Waivers for Special Projects:
Application process and procedure for review and approval
A/R 5-211 OFFICE OF EMERGENCY MEDICAL SERVICES
Administrative Requirements Manual EFFECTIVE: 4/1/03 AUTHORIZATION: LG PAGE: 1
of 4 A/R TITLE: WAIVERS FOR SPECIAL PROJECTS: APPLICATION PROCESS AND PROCEDURE
FOR REVIEW AND APPROVAL SUPERSEDES: 5/1/01
PURPOSE:
To define the requirements for obtaining waivers for special projects, pursuant
to 105 CMR 170.405.
DEFINITION:
105 CMR 170.405 provides that "at the discretion of the Department, regulations
established in 105
CMR 170.000 may be waived for special projects which demonstrate innovative
delivery of
emergency medical care services. Proposals for special projects must be
submitted to the Department
in writing and no regulatory standards will be waived without explicit
Department approval. Special
projects will be considered experimental in nature and will be reviewed and
renewed at such time
periods as the Department shall establish." The Department interprets
experimental to mean
innovative, and would include in this category projects that would require
institutional review board
(IRB) review.
APPLICATIONS:
All applications for waivers for special projects must be submitted in writing
to the Director of the
Office of Emergency Medical Services (OEMS).
A. Each application must include the following:
1. Name and address of the Applicant
a. Licensed Ambulance Service(s) involved;
b. Regional affiliation(s)
c. Hospital(s) involved in project;
d. Contact person for special project, including address, phone number, FAX
number and email
address.
2. A detailed description of the proposed special project, indicating why a
waiver is required,
including, but not limited to:
a. Level of EMT(s) involved in the special project;
b. The number of EMTs involved in the special project;
c. Name of Licensee;
d. Name of Medical Director(s) for service, project, and affiliate hospital, if
relevant;
e. Regulation(s) requiring a waiver;
f. Purpose for/goals of special project;
g. Proposed time frame for special project;
h. Nature of the project;
i. Description of the population to be served by the special project;
j. A letter of review and evaluation from the relevant regional Medical
Director and
regional Executive Director;
k. A letter of review and evaluation from other relevant institutions involved
in or
impacted by the project, i.e., hospitals, MACEP, MMS, MHA, etc.
3. Analysis of available literature that supports the safety and efficacy of
the proposed waiver
and a description of why the public health and safety will not be compromised
by the
proposed special project.
4. Documentation of out-of-hospital programs in other states with the same or
comparable
projects, including a description of the duration of the program and a summary
of the
results.
5. Plan for QA/QI and on-going review of the special project with specific time
frames,
guidelines and evaluation tools. Include the name of the individual
responsible for quality
review and the organizational structure for quality review. This section should
include a
description of factors that would mandate that the special project waiver
designation be
withdrawn, if specific conditions are not met.
B. Time Frames for Submission of Applications
Applications may be submitted at any time to the Director of OEMS. Applications
for special
projects will be reviewed and voted on in a timely manner. The Director of OEMS
will set the time
schedule for review of such applications.
C. Review of Applications for Special Projects
OEMS staff shall review all applications for special projects upon receipt to
determine whether
the application is complete. No application will be considered if incomplete.
1. Two members of a volunteer group of emergency physicians and paramedics will
be
assigned to assist OEMS in the review of those clinically-based special project
proposals
that OEMS approves for further assessment. These individuals will review the
project
within 30 days and submit written comments, along with a non-binding
recommendation, to
OEMS. Prior to being assigned to review a particular special project proposal,
volunteer
group members must sign confidentiality and conflict of interest statements
provided by OEMS.
Volunteer group members shall not review a
special project proposal that presents a
conflict of interest, and shall abide by strict confidentiality requirements.
2. The Medical Services Committee will review all applications where clinical
content is a
component. The Committee, upon review, will make a non-binding recommendation
on
relevant clinical aspects of special project proposals.
3. The OEMS State Medical Director and Clinical Coordinator will review both
the volunteer
reviewers' recommendations and any Medical Services Committee recommendations,
and
make their own recommendations to the Director of OEMS. A committee to review
special
project waivers, as defined in subsection E, below, will be conve ned for each
special
project, when OEMS deems necessary.
4. The Department retains the final authority to oversee the review and
approval or denial of
the special project waiver. EMCAB committee review shall include clinical
review by the
Medical Services Committee described above and may include Executive Committee
and
other Standing Committee review, at the Department's discretion. Any approval
shall be
signed by the Commissioner or the Director of OEMS as designated and is the
final
decision of the Department regarding the special project waiver.
D. Special Project Designation
1. No special project shall commence until the applicant receives written
authorization from
the Director of OEMS or the Commissioner. The Department shall have the right
to deny
consideration of approval for any applicant who commences the special project
prior to
receiving explicit written approval from the Department.
2. The Department may attach conditions to the approval of special projects.
3. Special projects will be required to sub mit data results timely. Failure to
submit data timely
may disqualify the project from consideration for renewal or may constitute a
basis for
revocation of the approval.
4. Special projects may be approved for one or two years, and may be renewed
for comparable
periods, if the extension is justified to fulfill the stated goals of the
project.
5. Special projects once approved and underway
may be amended only with the explicit
approval of the Department.
6. The Department may deny, suspend or revoke any special project approval,
under the
following circumstances:
a. The continuation of the project is a threat to the public health and safety;
b. The project fails to adhere to all the terms and conditions of the special
project
designation;
c. The project fails to submit required data;
d. The project fails to cooperate with the Department.
7. The approval of a special project is within the discretion of the
Department.
8. The denial of a special project is not subject to administrative appeal.
E. Committee to Review Special Project Waivers
1. The Department shall appoint as necessary a review committee charged with:
(1) reviewing
and analyzing the applications, (2) providing recommendations to the
Department; and (3)
conducting reviews of on- going projects. 2. Make up of the committee:
a. Individual with study design experience
b. Statistician
c. Representative from a School of Public Health
d. State Medical Director, OEMS
e. Deputy Director, Bureau of Health Quality Management
f. Legal Counsel
g. Prehospital provider representative
h. Appropriate medical discipline(s) — Hospital and/or Pre-hospital
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