Ariz. Admin. Code § R9-25-1307 - Designation and Dedesignation (A.R.S. Sections 36-2202(A)(4), 36-2209(A)(2), and 36-2225(A)(4))
A.
For initial designation or renewal of designation of a health care institution
based on verification, the Department shall, within 45 calendar days after
receiving a complete application from an owner:
1. Except as provided in subsection (H)(2),
if the application complies with the applicable requirements in this Article,
issue a designation for the health care institution that is valid for the
duration of the verification; or
2.
If the application does not comply with the applicable requirements in this
Article, provide a written notice that complies with A.R.S. Title 41, Chapter
6, Article 10, that the Department intends to decline to issue a designation
for the health care institution.
B. Except as provided in subsection (F)
specifying requirements for renewal of a one-year designation, for initial
designation or renewal of designation of a health care institution based on an
assessment by a national verification organization, the Department shall,
within 60 calendar days after receiving a complete application from an owner,
review the application and, if the Department determines that:
1. The application and the health care
institution comply with the applicable requirements in this Article, except as
provided in subsection (H)(1), issue a designation for the health care
institution that is valid for three years from the issue date;
2. The application complies with the
applicable requirements in this Article, the health care institution is in
substantial compliance with the applicable requirements in this Article, and
the Department has accepted a written corrective action plan submitted
according to
R9-25-1306(E), issue a designation for the health care institution that is valid for one year
from the issue date; or
3. The
application or the health care institution does not comply with the applicable
requirements in this Article, provide a written notice that complies with
A.R.S. Title 41, Chapter 6, Article 10, that the Department intends to decline
to issue a designation for the health care institution.
C. Except as provided in subsection (F)
specifying requirements for renewal of a one-year designation, for initial
designation or renewal of designation of a health care institution as a Level
III trauma center or a Level IV trauma center based on an assessment by the
Department, an owner shall include as part of the application required in
R9-25-1303(A) :
1. The following information in
a Department-provided format:
a. The name of
the health care institution for which the owner is requesting
designation;
b. The services the
health care institution is providing or plans to provide as part of the trauma
service;
c. The name and title of
the liaison to the trauma service from each of the services listed according to
subsection (C)(1)(b);
d. If
applicable, the name, e-mail address, telephone number, and, if available, fax
number of the health care institution's emergency department physician
director;
e. If applicable, the
name, e-mail address, telephone number, and, if available, fax number of the
health care institution's surgical director or co-director;
f. If a multidisciplinary peer review
committee is required according to Table 13.1 for the Level of the trauma
center, the name and title of each member of the multidisciplinary peer review
committee;
g. If the health care
institution's trauma registry will be part of a centralized trauma registry, a
description of the training provided to the trauma program manager to enable
the trauma program manager to comply with
R9-25-1308(D)(2);
h. If applicable, for an application for
initial designation, a description of the health care institution's plans for
the continuing education activities related to trauma care, required in
R9-25-1308(G)(4);
i. For renewal of designation, a description
of the continuing education activities conducted during the term of the
designation;
j. If applicable, the
name, e-mail address, telephone number, and, if available, fax number of the
health care institution's injury prevention coordinator;
k. A description of the methods by which
trauma team personnel members communicate with EMS personnel;
l. A description of the trauma-related
training received by registered nurses in the intensive care unit;
m. An attestation that the owner of the
health care institution will prohibit:
i. The
trauma medical director from serving as trauma medical director for another
health care institution; and
ii. A
physician on-call for general surgery, neurosurgery, or orthopedic surgery to
be on-call or on a back-up call list at another health care institution;
and
n. The dated
signature of the applicable individual according to R9-25-102;
2. A copy of the policies and
procedures required in
R9-25-1308(B)(6)
for the health care institution's trauma registry;
3. A copy of the policies and procedures
required in
R9-25-1308(B)(7)
for the health care institution's performance improvement program;
4. A copy of the policies and procedures
required in
R9-25-1308(F)(2)
for the health care institution's trauma service;
5. If applicable, a copy of the policies and
procedures required in
R9-25-1308(F)(9)
for operating rooms;
6. A copy of
the applicable policies and procedures required in
R9-25-1308(H)(4);
7. A copy of the health care institution's
clinical practice guidelines, describing the health care institution's
capability to resuscitate, stabilize, and transfer pediatric
patients;
8. If applicable, a copy
of the bylaws of the health care institution's multidisciplinary peer review
committee;
9. Copies of the job
descriptions for the health care institution's:
a. Trauma program manager;
b. Trauma registrar; and
c. If applicable, injury prevention
coordinator;
10. A list
of the trauma care parameters the health care institution is or will be
monitoring as part of the performance improvement program;
11. A list of trauma team members, including:
a. Name,
b. Title, and
c. Role on the trauma team;
12. If required for an individual
listed according to subsection (C)(11), a copy of documentation of the
individual's:
a. Board certification or board
eligibility,
b. Most recent
certification in a trauma critical care course,
c. Pediatric-specific credentials,
and
d. Other trauma-related
training; and
13. If the
trauma medical director is not a member of the trauma team, the applicable
documentation required in subsection (C)(12) for the trauma medical
director.
D. Except as
provided in subsection (F) specifying requirements for renewal of a one-year
designation, for initial designation or renewal of designation of a health care
institution as a Level I trauma center, Level I Pediatric trauma center, Level
II trauma center, or Level II Pediatric trauma center based on an assessment by
the Department under
R9-25-1302(C), an
owner shall include as part of the application required in
R9-25-1303(A) :
1. A copy of the documentation submitted to
the national verification organization as part of an application for
verification;
2. If not included in
the documentation in subsection (D)(1):
a.
Any information or documents required in subsection (C);
b. For an application for initial
designation, a description of the health care institution's plans for:
i. Injury prevention activities, required in
R9-25-1308(G)(5)(a); and
ii.
Educational outreach activities, required in
R9-25-1308(G)(5)(b);
and
c. For an
application for renewal of designation, a description of the injury prevention
activities and educational outreach activities conducted during the term of the
designation;
3. A copy of
the national verification's organization's written report to the health care
institution describing the results of the national verification organization's
assessment of the health care organization;
4. A copy of the written report in
R9-25-1306(G); and
5. If
applicable, the written plan to correct instances of non-compliance in
R9-25-1306(H).
E. Except for renewal of a
one-year designation as provided in subsection (G), for initial designation or
renewal of designation of a health care institution based on an assessment by
the Department according to subsection (C) or (D), the Department shall, within
90 calendar days after receiving a complete application from an owner, review
the application, inspect the health care institution, if applicable, and, if
the Department determines that:
1. The
application and the health care institution comply with the applicable
requirements in this Article, except as provided in subsection (H)(1), issue a
designation for the health care institution that is valid for three years from
the issue date;
2. The application
complies with the applicable requirements in this Article, the health care
institution is in substantial compliance with the applicable requirements in
this Article, and the Department has accepted the document submitted according
to R9-25-1306(E) or subsection (D)(5), issue a designation for the health care
institution that is valid for one year from the issue date; or
3. The application or the health care
institution does not comply with the applicable requirements in this Article,
provide a written notice that complies with A.R.S. Title 41, Chapter 6, Article
10, that the Department intends to decline to issue a designation for the
health care institution.
F. For renewal, at the same Level of trauma
center, of a one-year designation issued according to subsection (B)(2) or
(E)(2), an owner shall include, as part of the application required in
R9-25-1303(A), documentation related to the completion of the plan specified in the document
accepted by the Department in subsection (B)(2) or (E)(2).
G. The Department shall, within 60 calendar
days after receiving from an owner an application submitted according to
subsection (F), review the information and documentation, inspect the health
care institution if applicable, and:
1. Issue
a designation for the health care institution that is valid for two years from
the issue date if the Department determines that:
a. The application and the health care
institution comply with the applicable requirements in this Article;
and
b. The owner has completed the
plan specified in the document accepted by the Department in subsection (B)(2)
or (E)(2), as applicable; or
2. Provide a written notice that complies
with A.R.S. Title 41, Chapter 6, Article 10, that the Department intends to
decline to issue a designation for the health care institution if the
Department determines that:
a. The application
or the health care institution do not comply with the applicable requirements
in this Article; or
b. The owner
has not completed all of the components of the plan specified in the document
accepted by the Department in subsection (B)(2) or (E)(2), as applicable.
H. The Department
shall review according to
R9-25-1303(C) and
subsection (A), (B), or (E), as applicable, an application for renewal of
designation submitted by the owner of a trauma center that:
1. Had been issued a one-year
designation according to subsection (B)(2) or (E)(2); and
2. Has not completed all of the
components of the plan specified in the document accepted by the Department in
subsection (B)(2) or (E)(2), as applicable.
H. The Department may:
1. Issue or extend a designation to a health
care institution that is longer than three years if:
a. The health care institution would be
eligible for designation under
R9-25-1302(A)(2)(a)(ii)
or (iii), (A)(2)(b)(ii) or (iii), (A)(2)(c)(ii) or (iii), (A)(2)(d)(ii) or
(iii), or (A)(2)(e)(ii) with assessment from a national verification
organization;
b. The national
verification organization either:
i. Will not
allow the health care institution to apply for verification within the
time-frame necessary to comply with
R9-25-1302(C), or
ii. Does not schedule an
assessment visit to the health care institution within six months after the
date of the health care institution's request;
c. The health care institution and, if
applicable, the application comply with the applicable requirements in this
Article; and
d. The health care
institution provides to the Department documentation supporting subsection
(H)(1)(b); or
2. Issue a
designation based on verification to a health care institution, according to
subsection (A)(1), that is shorter than the duration of the verification if the
expiration of the verification is more than five years after the date of
issuance.
I. For
modification of a designation according to
R9-25-1305, the Department shall,
within 30 calendar days after receiving a complete application for modification
in R9-25-1305(A) from
an owner, review the application, inspect the health care institution, if
applicable, and:
1. Issue a modified
designation for the Level of designation requested for the health care
institution that is valid for the duration of the original designation or one
year from the issue date, whichever is longer, if the Department determines
that:
a. The application and the health care
institution comply with the applicable requirements in this Article for the
Level of designation requested; or
b. The application complies with the
applicable requirements in this Article, the health care institution is in
substantial compliance with the applicable requirements in this Article for the
Level of designation requested, and the Department has accepted a written
corrective action plan submitted according to
R9-25-1306(E);
2. Issue a modified designation
for a lower Level of designation than the Level of designation requested for
the health care institution that is valid for the duration of the original
designation or one year from the issue date, whichever is longer, if the
Department determines that:
a. The application
and the health care institution comply with the applicable requirements in this
Article for the lower Level of designation and the health care institution:
i. Does not comply with the applicable
requirements in this Article for the Level of designation requested; or
ii. Is in substantial compliance
with the applicable requirements in this Article for the Level of designation
requested, and the Department has not accepted a written corrective action plan
submitted according to
R9-25-1306(E);
or
b. The application
complies with the applicable requirements in this Article, the health care
institution is in substantial compliance with the applicable requirements in
this Article for the lower Level of designation, and the Department has
accepted a written corrective action plan according to
R9-25-1306(E);
or
3. Provide a written
notice that complies with A.R.S. Title 41, Chapter 6, Article 10 that the
Department intends to decline to issue a modified designation for the health
care institution if the Department determines that the application or the
health care institution does not comply with the applicable requirements in
this Article.
J. The
Department may dedesignate a health care institution as a trauma center if an
owner:
1. Has provided false or misleading
information to the Department;
2.
Is not eligible for designation under
R9-25-1302(A) or
(B); or
3. Fails to comply with an applicable
requirement in A.R.S. Title 36, Chapter 21.1 or this Article.
K. In determining whether to
dedesignate a health care institution as a trauma center, the Department shall
consider:
1. The severity of each instance
relative to public health and safety;
2. The number of instances;
3. The nature and circumstances of each
instance;
4. Whether each instance
was corrected, the manner of correction, and the duration of the instance;
and
5. Whether the instances
indicate a lack of commitment to having the trauma center meet the verification
standards of a national verification organization or, if applicable, the
standards specified in
R9-25-1308 and Table
13.1.
L. If the
Department intends to dedesignate a health care institution, the Department
shall send to the owner a written notice that complies with A.R.S. Title 41,
Chapter 6, Article 10.
M. An owner
who receives a written notice in subsection (A)(2), (B)(3), (E)(3), (G)(2),
(I)(3), or (J) may file a written notice of appeal with the Department that
complies with A.R.S. Title 41, Chapter 6, Article 10.
Notes
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