b) The Department shall
have the authority to take the following action, as appropriate, after
determining that a trauma center is in violation of the Act or this Part:
1) If the Director determines that the
violation presents a substantial probability that death or serious physical
harm will result and if the trauma center fails to eliminate the violation
immediately or within a fixed period of time, not exceeding 10 days, as
determined by the Director, the Director may immediately revoke the trauma
center designation. The trauma center may appeal the revocation within 15 days
after receiving the Director's revocation order, by requesting a hearing as
provided by Section 3.135 of the Act. The Director shall notify the chair of
the Region's Trauma Center Medical Directors Committee and EMS Medical
Directors for the appropriate EMS Systems of such a trauma center designation
revocation.
2) If the Director
determines that the violation does not present a substantial probability that
death or serious physical harm will result, the Director shall issue a notice
of violation and request a plan of correction which shall be subject to the
Department's approval. The trauma center shall have 10 days after the receipt
of the notice of violation in which to submit a plan of correction. The
Department may extend this period for up to 30 days. (Section
3.90(b)(10)(B)
of the Act)
A) The Department will consider
the following factors in determining whether or not to extend the period for
submission of the plan of correction to a maximum of 30 days: whether a
substantial probability that death or serious physical harm will result still
exists, and whether the delay could lead to physical harm.
B) The plan shall include a fixed time period
not in excess of 90 days within which violations are to be corrected. The plan
of correction and the status of its implementation by the trauma center shall
be provided, as appropriate, to the EMS Medical Directors for the appropriate
EMS Systems. If the Department rejects a plan of correction, it shall send
notice of the rejection and the reason for the rejection to the trauma center.
The trauma center shall have 10 days after receipt of the notice of rejection
in which to submit a modified plan. If the modified plan is not timely
submitted, or if the modified plan is rejected, the trauma center shall follow
an approved plan of correction imposed by the Department. If, after notice and
opportunity for hearing, the Director determines that a trauma center has
failed to comply with an approved plan of correction, the Director may revoke
the trauma center designation. The trauma center shall have 15 days after
receiving the Director's notice in which to request a hearing. Such hearing
shall conform to the provisions of Section 3.135 of the Act. (Section
3.90(b)(10)(B)
of the Act)
C) Each plan of
correction shall be based on an assessment by the facility of the conditions or
occurrences which are the basis of the violation and an evaluation of the
practices, policies, and procedures which have caused or contributed to the
conditions or occurrences. Evidence of such assessment and evaluation shall be
maintained by the facility. Each plan shall include:
i) A description of the specific corrective
action the facility is taking, or plans to take, to abate, eliminate, or
correct the violation cited in the notice;
ii) A description of the steps that will be
taken to avoid future occurrences of the same or similar violations.
D) The Department shall review
each plan of correction to ensure that it provides for the abatement,
elimination, or correction of the violation. The Department shall reject a
submitted plan if it finds any of the following deficiencies:
i) The plan does not address the conditions
or occurrences that are the basis of the violation and an evaluation of the
practices, policies, and procedures that have caused or contributed to the
conditions or occurrences.
ii) The
plan is not specific or does not provide measures to indicate the actual
actions the facility will be taking to abate, eliminate, or correct the
violation(s).
iii) The plan does
not provide steps that will avoid future occurrences of the same and similar
violations.
iv) The plan does not
provide for timely completion of the corrective action, considering the
seriousness of the violation, any possible harm to patients, and the extent and
complexity of the corrective action.
E) The Department shall verify the completion
of the corrective action:
i) By requiring the
trauma center to submit monthly reports to the Department for up to one year,
which consists of current hospital trauma plan (first month only); trauma
quality monitoring plan and indicators (first month only); minutes of all
meetings pertaining to trauma, including but not limited to Trauma Service
Committee, Department of Surgery, and Morbidity and Mortality Review Committee;
a list of all Category I and II trauma patients treated in the previous month,
which includes but is not limited to medical record number, date and time of
arrival at the trauma center, sex, mechanism of injury, trauma category
classification and time; trauma surgeon and surgical specialty; time of
notification and arrival time; and
ii) Through subsequent investigations,
surveys and evaluations of the trauma center.