Need Criterion 1: Staffing
Requirements
a. The applicant
for invasive DA services shall demonstrate that proper protocols for screening
and medical specialty backup are in place before services are rendered by
personnel other than those with specialized training. The protocols shall
include, but are not limited to, having prior arrangements for
consultation/backup from a vascular surgeon, cardiologist, radiologist or
nephrologist credentialed and accredited for interventional peripheral vascular
procedures.
b. Identify physicians
in the group and state which physicians(s) will perform intravascular
interventions using DA. Certify that:
i. Each
physician will maintain medical staff privileges at a full service hospital; or
ii. At least one member of the
physician group has staff privileges at a full service hospital and will be
available at the facility or on call within a 30-minute travel time of the full
service hospital during the hours of operation of the facility.
Need Criterion 2: Types of
Procedures
a. Procedures in a
freestanding facility are generally non-emergent nor life threatening in nature
and require a patient stay of less than 24 consecutive hours. The procedures
shall not be of a type that:
i. Generally
result in blood loss of more than ten percent of estimated blood volume in a
patient with a normal hemoglobin;
ii. Require major or prolonged intracranial,
intrathoracic, abdominal, or major joint replacement procedures, except for
laparoscopic procedures; or
iii.
Involve major blood vessels.
1. Major blood
vessels are defined as the group of critical arteries and veins including the
aorta, coronary arteries, pulmonary arteries, superior and inferior vena cava,
pulmonary veins, carotid arteries, and any intra-cerebral artery or
vein.
b.
Percutaneous endovascular interventions of the peripheral vessels not excluded
in a.iii.1. above are permitted to be performed in a freestanding facility.
These procedures are defined as procedures performed without open direct
visualization of the target vessel, requiring only needle puncture of an artery
or vein followed by insertion of catheters, wires, or similar devices which are
then advanced through the blood vessels using imaging guidance. Once the
catheter reaches the intended location, various maneuvers to address the
diseased area may be performed which include, but are not limited to, injection
of contrast for imaging, ultrasound of the vessel, treatment of vessels with
angioplasty, artherectomy, covered or uncovered stenting, intentional occlusion
of vessels or organs (embolization), and delivering of medications, radiation,
or other energy such as laser, radiofrequency, or cryo.
Need Criterion 3: Transfer
Agreement
The applicant must certify that the proposed facility
will have a formal transfer agreement with a full service hospital to provide
services which are required beyond the scope of the freestanding facility's
programs.
Need Criterion 4: CON Exemption
Before utilizing or providing the equipment or service,
the applicant desiring to provide the digital angiography equipment or invasive
DA services shall have CON approval or written evidence that the equipment or
service is exempt from CON approval as determined by MSDH through a
determination of reviewability.
