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:
2. Nurses; and
(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.)