Risk Management, Patient Safety, and Documentation Strategies for the Cardiac Catheterization Laboratory

11 Risk Management, Patient Safety, and Documentation Strategies for the Cardiac Catheterization Laboratory



Joseph D. Babb, Jody C. Cook


Cardiac catheterizations are performed primarily in acute care facilities that may or may not have cardiac surgery backup and to a lesser degree in free-standing facilities as outpatient. Cardiac catheterizations and other percutaneous coronary interventions (PCI) are generally safe procedures done by highly competent providers who are supported by a competent multidisciplinary team. Current consensus recommendations are that elective PCIs be performed preferentially in acute care facilities for optimal patient safety. But as with any health care procedure, there are risks to the patient, the cardiologist, the team, and the institution. This chapter briefly addresses the responsibilities for risk reduction at each level of the cardiac catheterization laboratory management and leadership.



Risk Management


Risk management is a systematic, proactive process that complements the existing patient safety and quality improvement programs within the cardiac catheterization laboratory. It is everyone’s responsibility and should not be delegated to a single person. The success of a risk management program is not measured by the number of malpractice lawsuits filed or not filed.



Patient Safety


Patient safety is defined as being free from accidental harm as a result of a health care encounter. It is the responsibility of the cardiac catheterization team to make that commitment to every patient and to each other. In other words, cardiac catheterization laboratory leadership must create and nurture a culture of safety in which each individual team member is valued as vital to the team and has the voice to call out safety issues, as well as to be part of the solution when safety issues are identified. The Joint Commission requires accredited organizations to have a patient safety program that is intended to prevent errors from reaching the patient and to have a response program in the event that harm does occur.


A well-functioning unit with a culture of safety, demonstrated clinical quality outcomes, and high internal/external customer satisfaction scores can avoid the risks associated with a less reliable unit.



Corporate/Organizational Responsibilities


The leaders within an organization must ensure that there is an adequate infrastructure to the support the cardiac catheterization laboratory’s function. The American College of Cardiology, the American Heart Association, The Society for Cardiovascular Angiography and Interventions, and the American College of Cardiovascular Nurses are just a few of the professional organizations that set out standards for the cardiac catheterization laboratory.


Leaders are ultimately responsible to ensure compliance with applicable federal and state regulations. If state regulations require a certificate of need (CON) before the catheterization laboratory can perform its first procedure, leadership must make certain that the appropriate paperwork is completed and submitted in a timely fashion.


Policies and procedures are necessary to establish behavior expectations and performance standards. If the cardiac catheterization laboratory is part of a larger corporation/organization, there will be at least two levels of policies and procedures. The first level of policies applies to everyone within the organization and includes such topics as patient safety, infection control, blood exposure control plan, communication of disappointing or unanticipated outcomes, internal chain of command communication, human resources policies, equipment management, and vendor management that defines when and under what circumstances vendors may be present during patient procedures. The second level of policies applies only to the cardiac catheterization laboratory operations. Although the leaders are also ultimately responsible for all policies and procedures within the organization, they should not write policies for specific functions and locations such as the cardiac catheterization laboratory.


It is also the responsibility of leaders to ensure that there is an adequate number of qualified staff members, as well as appropriate and adequate equipment for the cardiac catheterization laboratory.



Division/Unit Leadership/Management


A nonphysician director and a medical director are generally the leadership team in a cardiac catheterization laboratory. The size of the leadership team is dependent on the size and function of the cardiac catheterization laboratory. This leadership structure is responsible for the day-to-day operation of the laboratory. It sets performance expectations; facilitates policy and procedure development and implementation to include emergency response and other safety standards including documentation; and ensures that adequate and appropriate equipment is functional and well maintained in accordance with federal, state, and local policies and contractual obligations.


This team is also charged with making sure that all staff are initially oriented to the cardiac catheterization laboratory; obtain and maintain current clinical competence; are oriented to new equipment and procedures; and know, understand, and comply with all applicable policies and procedures.


This leadership team is also responsible for a unit-specific quality program. The quality program should include monitors to measure such elements as patient satisfaction, internal customer satisfaction, clinical outcomes, complication rates, and compliance with external regulatory and/or accrediting bodies, as well as internal policies and procedures.



Interventional Cardiologist and Other Staff


All staff members within the cardiac catheterization laboratory are expected to comply with all policies and procedures. Caring for patients undergoing cardiac catheterizations and/or other PCIs is a multidisciplinary team effort. Each staff is responsible for the safety of the patient, each other, and the organization.



Informed Consent


Patients have the right to self-determine their care including whether to undergo a cardiac catheterization or other PCI. The cardiologist has a nondelegable duty to provide the patient or responsible party with adequate information about the planned procedure(s) to include why it is being recommended, the benefits of having the procedure, the potential risks of the procedures and the risks of refusing the recommended procedure, and the alternatives of the procedures that includes refusing to have the procedure. The patient must be given the opportunity to ask and have his or her questions answered so that he or she understands the answers. The consent discussion must be documented in the medical record by the cardiologist who discussed the proposed procedure with the patient or responsible party. In academic settings, this is often the resident or cardiology fellow.


Each state regulates who can consent for proposed procedures in the event that the patient is unable to consent. Each state also regulates how a physician deems the patient’s condition an emergency and can, therefore, proceed with care and treatment to include a cardiac catheterization and/or other PCI. Generally, each facility will have organizational policies governing consents for treatment. Failure to properly obtain informed consent is assault and battery.


The consent form is an administrative tool that, when signed by the patient or responsible party, informs the facility that the cardiologist has provided sufficient information about the proposed procedure(s). Someone other than the cardiologist and/or family must witness the patient or responsible party signing and dating the consent form and then document the signature with his or her own signature and date. If the patient or responsible party does not fully understand the proposed procedure, the cardiologist must be notified so that further discussion can occur.

Related posts:

  1. High-Risk Cardiac Catheterization
  2. Angiographic Data
  3. Special Techniques
  4. Hemodynamic Data and Basic Electrocardiography

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Jun 4, 2016 | Posted by in CARDIAC SURGERY | Comments Off on Risk Management, Patient Safety, and Documentation Strategies for the Cardiac Catheterization Laboratory

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