Standards initially adopted 1980; revised 1989, 1994 adopted by the:

Commission on Accreditation of Allied Health Education Programs
American Association for Thoracic Surgery
American Board of Cardiovascular Perfusion
American Medical Association
American Society of Extra-Corporeal Technology
Perfusion Program Directors' Council
Society of Cardiovascular Anesthesiologists
Society of Thoracic Surgeons

Standards are the minimum standards of quality used in accrediting programs that prepare individuals to enter the perfusion profession. The extent to which a program complies with these standards determines its accreditation status; the Standards, therefore, are printed in regular typeface in outline form.

Guidelines provide examples intended to assist in interpreting the Standards. Guidelines are indented and printed in italic typeface in narrative form.

Preamble

Objective

These standards are to be used for the development and self-evaluation of educational programs. On-site review teams assist in the evaluation of the program's compliance with the Standards. Lists of accredited programs are published for the information of prospective students, for employers and the public.

Description of the Profession

The perfusionist is educated to conduct extracorporeal circulation and to ensure the safe management of physiologic functions by monitoring and adjusting the necessary variables. Furthermore, the perfusionist is trained/educated in the administration, on prescription and/or according to approved protocol, of blood products, anesthetic agents and drugs through the extracorporeal circuit. The perfusionist is knowledgeable and competent in the use of a variety of techniques such as hypothermia and hemodilution. Perfusion (extracorporeal circulation) procedures involve specialized instrumentation and/or advanced life support techniques and may include a variety of related functions.

SECTION I: REQUIREMENTS FOR ACCREDITATION

1. The sponsoring institution and affiliates, if any, must be accredited by recognized agencies or meet equivalent standards.

   Hospitals involved in an educational program must maintain current accreditation through the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or maintain equivalent standards. Hospitals without JCAHO accreditation will be considered individually.

   Institutional accreditation establishes evidence that the program sponsor meets recognized professional standards for its primary mission. This same evidence should also be the basis for determining whether an institution meets equivalent standards.

   Sponsoring institutions utilizing affiliate clinical settings are expected to ensure that these health care facilities are appropriately accredited.

2. Educational programs may be established in:
   1. Senior colleges and universities
   2. Hospitals
   3. Medical schools

   A consortium of any or several of the aforementioned facilities may constitute an appropriate sponsor.

3. Sponsoring institutions must be authorized under applicable law or other acceptable authority to provide a program of postsecondary education.

   Programs should be established in institutions authorized to grant academic credit.

4. In programs in which academic and clinical didactic and supervised practice are provided by two or more institutions, responsibilities for program administration, instruction, supervision and other functions of the sponsoring institutions and of each affiliate must be clearly documented as a formal affiliation agreement or memorandum of understanding.

   The written affiliation agreement, signed by the appropriate officers, should include a clear delineation of responsibilities with regard to program administration, instruction, student supervision, evaluation, liability and appropriate financial arrangements. This agreement should include a termination clause with sufficient notice to protect enrolled students and ensure an orderly revision of the educational program. Affiliation agreements should be periodically reviewed and revised as necessary. Each institution should maintain a copy of the affiliation agreement.

5. The sponsoring institution assumes primary responsibility for student admission, curriculum planning, selection of course content, coordination of classroom teaching and supervised clinical practice, appointment of faculty, receiving and processing applications for admission and granting the certificate or degree documenting satisfactory completion of the educational program. The sponsoring institution shall also be responsible for providing assurance that the practice activities assigned to students in a clinical setting are appropriate to the educational goals.

6. Clinical settings shall be recognized by the Accreditation Committee - Perfusion Education.

   Clinical sites should have adequate numbers and varieties of cases to meet the objective of the clinical experience. Perfusion staff should be adequate to provide clinical education without compromising the delivery of patient care.

1. General Resources

   Resources must be adequate to support the number of students admitted to the program. The instructor/student ratio shall be adequate to achieve the stated objectives of the curriculum.

2. Personnel
   1. Program Officials

      Job descriptions shall be available for each position.

      (1) Program Director

      (a) Responsibilities

      The director shall be responsible for the organization, administration, periodic review, continued development and general effectiveness of the program. The director shall be responsible for evaluating and assuring clinical education effectiveness including a schedule of regular contact with the clinical affiliates. Documentation of all visits shall be maintained. The clinical assignment of the director must allow adequate time for administrative and teaching responsibilities.

      Contact with clinical affiliates may include, but is not limited to, clinical visits, teleconferences and direct written correspondence.

      (b) Qualifications

      Must possess a baccalaureate degree or suitable educational equivalent, with a minimum of three years of professional experience as a perfusionist.

      Shall possess proficiency in instructional methodology, curriculum design, program planning and counseling, and participate in appropriate continuing education.

      Should have at least two years' experience as an instructor at an accredited educational program in perfusion.

      It is desirable that the director hold an advanced degree.

      (2) Medical Advisor

      (a) Responsibilities
      The medical advisor participates in planning, organizing, conducting, revising and evaluating the perfusion education program.

      (b) Qualifications
      The medical advisor of the program shall be a currently licensed physician credentialed in an appropriate medical specialty.

      The medical advisor should be board-certified or eligible for certification in thoracic surgery or anesthesiology.

   2. Clinical Perfusion Faculty

      At least one clinical instructor shall be designated at each clinical setting.

      (1) Responsibilities

      The clinical instructor(s) shall be knowledgeable of the program goals, clinical objectives and clinical evaluation system. The clinical instructor(s) shall provide students with appropriate and adequate clinical instruction/supervision and shall evaluate student clinical competence.

      During clinical instruction in which the student is operating extracorporeal circulation equipment, there must be direct one-to-one supervision by a clinical instructor. The instructor and physician in charge of the procedure shall be responsible for patient safety.

      The clinical instructor(s) shall maintain competency in perfusion, instructional and evaluative techniques through continuing professional development.

      A position description for the clinical instructor(s) shall specify the tasks related to these responsibilities. Sufficient time for accomplishing the clinical objectives shall be provided. The clinical instructor(s) shall communicate regularly with the program officials.

      (2) Qualifications

      (a) A clinical instructor must be knowledgeable and effective in teaching the subjects assigned.

      (b) To supervise students operating extracorporeal circulation equipment, the clinical instructor must be certified.

      (c) Certification by the American Board of Cardiovascular Perfusion, or equivalent agency, satisfies the certification requirement.

   3. Didactic Faculty

      (1) Responsibilities

      Didactic faculty shall be responsible for submitting for each course assigned by the program director, evaluating students and reporting progress, as required by the sponsoring institution, and cooperating with the program director in periodic review and revision of course materials. Didactic faculty shall maintain appropriate expertise and competencies through continuing professional development.

      (2) Qualifications

      Didactic faculty must be individually qualified and must be effective in teaching the subject(s) assigned and must meet the standards defined by the sponsoring institution.

   4. Support Staff

      Adequate clerical and support staff must be available.

3. Administration
   1. Financial Resources

      Financial resources for continued operation of the educational program and for continuing education of the faculty must be assured.

      The program director and faculty should take part in preparing annual budgets for the operation of the program. Records of expenses and budgetary allocations should be maintained in accordance with good bookkeeping practice and kept as per usual statute of limitations.

   2. Professional Development/Continuing Education

      The program must have a policy that requires professional development/continuing education in appropriate subject areas for instructional staff and assures ongoing instruction in teaching and evaluation techniques.

      Professional development/continuing education policies should apply to both didactic and clinical faculty.

   3. Physical Resources

      (1) General

      Adequate classrooms, laboratories, administrative offices and other facilities shall be provided. All affiliated institutions shall provide adequate and appropriate space to assure achievement of program goals and educational objectives.

      The instructional facilities should be compatible with the instructional strategies employed by the program and aid the achievement of program goals and curricular objectives. The facilities provided for instruction are one measure of institutional commitment to the program and the achievement of its goals.

      Laboratory equipment should aid and support development of clinical competencies. The objectives and evaluation methods for the use of this equipment should be made available to the students. Laboratory experiences should be supervised.

      Offices for administrative and instructional staff should be reasonably accessible and suitably private to be conducive to planning, research, evaluation and counseling activities. Security for student records, instructional materials and other appropriate program-related materials should be provided.

      (2) Clinical Settings

      Appropriate facilities for supervised clinical education shall be available. The sponsoring institution shall assure that clinical settings include operating facilities to achieve the curriculum requirement for clinical experience.

      Characteristics of clinical settings shall be reviewed by the AC-PE to ensure that they meet the criteria to provide appropriate clinical education opportunities. Clinical settings require AC-PE recognition.

      (3) Equipment and Supplies

      Appropriate modern equipment and supplies, with adequate storage space, shall be provided in sufficient quantities to meet both didactic and supervised clinical education objectives.

      Both didactic educational and clinical activities should have appropriate modern equipment suitable for concurrent operation. It is not necessary to duplicate all equipment; however, classes or laboratory experiences should not be canceled due to equipment or space needs for clinical or other activities.

   4. Learning Resources

      (1) Library

      A library shall be readily accessible and contain up-to-date books, periodicals and other reference materials that are comprehensive to the fields of perfusion, medicine and allied health.

      The library should be available to students during usual operating hours, weekends and evenings. Perfusion textbooks should be acquired as they become available. Thoracic surgery, hematology, anesthesiology, cardiology, blood component therapy and perfusion technology periodicals should be a part of the library holdings. The library and/or the program budget should be adequate for the prompt acquisition of new textbooks and periodicals.

      (2) Instructional Aids

      Instructional aids such as clinical materials, computers, reference materials, demonstration models and other multimedia materials must be provided.

1. Admission Policies and Procedures

   Admission of students, including advanced placement, shall be made in accordance with defined and published practices of the institution. Any academic and technical standards required for admission to the program shall be defined, published and accessible to prospective students and the public.

   Policies for advanced placement, transfer of credit and credit for experiential learning shall be accessible to prospective students. Requirements for previous education or work experience, if required, must be provided and be accessible.

2. Evaluation of Students

   Criteria for successful completion of each segment of the curriculum and for graduation shall be given in advance to each student. Methods of evaluation of students shall include content related to the objectives and competencies described in the curriculum for both didactic and supervised clinical education components. Evaluation shall be employed frequently enough to provide students and program officials with timely indications of the students' progress and academic standing and to serve as a reliable indicator of the effectiveness of course design and instruction.

   There shall be a mechanism for evaluating the clinical competency of each student based on completed evaluation forms for each clinical experience which shall be reviewed by faculty with the student.

   A clinical competency committee should assist in this evaluation process.

3. Appeals

   Appeal mechanisms for decisions regarding academic or clinical performance or infractions of institutional policies shall be made known and be available to all students and faculty.

   The process should be expedient while preserving the students' rights to due process. Deadlines for instituting and resolving the appeal should be published and known to the students and faculty. The appeal mechanism should include individuals not involved with the program as participants in the process.

4. Health

   The program officials shall establish a procedure for determining that the applicants' or students' health will permit them to meet the written technical standards of the program. Students must be informed of and have access to the health care services provided to other students of the institution, including emergency care. Personal counseling, by other than program officials, shall be available and made known to the students and faculty. Education in infection control practices must be provided.

5. Guidance

   Guidance shall be available to assist students in understanding course content and in observing program policies and practices and to provide counseling or referral for problems that may interfere with the students' progress through the program.

1. Fair Practices
   1. Announcements and advertising must reflect accurately the program offered.

   2. Student and faculty recruitment, student admission and faculty employment practices shall be nondiscriminatory with respect to race, color, creed, sex, sexual orientation, age, disability(ies) and national origin.

   3. Academic credit and costs to the student shall be stated, published and made known to all applicants.

   4. The program or sponsoring institution shall have a published policy and procedure for processing student and faculty grievances, which will be made known to all students and faculty.

   5. Policies and processes for student withdrawal and for refunds of tuition and fees shall be published and made known to all applicants.

   6. Policies and processes by which students may perform service work while enrolled in the program must be published and made known to all concerned in order to avoid practices in which students are substituted for regular staff. Students must not take the responsibility for or the place of staff.

   7. The health and safety of patients, students and faculty associated with the educational activities of the students must be safeguarded.

   8. The program must comply with Occupational Safety and Health Administration blood-borne pathogen requirements. Education in infection control practices must be provided.

2. Student Records

   Satisfactory records shall be maintained for student admission, attendance, evaluation and program completion/graduation. Grades and credits for courses shall be recorded on the student transcript and permanently maintained by the sponsoring institution in a safe and accessible location.

   Records should be maintained for all courses for which the student is registered after the institution's add/drop period.

   The master plan for education should include a system for maintaining records in order to document achievement of program goals and objectives, to indicate compliance with accrediting and program policies, and to provide a database for program self-evaluation. Provisions for availability and security of records should comply with the "Family Educational Rights and Privacy Act of 1974" (Buckley Amendment). The system should be sufficiently detailed to provide for the continuity, delivery and evaluation of the program in the event of staff changes.

To graduate, a student must hold a baccalaureate degree obtained prior to or at the completion of the perfusion program.

Instruction shall follow a master plan that documents the following:

1. A structured curriculum setting forth written course syllabi describing learning and competency objectives and competencies necessary for graduation. Course work must show integration with clinical practice. Program faculty must maintain current files of all course syllabi, objectives and evaluation procedures.

   The length of the educational program shall be sufficient to meet the professional requirements and degree requirements of the educational institution.

2. The following curriculum requisites must either be met prior to the perfusion education program or be presented as initial course work; they must include but are not limited to college level courses in the following:
   1. Anatomy and pathology
   2. Physiology
   3. Chemistry
   4. Pharmacology
   5. Mathematics
   6. Physics

   Biochemistry is highly desirable.

   Tests used to assess prerequisite knowledge or advanced standing should be nationally recognized and accepted.

3. Assignment of appropriate instructional materials to reflect the current body of knowledge in perfusion.

4. Classroom presentations, discussions and demonstrations.

5. Supervised practice, clinical experience and discussions.

6. The evaluation of students to assess knowledge, problem-solving skills and motor and clinical competencies.

7. Clinical experience incorporating and requiring the performance of extracorporeal circulation procedures reflecting the variety, in both case distribution and systems, used in clinical practice.

   Clinical affiliations should be used to provide additional variety and experience.

8. Course work in the major current clinical applications of the technology which includes, but is not limited to the following:
   1. Cardiopulmonary bypass and pathophysiologic response of adult, pediatric and infant patients undergoing cardiac surgery. These procedures require student knowledge, preparation and demonstrated competence in the following areas of application:

      (1) blood-propelling devices
      (2) filtration
      (3) gas exchange
      (4) gas exchange devices
      (5) hemodilution
      (6) myocardial preservation
      (7) hypothermia
      (8) perfusion circuitry
      (9) pharmacologic intervention
      (10) blood conservation techniques
      (11) coagulation management

   2. Extracorporeal life support which includes but is not limited to the following:

      (1) right and left heart bypass
      (2) ventricular assist devices
      (3) total artificial heart
      (4) extracorporeal membrane oxygenation (ECMO)

   3. Catastrophic event management which includes, but is not limited to, laboratory simulation of the following:

      (1) device failure
      (2) massive air emboli
      (3) arterial dissections

   4. Continuous quality improvement

   5. Adjunctive techniques used with extracorporeal circulation, which includes but is not limited to the following:

      (1) intra-aortic balloon counterpulsation
      (2) pulsatile perfusion techniques
      (3) hemoconcentration
      (4) autotransfusion
      (5) aseptic technique
      (6) cardiac operative techniques
      (7) anesthetic management
      (8) circulatory arrest procedures
      (9) organ preservation and transplantation
      (10) portable cardiopulmonary support

      Special applications of the technology should include but not be limited to the following:

      • perfusion of the pregnant patient
      • hypothermic resuscitation perfusion
      • isolated limb perfusion
      • organ perfusion
      • hemodialysis
      • biocompatibility

   6. Monitoring of the patient undergoing extracorporeal circulation including but not limited to:

      (1) hemodynamic monitoring and measurement
      (2) blood gas analysis
      (3) bubble detection
      (4) level sensing
      (5) temperature monitoring
      (6) electrocardiography
      (7) fluid and electrolyte balance
      (8) coagulation monitoring
      (9) adequacy of perfusion
      (10) echocardiography

      Cardiac catheterization laboratory observation and computer-assisted monitoring should be included.

   7. Principles of laboratory analysis, including quality control, for instrumentation encountered in the conduct of perfusion must be provided. These include but are not limited to devices that measure the following:

      (1) blood gases
      (2) electrolytes
      (3) coagulation
      (4) hematocrit/hemoglobin

9. Prior to graduation, the student must demonstrate competence in the application of the following techniques:
   1. Cardiopulmonary bypass
   2. Intra-aortic balloon pump (IABP)
   3. Hemoconcentration
   4. Autotransfusion
   5. Performance of laboratory analysis of blood gases, electrolytes, hematocrit/hemoglobin, coagulation
   
   
10. Clinical case availability must be adequate to support the number of students admitted to the program. A minimum of 75 clinical cases requiring cardiopulmonary bypass must be the goal for each student prior to graduation. A minimum of 10 clinical pediatric cases requiring cardiopulmonary bypass must be observed or performed prior to graduation.

    There should be an equitable distribution of available clinical cases among the students. A student's involvement in cardiopulmonary bypass should include but not be limited to the following:

    1. preoperative preparation
    2. perfusion equipment selection and assembly
    3. perfusion management and decision making

11. The program must provide simulation and wet laboratory experiences. The space must be sufficient to accommodate the number of students and equipment necessary to model clinical elements.

    Adequate equipment, supplies and faculty should be available to the program to assure meeting the educational goals for all students.

12. Orientation to research methodology.

    The curriculum should provide orientation and participation in research design, evaluation and reporting.

13. Course work in professional ethics is required.

    Topics covered may include but are not limited to patient's rights, confidentiality, procurement, commitment to the inter-disciplinary team, scientific ethics, responsibility for continuing professional education and responsibilities in professional employment.

14. A plan for evaluation of the curriculum to serve as a reliable indicator of the effectiveness of instruction and course design shall be maintained. This plan shall include evaluation of courses, faculty and instructional methods.

    Periodic evaluation should be conducted at intervals appropriate to the overall length of the educational program.

1. Outcomes

   Programs shall routinely secure sufficient qualitative and quantitative information regarding the program graduates to demonstrate an ongoing evaluation of outcomes consistent with the graduate competencies.

   Within one year of graduation, the program should obtain and review a survey of the graduates and employers addressing employment settings, type and scope of practice, salary, job satisfaction, education and skills adequately and inadequately addressed in the educational program, interviews with program graduates and employers of graduates, and data on the evaluation of student performance on the American Board of Cardiovascular Perfusion certifying examination and other nationally recognized standardized tests.

2. Results of Ongoing Program Evaluation

   The results of ongoing evaluation must be appropriately reflected in the curriculum and other dimensions of the program. In particular, the program must use systemically the information obtained in its evaluation to foster student achievement.

   Ongoing program evaluation should include, but is not limited to, assessment of the following items:

   • Attrition/retention/academic delinquency rates and reasons

   • Student's characteristics in comparison with other students enrolled in the institution in areas such as grade distribution, membership in professional societies, honors and awards

   • Relevance of employment setting to the educational program

   • Percentage of graduates passing credentialing exams (with number of attempts) and exam scores

   • Follow-up studies of alumni and employer satisfaction

   • Input from the admission, curriculum and competency committees and from other channels of communication should be solicited and documented

III. MAINTAINING AND ADMINISTERING ACCREDITATION

1. Applying for Accreditation

   The accreditation review process conducted by the Commission on Accreditation of Allied Health Education Programs (CAAHEP) can be initiated only at the written request of the chief executive officer or an officially designated representative of the sponsoring institution.

   The process is initiated by requesting an application form from and returning it to:

   Commission on Accreditation of Allied Health Education Programs
   35 East Wacker Drive
   Suite 1970
   Chicago, IL 60601-2208
   Phone: (312) 553-9355
   Fax: (312) 553-9616

   The Accreditation Committee-Perfusion Education requests additional application materials prior to guiding the program through completion of a self-study and preparation of a self-study report, which should be sent to:

   Accreditation Committee-Perfusion Education
   7108-C South Alton Way
   Englewood, Colorado 80112-2106
   Phone: (303) 694-9262
   Fax: (303) 694-9169

   At any time before the final accreditation action is made by CAAHEP, a program or sponsoring institution may withdraw its request for initial or continuing accreditation.

   Initial accreditation for a program should be no more than three years. If the self-study is not acceptable to the AC-PE, the program may reapply, submit a new self-study report and pay appropriate fees.

2. Administrative Requirements for Maintaining Accreditation

   To maintain accreditation, the following actions are required:

   1. The program must submit a self-study report or a required progress report within the time determined by the Accreditation Committee-Perfusion Education (AC-PE).

   2. The program must agree to a site visit date before the end of the period for which accreditation was awarded.

   3. The program must inform the AC-PE within 30 days of changes in program officials. If any position remains vacant for 30 days, the program shall send the AC-PE a description of the actions taken to maintain the continuity and effectiveness of the program.

   4. The sponsoring institution must inform CAAHEP and the AC-PE of the transfer of program sponsorship, in accordance with CAAHEP policy.

   5. The program and the sponsoring institution must pay the AC-PE and CAAHEP accreditation fees within the time determined by the AC-PE and CAAHEP, respectively.

   6. Periodic reports required by the Accreditation Committee-Perfusion Education must be filed on a timely basis.

   Failure to meet these administrative requirements for maintaining accreditation may place the program on administrative probation and ultimately to withdrawal of accreditation.

1. Administering the Accreditation Review Process

   At the written request of the chief executive officer or other officially designated representative, the AC-PE and CAAHEP assess the relative compliance of the program with the Standards.

   The accreditation review process includes an on-site evaluation of the program. If the performance of a site visit team is unacceptable, the institution may request a second site visit.

2. Sponsor Review

   Before the AC-PE formulates its accreditation recommendation to CAAHEP, the sponsoring institution is given an opportunity to comment in writing on the report of the site visit team and to correct factual errors.

3. Probationary Accreditation

   If the AC-PE determines that a status of probationary accreditation will be recommended to CAAHEP, the AC-PE provides the sponsoring institution an opportunity to respond in writing to the cited deficiencies in the program's relative compliance with the Standards. The AC-PE reconsideration of a recommendation for probationary accreditation is made on the basis of conditions existing when the AC-PE arrived at its recommendation to CAAHEP and on subsequent evidence of corrected deficiencies provided by the applicant.

   CAAHEP assignments of probationary accreditation, including those following AC-PE reconsideration, are final and are not eligible for further appeal.

4. Withholding or Withdrawing Accreditation

   Before recommending that accreditation be withheld or accreditation be withdrawn by CAAHEP, the AC-PE provides the sponsoring institution with an opportunity to request reconsideration. Decisions to withhold or withdraw accreditation may be appealed. A copy of 5.500 CAAHEP Appeals Procedures for Withholding or Withdrawing Accreditation accompanies the letter notifying the sponsoring institution of one of these actions. When accreditation is withdrawn, the institutional sponsor's chief executive officer is provided with a statement of each deficiency in the program's relative compliance with the Standards and is informed that application for accreditation as a new applicant may be made whenever the program is considered to be in compliance with the Standards. All students completing a program that holds accreditation at any point during their enrollment are regarded as graduates of that CAAHEP-accredited program.

5. Inactive Programs

   The sponsoring institution may request inactive status for a program that does not enroll students for up to two years. The sponsoring institution must continue to pay annual program fees. After being inactive for two years, the program will be considered as discontinued, and accreditation may be withdrawn following notice to the sponsoring institution.