Health care regulations are always changing, and ensuring that your organization both understands and complies with requirements is an ongoing task. From CHNA reports to long-term care regulations, the INCompliance team can help walk you through the details.

Cardiac catheterization programs are required to have at least two licensed physicians on staff who are knowledgeable about the laboratory’s protocols and equipment. These physicians must be credentialed to provide cardiac catheterization services, however, guidance from the Ohio Department of Health (ODH) suggests that these physicians do not have to be credentialed to perform all procedures within the program’s scope of service.

For example, a level 1 service may have one physician credentialed to perform all diagnostic cardiac catheterization procedures and one physician only credentialed to perform device implantation.

For a level II or level III service, individual physicians do not have to provide all therapeutic cardiac catheterization procedures within the service’s scope of service. However, because a level II and level III service must operate on a 24/7 basis to perform primary percutaneous coronary intervention (PCI), at least two physicians should be credentialed to perform primary PCI to ensure adequate coverage.

Cardiac catheterization programs are required to have at least two licensed physicians on staff who have been credentialed to provide cardiac catheterization services by meeting all of the following criteria:

• Completed training that includes at least one year dedicated to cardiac catheterization procedures
• Designated as a fully-accredited member of the service’s staff
• Participate in the cardiac catheterization laboratory’s quality assurance programs, including peer review

In addition, physicians performing percutaneous coronary intervention (PCI) who have not performed PCI prior to March 20, 1997, must have completed a fellowship training program in interventional cardiology.

It’s likely time to review your credentialing criteria to ensure that your physicians performing cardiac catheterization procedures meet these requirements.

If a level I or level II cardiac catheterization service provides emergency care outside the designated scope of services, it must provide written notice to ODH within 48 hours of the incident. While maintaining patient confidentiality, the notification must include the following:

• When the incident occurred
• The nature of the emergency and actions taken
• The patient’s outcome

Be sure to incorporate this notification requirement into your service’s policies and procedures and ensure that timely notification is provided.

Cardiac catheterization services are required to obtain a signed informed consent form from each patient or patient designee prior to the procedure. For a level I or level II service, the informed consent must include an acknowledgment that the procedure is being performed in a cardiac catheterization service without on-site open heart surgery and that, if necessary as the result of an adverse event, the patient may be transferred to a receiving service for medical/surgical management.

While a general hospital informed consent may be used for a level III service, a level I or level II service must use an informed consent that includes this language.

A cardiac catheterization service specific rule from the Ohio Department of Health (ODH) provides that major complications and emergency transfers should be reviewed at least once every 90 days by the quality assessment review process. However, the ODH general quality assessment and performance improvement rule requires the program to hold regular meetings, chaired by the medical director of the health care service or designee, at least within 60 days after a death or complication to review all deaths and complications and to report findings. To be compliant, providers must meet the 60-day requirement for review of any death or complication.

The Ohio Department of Health requires an appropriate number of scrub nurses or technicians and a circulating nurse for each open heart surgery procedure. The number of staff present at each procedure should be based on the needs of the surgeons and the patient. At a minimum, there must be two staff present for each procedure, including a circulating nurse and one scrub nurse or technician.

Be sure to include these requirements in your open heart surgery service’s policies and procedures and document compliance.

Effective August 1, 2017, the Ohio Department of Health requires a provider of an adult open heart surgery service to utilize a multidisciplinary approach to patient care. This approach is to include meetings between cardiologists and cardiovascular surgeons as necessary to address the needs of patients with complex cardiovascular disease. In addition, as part of the service’s quality assessment and performance improvement process, there must be a periodic review and evaluation of the multidisciplinary meetings.

Be sure to include these requirements in your open heart surgery service policies and procedures. Also, document the meetings, reviews and evaluations.

An Ohio Department of Health (ODH) rule requires that providers of adult open heart surgery services conduct a thorough internal review of any surgeon with a combination of high risk adjusted mortality and low individual surgeon volume. ODH also requires providers to have a written policy requiring the documentation of the internal review of surgeons with this combination. Rules further specify that a volume goal of at least 25 open heart procedures per surgeon per year is recommended.

Be sure to include this requirement in your open heart surgery service’s policies and procedures and also document the surgeon review process.

The Ohio Department of Health recently added a new requirement for all Chapter 84 health care services listed below:

• Adult cardiac catheterization

• Adult open heart surgery

• Solid organ transplantation

• Bone marrow transplantation

• Pediatric intensive care unit

• Radiation therapy

• Pediatric cardiac catheterization

• Pediatric cardiovascular surgery

Beginning August 1, 2017, each service must have an ongoing process for ensuring the competence of “staff members,” defined as the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract, or voluntary basis. This process must include a periodic assessment and re-determination of necessary skill levels for each staff position practicing within the health care service. Note that this requirement cannot be met by providing training – there must be an assessment of skill level for each staff member. At least every 36 months, a performance evaluation must be conducted stating whether each staff member has achieved the skill levels for the position.

Be sure to include this requirement in your policies and procedures and document the assessment in each individual’s personnel file, explicitly stating whether the staff member has achieved the skill levels for the position.