Administrative Code

Virginia Administrative Code
1/27/2022

Part IV. Cardiac Services

Article 1
Criteria and Standards for Cardiac Catheterization Services

12VAC5-230-380. Travel time.

Article 1
Criteria and Standards for Cardiac Catheterization Services

Cardiac catheterization services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-390. Need for new service.

A. No new fixed site cardiac catheterization service should be approved for a health planning district unless:

1. Existing fixed site cardiac catheterization services located in the health planning district performed an average of 1,200 cardiac catheterization DEPs per existing and approved laboratory for the relevant reporting period;

2. The proposed new service will perform an average of 200 DEPs in the first year of operation and 500 DEPs in the second year of operation; and

3. The utilization of existing services in the health planning district will not be significantly reduced.

B. Proposals for mobile cardiac catheterization laboratories should be approved only if such laboratories will be provided at a site located on the campus of an inpatient hospital. Additionally, applicants for proposed mobile cardiac catheterization laboratories shall be able to project that they will perform an average of 200 DEPs in the first year of operation and 350 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the health planning district below 1,200 procedures.

C. Preference may be given to a project that locates new cardiac catheterization services at an inpatient hospital that is 60 minutes or more driving time one way under normal conditions from existing services if the applicant can demonstrate that the proposed new laboratory will perform an average of 200 DEPs in the first year of operation and 400 DEPs in the second year of operation without significantly reducing the utilization of existing laboratories in the health planning district.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-400. Expansion of services.

Proposals to increase cardiac catheterization services should be approved only when:

1. All existing cardiac catheterization laboratories operated by the applicant's facilities where the proposed expansion is to occur have performed an average of 1,200 DEPs per existing and approved laboratory for the relevant reporting period; and

2. The applicant can demonstrate that the expanded service will achieve an average of 200 DEPs per laboratory in the first 12 months of operation and 400 DEPs in the second 12 months of operation without significantly reducing the utilization of existing cardiac catheterization laboratories in the health planning district.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-410. Pediatric cardiac catheterization.

No new or expanded pediatric cardiac catheterization services should be approved unless:

1. The proposed service will be provided at an inpatient hospital with open heart surgery services, pediatric tertiary care services or specialty or subspecialty level neonatal special care;

2. The applicant can demonstrate that the proposed laboratory will perform at least 100 pediatric cardiac catheterization procedures in the first year of operation and 200 pediatric cardiac catheterization procedures in the second year of operation; and

3. The utilization of existing pediatric cardiac catheterization laboratories in the health planning district will not be reduced below 100 procedures per year.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-420. Nonemergent cardiac catheterization.

A. Simple therapeutic cardiac catheterization. Proposals to provide simple therapeutic cardiac catheterization are not required to offer open heart surgery service available on-site in the same hospital in which the proposed simple therapeutic service will be located. However, these programs shall adhere to the requirements described in subdivisions 1 through 9 of this subsection.

The programs shall:

1. Participate in the Virginia Heart Attack Coalition, the Virginia Cardiac Services Quality Initiative, and the Action Registry-Get with the Guidelines or National Cardiovascular Data Registry to monitor quality and outcomes;

2. Adhere to strict patient-selection criteria;

3. Perform annual institutional volumes of 300 cardiac catheterization procedures, of which at least 75 should be percutaneous coronary intervention (PCI) or as dictated by American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories effective 1991;

4. Use only AHA/ACC-qualified operators who meet the standards for training and competency;

5. Demonstrate appropriate planning for program development and complete both a primary PCI development program and an elective PCI development program that includes routine care process and case selection review;

6. Develop and maintain a quality and error management program;

7. Provide PCI 24 hours a day, seven days a week;

8. Develop and maintain necessary agreements with a tertiary facility that must agree to accept emergent and nonemergent transfers for additional medical care, cardiac surgery, or intervention; and

9. Develop and maintain agreements with an ambulance service capable of advanced life support and intra-aortic balloon pump transfer that guarantees a 30-minute or less response time.

B. Complex therapeutic cardiac catheterization. Proposals to provide complex therapeutic cardiac catheterization should be approved only when open heart surgery services are available on-site in the same hospital in which the proposed complex therapeutic service will be located. Additionally, these complex therapeutic cardiac catheterization programs will be required to participate in the Virginia Cardiac Services Quality Initiative and the Virginia Heart Attack Coalition.

Statutory Authority

§§ 32.1-12 and 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009; amended, Virginia Register Volume 37, Issue 14, eff. March 31, 2021.

12VAC5-230-430. Staffing.

A. Cardiac catheterization services should have a medical director who is board certified in cardiology and has clinical experience in performing physiologic and angiographic procedures.

In the case of pediatric cardiac catheterization services, the medical director should be board-certified in pediatric cardiology and have clinical experience in performing physiologic and angiographic procedures.

B. Cardiac catheterization services should be under the direct supervision or one or more qualified physicians. Such physicians should have clinical experience in performing physiologic and angiographic procedures.

Pediatric catheterization services should be under the direct supervision of one or more qualified physicians. Such physicians should have clinical experience in performing pediatric physiologic and angiographic procedures.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

Article 2
Criteria and Standards for Open Heart Surgery

12VAC5-230-440. Travel time.


Article 2
Criteria and Standards for Open Heart Surgery

A. Open heart surgery services should be within 60 minutes driving time one way under normal conditions of 95% of the population of the health planning district using mapping software as determined by the commissioner.

B. Such services shall be available 24 hours a day, seven days a week.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-450. Need for new service.

A. No new open heart services should be approved unless:

1. The service will be available in an inpatient hospital with an established cardiac catheterization service that has performed an average of 1,200 DEPs for the relevant reporting period and has been in operation for at least 30 months;

2. Open heart surgery services located in the health planning district performed an average of 400 open heart and closed heart surgical procedures for the relevant reporting period; and

3. The proposed new service will perform at least 150 procedures per room in the first year of operation and 250 procedures per room in the second year of operation without significantly reducing the utilization of existing open heart surgery services in the health planning district.

B. Preference may be given to a project that locates new open heart surgery services at an inpatient hospital more than 60 minutes driving time one way under normal condition from any site in which open heart surgery services are currently available and:

1. The proposed new service will perform an average of 150 open heart procedures in the first year of operation and 200 procedures in the second year of operation without significantly reducing the utilization of existing open heart surgery rooms within two hours driving time one way under normal conditions from the proposed new service location below 400 procedures per room; and

2. The hospital provided an average of 1,200 cardiac catheterization DEPs during the relevant reporting period in a service that has been in operation at least 30 months.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-460. Expansion of service.

Proposals to expand open heart surgery services shall demonstrate that existing open heart surgery rooms operated by the applicant have performed an average of:

1. 400 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed increase is within one hour driving time one way under normal conditions of an existing open heart surgery service; or

2. 300 adult equivalent open heart surgery procedures in the relevant reporting period if the proposed service is in excess of one hour driving time one way under normal conditions of an existing open heart surgery service in the health planning district.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-470. Pediatric open heart surgery services.

No new pediatric open heart surgery service should be approved unless the proposed new service is provided at an inpatient hospital that:

1. Has pediatric cardiac catheterization services that have been in operation for 30 months and have performed an average of 200 pediatric cardiac catheterization procedures for the relevant reporting period; and

2. Has pediatric intensive care services and provides specialty or subspecialty neonatal special care.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

12VAC5-230-480. Staffing.

A. Open heart surgery services should have a medical director who is board certified in cardiovascular or cardiothoracic surgery by the appropriate board of the American Board of Medical Specialists.

In the case of pediatric cardiac surgery, the medical director should be board certified in cardiovascular or cardiothoracic surgery, with special qualifications and experience in pediatric cardiac surgery and congenital heart disease, by the appropriate board of the American Board of Medical Specialists.

B. Cardiac surgery should be under the direct supervision of one or more qualified physicians.

Pediatric cardiac surgery services should be under the direct supervision of one or more qualified physicians.

Statutory Authority

§ 32.1-102.2 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 9, eff. February 15, 2009.

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