Colorado Nurses Association 2013 – 2014 Continuing Education Provider Manual Revised November 2013 2013-2014 Approval Board Kathy Brown, Chair Susan Clarke Deb Craven Jennifer Disabato Connie Pardee Kasey Grohe, Administrator Colorado Nurses Association 2170 South Parker Road, Suite 145 Denver, CO 80231 www.nurses-co.org Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 1 of 78 CNA Approval Board Approved Provider Application Manual and Instructions This document provides step-by-step instructions on what is required to apply for approval to award CNE as a Full Provider or for Individual Activity Applicants by the Colorado Nurses Association. Before applying for approval, you must meet the eligibility requirements listed below and demonstrate knowledge of the criteria and requirements from the 2013 Accreditation Manual. The Colorado Nurses Association is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 2 of 78 Table of Contents: Chapter 1: The Application Process Directions for Submission for Approved Providers ........................................... 4 Directions for Submission for Individual Activity Applicants ............................ 5 Due Date ............................................................................................................ 6 Approved Provider Fees .................................................................................... 6 Individual Activity Applicant Fees...................................................................... 6 Approval Period ................................................................................................. 7 General Information .......................................................................................... 7 Chapter 2: Educational Design Process Educational Design Process ............................................................................... 8 Assessment of Learner Needs ........................................................................... 9 Planning Educational Activities ......................................................................... 10 Design Principles................................................................................................ 11 Awarding Contact Hours ................................................................................... 13 Evaluation .......................................................................................................... 13 Accreditation/Approval Statement ................................................................... 14 Documentation of Completion .......................................................................... 14 Commercial Support and Sponsorship .............................................................. 14 Conflicts of Interest Evaluation and Resolution ................................................ 16 Disclosures Provided to Participants ................................................................. 18 Recordkeeping ................................................................................................... 19 Co-Providing Continuing Nursing Education Activities...................................... 21 Chapter 3: Approved Provider Application Approved Provider Eligibility ............................................................................. 23 Approved Provider Applicant Eligibility Verification Form ................................ 27 Approved Provider Eligibility Commercial Interest Addendum ........................ 29 Approved Provider Self Study ........................................................................... 30 Responsibilities of Approved Providers............................................................. 41 Biographical and Conflict of Interest Form ....................................................... 47 Chapter 4: Individual Activity Applicant Application Eligibility for Approval of Individual CNE Activities ........................................... 50 Educational Design Process ............................................................................... 51 Responsibilities of Individual Activity Applicants .............................................. 53 Individual Educational Activity Applicant Eligibility Verification Form ............. 59 Individual Activity Applicant Eligibility Commercial Interest Addendum .......... 60 Individual Educational Activity Application ....................................................... 60 Biographical and Conflict of Interest Form ....................................................... 72 Educational Planning Table ............................................................................... 74 Co-Provider Agreement ..................................................................................... 74 Commercial Support Agreement ....................................................................... 75 Sample Evaluation Form.................................................................................... 75 Sample Certificate of Completion ..................................................................... 75 Glossary .................................................................................................................... 76 Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 3 of 78 Chapter 1: The Application Process Directions for Submission for Approved Providers 1. The following documents must be included in the submission: Approved Provider Applicant Eligibility Verification Approved Provider Commercial Interest Addendum (if necessary) Full Provider Application/Self Study (The application includes additional forms required for the submission.) Three (3) complete Individual Activity files 2. Completed documents must be submitted in the following order: Approved Provider Applicant Eligibility Verification form Approved Provider Commercial Interest Addendum (if necessary) Full Provider Application/Self Study Three (3) complete Individual Activity files Attachments/Appendices Information should be organized in accordance with the outline presented on the Full Provider Application/Self Study form, with sections clearly titled and pages numbered. The form is available in a WORD version that allows you to type directly onto the form, or you may submit the Self Study on your own word processing software. Be sure to follow the outline and complete all sections. Applications must be collated, typed, paginated, and bound. 3. All sections of this application must be typed. 4. Provide two (2) complete bound copies (with all materials included). Send completed application with required processing fee to: Colorado Nurses Association Attn: Approval Board 2170 South Parker Road Suite 145 Denver, CO 80231 5. Electronic Submission The CNA Approval Board will NOT accept electronic submission of application materials for approved providers. Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 4 of 78 Directions for Submission for Individual Activity Applicants 1. The following documents must be included in the submission: Individual Educational Activity Applicant Eligibility Verification Individual Activity Applicant Eligibility Commercial Interest Addendum (if necessary) Individual Education Activity Application (The application includes additional forms required for the submission.) 2. Completed documents must be submitted in the following order: Individual Educational Activity Applicant Eligibility Verification form Individual Activity Applicant Eligibility Commercial Interest Addendum (if necessary) Individual Education Activity Application Attachments/Appendices: o Conflict of Interest Forms for Planners o Conflict of Interest Forms for Presenters o Educational Planning Table o Agenda o Evaluation Tool o Sample Certificate of Completion o Marketing Materials 3. All sections of this application must be typed. 4. Provide two (2) complete bound copies (with all materials included). Send completed application with required processing fee to: Colorado Nurses Association Attn: Approval Board 2170 South Parker Road Suite 145 Denver, CO 80231 5. Electronic Submission The CNS Approval Board will accept electronic submission of application materials. Documents must be submitted as a single PDF attachment and in the order described above. Applications not submitted in this format will not be considered. Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 5 of 78 Due Date All application materials received by the second Friday of the month will be reviewed at the next Approval Board meeting held on the third Friday of the month. Applications must be complete at the time of submission. Application materials must be received three (3) months (3 review cycles) prior to any scheduled event. Currently Approved Providers must submit the application not less than two (2) months prior to the expiration date to have uninterrupted approval. Extensions may be granted for up to two months at a charge of $150.00 per month. Requests for extension must be made in writing before the expiration date. Expedited review will cost an additional $150.00 and is subject to approval and availability of the Nurse Peer Reviewers. Expedited reviews are not available for Approved Provider Applications. Retroactive approval is never granted for Individual Activity Applicants. Approved Provider Fees Fees are to be submitted with the application materials and are not refundable once the review process has begun. Colorado Nurses Association reserves the right to change fees at any time without notice. Fees may be paid by check, money order, or credit card. Application fee: $2000.00. Extension Fee: $150.00 per month for up to two months. Extensions will not be granted for periods extending beyond two months past the original expiration. Individual Activity Applicant Fees Fees are to be submitted with the application materials and are not refundable once the review process has begun. Colorado Nurses Association reserves the right to change fees at any time without notice. Fees may be paid by check, money order, or credit card. Application fee: $400.00 for the first 10 contact hours. Additional Contact hours: $25.00 for each additional contact hour over the first 10 contact hours. The total number of contact hours is determined as the maximum number of contact hours a single person could receive for the event. For example, a 15 hour course would be $475.00. Expedited Review Fee: $150.00 Extension Fee: $150.00 per month for up to two months. Extensions will not be granted for periods extending beyond two months past the original expiration. Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 6 of 78 Approval Period Full Provider approval is for a period of three (3) years. During the three year period, the Approved Provider may offer an unlimited number of CNE activities. Individual Educational Activities are approved for a period of two (2) years. During the two year period, the CNE activity may be repeated as often as desired unless substantial changes are made to the Individual Educational Activity content or presenters. General Information Approval as a provider on Continuing Nursing Education is recognition of a provider unit’s capacity to award contact hours for continuing education activities. These activities must be assessed, planned, implemented, and evaluated by the approved provider unit. Under no circumstance may the approved provider act as an approval unit or approve activities. The approved provider unit may offer an unlimited number of educational activities during the three year period of approval. Your organization, upon achieving approval as a provider unit, is authorized to assess, plan, implement, and evaluate continuing education activities according to the criteria and rules and award contact hours for those activities. Provider units never have the authority to approve their own or anyone else’s activities. The words “approved,” “application,” or “applicant” should never be used in connection with any activity your provider unit plans and presents. Continuing education activities provided by the approved provider must be related to professional development of the nurse. The content of the educational activity should enable the learner to acquire or improve knowledge or skills beyond basic knowledge and enhance professional development or performance as a nurse, regardless of the employer. CNE activities may be but are not limited to conventions, courses, seminars, workshops, lecture series, distance learning activities such as teleconferences and audio conferences, packaged programs such as (web based, paper/pen, etc.), learner directed independent study activities or point of care learning. Knowledge and use of adult learning principles should be reflected in all aspects of the educational design. Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 7 of 78 Chapter 2: Educational Design Process Educational Design Process The following section describes the process of developing and/or evaluating individual educational activities according to ANCC Accreditation Program criteria. The educational design expectations described in this section and applicable at the individual activity level are fundamental to highquality continuing nursing education. Accordingly, applicants must ensure that these expectations are met and that the ANCC criteria for accreditation are applied in such a manner as to ensure the applicant’s Provider unit offers individual educational activities that meet these criteria. ANCC’s Accreditations Program specifies a comprehensive set of educational design criteria to ensure that individual education activities are effectively planned, implemented, and evaluated according to educational standards and adult learning principles. contact hour A unit of measurement that describes 60 minutes of an organized learning activity. One contact hour = 60 minutes. continuing nursing education (CNE) activities Those learning activities intended to build upon the educational and experiential bases of the professional RN for the enhancement of practice, education, administration, research, or theory development, to the end of improving the health of the public and RNs’ pursuit of their professional career goals. CNE involves “systematic professional learning experiences designed to augment the knowledge, skills, and attitudes of nurses, and therefore enrich nurses’ contributions to quality healthcare… (ANA, 2010, p.43). Types of activities: Provider-directed, provider-paced: The provider controls all aspects of the learning activity. The provider determines the learning objectives based on a needs assessments, the content of the learning activity, the method by which it is presented, and evaluation method. (Examples include live activities and live Webinars.) Provider-directed, learner-paced: The provider controls the content of the learning activity, including the learning objectives based on a needs assessment, the content of the learning activity, the method by which it is presented, and the evaluation methods. The learner determines the pace at which the learner engages in the learning activity. (Examples include print articles, online courses, e-books, and self-learning modules/independent studies.) Learner-directed, learner-paced: The learner takes the initiative in identifying his or her learning needs, formulating learning goals, identifying human and material resources for learning, choosing and implementing appropriate learning strategies, and evaluating learning Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 8 of 78 outcomes. The learner also determines the pace at which he or she engaged in by only one individual. The fundamental basis for all CNE activities is the educational design proves. This chapter outlines the required components of a individual education activity in accordance with ANCC accreditation criteria. ASSESSMENT OF LEARNER NEEDS CNE activities are developed in response to, and with consideration for, the unique educational needs of the target audience. Each educational activity is based on a needs assessment that may be conducted using a variety of methods that may include but are not limited to: Surveying stakeholders, target audience members, subject matter experts, or similar Requesting input from stakeholders such as learners, managers, or subject matter experts Reviewing quality studies and/or performance improvement activities to identify opportunities for improvement Reviewing evaluations of previous educational activities Reviewing trends in literature, law, and healthcare needs assessment The process by which a discrepancy between what is desired and what exists is identified. Sources of supporting evidence for needs assessment data may include but are not limited to: Planning Committee At least 2 individuals responsible for planning each educational activity; one individual must be a Nurse Planner and one individual must have appropriate subject matter expertise. Annual employee survey data Literature review Outcome data Survey results from stakeholders Quality data Requests (via phone, in person, or by e-mail) Written evaluation summary requests Assessment data is evaluated by the Nurse Planner and Planning Committee and is used to validate the need for each educational activity. Assessment data is used to identify and validate a gap in knowledge, skills, or practice that the educational activity is designed to improve or meet. Data is then used to formulate the objectives for the educational activity. The purpose and objectives address current needs of the learners in the target audience related to their practice or professional development. The faculty/presenters/authors, if applicable, work with the Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 9 of 78 Nurse Planner and Planning Committee to develop objectives, content, and teaching methods for the target audience of nurses, including advanced practice and specialty nurses. PLANNING EDUCATIONAL ACTIVITIES Planning Committees must have a minimum of one Nurse Planner and one other planner to plan each educational activity. The Nurse Planner is knowledgeable about the CNE process and is responsible for adherence to ANCC criteria. One planner needs to have appropriate subject matter expertise for the educational activity being offered. If additional individuals, such as faculty, presenters, or authors, will be creating or delivering content for the educational activity, Planning Committee members must identify the needed qualifications of the individuals chosen. The qualifications identified for faculty/presenters/authors for the educational offering may include but are not limited to: conflict of interest An affiliation or relationship of a financial nature with a Commercial Interest Organization that might bias a person’s ability to objectively participate in the planning, implementation, or review of a learning activity. All planners, reviewers, and faculty/presenters/authors are required to complete Biographical/Conflict of Interest forms. bias The tendency or inclination to cause partiality, favoritism or influence. content reviewer An individual selected to evaluate an educational activity during the planning process or after it has been planned but prior to delivery to learners for q2uality of content, potential bias, and any other aspects of the activity that may require evaluation. content “Subject matter of education activity that relates to the educational objectives.” (Nursing Professional Development: Scope and Standards of Practice, ANA, 2010) Content expertise Demonstrated comfort with teaching methodology (e.g., Web-based) Presentation skills Familiarity with target audience The Nurse Planner is responsible for ensuring completion and review of Biographical/Conflict of Interest forms by each Planning Committee members and each faculty/presenter/author to ensure appropriate qualifications and evaluation of actual or potential bias. Faculty/presenters/authors must have documented qualifications that demonstrate their education and/or experience in the content area they are developing or presenting. Expertise in subject matter may be evaluated based on characteristics such as education, professional achievements and credentials, work experience, honors, awards, professional publications, or similar. The qualifications must address how the individual is knowledgeable about the topic and how the individual gained the expertise. The Planning Committee, during the planning process, may also identify an individual(s) who functions as content reviewer(s). The purpose of a content reviewer is to evaluate an educational Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 10 of 78 activity during the planning process or after it has been planned but prior to delivery to learners, for quality of content, potential bias, and any other aspects of the activity that may require evaluation. Content reviewers must also complete Biographical/Conflict of Interest forms that are reviewed by the Nurse Planner. The Nurse Planner is responsible for evaluating actual or potential conflicts of interest and applying the resolution process to an actual or potential conflict of interest, if present. During the planning phase, the Planning Committee is responsible for determining how participants will successfully complete the learning activity. The committee also evaluates whether the activity has or will have sponsorship or commercial support and, if so, how content integrity will be maintained, including what/how precautions should be taken to prevent bias in the educational content, and the methods that will be used to ensure full disclosure to activity participants. DESIGN PRINCIPLES The educational design process incorporates measurable educational objectives, best-available evidence, and appropriate teaching methods. Once a gap in knowledge, skills, and/or practice has been identified through the needs assessment findings, thereby validating the need for the educational activity, the purpose can be developed. The purpose should be written as an outcome statement related to the learner at the conclusion of the activity (i.e., “The purpose of this activity is to enable the learner to …”). Next are educational objectives, which are derived from the overall purpose of the activity. Educational objectives are written statements that describe learneroriented outcomes that may be expected as a result of participation in the educational activity. These statements describe knowledge, skills, and/or practice changes that should occur upon successful completion of the educational activity. sponsorship Financial or in-kind contribution from an organization that does not fit the category of a commercial interest. commercial support Financial or in-kind contributions given by a commercial interest that are used to pay for all or part of the costs of a CNE activity. Providers of commercial support may not be providers or coproviders of an educational activity. educational objectives Derived from the overall purpose of the activity, educational objectives are written statements that describe learneroriented outcomes that may be expected as a result of participation in the educational activity. These statements describe knowledge, skills, and/or attitude changes that should occur upon successful completion of the educational activity. Specific objectives for the learning activity are developed collaboratively by the planners and faculty/presenters/authors (if applicable) and must relate to the purpose of the activity. Each objective should have one measurable action verb and specify what the learner will know or do once the objective has been completed (the outcome of attaining the objective). Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 11 of 78 For an educational activity lasting 8 hours or less, with a single focus and purpose, it is appropriate to have objectives that flow from the purpose and reflect the learner’s progression through the activity. For an educational activity lasting more than 8 hours, or with multiple “tracks” or purposes, objectives should be specific to each session in that track. Content for the educational activity must be congruent with each objective. Descriptions may not be a restatement of the objectives. Content should be selected based on the most current available evidence. Documentation should support quality of evidence chosen for content. Examples include but are not limited to evidence-based practice, literature/peer-reviewed journals, clinical guidelines, best practices, and content experts/expert opinion. Following development of objectives and selection of content, teaching-learning strategies are determined. The methods, strategies, and materials to be used by the faculty/presenters/authors to cover each educational objective are identified. These must be congruent with both objectives and content. As part of the design process, the Planning Committee must develop ways in which learners will be provided feedback. This can include but is not limited to having question/answer sessions during or at the conclusion of a learning activity, self-check questions, or comments within an activity, returning preand/or post-test questions with answers, or engaging learners in dialogue during or after the learning activity. Successful completion for both live and enduring material/Web-based activities should be defined for each educational activity, consistent with the purpose, objectives, and teaching/learning strategies. The criteria for successful completion are based on the format of the educational activity and should indicate what constitutes successful completion, the rationale for the method of determining successful completion, and whether or not partial credit is awarded for participation. Criteria for successful completion may include attendance at the entire event or session, attendance for a predetermined percentage of the event, attendance at one or more sessions, completion/submission of the evaluation form, achieving a passing score on a post-test, and/or a return demonstration. The Planning Committee may elect to provide partial credit for educational activities. This could be contact hours awarded based on half-day attendance or on a certain number of sessions attended in a multiday conference. The Planning Committee must determine how participation will be verified. The attendance/participation verification may include but is not limited to sign-in sheets/registration forms, signed attestation statement by participant verifying completion of an entire activity, or a collection of participation verification via computer log. Recordkeeping requires that the Planning Committee determine the method to collect both the participant’s name and a unique identifier. AWARDING CONTACT HOURS Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 12 of 78 Contact hours are determined in a logical and defensible manner. Contact hours are awarded to participants for those portions of the educational activity devoted to the learning experience and time spent evaluating the activity. One contact hour = 60 minutes. If rounding is desired in the calculation of contact hours, the provider must round down to the nearest 1/10th or 1/100th (e.g., 2.758 should be 2.75 or 2.7, not 2.8). Educational activities may also be conducted “asynchronously” and contact hours awarded at the conclusion of the activities. Time frames must match and support the contact hour calculation for live activities. For enduring materials, print, electronic, Web-based, etc., the method for calculating the contact hours must be identified. The method may include but is not limited to a pilot study, historical data, or complexity of content. Contact hours may not be awarded retroactively except in the case of a pilot study. Participants in a pilot study assist in determining the length of time required or completing an educational activity in order to calculate the number of contact hours to award. Those participants may be awarded contact hours once the number is determined. The Commission on Accreditation (COA) reviewed and revised content eligible for awarding ANCC contact hours effective May 1, 2013. Content eligible for awarding ANCC contact hours The Commission on Accreditation (COA) will permit content that is provided through in-service and/or staff development activities to be eligible for awarding continuing nursing education (CNE) credit. Significant learning opportunities for registered nurses can occur during in-service or staff development activities and therefore these activities are eligible for awarding ANCC contact hours. Awarding ANCC contact hours for content in “repeat” courses (ACLS, PALS, NRP or similar) Contact hours may be awarded for all content in courses that are repeated on a regular basis for all learners. This is a change from previous standards. Learning is reinforced through repeat exposure to educational content, and repeat exposure may be more likely to result in behavioral change. Learners are accountable for choosing educational activities that meet their learning needs. Contact hours may not be awarded for Basic Life Support courses. EVALUATION A clearly defined method that includes learner input is used to evaluate the effectiveness of each educational activity. The Planning Committee must determine the method(s) of the evaluation to be used. The evaluation components and method of evaluation should be relative to the desired outcome of the educational activity. Evaluations may include both short- and long-term method. Evaluation Methods Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 13 of 78 Short-Term Evaluation form with questions related to individual activity objectives. For example: o Effectiveness of speakers o Anticipated change in practice Active participation in learning activity Post-test Return demonstration Case study analysis Role-play Long-Term Longitudinal study with self-reported change in practice Data collection related to quality outcome measures Observation of performance Once the evaluations are complete, a summative evaluation is generated. The Planning Committee and/or Nurse Planner review the summative evaluation to assess the activity’s effectiveness and to identify how results may be used to guide future educational activities. ACCREDITATION/APPROVAL STATEMENT The accreditation/approval statement is the mark of an ANCC-accredited or approved organization. All Approved Providers and Individual Activity Applicants are required to include the approval statement of the accredited organization that has either developed or approved the activity prior to the start of every educational activity. The accreditation/approval statement must be displayed clearly to the learner and worded correctly according to the most current Accreditation Manual. The accreditation/approval statement must stand alone on its own line(s) of text. When referring to contact hours, the term “accredited contact hours” should never be used. An organization is accredited or approved; contact hours are awarded. DOCUMENTATION OF COMPLETION A document or certificate of completion is awarded to a participant who successfully completes the requirements for the individual activity. The document or certificate must include: Title and date of the educational activity Name and address of the provider of the educational activity (Web address acceptable) Number of contact hours awarded Accreditation/approval statement Participant name COMMERCIAL SUPPORT AND SPONSORSHIP A commercial interest, as defined by ANCC, is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients, or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 14 of 78 used on patients. Exceptions are made for nonprofit or government organizations, non-healthcare – related companies and healthcare facilities. Commercial Support is financial or in-kind contributions given by a commercial interest that are used to pay for all or part of the costs of a CNE activity. Sponsorship is financial or in-kind contributions from an organization that does not fit the category of a commercial interest and that are used to pay for all or part of the costs of a CNE activity. Organizations providing commercial support or sponsorship may not provide or co-provide an educational activity. Content integrity of the educational activity must be maintained in the presence of commercial support or sponsorship. The provider developing the educational activity is responsible for ensuring content integrity. Providers developing educational activities must develop written policies and/or procedures for managing commercial support and/or sponsorship if the provider accepts commercial support or sponsorship. Written policies and/or procedures related to managing commercial support and sponsorship must address the following: Template of an agreement to be used for commercial support (Commercial Support Agreement) or Sponsorship (Sponsorship Agreement) The agreement must include: o Statement that the provider of commercial support or sponsorship may not participate in any component of the planning process of an educational activity, including: Assessment of learning needs Determination of objectives Selection or development of content Planners, presenters, faculty, authors and/or content reviewers Selection of teaching/learning strategies Evaluation methods o Statement of understanding that the commercial support or sponsorship will be disclosed to the participants of the educational activity o Statement of understanding that the provider of commercial support or sponsorship must agree to abide by the provider’s policies/procedures o Amount of commercial support or sponsorship and description of in-kind donation o Name and signature of the individual who is legally authorized to enter into contracts on behalf of the provider of commercial support or sponsorship o Name and signature of the individual who is legally authorized to enter into contracts on behalf of the provider of the educational activity o Date the agreement was signed Method of documenting how commercial support or sponsorship was used for the educational activity or activities CONFLICTS OF INTEREST EVALUATION AND RESOLUTION Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 15 of 78 The potential for conflicts of interest exists when an individual has the ability to control or influence the content of an educational activity and has a financial relationship with a commercial interest,* the products or services of which are pertinent to the content of the educational activity. The Nurse Planner is responsible for evaluating the presence or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest during the planning and implementation phases of an educational activity. If the Nurse Planner has an actual or potential conflict of interest, he or she should recuse himself or herself from the role as Nurse Planner for the educational activity. Conflict of Interest Conflict of Interest is considered an affiliation or relationship with a Commercial Interest Organization of a financial nature that might bias a person’s ability to objectively participate in the planning, implementation, or review of a learning activity. All planners, reviewers, faculty, presenters, authors, and content reviewers are required to complete Biographical/Conflict of Interest forms. Is there any type of affiliation or relationship to disclose? No Conflict of Interest exists No Yes Is the affiliation or relationship related to the content of the educational activity? No Conflict of Interest related to this educational activity No Yes Conflict of interest to disclose and a resolution is required Resolutions may include, but are not limited to the following: Removing individual with conflict of interest from participating in all parts of the educational activity Revising the role of the individual with conflict of interest so the financial relationship is no longer relevant Not awarding contact hours for a portion of all of the educational activity Content of the educational activity evaluated for bias and activity monitored to evaluate for commercial bias Content of educational activity evaluated for bias and participant feedback reviewed for commercial bias *Commercial interest, as defined by ANCC, is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients, or an entity that is owned or controlled Rev. 11/17/13 Continuing Education Provider Manual and Instructions Page 16 of 78 by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. Nonprofit or government organizations, non-healthcare-related companies, and healthcare facilities are not considered commercial interests. The Nurse Planner is responsible for ensuring that all individuals who have the ability to control or influence the content of an educational activity disclose all relevant relationships** with any commercial interest, including but not limited to members of the Planning Committee, speakers, presenters, authors, and/or content reviewers. Relevant relationships must be disclosed to the learners during the time when the relationship is in effect and for 12 months afterward. All information disclosed must be shared with the participants/learners prior to the start of the educational activity. **Relevant relationships, as defined by ANCC, are relationships with a commercial interest if the products or services of the commercial interest are related to the content of the educational activity. Relationships with any commercial interest of the individual’s spouse/partner may be relevant relationships and must be reported, evaluated, and resolved. Evidence of a relationship with a commercial interest may include but is not limited to receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (stock and stock options, excluding diversified mutual funds), grants, contracts, or other financial benefit directly or indirectly from the commercial interest. Financial benefits may be associated with employment, management positions, independent contractor relationships, other contractual relationships, consulting, speaking, teaching, membership on an advisory committee or review panel, board membership, and other activities from which remuneration is received or expected from the commercial interest. Evaluation The Nurse Planner is responsible for evaluating whether any relationship with a commercial interest is considered relevant to the content of the educational activity. Disclosures may be categorized in the following ways: No relevant relationship with a commercial interest exists. No resolution required. Relevant relationship with a commercial interest exists. The relevant relationship with the commercial interest is evaluated by the Nurse Planner and determined not to be pertinent to the content of the educational activity. No resolution required. Relevant relationship with a commercial interest exists. The relevant relationship is evaluated by the Nurse Planner and determined to be pertinent to the content of the educational activity. Resolution is required. Resolution and Activity Assessment Rev. 06/19/13 Continuing Education Manual and Instructions Page 17 of 78 Actions taken to resolve conflicts of interest must demonstrate resolution of the identified conflicts of interest prior to presenting/providing the educational activity to learners. Such actions must be documented and the documentation must demonstrate (1) the identified conflict and (2) how the conflict was resolved. Actions may include but are not limited to the following: Removing the individual with conflicts of interest from participating in all parts of the educational activity Revising the role of the individual with conflicts of interest so that the relationship is no longer relevant to the educational activity Not awarding continuing education contact hours for a portion or all of the educational activity Undertaking review of the educational activity by a content reviewer to evaluate for potential bias, balance in presentation, evidence-based content or other indicator of integrity, and absence of bias, AND monitoring the educational activity to evaluate for commercial bias in the presentation Undertaking review of the educational activity by a content reviewer to evaluate for potential bias, balance in presentation, evidence-based content or other indicator of integrity, and absence of bias, AND reviewing participant feedback to evaluate for commercial bias in the activity DISCLOSURES PROVIDED TO PARTICIPANTS Learners must receive disclosure of required items prior to the start of an educational activity. In live activities, disclosures must be made to the learner prior to initiation of the educational content. In enduring materials (print, electronic, or Web-based activities), disclosures must be visible to the learner prior to the start of the educational content. Required disclosures may not occur or be located at the end of an educational activity. If a disclosure is provided verbally, an audience member must document both the type of disclosure and the inclusion of all required disclosure elements. Disclosures always required include: Notice of requirement for successful completion of the educational activity: Learners are informed of the purpose and/or objectives of the learning activity and the criteria that will be used to determine successful completion, which may include but are not limited to: o Required attendance time at activity (e.g., 100% of activity, or miss no more than 10 minutes of activity) o Successful completion of post-test (e.g., attendee must score X% or higher) enduring materials A non-live CNE activity that “endures” over time. Examples include programmed texts, audiotapes, videotapes, monographs, computer-assisted learning materials, or other electronic media that are used alone or with printed or written materials. Enduring materials can also be delivered via the Internet. The learning experience by the nurse can take place at any time and in any place rather than only one time or in one place. Rev. 06/19/13 Continuing Education Manual and Instructions Page 18 of 78 o Completed evaluation form o Return demonstration Presence or absence of conflicts of interest for planners, presenters, faculty, authors, and content reviewers: Any influencing relationships, or lack thereof, of planners, presenters, faculty, authors, or content reviewers in relation to the educational activity. Individuals must disclose: o Name of individual o Name of commercial interest o Nature of the relationship the individual has with the commercial interest Disclosures required, if applicable, include: Commercial support: o Learners must be informed if a commercial interest has provided financial or in-kind support for the educational activity, including how content integrity is maintained and bias prevented. Sponsorship: o Learners must be informed if an entity has provided financial or in-kind support for the educational activity, including how content integrity is maintained and bias prevented. Expiration of enduring materials: o Educational activities provided through an enduring format (e.g., print, electronic, Webbased) are required to include an expiration date documenting how long contact hours will be awarded. This date must be visible to the learner prior to the start of the educational content. The period of expiration of enduring materials should be based on the content of the material but cannot exceed 3 years. ANCC requires review of each enduring material at least once every 3 years, or more frequently if indicated by new developments in the field specific to the enduring material. Upon review of enduring material for accuracy and current information, a new expiration date is established. RECORDKEEPING Activity file records must be maintained in a retrievable file (electronic or hard copy) accessible to authorized personnel for 6 years. Required recordkeeping components include: Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Rev. 06/19/13 Continuing Education Manual and Instructions Page 19 of 78 Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and content expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Conflict of interest disclosure statements from planners Resolution of conflicts of interest for planners, if applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers, if applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to 3 hours of content (Note: If more than 3 contact hours were awarded for the activity, documentation demonstrating a minimum of 3 hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Number of contact hours awarded for activity, including method of calculation (provider must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (of applicable) Commercial Support Agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship Agreement with signature and date (if applicable) Evidence of disclosing to the learner: o Purpose and/or objectives and criteria for successful completion o Presence or absence of conflicts of interest for all members of the Planning Committee, presenters, faculty, authors, and content reviewers o Sponsorship or commercial support (if applicable) o Expiration date (enduring materials only) o Evidence of verbal disclosure (if applicable) Documentation of completion must include: o Title and date of the educational activity Rev. 06/19/13 Continuing Education Manual and Instructions Page 20 of 78 o Name and address of provider of the educational activity (Web address acceptable) o Number of contact hours awarded o Accreditation/approval statement o Participant name Summative evaluation List of participant names with unique identifier (Include a representative sample of data collected in the activity file to be reviewed. The provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) CO-PROVIDING CONTINUING NURSING EDUCATION ACTIVITIES ANCC Accredited Providers, Approved Providers, and Individual Activity Applicants may co-provide educational activities with other organizations. The co-providing organization may not be a commercial interest or sponsor. The ANCC Accredited Provider, Approved Provider, or Individual Activity Applicant’s Nurse Planner must be on the Planning Committee and is responsible for ensuring adherence to the ANCC accreditation criteria. The ANCC Accredited Provider, Approved Provider, or Individual Activity Applicant is referred to as the provider of the educational activity. The other organization(s) is referred to as the co-provider(s) of the educational activity. In the event that 2 or more organizations are ANCC Accredited or Approved Providers, one will act as the provider of the educational activity and the other(s) will act as the coprovider(s). The ANCC Accredited Provider, Approved Provider, or Individual Activity Applicant acting as the provider of the educational activity is responsible for obtaining a written co-provider agreement, signed by an authorized representative of the co-provider that addresses the following: Name of ANCC Accredited Provider, Approved Provider, or Individual Activity Applicant acting as the provider The name(s) of the organization(s) acting as the co-provider(s) Statement of responsibility of the provider, including the provider’s responsibility for: o Determining educational objectives and content,; selecting planners, presenters, faculty, authors and/or content reviewers o Selection of content specialists and presenters o Awarding of contact hours o Recordkeeping procedures o Evaluation methods o Management of commercial support or sponsorship Name and signature of the individual legally authorized to enter into contracts on behalf of the provider Rev. 06/19/13 Continuing Education Manual and Instructions Page 21 of 78 Name and signature of the individual legally authorized to enter into contracts on behalf of the co-provider(s) Date the agreement was signed Rev. 06/19/13 Continuing Education Manual and Instructions Page 22 of 78 Chapter 3: Approved Provider Application Approved Provider Eligibility An Approved Provider is defined structurally and operationally as the members of the organization who support the delivery of continuing nursing education activities. The Provider Unit may be a single focused organization devoted to offering continuing nursing education activities or a separately identified unit within a larger organization. If the Provider Unit is within a larger organization, the larger organization is defined as a multi-focused organization (MFO). (For example, the Provider Unit may be placed within the Education Department of a hospital or school of nursing.) The applicant applying for approval is the Provider Unit (PU). The MFO organization is not the applicant. Within a MFO organization, the Provider Unit structure must be identified with clear lines of authority and be clearly delineated for accountability and responsibility. Therefore, all criteria that pertain to the applicant are demonstrated by the functions of the Primary Nurse Planner, Nurse Planners (if applicable), and key personnel of the PU. Provider Units assess learners’ needs and plan, implement, and evaluate CNE activities according to Colorado Nurses Association’s guidelines, which are based on ANCC accreditation criteria. Provider Units are responsible for developing individual education activities and awarding contact hours to nurses for use in fulfilling their own goals for professional development, licensure, and certification. Each educational activity is led by a Nurse Planner in collaboration with at least one other planner. Contact hours may not be awarded for CNE activities developed without the direct involvement of a Nurse Planner. Provider Units may co-provide activities, but they may not approve activities. To be eligible to apply for Approved Provider status, an organization must: Be one of the following: o C/SNA of the ANA Provider Unit Comprises the members of an organization who support the delivery of continuing nursing education activities. multi-focused organization (MFO) An organization that exists for other purposes in addition to providing CNE. Primary Nurse Planner A currently licensed RN with a baccalaureate degree or higher in nursing who is designated as the Primary Nurse Planner and serves as the liaison between the CNA and the Approved Provider Unit. Nurse Planner A currently licensed RN with a baccalaureate degree or higher in nursing who is actively involved in all aspects of planning, implementation, and evaluation of each CNE activity. The Nurse Planner is responsible for ensuring that appropriate educational design principles are used and processes are consistent with the requirements of the ANCC Primary Accreditation Program. key personnel Individuals who contribute to the overall functioning of the Provider unit it a substantive, measurable way, without regard to pay or employment status. Rev. 06/19/13 Continuing Education Manual and Instructions Page 23 of 78 o College or University o Healthcare Facility o Health-Related Organization o Multidisciplinary Educational Group o Professional Nursing Education Group o Specialty Nursing Organization Be administratively and operationally responsible for coordinating the entire process of planning, implementing, and delivering CNE Identify one Nurse Planner who will act as the Primary Nurse Planner and serve as the liaison between Colorado Nurses Association and the Approved Provider Unit Have a Primary Nurse Planner who holds a current, valid license as an RN and a baccalaureate degree or higher in nursing Have a Primary Nurse Planner who has authority within the organization to ensure compliance with CNA’s guidelines in the provision of CNE Have a Primary Nurse Planner who is responsible for the orientation of all Nurse Planners and key personnel in the organization to CNA’s guidelines Ensure that all other Nurse Planners in the Approved Provider Unit hold current, valid licenses as RNs with a baccalaureate degree or higher in nursing Ensure that each CNE activity has a qualified Nurse Planner who is an active participant in the planning, implementing, and evaluation process Be operational for a minimum of six months prior to application Initial applicants must have completed the process of assessment, planning, implementation, and evaluation for at least three separate educational activities provided at separate and distinct events: o With the direct involvement of a Nurse Planner o That adhered to CNA’s guidelines o That were each a minimum of one hour (60 minutes) in length (Contact hours may or may not have been offered.) o That were not co-provided Not be a commercial interest as defined in the glossary and the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities Marketing the majority (>50%) of their CNE activities to nurses in their local geographic region; if marketing >50% of their CNE activities to nurses in multiple regions, or in states other than those within or contiguous to a single region, they may not be an Approved Provider and must Rev. 06/19/13 Continuing Education Manual and Instructions Page 24 of 78 apply to ANCC as an Accredited Provider through the accreditation process (based on the DHHS regions: http://www.hhs.gov/about/regions) Be in compliance with all applicable federal, state, and local laws and regulations that affect the organization’s ability to meet CNA’s guidelines Disclose previous denials, suspensions, and/or revocations received from other ANCC Accredited Approver Units and/or other accrediting /approving organizations. Applicant and Approved Provider Responsibilities Must be in compliance with all applicable federal, state, and local laws and regulations that affect the organization’s ability to meet CNA’s guidelines Must identify a Primary Nurse Planner who holds overall responsibility for Approved Provider Unit compliance with ANCC criteria Must identify a Primary Nurse Planner who is responsible for orienting Nurse Planners and key personnel to CNA’s guidelines Must ensure that a Nurse Planner is an active participant in the planning, implementing, and evaluation of each educational activity Must ensure that Planning Committees have a minimum of a Nurse Planner and one other planner to plan each educational activity; the Nurse Planner is knowledgeable about the CNE process and is responsible for adherence to CNA’s guidelines; one planner needs to have appropriate subject matter expertise for the educational activity being offered Must ensure that the Nurse Planner is responsible for ensuring completion and review of Biographical/Conflict of Interest forms by each Planning Committee member, planner, faculty, presenter, author, and content reviewer, to ensure appropriate qualifications and evaluation of actual or potential bias Must notify CNA in writing, within seven (7) business days of the discovery or occurrence of the following: o Significant changes or events that impair their ability to meet or continue to meet Accreditation Program requirements or that make them ineligible for Approved Provider status o Loss of status as a C/SNA of the ANA (if applicable) o Any event that might result in adverse media coverage related to the delivery of CNE o Change in commercial interest status The Primary Nurse Planner or designee must notify CNA, in writing and within 30 days, of any change within the Approved Provider organization, including but not limited to: Rev. 06/19/13 Continuing Education Manual and Instructions Page 25 of 78 o o o o o Changes that alter the information provided in the Approved Provider application, including change of address or name Change in Primary Nurse Planner or suspension, lapse, revocation, or termination of the Primary Nurse Planner’s registered nursing license Change in Nurse Planners or suspension, lapse, revocation, or termination of any of the Nurse Planners registered nursing licenses Change in ownership Indication of potential instability (e.g., labor strike, reduction in force, bankruptcy) that may impact the organization’s ability to function as an Approved Provider Rev. 06/19/13 Continuing Education Manual and Instructions Page 26 of 78 Approved Provider Applicant Eligibility Verification Form The Individual Educational Activity Applicant Eligibility Verification form is utilized to verify that organization/individual applying to offer CNE for an educational offering are eligible under ANCC Eligibility Requirements. Organizations deemed ineligible will not be considered for approval by the Colorado Nurses Association. This form requests information on the applicant’s demographic data and the type of organization. All questions must be answered to determine eligibility. You must complete this form to be considered. All parts of the form must be completed as directed. Section 1 Demographic Data: Name of Applicant: Please note that the applicant name is generally the name of the organization and not the name of the person completing the form. The Applicant name will be listed as the provider of the activity on the certificate and advertising. The Primary Point of Contact is the person through which all communication will be addressed. This person is not required to be a nurse. If the contact person is also part of the planning committee, include his/her name on the planning committee list. Section 2 Nurse Planners: A licensed registered nurse with a baccalaureate degree or higher in nursing must be actively involved in all aspects of planning, implementation, and evaluation. The Nurse Planner is responsible for ensuring that appropriate educational design principles are used and processes are consistent with the requirements of the ANCC Primary Accreditation Program. The planning committee must have a minimum of one Nurse Planner and one other planner to plan each educational activity. One planner must have appropriate subject matter expertise. All members of the provider unit planning committees must be listed including the Primary Nurse Planner. At least one member from this planning committee must be a planner in every educational activity offered. Section 3 Regional Target Market: This section determines eligibility based on the target market for continuing nursing education activities. Organizations providing more than 50% of their activities targeted to a market outside the DHHS region and contiguous states are not eligible to apply for approval through the Colorado Nurses Association. Rev. 06/19/13 Continuing Education Manual and Instructions Page 27 of 78 These organizations are not eligible for Approved Provider status but may be eligible for Accredited Provider status directly through ANCC. If you offer activities over the internet and they are targeted to an area outside the geographical region, then you need to apply to ANCC Accreditation Program as an accredited provider unit. Section 4: All organizations seeking approval must have been operational for 6 months prior to application and must have been using the ANCC criteria during that time period. Organizations must have planned, implemented, and evaluated at least three separate educational activities in the prior 12 months that meet the defined criteria. Applicants must be in compliance with all Federal, State, and Local laws and regulations that apply to the delivery of continuing nursing education. Section 5 Commercial Interest: This section addresses whether the organization is exempt from ANCC’s definition of a commercial interest. ANCC defines a commercial interest as “any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. These sections are completed by organizations that are not exempt from the definition of a commercial interest. All questions must be answered to determine eligibility. Section 6: Organizations that are not exempt from the ANCC Accreditation Program’s definition of commercial interest must complete this section. Section 7: This section is completed by organizations that are part of a Multi-Focused Organization (MFO). Section 8 Statement of Understanding: The Statement of Understanding must be completed. Fill in the name of the Applicant in the appropriate locations. All questions must be answered. Rev. 06/19/13 Continuing Education Manual and Instructions Page 28 of 78 Approved Provider Eligibility Commercial Interest Addendum The Commercial Interest Addendum needs to be completed only if directed to do so by the Individual Educational Activity Eligibility Verification form. All questions must be answered for consideration of the application. This form must be signed and dated and included with the application materials. Rev. 06/19/13 Continuing Education Manual and Instructions Page 29 of 78 Approved Provider Self Study ORGANIZATIONAL SELF-STUDY/WRITTEN DOCUMENTATION The following four sections are required written documentation for new Approved Provider applicants and those organizations currently approved as providers and reapplying to maintain their status: Organizational Overview (OO) Approved Provider Criterion 1: Structural Capacity (SC) Approved Provider Criterion 2: Educational Design Process Approved Provider Criterion 3: Quality Outcomes (QO) Note: All documents will be reviewed for adherence to Accreditation criteria and Approver Unit requirements at the time educational activities were planned, implemented, and evaluated. APPROVED PROVIDER ORGANIZATIONAL OVERVIEW (OO) The Organizational Overview (OO) is an essential component of the application process that provides a context for understanding the Approved Provider Unit/organization. The applicant must submit the following documents and/or narratives: Structural Capacity OO1. Demographics Submit a description of the features of the Approved Provider Unit, including but not limited to scope of services, size, geographical range, target audience(s), content areas, and the types of educational activities offered. If the Approved Provider Unit is part of a multi-focused organization, describe the relationship of these scope dimensions to the total organization. OO2. Lines of Authority and Administrative Support Submit a list of the names, credentials, positions, and titles of the Primary Nurse Planner, other Nurse Planner(s) (if any), and all key personnel in the Approved Provider Unit. Rev. 06/19/13 Continuing Education Manual and Instructions Page 30 of 78 Submit position descriptions of the Primary Nurse Planner, Nurse Planners (if any), and key personnel in the position description Approved Provider Unit. Position descriptions should be Description of the functions specific to your role in the provider unit, not your “job specific to the role of Primary Nurse Planner, Nurse Planner, description”, unless they are the same. and key personnel that relate Submit a chart depicting the structure of the Approved to the Provider Unit. Provider Unit, including the Primary Nurse Planner, other Nurse Planner(s) (if any), and all key personnel. If part of a larger organization, submit an organizational chart, flow sheet, or similar kind of image that depicts the organizational structure and the Approved Provider Unit’s location within the organization. Educational Design Process OO3. Data Collection and Reporting Approved Provider organizations report data, at a minimum, annually to CNA: Submit a complete list of all CNE offerings provided in the past 12 months, including activity dates; titles; target audience; total number of participants; number of contact hours offered for each activity; co-provider status; and any sponsorship or commercial support, including monetary or in-kind amount. Examples of outcome measures include, but are not limited, to the following : o Cost savings for customers o Cost savings for Provider Unit o Volume of participants in educational activities o Volume of educational activities provided o Satisfaction of staff and volunteers o Satisfaction of learners o Satisfaction of faculty o Change in format of CNE activities to meet the needs of learners o Change in operations to achieve strategic goals o Operational improvements o Quality/cost measures o Turnover/vacancy for Provider Unit staff and volunteers o Professional development opportunities for staff and volunteers Rev. 06/19/13 Continuing Education Manual and Instructions Page 31 of 78 New applicants: Submit a list of the CNE offerings approved by CNA and provided within the past 12 months. Annual Report requests will be sent out annually detailing additional information required to complete the data collection and reporting process. Quality Outcomes OO4. Evidence List Approved Provider Unit’s strategic goals with respect to CNE for the past 12 months. Submit a list of the quality outcome measures the Approved Provider collects, monitors, and evaluates specific to the Approved Provider Unit. Submit a list of the quality outcome measures the Approved Provider collects, monitors, and evaluates specific to Nursing Professional Development. Nursing Professional development is defined as “The lifelong process of active participation by nurses in learning activities that assist in developing and maintaining their continuing competence, enhancing their professional practice, and support achievement of their career goals” (Nursing Professional Development: Scope and Standards of Practice, ANA, 2010). Examples of Nursing Professional Development include, but are not limited to the following: o Professional practice behaviors o Leadership skills o Critical thinking skills o Nurse competency o High-quality care based on best-available evidence o Improvement in nursing practice o Improvement in patient outcomes o Improvement in nursing care delivery Note: New applicants should develop and submit with their self-study a list of strategic goals for the initial 3 years after receiving Approved Provider status and a list of quality outcome measures that will be collected, monitored, and evaluated. The remaining criteria will require a narrative description of the process and an example. To successfully complete this application process, you must include a narrative response detailing the process. Additionally, you must also provide a specific example that illustrates how the criterion is operationalized within the Provider Unit. Rev. 06/19/13 Continuing Education Manual and Instructions Page 32 of 78 APPROVED PROVIDER CRITERION 1: STRUCTURAL CAPACITY (SC) The capacity of an Approved Provider Unit is demonstrated by commitment, identification and responsiveness to learner needs; continual engagement in improving outcomes; accountability; leadership; and resources. Applicants will write narrative statements that address each of the criteria under Commitment, Accountability, Leadership, and Resources to illustrate how structural capacity is operationalized. Each narrative must include a specific example that illustrates how the criterion is operationalized within the Provider Unit. Commitment. The Primary Nurse Planner demonstrates commitment to ensuring RNs’ learning needs are met by evaluating Approved Provider Unit goals in response to data that may include but is not limited to aggregate individual educational activity evaluation results, stakeholder feedback (staff, volunteers), and learner/customer feedback. Describe and, using an example, demonstrate the following: SC 1. The Primary Nurse Planner’s (PNP) commitment to learner needs, including how Approved Provider Unit processes are revised based on data. Complete SC2 only if Provider Unit is part of a larger organization. SC 2. How the organization’s leadership is committed to supporting the goals of the Approved Provider Unit. Accountability. The Primary Nurse Planner is accountable for ensuring that all Nurse Planners and key personnel in the Approved Provider Unit adhere to the ANCC accreditation criteria. Describe and, using an example, demonstrate the following: SC 3. How the Primary Nurse Planner ensures that all Nurse Planner(s) and the personnel of the Approved Provider Unit maintain adherence to the ANCC accreditation criteria. SC 4. How the Primary Nurse Planner is accountable for resolving issues related to providing CNE Rev. 06/19/13 Continuing Education Manual and Instructions Page 33 of 78 Leadership. The Primary Nurse Planner demonstrates leadership of the Approved Provider Unit through direction and guidance given to individuals involved in the process of assessing, planning, implementing, and evaluating CNE activities in adherence to ANCC accreditation criteria. Describe and, using an example, demonstrate the following: SC 5. How the Primary Nurse Planner ensures that every Nurse Planner maintains accreditation standards and guides the Planning Committee or team for an individual educational activity. SC 6. How the Nurse Peer Review Leader of CAN is used as a resource by the Primary Nurse Planner and/or other Nurse Planner(s) in the Approved Provider Unit. Resources. The Primary Nurse Planner advocates for and utilizes available human, material, and financial resources to ensure that the Approved Provider Unit achieves its goal of meeting identified quality outcome measures. Describe and, using an example, demonstrate the following: SC 7. How the Primary Nurse Planner advocates for resources to ensure that the Approved Provider Unit achieves its goals related to quality outcome measures. The following criteria will require a narrative description of the process and an example. To successfully complete this application process, you must include a narrative response detailing the process. Additionally, you must also provide a specific example that illustrates how the criterion is operationalized within the Provider Unit. APPROVED PROVIDER CRITERION 2: EDUCATION DESIGN PROCESS (EDP) The Approved Provider Unit has a clearly defined process for assessing needs as the basis for planning, implementing, and evaluating CNE. CNE activities are designed, planned, implemented, and evaluated in accordance with adult learning principles, professional education standards, and ethics. As a component of the educational design process, the Approved Provider applicant should select and submit three CNE activity files with the application. These activities should have been planned within 12 Rev. 06/19/13 Continuing Education Manual and Instructions Page 34 of 78 months of the Approved Provider application date and comply with ANCC criteria. Please see the section “Individual Activity Files” for specific instructions on the submission of CNE activity files. The Colorado Nurses Association Approval Board will review the activity files to evaluate the Approved Provider on the following: Assessment of Learning Needs. Continuing education activities are developed in response to, and with consideration for, the unique educational needs of the target audience. Planning. Planning for each educational activity must include one Nurse Planner and one other planner. One of the planners must have appropriate subject matter expertise for the educational activity. Design Principles. The educational design process incorporates measurable educational objectives and appropriate teaching methods. Achievement of Objectives. A clearly defined method that includes learner input is used to evaluate the effectiveness of each educational activity. Results from the activity evaluation are used to guide future activities. Each activity file must include evidence of: o o o o o o o o o o o o Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and content expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Conflict of interest disclosure statements from planner Resolution of conflicts of interest for planners, if applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Rev. 06/19/13 Continuing Education Manual and Instructions Page 35 of 78 o o o o o o o o o o o o o o o o o o Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers, if applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to 3 hours of content (Note: If more than 3 contact hours were awarded for the activity, documentation demonstrating a minimum of 3 hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Number of contact hours awarded for activity, including method of calculation (Provider must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (if applicable) Commercial Support Agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship Agreement with signature and date ( if applicable) Evidence of disclosing to the learner: Purpose and/or objectives and criteria for successful completion Presence or absence of conflicts of interest for all members of the Planning Committee, presenters, faculty, authors, and content reviewers Sponsorship or commercial support (if applicable) Expiration date (enduring materials only) Evidence of verbal disclosure (if applicable) Documentation of completion must include: Title and date of the educational activity Name and address of provider of the educational activity (Web address acceptable) Number of contact hours awarded Rev. 06/19/13 Continuing Education Manual and Instructions Page 36 of 78 o o o o Approved Provider statement Participant name Summative evaluation List of participant names with unique identifier (Include a representative sample of data collected in activity file to be reviewed. The provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) Note: First-time applicants should prepare and submit a sample certificate of completion containing the Approved Provider statement to be used once approval is attained. Each narrative must include a specific example that illustrates how the criterion is operationalized within the Provider Unit. Examples for the narrative component of the provider application (EDP 1-13) may be chosen from but are not limited to those contained in the submitted activity files. Evidence must demonstrate how the Approved Provider Unit complies with each criterion. Assessment of Learning Needs. CNE activities are developed in response to, and with consideration for, the unique educational needs of the target audience. Describe and, using an example, demonstrate the following: EDP 1. The Nurse Planner’s methods of assessing the current learning needs of the target audience. EDP 2. How the Nurse Planner uses data collected to develop an educational activity that addresses the identified gap in knowledge, skills and/or practices. Planning. Planning for each educational activity must include one Nurse Planner and one other planner. One of the planners must have appropriate subject matter expertise for the educational activity. Describe and, using an example, demonstrate the following: EDP 3. The process used to select a planning team/committee for an educational activity, including why an individual member was chosen. Rev. 06/19/13 Continuing Education Manual and Instructions Page 37 of 78 EDP 4. The process used to identify all actual and potential conflicts of interest for all members of the Planning Committee, presenters, authors, and content reviewers. EDP 5. The process for resolution of an actual or potential conflict of interest and the outcome achieved. EDP 6. The process utilized during the planning phase of the educational activity to determine how participants will successfully complete the learning activity Design Principles. The educational design process incorporates measurable educational objectives, bestavailable evidence, and appropriate teaching methods. Describe and, using an example, demonstrate the following: EDP 7. How measurable educational objectives are developed that address the change in nursing practice or nursing professional development. EDP 8. How the content of the educational activity is selected based on best-available current evidence (e.g., clinical guidelines, peer-reviewed journals, experts in the field) EDP 9. How content integrity is maintained for CNE activities, including what precautions are taken to prevent bias and how those precautions are implemented. Note: If the applicant or Approved Provider never accepts commercial support/sponsorship, do not provide a narrative for EDP10, and proceed to EDP11. EDP 10. In the presence of commercial support/sponsorship, how additional precautions are taken to maintain content integrity for CNE activities, including what precautions are taken to prevent bias and how those precautions are implemented. EDP 11. How teaching methods were chosen that are appropriate to achieve the purpose and objectives of the CNE activity. Achievement of Objectives. A clearly defined method that includes learner input is used to evaluate the effectiveness of each educational activity. Results from the activity evaluation are used to guide future activities. Rev. 06/19/13 Continuing Education Manual and Instructions Page 38 of 78 Describe and, using an example, demonstrate the following: EDP 12. How summative evaluation data for an educational activity were used to guide future activities. EDP 13. How evaluation data were collected to measure change in nursing practice or nursing professional development. The following criteria will require a narrative description of the process and an example. To successfully complete this application process, you must include a narrative response detailing the process. Additionally, you must also provide a specific example that illustrates how the criterion is operationalized within the Provider Unit. APPROVED PROVIDER CRITERION 3: QUALITY OUTCOMES (QO) The Approved Provider Unit engages in an ongoing evaluation process to analyze its overall effectiveness in fulfilling its goals and operational requirements to provide quality CNE. Each narrative must include a specific example that illustrates how the criterion is operationalized within the Provider Unit. Approved Provider Unit Evaluation Process. The Approved Provider Unit must evaluate the effectiveness of its overall functioning as an Approved Provider Unit. Describe and, using an example, demonstrate the following: QO 1. The process utilized for evaluating effectiveness of the Approved Provider Unit in delivering quality CNE. QO 2. How the evaluation process for the Approved Provider Unit resulted in the development or improvement of an identified quality outcome measure. (Refer to identified quality outcomes list in OO4.) Rev. 06/19/13 Continuing Education Manual and Instructions Page 39 of 78 Approved Provider Unit Evaluation Participants. The Approved Provider Unit shall include a variety of stakeholders, comprising those with a vested interest in Approved Provider Unit outcomes, in the evaluation process. Describe and, using an example, demonstrate the following: QO 3. Why the Approved Provider Unit selects specific stakeholders to participate in the evaluation process. Approved Provider Unit Quality Outcome Measures. The Approved Provider Unit must demonstrate quality improvement efforts including identifying strategies for working on targeted goals, evaluating progress toward goals, and revisiting or establishing new goals. Describe and, using an example, demonstrate the following: QO 4. How input from stakeholders resulted in development of or an improvement in quality outcome measures for the Approved Provider Unit. (Refer to identified quality outcomes list in OO4.) Value/Benefit to Nursing Professional Development. The Approved Provider Unit shall evaluate data to determine how the Approved Provider Unit, through the learning activities it has provided, has influenced the professional development of its nurse learners. Describe and, using an example, demonstrate the following: QO 5. How, over the past 12 months, the Approved Provider Unit has enhanced nursing professional development. (Refer to identified quality outcomes list in OO4.) Rev. 06/19/13 Continuing Education Manual and Instructions Page 40 of 78 Responsibilities of Approved Providers Awarding Contact Hours Contact hours are determined in a logical and defensible manner. Contact hours are awarded to participants for those portions of the educational activity devoted to the learning experiences and time spent evaluating the activity. One contact hour = 60 minutes. If rounding is desired in the calculation of contact hours, the provider must round down to the nearest 1/10th or 1/100th. Educational activities may also be conducted “asynchronously” and contact hours awarded at the conclusion of the activity. Contact hours may not be awarded retroactively except in the case of a pilot study. Participants in the pilot study assist in determining the length of time required for completing an educational activity in order to calculate the number of contact hours to award. Those participants may be awarded contact hours once the number is determined. Approved Provider Statement Prior to the start of every educational activity and on each certificate of completion the Approved Provider status must contain the official approval statement, begin and end on a line separate from other text, and be written as follows: [Name of Approved Provider] is an approved provider of continuing nursing education by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation Documentation of Completion Participants receive written verification of their successful completion of an activity, which includes, at a minimum: Title and date of the educational activity Name and address of provider of the educational activity (Web address acceptable) Number of contact hours awarded Approved Provider statement Approved Provider number and expiration date Participant name Rev. 06/19/13 Continuing Education Manual and Instructions Page 41 of 78 Commercial Support and Sponsorship The Provider Unit must adhere to the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities at all times. The Provider Unit must have a written policy or procedure and a signed, written agreement if commercial support or sponsorship is accepted. Organizations providing commercial support or sponsorship may not provide or co-provide educational activities. Conflicts of Interest The Nurse Planner is responsible for evaluating the presence or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest during the planning and implementation phases of an educational activity. If the Nurse Planner has an actual or potential conflict of interest, he or she should recuse himself or herself from the role as Nurse Planner for the educational activity. Disclosure Responsibilities Disclosures in the Planning Process: Signed Conflict of Interest Disclosure Form. All planners, presenters, faculty, authors, and content reviewers must disclose any conflicts of interest related to planning of an educational activity. Forms must be signed and dated. Disclosure must be relative to each educational activity. If a potential or actual conflict is identified, the planning process must include a mechanism for resolution. Disclosures provided to the Learner: Learners must receive disclosure of required items prior to the start of an educational activity. In live activities, disclosures must be made to the learner prior to initiation of the educational content. In enduring print materials or Web-based activities, disclosures must be visible to the learner prior to the start of the educational content. Required disclosures may not occur or be located at the end of an educational activity. Evidence of the disclosures to the learner must be retained in the activity file. If a Rev. 06/19/13 Continuing Education Manual and Instructions Page 42 of 78 disclosure is provided verbally, an audience member must document both the type of disclosure and the inclusion of all required disclosure elements. Disclosures always required include Notice of requirements for successful completion of the educational activity: Prior to the start of an educational activity, learners must be informed of the purpose and/or objectives of the educational activity and the criteria used to determine successful completion which may include but are not limited to: o Required attendance time at activity (e.g., 100% of activity, or miss no more than 10 minutes of activity) o Successful completion of post-test (e.g., attendee must score X% or higher) o Completed evaluation form o Return demonstration Presence of absence of conflict of interest for planners, presenters, faculty, authors, and content reviewers. Any influencing relationships, or lack thereof, of planners, presenters, faculty, authors, or content reviewers in relation to the educational activity. Individuals must disclose: o Name of individual o Name of commercial interest o Nature of the relationship the individual has with the commercial interest Commercial Support. Learners must be informed id a commercial interest has provided financial or in-kind support for the educational activity. Sponsorship. Learners must be informed if an entity has provided financial or in-kind support for the educational activity. Expiration of Enduring Material. Educational activities provided through an enduring format (e.g., print, electronic, Web-based) are required to include an expiration date documenting how long contact hours will be awarded. This date must be visible to the learner prior to the start of the educational content. The period of expiration of enduring material should be based on the content of the material but cannot exceed 3 years. ANCC requires review of each enduring material at least once every 3 years, or more frequently if indicated by new developments in the field specific to the enduring material. Upon review of enduring material for accuracy and current information, a new expiration date is established. Rev. 06/19/13 Continuing Education Manual and Instructions Page 43 of 78 Approved Provider Recordkeeping The Approved Provider is responsible for maintaining activity file records in a retrievable file (electronic or hard copy) accessible to authorized personnel for 6 years. The criteria delineated under the Provider Educational Design process must be followed consistently during the period of approval, and the recordkeeping files must include evidence in the form of: Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and content expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Conflict of interest disclosure statements from planners Resolution of conflicts of interests for planners, of applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers, if applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to 3 hours of content (Note: If more than 3 contact hours were awarded for the activity, documentation demonstrating a minimum of 3 hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Rev. 06/19/13 Continuing Education Manual and Instructions Page 44 of 78 Number of contact hours awarded for activity, including method of calculation (Provider must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (if applicable) Commercial Support Agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship Agreement with signature and date (if applicable) Evidence of disclosing to the learner: o Purpose and/or objectives and criteria for successful completion o Presence or absence of conflicts of interest for all members of the Planning Committee, presenters, faculty, authors, and content reviewers o Sponsorship or commercial support (if applicable) o Expiration date (enduring materials only) o Evidence of verbal disclosure (of applicable) Documentation of completion must include: o Title and date of the educational activity o Name and address of provider of the educational activity (Web address acceptable) o Number of contact hours awarded o Approved Provider statement o Approved provider number and expiration date o Participant name Summative evaluation List of participant names with unique identifier (Include a representative sample of data collected in activity file to be reviewed. The provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) Note: First-time applicants should prepare and submit a sample certificate of completion containing Approved Provider statement to be used once approval is attained. Co-Providing Activities for Continuing Nursing Education When an activity is co-provided, the Approved Provider is referred to as the provider of the educational activity. The other organization(s) is referred to as the co-provider(s) of the educational activity. The co-providing organization may not be a commercial interest or sponsor. The Approved Provider Unit’s Rev. 06/19/13 Continuing Education Manual and Instructions Page 45 of 78 Nurse Planner mist be on the Planning Committee and is responsible for ensuring adherence to the ANCC accreditation criteria. When an educational activity is co-provided, the Provider Unit’s Nurse Planner is responsible for: Signed co-provider agreement Ensuring that the Approved Provider name is prominently displayed in all marketing material and certificate The name(s) of the organizations acting as the co-provider(s) Statement of responsibility of the provider, including: o Determining educational objectives and content o Selecting planners, presenters, faculty, authors, and content reviewers o Awarding contact hours o Recordkeeping procedures o Developing evaluation methods o Managing commercial support or sponsorship Name and signature of the individual legally authorized to enter into contracts on behalf of the Approved Provider Name and signature of the individual legally authorizes to enter into contracts on behalf of the co-provider(s) In the event that 2 or more organizations are ANCC Accredited or Approved Providers, one will act as the provider of the educational activity and the other(s) will act as the co-provider(s). If collaborating providers are all ANCC-accredited or approved, one is designated to retain the provider responsibilities by mutual, written agreement. The Accredited or Approved Provider designated to retain these responsibilities is referred to as the provider, and the other collaborating providers are referred to as co-providers. Rev. 06/19/13 Continuing Education Manual and Instructions Page 46 of 78 Biographical and Conflict of Interest Form A Biographical and Conflict of Interest Form must be completed for each activity. Every member of the planning committee, presenters, faculty, authors, and content reviewers must complete this form. It is recommended that you use the form provided; however, you may use a form specific to your organization. If using a different form, you must ensure that all the same elements are clearly addressed and defined on the form. Complete the first section of the form with the title of the educational activity, date of the activity, and select the role the person plays in the activity. Section 1: Demographics Data All persons completing this form must complete the demographic data section. Credentials must be provided. Section 2: Expertise – Planning Committee All members of the planning committee must complete this section. You must identify what role the person plays on the planning committee. Additionally, provide a description of the expertise and training that makes this person qualified to be a member of the planning committee. This should be more than a brief statement. Section 3: Expertise – Presenter/Faculty/Author/Content Review This section must be completed by all presenters, faculty, authors, and content reviewers. If a member of the planning committee is also a presenter, both section 2 and 3 must be completed. Once again, provide a description of the expertise and training that makes this person qualified to be a presenter. This should be more than a brief statement. Section 4: Conflict of Interest The potential for conflicts of interest exists when an individual has the ability to control or influence the content of an educational activity and has a financial relationship with a commercial interest, the products or services of which are pertinent to the content of the educational activity. The Nurse Planner is responsible for evaluating the presence or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest during the planning and implementation phases of an educational activity. If the Nurse Planner has an actual or potential conflict of interest, he or she should recuse himself or herself from the role as Nurse Planner for the educational activity. Rev. 06/19/13 Continuing Education Manual and Instructions Page 47 of 78 Commercial interest, as defined by ANCC, is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients, or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. Commercial Interest Organizations are ineligible for accreditation. An organization is NOT a Commercial Interest Organization if it is: A government entity; A non-profit (503(c)) organization; A provider of clinical services directly to patients, including but not limited to hospitals, health care agencies and independent health care practitioners; An entity the sole purpose of which is to improve or support the delivery of health care to patients, including but not limited to providers or developers of electronic health information systems, database systems, and quality improvement systems; A non-healthcare related entity whose primary mission is not producing, marketing or selling or distributing health care goods or services consumed by or used on patients; Liability insurance providers; Health insurance providers; Group medical practices; Acute care hospitals (for profit and not for profit); Rehabilitation centers (for profit and not for profit); Nursing homes (for profit and not for profit); Blood banks; Diagnostic laboratories All individuals who have the ability to control or influence the content of an educational activity must disclose all relevant relationships** with any commercial interest, including but not limited to members of the Planning Committee, speakers, presenters, authors, and/or content reviewers. Relevant relationships must be disclosed to the learners during the time when the relationship is in effect and for 12 months afterward. All information disclosed must be shared with the participants/learners prior to the start of the educational activity. **Relevant relationships, as defined by ANCC, are relationships with a commercial interest if the products or services of the commercial interest are related to the content of the educational activity. Rev. 06/19/13 Continuing Education Manual and Instructions Page 48 of 78 Relationships with any commercial interest of the individual’s spouse/partner may be relevant relationships and must be reported, evaluated, and resolved. Evidence of a relevant relationship with a commercial interest may include but is not limited to receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (stock and stock options, excluding diversified mutual funds), grants, contracts, or other financial benefit directly or indirectly from the commercial interest. Financial benefits may be associated with employment, management positions, independent contractor relationships, other contractual relationships, consulting, speaking, teaching, membership on an advisory committee or review panel, board membership, and other activities from which remuneration is received or expected from the commercial interest. Complete the table detailing all actual, potential, or perceived conflicts of interest. Section 5: Conflict Resolution (to be completed by Nurse Planner) The Nurse Planner must complete section 5 on all Conflict of Interest Disclosure forms except their own. Identify the procedures used to resolve conflict of interest or potential bias. Section 6: Statement of Understanding Both the person completing the form and the Nurse Planner must provide and sign the form. An electronic signature is acceptable. Rev. 06/19/13 Continuing Education Manual and Instructions Page 49 of 78 Chapter 4: Individual Activity Applicant Application Individual Activity Applicants ELIGIBILITY FOR APPROVAL OF INDIVIDUAL CNE ACTIVITIES The Individual Activity Applicant is defined as an individual, organization, or part of an organization submitting an educational activity for approval from an Accredited Approver. The Individual Activity Applicant must have at least one currently licensed registered nurse prepared at the baccalaureate degree level or higher who functions as the Nurse Planner for the activity. The Nurse Planner is responsible for ensuring that the educational activity is developed according to ANCC Accredited Approver criteria, which are based on ANCC accreditation criteria. Those interested in submitting a CNE activity for approval from an Accredited Approver must complete the eligibility verification process and meet all eligibility requirements. The Accredited Approver is responsible for ensuring that the applicant is eligible to apply. To be eligible to apply for activity approval, the applicant must: Nurse Planner A currently licensed RN with a baccalaureate degree or higher in nursing who is actively involved in all aspects of planning, implementation, and evaluation of each CNE activity. The Nurse Planner is responsible for ensuring that appropriate educational design principles are used and processes are consistent with the requirements of the ANCC Primary Accreditation Program. Be administratively and operationally responsible for coordinating the entire process of planning, implementing, and delivering the CNE activity Have a minimum of one Nurse Planner Nurse Planners must have a current, valid licensed as an RN with a baccalaureate degree or higher in nursing Ensure a qualified Nurse Planner is an active participant in the planning, implementation, and evaluation proves of the CNE activity Have a Planning Committee with a minimum of one Nurse Planner and one other planner to plan each educational activity. The Nurse Planner is knowledgeable about the CNE proves and is responsible for adherence to ANCC Accredited Approver criteria. One planner needs to have appropriate subject matter expertise for the educational activity being offered. Ensure the Nurse Planner is responsible for ensuring completion and review of Biographical/Conflict of Interest forms by each Planning Committee member and each faculty/presenter/author/content reviewer, to ensure appropriate qualifications and evaluation of actual or potential bias Not be a commercial interest as defined in the glossary and the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities Rev. 06/19/13 Continuing Education Manual and Instructions Page 50 of 78 Be in compliance with all applicable federal, state, and local laws and regulations that affect the organization’s ability to meet ANCC accreditation criteria Disclose previous denials, suspensions, and/or revocations of ANCC accreditation or accreditation/approval by any other organization EDUCATIONAL DESIGN PROCESS The Individual Activity Applicant must have a clearly defined process for assessing needs as the basis for planning, implementing, and evaluating CNE. CNE activities are designed, planned, implemented, and evaluated in accordance with adult learning principles, professional education standards, and ethics. Note: Review the Chapter 2: Educational Design Process The Colorado Nurses Association Approval Board will review the activity file to evaluate the following evidence: Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and content expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Conflict of interest disclosure statements from planners Resolution of conflicts of interest for planners, if applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers, if applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to 3 hours of content (Note: If more than 3 contact hours were awarded for the activity, Rev. 06/19/13 Continuing Education Manual and Instructions Page 51 of 78 documentation demonstrating a minimum of 3 hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Number of contact hours awarded for activity, including method of calculation (Provider must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (if applicable) Commercial Support Agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship Agreement with signature and date ( if applicable) Evidence of disclosing to the learner: o Purpose and/or objectives and criteria for successful completion o Presence or absence of conflicts of interest for all members of the Planning Committee, presenters, faculty, authors, and content reviewers o Sponsorship or commercial support (if applicable) o Expiration date (enduring materials only) o Evidence of verbal disclosure (if applicable) Documentation of completion must include: o Title and date of the educational activity o Name and address of provider of the educational activity (Web address acceptable) o Number of contact hours awarded o Individual Activity approval statement o Participant name Representative sample of participant names with unique identifier to be collected (Provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) Note: If a first-time Individual Activity Applicant file is being submitted, a sample certificate of completion containing the Individual Activity approval statement to be used once the activity is approved needs to be included. Rev. 06/19/13 Continuing Education Manual and Instructions Page 52 of 78 RESPONSIBILITIES OF INDIVIDUAL ACTIVITY APPLICANTS Compliance with the responsibilities listed here will be evaluated based on evidence submitted in the required activity file. Awarding Contact Hours Contact hours are determined in a logical and defensible manner. Contact hours are awarded to participants for those portions of the educational activity devoted to the learning experiences and time spent evaluating the activity. One contact hour = 60 minutes. If rounding is desired in the calculation of contact hours, the provider must round down to the nearest 1/10th or 1/100th. Educational activities may also be conducted “asynchronously” and contact hours awarded at the conclusion of the activity. Contact hours may not be awarded retroactively except in the case of a pilot study. Participants in the pilot study assist in determining the length of time required for completing an educational activity in order to calculate the number of contact hours to award. Those participants may be awarded contact hours once the number is determined. Approval Statement for Individual CNE Activities The approval statement must be visible prior to the start of every educational activity and on each certificate of completion. The approval statement must be displayed clearly to the learner, stand alone on its own line of text, and be written exactly as indicated by the Colorado Nurses Association Approval Board. The following approval statement should be used for individual activities one approval has been awarded: This continuing nursing education activity was approved by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation Rev. 06/19/13 Continuing Education Manual and Instructions Page 53 of 78 Documentation of Completion Participants receive written verification of their successful completion of an activity, which includes, at a minimum: Title and date of the educational activity Name and address of provider of the educational activity (Web address acceptable) Number of contact hours awarded Individual Activity approval statement Participant name Commercial Support and Sponsorship The Individual Activity Applicant must adhere to the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities at all times. The Individual Activity Applicant must have a written policy or procedure and a signed, written agreement if commercial support or sponsorship is accepted. Organizations providing commercial support or sponsorship may not provide or co-provide educational activities. Conflicts of Interest The Nurse Planner is responsible for evaluating the presence or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest during the planning and implementation phases of an educational activity. If the Nurse Planner has an actual or potential conflict of interest, he or she should recuse himself or herself from the role as Nurse Planner for the educational activity. Note: Refer to Chapter 2: Educational Design Process, section titled Conflicts of Interest Evaluation and Resolution Rev. 06/19/13 Continuing Education Manual and Instructions Page 54 of 78 Disclosure Responsibilities Disclosures in the Planning Process: Signed Conflict of Interest Disclosure Form. All planners, presenters, faculty, authors, and content reviewers must disclose any conflicts of interest related to planning of an educational activity. Forms must be signed and dated. Disclosure must be relative to each educational activity. If a potential or actual conflict is identified, the planning process must include a mechanism for resolution. Disclosures provided to the Learner: Learners must receive disclosure of required items prior to the start of an educational activity. In live activities, disclosures must be made to the learner prior to initiation of the educational content. In enduring print materials or Web-based activities, disclosures must be visible to the learner prior to the start of the educational content. Required disclosures may not occur or be located at the end of an educational activity. Evidence of the disclosures to the learner must be retained in the activity file. If a disclosure is provided verbally, an audience member must document both the type of disclosure and the inclusion of all required disclosure elements. Disclosures always required include: Notice of requirements for successful completion of the educational activity: Prior to the start of an educational activity, learners must be informed of the purpose and/or objectives of the educational activity and the criteria used to determine successful completion which may include but are not limited to: o Required attendance time at activity (e.g., 100% of activity, or miss no more than 10 minutes of activity) o Successful completion of post-test (e.g., attendee must score X% or higher) o Completed evaluation form o Return demonstration Presence of absence of conflict of interest for planners, presenters, faculty, authors, and content reviewers. Any influencing relationships, or lack thereof, of planners, presenters, faculty, authors, or content reviewers in relation to the educational activity. Individuals must disclose: o Name of individual Rev. 06/19/13 Continuing Education Manual and Instructions Page 55 of 78 o o Name of commercial interest Nature of the relationship the individual has with the commercial interest Disclosures required, if applicable include: Commercial Support. Learners must be informed id a commercial interest has provided financial or in-kind support for the educational activity. Sponsorship. Learners must be informed if an entity has provided financial or in-kind support for the educational activity. Expiration of Enduring Material. Educational activities provided through an enduring format (e.g., print, electronic, Web-based) are required to include an expiration date documenting how long contact hours will be awarded. This date must be visible to the learner prior to the start of the educational content. The period of expiration of enduring material should be based on the content of the material but cannot exceed 3 years. ANCC requires review of each enduring material at least once every 3 years, or more frequently if indicated by new developments in the field specific to the enduring material. Upon review of enduring material for accuracy and current information, a new expiration date is established. Individual Activity Applicant Recordkeeping Individual Activity Applicant is responsible for maintaining documentation for each educational activity in a secure, confidential, and retrievable manner for 6 years. The criteria delineated under the provider’s Educational Design Process (EDP) must be followed consistently during the period of approval, and the recordkeeping files must include the evidence in the form of: Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and content expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Rev. 06/19/13 Continuing Education Manual and Instructions Page 56 of 78 Conflict of interest disclosure statements from planners Resolution of conflicts of interests for planners, of applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers, if applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to 3 hours of content (Note: If more than 3 contact hours were awarded for the activity, documentation demonstrating a minimum of 3 hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Number of contact hours awarded for activity, including method of calculation (Provider must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (if applicable) Commercial Support Agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship Agreement with signature and date (if applicable) Evidence of disclosing to the learner: o Purpose and/or objectives and criteria for successful completion o Presence or absence of conflicts of interest for all members of the Planning Committee, presenters, faculty, authors, and content reviewers o Sponsorship or commercial support (if applicable) o Expiration date (enduring materials only) o Evidence of verbal disclosure (of applicable) Documentation of completion must include: o Title and date of the educational activity o Name and address of provider of the educational activity (Web address acceptable) Rev. 06/19/13 Continuing Education Manual and Instructions Page 57 of 78 o Number of contact hours awarded o Individual Activity approval statement o Participant name Representative sample of participant names with unique identifier to be collected (Provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) Note: If a first-time Individual Activity Applicant, a sample certificate of completion containing the Individual Activity approval statement to be used once the activity is approved needs to be included. Co-Providing Activities for Continuing Nursing Education When an activity is co-provided, the Individual Activity Applicant is referred to as the provider of the educational activity. The other organization(s) are referred to as the co-provider(s) of the educational activity. The co-providing organization may not be a commercial interest or sponsor. The Individual Activity Applicant’s Nurse Planner must be on the Planning Committee and is responsible for ensuring adherence to the ANCC accreditation criteria. When an educational activity is co-provided, the Individual Activity Applicant’s Nurse Planner is responsible for: Signed co-provider agreement Ensuring that the Individual Activity Applicant’s name is prominently displayed in all marketing material and certificate The name(s) of the organizations acting as the co-provider(S) Statement of responsibility of the provider, including: o Determining educational objectives and content o Selecting planners, presenters, faculty, authors, and content reviewers o Awarding of contact hours o Recordkeeping procedures o Developing evaluation methods o Managing commercial support or sponsorship Name and signature of the individual legally authorized to enter into contract on behalf of the Individual Activity Applicant Name and signature of the individual legally authorized to enter into contracts on behalf of the co-provider(s) Date the agreement was signed Rev. 06/19/13 Continuing Education Manual and Instructions Page 58 of 78 Individual Educational Activity Applicant Eligibility Verification Form The Individual Educational Activity Applicant Eligibility Verification form is utilized to verify that organization/individual applying to offer CNE for an educational offering are eligible under ANCC Eligibility Requirements. Organizations deemed ineligible will not be considered for approval by the Colorado Nurses Association. This form requests information on the applicant’s demographic data and the type of organization. All questions must be answered to determine eligibility. Section 1: 1. Name of Applicant: Please note that the applicant name is generally the name of the organization and not the name of the person completing the form. The Applicant name will be listed as the provider of the activity on the certificate and advertising. 2. The Primary Point of Contact is the person through which all communication will be addressed. This person is not required to be a nurse. If the contact person is also part of the planning committee, include his/her name on the planning committee list. 3. A licensed registered nurse with a baccalaureate degree or higher in nursing must be actively involved in all aspects of planning, implementation, and evaluation. The Nurse Planner is responsible for ensuring that appropriate educational design principles are used and processes are consistent with the requirements of the ANCC Primary Accreditation Program. 4. The planning committee must have a minimum of one Nurse Planner and one other planner to plan each educational activity. One planner must have appropriate subject matter expertise. Section 2: This section addresses whether the organization id exempt from ANCC’s definition of a commercial interest. ANCC defines a commercial interest as “any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. Rev. 06/19/13 Continuing Education Manual and Instructions Page 59 of 78 Section 3 and 4: These sections are completed by organizations that are not exempt from the definition of a commercial interest. All questions must be answered to determine eligibility. Section 5: The Statement of Understanding must be completed. Fill in the name of the Applicant in the appropriate locations. All questions must be answered. If you answer “no” to the first question, you ARE NOT eligible for approval. Individual Activity Applicant Eligibility Commercial Interest Addendum The Commercial Interest Addendum needs to be completed only if directed to do so by the Individual Educational Activity Eligibility Verification form. Individual Educational Activity Application Demographic Data: This section includes the title of the event, date form completed, number of contact hours, type of activity, and Names and contact information for the Nurse Planner. You must include the date of the live activity. If the activity is an enduring activity, you must include the start date and expiration date. Assessment of Learner Needs: A. Identify the target audience for the activity. RNs must be included. B. Type of needs assessment method used to plan the event. C. Indicate source of supporting evidence for the needs assessment data. All applicants must be able to access this data upon request. D. Identify the appropriate gap for the intended target audience that the educational activity will address based on the needs assessment data. Organizations may use the Gap Analysis worksheet to identify and validate a gap in knowledge, skills, or practice. This form is not a required part of the application. Qualified Planners and Faculty/Presenters/Authors/Content Reviewers: A. Planning Committee Rev. 06/19/13 Continuing Education Manual and Instructions Page 60 of 78 Planning committees must have a minimum of a Nurse Planner and one other planner to plan each educational activity. The Nurse Planner must have a baccalaureate degree or higher in nursing. Additionally, the Nurse Planner must be knowledgeable of the CNE process and is responsible for adherence to ANCC criteria. One planner needs to have appropriate subject matter expertise. Each member of the planning committee must complete a Biographical and Conflict of Interest form. The completed forms must be included in the activity file as an attachment. Members of the planning committee must complete the section for the planners of the activity. They may also complete the sections for Faculty/Presenters if necessary. Conflict of interest must be evaluated on the Nurse Planner. You must identify who reviewed the conflict of interest information for the Nurse Planner. The Nurse Planner reviews all Biographical and Conflict of Interest forms to determine if a potential conflict or bias exists. If a conflict of interest is identified, resolution is required. You must document the actions taken to resolve the conflict. Identify the Content Reviewer if used as part of the resolution process on each planner’s conflict of interest form. Conflict of interest must also be evaluated for the Content Reviewer. B. Faculty/Presenters/Authors All faculty/presenters/authors must have documented qualifications that demonstrate their education and/or experience in the content area they are presenting. Expertise in a subject matter can be evaluated based on education, professional achievements and credentials, work experience, honors, awards, professional publications, etc. Presenters do not have to be nurses, but nurses should address nursing care and nursing implications, as applicable. You must identify how the needed qualifications of the Faculty/Presenters/Authors are identified and how the qualifications are deemed to be appropriate and adequate. The completed Biographical and Conflict of Interest form needs to be specific to the activity. All Biographical and Conflict of Interest forms must be included as an attachment to the application. The Nurse Planner is responsible for evaluating whether any Faculty/Presenter/Author has a relationship with a commercial interest organization. If a relevant relationship is identified, resolution is required. You must document the actions taken to resolve the conflict. Rev. 06/19/13 Continuing Education Manual and Instructions Page 61 of 78 Identify the Content Reviewer if used as part of the resolution process on each planner’s conflict of interest form. Conflict of interest must also be evaluated for the Content Reviewer. Effective Design Principles: Use the Educational Planning Table to document the items A-E below. A. Identified gaps: Document the type of gap addressed by this activity. B. Purpose: The purpose of the activity must be clearly stated and supported by the needs assessment, objectives, and content. The purpose should be written as an outcome statement related to the learner at the conclusion of the activity. “The purpose of this activity is to enable the learner to…” C. Educational Objectives: Specific objectives for the learning activity are developed collaboratively by the planners and Faculty/Presenters/Authors and must relate to the purpose of the activity. Each objective should be expressed in measurable terms (using a measurable action verb), identify observable actions, and specify on action or outcome per objective. These objectives describe knowledge, skills, and/or practice changes that should occur upon successful completion of the educational activity. The objectives are derived from the overall purpose of the activity. Educational objectives are written statements that describe the learner-oriented outcomes which may be expected as a result of participation in the educational activity. D. Quality of Content and Time Frames: Provide the content for each objective using the Education al Planning Table. The content must be related to and consistent with the objectives and is congruent with the activity goal. Each objective must have a corresponding content outline. Please number content to reflect the objective being addressed. The content must include details beyond a restatement of the objectives. Content should be selected based on the most current available evidence. Documentation should support quality of evidence chosen for content and may include evidence-based practice, Rev. 06/19/13 Continuing Education Manual and Instructions Page 62 of 78 literature/peer-reviewed journals, clinical guidelines, best practices, and content experts/expert opinion. Provide the timeframe for the presentation of the content. Time allotted for the activity should be consistent with the objectives and appropriate for the content being presented. Identify on the Individual Educational Activity Application where content was chosen from and provide the necessary documentation. (For example, the reference of the peer-reviewed journal, clinical guideline). E. Teaching-Learning Strategies: List the methods and instructional strategies used by the Faculty/Presenters/Authors to cover each objective on the Educational Planning Table. The Teaching-learning strategies must be congruent with the objectives and content. Instructional methods that support attainment of the educational objectives must be used. The action indicated as the expected outcome determines the teaching strategies to be used. For example, a learning objective that requires the learner to successfully demonstrate a psychomotor skill should include teaching strategies that use demonstration and return demonstration. Principles of adult learning should be evident in the selected strategies. Teaching methods may include lecture, panel discussion, role play, question and answer, demonstration, practice, specific audiovisuals, etc. **The remaining items under Effective Design Principles are not part of the Educational Planning Table. F. Learner Feedback: Please select the option that represents how learners will be provided feedback. G. Successful Completion: Select the option that best describes how successful completion for the activity is determined. This needs to be consistent with the purpose, objectives, and teaching and learning strategies employed. Provide the rational for the method selected. If partial credit is awarded, provide the details of how credit will be determined. Rev. 06/19/13 Continuing Education Manual and Instructions Page 63 of 78 Criteria for of successful completion must be determined as part of the overall planning of the activity. Educational activities may differ in expectation and requirements. The learner is informed of these criteria prior to participation in the activity. Successful completion may be achieved by a variety of methods. For example, submission of a written post-test and a self-reported level of achievements, return demonstration, attendance at the entire event, etc. H. Awarding Contact Hours: Contact hours are determined in a logical and defensible manner, consistent with the objectives, content, teaching/learning strategies, and target audience. Contact hours may not be awarded retroactively except in the case of a pilot study. A contact hour is a 60 minute hour. The contact hour may be taken to the hundredths but may not be rounded up. Contact hours are only calculated for the time spent on didactic learning or clinical experience. This does not include “Welcome and Introductions” or break times. Evaluation of the activity is included in the calculation of contact hours. Live events: calculate the number of contact hours based on the learning activity, clearly stating the time spent on welcome, introductions, pre/post tests, presentation, clinical experience, breaks, and evaluation. Contact hours are awarded to participant for those portions of the educational activity devoted to didactic or clinical experience or to evaluating the activity. Include a copy of the agenda that clearly defines all aspects of the schedule. The agenda must match the timeframes detailed on the Educational Planning Table. Enduring Materials: Select the method used to calculate contact hours. Provide a description of the method used for calculating contact hours. You must be able to provide the documentation and evidence of how contact hours were calculated if requested. NOTE: Participants in the pilot study assist in determining the length of time required for completing the activity in order to calculate the number of contact hours awarded. Once that number is determined, those participants may be awarded contact hours. I. Verify Participation: Select the option that details how participation at the event was verified. The learner is informed of these criteria prior to participation in the activity. Rev. 06/19/13 Continuing Education Manual and Instructions Page 64 of 78 Evaluation: A. Check or describe the methods of evaluation to be used. Include a copy of the evaluation tool used. A sample evaluation form is available. It is recommended that the evaluation include all learning objectives for the activity as well as evaluation of the speaker/presenter. B. A summative evaluation must be completed as part of the activity. This data must be maintained in the activity file. C. The Nurse Planner and planning committee must review the summative evaluation. You may be required to provide documentation of this on the annual report or during interim monitoring. Approval Statement for Individual CNE Activities: All communications, marketing materials, certificates, and other documents that refer to awarding contact hours or continuing education credit for an individual educational activity must include the approval statement of the accredited organization. The approval statement must be displayed clearly to the learner, stand alone on its own line of text, and be written exactly as indicated by the Colorado Nurses Association. When referring to contact hours, the term “accredited contact hours” should never be used. An organization is accredited or approved; contact hours are awarded. If advertising is to be released prior to approval AND after the application has been submitted, the following statements may be used: This activity has been submitted to the Colorado Nurses Association for approval to award contact hours. The Colorado Nurses Association is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. If advertising is to be released after approval is received, then use the following statement: This continuing nursing education activity was approved by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. A. Identify the type of advertising material to be used. Advertising material includes any method of announcing an educational activity. This material must be provided with the application. If advertising is provided on a website, please include information on where and how to find it. Rev. 06/19/13 Continuing Education Manual and Instructions Page 65 of 78 Also, include a hard copy of the e-mail or website advertising. All finalized copies of advertising materials must be submitted to the Colorado Nurses Association for inclusion in the applicant’s file. Commercial Support and Sponsorship: A commercial interest is defined by ANCC as any entity either producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients or an entity that is owned or controlled by an entity that produces, markets, re-sells or distributes health care goods or services consumed by, or used on, patients. Exceptions are made for non-profit or government organizations and non-health care related companies. Commercial Support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CNE activity. A sponsor is identified as an organization that does not meet the definition of commercial interest. Sponsorship is financial, or in-kind, contributions given by an entity that is not a commercial interest, which is used to pay all or part of the costs of a CNE activity. A. Check this box if the activity did not receive and commercial support or sponsorship. If no commercial support or sponsorship was received, the remaining items under this section do not need to be completed. If the activity did receive commercial support or sponsorship, complete the remaining items. B. Identify the name of the organization that provided commercial support or sponsorship in the first column. In the second column, identify the amount of funding or in-kind support provided. In the final column, identify whether the organization is a commercial interest or noncommercial interest. C. Select the method by which content integrity for the educational offering is maintained. D. Identify the precautions that will be taken to prevent bias in the educational content. E. Include a copy of the commercial support or sponsor agreement. A sample agreement is available. This agreement must include: A statement that the provider of commercial support or sponsorship may not participate in any component of the planning process of an educational activity, including assessment of learning needs, determination of objectives, selection or development of content, selection of presenters or faculty, selection of teaching/learning strategies, and evaluation. Rev. 06/19/13 Continuing Education Manual and Instructions Page 66 of 78 A statement of understanding that the commercial support or sponsorship will be disclosed to the participants of the educational activity. A statement of understanding that the provider of commercial support or sponsorship must agree to abide by the provider’s policies and procedures. Amount of commercial support or sponsorship and description of in-kind donation. Name and signature of the individual who is legally authorized to enter into contracts on behalf of the provider of commercial support or sponsorship. Name and signature for the individual who is legally authorized to enter into contracts on behalf of the provider of the educational activity. Date the agreement was signed. Commercial support, exhibits, sponsorship, or the presentation of research conducted by a commercial company is not permitted to affect the design and scientific objectivity of any educational activity. Commercially-supplied funds for an educational activity are given in the form of an educational grant or in-kind assistance and are acknowledged in the brochures and/or printed material for the activity. Disclosures Provided to Participants: Learners must receive disclosures of required items prior to the start of an educational activity. In live activities, disclosures must be made to the learner prior to initiation of the educational content. In enduring materials (print, electronic, or Web-based activities), disclosures must be visible to the learner prior to the start of the educational content. Required disclosures may not occur or be located at the end of an educational activity. If a disclosure is provided verbally, an audience member must document both the type of disclosure and the inclusion of all required disclosure elements. With respect to this written verification: A representative of the provider who was in attendance at the time of the verbal disclosure must attest, in writing: o That verbal disclosure did occur; and o Itemize the content of the disclosed information or that there was nothing to disclose. The document that verifies that adequate verbal disclosure did occur must be completed within one month of the activity and placed in the file. A. Certain disclosures are always required. Select the appropriate description of how these disclosures are provided to participants: 1. Notice of requirements for successful completion: Learners are informed in advance of the criteria, goals and objectives to be used to determine successful completion of an educational activity. (Note: Not applicable is not an acceptable response.) Rev. 06/19/13 Continuing Education Manual and Instructions Page 67 of 78 2. Conflicts of interest or lack thereof: Learners are informed of any influencing financial relationships or lack thereof disclosed by planners, presenters or content reviewers. You must identify whether a conflict of interest was present and with whom. Additionally, you must select the option that details how the disclosure is provided to the learner. B. The following disclosures may be required, if needed: 3. Commercial support: Learners are made fully aware of the nature of any commercial support related to an educational activity or lack thereof. 4. Sponsorship: Learners are made fully aware of the nature of any sponsorship related to an educational activity or lack thereof. 5. Non-endorsement of products: Learners are advised that approval of the CNE activity does not imply endorsement by the provider, ANCC, or CNA of any commercial products displayed in conjunction with an activity. 6. Expiration date for awarding enduring materials contact hours: The expiration date must be visible to the learner prior to the start of the educational content. Endurable educational documents must include a statement that explains how long contact hours will be awarded for an activity. This statement must appear on all marketing material and on the educational material. Documentation of Completion: Learners receive documentation of successful completion of the educational activities. The document/certificate must include: Name and address of the provider of the educational activity (Web address is acceptable) Title and date of completion of the educational activity Number of contact hours awarded Official approval statement: The approval statement must stand alone, meaning that it should be on a separate line from any other statement, including number of contact hours awarded, or references to ANCC. It must start and end on a line separate from other text. Name of learner Include a copy of the completed certificate to be awarded to learners. A sample certificate is available. Official Approval Statement: This continuing nursing education activity was approved by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Rev. 06/19/13 Continuing Education Manual and Instructions Page 68 of 78 Recordkeeping: A. Recordkeeping requirements for each activity file: Title and location (if live) of activity Type of activity format: live or enduring Date live activity presented or, for ongoing enduring activities, date first offered and subsequent review dates Description of the target audience Method of the needs assessment Findings of the needs assessment Names, titles, and expertise of activity planners Role held by each Planning Committee member (must include identification of the Nurse Planner and Content Expert(s)) Names, titles, and expertise of activity presenters, faculty, authors, and/or content reviewers Conflict of interest disclosure statements from planners Resolution of conflicts of interest for planners, if applicable Conflict of interest disclosure statements from presenters, faculty, authors, and/or content reviewers Resolution of conflicts of interest for presenters, faculty, authors, and/or content reviewers. If applicable Purpose of activity Objectives of activity Evidence of gap in knowledge, skill, or practice for the target audience Content of activity: an Educational Planning Table or other documentation showing up to three hours of content (Note: if more than three contact hours were awarded for the activity, documentation demonstrating a minimum of three hours of content along with the schedule and advertising for the full activity must be submitted for review. The entire content of the activity must be maintained in the provider’s secure files with all other recordkeeping components.) Instructional strategies used Evidence of learner feedback mechanisms Rationale and criteria for judging successful completion Method or process used to verify participation of learners Rev. 06/19/13 Continuing Education Manual and Instructions Page 69 of 78 Number of contact hours awarded for activity, including method of calculation (Individual Activity Applicant must keep a record of the number of contact hours earned by each participant.) Template of evaluation tool(s) used Marketing and promotional materials Means of ensuring content integrity in the presence of commercial support (if applicable) Commercial support agreement with signature and date (if applicable) Means of ensuring content integrity in the presence of sponsorship (if applicable) Sponsorship agreement with signature and date (if applicable) Evidence of disclosing to the learner: o Purpose and/or objectives and criteria for successful completion o Presence or absence of conflicts of interest for all members of the planning committee, presenters, faculty, authors, and content reviewers o Sponsorship or commercial support (if applicable) o Non-endorsement of products (if applicable) o Expiration date (enduring materials only) o Evidence of verbal disclosure (if applicable) Documentation of completion must include: o Title and date of the educational activity o Name and address of provider of the educational activity (Web address acceptable) o Number of contact hours awarded o Approval statement o Participant name Representative sample of participant names with unique identifier to be collected (The provider must maintain all participant data in a safe and secure manner.) Division of responsibilities among co-providers (if applicable) Co-provider agreement with signature and date (if applicable) All correspondence with the Colorado Nurses Association regarding the application and follow-up information. B. Identify the location where records will be filed and stored. Activity file records must be maintained in a retrievable file (electronic or hard copy) accessible to authorized personnel for 6 years. Rev. 06/19/13 Continuing Education Manual and Instructions Page 70 of 78 Co-Providership Co-providership refers to two or more groups working together to plan and present a CNE activity. The groups must each be actively involved in the planning, developing, and implementing of the educational activity. It is very important to clearly define the roles of each group prior to presenting the CNE event. If the activity will not be co-provided, select option A. The remaining items under this section do not need to be completed. If the activity will be co-provided, select option B and attach a signed and dated co-provider agreement. A sample Co-Provider Agreement is available. B. Provide the name of the organization that is co-providing the activity. When an educational activity is co-provided, the Individual Activity Applicant’s Nurse Planner is responsible for: Name of the Individual Activity Applicant is prominently displayed in all marketing material and certificates The names of the organization(s) acting as the co-provider(s) Statement of responsibility of the Individual Activity Applicant, which should include the following: o Determination of educational objectives and content o Selecting planners, presenters, faculty, authors, and/or content reviewers o Awarding contact hours o Recordkeeping procedures o Developing evaluation methods and categories o Management of commercial support or sponsorship Name and signature of the individual legally authorized to enter into contracts on behalf of the Individual Activity Applicant Name and signature of the individual legally authorized to enter into contracts on behalf of the co-provider(s) Date the agreement was signed The person completing this document must sign and date the document. Include the credentials of the person completing the form. Rev. 06/19/13 Continuing Education Manual and Instructions Page 71 of 78 Biographical and Conflict of Interest Form A Biographical and Conflict of Interest Form must be completed for each activity. Every member of the planning committee, presenters, faculty, authors, and content reviewers must complete this form. It is recommended that you use the form provided; however, you may use a form specific to your organization. If using a different form, you must ensure that all the same elements are clearly addressed and defined on the form. Complete the first section of the form with the title of the educational activity, date of the activity, and select the role the person plays in the activity. Section 1: Demographics Data All persons completing this form must complete the demographic data section. Credentials must be provided. Section 2: Expertise – Planning Committee All members of the planning committee must complete this section. You must identify what role the person plays on the planning committee. Additionally, provide a description of the expertise and training that makes this person qualified to be a member of the planning committee. This should be more than a brief statement. Section 3: Expertise – Presenter/Faculty/Author/Content Review This section must be completed by all presenters, faculty, authors, and content reviewers. If a member of the planning committee is also a presenter, both section 2 and 3 must be completed. Once again, provide a description of the expertise and training that makes this person qualified to be a presenter. This should be more than a brief statement. Section 4: Conflict of Interest The potential for conflicts of interest exists when an individual has the ability to control or influence the content of an educational activity and has a financial relationship with a commercial interest, the products or services of which are pertinent to the content of the educational activity. The Nurse Planner is responsible for evaluating the presence or absence of conflicts of interest and resolving any identified actual or potential conflicts of interest during the planning and implementation phases of an educational activity. If the Nurse Planner has an actual or potential conflict of interest, he or she should recuse himself or herself from the role as Nurse Planner for the educational activity. Rev. 06/19/13 Continuing Education Manual and Instructions Page 72 of 78 Commercial interest, as defined by ANCC, is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients, or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. Commercial Interest Organizations are ineligible for accreditation. An organization is NOT a Commercial Interest Organization if it is: A government entity; A non-profit (503(c)) organization; A provider of clinical services directly to patients, including but not limited to hospitals, health care agencies and independent health care practitioners; An entity the sole purpose of which is to improve or support the delivery of health care to patients, including but not limited to providers or developers of electronic health information systems, database systems, and quality improvement systems; A non-healthcare related entity whose primary mission is not producing, marketing or selling or distributing health care goods or services consumed by or used on patients; Liability insurance providers; Health insurance providers; Group medical practices; Acute care hospitals (for profit and not for profit); Rehabilitation centers (for profit and not for profit); Nursing homes (for profit and not for profit); Blood banks; Diagnostic laboratories All individuals who have the ability to control or influence the content of an educational activity must disclose all relevant relationships** with any commercial interest, including but not limited to members of the Planning Committee, speakers, presenters, authors, and/or content reviewers. Relevant relationships must be disclosed to the learners during the time when the relationship is in effect and for 12 months afterward. All information disclosed must be shared with the participants/learners prior to the start of the educational activity. **Relevant relationships, as defined by ANCC, are relationships with a commercial interest if the products or services of the commercial interest are related to the content of the educational activity. Rev. 06/19/13 Continuing Education Manual and Instructions Page 73 of 78 Relationships with any commercial interest of the individual’s spouse/partner may be relevant relationships and must be reported, evaluated, and resolved. Evidence of a relevant relationship with a commercial interest may include but is not limited to receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (stock and stock options, excluding diversified mutual funds), grants, contracts, or other financial benefit directly or indirectly from the commercial interest. Financial benefits may be associated with employment, management positions, independent contractor relationships, other contractual relationships, consulting, speaking, teaching, membership on an advisory committee or review panel, board membership, and other activities from which remuneration is received or expected from the commercial interest. Complete the table detailing all actual, potential, or perceived conflicts of interest. Section 5: Conflict Resolution (to be completed by Nurse Planner) The Nurse Planner must complete section 5 on all Conflict of Interest Disclosure forms except their own. Identify the procedures used to resolve conflict of interest or potential bias. Section 6: Statement of Understanding Both the person completing the form and the Nurse Planner must provide and sign the form. An electronic signature is acceptable. Educational Planning Table The Educational Planning Table may be used to detail the educational offering. Complete all sections on the planning table. Refer to the Activity Application instructions for detailed information on the specific content areas. Co-Provider Agreement A Co-Provider Agreement must be included in the application materials for any activity that is coprovided with another organization. This form is a sample form that may be used. However, you may use a form specific to your organization. If using a different form, you must ensure that all the same elements are clearly addressed and defined on the form. Rev. 06/19/13 Continuing Education Manual and Instructions Page 74 of 78 Refer to the Activity Application instructions for detailed information on Co-Provided activities and requirements. Commercial Support Agreement A Commercial Support Agreement must be completed and included in the application materials for any activity that has received commercial support or sponsorship. This form is a sample form that may be used. However, you may use a form specific to your organization. If using a different form, you must validate that all required elements are clearly documented. Refer to the Activity Application instructions for detailed information on Commercial Support/Sponsorship and requirements. Sample Evaluation Form A copy of the evaluation tool being used by all participants for the activity must be included in the application. A sample evaluation form is available as a separate download from the CNA website. Sample Certificate of Completion A copy of the Certificate of Completion must be included in the activity application. A sample certificate is available as a separate download from the CNA website. Refer to the Activity Application instructions for detailed information on the required elements on the Certificate of Completion. (Adapted with permission from the 2013 ANCC Primary Accreditation Application Manual for Providers and Approvers ©2011 American Nurses Credentialing Center. All rights reserved. Reproduced with the permission of the American Nurses Credentialing center.) Rev. 06/19/13 Continuing Education Manual and Instructions Page 75 of 78 Glossary Bias The tendency or inclination to cause partiality, favoritism or influence. Commercial support Financial or in-kind contributions given by a commercial interest that are used to pay for all or part of the costs of a CNE activity. Providers of commercial support may not be providers or co-providers of an educational activity. Conflict of interest An affiliation or relationship of a financial nature with a Commercial Interest Organization that might bias a person’s ability to objectively participate in the planning, implementation, or review of a learning activity. All planners, reviewers, and faculty/presenters/authors are required to complete Biographical/Conflict of Interest forms. Contact hour A unit of measurement that describes 60 minutes of an organized learning activity. One contact hour = 60 minutes. Content “Subject matter of education activity that relates to the educational objectives.” (Nursing Professional Development: Scope and Standards of Practice, ANA, 2010) Content reviewer An individual selected to evaluate an educational activity during the planning process or after it has been planned but prior to delivery to learners for q2uality of content, potential bias, and any other aspects of the activity that may require evaluation. Continuing nursing education (CNE) activities Those learning activities intended to build upon the educational and experiential bases of the professional RN for the enhancement of practice, education, administration, research, or theory development, to the end of improving the health of the public and RNs’ pursuit of their professional career goals. Rev. 06/19/13 Continuing Education Manual and Instructions Page 76 of 78 Educational objectives Derived from the overall purpose of the activity, educational objectives are written statements that describe learner-oriented outcomes that may be expected as a result of participation in the educational activity. These statements describe knowledge, skills, and/or attitude changes that should occur upon successful completion of the educational activity. Enduring materials A non-live CNE activity that “endures” over time. Examples include programmed texts, audiotapes, videotapes, monographs, computer-assisted learning materials, or other electronic media that are used alone or with printed or written materials. Enduring materials can also be delivered via the Internet. The learning experience by the nurse can take place at any time and in any place rather than only one time or in one place. Key personnel Individuals who contribute to the overall functioning of the Provider unit it a substantive, measurable way, without regard to pay or employment status. Multi-focused organization (MFO) An organization that exists for other purposes in addition to providing CNE. Needs assessment The process by which a discrepancy between what is desired and what exists is identified. Nurse Planner A currently licensed RN with a baccalaureate degree or higher in nursing who is actively involved in all aspects of planning, implementation, and evaluation of each CNE activity. The Nurse Planner is responsible for ensuring that appropriate educational design principles are used and processes are consistent with the requirements of the ANCC Primary Accreditation Program. Planning committee At least 2 individuals responsible for planning each educational activity; one individual must be a Nurse Planner and one individual must have appropriate subject matter expertise. Position description Description of the functions specific to the role of Primary Nurse Planner, Nurse Planner, and key personnel that relate to the Provider Unit. Rev. 06/19/13 Continuing Education Manual and Instructions Page 77 of 78 Primary nurse planner A currently licensed RN with a baccalaureate degree or higher in nursing who is designated as the Primary Nurse Planner and serves as the liaison between the CNA and the Approved Provider Unit. Provider unit Comprises the members of an organization who support the delivery of continuing nursing education activities. Sponsorship Financial or in-kind contribution from an organization that does not fit the category of a commercial interest. (Adapted with permission from the 2013 ANCC Primary Accreditation Application Manual for Providers and Approvers ©2011 American Nurses Credentialing Center. All rights reserved. Reproduced with the permission of the American Nurses Credentialing center.) Rev. 06/19/13 Continuing Education Manual and Instructions Page 78 of 78
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