Standards 1-3 Institutional Affiliation, Sponsorship and Responsibilities of the Sponsor

1. Standards 1-3Institutional Affiliation, Sponsorship and Responsibilities of the Sponsor

2. Recommended Materials • Guide to Accreditation • NAACLS Glossary of Terms

3. Standards 1-3 Learning Outcomes Upon completion of this instructional unit and review of additional resources, the learner shall be able to: • Provide an example of an accrediting agency for a university or college, hospital and clinical affiliate • Identify the general and specific provisions required for an affiliation agreement. • Recognize acceptable institutions for NAACLS accredited/approved educational programs

4. Standards 1-3 Learning Outcomes cont’d 4. Define sponsoring institution and list its responsibilities related to accreditation. 5. Review an affiliation agreement to insure the required provisions are present.

5. Standard 1 The standard states: 1. Institutional Affiliation The sponsoring institution (or at least one participating entity in the case of a consortium or joint venture) and affiliates, clinical and/or academic, if any, must be accredited by recognized regional and/or national agencies. In programs in which the education is provided by two or more institutions, responsibilities of the sponsor and of each affiliate for program administration, instruction, and supervision must be described in writing and signed by both parties. All provisions of the agreement must be active with written documentation of the following items: A. General 1. Reason for the agreement 2. Responsibilities of the academic facility 3. Responsibilities of the clinical facility 4. Joint responsibilities B. Specific 1. Supervisory responsibilities for the students 2. Student professional liability coverage 3. Student health and safety policies 4. Provision for renewal 5. Termination clause providing for program completion of enrolled students

6. Standard 1 • The sponsoring institution assumes primary responsibility for those functions listed in Standard 3. • It and each clinical or academic affiliate must be accredited by a recognized regional or national agency. • Universities and colleges are usually accredited by organizations recognized by the Council for Higher Education (CHEA) and/or the U.S. Department of Education (USDE) • Examples • Middle States Association of Colleges and Schools Middle States Commission on Higher Education (MSCHE) • Southern Association of Colleges and Schools Commission on Colleges (SACS) • Accrediting Bureau of Health Education Schools (ABHES)

7. Standard 1 Hospitals are often accredited by organizations approved by the U.S. Centers for Medicare & Medicaid Services (CMS) • Examples • The Joint Commission • American Osteopathic Association • National Integrated Accreditation for Healthcare Organizations

8. Standard 1 Medical laboratories are often accredited by organizations with deemed status under the Clinical Laboratory Improvement Amendments (CLIA) as implemented by CMS • Examples • AABB • American Osteopathic Association • American Society for Histocompatibility and Immunogenetics • College of American Pathologists • COLA • The Joint Commission

9. Standard 1 Joint venture or consortium • Two or more participating entities, formed by agreement, to undertake a common enterprise as a sponsoring entity • Example • A university system that opens MLS programs at multiple campuses across state lines with one program director, over all campuses, and an education coordinator at each site. • In the case of a joint venture or consortium: • When providing an educational program, one institution, within the sponsoring entity, must be accredited by a recognized regional or national agency.

10. Standard 1 Other institutions, outside the traditional 2 or 4 year academic facilities and hospitals, may provide education in clinical laboratory science provided they are accredited by a recognized organization. • Examples • Research laboratory • Physician office laboratory • Public health laboratory • Molecular biology or biotechnology laboratory • Vocational technical schools authorized to grant the associate degree

11. Standard 1 An affiliation agreement is usually written with input of the legal counsels for both the sponsoring institution and affiliate. Affiliation can be initiated by either the academic facility, hospital or other institution • The signed, written affiliation agreement must document the responsibilities of the sponsoring institution and affiliate(s) for: • Program administration • Instruction • Supervision

12. Standard 1 The affiliation agreement must document these provisions: • Reason for the agreement • This is often identified in the first paragraph of the agreement • Responsibilities of the academic facility • Responsibilities of the clinical facility • Joint responsibilities of both facilities

13. Standard 1 The affiliation agreement must document the: • Supervisory responsibilities for the students • This identifies who is responsible for supervision of students whether on the university, college, or hospital campus or in the applied education (clinical rotation) setting • Example affiliation agreement statement: • The facility instructors shall ensure the students are under supervision at all times and meet all local, state and federal regulations.

14. Standard 1 The affiliation agreement must document the: • Student professional liability coverage • This provision names who will be responsible for providing the student coverage for professional liability in case of student errors • Is it the student, university, college, hospital or the institution providing the applied education? • Example statement: • Students shall be required to purchase and maintain professional liability insurance prior to assignment to the clinical facility.

15. Standard 1 The affiliation agreement must document the: • Student health and safety policies • The affiliation agreement must denote who is responsible for providing the student orientation and training on the health and safety polices and procedures of the university, college, hospital campus or in the applied education (clinical rotation) setting • Example statement: • The student shall be provided instruction on the current policies and procedures of the facility. • Note - There does not need to be specific statements related to health and safety polices provided a general, inclusive statement is provided. • An article in NAACLS News Archives, Volume 101, Spring 2009 provides information on interpretation of Standard 1 related to health and safety policies. http://www.naacls.org/PDFviewer.asp?mainUrl=/docs/naacls-news/vol101.pdf

16. Standard 1 The affiliation agreement must document the: • Provision for renewal • There must a statement which insures the affiliation agreement is renewable. • It can be: • an annual, automatic renewal which remains in effect until one party executes their right to terminate the agreement • for a designated number of years. • Due to the intense and prolonged effort required for creation and review of a new affiliation agreement, many programs have chosen to use automatic renewal which remains active until one party chooses to terminate the agreement.

17. Standard 1 The affiliation agreement must document the: • Termination clause providing for program completion of enrolled students • If one institution exercises it right to terminate the affiliation agreement: • This provision provides the current class of students the opportunity to complete their education prior to termination of the agreement • Example statement: • This agreement may be cancelled by either party without cause at any time during the contract by giving 90 days notice. Students assigned to the facility shall be given the opportunity to complete their affiliation.

18. Standard 1 • Affiliation agreements with federal facilities, such as a Department of Veterans Affairs (VA) medical facility, have proven to be frustrating for many program directors. • VA Addendums have proven to be difficult when attempting to insure documentation of all of the required affiliation agreement provisions. • The VA form 10-0094g and other VHA documents help fulfill the intent of all required provisions of Standard 1. • Additional details on these VA documents can be found in the NAACLS News Archives – volume 101, Spring 2009 http://www.naacls.org/PDFviewer.asp?mainUrl=/docs/naaclsnews/vol101.pdf

19. Standard 1 An addendum or a memo of understanding is an appropriate addition for provisions not found in the body of the original affiliation agreement • Must be current and signed • Is considered an official part of the original document once in place

20. Standard 1 Helpful Tool • The NAACLS’ Guide to Accreditation Section IV provides an “Affiliation Agreement Tracking Tool” that allows programs to easily document the location of the required provisions in each affiliation agreement in place.

21. Standard 1 An affiliation agreement is not required, by the Standards, for an “enrichment site”. • An enrichment site is designated as a clinical rotation that is not essential to meeting the program curriculum for a specific discipline • Example • An MLS program sends their students to the county forensic laboratory for a three day enrichment rotation. • If this unique clinical rotation was no longer available, the students would still receive the required curriculum in the MLS program.

22. Standard 1 While not required by Standard 1, a review of the Standards may provide additional items that may be documented in the affiliation agreement. • Examples: • Emergency care for students while in attendance • Primary responsibilities of sponsor as listed in Standard 3 • Requirement for student health insurance • Granting of degree is not contingent on passing a certification or licensure examination

23. Standard 2 The standard states: 2. Sponsorship Educational programs must be sponsored by: A. colleges and universities; B. hospitals and medical centers; C. medical laboratories, D. consortia or joint ventures, consisting of two or more participating entities and formed by agreement to undertake a common enterprise as a sponsoring entity, whereby at least one member of the consortium or joint venture must meet the requirements of Standard 1, or; E. other institutions which meet comparable standards for education in clinical laboratory science.

24. Standard 2 Educational program sponsorship was discussed earlier in this presentation The educational program must be: • Accredited • Meet comparable standards for education in the discipline specific clinical laboratory science

25. Standard 3 The standard states: 3. Responsibilities of the Sponsor Accreditation is granted to the sponsor (and participating entities, in cases of consortia) that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and applied education, appoints faculty to the program, receives and processes applications for admission, and assures that graduates of the program have obtained the appropriate degrees/certificates upon completion of the program, as detailed in Standard 14G: A. The sponsor (and participating entities, in cases of consortia) must be responsible for providing assurance that the activities assigned to students in the clinical setting are educational. B. There must be documented ongoing communication between the sponsor (and participating entities, in cases of consortia) and its affiliates for exchange of information and coordination of the program.

26. Standard 3 The sponsoring institution must perform and satisfactorily document all of the functions described in the Standard. • Curriculum planning • This can be documented using a schedule of course work required for the entire program • Selection of course content • Course descriptions provide this content. • Coordination of classroom teaching and applied education • Student schedule showing classroom courses and clinical rotation schedule

27. Standard 3 The sponsor’s primary responsibilities cont’d: • Appointment of faculty • Polices and procedures for hiring/appointing faculty • Receipt and processing of applications for admission • Policies and procedures for the application process • Assurance that graduates of the program have obtained the appropriate degree/certificate upon completion of the program • A copy of the diploma or certificate awarded

28. Standard 3 Activities assigned to students, in the clinical setting, must be relevant to their education. • This is most often accomplished by supervision during the clinical rotation as defined by the provision in Standard 1 • This standard is also related to the discipline specific Standard 22 in which students cannot be used to perform service work.

29. Standard 3 The sponsor must document ongoing communication, for exchange of information and coordination of the program, with its affiliates: • This is most often accomplished by the program director maintaining an email file or journal log.

30. Assessment Which of the following accrediting agencies most often accredits hospitals? • Accrediting Bureau of Health Education Schools • AABB • The Joint Commission • COLA

31. Assessment Which of following facilities is not an acceptable facility as a sponsor of a NAACLS educational program? • University accredited by MSCHE • Reference laboratory accredited by The Joint Commission • Hospital laboratory accredited by CAP • Veterinary office laboratory accredited by the Better Business Bureau

32. Assessment Which of the following responsibilities is not required by the sponsoring institution as stated in the NAACLS Standards 1 through 3? • Create the affiliation agreement • Plan course content • Appoint faculty • Document ongoing communication with affiliates

33. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. • Joint responsibilities • Section I • Section II • Section III • None of the above

34. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. • Student supervision • Section IG • Section IK • Section IIK • None of the above

35. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. 3. Liability coverage a. Section IK b. Section IIG c. Section IIK d. None of the above

36. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. 4. Student health and safety a. Section IJ b. Section IK c. Section IIG d. None of the above

37. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. 5. Renewal provision a. Section IIIB b. Section IIIC c. Section IIIF d. None of the above

38. Assessment Review the sample affiliation agreement provided to identify the location of the following provision. 6. Termination clause a. Section IIIB b. Section IIIC c. Section IIIF d. None of the above

39. Glossary • Sponsoring institution • An accredited facility that that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and applied education, appoints faculty to the program, receives and processes applications for admission, and assures that graduates of the program have obtained the appropriate degrees/certificates upon completion of the program.

40. Glossary Cont’d • Joint venture or consortium • Two or more participating entities, formed by agreement, to undertake a common enterprise as a sponsoring entity and at least one entity must be accredited • Enrichment site • A clinical rotation that is not essential to meeting the program curriculum for a specific discipline