La. Admin. Code tit. 48 § I-11513

Current through Register Vol. 50, No. 9, September 20, 2024

Section I-11513 - Cardiac Catheterization Units

A. Definition/Description of Service

1. Cardiac catheterization is a hospital-based diagnostic medical procedure, for examination of the heart and surrounding blood vessels. The "invasive" procedure involves the insertion of a catheter into the patient's arm or leg and into the chambers of the heart.

2. The term cardiac catheterization is used to describe a broad range of invasive cardiac diagnostic procedures, the most common of which are angiocardiography and coronary arteriography. These and other studies provide otherwise unavailable information in many types of heart diseases, and permit a definitive diagnosis of a number of heart and circulatory conditions affecting an age range from newborn to geriatric.

3. Patients are generally referred for catheterization after other noninvasive (and less serious) diagnostic tests have indicated or confirmed abnormal heart/circulatory function, but have not provided a precise diagnosis. Because it is sophisticated and expensive, and because of its invasive nature, it is not lightly chosen as a diagnostic technique.

4. In the United States, cardiovascular illness claims nearly one million lives each year. Heart disease is the nation's number one killer, accounting for half of all deaths recorded annually. In 1977, cardiovascular diseases alone cost the American people more than $27 billion, including physicians' fees, hospital costs, drugs, and lost wages.

B. Access to Coronary Care Units/Relationship to Open Heart Surgery

1. Because of the need for close interaction among the disciplines, there can be little justification for the development of highly specialized facilities unless expertise in cardiology, cardiovascular radiology, and cardiovascular surgery are immediately available. Ideally, therefore, cardiac catheterization labs should be located only in institutions with well organized and closely related programs of cardiovascular surgery, and with experienced personnel who have worked together as a team. Consultation is necessary between the cardiologist and the cardiac surgeon, and emergency situations often necessitate the availability of an open heart team.

2. There is a close relationship between cardiac catheterization and cardiac surgery. Cardiac catheterization is the primary procedure used in the evaluation of a potential candidate for open heart surgery, and the procedure is often predicated on the patient's suitability for surgery. For every four cardiac catheterizations, there is one open heart surgery performed. Because cardiac catheterization is essential to decision making for cardiac surgery, the number and complexity of cardiac catheterizations performed will increase as the number of procedures for repair and replacement of damaged coronary arteries increases. The increases in both services have resulted in the diffusion of cardiac catheterization laboratories and cardiovascular surgical programs to community hospitals throughout the country. Because of their complexity and costs, careful planning for both services is essential.

Cardiac catheterization units should be available to the population on a regional basis, with one adult unit per 300,000 population, and one pediatric unit per 30,000 live births annually.

C. Cost/Volume/Risk Relationships

1. Increases in numbers of cardiac catheterization units and in the complexity of procedures has led to concern regarding quality, cost, and continuity of services. The technique is costly and usually requires a two-night stay in the hospital. The cost is usually paid by a third party. The equipment used in catheterization and the radiation shielding required for the examination rooms generally place the initial costs of the laboratory in excess of $500,000.

2. There are substantial replacement and maintenance costs, since the life of the equipment is fairly short, and generally must be replaced every four to seven years. The financial situation with a catheterization laboratory corresponds to several other types of costly, sophisticated technology (linear accelerators used in cancer therapy have sizeable maintenance costs; CT scanners have a short useful life). However, there is an important difference in that many of these technologies have a substantially greater capacity for serving patients than do catheterization laboratories. Depending on the type of procedure, a cardiac catheterization study can last for several hours. The high fixed costs must therefore be carried over a smaller volume of patient procedures. Additionally, highly specialized personnel and staff are required to perform a catheterization, which adds considerably to the costs. Although this does not represent a cost to the catheterization laboratory, it adds costs to this form of diagnosis when compared to procedures that can be utilized on an outpatient basis.

3. There is the opinion within the medical profession that a certain minimal workload is essential to assure cost-effective, high quality, safe results. Because of its invasive nature, cardiac catheterization carries aslight mortality and complication risk: one of every 1,000 patients dies from the procedure. The Inter-Society Commission on Heart Disease Resources (ICHDR) recommends a 3 percent mortality rate in catheterization laboratories as a tolerance level above which the quality of care must be questioned and patients referred elsewhere.

4. The ICHDR recommends that 300 adult catheterizations or 150 pediatric catheterizations be performed per year, per team, to maintain skills to reduce risks to patients. The principal consideration is excellence in cardiovascular diagnosis obtained at minimum risk to the patient.

D. Service Area

1. The service area for cardiac catheterization units is the health planning district in which the facility or proposed facility is located.

E. Resource Goals

1. Within three years after initiation of a cardiac catheterization unit, there should be at least 300 adult or 150 pediatric procedures performed annually.

2. No unit should be operated in a facility not performing open heart surgery.

3. Adult cardiac catheterization services should be available to the population in need of such services within 80 road miles one way.

La. Admin. Code tit. 48, § I-11513

Promulgated by the Department of Health and Human Resources, Office of Management and Finance, LR 13:246 (April 1987).

AUTHORITY NOTE: Promulgated in accordance with P.L. 93-641 as amended by P.L. 96-79, and R.S. 36:256(b).