PH Care Centers

Accreditation Criteria

Pulmonary Hypertension Care Centers (PHCCs) will be designated as either a PHA-accredited Center of Comprehensive Care (CCC) or a PHA-accredited Regional Clinical Program (RCP) based on a number of factors, including quality and depth of resources available for the expert care of their PH patients, as well as the array of therapies offered by the Center. This two-level system stems from an acknowledgement that some PH care providers are qualified to correctly diagnose and initiate first line treatment in less sick PH patients with subsequent referral to a CCC for a more advanced therapies, when necessary.

It should be stressed that both CCCs and RCPs will be accredited by PHA after undergoing a thorough evaluation and satisfactorily meeting the respective criteria set forth in the table below. In turn, all PHA-accredited Centers will be expected to uphold the principles of delivering appropriate and effective care to PH patients outlined in the PHCC Charter Document.

If you have any feedback, comments or concerns that you would like to provide to the PHCC initiative leadership, please email gro.noitaicossAHP@CCHP.

PHA Centers of Comprehensive Care PHA Regional Clinical Program

Center Director

 Must have completed Fellowship in pulmonary medicine, critical care medicine, and/or cardiology Must have completed Fellowship in pulmonary medicine, critical care medicine, and/or cardiology
Should be board certified in pulmonary medicine, critical care medicine, and/or cardiology Should be board certified in pulmonary medicine, critical care medicine, and/or cardiology
Must have a minimum of two (2) years experience treating PAH after fellowship Must have a minimum of two (2) years experience treating PAH after fellowship
Must be an active participant (Organizing/Steering Committee, Presenting/Speaking, Poster Presenter, etc.) in at least one of the following in the last three (3) years:

  • Regional Meetings;
  • National Meetings;
  • International Meetings; or
  • PH Task Force
 Must be an active participant (Organizing/Steering Committee, Presenting/Speaking, Poster Presenter, etc.) and attended at least 1 in the prior year

  • Regional Meetings
Must be involved in PH-related education exemplified by some of the following endeavors:

  • Educating Center and Hospital Staff
  • Mentoring Trainees
  • Involved in Community Outreach
  • PH-related Committee Work
 Must provide ongoing education/mentoring of staff
Should be a member of Pulmonary Hypertension Clinicians and Researchers (PHCR) Should be a member of Pulmonary Hypertension Clinicians and Researchers (PHCR)
Should have completed thirty (30) hours of CME related to PH over the past 3 years (attending and/or presenting) Should have completed twenty (20) hours of CME related to PH over the past 3 years (attending and/or presenting)
See “Facilities” section below When appropriate, Director collaborates and co-manages patients with a regional CCC

  • Advanced medical therapies
  • Advanced surgical interventions
  • Investigational protocols

Center Coordinator

 Must be an allied health professional employed by the CCC, practice or institution

  • ≥ 1.0 FTE (can be satisfied by more than one person)
 Must be an allied health professional employed by the RCP, practice, or institution

  • ≥ 0.25 FTE
Must be a RN, APRN, PA, RRT or Pharmacist Must be a RN, APRN, PA, RRT or Pharmacist
Must be proficient in disease state and with all PAH therapies (oral, inhaled, IV/SQ) and delivery devices

Must also be knowledgeable about the approval, initiation and maintenance of all PAH therapies

 Must be proficient in disease state and with all oral PAH therapies

Must also be knowledgeable about the approval, initiation and maintenance of oral PAH therapies
Must be an active participant in regional / national / international PH congresses (one or more of the following occurred within the preceding three [3] years):

  • Task Force Membership
  • Organizing/Steering Committee
  • Presenting/Speaking (oral, poster, meet-the-expert, CME, etc.)
 Must be an active participant (Task Force Membership, Organizing/Steering Committee, Presenting/Speaking, etc.) in regional PH congresses
Should be involved in PH-related education exemplified by some of the following endeavors:

  • Educating Institution’s Staff
  • Educating Allied Healthcare Practitioners
  • Promotion of Medical and General Community Disease Awareness
  • Involvement in PH Support Group Activities
 Should provide ongoing education/mentoring of staff
Should be a member of the Pulmonary Hypertension Professional Network (PHPN) Should be a member of the Pulmonary Hypertension Professional Network (PHPN)
Should have completed 12 hours of CME/CEU related to PH over the past 3 years (attending and/or presenting) Should have completed 12 hours of CME/CEU related to PH over the past 3 years (attending and/or presenting)

Program Staff and Support Services

 Physicians’ effort towards PH program, including clinical care, clinical research, and administrative duties, should total at least 0.75 FTE

  • Director’s efforts towards PH program should be at least 0.5 FTE
 Not applicable
Should actively be managing a substantial cohort of patients

  • ≥ 75 patients with either Group I or Group IV PH diagnosis (Simonneau G, et al. J Am Coll Cardiol. 2013; 62(25S): 34-41; http://www.ncbi.nlm.nih.gov/
    pubmed/24355639)
  • Mitigating factors will be taken into consideration (e.g., regional population, Center catchment area, proximity to other Centers, duration of Center’s existence, tenure of Center director etc.)
 Should actively be managing a minimum of 25 patients
Must follow available diagnosis and treatment consensus guidelines when possible1 Must follow available diagnosis and treatment consensus guidelines when possible1
Must have proficiency and experience with all PAH therapies (oral, inhaled, parenteral) Must have proficiency and experience with all non-parenteral PAH therapies
Must have adequate experience prescribing and managing parenteral prostanoid infusions.

  • Managing ≥ 20 infusion patients over preceding 3 years
 Not applicable
Program support staff FTE must be commensurate with the program’s volume of patients and adequate to manage the program’s patients on parenteral therapies Program support staff FTE must be commensurate with the program’s volume of patients and adequate to manage the program’s patients on PAH-specific therapies
Pulmonary and/or Cardiology service on-call 24/7† Pulmonary and/or Cardiology service on-call 24/7†
Rheumatology consultation† Rheumatology consultation‡
Social work‡ Social Work‡
Dietary / Nutritional service‡ Dietary / Nutritional services‡
Cardiac Anesthesia†
Pulmonary transplant service or referral process†
Congenital heart disease consultant or referral process†
PTE service or referral process†
Coagulation service‡
Palliative care service‡
Pulmonary and/or cardiac rehabilitation on site‡
Center staff must have published at least one PH-related publication within the last 5 years in a peer-reviewed journal in the field of pulmonary vascular disease

Facility

 Members of the PH Center must be directly involved with care of the CCC’s inpatients Members of the PH Center must be directly involved with care of the RCP’s inpatients
Must have inpatient wards with specially-trained staff and specific protocols for managing PAH, including chronic prostacyclin infusion Not Applicable
Must have ICU facilities (within affiliated hospital) with specially trained staff and specific protocols for managing PAH, including chronic prostacyclin infusion Must have ICU facilities (within affiliated hospital)
Must have cardiac catheterization laboratory

  • Must have experience with acute vasodilator testing using inhaled nitric oxide, prostacyclin or adenosine
 Must have cardiac catheterization laboratory

  • Must have experience with acute vasodilator testing using inhaled nitric oxide, prostacyclin or adenosine
Either the PH program director or a designated physician must perform or preside over right heart catheterization and must personally review tracings Either the PH program director or a designated physician must perform or preside over right heart catheterization and must personally review tracings
Must have an echocardiography laboratory with experience in PH

  • The echocardiography laboratory should have accreditation by the Intersocietal Accreditation Commission
 Must have an echocardiography laboratory with experience in PH

  • The echocardiography laboratory should have accreditation by the Intersocietal Accreditation Commission
Must have a pulmonary function laboratory Must have a pulmonary function laboratory
Must be able to perform Exercise Testing (e.g., 6-Minute Walk, CPET, treadmill test, or other)

  • Must display manual of procedures and provide report document
 Must be able to perform Exercise Testing (e.g., 6-Minute Walk, CPET, treadmill test, or other)

  • Must display manual of procedures and provide report document
Must have a pharmacy with access to and proficiency with parenteral prostacyclin agents.

  • Pharmacy staff must be proficient with preparation of prostacyclin infusions
 Not Applicable
Must have an active Radiology department with experience in PH:

  • Vascular access for placing and helping manage chronic indwelling catheters, if parenteral therapy prescribed (unless performed by institution’s Surgery Department)
  • Thoracic Radiology
  • Nuclear Medicine (for performance and interpretation of V/Q scans)
 Must have an active Radiology department with experience in PH:

  • Vascular access for placing and helping manage chronic indwelling catheters, if parenteral therapy prescribed (unless performed by institution’s Surgery Department)
  • Thoracic Radiology
  • Nuclear Medicine (for performance and interpretation of V/Q scans)
Must have system in place to assure patient confidentiality Must have system in place to assure patient confidentiality
Should accept patients insured by Medicare & Medicaid Should accept patients insured by Medicare & Medicaid
Must have institutional support for the PH Program Must have institutional support for the PH Program
Should have the ability to accept transfer of referred patients via an expedited route

  • Assistance to nearby RCPs, including the acceptance of patients in need of advanced PAH therapies, should be provided when requested
 Not Applicable

Research

 *CCC demonstrates a strong commitment to clinical research, as a part of the larger PH community’s efforts to improve outcomes and find a cure.*
Center staff (physicians and/or coordinators) must have actively participated in at least three (3) separate IRB-approved PH clinical investigations within the previous three (3) years.

  • May include sponsored research or institutional initiated single or multi-center studies
  • May include therapeutic or non-therapeutic investigations (e.g. pharmacologic, non-pharmacologic, genetic, epidemiologic, or mechanistic studies)
  • One of the three IRB-approved studies may be a multi-center registry
  • Active participation requires enrollment of subjects into at least one of the aforementioned clinical investigations, other than a registry
  • Program staff (physicians and coordinators) must show evidence of current human subjects research training (e.g. CITI modules and/or local institutional required training)
 Not applicable
Must have research staff actively participating in PH research

  • At least one phase 2 or 3 PH clinical investigation and/or non-industry investigation in the past three (3) years.
Should have access to an Investigational Drug Service
Must have institutional IRB or the ability to use outside (central) IRB
Center staff must have published at least one PH-related publication within the last 5 years in a peer-reviewed journal in the field of pulmonary vascular disease
1 – a) V/Q scans to exclude CTEPH; b) right heart catheterization to confirm PAH diagnosis; c) Acute Vasodilator Testing in IPAH patients (or document valid reason for not performing); and d) Parenteral prostacyclins for WHO FC IV patients (or document valid reason for not using)
† – Must have resources or established referral pattern
‡ – Should have resources or established referral pattern
* – Criteria subject to modification
PH Congresses – implies meetings such as ACCP, ATS, ISHLT, PHA, PVRI, etc.

PHA Centers of Comprehensive Care PHA Regional Clinical Program

Center Director

 Must be board certified in pediatric pulmonary medicine, critical care medicine, cardiology, or neonatology

TBA

↓

Must have a minimum of 4 years of experience treating pediatric PAH and actively be managing a substantial cohort of PAH patients under the age of 18 (one of the years may have been specialized fellowship training in pulmonary hypertension
Must be an active participant (Organizing/Steering Committee, Presenting/Speaking, Poster Presenter, etc.) in at least one of the following in the last three (3) years:

  • Regional Meetings;
  • National Meetings;
  • International Meetings; or
  • PH Task Force
Must be involved in PH-related education exemplified by some of the following endeavors:

  • Educating Center and Hospital Staff
  • Mentoring Trainees
  • Involved in Community Outreach
  • PH-related Committee Work
Should be a member of Pulmonary Hypertension Clinicians and Researchers (PHCR)
Should have completed twenty five (25) hours of CME related to PH over the past 3 years (attending and/or presenting)
See “Facilities” section below

Center Coordinator

 Must be an allied health professional employed by the CCC, practice or institution

  • ≥ 1.0 FTE (can be satisfied by more than one person)
Must be a RN, NP, or PA
Must be proficient in disease state and with all PAH therapies (oral, inhaled, parenteral) and delivery devices

Must also be knowledgeable about the approval, initiation and maintenance of all PAH therapies
Must be an active participant in regional / national / international PH congresses (one or more of the following occurred within the preceding three [3] years):

  • Task Force Membership
  • Organizing/Steering Committee
  • Presenting/Speaking (oral, poster, meet-the-expert, CME, etc.)
Should be involved in PH-related education exemplified by some of the following endeavors:

  • Educating Institution’s Staff
  • Educating Allied Healthcare Practitioners
  • Promotion of Medical and General Community Disease Awareness
  • Involvement in PH Support Group Activities
Should be a member of the Pulmonary Hypertension Professional Network (PHPN)
Must have completed 12 hours of CME/CEU related to PH over the past 3 years (attending and/or presenting)

Program Staff and Support Services

 Physicians’ effort towards PH program, including clinical care, clinical research, and administrative duties, should total at least 0.75 FTE
Should actively be managing a minimum of 75 PH patients with at least 50 patients classified as Group I PAH and at least 20 patients classified as Group 3 PH e.g. BPD, CDH

    • A deidentified list of Group I (PAH), their type of PAH and diagnostic workup, and the class of PAH therapy used (oral, inhaled, IV/SC) must be provided
    • Must demonstrate proof of outpatient follow-up, screening protocol and a multidisciplinary team approach for Group 3 patients
    • If a Center’s census falls slightly below this range, a number of other factors will be taken into consideration, including:
      • Duration of Center’s existence
      • Tenure of Director at the Center
      • Number and proximity of additional PH Centers near the candidate Center
      • Regional population and Center’s catchment area
    • Ultimate accreditation decision will rely on the Center’s overall application
Should follow available diagnosis and treatment consensus guidelines when possible1
Must have proficiency and experience with all PAH therapies (oral, inhaled, parenteral)
Must have adequate experience prescribing and managing parenteral prostanoid infusions.

  • Managing ≥ 16 outpatient infusion patients, over preceding 4 years, of which at least half included an intravenous prostanoid infusion
Program support staff FTE must be commensurate with the program’s volume of patients and adequate to manage the program’s patients on parenteral therapies
On-call PH service 24/7†
Pediatric Rheumatology consultation†
Social work‡
Dietary / Nutritional service‡
Pediatric Anesthesia with extensive PH experience†
Pulmonary/Cardiac transplant service or referral process†
Congenital heart disease specialist†
Congenital heart surgeon†
Neonatal/Pediatric critical care services† for the management of infants and children with all forms of PH
Pediatric Pulmonary consultation†
Pediatric Surgery consultation†
Experienced Central Line placement and repair personnel with PH experience†
Coagulation service‡
Palliative care service‡
Pediatric exercise test specialist‡

Facility

 Members of the PH Center must be directly involved with care of the CCC’s inpatients
Must have inpatient pediatric wards with specially-trained staff and specific protocols for managing PAH, including chronic prostacyclin infusion
Must have ICU facilities including NICU and PICU (within affiliated hospital) with specially trained staff and specific protocols for managing PAH, including chronic prostacyclin infusion
Must have cardiac catheterization laboratory

  • Must have experience with acute vasodilator testing using inhaled nitric oxide, prostacyclin or adenosine
Either the PH program director or a designated physician should perform or preside over right heart catheterization and must personally review tracings
Must have an echocardiography laboratory with experience in PH

  • The echocardiography laboratory should have accreditation by the Intersocietal Accreditation Commission
Must have a pulmonary function laboratory
Must be able to perform Exercise Testing (e.g., 6-Minute Walk, CPET, treadmill test, or other)

  • Must display manual of procedures and provide report document
Must have a pharmacy with access to and proficiency with parenteral prostacyclin agents.

  • Pharmacy staff must be proficient with preparation of prostacyclin infusions
Must have an active Pediatric Radiology department with experience in PH
Must have the ability to perform pulmonary thromboendarterectomy or refer for surgical treatment
On site ability to deliver inhaled Nitric Oxide
Must have system in place to assure patient confidentiality
Should accept patients insured by Medicare & Medicaid
Must have institutional support for the PH Program
Should have the ability to accept transfer of referred patients via an expedited route

Research

 *CCC demonstrates a strong commitment to clinical research, as a part of the larger PH community’s efforts to improve outcomes and find a cure.*
Center staff (physicians and/or coordinators) must have actively participated in at least one (1) phase 2 or 3 IRB-approved PH clinical investigation within the previous three (3) years.

  • Enrollment in therapeutic (e.g. pharmacologic or non-pharmacologic) or non-therapeutic investigations (e.g. genetic, epidemiologic, or mechanistic studies that are not clinical trials)
  • Inclusive of locally-initiated, single-center projects
  • Requirements cannot be satisfied by observational registries.
Must have research staff actively participating in PH research

  • At least one phase 2 or 3 PAH clinical investigation and/or non-industry investigation in the past five (5) years.
Should have access to an Investigational Drug Service
Must have institutional IRB or the ability to use outside (central) IRB
Center staff must have published at least one PH-related publication within the last 5 years in a peer-reviewed journal in the field of pulmonary vascular disease
1 – a) V/Q scans to exclude CTEPH; b) right heart catheterization to confirm PAH diagnosis; c) Acute Vasodilator Testing in IPAH patients (or document valid reason for not performing); and d) Parenteral prostacyclins for WHO FC IV patients (or document valid reason for not using)
† – Must have resources or established referral pattern
‡ – Should have resources or established referral pattern