900 KAR 6:120. Certificate of need angioplasty

two (2) year trial program.

 

      RELATES TO: KRS 216B.010-216B.130,

216B.330-216B.339, 216B.990

      STATUTORY AUTHORITY: KRS 194A.030,

194A.050, 216B.040(2)(a)1

      NECESSITY, FUNCTION, AND CONFORMITY: KRS

216B.040(2)(a)1 requires the Cabinet for Health and Family Services to

administer Kentucky's certificate of need program and to promulgate

administrative regulations as necessary for the program. This administrative

regulation establishes the provisions for the certificate of need approved

angioplasty two (2) year trial program in hospitals without on-site open heart

surgery.

 

      Section 1. Definitions. (1)

"Cabinet" is defined by KRS 216B.015(6).

      (2) "Days" means calendar days,

unless otherwise specified.

      (3) "Trial" means the certificate

of need approved angioplasty two (2) year trial program in hospitals without

on-site open heart surgery.

 

      Section 2. Angioplasty Two (2) Year Trial

Program. The provisions of this section shall apply during the two (2) year

period of the trial for primary (i.e. emergency) and elective angioplasty in

hospitals without on-site open heart surgery.

      (1) Hospitals participating in the trial

shall, within twenty-four (24) hours of the event or on the first business day

following the event, report the following events to the Office of Health Policy

by fax at (502) 564-0302 or by emailing the executive director:

      (a) A death that occurs within

twenty-four (24) hours of the cardiac catheterization procedure or hospital

discharge. The report shall indicate if the death was a cardiac death or a

noncardiac death.

      1. A death shall be considered a cardiac

death if the death was due to any of the following:

      a. Acute myocardial infarction;

      b. Cardiac perforation/pericardial

tamponade;

      c. Arrhythmia or conduction abnormality;

      d. Cerebrovascular accident related to,

or suspected of being related to, the cardiac catheterization procedure. An

event shall be considered to be a cerebrovascular accident if there were acute

neurological deficits recorded by clinical staff that persisted more than

twenty-four (24) hours. The report shall note if these events occurred:

      (i) During the index catheterization; or

      (ii) During the index hospitalization;

      e. Death due to complication of the

procedure including bleeding, vascular repair, transfusion reaction, or bypass

surgery; or

      f. Any death in which a cardiac cause

could not be excluded.

      2. A death shall be considered a

noncardiac death if the death was not due to cardiac causes as described in

subparagraph 1 of this paragraph;

      (b) Emergency coronary artery bypass

graft surgery (CABG) within twenty-four (24) hours of the procedure or hospital

discharge. An event shall be considered to be an emergency if there is a sudden

and often life-threatening mishap that arises in the course of, and as a result

of, the performance of a cardiac catheterization or angioplasty procedure. It

shall not include patients either transferred directly from the cardiac

catheterization procedure room or taken within twenty-four (24) hours to the

operating room for surgical correction of emergent or life threatening cardiac

disease; or

      (c) Shock within twenty-four (24) hours

of the procedure or hospital discharge.

      (2) Hospitals participating in the trial shall

report in writing within seven (7) days to the Office of Health Policy any of

the following events:

      (a) Cerebrovascular accident, which are

acute neurological deficits recorded by clinical staff that persisted more than

twenty-four (24) hours. The report shall note if these events occurred within

thirty (30) days after the catheterization but were not clearly related to the

procedure;

      (b) Any intracranial bleed within thirty

(30) days of the cardiac catheterization procedure;

      (c) Recurrent Q wave or Non-Q wave

myocardial infarction (MI) during the initial hospitalization; or

      (d) Vascular complications which occur

within twenty-four (24) hours of the cardiac catheterization procedure or

hospital discharge. These shall include:

      1. Hematoma of more than four (4)

centimeters;

      2. Retroperitoneal Bleed;

      3. False Aneurysm;

      4. AV fistula;

      5. Peripheral ischemic/nerve injury; or

      6. Hemolysis and Hemolytic anemia.

      (3) Hospitals participating in the trial

shall:

      (a) Establish a Joint Performance

Improvement Committee (Joint PI Committee) with its collaborating tertiary

hospital or with practicing interventional cardiologists. The membership of the

Joint PI Committee shall, at a minimum, include each of the following disciplines

from both the hospital participating in the trial and the collaborating

tertiary hospital:

      1. Physicians;

      2. Nurses; and

      3. Administrators;

      (b) Convene the Joint PI Committee at

least quarterly but sooner if twenty-five (25) patients have been treated to

review the care provided to patients under the trial. This review process shall

focus on patient outcomes and, at a minimum, include:

      1. An assessment of the appropriateness

of the selection of each patient entered into the trial;

      2. All complications, any adverse

outcomes, and for transfers, the number of patients requiring transfer and the

reason for each transfer to a tertiary facility;

      3. The technical quality of the

catheterization and angioplasty procedures performed; and

      4. The "door to cath lab time"

and "door to treatment time";

      (c) Develop and implement a plan of

correction for any problems identified;

      (d) Develop a process for including the

findings of the Joint PI Committee’s review in the trial hospital’s performance

improvement program; and

      (e)Require all staff, including

interventional cardiologists, nurses, and technicians, as well as

representatives of the Emergency Department and Critical Care Unit staffs

participating in the trial performance improvement process, to attend a minimum

of one (1) meeting of the Joint PI Committee per year.

      (4) Performance of primary and elective

angioplasty at a hospital as measured by quality indicators including

mortality, morbidity, and adverse reactions shall be comparable, on a risk

adjusted basis, to the performance of existing angioplasty programs in Kentucky

and with similar organizations nationally, according to the National Cardiovascular

Data Registry.

      (a) If the outcomes are worse at a

hospital participating in the trial, that facility shall file and implement a

plan of correction with the Office of Health Policy.

      (b) If the facility’s results do not

improve after one (1) quarter of implementing a plan of correction, the Office

of Health Policy may terminate the facility’s participation in the trial.

      (5) Hospitals participating in the trial shall:

      (a) Continue to make available the

primary angioplasty service twenty-four (24) hours per day and seven (7) days

per week;

      (b) Develop policies and procedures that

will assure that all interventional cardiologists performing angioplasty procedures

at the hospital participating in the trial maintain an appropriate level of proficiency

as a member of the team performing angioplasty at the hospital participating in

the trial. The policies and procedures shall detail the process the physician

director will utilize to assure the establishment, maintenance, and monitoring

of the proficiency of each interventional cardiologist; and

      (c) Maintain a collaborative association

and a current, valid collaboration agreement with a tertiary hospital including

Joint PI and staff education programs.

      (6) All physicians performing angioplasty

procedures at a hospital participating in the trial shall:

      (a) Continue to perform no fewer than seventy-five

(75) angioplasties per year; and

      (b) Be board certified by the American

Board of Internal Medicine in interventional cardiology.

      (7)(a) All staff that are hired after the

completion of the initial training at the hospital participating in the trial

shall complete a training program that mirrors the initial training program.

The hospital participating in the trial and its collaborating tertiary hospital

shall develop this training program.

      (b) Training of all staff including all

interventional cardiologists, nurses, and technicians, shall be performed on

the intra-aortic balloon pump annually.

      (c) All staff involved in providing PCI,

including the interventional cardiologists, nurses and technicians, shall have

a current Advanced Cardiac Life Support (ACLS) certification.

      (d) Inservice programs shall be based

upon need identified through staff evaluations and the quality assurance

process.

      (8) The Office of Health Policy may

discontinue the trial at a participant hospital at any time after reviewing the

following:

      (a) Quarterly reports made by the

American College of Cardiology - National Cardiovascular Data Registry

(ACC-NCDR);

      (b) Records obtained through an audit; or

      (c) Patient medical records.

      (9) Upon notification to the hospital by

the Office of Health Policy, the hospital shall terminate the trial and cease to

perform angioplasty procedures.

      (10) In order to assist the Office of

Health Policy in evaluating the trial program, the performance of hospitals

participating in the trial, and the formulation of recommendations for

continuing or modifying the trial program, the Office of Health Policy may

collaborate with university based researchers to:

      (a) Evaluate and compare performance data

of hospitals participating in the trial with existing Kentucky angioplasty programs;

and

      (b) Conduct an evaluation of the short-and

long-term outcomes of patients undergoing angioplasty at hospitals participating

in the trial with those patients transferred to hospitals with open heart surgical

backup.

      (11) The Office of Health Policy may

convene all hospitals participating in the trial on a regular basis for the

purpose of discussing and assessing the trial program. (36 Ky.R. 257; Am. 818;

eff. 10-21-09; 40 Ky.R. 176; eff. 9-18-2013.)