Current through Register Vol. 35, No. 18, September 24, 2024
A.
Levels of trauma centers: the Bureau shall identify trauma centers by
levels of care capability as defined in these regulations. The levels
are as follows:
(1) level I trauma
center
(2) level II trauma
center
(3) level III trauma
center
(4) level IV trauma
center
B.
Phases
of Designation:
(1) phase one (1),
letter of intent: the first phase of the designation process is an invitation
issued by the Bureau to all hospitals/healthcare facilities in the State that
applications for designations are initiated by a letter of intent.
(2) phase two (2), application: the hospital
shall submit an application, that has been developed by the Bureau, to the
Bureau identifying the desired level of trauma center designation.
(3) phase three (3), review: the third phase
is the review phase which begins with the on-site review of the
hospital/healthcare facility and ends with the Bureau's recommendation to the
Secretary to designate the hospital/healthcare facility as a trauma
center.
(4) phase four (4), final:
the fourth phase is the final phase which begins with the Secretary reviewing
the Bureau's recommendations and ends with a final decision as to the level of
trauma center designation by the Department. This phase also includes an appeal
procedure for the denial of a designation application in accordance with these
regulations.
C.
Application Process:
(1) the Bureau
shall develop and issue an application packet to hospitals or healthcare
facilities, which have submitted a letter of intent in seeking initial
designation as a trauma center.
(2)
the application packet shall describe the information required from an
applicant to be considered for trauma center designation. Such information
shall include:
(a) application
requirements,
(b) system standards
for the level at which the hospital/healthcare facility is applying together
with the current status on each standard and category of designation
sought,
(c) evaluation
criteria,
(d) statement and
documentation of attendance and participation in the area ReTrAC and a
commitment to serve the trauma care needs of their desired trauma services area
and as a partner in the Statewide Trauma System,
(e) geographic area proposed to be covered,
and appropriate utilization of data, and
(f) evidence of financial viability
compliance.
(3) if there
is a designated trauma center or centers at the same or higher level of
designation in the proposed geographical area to be served by the applicant,
the applicant shall include in its application the following:
(a) a statement of the proposed role of the
applicant hospital assuring that the applicant's trauma program and activities
would not have a negative financial or operational impact on the existing
designated trauma center(s) program or services, and
(b) a statement by the area ReTrAC that the
proposed trauma program of the applicant is consistent with and addresses the
needs of the regional trauma program as described in the approved regional
trauma plan.
(4) the
Bureau shall:
(a) conduct a review of each
applicant's submitted proposal for completeness. If any proposal is incomplete,
the applicant shall be notified by the Bureau and afforded the opportunity to
complete the application at least within twenty (20) working days of the
Bureau's notification; and,
(b)
evaluate applications for potential multiple hospital designation following the
same criteria as for a single-facility application. Applications for multiple
hospital designation must demonstrate that the goals of these regulations are
met as defined in their applications.
D.
On-Site Review for
Designation:
(1) the Bureau shall
conduct an on-site review of an applicant hospital/healthcare facility for
levels I, II, III, and IV trauma centers, prior to designation.
(2) the Bureau shall establish
multi-disciplinary on-site review teams composed of individuals knowledgeable
in trauma care and systems, appropriate to the level of designation
requested.
(3) for the initial
designation for a level I and II trauma center, the team shall include but not
be limited to a:
(a) trauma surgeon,
(b) emergency physician, and
(c) trauma nurse coordinator.
(4) for the designation for a
level III and IV trauma center, the team shall include a:
(a) trauma surgeon or emergency physician,
and
(b) trauma nurse
coordinator.
(5) the
composition of subsequent survey teams shall be determined by the
Bureau.
(6) such teams shall
consist of professionals who do not live or work:
(a) in the same state as the applicant for
the designation of levels I and II trauma centers, or,
(b) in the same county as the applicant for
designation of level III or IV trauma centers.
(7) the Bureau will consider the allegation
of conflict of interest of an on-site review team member if a hospital or
healthcare facility can demonstrate a reasonable basis for concern as
determined by the Department. Concerns accompanied by the proof upon which the
hospital or healthcare facility relies on must be submitted in writing within
ten (10) working days of the Bureau's announcements of proposed on-site review
team members.
(8) the applicant's
administration, faculty, medical staff, employees and representatives are
prohibited from having any contact with any on-site review team member after
the announcement of the team members and before the on-site review, except as
authorized by the Bureau. A violation of this provision may be grounds for
denying that applicant's proposal, as determined by the Bureau.
(9) the on-site review team shall evaluate
the appropriateness and capabilities of the applicant to provide trauma care
services, and validate the hospital/healthcare facility's ability to meet the
responsibilities, equipment, and performance standards for the level of
designation sought and to meet the overall needs of the trauma system in that
region by:
(a) familiarizing themselves with
the hospital or healthcare facility's proposal;
(b) inspecting the hospital or healthcare
facility's physical plant and interviewing of key staff,
(c) examining hospital or healthcare facility
trauma related documents, including patient care records;
(d) interviewing other appropriate
individuals;
(e) reviewing past
applicant or similar proposals for the regions; and, reviewing other materials
as deemed appropriate by the Bureau.
(10) the on-site review team shall:
(a) make a verbal summary of preliminary
findings to the applicant upon completion of the on-site review; and,
(b) make written recommendations to the
Bureau of the on-site review.
(11) the Bureau and the members of the
on-site review team shall maintain confidentiality of information, records, and
reports developed pursuant to on-site reviews as permitted by state and federal
laws. Information obtained by the on-site team, their oral and written reports,
and deliberations shall be kept confidential by the Bureau.
(12) the applicant's application will become
the property of the Bureau and shall be considered public information at the
end of the designation process, subject to state and federal laws.
(13) hospitals applying for level I or level
II may, at their discretion, request a verification site survey by
representatives of the American College of Surgeons. The Bureau will accept the
findings of the verification site visit and incorporate a copy of the findings
in its report to the Secretary recommending or not recommending designation at
the level applied for.
E.
Designation of Trauma
Center:
(1) as soon as practical, but
no later than forty five (45) days after receipt of the on-site report survey
document, the Bureau shall make recommendations to the Secretary based on:
(a) evaluation of pre-review documentation
submitted as part of the application,
(b) recommendations from the on-site review
team,
(c) ability of each applicant
to comply with goals of the State and regional trauma plans, and,
(d) compliance with agreements with the
Bureau, including compliance with regional review criteria as applicable during
the previous designation period.
(2) after completion of the on-site review,
the Bureau:
(a) may recommend to the Secretary
approval at the level of designation proposed by the hospital or healthcare
facility; or,
(b) may recommend to
the Secretary a lower designation, if, according to the site surveyor's
evaluation, the hospital or healthcare facility is unable to meet the standards
of the designation for which the applicant applied; or,
(c) may require the hospital or healthcare
facility to submit an application for the lower designation, to be followed by
an on-site review.
(3)
upon approval of the recommended level of designation by the Secretary, the
Bureau shall require the hospital or healthcare facility, after receiving
notification of the Secretary's decision, to respond within ten (10) working
days to accept or decline the proposed designation.
(4) hospitals or healthcare facilities
designated as a trauma center shall comply with applicable standards as set
forth by the Bureau.
F.
Categories of Designation:
(1)
provisional: the Bureau may initially designate a trauma center as
"provisional" for a term not to exceed one (1) year except for good cause shown
as granted by the Bureau;
(a) shall require
all provisional trauma centers to have a written work plan of objectives to
rectify deficiencies and to demonstrate progress on the work plan throughout
the twelve (12) month time period; and,
(b) shall, at the end of the provisional
period, grant full designation, extend the provisional period, or suspend the
trauma center for cause.
(2) full designation: the Bureau may grant
full designation to any hospital or healthcare facility in full compliance with
these regulations, subject to the review process described, for a period not to
exceed three (3) years.
G.
Agreement Process: the
Bureau and the designated trauma center shall enter into a written agreement.
The agreement shall:
(1) authorize the
hospital or healthcare facility to function and identify itself as a designated
trauma center for either provisional or full designation;
(2) identify the requirements and
responsibilities of both the trauma center and the Bureau, including attendance
requirements at local, regional, state and national meetings;
(3) allow the Bureau to monitor compliance
with regulations and standards during the designation period, including access
to:
(a) patient discharge summaries
(b) patient care logs
(c) patient care records
(d) hospital trauma process improvement
program records, including minutes, and,
(e) other relevant documents as determined by
the Bureau, and
(4)
require confidentiality of information relating to individual patient,
provider, and hospital/healthcare facility's care outcomes in accordance with
state and federal laws.
H.
Denial, Revocation or Suspension of
Designation:
(1) the Bureau may deny
the application for designation if it finds that the hospital/healthcare
facility:
(a) is not the most qualified
applicant within a geographic area;
(b) is unable to meet the requirements of
these regulations for the level of designation sought;
(c) makes a false statement of a material
fact in the hospital/healthcare facility's application for
designation;
(d) refuses to allow
representatives of the Bureau to inspect any part of the hospital/healthcare
facility, records, documentation, or files pertaining to the designation
process;
(e) is unable to meet or
comply with the requirements as stated in Paragraph (5) of Subsection C
of 7.27.7.8 NMAC for participation in the activities of an area ReTrAC
and the requirements of an approved regional trauma plan.
(f) engages in unauthorized contact with any
on-site review team member.
(2) the Bureau may revoke or suspend a trauma
center designation if the trauma center:
(a)
fails, refuses to comply or violates the provisions of the State hospital
licensure requirements of the State trauma regulations or provisions of
applicable federal law; or the trauma center agreement;
(b) fails to provide data to the Trauma
Registry;
(c) makes a false
statement of a material fact in the application for designation, or in any
record required by these regulations, or in a matter under
investigation;
(d) prevents,
interferes with, or attempts to impede in any way, the work of a representative
of the Bureau in the lawful enforcement of these regulations or any other
applicable state law;
(e) uses
false, fraudulent, or misleading advertising, or makes any public claims
regarding the hospital/healthcare facility's ability to care for non-trauma
patients based on its trauma center designation status;
(f) misrepresents or is fraudulent in any
aspect of conducting business;
(g)
is substantially out of compliance with the requirements of these regulations,
and has been unable or refused to comply as required by the Bureau.
(3) the following procedures will
be used for any investigation of a designated trauma center by the Bureau:
(a) any person or entity may communicate a
complaint or knowledge of an incident of any alleged violation of these
regulations to the Bureau. Complaints shall be submitted in signed written form
to the Bureau. The Bureau may begin an investigation without a signed written
complaint if there is sufficient cause.
(b) trauma centers being investigated shall
receive written notification within ten (10) working days after a decision is
made to begin a preliminary investigation.
(c) at the conclusion of the Bureau's
preliminary investigation, the Bureau shall report its findings to the trauma
center in written form, including any requirements for corrective
action.
(d) if the trauma center
does not respond, the corrective action is insufficient, or if the complaint is
of such serious nature as to warrant suspension or revocation of designation,
as determined by the Bureau, the Bureau shall proceed to the procedure as
outlined in Paragraph (4) of Subsection H of 7.27.7.9 NMAC
below.
(4)
preliminary and further investigations shall be conducted by the Bureau.
(a) preliminary investigations shall be
initiated when the Bureau receives information, which might form the basis for
action against a trauma center. This fact finding/information gathering
investigation will determine for the Bureau whether justification exists to
initiate an action or to conduct a further investigation.
(b) further investigations shall be
undertaken when additional information is required to allow the Bureau to
determine if it will initiate an action. Notice will be given to the trauma
center, which is the subject of the investigation unless extenuating
circumstances exist which would reasonably preclude notification.
(c) the Bureau will take every precaution to
ensure that preliminary and further investigations are conducted in a
confidential manner.
(d) an
official record is maintained for every designated trauma center in New Mexico
under these regulations. If the Bureau begins a preliminary or further
investigation, a confidential record will be created containing all
investigatory material. If the Bureau initiates an action, all records not
exempt from disclosure under the Inspection of Public Records Act, Section
14-2-1,
et seq, NMSA 1978, will be placed in the designated trauma center's official
record. Any request for records maintained by the Bureau will be processed in
accordance with the Inspection of Public Records Act.
(5) the following process shall be used when
designation is contemplated to be denied, revoked, or suspended:
(a) the Bureau shall notify a
hospital/healthcare facility in writing of contemplated denial of designation,
revocation, or suspension of designation by issuing a Notice of Contemplated
Action (NCA). Such NCA shall include:
(i) the
reasons for the action, and,
(ii)
rights of the hospital/healthcare facility, which include a right to a hearing,
and may, for contemplated suspension or revocation actions, at the discretion
of the Bureau, include authorization to submit a plan of correction.
(b) the Bureau shall notify the
recognized ReTrAC (if applicable) of the action taken.
(c) should a plan of correction be authorized
by the Bureau pending contemplated revocation or suspension of designation of a
trauma center, the following procedure shall be followed:
(i) the Bureau shall specify a deadline for
submission of the plan of correction in the NCA. The plan shall include steps,
which the trauma center intends to take in order to correct deficiencies and
projected date of completion.
(ii)
the Bureau shall approve or disapprove the plan within fifteen (15) calendar
days of receipt. If the plan is disapproved by the Bureau, the
hospital/healthcare facility shall have twenty (20) days to request a hearing
in accordance with Paragraph (6) of Subsection H of 7.27.7.9 NMAC
below.
(iii) upon notification that
the plan of correction is approved by the Bureau, the trauma center shall begin
implementation of the plan immediately and notify the Bureau upon completion of
the plan.
(iv) upon satisfactory
evidence of compliance, which may include an on-site review, the trauma center
shall retain the designation status.
(6) the following process of appeal will be
available to any hospital/healthcare facility which has received a Notice of
Contemplated Action (NCA) to deny, suspend or revoke a trauma center
designation.
(a) within twenty (20) calendar
days of receipt of the contemplated action to deny, suspend or revoke a trauma
center designation,
(b) a
hospital/healthcare facility may formally appeal by requesting a hearing in
writing, by certified return receipt letter to the Secretary of the Department,
PO Box 26110, Santa Fe, New Mexico, 87502-6110.
(c) upon receipt of a timely appeal, and
request for a hearing, the Secretary shall appoint a Hearing Officer and
schedule a hearing, to be held in Santa Fe, New Mexico within forty five (45)
working days. If no timely request for hearing is received, the Bureau will
take the action contemplated in the NCA.
(d) the Department shall notify the
hospital/healthcare facility of the date, time, and place of the hearing, the
identity of the Hearing Officer, and the subject matter of the hearing, not
less than thirty (30) days prior to the date of the hearing.
(e) the Hearing Officer shall preside over
the hearing, administer oaths, take evidence and decide evidentiary objections
and rule on any motions or other matters that arise prior to the
hearing.
(f) the hearing is open to
the public unless requested to be closed by the hospital or the
Department.
(g) the Hearing Officer
shall make a written report and recommendation(s) to the Secretary containing a
statement of the issue raised at the hearing, proposed findings of fact,
conclusions of law, and a recommended determination.
(h) The Hearing Officer, or designee, shall
record the hearing by means of mechanical sound recording device provided by
the Department.
(i) The Hearing
Officer's written report shall be submitted to the Secretary no later than
thirty (30) working days after the close of the hearing.
(j) the Secretary shall render a final
determination within ten (10) working days of the submission of the Hearing
Officer's report. A copy of the final decision shall be mailed to the appealing
hospital/healthcare facility by certified mail, and a copy shall be provided to
the Office of General Counsel of the Department of Health.
I.
Change in Trauma Center
Designation Status:
(1) a designated
trauma center shall have the right, with ninety (90) days notice, to withdraw
as a trauma center or to request a designation lower than their current
designated level.
(2) a designated
trauma center shall:
(a) notify the Bureau and
the approved ReTrAC within five (5) calendar days if temporarily unable to
comply, and the reasons, with designation standards;
(b) notify the Bureau and the ReTrAC if it
chooses to no longer provide trauma services commensurate with its designation
level; and,
(c) if the trauma
center chooses to apply for a lower level of designation, the Bureau, at its
discretion, may repeat all or part of the designation process as described in
these regulations.
J.
Renewal of Trauma Centers
Designation:
(1) all trauma centers
shall repeat the designation process as described in these regulations every
three (3) years prior to the trauma center's expiration of designation. The
trauma center shall apply to the Bureau for re-designation for a period of
three (3) years. A designated trauma center, in good standing, shall remain
designated until the application process is completed.
(2) each level I, II, and III trauma center
shall be resurveyed as described in the designation process in Section M of
these regulations. Each level IV trauma center may be resurveyed, at the
discretion of the Bureau.
(3) at
the discretion, and for good cause, the Bureau may extend for up to one year
the current designation status of any trauma center.
K.
Trauma System Fees: the
Bureau shall establish and publish a fee structure for trauma centers
applicants for designation as a trauma center to help defray the costs
associated with review of the application, the on-site review process and
ongoing trauma system management.
L.
Prohibition of the Use, Advertising
or Marketing of Terms: to protect against public misconception of the
capabilities of individual institutions and the usage of misleading terms, the
following are prohibited:
(1) after January
1, 1996, no person, emergency medical service, hospital/healthcare facility
shall, by any means, advertise, assert, represent, offer, provide or imply that
such person, service, clinic or facility is a trauma center or use the terms;
"trauma center", "trauma facility", trauma hospital", "trauma care hospital" or
similar terminology or state in any manner that the person, organization or
facility has the capabilities for providing treatment to major trauma patients
except as permitted within the scope of the trauma center designation as
provided herein.
(2) no trauma
center shall, in any manner, advertise or publicly assert that its trauma
designation affects the hospital/healthcare facility's care for non-trauma
patients, nor that the designation should influence the referral of non-trauma
system patients.
M.
Trauma Center Fiscal Viability Requirement: in order to assure
that each designated trauma center has adequate financial and facility
resources and a qualified medical workforce to provide optimal care to the
injured patient and to meet the requirements of these regulations, each
designated trauma center shall:
(1) establish
a trauma program fee and charge schedule for services rendered to qualifying
trauma patients that accurately reflect the cost of services rendered to
qualifying trauma patients and the financial risk associated with rendering
trauma services as a designated trauma center;
(2) enter into reimbursement agreements or
contracts with all third party payer organizations including, but not limited
to, managed care organizations, Blue Cross and Blue Shield and preferred
provider organizations. These reimbursement agreements are intended to:
(a) adequately reimburse the designated
trauma center the cost for rendering emergency and in-hospital care to
qualifying trauma patients, and
(b)
adequately reimburse the hospital employed or contracted trauma team physicians
the cost of rendering care to qualified trauma patients and the cost of trauma
team alerting and trauma team activation.
(3) the designated trauma center, or an
organization acting in its behalf such as the New Mexico Trauma Foundation,
with the contractual authority to negotiate payment and reimbursement
agreements and/or to perform other financial and collection services for the
designated trauma center shall not discount or otherwise attempt to collect
charges and fee less than the trauma program fee and charge schedule developed
by the designated trauma center.
(4) a designated trauma center hospital may
request from the Bureau a waiver of the financial viability requirements
enumerated in this Section. The waiver request shall specify that the
applicant's trauma program generates sufficient revenue to cover the cost of
the trauma program and the financial risk associated with trauma center
designation.
N.
Trauma Team Physician Fiscal Viability Requirement: in order to assure
that each trauma team physician participating on the trauma teams at the
designated trauma centers has the financial resources needed to provide optimal
care to the injured patient and to meet the requirements of these regulations,
each trauma team participating physician shall:
(1) establish a trauma fee and charge
schedule for physician services rendered to qualifying trauma patients that
accurately reflect the cost of physician services rendered to qualifying trauma
patients and the financial risk associated with rendering trauma care services
as a trauma team physician; and
(2)
enter into reimbursement agreements or contracts with all third party payer
organizations including, but not limited to, managed care organizations, Blue
Cross and Blue Shield and preferred provider organizations. These reimbursement
agreements shall adequately reimburse the physician for physician services
rendered to qualifying trauma patients.
(3) the trauma team physician or, an
organization acting in his or her behalf such as the New Mexico Trauma
Foundation, with the authority to negotiate payment and reimbursement
agreements and/or to perform other financial and collection services for the
physician shall not discount or otherwise attempt to collect charges and fee
less than the trauma fee and charge schedule developed by the
physician.
(4) a physician
participating on the trauma team at a designated trauma center hospital may
request from the Bureau a waiver of the financial viability requirements
enumerated in this Section. The waiver request shall specify that the physician
generates sufficient revenue to cover the cost of the trauma program
participation. "
O.
Trauma Managed Care Patients: each designated trauma center
shall:
(1) facilitate the transfer of a
member of a health maintenance organization or system when the medical
condition of the patient permits as defined by the patient's attending trauma
physician and trauma center's trauma protocols.
(2) develop written policies, in cooperation
with managed care healthcare systems and hospitals owned or contracted to
provide care to the managed care providers, to:
(a) notifying the healthcare plan within
forty-eight (48) hours of a trauma patient's admission,
(b) coordinate discharge planning of plan
patients, and,
(c) facilitate
transfer of patients.