site visit report and recommendation, the self study, the school's application for approval, and any additional documentation submitted by the institution in support of the application;
(c) any response submitted by the school to the report and recommendation of the Advisory Committee, provided that such submission shall be limited to a discussion of the documentary material already submitted and shall not contain new documentary material.
(ii) Based on the record described in subparagraph (i) of this paragraph, the Board of Regents will make a final determination on the application.
(e) Annual Report. No later than September 30 of each year, an international medical school that has been approved to place its students in long-term clinical clerkships in New York shall submit an annual report in a form prescribed by the Department.
(f) Revocation of approval or placement in probationary status. Upon a finding of substantial non-compliance with the approval standards set forth in this section, the Department or Advisory Committee may at any time during the approval period recommend to the Board of Regents that the approval be revoked or that the school be placed in probationary status in accordance with the following procedure:
(1) The Department or the Advisory Committee shall provide written notice to the school of its recommendation to revoke the school's approval or place the school in probationary status and the reasons therefore.
(2) The school may reply to such notification within 30 days.
(3) If a reply is received, such reply and the Department's or Advisory Committee's recommendation shall be forwarded to the Board of Regents for action thereon. Based on such recommendation and/or reply, the Board of Regents may:
(i) revoke the school's approval, subject to any conditions set by the Board of Regents;
(ii) continue its approval;
(iii) modify the time period for approval; and/or
(iv) place the school in probationary status.
(4) For purposes of this section, placement in probationary status shall mean the continued approval of the school by the Board of Regents for a specified period of time and subject to certain limitations, restrictions and/or remediation action as prescribed by the Board of Regents.
(g) Reporting requirements.
(1) The institution and /or school shall submit any reports requested by the Department, the Advisory Committee and/or the Board of Regents.
(2) The institution and/or school shall notify the Department of any denial, withdrawal, suspension, revocation, or termination of recognition, approval, accreditation or any other adverse action by any other body against the institution and/or school within 72 hours after receiving official notification of that action by providing to the Department a copy of such action.
This notice is intended:
to serve as both a notice of emergency adoption and a notice of proposed rule making. The emergency rule will expire July 22, 2012.
Text of rule and any required statements and analyses may be obtained from:
Mary Gammon, NYS Education Department, Office of Counsel, 89 Washington Avenue, Room 138, Albany, NY 12234, (518) 473-2183, email: mgammon@mail.nysed.gov
Data, views or arguments may be submitted to:
Douglas E. Lentivech, New York State Education Department, 89 Washington Avenue, 2nd Floor, Albany, New York 12234, (518) 474-3817, email: www.op.nysed.gov
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
1. STATUTORY AUTHORITY:
Section 207 of the Education Law grants general rule making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.
Section 6501 of the Education Law provides that, to qualify for admission to a profession, an applicant must meet requirements prescribed in the article of the Education Law that pertains to the particular profession.
Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.
Subdivision (1) of section 6506 of the Education Law authorizes the Board of Regents to promulgate rules relating to the professions.
Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations relating to the professions.
Subdivision (1) of section 6508 of the Education Law authorizes the state boards for the professions to assist the Regents and the Department in matters of professional licensure and practice.
2. LEGISLATIVE OBJECTIVES:
The proposed amendment establishes the standards for the approval of international medical schools to place students in long-term clinical clerkships in New York. The standards require that the school be recognized by the appropriate civil authorities in the country in which it is located as an acceptable education program for physicians in that country. In addition, the school must have in place institutional policies and leadership to prepare students effectively for the practice of medicine and must have sufficient resources to achieve its goals. The school must provide at least 130 weeks of instruction, and the curriculum must incorporate the fundamental principles of medicine, promote the development of skills of critical judgment, and develop the ability of students to use such principles and skills effectively. The proposed regulation requires schools to provide clinical, as well as didactic instruction, and the clinical experiences must provide for students to undertake appropriate and progressive responsibilities. To be approved, a school must also provide instruction in ethics and human values and must have in place systems for the effective assessment of student achievement. The school must also have a sufficient number of qualified faculty members and provide appropriate assessment and development opportunities for them. With regard to clinical clerkships, the school must have affiliation agreements with the facilities providing such clerkships, and the clerkships must be provided at facilities where there is appropriate oversight and supervision. The medical school is required to inform the Department of the facilities with which it has affiliation agreements and of anticipated changes in its agreements.
The proposed amendment also establishes the application and approval process for these schools. Schools seeking approval would be required to submit to the Department an application, on a form prescribed by the Commissioner, which shall include a self-study. Once a determination is made that the application adequately addresses the approval standards, a site visit would be conducted. The school would be provided with a copy of the site visit report and have an opportunity to respond. The Advisory Committee would then make findings with respect to compliance with the approval standards and submit a report and recommendation to the Board of Regents. The report shall include a recommendation to approve or deny the application and provide the rationale for the recommendation, reflecting majority and minority opinions. The Board of Regents would then make a final determination on the application. Any approvals may be subject to certain limitations and restrictions imposed by the Board of Regents.
Schools would be required to submit an annual report. Upon receipt of the annual report, if the Advisory Committee determines that there has been a substantial change in the approved medical program that is not in compliance with the approval standards set forth in this section, the Advisory Committee may recommend corrective action which may include a site visit, additional reporting requirements, submission of a new application and/or self-study, or revocation by the Board of Regents or placement in probationary status.
The proposed amendment would also authorize the Advisory Committee or the Department to recommend to the Board of Regents at any time the revocation of a medical school's approval to place students in New York clinical clerkships and/or placement of the medical school in probationary status and establishes procedures for such actions.
3. NEEDS AND BENEFITS:
Between November 2010 and January 2011, the Professional Practice Committee of the Board of Regents engaged in discussions with Department staff and the Chair of the New York State Board for Medicine regarding the oversight of dual-campus international medical schools that seek authorization to place students in long-term clinical clerkships in NYS hospitals. The discussions with the PPC incorporated input from the Study Group on International Medical Schools which included representation from a broad spectrum of the medical education and hospital services communities, including representatives from the affected schools. After consideration of certain changes that had taken place in the provision of medical education, the Board of Regents concluded that it was time to review the applicable regulations and policies governing the standards for placement of international medical students in long term clerkships in New York State. Accordingly, the Board of Regents established an Advisory Committee to provide advice on matters related to the evaluation and approval of dual-campus international medical schools seeking authorization to place students in long-term clinical clerkships in New York State. The plan approved by the PPC at it meeting in February 2011 specifically provided for the Advisory Committee to examine the standards and processes for such evaluations and approvals. The proposed addition of section 60.10 reflects the approval standards and procedures recommended by the Committee.
4. COSTS:
(a) Costs to State government: There are no additional costs to the government. Any costs related to the conduct of site visits will be borne by the medical school seeking authorization to place students in long-term clinical clerkships.
(b) Cost to local government: The proposed amendment establishes the standards and process for approval of international medical schools that seek authorization to place students in long-term clinical clerkships. Local governments play no role in the process of evaluating international medical schools. As such, there will be no cost to local government.
(c) Cost to private regulated parties: The proposed regulation will not impose any new costs on applicants for approval to place students in long-term clinical clerkships. Such applicants will continue to pay for the costs of site visits, as they have under previous regulations.
(d) Cost to the regulatory agency: See Cost to State Government above.
5. LOCAL GOVERNMENT MANDATES:
The proposed amendments to the Rules and the Regulations are applicable to international medical schools only and do not impose any program, service, duty or responsibility upon local governments.
6. PAPERWORK:
The school will be required to submit an application, a self-study and will be required to notify the Department of any denial, withdrawal, suspension, revocation, or termination of recognition, approval, accreditation or any other adverse action by any other body against the institution and/or school within 72 hours after receiving official notification of that action by providing to the Department a copy of such action. The school will also be required to submit such other reports as may be requested by the State Education Department, the Advisory Committee, and/or the Board of Regents.
7. DUPLICATION:
The proposed amendments to the Rules and the Regulations do not duplicate other existing State or Federal requirements.
8. ALTERNATIVES:
The proposed amendments to the Rules and the Regulations are necessary to update the standards and process for the approval of international medical schools to place students in long-term clinical clerkships in New York State. Because changes in foreign medical education and the availability of limited resources make continuation of the existing process problematic, there are no viable alternatives to the proposed amendments.
9. FEDERAL STANDARDS:
There are no Federal standards applicable to approval of international medical schools to place students in long-term clinical clerkships.
10. COMPLIANCE SCHEDULE:
Compliance with the standards and processes included in the amendment will be required immediately upon adoption.
Regulatory Flexibility Analysis
The purpose of the proposed amendment is to establish the standards and process for approval of international medical schools that seek approval to place students in long-term clinical clerkships in New York State hospitals.
The amendments are applicable to international medical schools only. Small businesses and local governments will not be impacted by the proposed amendment. Accordingly, no further steps were needed to ascertain the impact on small businesses and local governments.
Rural Area Flexibility Analysis
1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:
The purpose of the proposed amendment is to establish the standards and the procedures for the evaluation of international medical schools that seek authorization to place students in long-term clinical clerkships in New York State.
These amendments will not be applicable to any New York State medical schools, including any that provide services in the 44 rural counties with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less.
2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:
The school will be required to submit an application and a self-study and to notify the Department of any denial, withdrawal, suspension, revocation, or termination of recognition, approval, accreditation or any other adverse action by any other body against the institution and/or school within 72 hours after receiving official notification of that action by providing to the Department a copy of such action. The school will also be required to submit such other reports as may be requested by the State Education Department, the Advisory Committee, and/or the Board of Regents.
3. COSTS:
The proposed amendment does not impose any costs on individuals or entities located in rural areas.
4. MINIMIZING ADVERSE IMPACT:
The proposed amendments are intended to ensure competent medical education for international medical students undertaking clinical training in New York State and thereby protect the health of the public. Due to the nature of the proposed amendment, there would be no reason to establish different requirements for institutions located in rural areas in New York, if there were any.
5. RURAL AREA PARTICIPATION:
Comments on the development of the proposed amendment were solicited from the State Board for Medicine and from statewide professional associations, hospital organizations and medical schools, who collectively represent or include individuals and entities located in rural areas.
Job Impact Statement
The purpose of the proposed amendment is to establish the standards and procedures for the evaluation of international medical schools that seek authorization to place students in long-term clinical clerkships in New York State.
Because it is evident from the nature of the proposed amendment that there will be no impact on jobs or employment opportunities, no further steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.
