(A)
The provisions of rules
3701-84-36 to
3701-84-40 of the Administrative
Code are applicable to
each provider of
open heart surgery services performing procedures on adult patients greater
than or equal to
twenty-two
eighteen years of age
,
regardless of the date service was initiated. An adult open heart
surgery service may serve a patient
greater
less than
or equal
to eighteen years of age
and less than
twenty-two years of age if the patient's attending physician and the
adult service's medical director determine that the adult service best serves
the needs of the patient.
(B) Each
provider of an open heart surgery service
shall
will
have available at all times and accessible by gurney in the same building,
adequate facilities for the open heart surgery service, including but not
limited to the following:
(1) Cardiac
operating rooms;
(2) A cardiac
surgery intensive care unit;
(3) A
post-intensive care "step-down" unit; and
(4) Cardiac catheterization
services.
(C) Each
provider of an open heart surgery service
shall
will
have the capability, equipment, and personnel to perform emergency open heart
procedures on a twenty four hour a day, seven days a week basis. A
cardiovascular surgical team shall
will be available in less than sixty minutes on a
twenty-four hour a day basis.
(D)
Each
provider of an open heart surgery
service
shall
will have access to the following services:
(1) Cardiology;
(2) Hematology;
(3) Nephrology;
(4) Pulmonary medicine;
(5) Infectious disease;
(6) Radiology;
(7) Neurology;
(8) Emergency care;
(9) Electrocardiography;
(10) Stress testing;
(11) Nuclear medicine;
(12) Pathology;
(13)
Blood banking
services;
(13)(14)
Echocardiography;
(14)(15) Pulmonary
function testing;
(15)(16) Cardiac
rehabilitation;
(16)(17) Pre-admission
testing; and
(17)(18) Follow-up
outpatient nursing referral services.
(E) An open heart surgery service
shall
will
only be provided in a fully permanent setting within the permanent frame of the
building of a registered hospital that is
classified as a general hospital or as a special hospital - cardiac that
primarily furnishes limited services to patients with cardiac conditions. The
hospital shall
will be fully equipped and
have all resources necessary to perform the
service
open heart surgery.
(F) Each provider
of an adult open heart surgery service shall
will obtain and
maintain enrollment in the society for thoracic
surgeons (STS) adult cardiac surgery database. Adult open heart surgery
services in operation as of the effective date of this rule shall obtain
enrollment no later than January 1, 2018
a
data registry to monitor operator and institutional volumes and
outcomes.
(G)
Beginning July 1, 2019, each provider of an adult
open heart surgery service shall submit an annual report to the department
based upon the data submitted to the STS during the preceding calendar year. At
a minimum, the report shall
Reporting:
(1)
Maintain
patient confidentiality
Beginning January 1,
2023 and ending December 31, 2024, each adult open-heart service will submit an
annual report to the department by March first of each year that;
(a)
Maintains patient
confidentiality;
(b)
Includes numbers for the following:
(i)
The number of
procedures performed by the adult open heart service;
(ii)
Post procedure
in-hospital mortality number;
(iii)
In hospital
prolonged intubation (ventilation) for a period of longer than seven
days;
(iv)
Deep sternal wound infection
(mediastinitis);
(v)
Post-operative renal insufficiency;
(vi)
Surgical
re-exploration; and
(vii)
Stroke.
(2)
Beginning January
1, 2025, each level III service will submit the following information to the
department by March first of each year as part of the hospital's annual report
that:
(a)
Maintains patient confidentiality;
(b)
Includes numbers
for the following:
(i)
The number of procedures performed by the adult open
heart service;
(ii)
Post procedure in-hospital mortality
number;
(iii)
In hospital prolonged intubation (ventilation) for a
period of longer than seven days;
(iv)
Deep sternal
wound infection (mediastinitis);
(v)
Post-operative
renal insufficiency;
(vi)
Surgical re-exploration; and
(vii)
Stroke.
(2) Include the following
information:
(a) The number of open heart
procedures performed;
(b) The number of coronary artery
bypass grafting (CABG) procedures performed;
(c) In-patient risk adjusted
mortality rate for CABG; and
(d) Risk adjusted rate of the
following for CABG;
(i) Prolonged intubation
(ventilation);
(ii) Deep sternal wound infection
(mediastinitis);
(iii) Post-operative renal
insufficiency;
(iv) Surgical re-exploration;
and
(v) Permanent
stroke.
(H) Each adult open heart surgery
service shall provide notice to the department within thirty days of receipt of
their service's STS report for any reporting period in which the service falls
at or below the tenth percentile for the national quality forum (NQF) measures
for CABG. The report shall include an explanation as to why the service did not
meet the measure, and how the service intends to meet the measure in the
future. The report shall be based upon the risk adjusted rates for the
following:
(1) In-patient mortality
rate;
(2) Prolonged intubation
(ventilation);
(3) Deep sternal wound infection
(mediastinitis)
(4) Post-operative renal
insufficiency;
(5) Surgical re-exploration;
and
(6) Stroke/cerebrovascular
accident.
(I)(H)
Each provider of an adult open heart
surgery service shall
will have a written policy requiring the
documentation of any internal review of surgeons with a combination of
high
higher than
expected risk adjusted mortality and low individual surgeon
volume.
(J)(I) Each
provider of an adult open heart surgery
service shall
will utilize a coordinated and integrated
multidisciplinary approach to patient care, including meetings between
cardiologists and cardiovascular surgeons as necessary, to address the needs of
patients with complex cardiovascular disease.
(K)(J) Each
provider of an adult open heart surgery
service shall
will have established criteria that cardiologists and
surgeons must
will utilize for the purposes of patient selection and
appropriateness.
(L)(K) Each
provider of an adult open heart surgery
will have patient selection and appropriateness
criteria:
(1)
Shall
be consistent
Consistent with the
2011
2021
American college of cardiology/American heart association (ACC/AHA) guideline
update for coronary artery bypass graft surgery, available at
www.acc.org; and
(2) For patients with adult congenital heart
disease,
are consistent with the
2008
2018
American college of cardiology/American heart association guidelines for the
management of adults with congenital heart disease: executive summary,
available at
www.acc.org.
Notes
Ohio Admin. Code
3701-84-36
Effective:
5/15/2023
Five Year Review (FYR) Dates:
2/27/2023 and
05/05/2028
Promulgated
Under: 119.03
Statutory
Authority: 3702.11,
3702.13
Rule
Amplifies: 3702.11,
3702.12,
3702.13,
3702.14,
3702.141,
3702.15,
3702.16,
3702.18,
3702.19,
3702.20
Prior
Effective Dates: 03/01/1997, 03/24/2003, 05/15/2008, 06/21/2012,
08/01/2017
