Current through Register Vol. 24-06, March 15, 2024
The department designates health care facilities to provide
adult and pediatric acute care trauma services ("trauma services") and adult
and pediatric trauma rehabilitation services ("trauma rehabilitation services")
as part of the statewide emergency medical services and trauma care EMS&TC)
system. This section describes the designation process.
(1) The department must:
(a) Provide written notification to all
licensed hospitals and to other health care facilities that a new designation
period is beginning. The written notification and the EMS&TC regional plans
are posted on the department's web site;
(b) Provide a trauma designation application
schedule outlining the steps and timeline requirements for a facility to apply
for trauma service designation. The schedule must provide each facility at
least ninety days to complete an application for trauma designation. The
application schedule is posted on the department's web site;
(c) Provide an application for each level,
type and combination of designation. Designation applications are released
region by region, according to the established schedule;
(d) Conduct a site review for any hospital
applying for level I, II, or III adult and pediatric trauma service designation
to determine compliance with required standards;
(e) Initiate a three-year contract with
successful applicants to authorize participation in the trauma
system.
(2) To apply for
trauma service designation the health care facility must do the following
according to the application schedule:
(a)
Request an application;
(b) Submit
a letter of intent to apply for trauma service designation indicating what
level they are applying for;
(c)
Submit a completed application(s);
(d) For health care facilities applying for
level I, II, III adult and pediatric trauma service designation, the facility
must complete a site review arranged and conducted by the department according
to the following process:
(i) The department
will contract with trauma surgeons and trauma nurses to conduct the site
review. The review team members must:
(A)
Work outside the state of Washington, for level I and II site
reviews;
(B) Work outside the
applicant's EMS&TC region, for level III site reviews;
(C) Maintain the confidentiality of all
documents examined, in accordance with
RCW
70.41.200 and
70.168.070.
This includes, but is not limited to, all trauma patient data, staff
discussions, patient, provider, and facility care outcomes, and any reports
resulting from the site review;
(D)
Present their preliminary findings to the health care facility at the end of
the site review visit;
(ii) The department will provide the
applicant the names of review team members prior to the site review. Any
objections must be sent to the department within ten days of receiving the
department's notification of review team members;
(iii) A site review fee, as established in
WAC
246-976-990, is
charged and must be paid by the health care facility to the department prior to
the site review. A standard fee schedule is posted on the department's web
site. For facilities applying for more than one type of designation or for
joint designation, fee rates can be obtained by contacting the
department;
(iv) The applicant must
provide the department and the site review team full access to the facility,
facility staff, and all records and documents concerning trauma care including
trauma patient data, education, training and credentialing documentation,
standards of care, policies, procedures, protocols, call schedules, medical
records, quality improvement materials, receiving facility patient feedback,
and other relevant documents;
(e) For health care facilities applying for
level IV or V trauma service designation, level I or II trauma rehabilitation
service designation or level I pediatric trauma rehabilitation service
designation, the department may, at its discretion, conduct a site review as
part of the application process to determine compliance with required
standards. If a site review is conducted, the process will be the same as
identified in (d) of this subsection, except a site review fee will not be
charged.
(3) The
department will designate the health care facilities it considers most
qualified to provide trauma care services including when there is competition
for trauma service designation within a region. There is competition for
designation within a region when the number of applications for a level and
type of designation is more than the maximum number of trauma services
identified in the approved EMS&TC regional plan. The department will
evaluate, at a minimum, the following in making its decisions:
(a) The quality of the health care facility's
performance based on:
(i) The submitted
application, attachments, and any other information the department requests
from the facility to verify compliance, or the ability to comply with trauma
standards;
(ii) Recommendations
from the site review team;
(iii)
Trauma patient outcomes during the previous designation period, if
applicable;
(iv) Compliance with
the contract during the previous designation period, if applicable;
(b) The health care facility's
conformity with the EMS&TC regional and state plans, based on:
(i) The impact of the facility's designation
on the effectiveness of the trauma system;
(ii) Patient volumes for the area;
(iii) The number, level, and distribution of
trauma services identified in the state and approved regional plans;
(iv) The facility's ability to comply with
state and regional EMS&TC plan goals.
(4) After trauma service designation
decisions are made in a region, the department will:
(a) Notify each applicant in writing of the
department's designation decision;
(b) Send each applicant a written report
summarizing the department's findings, recommendations and additional
requirements to maintain designation. If a site review was conducted as part of
the application process, the review team findings and recommendations are also
included in the written report. Reports are sent:
(i) Within sixty days of announcing
designation decisions for level IV and V trauma services and trauma
rehabilitation services;
(ii)
Within one hundred twenty days of the site review for level I, II and III adult
and pediatric trauma services and any other facility that received a site
review as part of the application process;
(c) Notify the EMS&TC regional council of
designation decisions within the region and all subsequent changes in
designation status;
(d) Initiate a
trauma designation contract with successful applicants. The contract will
include:
(i) Authority from the department to
participate in the state trauma system, receive trauma patients from EMS
agencies, and provide trauma care services for a three-year period;
(ii) The contractual and financial
requirements and responsibilities of the department and the trauma
service;
(iii) A provision to allow
the department to monitor compliance with trauma service standards;
(iv) A provision to allow the department to
have full access to trauma patient data, the facility, equipment, staff and
their credentials, education, training documentation, and all trauma care
documents such as: Standards of care, policies, procedures, protocols, call
schedules, medical records, quality improvement documents, receiving facility
patient feedback, and other relevant documents;
(v) The requirement to maintain
confidentiality of information relating to individual patient's, provider's and
facility's care outcomes under
RCW
70.41.200 and
70.168.070;
(e) Notify the designated trauma
service and other interested parties in the region of the next trauma
designation application process at least one hundred fifty days before the
contract expires.
(5)
Designated trauma services may ask the department to conduct a site review for
technical assistance at any time during the designation period. The department
has the right to require reimbursement for the costs of conducting the site
review.
(6) The department will not
approve an application for trauma service designation if the applicant:
(a) Is not the most qualified, when there is
competition for designation; or
(b)
Does not meet the trauma care standards for the level applied for; or
(c) Does not meet the requirements of the
approved EMS&TC regional plan; or
(d) Has made a false statement about a
material fact in its designation application; or
(e) Refuses to permit the department to
examine any part of the facility that relates to the delivery of trauma care
services, including, but not limited to, records, documentation, or
files.
(7) If the
department denies an application, the department will send the facility a
written notice to explain the reasons for denial and to explain the facility's
right to appeal the department's decision in accordance with chapters 34.05 RCW
and 246-10 WAC.
(8) To ensure
adequate trauma care in the state, the department may:
(a) Provisionally designate health care
facilities that are not able to meet all the requirements of this chapter. The
provisional designation will not be for more than two years. A
department-approved plan of correction must be prepared by the health care
facility specifying steps necessary to bring the facility into compliance and
an expected date of compliance. The department may conduct a site review to
verify compliance with required standards. If a site review is conducted, the
department has the right to require reimbursement for the cost of conducting
the site review;
(b) Consider
additional applications at any time, regardless of the established schedule, if
necessary to attain the numbers and levels of trauma services identified in the
approved EMS&TC regional and state plan;
(c) Consider applications from hospitals
located and licensed in adjacent states. The department will evaluate an
out-of-state application in the same manner as all other applications. However,
if the out-of-state applicant is designated as a trauma service in an adjacent
state with an established trauma system whose standards meet or exceed
Washington's standards and there is no competition for designation at that
level, then the department may use the administrative findings, conclusions,
and decisions of the adjacent state's designation evaluation to make the
decision to designate. Additional information may be requested by the
department to make a final decision.
(9) The department may suspend or revoke a
trauma designation if the facility or any owner, officer, director, or managing
employee:
(a) Is substantially out of
compliance with trauma care standards WAC
246-976-700
through
246-976-800
or chapter 70.168 RCW and has refused or is unwilling to comply after a
reasonable period of time;
(b)
Makes a false statement of a material fact in the designation application, or
in any document required or requested by the department, or in a matter under
investigation;
(c) Prevents,
interferes with, or attempts to impede in any way, the work of a department
representative in the lawful enforcement of chapter 246-976 WAC, 34.05 RCW,
246-10 WAC, or 70.168 RCW;
(d) Uses
false, fraudulent, or misleading advertising, or makes any public claims
regarding the facility's ability to care for nontrauma patients based on its
trauma designation status;
(e)
Misrepresents or is fraudulent in any aspect of conducting business.
(10) The Administrative Procedure
Act, chapter 34.05 RCW, and chapter 246-10 WAC govern the suspension and
revocation process. The department will use the following process to suspend or
revoke a facility's trauma designation:
(a)
The department will send the facility a written notice to explain the reasons
it intends to suspend or revoke the designation and to explain the facility's
right to a hearing to contest the department's intended action under WAC
246-10-201
through
246-10-205;
(b) The notice will be sent at least
twenty-eight days before the department takes action, unless it is a summary
suspension, as provided for in the Administrative Procedure Act, chapter 34.05
RCW and WAC
246-10-301
through
246-10-306;
(c) If a facility requests a hearing within
twenty-eight days of the date the notice was mailed, a hearing before a health
law judge will be scheduled. If the department does not receive the facility's
request for a hearing within twenty-eight days of the date the notice was
mailed, the facility will be considered in default under WAC
246-10-204;
(d) For nonsummary suspensions, in addition
to its request for a hearing, the facility may submit a plan within
twenty-eight days of receiving the notice of the department's intent to
suspend, describing how it will correct deficiencies:
(i) The department will approve or disapprove
the plan within thirty days of receipt;
(ii) If the department approves the plan, the
facility must begin to implement it within thirty days;
(iii) The facility must notify the department
when the problems are corrected;
(iv) If, prior to sixty days before the
scheduled hearing, the facility is able to successfully demonstrate to the
department that it is meeting the requirements of chapters 246-976 WAC and
70.168 RCW, which may require a site review at the facility's expense, the
department will withdraw its notice of intent to suspend designation;
(e) The department will notify the
regional EMS&TC council of the actions it has taken.
(11) A facility may seek judicial review of
the department's final decision under the Administrative Procedure Act,
RCW
34.05.510 through
34.05.598.
(12) A newly designated or upgraded trauma
service must meet education requirements for all applicable personnel according
to the following schedule:
(a) At the time of
the new designation, twenty-five percent of all personnel must meet the
education and training requirements in WAC
246-976-700
through
246-976-800;
(b) At the end of the first year of
designation, fifty percent of all personnel must meet the education and
training requirements in WAC
246-976-700
through
246-976-800;
(c) At the end of the second year of
designation, seventy-five percent of all personnel must meet the education and
training requirements defined in WAC
246-976-700
through
246-976-800;
(d) At the end of the third year of
designation, and all subsequent designation periods, ninety percent of all
personnel must meet the education and training requirements defined in WAC
246-976-700
through
246-976-800.
(13) All currently designated
trauma services must have a written education plan with a process for tracking
and assuring that new physicians and staff meet all trauma education
requirements within the first eighteen months of employment.
Statutory Authority:
RCW
70.168.050,
70.168.060, and
70.168.070. 09-23-085, §
246-976-580, filed 11/16/09, effective
12/17/09.