Criteria & Guidelines for AFFILIATE PROGRAM ACCREDITATION. -- CARE and INFRASTRUCTURE

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1 Criteria & Guidelines for AFFILIATE PROGRAM ACCREDITATION The Cystic Fibrosis Foundation (CFF) Center Committee will consider an application for accreditation of a CF Affiliate Program if it meets all criteria and complies with the Guidelines for Establishment and Administration of Affiliate Cystic Fibrosis Programs as outlined below, and fulfills a geographic and consumer need. -- CARE and INFRASTRUCTURE A CFF Affiliate Program must provide age-appropriate care for pediatric and adult patients in both inpatient and outpatient settings. If the size of the adult patient population meets the criteria for establishing an adult program as outlined in this document, the Affiliate Program is required to develop a sustainable adult care program and submit an application for accreditation of the adult program. For an Affiliate Program treating only pediatric patients, a formal pediatric to adult care transition plan must be in place with a partnering CFF-accredited Center or Program within the local region to provide adult care. If a suitable partner does not exist in the local region, the affiliate is expected to provide age-appropriate care to pediatric and adult patients. CLINICAL CARE GUIDELINES FOR CF All CFF-accredited centers and programs are expected to adhere to the Cystic Fibrosis Foundation s Clinical Practice Guidelines for CF (available on the CFF Web site). MULTI-DISCIPLINARY CARE TEAM & OTHER SPECIALISTS The following required care team members must regularly attend outpatient clinics and team conferences and be available for inpatient consultation or coordination of care with inpatient staff. 1. Director (physician as described below) 2. Associate Director (physician as described below) 3. Clinic Coordinator* (team member other than physician) 4. Dietitian/Nutritionist* (Registered Dietitian) 5. Nurse 6. Respiratory Therapist* 7. Social Worker* The full time equivalents (FTE) outlined below represent the minimum staffing levels necessary to maintain an effective outpatient multidisciplinary team. These guidelines are used to review and accredit care centers by the Cystic Fibrosis Foundation. Guidelines for CFF Center Personnel Time Allotments 1. Physician: 1 Full Time Equivalent (FTE) per patients. Please note there is a minimum requirement of 2 M.D. s per center. 2. Registered Nurse: 1 FTE per patients. 3. Social Worker: 1 FTE per patients. 4. Dietitian: 1 FTE per patients. 5. Respiratory Therapist: 1 FTE per patients. * 101 Document regarding the skills, role and responsibilities of this required Role is available to CFF-accredited Centers and Programs on PortCF in the Resources section under Mentoring Program.

2 Affiliate Program with accredited pediatric and adult care programs must adhere to one of the models listed in Appendix II below. In addition to the above required team members, the team members listed below are also recommended. Administrative Assistant Pharmacist Physical Therapist* Psychologist FACILITIES AND SERVICES 1. Hospital for inpatient care (must be JCAHO approved) 2. Outpatient clinic area 3. Age-appropriate setting for adult patients 4. Personnel and facilities available 24 hours a day, 7 days a week to stabilize patients, assure airway access and prepare critically ill patients for transport as needed. Transport arrangements with that facility must be established. 5. Availability of: a. sweat test by quantitative pilocarpine iontophoresis according to NCCLS guidelines at the Affiliate Program, or at the CF Center if within 50 miles, or screen for CF with the Sweat Check Analyzer and refer all patients with a conductivity value of 50 mmol/l or above to the CF Center for a quantitative sweat test b. Spirometry for inpatient and outpatient services c. Daily, round the clock: 1) blood chemistries, 2) arterial blood gases, 3) medical imaging, 4) respiratory therapy, 5) microbiology laboratory OTHER REQUIREMENTS 1. An Affiliate Program must regularly care for a minimum of 20 CF patients. 2. Written or electronic patient records are to include, but not limited to: a. Documentation of definitive CF diagnosis (i.e., sweat test and genotype) b. Outpatient clinic visit records c. Discharge summaries d. Growth chart (Pediatrics) e. Laboratory data f. Pulmonary function test reports g. Radiology reports 3. The CFF strongly recommends that all sweat test results be reviewed by the Affiliate Pediatric Program Director. 4. Referral plans must be in place for procedures or unique services such as transplantation. 5. All outpatient clinic reports and discharge summaries should be sent to referring physician as appropriate. 6. Minimum of 1/2-day clinic every other week is required. 7. Care team meetings are to occur on a regular basis. 8. There must be annual meetings with the Core Center team. 9. Ongoing accreditation requires annual submission of the CFF Center Grant Application and entry of patient registry data. Site visits by the Core Center to the Affiliate Program are required every other year by the dates 2 Criteria & Guidelines for CFF Affiliate Program Accreditation

3 specified by the Core Center or CFF. The Periodic Status Report (PSR) Form must be submitted for those visits. Centers must also adhere to the CFF Terms and Conditions Governing CF Center Accreditation and CF Center Grants Awarded by the Cystic Fibrosis Foundation. 1. Integration of CF into the core curriculum of your medical school and opportunities for AFFILIATE PROGRAM DIRECTOR QUALIFICATIONS and RESPONSIBILITIES AFFILIATE PROGRAM DIRECTOR The Affiliate Program Director is responsible for providing oversight of the operation of the Program, which includes the coordination of care and administrative requirements. I. Qualifications a. The Program Director must be board certified in Pediatrics, Internal Medicine, Family Medicine or a relevant Pediatric or Medicine Subspecialty with at least 2 years post residency-training and/or clinical experience in the care of cystic fibrosis patients.. b. Board certification in Pulmonary Medicine or Gastroenterology is recommended. However, other subspecialists or board certified pediatricians, internists, or family practitioners also may serve as Directors if their clinical training included the requisite clinical experience in the care of cystic fibrosis patients. II. Care/Administrative Responsibilities The Director provides quality assurance for all aspects of patient care and the operation of the CF program. a. Ensures that CFF requirements relating to sweat testing, microbiology, clinical practice guidelines, continuous quality improvement and all other accreditation criteria are met and maintained. b. It is incumbent upon the Director to ensure that requirements regarding grant application submissions for continued accreditation and funding, and patient registry data entry are met annually. c. Assures that the institution is providing adequate facilities and ancillary support to the CF program. d. Assures that CF personnel (physician and non-physician) are of the highest quality and maintain expertise in cystic fibrosis care. e. Assures that personnel time for the multidisciplinary team allotted to the care of CF patients is appropriate for the CF patient population. f. Assures that all aspects of the agreement with the Core CF Center are met. g. Assures that complete patient data are entered in the CFF Patient Registry annually. h. Assures that consultant arrangements are in place particularly in the areas of Pulmonary (as needed), Gastroenterology and Endocrinology, to provide appropriately experienced caregivers who are knowledgeable in the care of patients with CF. e. Is actively involved in teaching activities related to CF. h. Participates in CF related research or absent an internal research program, works with other CFF-accredited Centers and Programs to provide research participation opportunities to patients and families. 3 Criteria & Guidelines for CFF Affiliate Program Accreditation

4 III. NACFC Attendance Directors must attend the CFF North American CF Conference a minimum of every other year. AFFILIATE PROGRAM ASSOCIATE DIRECTOR I. The Associate Director should have the same or comparable training as the program director so that he/she is fully capable of assuming directorship in the Program Director s absence. Therefore, he/she must be board certified or eligible in Pediatrics, Internal Medicine, Family Medicine or a relevant subspecialty, with at least 1 year post residency-training and/or clinical experience in the care of cystic fibrosis patients. Subspecialty board certification/eligibility is recommended. II. III. This person must be involved on a day-to-day basis with inpatient and outpatient care, attend team conferences, assist the Director in the operation of the Affiliate Program, and have enough understanding of the patient care and administrative aspects of the program to replace the Director during vacations or other periods of absence. It is strongly recommended that Associate Directors attend NACFC a minimum of every other year. 4 Criteria & Guidelines for CFF Affiliate Program Accreditation

5 GUIDELINES for the ESTABLISHMENT and ADMINISTRATION of CFF AFFILIATE PROGRAMS I. INTRODUCTION The purpose of establishing cystic fibrosis Affiliate Programs is to extend the comprehensive care and research protocols of the Cystic Fibrosis Foundation to serve a larger number of patients and families affected by cystic fibrosis. The formation of an Affiliate Program is intended to provide quality care for under-served areas. The core center relationship is intended to provide guidance, support and oversight as the affiliate program develops. Establishing an Affiliate Program also allows physicians who care for 20 or more CF patients to develop a formal affiliation for tertiary care and consulting services with a CFF-accredited Core Center. Geographic need will be strongly considered by the CFF Center Committee when making decisions regarding approval of Affiliate Program relationships and each such application will be judged on its own individual merit. II. DEFINITION An Affiliate Program is defined as one that meets all clinical care requirements including a physician director, associate director, multidisciplinary care team, and inpatient and outpatient facilities, and appropriate support services and personnel to meet the Affiliate Program Criteria. Such programs may not be able to attain fully accredited center status because of patient numbers or an inability to meet teaching and/or research requirements. An outreach program is defined as one where personnel from the CF Center or Program travel to a different location to see patients, thereby, operating the facility as a remote office site. Outreach programs do not qualify for affiliate status. III. ESTABLISHING AN AFFILIATE ARRANGEMENT Affiliate Program relationships may be developed only in collaboration with a fully accredited CF Center in good standing with an approved adult program (Core Center) or one that has a formal, implemented pediatric to adult care transition process in place. These relationships must be approved by the Center Committee. Developing a working relationship between two or more medical institutions is often complex and must be individualized. The following guidelines have been developed to aid in formulating such arrangements. To initiate a successful relationship, the following four basic principles must be met: A. There must be mutual respect between the Core Center and its Affiliate Program. Both parties must feel there is a benefit from such a relationship. B. The financial arrangements between the Core Center and its Affiliate Program(s) must be clearly defined. C. There must be a clear understanding of the circumstances under which caregivers from the Core Center will serve as a clinical resource or provide direct care for patients at the Affiliate Program. 5 Criteria & Guidelines for CFF Affiliate Program Accreditation

6 D. The patients and caregivers in the Affiliate Program must have access to current medical information, referral medical care and research protocols at the Core Center. One of the key roles of a Core Center is to provide educational opportunities for its Affiliate Program(s). An advantage of being an Affiliate Program is the access to information and resources from the CFF. APPLICATION PROCESS Below are the details of the application process for Affiliate Program accreditation. 1. The program seeking Affiliate accreditation will submit a CFF Affiliate Program Application to the CFFaccredited Core Center. a. Affiliate Program Applications may be requested from cffcenterassist@cff.org or the Core Center Director may obtain a copy of the application along with all other materials pertaining to accreditation of an Affiliate Program from PortCF/Resources. 2. The director of the Core Center will then conduct a site visit at the proposed Affiliate Program site. 3. Following the site visit, the Core Director must complete a narrative and critique report of the visit (templates available on PortCF as noted above). 4. If the program fulfills the requirements for affiliate status, both directors must meet to develop a formal agreement and a signed contract/letter of agreement (see Appendix I). The key issues to be included within the agreement are: a. The nature and frequency of interactions between personnel from the Core Center and the Affiliate Program to include routine quality assurance site visits by the Core Center Director to the Affiliate Program as required by section IV of these guidelines, and Affiliate Program personnel visits to the Core for benchmarking and learning purposes to occur at least every other year. The conditions under which patients from the Affiliate Program will have access to medical care in the Core Center and the plans for care of patients who develop the uncommon but expected complications of CF (i.e., pulmonary hemorrhage, liver failure, etc.); Mechanisms for consultative support to the Affiliate Program by the Core Center. b. Educational opportunities to be made available to Affiliate Program personnel and patients; c. Responsibilities of the Core Center and Affiliate Program personnel with regard to recruitment and inclusion of patients from the Affiliate Program in research projects at the Core Center; d. And, a financial agreement. 5. This completed agreement, along with the items below must be submitted via at cffcenterassist@cff.org to the CFF Center Committee for approval of the relationship. a. proposed CFF Affiliate Program s accreditation application, b. care team listing, c. physician CVs, d. pediatric to adult care transition plan, e. research referral plan (if applicable), and f. the Core Center Director s site visit reports (narrative and critiques). IV. PERIODIC QUALITY ASSURANCE SITE VISIT OF AFFILIATE PROGRAM BY CFF CORE CENTER PERSONNEL A complete quality assurance assessment of the Affiliate Program must be conducted for the initial affiliation and repeated in year two of the relationship. If deficiencies are identified, a follow-up quality assurance site visit should be performed within a year. Thereafter, a complete assessment is required every other year. The goal of quality assurance site visits is to review the activities of the Affiliate Program for adherence to CFF 6 Criteria & Guidelines for CFF Affiliate Program Accreditation

7 standards and to learn how the Affiliate s Core Center and the CF Foundation may better support the Affiliate Program as well as the Affiliate/Core relationship. Quality assurance site visits to Affiliate Programs are to be conducted by the Core Center Director (or appropriate Program Director(s) Pediatric and/or Adult depending on the patient population cared for at the Affiliate) and multi-disciplinary care team members as appropriate. The Adult Program Director should participate in the quality assurance site visit of any Affiliate Program with >20 adult patients (see section X.B below). The Pediatric Program Director should participate if the population at the Affiliate cares for primarily pediatric patients. Materials required for the Core Directors to complete site visits to their Affiliate Program(s) are available on PortCF/Resources. Site visit orientation sessions for Core Directors with Affiliates also will be offered as needed at the North American CF Conference. Site visit materials include: A. Periodic Status Report (PSR) which includes the care center team listing to be completed by the Affiliate Program and submitted to the Core Center Director B. Affiliate Program physician CVs to be submitted with the PSR C. Site visit itinerary developed by the Affiliate Program and submitted to the Core Center D. Site visit guidelines for the Affiliate Program E. Site visit guidelines for the Core Directors F. Administration Talking Points for the Core Director G. Care Center Network background materials H. Site visit workbook for the Core Director. This contains the templates for the required narrative and critique reports. The Core Director's site visit to an Affiliate should be conducted in a manner similar to the site visits made by members of the CFF Center Committee using the standard evaluation tools. The following should be assessed during the visit: A. Care team experience and availability for Affiliate Program clinics and other activities; 1. physician and team availability to patients for routine and acute care visits; 2. institutional support; and 3. facilities. B. Ten patient charts should be reviewed for documentation of team involvement in patient care and adherence to standards of care. This chart review should reflect a mix of adult and pediatric patients. C. The Core Center/Program Director and the Affiliate Program Director should discuss the visit and jointly set goals for improvement in patient care, education, and research. D. Subsequently, a letter and critique report summarizing the visit should be sent to the Affiliate Program Director with a copy provided to the Center s Adult Program Director. A copy of the letter and critique report must also be submitted to the CF Foundation either as an attachment to the Core s CFF annual center grant application update or ed to cffcenterassist@cff.org. The CFF should be provided the opportunity to participate in summation meetings with Core and Affiliate Directors at the end of the Core Center visit to the Affiliate Program via conference call or Web conferencing if so requested by either the Core Center or Affiliate Program. A site visit by the CFF Center Committee to the Affiliate Program may be requested under special circumstances by either the Core Center or Affiliate Program. Such requests must be made in writing and will be considered by the Center Committee. 7 Criteria & Guidelines for CFF Affiliate Program Accreditation

8 V. REPORTING The Core Center must assure that Affiliate Program patient registry data are entered into Port CF, and IRB approval and informed assents/consents have been secured and documentation is readily available. The Core Center Director will receive a copy of the program specific registry data report on the Affiliate Program. Information on interaction with and status of the Affiliate Program must be included in the Core Center s annual center grant application update. VI. FINANCIAL ARRANGEMENT The Core Center and Affiliate Program must agree on a financial arrangement with respect to the Center Grant. The CFF will make separate payments to each program, if so directed. Alternatively, the funds can be directed to the Core Center for disbursement to the Affiliate Program. The CFF Grants Office will issue an Award Designation letter to all program directors in May of each year which allows directors to choose how the funds should be disbursed for the following grant year. The Core Center may retain funds for documented administrative costs relating to the Affiliate Program, including costs of travel to the site for clinical care, patient and team education, shared personnel such as registry coordinator at the Core Center who also enters Affiliate Program patient data, and quality assurance site visits. A. The Affiliate Program should receive a mutually agreed upon remuneration commensurate with its patient census. A portion of this money must be used for the Affiliate Program Director or his/her designee to attend the annual North American CF Conference (see Criteria). B. If CFF makes direct payment to the Affiliate Program, the Affiliate Program Director is responsible for submitting an annual Expense Report to the CFF describing the use of funds. C. If Affiliate funds are paid to the Core Center, it is the responsibility of the Core Center to record all funds transferred to the Affiliate Program(s) on the annual Center Financial Reporting Form. D. Affiliate Program agreements should be reevaluated annually. VII. PATIENT CARE CONSULTATIONS The conditions under which the Core Center will be the primary consultant and provide referral service for patients from the Affiliate Program must be established for patients of all ages and conditions (i.e., pregnancy, surgical emergencies, etc.). It is recommended that the Core Center serve as the primary referral center for patients with CF-related problems needing referral care unless patients need a service which is not available at the Core Center (e.g., transplantation). 8 Criteria & Guidelines for CFF Affiliate Program Accreditation

9 VIII. EDUCATIONAL PROGRAMS The Core Center is responsible for education/training of Affiliate Program personnel. It is important that the Affiliate Program personnel be invited to attend and participate in relevant educational opportunities, such as conferences, grand rounds, patient information days, etc. A mutual exchange on teaching cases is also beneficial. It is expected that members of the Core Center and Affiliate Program teams "network" so that each Core Center team member can provide up-to-date medical information to the corresponding Affiliate Program team member on a routine basis. Affiliate Program multi-disciplinary team members should attend the CFF North American CF Conference on a regular basis. IX. RESEARCH Affiliate Programs may apply for Therapeutic Development Network designation and funding. In cases where Affiliate Programs do not have the infrastructure for a research program, a formal referral plan for patients of Affiliate Programs to participate in research at the Core Center must be developed and implemented between the Affiliate Program and the Core Center. All Affiliate Program patients should be encouraged to participate in research protocols of the Core Center (if geographically feasible). The Core Center should provide copies of protocols and consent forms to Affiliate Program personnel in a timely manner to allow submission of documents to the IRB of the Affiliate Program s institution for effective recruitment of patients. X. OTHER REQUIREMENTS A. At the time of the Core Center s site visit by the CFF Center Committee, the director of the Affiliate Program will be expected to participate in the visit, either in person or by phone, depending on geographic considerations. B. The Adult Program Director of the Core Center is to be involved with all Affiliate Program relationships when the Affiliate Program is not exclusively a Pediatric Program. The Adult Program Director should participate in the quality assurance site visit of any Affiliate Program with >20 adult patients. This contact will facilitate subsequent telephone conversations on adult issues (e.g., pregnancy) and will ease the referral of adults to the CF Center, when necessary. Furthermore, the Adult Program Director may be able to assist in the identification of internists or pulmonologists at the Affiliate location to assist with the day-to-day management of patients. Affiliate Programs that follow 40 or more CF patients over the age of 21 must have an adult program which meets one of the models for approved adult programs (Models II, III, IV, V see Appendix II). Those with less than forty but more than twenty CF patients over the age of 21 must have an Adult Program which at least meets Model I for adult care. Affiliates with less than 20 CF patients over the age of 21 should ensure that, each patient has an adult medicine specialist as a primary care provider. XI. SUMMARY The benefits of an Affiliate Program arrangement include improved access to quality CF care for people with CF who might otherwise be unable to receive care within the CFF-accredited center network and a broader patient base for clinical trials and patient registry data. Open communication will minimize problems such as personality conflicts, competition between Core Center and Affiliate Program personnel and conflicts between institutions, which can be detrimental to an ongoing Affiliate Program agreement. 9 Criteria & Guidelines for CFF Affiliate Program Accreditation

10 Appendix I * SAMPLE ** LETTER OF AGREEMENT BETWEEN CFF CORE CENTER AND AFFILIATE PROGRAM The parties identified herein above agree as follows: 1. The Cystic Fibrosis Center at (referred to below as the Center) agrees to maintain an Affiliate Program at (referred to below as the Affiliate). 2. The Affiliate Program will be directed by Dr. under the supervision of Dr., Director of the Cystic Fibrosis Center/Program at. 3. The administration (or Department of Pediatrics, etc.) of (Affiliate) commits itself to support the director of the Affiliate Program so that he/she may provide optimal care to patients with cystic fibrosis. The administration agrees to provide an equally qualified replacement should the director leave. 4. The director of the Center will be notified of changes in procedures, operations or staffing of the Affiliate which relate to the Affiliate Program criteria of the Cystic Fibrosis Foundation (CFF). 5. Patients will be cared for at the Affiliate for both outpatient and inpatient care. Or, patients will have the option of being admitted to either the Affiliate or the Core Center. Or, another scenario which fits the situation and is mutually agreed upon. 6. It will be the responsibility of the Core Center to ensure that the Affiliate Program reports on its patients to the CFF (PLEASE NOTE: The Center Director and the Affiliate Director should discuss and agree upon a financial agreement as part of the process of entering into the Affiliate arrangement. The financial agreement may be part of this Letter of Agreement or may be a separate document.) 7. The Core Center will provide consultative services, educational support and training to the Affiliate. The Affiliate Program will direct all consultations to the Core Center unless other arrangements are specifically agreed upon by the Center and Affiliate Directors. Educational activities hosted by the Core Center will be attended by physicians and CF care teams. 8. Routine site visits by the director of the Core Center and/or person(s) designated by him/her will take place at a time agreeable to both parties. During this site visit all aspects of cystic fibrosis care at the Affiliate will be reviewed. 9. Schedule for Affiliate Program personnel to visit the Core Center at least every other year for quality improvement and educational purposes must be outlined in this agreement. 10 Criteria & Guidelines for CFF Affiliate Program Accreditation

11 10. The Affiliate Program Director will be available (in person or by phone) for CFF site visits to the Core Center. 11. Patients at the Affiliate will have the opportunity to participate in research projects conducted by the Core Center. A formal research referral process must be developed and implemented between the Core Center and Affiliate Program and included in this agreement. Signature of Affiliate Program Director Date Signature of Affiliate Program Hospital Administrator (Department Chairman) Date Signature of CFF Core Center Director Date Signature of Core Center Hospital Administrator (Department Chairman) Date 11 Criteria & Guidelines for CFF Affiliate Program Accreditation

12 APPRENDIX II ADDITIONAL CRITERIA FOR ADULT CARE Active transition of patients to adult care should occur between the ages of years. At least 90% of adult patients at the center past their 21 st birthday must be transitioned to the Adult Program. All Centers and Programs must provide CF care to adults that conforms to one of the five acceptable models below. Centers and Programs with 20 patients, 18 years old or greater, as confirmed by the CF Foundation Patient Registry, who are cared for in the Adult CF Program and meets the criteria established for Models II, III or IV may apply for accreditation. Centers and Programs with > 40 patients past their 21 st birthday must have an accredited Adult Program that meets the criteria described in Models II, III or IV below. Model I. Model I is acceptable for use by Programs with less than 40 CF patients past their 21 st birthday; however, this model does not meet the criteria for attaining an accredited Adult Program. a. All adult patients have an adult care specialist as a primary care provider. b. CF-specific care is provided by the local CFF-accredited Program team. c. Adult patients are evaluated in adult-specific clinics for routine CF Program visits. d. Programs with > 20 adult CF patients are strongly encouraged to identify an adult care provider to attend the adult clinic, with the understanding that this individual will begin to develop expertise to become the Adult Program Director as the adult population grows. e. An age-appropriate setting is required for inpatient care. Model II. a. The Adult Program Director and other Adult Program physicians provide CF inpatient and outpatient care to all patients in the Adult Program. b. CF Affiliate team and coordinator have adult CF experience and routinely interface with the adult Program physicians. c. Outpatient care is provided in either adult clinic areas or pediatric clinics with adults during designated times for adults. d. Adult Program Director or partner sees patients for sick visits. e. The Adult Program Director, Associate Director or partners, fellows or coordinator respond to patient calls. f. Patients are hospitalized on an adult unit or in an adult hospital. Model III. Model IV. Model V. Same as #2 above except: a. There is a separate coordinator for the Adult Program. Same as #2 above except: a. A separate adult team and coordinator provide team care. b. Outpatient care is provided in the adult outpatient department. In certain cases, the CF Foundation will consider a pediatric to adult care transition between a pediatric Affiliate Program and the Adult Program at the core center or to a CFF-accredited Affiliate Adult Program. These relationships will be considered on a case-by-case basis by the 12 Criteria & Guidelines for CFF Affiliate Program Accreditation

13 CFF Center Committee when they do not pose a logistical burden to CF patients and no other practical options are available. 13 Criteria & Guidelines for CFF Affiliate Program Accreditation