Pulmonary Hypertension Care Centers Instructions for Applicants

advertisement
PULMONARY HYPERTENSION CARE CENTERS
INSTRUCTIONS FOR APPLICANTS
The purpose of the Pulmonary Hypertension Care Centers (PHCC) initiative is to establish a program of
accredited centers with expertise in pulmonary hypertension that aspires to improve overall quality of care
and ultimately improve outcomes of patients with pulmonary hypertension, particularly pulmonary arterial
hypertension, a rare and life-threatening disease.
ACCREDITATION PROCESS
Introduction
The process of PHCC accreditation by the Pulmonary Hypertension Association (PHA) is designed to reflect
the overall goals and objectives of the PHCC program and aims to balance high quality of patient care with
appropriate access/availability of care for patients. The accreditation process is designed to give
stakeholders (patients, providers and medical institutions/practices) a clear awareness of expectations.
Accreditation decisions are at the programmatic level and aims to identify the involved individuals,
resources, facilities, and performance. Goals of the PHCC program are to assist in directly or indirectly
ensuring that adequate resources are available at each site, to help facilitate quality improvement processes
by raising the level of care for PAH patients, to improve access to expert PH care, to foster collaboration
between PHCCs, to provide guidance for prospective programs desiring to become a PHCC, and to grow the
PH community.
A PHCC will be designated as a PHA-accredited “Center of Comprehensive Care” (CCC) or a PHA-Accredited
“Regional Clinical Program” (RCP) based on the spectrum of resources available and therapies offered by
the program. The PHCC accreditation criteria focus on the evaluation of PH patients, diagnosis of PAH, and
appropriate use of therapies for Group I (PAH) patients. The criteria emphasize appropriate staff and facility
resources, diagnostic evaluations of PH patients (based upon published consensus guidelines), access to
PAH specific therapy, and experience in treating PAH. Participation in clinical research is also a focus area
for CCC level PHCCs. All PHA-accredited PHCCs will be expected to uphold the principles of delivering
appropriate and effective care to PH patients. Collaboration between the RCPs and CCCs is highly
encouraged.
Page 1 of 28
PHA STAFF AND PHCC COMMITTEE ROLES AND RESPONSIBILITIES
PHA Pulmonary Hypertension Care Centers Staff

Reviews accreditation applications to ensure completion, check for inconsistencies, process
applications, coordinates scheduling site visits.

Communicates with each site on behalf of the Review Committee.

For all inquiries, please contact:
PHCC Program Staff
Email: PHCC@phassociation.org
Telephone: (301) 565-3004 extentions:778; 804; 770
PHCC Review Committee (RC)

Reviews applications, clarifies ambiguity in application answers, and determines program
eligibility for a site visit. Provides direct communication to each program regarding
accreditation decisions.

Two members of the PHCC RC (one physician and one coordinator) perform a one day site visit
to meet key personnel and inspect the facilities, ensure accuracy of the application, perform
patient chart review to assess diagnostics and treatment and gauge the overall commitment of
the staff and the institution. The site visitors complete evaluation documentation and summary
reports for the RC to review.

Determines which applicants warrant accreditation as a CCC or a RCP and those with
deficiencies that need addressing prior to formal designation as a PHCC.

Reviews periodic status reports from each established PHCC, as requested between
accreditation cycles.

Re-accredits existing Centers based on status reports and site visits.

Notifies the PHCC Oversight Committee (OC) about deficiencies and need for potential
corrective actions (to be determined by OC).

Process appeals from candidate programs and communicate information to OC for adjudication.
Page 2 of 28
Oversight Committee (OC)

Appoints and governs the Review Committee (RC).

Analyzes and updates PHCC criteria and evaluation tools.

Modifies accreditation scoring system.

Adjudicates candidate Center’s appeals .

Notifies Centers about deficiencies and specifies corrective actions.

Manages PHCC Finances.

Resolves Conflict of Interest (COI) issues within the RC.
PHA-ACCREDITED PH CARE CENTER ROLES AND RESPONSIBILITIES
The PHA seeks to improve the care of PH patients and help advance the field by accrediting US-based
PHCCs. Accreditation ensures that Centers are committed to providing comprehensive and specialized care
for PH patients at a high level of proficiency. Centers applying for accreditation must meet specific
requirements applicable to the care of PH patients.
Centers of Comprehensive Care (CCC):
An accredited CCC will:

Provide comprehensive PH patient care with well-organized systems, services, facilities, highlytrained and experienced physicians and PH team members, with emphasis on quality.

Use evidence-based, guideline-driven, standardized methods of delivering care.

Support patient safety, education, and community awareness.

Provide coordinated care with treatments tailored to individual needs.

Promote the flow of patient information across settings and providers, while protecting patient’s
rights, security, and privacy.

Participate in research efforts to further the pulmonary vascular field.
Page 3 of 28
Regional Clinical Programs (RCP):
An accredited RCP will:

Provide PH patient care with well-organized systems, services, facilities, experienced physicians and
staff, with emphasis on quality and close follow up.

Use evidence-based, guideline-driven, standardized methods of delivering care.

Consult with regional PHCC Program for complex cases.

Appropriately transfer patients needing advanced PAH therapies to regional CCC Program, if
advanced therapy not available at the RCP.

Support patient safety, education, and community awareness.

Provide coordinated care with treatments tailored to individual needs.

Promote the flow of patient information across settings and providers while protecting patient’s
rights, security, and privacy.

Promote access to pulmonary vascular clinical research to appropriate patients.
PHCC Applicants
All PHCC Applicants will:

Complete Application (see instructions below).

Provide Letters of Support from ancillary program services as noted within the application (PHA
will provide templates; see appendix for document checklist).

Complete a Business Letter of Agreement and/or data Security Agreement between your
hospital and PHA which will allow RC access to patient records (PHA will provide a template if
needed; see appendix).

Help coordinate a one-day site visit with the PHA PHCC Staff. Provide copies of the additional
supporting documentation regarding your program as noted in the application to the site
visitors to review.

Provide a roster of updated NICE classification group 1 (PAH) and group 4 (CTEPH) patients (see
page 8) to the site reviewers for a limited chart review (with Director and Coordinator present)
to occur on the day of the site visit.

Maintain their PAH/CTEPH Patient Roster for annual updates to the PHCC.

Agree to participate in a future PHCC Patient Registry (currently under development) for quality
improvement purposes. Once open, the Registry will enroll ALL PAH and CTEPH patients at the
PHCC who consent to participate.
Page 4 of 28
Application Fees
Application
Site Review
Accreditation Notification
Annual Fee for CCC
Annual Fee for RCP
Re-accreditation Fee
$500
$6500
$4000
$2000
$1000
$10,000
Due with Application, non-refundable
Due prior to site review
Due at Accreditation Notification
Due in years 2 and 3 of a cycle
Due in years 2 and 3 of a cycle
Due prior to site review and towards
the end of the previous cycle
If you would like to pay with credit card, please call: 240-485-0778. Payments by check or money order can
be made to:
Pulmonary Hypertension Association
Attn: Olivia Onyeador, PHCC Program Manager
801 Roeder Road, Suite 1000
Silver Spring, MD 20910
Page 5 of 28
PHCC APPLICATION INSTRUCTIONS
COMPLETING YOUR APPLICATION
(Estimated time to complete: 2-6 hours per each 100 patients in the roster; 2-4 hours for application)
For linked programs seeking single Accreditation, (e.g. adult & pediatric and/or more than 2 hospitals):
each program will be reviewed independently; if either program fails to meet criteria, the whole
program will not be accredited. Each site for a linked program should complete a separate online
application with a notation to the PHA that they should be evaluated as a single linked site. While there
may be overlap between these applications, it will best enable the Review Committee to review all
components of the program at each site. Prior to application submission, a site should consider whether
one component should apply independently as a Regional Clinical Program (RCP). Please also refer to
the flowchart below for multi-site scenarios.
All questions and communications should be directed to the PHA PHCC staff during the accreditation
process. The PHA PHCC staff will contact you to process your materials, clarify any ambiguities, and
facilitate scheduling a site visit as appropriate.
Page 6 of 28
The PAH/CTEPH Patient Roster (see page 8) should be completed FIRST as this will facilitate answering
the application questions and will provide the basis for the randomly –selected chart review during
your site visit. It should ONLY include patients who predominantly fit into WHO Diagnostic Groups 1 or
4 PH. PH patients from WHO Diagnostic Groups 2, 3 and 5 should be excluded from the roster. If a
patient who does not meet the traditional hemodynamic definition of PAH (i.e. mean PAP ≥ 25 mmHg
and PAWP or LVEDP ≤ 15 mmHg) is included in the roster and selected during the chart review, the site
must provide a rationale for inclusion as PAH/CTEPH patient. The PAH/CTEPH Patient Roster should
NOT be sent with your application but should be retained by your program as it contains protected
health information (PHI). It will be reviewed during your site visit as part of the chart review process.
The PH Care Centers Reviewers will not remove any PHI or identifiable patient information from the
applicant site. Extensive knowledge of the patient cohort and local EMR enhances the chart review
process therefore the Director and Coordinator are requested to be present and participate in the on
site chart review process.
In general, each potential Adult PHCC CCC should actively be managing at least 75-100 PAH and CTEPH
patients. Additionally, a potential CCC must also show proficiency and experience with all PAH therapies
(oral, inhaled, and parenteral). Adult programs should have managed at least 20 PAH patients on
parenteral (IV and SC) prostanoids during the preceding 3 years. It is recognized that some programs
will have numbers below this range and pertinent influential factors will be considered such as the
duration of program’s existence and experience of the director, the number and proximity of other
nearby PH programs, and your regional population and patient catchment area.
Each potential Adult PHCC RCP should actively be managing a minimum of 25 PAH and CTEPH patients
and demonstrate proficiency and experience with all non-parenteral PAH therapies. Experience with
administering parenteral therapies is NOT required of an RCP. Potential RCP directors should
demonstrate collaboration and co-management of PAH and CTEPH patients with a CCC, particularly
when the need arises for more advanced care that cannot be provided at the RCP (for example
parenteral prostanoids, transplantation, thromboendarterectomy, or need for a more experienced
facility). RCPs are also encouraged to work with CCCs to evaluate patients for investigational protocols
not available at the RCP.
Each accreditation decision will be based on the comprehensive overall application. If your program's
patient care volume or experience falls outside these ranges, or if you are applying for Pediatric PHCC
status, please contact the PHA PHCC staff to discuss your application in greater detail.
Page 7 of 28
PAH/CTEPH PATIENT ROSTER
Please complete the following roster with all PAH (Group 1) & CTEPH (Group 4) patients seen and managed
within the prior 3 calendar years. Patients who are included but don’t meet traditional hemodynamic
definition of PAH [Hoeper MM, et al. JACC. 2013; 62: D45-50] may need justification to site reviewers for
inclusion in the roster. Do NOT submit with your application. Please make copies of the template as needed.
ID #
Initials
SEX
DOB
(DD/MM
/YY)
DATE OF
1ST
Encounter
(MM/YY)
DIAGNOSIS
IPAH
NonIPAH
PAH
CTEPH
MEDICATIONS
Current PAH medications (may be
multiple)
PO
__1
__2
__3
__4
__5
__6
__7
__8
__9
__0
__1
__2
__3
__4
__5
__6
__7
__8
__9
__0
Page 8 of 28
IH
IV
SQ
Date of
parenteral
drug
initiation, if
applicable
(MM/YY)
PAST
TREATMENTS
Been on
IV/SQ
therapy
within last 3
years
VITAL STATUS
(may be
multiple)
A = Alive
T=
Transplanted
P = PTE
D = Dead
L = Lost to
follow up
Please complete the Application as directed and attach all requested Letters of Support (LOS) and other
documents as noted (see Appendix for LOS templates and the document checklist). A program site visit
will generally be scheduled in advance with enough time to allow for site visit preparation (see below
under “Preparing for Your Site Visit”).
A. Contact Information
Please complete the contact information regarding the name and affiliation of your program as well as
the principal contact individual for correspondence with the PHA PHCC staff.
B. Pulmonary Hypertension Program Narrative Report
The Program Director should complete this narrative to give the PHCC Review Committee an
overview of your program. Please add any additional relevant information you feel is important for
the PHA site reviewers to understand about your program to aide in the review or accreditation
process.
C. Center Director
Q1-4: Please provide contact information, medical license and specialty board certification status.
Q5: Please provide estimate of years of PAH clinical experience since completion of fellowship
training.
Q6: Please complete regarding PH clinical and scientific meeting participation. Please provide
supporting documents at the site visit as available (participation with organizing/steering
committee, lectures, poster presentations, CME, etc.)
Q7: Please provide supporting documents regarding PH educational activities at the site visit as
available.
Q9: CME hours may include any regional, national, or international meeting where PH-related
subjects are discussed (cardiology, pulmonary, transplantation, PAH specific, etc).
Q10: Please upload a copy of the Director’s CV with the application as noted.
D. Center Coordinator
Q1-2: Please provide contact information, professional credentials, medical license and FTE
dedicated to the PH program. Although only one individual may serve as a designated Coordinator,
multiple individuals may contribute FTE to the Coordinator functions for the total time calculation.
Q3: Please note the financial support for the PH Coordinator.
Q4: Coordinator Roles: Please have supporting documents regarding Coordinator PH educational
activities (educational materials) and safety monitoring methods for review at the site visit as
available.
Page 9 of 28
Q5: Please complete regarding Coordinator PH clinical and scientific meeting participation. Please
provide supporting documents at the site visit as available (participation with organizing/steering
committee, lectures, poster presentations, CME, etc.)
Q6: Please provide supporting documents at the site visit as available.
Q8: CEU/CME hours may include any regional, national, or international meeting where PH-related
subjects are discussed (cardiology, pulmonary, transplantation, PAH specific, etc).
Q9: Please upload a copy of the Coordinator’s CV.
Q10: Please upload a copy of the Coordinator’s Professional License.
E. Program Staff and Support Services
Q1: Please note the name and title of your PH program physician staff. Provide an approximate
PH-related FTE (> 5%) for each physician and total FTE for your program.
Q2: Please provide the number of PAH patients being actively managed by your program from your
completed PAH/CTEPH Patient Roster (see Appendix). Information in the Roster should be for PAH
and CTEPH patients managed within the prior 3 years only. Please have your PAH/CTEPH Patient
Roster available at the site visit.
Q3: Please estimate the percent (%) for each question.
Q4: Please note PAH therapies provided at your site and the of number of PAH patients on each
therapy from your completed PAH/CTEPH Patient Roster (see Appendix). Information in the Roster
should be for PAH and CTEPH patients managed within the prior 3 years only. Please have your
PAH/CTEPH Patient Roster available at the site visit.
Q5: Please note the name and title/role of your PH program non-physician support staff. Provide
an approximate PH-related FTE (> 5%) for each individual.
Q6: Please upload a copy of recent call schedule with the application as noted.
Q7-10: Please upload letters of support with the application as noted.
Q16-17: Please upload letters of support with the application as noted.
F.
Facilities
Q1: Please provide supporting documents regarding hospital staff training and management
protocols at the site visit as available.
Q2: Please upload a Cardiac Catheterization Laboratory letter of support with the application as
noted. Please provide supporting documents regarding cardiac catheterization laboratory PH
related protocols at the site visit as available.
Q3: Please upload the Echocardiography Laboratory letter of support, IAC accreditation letter, and
exercise study report form with the application as noted.
Q4: Please upload the PFT Laboratory letter of support and Exercise Study Report Form with the
application as noted. Please provide supporting documents regarding PFT laboratory PH related
procedural manuals and protocols at the site visit as available.
Page 10 of 28
Q5: Please provide supporting documents regarding pharmacy PH medication protocols at the site
visit as available.
Q10: Please upload the institutional letter of support with your application.
G. Research
Q1: Please note the name and title of your PH program clinical research staff.
Q2: Please complete the table regarding your IRB-approved studies performed within the past 3
years. Include only your 5 most recent studies with the sponsor name and current or final
enrollment information as appropriate. Do not include any registry studies.
Please upload copies of IRB approval or renewal letters for the above listed studies
Please upload copies of the Curriculum Vitae for all associated Clinical Research Coordinators (CRCs).
Please upload copies of current documentation regarding completion of education on the
protection of human subjects (e.g., NIH, Collaborative IRB Training Initiative “CITI” or equivalent) for
all listed CRCs and Principal Investigators.
Q5: Please upload a bibliography list of peer-reviewed publications from the program staff
(limit to prior 5 years only), if not already listed on Director or Coordinator CVs.
Page 11 of 28
PREPARING FOR YOUR SITE VISIT
The Business Associate Agreement (see Appendix) must be completed between your program institution
and the Pulmonary Hypertension Association before a visit can be scheduled. This will allow the PHCC
reviewers to perform the site review and access patient protected health information (PHI). The PHA
PHCC staff will assist you in this agreement process.
Please maintain your PAH/CTEPH Patient Roster (see Instructions and page 8). In addition, compile a list
of your infusion patients from the preceding three years; this should be a subset of your Patient Roster.
The information should include prescribed infusion, current dose of infused drug, and duration on
infusion therapy. This information will be retained by your site after the site visit.
You should collect and collate copies of the remaining Supporting Documents which will be reviewed
during your site visit (see Appendix - Document List 2). These will be kept at the PHA as part of your
completed application. Finally, the schedule of Interviews will need to be finalized prior to the site visit
day (see Appendix).
DAY OF SITE VISIT - WHAT TO EXPECT
The template for the site review interviews is attached in the Appendix. The order and time allocated for
each of these meetings should be scheduled according to the attached template as much as feasible.
Changes to the schedule should not be made without prior discussion and approval from the PHA PHCC
staff. Please arrange for all interviews to be held in a quiet, private meeting space appropriate to the size of
the group. Interviews with program support, ancillary and research staff are to be held with the site visitors
alone (Program Leadership not needed). Please adjust schedule to allow for adequate travel time between
locations as required.
The chart review will take approximately 1 hour. The Director and Coordinator should be present during
the chart review to access charts and assist the site reviewers in finding clinical information.
At the end of the day, site reviewers will provide feedback to the program leadership and answer any
questions.
AFTER YOUR SITE VISIT
The PHA PHCC Review Committee meets to discuss all completed applications and all final accreditation
decisions are made by the PHCC Review Committee. Letters of PHA PHCC accreditation status will be
sent out by the PHCC Review Committee twice annually. Your site reviewers will be able to provide you
with a general timeframe for your accreditation determination and notification.
If your program is accredited,
 You will need to continue maintaining a roster of new PAH and CTEPH patients evaluated at
your Center.
 You will need to submit annual updates about your program and report any major
programmatic changes to the PHCC.
Page 12 of 28


Your Center is expected to participate in the PHCC patient registry, currently under
development.
Your Center will need to pay annual fees and apply for reaccreditation in approximately 3 years,
in order to maintain your accreditation.
For further information, please contact the PHA PHCC staff office.
Page 13 of 28
APPENDIX: APPLICATION DOCUMENT CHECKLISTS
Document List 1: To submit electronically with application:
□ PHCC Director CV
□ PHCC Coordinator CV
□ PHCC Coordinator License
□ Cardiology and/or PCCM Call Schedule
□ Rheumatology Service LOS
□ Cardiac Anesthesia Service LOS
□ Transplantation Program LOS
□ Congenital Heart Disease Service LOS
□ Palliative Care Service LOS
□ Rehabilitation Service LOS
□ Institutional LOS
□ Cardiac Catheterization Laboratory Director LOS
□ Pulmonary Function Laboratory Director LOS
□ Exercise Testing Report Document
□ Echocardiography Laboratory Director LOS
□ Copy of Echocardiograph Laboratory Accreditation
□ IRB Approval or Renewal letters demonstrating the program's PH investigations (prior 3
years only)
□ Copy of Investigator and Clinical Research Coordinator's completion of Human
Investigation Training (e.g. Clinical Investigator Training Initiative "CITI" or equivalent).
Page 14 of 28
Document List 2: Provide the following supporting documents to the reviewers at the site
visit only:
□ PAH/CTEPH Patient Roster (see instruction and appendix)
Please show the following supporting documents to the reviewers at the site (and email
PDF electronic copies to the PHA after your site visit):
□ PH clinical and scientific meeting participation by Program Director (organizing/steering
committee assignments, lectures, poster presentations, CME certificates, etc.) if not on CV.
□ PH educational activities by Program Director (Educating Center and Hospital Staff,
Mentoring/Teaching Trainees, Community Outreach, PH-related committee work, etc.) if
not on CV.
□ PH clinical and scientific meeting participation by Coordinator (participation with
organizing/steering committee, lectures, poster presentations, CME, etc.) if not on CV.
□ PH educational activities by Coordinator (Educating Center and Hospital Staff,
Mentoring/Teaching Trainees, Community Outreach, PH-related committee work, etc.) if
not on CV.
□ PH patient related safety activities by Coordinator (safety monitoring methods and
materials such as labtrack or other methods)
□ PH related hospital RN and RT staff training materials, competencies, and inpatient
management protocols
□ Cardiac Catheterization Laboratory PH related protocols
□ PFT laboratory PH related procedural manuals and protocols (e.g. 6 MWD and CPET
testing)
□ Inpatient Pharmacy PH staff training materials, competencies, and inpatient medication
protocols
□ Program Publications (please list peer reviewed publications only within the prior 5 years
only), if not on CV.
Page 15 of 28
APPENDIX: LETTERS OF SUPPORT TEMPLATES
GENERAL LETTER OF SUPPORT TEMPLATE
Date
To the Pulmonary Hypertension Association (PHA) Pulmonary Hypertension Care Centers (PHCC)
Review Committee:
I am pleased to acknowledge my role as (note role) in support of the (name of institution) PH
program in their current application to become a PHA-accredited PHCC.
In conclusion, I confirm my support to the efforts of this program as it seeks accreditation through
the Pulmonary Hypertension Association Pulmonary Hypertension Care Centers initiative.
Respectfully,
Name
Title
Department/Division, Institution
INSTITUTIONAL LETTER OF SUPPORT TEMPLATE
Date
To the Pulmonary Hypertension Association (PHA) Pulmonary Hypertension Care Center (PHCC)
Review Committee:
This letter is to acknowledge that I am aware of the current PHA PHCC application from our local
program, including the financial obligations of the program. I additionally confirm that (name of
institution) supports the application for accreditation and provides ongoing financial support for this
clinical program. This support specifically includes but is not limited to (list examples of financial
support provided).
Please contact me if you have any questions or require additional information.
Sincerely,
Name
Title
Institution
Page 16 of 28
APPENDIX: BUSINESS ASSOCIATE AGREEMENT TEMPLATE
This HIPAA Business Associate Agreement ("Agreement") is entered into by and between Corporation
Name (format example: "Pulmonary Hypertension Association, Inc."), a Corporation Type (format
example: Maryland 501(c)(3) Public Charity) ("Covered Entity") and Business Associate, Pulmonary
Hypertension Association, a 501(c)(3) non-profit corporation ("Associate"). This Agreement shall
supplement and is made a part of the contracted date this _____ day of _______, 2015 (“Contract”)
between the parties. This Agreement shall be effective as of the effective date shown below
(“Effective Date”).
RECITALS
A. Covered Entity wishes to disclose certain information to Associate pursuant to the terms of the
Contract, some of which may constitute Protected Health Information ("PHI") (defined below).
B. Covered Entity and Associate intend to protect the privacy and provide for the security of PHI
disclosed to Associate pursuant to the Contract in compliance with the applicable provisions of
the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 ("HIPAA"),
the Health Information Technology for Economic and Clinical Health Act, Public Law 111-005
("the HITECH Act"), and regulations promulgated thereunder by the U.S. Department of Health
and Human Services (the "HIPAA Regulations") and other applicable laws.
C. As part of the HIPAA Regulations, the Privacy Rule and the Security Rule (defined below)
require Covered Entity to enter into a contract containing specific requirements with Associate
prior to the disclosure of PHI, as set forth in, but not limited to, Title 45, Sections 164.314(a),
164.502(a) and (e) and 164.504(e) of the Code of Federal Regulations ("CFR") and contained in
this Agreement.
In consideration of the mutual promises below and the exchange of information pursuant to this
Agreement, the parties agree as follows:
1
Definitions.
1.1
Breach shall have the meaning given to such term under the HITECH Act and HIPAA
Regulations [42 U.S.C. Section 17921 and 45 C.F.R. Section 164.402].
1.2
Breach Notification Rule shall mean the HIPAA Regulation that is codified at 45 C.F.R. Parts
160 and 164, Subparts A and D.
1.3
Business Associate shall have the meaning given to such term under the Privacy Rule,
including, the Security Rule, and the HITECH Act, including but not limited to, 42 U. S.C.
Section 17938 and 45 CFR Section 160.103.
1.4
Covered Entity shall have the meaning given to such term under the Privacy Rule, and the
Security Rule, including, but not limited to, 45 CFR Section 160.103.
1.5
Data Aggregation shall have the meaning given to such term under the Privacy Rule,
including, but not limited to, 45 CFR Section 164.501.
1.6
Designated Record Set shall have the meaning given to such term under the Privacy Rule,
including, but not limited to, 45 CFR Section 164.501.
1.7
Electronic Protected Health Information means Protected Health Information that is
Page 17 of 28
maintained in or transmitted by electronic media.
1.8
Electronic Health Record shall have the meaning given to such term in the HITECH Act,
including, but not limited to, 42 U.S.C. Section 17921.
1.9
Health Care Operations shall have the meaning given to such term under the Privacy Rule,
including, but not limited to, 45 CFR Section 164.501.
1.10
Privacy Rule shall mean the HIPAA Regulation that is codified at 45 CFR Parts 160 and 164
Subparts A & E.
1.11
Protected Health Information or PHI means any information, whether oral or recorded in
any form or medium: (i) that relates to the past, present or future physical or mental
condition of an individual; the provision of health care to an individual; or the past, present
or future payment for the provision of health care to an individual; and (ii) that identifies
the individual or with respect to which there is a reasonable basis to believe the information
can be used to identify the individual, and shall have the meaning given to such term under
the Privacy Rule, including, but not limited to, 45 CFR Section 164.501. Protected Health
Information includes Electronic Protected Health Information [45 C.F.R. Sections 160.103,
164.304].
1.12
Protected Information shall mean PHI provided by Covered Entity to Associate or created,
maintained, received, or transmitted by Associate on Covered Entity's behalf.
1.13
Security Incident shall have the meaning given to such term under the Security Rule,
including, but not limited to, 45 C.F.R. Section 164.304.
1.14
Security Rule shall mean the HIPAA Regulation that is codified at 45 C.F.R. Parts 160 and
164, Subparts A and C.
1.15
Unsecured PHI shall have the meaning given to such term under the HITECH Act and any
guidance issued pursuant to such Act including, but not limited to, 42 U.S.C. Section
17932(h) and 45 C.F.R. Section 164.402.
2
Obligations of Associate.
2.1
Permitted Uses. Associate shall use Protected Information only for the purpose of
performing Associate's obligations under the Contract and as permitted or required under
the Contract and Agreement, or as required by law. Further, Associate shall not use
Protected Information in any manner that would constitute a violation of the Privacy Rule or
the HITECH Act if so used by Covered Entity, except that Associate may use Protected
Information (i) for the proper management and administration of Associate, (ii) to carry out
the legal responsibilities of Associate, (iii) as required by law, or (iv) for Data Aggregation
purposes relating to the Health Care Operations of Covered Entity [45 C.F.R. Sections
164.504(e)(2), and 164.504(e)(4)(0]
2.2
Permitted Disclosures. Associate shall disclose Protected Information only for the purpose
of performing Associate's obligations under the Contract and as permitted or required
under the Contract and Agreement, or as required by law. Associate shall not disclose
Protected Health Information in any manner that would constitute a violation of the Privacy
Rule or the HITECH Act if so disclosed by Covered Entity. However, Associate may disclose
Protected Information as necessary (i) for the proper management and administration of
Page 18 of 28
Associate; (ii) to carry out the legal responsibilities of Associate, (iii) as required by law, or
(iv) for Data Aggregation purposes relating to the Health Care Operations of Covered Entity.
To the extent that Associate discloses Protected Information to a third party for purposes
set forth above in 2.2(i), 2.2(ii), and 2.2(iii), Associate must obtain, prior to making any such
disclosure, (i) reasonable written assurances from such third party that such Protected
Information will be held confidential as provided pursuant to this Agreement and used or
disclosed only as required by law or for the purposes for which it was disclosed to such third
party, and (ii) a written agreement from such third party to immediately notify Associate of
any breaches, suspected breaches, security incidents, or unauthorized uses or disclosures of
the Protected Information in accordance with paragraph 2.m of the Agreement, to the
extent it has obtained knowledge of such occurrences. [42 U.S.C. Section 17932; 45 C.F.R.
Sections 164.504(e)(2)(i), 164.504(e)(2)(i)(B), 164.504(e)(2)(ii)(A) and 164.504(e)(4)(ii)]
2.3
Prohibited Uses and Disclosures. Associate shall not use or disclose PHI to any person,
entity or organization outside the United States. Specifically, Associate shall not outsource
any PHI to any person or organization outside the continental United States.
Associate shall indemnify, defend, and hold harmless Covered Entity, and its officers,
directors, employees, agents, and representatives (collectively "Covered Entity"), against all
liability, demands, claims, costs, losses, damages, recoveries, settlements, and expenses
(including interest, penalties, attorney fees, accounting fees, and expert witness fees)
incurred by Covered Entity ("Losses"), known or unknown, contingent or otherwise, directly
or indirectly arising from or related to the disclosure of PHI to any person, entity or
organization outside the United States.
Associate shall not use or disclose PHI other than as permitted or required by the Contract
and Agreement, or as required by law. Associate shall not use or disclose Protected
Information for fundraising or marketing purposes. Associate shall not disclose Protected
Information to a health plan for payment or health care operations purposes if the patient
has requested this special restriction, and has paid out of pocket in full for the health care
item or services to which the PHI solely relates [42 U.S.C. Section 17935(a) and 45 C.F.R.
Section 164.522(a)(vi)]. Associate shall not directly or indirectly receive remuneration in
exchange for Protected Information, except with the prior written consent of Covered Entity
and as permitted by the HITECH Act, 42 U.S.C. Section 17935(d)(2), and the HIPAA
regulations, 45 C.F.R. Section 164.502(a)(5)(ii); however, this prohibition shall not affect
payment by Covered Entity to Associate for services provided pursuant to the Contract.
Covered Entity shall notify business associate of any restriction on the use or disclosure of
protected health information that Covered Entity has agreed to or is required to abide by
under 45 C.F.R. 164.522, to the extent that such restriction may affect business associate's
use or disclosure of protected health information.
2.4
Appropriate Safeguards. Associate shall implement appropriate safeguards as are necessary
to prevent the use or disclosure of Protected Information other than as permitted by this
Agreement, including, but not limited to, administrative, physical and technical safeguards
in accordance with the Security Rule, including, but not limited to, 45 Section 164.308,
164.310, and 164.312. [45 C.F.R. Section 164.504(e)(2)(ii)(B); 45 Section 164.308(b)].
Associate shall comply with the policies and procedures and documentation requirements
Page 19 of 28
of the Security Rule, including, but not limited to, 45 C.F.R. Section 164.316. [42 U.S.C.
Section 17931] Associate shall maintain a comprehensive written information privacy and
security program that includes administrative, technical and physical safeguards appropriate
to the size and complexity of the Associate's operations and the nature and scope of its
activities.
2.5
Business Associate's Subcontractors and Agents. Associate shall ensure that any agents and
subcontractors that create, receive, maintain or transmit Protected Information on behalf of
Covered Entity, agree in writing to the same restrictions and conditions that apply to
Associate with respect to such Protected Information and implement the safeguards
required by paragraph 2.4 above with respect to Electronic PHI [45 C.F.R. Sections
164.504(e)(2)(ii)(D); 45 C.F.R. Section 164.308(b)]. Associate shall implement and maintain
sanctions against agents and subcontractors that violate such restrictions and conditions
and shall mitigate the effects of any such violation (see 45 C.F.R. Sections 164.530(f) and
164.530(e)(1)).
2.6
Access to Protected Information. This provision will be effective only when Associate
maintains a Designated Record Set on behalf of Covered Entity. Associate shall make
Protected Information maintained by Associate or its agents or subcontractors in Designated
Record Sets available to Covered Entity for inspection and copying within five (5) Business
days of a request by Covered Entity to enable Covered Entity to fulfill its obligations under
state law [Health and Safety Code Section 123110] and the Privacy Rule, including, but not
limited to, 45 CFR Section 164.524 [45 C.F.R. Section 164.504(e)(2)(ii)(E)]. If Associate
maintains Protected Information in electronic format, Associate shall provide such
information in electronic format as necessary to enable Covered Entity to fulfill its
obligations under the HITECH Act and HIPAA Regulations, including, but not limited to, 42
U.S.C. Section 17935(e) and 45 C.F.R. Section 164.524.
2.7
Amendment of PHI. This provision will be effective only when Associate maintains a
Designated Record Set on behalf of Covered Entity. Within ten (10) business days of receipt
of a request from Covered Entity for an amendment of Protected Information or a record
about an individual contained in a Designated Record Set, Associate and its agents and
subcontractors shall make such Protected Information available to Covered Entity for
amendment and incorporate any such amendment or other documentation to enable
Covered Entity to fulfill its obligations under the Privacy Rule, including, but not limited to,
45 CFR Section 164.526. If any individual requests an amendment of Protected Information
directly from Associate or its agents or subcontractors, Associate must notify Covered Entity
in writing within five (5) business days of the request and of any approval or denial of
amendment of Protected Information maintained by Associate or its agents or
subcontractors [45 C.F.R. Sections 164.504(e)(2)(ii)(F)].
2.8
Accounting Rights. Within ten (10) business days of notice by Covered Entity to Associate of
a request for an accounting of disclosures of Protected Information for which Covered Entity
is required to account to an individual, Associate and its agents and subcontractors shall
make available to Covered Entity the information required to provide an accounting of
disclosures to enable Covered Entity to fulfill its obligations under the Privacy Rule,
including, but not limited to, 45 CFR Section 164.528 and the HITECH Act, including, but not
limited to 42 U.S.C. Section 17935©, as determined by Covered Entity. Associate agrees to
implement a process that allows for an accounting to be collected and maintained by
Page 20 of 28
Associate and its agents and subcontractors for at least six (6) years prior to the request.
However, accounting of disclosures from an Electronic Health Record for treatment,
payment or health care operations purposes are required to be collected and maintained for
only three (3) years prior to the request, and only to the extent that Associate maintains an
Electronic Health Record. At a minimum, the information collected and maintained shall
include: (i) the date of disclosure; (ii) the name of the entity or person who received
Protected Information and, if known, the address of the entity or person; (iii) a brief
description of Protected Information disclosed; and (iv) a brief statement of purpose of the
disclosure that reasonably informs the individual of the basis for the disclosure, or a copy of
the individual's authorization, or a copy of the written request for disclosure. In the event
that the request for an accounting is delivered directly to Associate or its agents or subcontractors, Associate shall within five (5) business days of a request forward it to Covered
Entity in writing. It shall be Covered Entity's responsibility to prepare and deliver any such
accounting requested. Associate shall not disclose any Protected Information except as set
forth in Sections 2.2 of this Agreement [45 C.F.R. Sections 164.504(e)(2)(ii)(G), 164.414(a),
164.528(a)(3), 165.528, and 164.530(j)(2)]. The provisions of this subparagraph shall survive
the termination of this Agreement.
2.9
Governmental Access to Records. Associate shall make its internal practices, books and
records relating to the use and disclosure of Protected Information available to Covered
Entity (with reasonable notice) and to the Secretary of the U.S. Department of Health and
Human Services (the "Secretary") for purposes of determining Associate's compliance with
the HIPAA [45 C.F.R. Sections 164.504(e)(2)(ii)(I)]. To the extent permitted by law, Associate
shall provide to Covered Entity a copy of any Protected Information and other documents
and records that Associate provides to the Secretary concurrently with providing such
Protected Information to the Secretary.
2.10
Disclosure of Minimum Necessary PHI. Associate, its agents and subcontractors shall
request, use and disclose only the minimum amount of Protected Information necessary to
accomplish the purpose of the request, use or disclosure. [42 U.S.C. Section 17935(b); 45
C.F.R. Sections 164.514(d)] Associate understands and agrees that the definition of
"minimum necessary" is in flux and shall keep itself informed of guidance issued by the
Secretary with respect to what constitutes "minimum necessary."
2.11
Data Ownership. Associate acknowledges that Associate has no ownership rights with
respect to the Protected information.
2.12
Retention of Protected Information. Notwithstanding Section 3.3 of this Agreement,
Associate and its agents and subcontractors shall retain all Protected Information
throughout the term of the Contract and shall continue to maintain the information
required under Section 2.8 of this Agreement for a period of six (6) years after termination
of the Contract 45 C.F.R. 164.414(a); 45 C.F.R. 164.528(a)(3); and 45 C.F.R. 164.530(j)(2).
2.13
Notification of Breach. Associate shall notify Covered Entity within two (2) business day of
any breach of protected Information; any use or disclosure of Protected Information not
permitted by the Agreement; any security incident (i.e., any successful unauthorized access,
use, disclosure, modification, or destruction of information or interference with system
operations in an information system) related to Protected Information, and any use or
disclosure of data in violation of any applicable federal or state laws by Associate or its
Page 21 of 28
agents or subcontractors. The notification shall include, to the extent possible, the
identification of each individual whose unsecured Protected Information has been, or is
reasonably believed by the business associate to have been, accessed, acquired, used, or
disclosed, as well as any other available information that Covered Entity is required to
include in notification to the individual, the media, the Secretary, and any other entity under
the Breach Notification Rule and any other applicable state or federal laws, including, but
not limited, to 45 C.F.R. Section 164.404 through 45 C.F.R. Section 164.408, at the time of
the notification required by this paragraph or promptly thereafter as information becomes
available. Associate shall take (i) prompt corrective action to cure any deficiencies and (ii)
any action pertaining to unauthorized uses or disclosures required by applicable federal and
state laws. [42 U.S.C. Section 17921; 45 C.F.R. Section 164.504(e)(2)(ii)(C); 45 C.F.R. Section
164.308(b)]
2.14
Breach Pattern or Practice by Business Associate's Subcontractors and Agents. Pursuant to
42 U.S.C. Section 17934(b) and 45 C.F.R. Section 164.504(e)(1)(ii), if Associate knows of a
pattern of activity or practice of a subcontractor or agent that constitutes a material breach
or violation of the subcontractor or agent's obligations under the Agreement or other
arrangement, the Associate must take reasonable steps to cure the breach or end the
violation. If the steps are unsuccessful, the Associate must terminate the Agreement or
other arrangement if feasible. Associate shall provide written notice to Covered Entity of
any pattern of activity or practice of a subcontractor or agent that Associate believes
constitutes a material breach or violation of the subcontractor or agent's obligations under
the Agreement or other arrangement within five (5) business days of discovery and shall
meet with Covered Entity to discuss and attempt to resolve the problem as one of the
reasonable steps to cure the breach or end the violation.
2.15
Audits, Inspection and Enforcement. Within ten (10) business days of a written request by
Covered Entity, Associate and its agents and subcontractors shall allow Covered Entity or its
agents or subcontractors to conduct a reasonable inspection of the facilities, systems,
books, records, agreements, policies and procedures relating to the use or disclosure of
Protected Information pursuant to this Agreement for the purpose of determining whether
Associate has complied with this Agreement or maintains adequate security safeguards;
provided, however, that (i) Associate and Covered Entity shall mutually agree in advance
upon the scope, timing and location of such an inspection, (ii) Covered Entity shall protect
the confidentiality of all confidential and proprietary information of Associate to which
Covered Entity has access during the course of such inspection; and (iii) Covered Entity shall
execute a nondisclosure agreement, upon terms mutually agreed upon by the parties, if
requested by Associate. The fact that Covered Entity inspects, or fails to inspect, or has the
right to inspect, Associate's facilities, systems books, records, agreements, policies and
procedures does not relieve Associate of its responsibility to comply with this Agreement,
nor does Covered Entity's (i) failure to detect or (ii) detection, but failure to notify Associate
or require Associate's remediation of any unsatisfactory practices, constitute acceptance of
such practice or a waiver of Covered Entity's enforcement rights under this Agreement.
Associate shall notify Covered Entity within five (5) business days of learning that Associate
has become the subject of an audit, compliance review, or complaint investigation by the
Office for Civil Rights or other state or federal government entity.
Page 22 of 28
2.16
Obligations Under Subpart E. To the extent Associate is to carry out one or more of covered
entity's obligations(s) under Subpart E of 45 C.F.R. Part 164, comply with the requirements of
Subpart E that apply to the Covered Entity in the performance of such obligation(s)
2.17
Indemnification. Associate shall indemnify, defend, and hold harmless Covered Entity, and its
officers, directors, employees, agents, and representatives (collectively "Covered Entity"),
against all liability, demands, claims, costs, losses, damages, recoveries, settlements, and
expenses (including interest, penalties, attorney fees, accounting fees, and expert witness fees)
incurred by Covered Entity ("Losses"), known or unknown, contingent or otherwise, directly or
indirectly, arising out of or in connection with any (a) unauthorized use or disclosure of PHI, (b)
failure in security measures affecting PHI; or (c) other material breach of the terms of this
Agreement by Associate or any person or entity under Associate's control. Indemnification is
conditioned upon Covered Entity notifying Associate in writing promptly upon learning of any
claim for which indemnification may be sought hereunder, and tendering the defense of such
claim to Associate. Associate will not be required to indemnify Covered Entity if any claim is
settled without Associate's written consent.
3
Termination.
3.1
Material Breach. A breach by Associate of any material provision of this Agreement, as
determined by Covered Entity, shall constitute a material breach of the Contract. Associate will
have 10 business days to cure such breach. In the event Associate does not cure the breach,
Covered Entity retains the right to immediately terminate the contract. [45 C.F.R. Section
164.504(e)(2)(iii)]
3.2
Judicial or Administrative Proceedings. Covered Entity may terminate this Contract, effective
immediately, if (i) Associate is named as a defendant in a criminal proceeding for a violation of
HIPAA, the HITECH Act, the HIPAA Regulations or other security or privacy laws or (ii) a finding
or stipulation that the Associate has violated any standard or requirement of HIPAA, the
HITECH Act, the HIPAA Regulations or other security or privacy laws is made in any
administrative or civil proceeding in which the party has been joined.
3.3
Effect of Termination. Upon termination of this Contract for any reason, Associate shall, at the
option of Covered Entity, return or destroy all Protected Information that Associate or its
agents and subcontractors still maintain in any form, and shall retain no copies of such
Protected Information. If return or destruction is not feasible, as determined by Covered Entity,
Associate shall continue to extend the protections of Section 2 of this Agreement to such
information, and limit further use of such PHI to those purposes that make the return or
destruction of such PHI infeasible. [45 C.F.R. Section 164.504(e)(ii)(2)(J)]. If Covered Entity elects
destruction of the PHI, Associate shall certify in writing to Covered Entity that such PHI has
been destroyed in accordance with the Secretary's guidance regarding proper destruction of
PHI.
3.4
Limitation of Liability. Any limitation of liability in the Contract shall not apply to damages
related to a breach of Associates privacy or security obligations under the Agreement.
3.5
Disclaimer. Covered Entity makes no warranty or representation that compliance by
Associate with this Agreement, HIPAA, the HITECH Act, or the HIPAA Regulations will be
adequate or satisfactory for Associate's own purposes. Associate is solely responsible for all
decisions made by Associate regarding the safeguarding of PHI.
Page 23 of 28
4
4.5
Amendment.
4.1
Amendment to Comply with Law. The parties acknowledge that state and federal laws
relating to data security and privacy are rapidly evolving and that amendment of this
Agreement may be required to provide for procedures to ensure compliance with such
developments. The parties specifically agree to take such action as is necessary to
implement the standards and requirements of HIPAA, the HITECH Act, the HIPAA
regulations and other applicable state or federal laws relating to the security or
confidentiality of PHI. The parties understand and agree that Covered Entity must receive
satisfactory written assurance from Associate that Associate will adequately safeguard all
Protected Information. Upon the request of either party, the other party agrees to promptly
enter into negotiations concerning the terms of an amendment to this Agreement
embodying written assurances consistent with the standards and requirements of HIPAA,
the HITECH Act, the HIPAA regulations or other applicable laws. Covered Entity may
terminate this Contract upon thirty (30) days written notice in the event (i) Associate does
not promptly enter into negotiations to amend this Agreement when requested by Covered
Entity pursuant to this Section or (ii) Associate does not enter into an amendment to this
Agreement providing assurances regarding the safeguarding of PHI that Covered Entity, in
its sole discretion, deems sufficient to satisfy the standards and requirements of applicable
laws.
4.2
Litigation or Administrative Proceedings. Associate shall notify Covered Entity within five
(5) business days of any litigation or administrative proceedings commenced against
Associate or its agents or subcontractors related to violations of HIPAA, the HITECH Act, the
HIPAA regulations, or other state or federal laws relating to the security and privacy of
health information. In addition, Associate shall make itself and any subcontractors,
employees and agents assisting Associate in the performance of its obligations under this
Agreement, available to Covered Entity, at no cost to Covered Entity, to testify as witnesses,
or otherwise, in the event of litigation or administrative proceedings being commenced
against Covered Entity, its directors, officers or employees based upon a claimed violation of
HIPAA, the HITECH Act, the HIPAA regulations, or other state or federal laws relating to
security and privacy, as a result of a breach of this Agreement by Associate or its
subcontractors, employees or agents, except where Associate or its subcontractors,
employees or agents are a named adverse party.
4.3
No Third Party Beneficiaries. Nothing express or implied in this Contract or any addendum
thereto is intended to confer, nor shall anything herein confer, upon any person other than
Covered Entity, Associate and their respective successors or assigns, any rights, remedies,
obligations or liabilities whatsoever.
4.4
Interpretation. The provisions of this Agreement shall prevail over any provisions in the
Contract that may conflict or appear inconsistent with any provision in this Agreement. This
Agreement and the Contract shall be interpreted as broadly as necessary to implement and
comply with HIPAA, the HITECH Act, the HIPAA regulations, and other state and federal laws
related to security and privacy. The parties agree that any ambiguity in this Agreement shall
be resolved in favor of a meaning that complies and is consistent with HIPAA, the HITECH
Act, the HIPAA regulations, and other state and federal laws related to security and privacy.
Notices/Supplying Information. Any notices to be given to a Party must be made
Page 24 of 28
via U.S. Mail or express courier to such Party's address given below, and/or via
facsimile to the facsimile telephone numbers listed below. Each Party may change
its address and that of its representative for notice in the manner herein provided:
4.6
Jurisdiction/Venue. This Agreement shall be interpreted under the laws of the
State of Maryland and any applicable US federal law. The parties agree that venue
for any and all disputes arising under this Agreement shall be in Montgomery
County, Maryland.
IF TO COVERED ENTITY
Corporation Name
Corporate Address
City, State Zip
Attention: Name
Facsimile: Number
Email: Email Address
(Not to constitute notice)
Phone: Phone Number
(Not to constitute notice)
IF TO ASSOCIATE:
Pulmonary Hypertension Association
801 Roeder Road, Suite 1000
Silver Spring, MD 20910
Attention: PHCC Program Manager
Facsimile: 301-565-3994
Email: Medical@PHAssociation.org
(Not to constitute notice)
Phone: 301-565-3004 x770
(Not to constitute notice)
Page 25 of 28
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement and the
Effective Date shall be as of the ____ day of _____, 2015.
COVERED ENTITY
Corporation Name
A Corporation Type
By: ________________________________
Print Name: _________________________
Title: ______________________________
Date: ______________________________
BUSINESS ASSOCIATE
Pulmonary Hypertension Association,
A 501(c)(3) Non-Profit Corporation
By: ____________________________________
Print Name: _____________________________
Title: __________________________________
Date: ________________________________
Page 26 of 28
APPENDIX: PHCC SITE VISIT SCHEDULE OF EVENTS
Please arrange for all interviews to be held in a quiet, private meeting space appropriate to the size of the group. Interviews
with program support, ancillary and research staff are to be held with the site visitors alone (Program Leadership not needed).
Changes to the schedule order should not be made without prior discussion and approval from the PHA PHCC staff. You may
adjust the travel schedule/times to allow for adequate time between locations if needed.
Appointments
1
2
3
4
5
6
7
8
9
10
11
12
Introductory meeting with Program Leadership
Team
Introductions, Review Agenda, Program Overview
presentation by Program Leadership (10-15 min
maximum)
Team members:
A. PHCC Physician interview with Director(s)
Team member:
B. PHCC AHCP interview with Coordinator(s)
(Please schedule in separate locations)
Team member:
Identification of charts by site visitors for later
review – Program Leadership Team to supply copy
of patient roster
Team members:
Visit to Outpatient Clinic and Interview with
Program Outpatient support team (PH support
staff, Respiratory Therapy/Pulmonary
Rehabilitation)
Team members:
Site visitor Supporting Document review
Interview with Patient
Name:
Interview with Catheterization Laboratory Director
Team member:
Break/Travel time
Visit to Inpatient Ward and Interview with Program
Inpatient support team (PAH Clinical Specialist,
Nursing staff, Inpatient Pharmacist)
Team members:
Lunch with Site Team
Team members:
Chart Review (12-15 records – see patient roster
form)
Interview with Clinical Research Support Staff
Team members:
Length
Time
45 min
8:00-8:45AM
30 min
8:45-9:15AM
15 min
9:15-9:30AM
30 min
9:30-10:00AM
30 min
10:00-10:30AM
15 min
10:30-10:45AM
15 min
10:45-11:00AM
15 min
11:00-11:15AM
30 min
11:15-12:15PM
45 min
12:15-1:00PM
60 min
1:00-2:00 PM
15 min
2:00-2:15PM
27
Location
14
Interview with Hospital Administrator
Team member:
Break/Travel time
15
Site visitors' private review and program discussion
30min
2:45-3:15PM
16
Wrap up meeting with the Program Medical
Director and Coordinator to give immediate
feedback
Team members:
30 min
3:15-3:45PM
13
15 min
2:15-2:30PM
15 min
2:30-2:45PM
28
Download