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The IAC Standards and Guidelines
for Cardiovascular Catheterization Accreditation

 

Click here for a printer-friendly PDF of the Cardiovascular Catheterization Standards

Part A:
Organization

Section 2A: Facility

STANDARD – Examination Areas

 

 

 

2.1A           Adequate facilities must be provided for all operations of the facility so that patient comfort, safety, dignity and privacy are ensured as well as staff comfort and safety. Procedure areas must have sufficient space, be well maintained and clean. There should be adequate space for the cardiovascular catheterization personnel to freely access the patient and for all staff to maintain the sterile field. Physical space requirements include, but are not limited to:

 

(See Guidelines below for further recommendations.)

 

2.1.1A            waiting, reception and patient/staff bathrooms;

 

2.1.2A            patient education, consultation and examination areas;

 

2.1.3A            readily accessible handwashing/sanitation for staff;

 

2.1.4A            performance of pre-test/post-procedures within appropriate proximity of the procedure area including adequate space for performing resuscitation in case of emergency;

 

2.1.5A            emergency cardiovascular surgical support must be immediately available in case of life-threatening procedural complications;

 

Comment: Refer to Part B for procedural requirements requiring emergency cardiovascular surgical support and protocol for the transfer of patients to a tertiary facility in the event of an emergency.


Comment: Cardiovascular catheterization procedures on pediatric patients, as well as patients of any age with complex congenital heart defects, should only be performed at centers with experienced cardiovascular surgical staff and the proper equipment to provide back-up for emergencies.13

 

Comment: Centers performing pediatric cardiovascular catheterization should have an on-site pediatric intensive care unit and an on-site pediatric cardiac surgery program, in addition to a pediatric cardiac anesthesia service. The pediatric cardiovascular catheterization laboratory (PCCL) should have access to rescue ECMO, in addition to standard resuscitation methods and technologies.6,20,32

 

Comment: Centers performing adult congenital heart defect (ACHD) cardiovascular catheterization should have an on-site cardiac intensive care unit with an ACHD consultation service, an on-site ACHD surgical program, and a cardiac anesthesia service. The ACHD catheterization laboratory should have access to rescue ECMO, in addition to standard resuscitation methods and technologies.6,20,32

 

2.1.6A            adequate space, facility configuration and doorways for the emergency transport of patients from patient care areas and for emergency exit of staff;

 

2.1.7A            the following procedure room type/area must comply with all Standards listed above (2.1.1A through 2.1.6A) and have or meet, but not limited to, the following6:

 

2.1.7.1A             Dedicated Cardiovascular Catheterization Suites: Cardiovascular catheterization procedure rooms that may additionally offer, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and use of robotics, which must provide for/include, but not limited to6,13,14,15,16:

i.               positive airflow;

ii.             high flow oxygen and vacuum for suctioning;

iii.           medical gas availability;

iv.           substerile scrub area;

v.             patient post-procedural care area(s);

vi.           Room utilities: Adequate utilities based upon the types of procedures and workload. These utilities include water taps, lighting, electrical outlets, emergency power, telephones, heating/cooling and ventilation.

vii.          General room lighting: Overhead and task lighting must be adequate to perform cardiovascular catheterization procedures and for clinical evaluation and treatment of the patient. The overhead lighting must be able to be dimmed during fluoroscopy. It is recommended that the overhead lighting be controlled by a foot pedal used by the operating physician.

·         Additionally, the procedure room must have surgical lighting.

viii.        Room power: The facility must have a plan that outlines the response to unexpected power loss or computer function, such as movement of the patient to another similarly capable procedure room in the immediate vicinity.

·         When normal power is not available, emergency power should provide a minimum of 10 minutes of fluoroscopy, and at least one hour of backup power for the computers, monitoring equipment and ancillary equipment.

·         For systems ordered after July 2011, there should be sufficient emergency power supply to run fluoroscopy for a duration of one hour and to run the remainder of the x-ray system components including lighting, for a minimum of 24 hours.

·         Utilization of emergency power must be visible by the operator at the normal working position.

·         An uninterruptible power supply for all computer equipment is required.

·         X-ray equipment and computers should not require rebooting during transition between normal and emergency power or during power line instabilities.

ix.           cardiovascular catheterization specific equipment:

·         contrast injectors.

x.             defibrillator;

xi.           electrocardiogram and hemodynamic monitoring equipment capabilities as described in Standard 2.4.4A;

xii.          radiolucent table to include, but not limited to:

·         height adjustable;

·         support more than 159kg/350 lbs.;

·         longitudinal and lateral displacement; and

·         length and width appropriate to accommodate the patient population being treated (e.g., pediatric, adult, bariatric).

xiii.        non-invasive blood pressure monitor;

xiv.        supplies specific to the procedure(s) being performed;

xv.          emergency equipment and supplies as required by Standard 2.4.3A;

xvi.        adequate space must be provided to facilitate the use of emergency support equipment to include, but not limited to:

·         cardiopulmonary bypass;

·         extracorporeal membrane oxygenation;

·         intra-aortic balloon pump;

·         Impella;

·         other.

xvii.      a fixed radiographic imaging system with flat-panel fluoroscopy offering cardiovascular catheterization laboratory-quality imaging;

xviii.    radiation shielded barriers that meet state and federal requirements; and

xix.        fluoroscopy equipment must comply with requirements set by the Standards (refer to Appendix A).

 

Comment: A bi-plane unit is recommended for procedures involving patients with congenital heart disease.

 

2.1.7.2A             Combined Hybrid Laboratories/Hybrid Surgical Suites: These are operating surgical rooms offering cardiovascular catheterization procedures such as; valve interventions, structural heart interventions, complex ACHD and pediatric interventions, which must provide for/include, but not limited to6,20,21,22,23:

 

i.               positive airflow;

ii.             high flow oxygen and vacuum for suctioning;

iii.           medical gas availability:

·         medical air;

·         nitrogen;

·         nitrous oxide;

·         oxygen.

iv.           waste gas lines;

v.             substerile scrub area;

vi.           patient post-procedural care area(s);

vii.          Room utilities: Adequate utilities based upon the types of procedures and workload. These utilities include water taps, lighting, electrical outlets, emergency power, telephones, heating/cooling and ventilation.

viii.        General room lighting: Overhead and task lighting must be adequate to perform cardiovascular catheterization procedures and for clinical evaluation and treatment of the patient. The overhead lighting must be able to be dimmed during fluoroscopy. It is recommended that the overhead lighting be controlled by a foot pedal used by the operating physician.

·         Additionally, the procedure room must have surgical lighting.

ix.           Room power: The facility must have a plan that outlines the response to unexpected power loss or computer function, such as movement of the patient to another similarly capable procedure room in the immediate vicinity.

·         When normal power is not available, emergency power should provide a minimum of 10 minutes of fluoroscopy, and at least one hour of backup power for the computers, monitoring equipment and ancillary equipment.

·         For systems ordered after July 2011, there should be sufficient emergency power supply to run fluoroscopy for a duration of one hour and to run the remainder of the x-ray system components including lighting, for a minimum of 24 hours.

·         Utilization of emergency power must be visible by the operator at the normal working position.

·         An uninterruptible power supply for all computer equipment is required.

·         X-ray equipment and computers should not require rebooting during transition between normal and emergency power or during power line instabilities.

x.             cardiovascular catheterization-specific equipment:

·         contrast injectors.

xi.           defibrillator;

xii.          electrocardiogram and hemodynamic monitoring equipment capabilities as described in Standard 2.4.4A;

xiii.        radiolucent table to include, but not limited to:

·         height adjustable;

·         support more than 159kg/350 lbs.;

·         longitudinal and lateral displacement; and

·         length and width appropriate to accommodate the patient population being treated (e.g., pediatric, adult, bariatric).

xiv.        non-invasive blood pressure monitor;

xv.          supplies specific to the procedure(s) being performed;

xvi.        emergency equipment and supplies as required by Standard 2.4.3A;

xvii.      snares and other retrieval devices;

xviii.    adequate space must be provided to facilitate the use of emergency support equipment to include, but not limited to:

·         cardiopulmonary bypass;

·         extracorporeal membrane oxygenation;

·         intra-aortic balloon pump;

·         other.

xix.        a fixed radiographic imaging system with flat-panel fluoroscopy offering cardiovascular catheterization laboratory-quality imaging;

xx.          radiation shielded barriers that meet state and federal requirements;

xxi.        fluoroscopy equipment must comply with requirements set by Standards (refer to Appendix A).

 

Comment: A bi-plane unit is recommended for procedures involving patients with congenital heart disease.

 

(See Guidelines below for further recommendations.)

 

2.1.7.3A             Pediatric Cardiovascular Catheterization Suites: Procedure rooms performing pediatric cardiovascular catheterization procedures have similar requirements as that of rooms detailed in Standards 2.1.7.2A and 2.1.7.3A with the exception of the following requirements, which must include, but not limited to1,6:

 

i.               pediatric resuscitation equipment;

ii.             pediatric appropriate medication dosages;

iii.           inventory of pediatric catheters;

iv.           inventory of pediatric basic supplies;

v.             fluoroscopy equipment must comply with requirements set by the Standards (refer to Appendix A);

vi.            fluoroscopy equipment must allow for digital acquisition or saved fluoroscopy.

Comment: Centers performing pediatric cardiovascular catheterization should have an on-site pediatric intensive care unit and an on-site pediatric cardiac surgery program, in addition to a pediatric cardiac anesthesia service. The pediatric cardiovascular catheterization laboratory (PCCL) should have access to rescue ECMO, in addition to standard resuscitation methods and technologies.6,20,32

 

Comment: Centers performing adult congenital heart disease (ACHD) cardiovascular catheterization should have an on-site cardiac intensive care unit with an ACHD consultation service, an on-site ACHD surgical program, and a cardiac anesthesia service. The ACHD catheterization laboratory should have access to rescue ECMO, in addition to standard resuscitation methods and technologies.6,20,32

 

Comment: Facilities offering cardiovascular catheterization procedures and personnel participating in these programs must have a protocol for emergency response when the need arises. There must be a mechanism in place to activate a rapid operating room response team that is capable of performing emergency surgery. This “disaster plan” should be regularly tested on a scheduled basis so that each member of the team knows exactly what to do and how to accomplish their role. This plan must be recorded as part of the written standard operating procedure of every extraction laboratory or operating room.

 

(See Guidelines below for further recommendations.)

 

2.1.8A            The control room/area must have or meet:

 

2.1.8.1A             if the procedure room is contiguous with the control room, a leaded wall with a large leaded viewing window;

 

2.1.8.2A             a full duplex intercom system;

 

2.1.8.3A             desk space adequate to accommodate:

 

i.               fluoroscopy monitors; and

ii.             a recording system.

 

(See Guidelines below for further recommendations.)

 

2.1.9A            The substerile entrance(s) must have or meet:

 

2.1.9.1A             entrance with dedicated or shared between adjacent procedure rooms;

 

2.1.9.2A             entrance for patient transport from the prep area to the cardiovascular catheterization laboratory(s); and

 

2.1.9.3A             egress that connects to hallways leading to the hospital wards and other areas.

STANDARD – Interpretation Areas

 

2.2A           Adequate space must be provided for the interpretation of examination results and preparation of reports.

 

(See Guidelines below for further recommendations.)

STANDARD – Storage Space

 

2.3A           Adequate space must be provided for:

 

2.3.1A            the storage must ensure confidentiality of data and be safe from fire/flood;

2.3.2A            patient records, reports and digital data storage areas;

 

2.3.3A            administration records and support areas; and

 

2.3.4A            equipment/supply storage areas.

 

(See Guidelines below for further recommendations.)

STANDARD – Equipment and Instrumentation

 

2.4A           Equipment and instrumentation used in the performance of cardiovascular catheterization procedures must be appropriate, in good working condition and should substantially comply with the International Electrotechnical Commission (IEC) 60601-2-43 interventional standard.

 

2.4.1A            All equipment and instrumentation must be routinely inspected for safety and proper functionality and records of the inspections kept on file. Equipment and instrumentation must include at a minimum the following17,18,45:

 

2.4.1.1A             a fixed (recommended) or portable, single or biplane (recommended) cine angiography system that must meet the following specifications;

 

2.4.1.2A             digital subtracted cine angiography imaging capable of cine frame rates from 15 to 60 frames per second;

 

2.4.1.3A             when applicable, digital subtraction angiography imaging of at least three frames per second, with the ability to do program change of rate during the image acquisition run;

 

2.4.1.4A             when applicable, high quality, subtracted digital radiographs;

 

2.4.1.5A             road-mapping with ability to refer back to an unsubtracted live image;

 

2.4.1.6A             last image hold;

 

2.4.1.7A             pulsed fluoroscopy;

 

2.4.1.8A             dose measurement capability;

 

2.4.1.9A             Digital Imaging and Communications in Medicine (DICOM) compatible digital image storage with capability of storing uncompressed images on portable format without loss of image resolution;

 

2.4.1.10A          ability to display and review prior relevant images during the procedure;

 

2.4.1.11A          minimum 9-inch field of view (FoV) imaging intensifier at a Source Image Receptor Distance (SID) of 30 inches;

 

2.4.1.12A          minimum spatial resolution of matrix of 512 x 512;

 

2.4.1.13A          for pediatric procedures, multiple focal spot sizes to accommodate the patient population imaged at the facility;

 

2.4.1.14A          image monitor performance using the Society of Motion Picture and Television Engineers (SMPTE) pattern;

 

2.4.1.15A          for equipment installed before 2006 that does not display cumulative dose and or dose area product (DAP), documentation of fluoroscopy time and the number of images per procedure is acceptable; and

2.4.1.16A          radiation use must be consistent with the “as low as reasonably achievable” principle or ALARA radiation safety guidelines.

 

(See Guidelines below for further recommendations.)

 

2.4.2A            All equipment and instrumentation must be routinely inspected for safety and proper functionality and records of the inspections kept on file.

 

2.4.3A            Emergency equipment and supplies (response cart or kit) must include, but not limited to:

 

2.4.3.1A             oxygen/suction;

 

2.4.3.2A             biphasic external defibrillator with a backup defibrillator immediately accessible;

 

2.4.3.3A             external pacemaker equipment;

 

2.4.3.4A             when applicable, intra-aortic balloon pump (IABP);

 

2.4.3.5A             when applicable, cardiopulmonary bypass (CPB);

 

2.4.3.6A             when applicable, extracorporeal membrane oxygenation (ECMO);

 

2.4.3.7A             emergency trays for pericardiocentesis;

 

Comment: For interventional procedures, there must be a process in place for immediate access to thoracotomy and sternotomy trays.

 

2.4.3.8A             standard Advance Cardiac Life Support (ACLS) medications (including a master list with verification of expiration date) to include, but not limited to:

 

i.               epinephrine;

ii.             atropine;

iii.           dopamine;

iv.           vasopressin;

v.             adenosine;

vi.           amiodarone;

vii.          magnesium sulfate;

viii.        calcium chloride;

ix.           potassium chloride;

x.             sodium bicarbonate; and

xi.           sedative reversal agents:

·         flumazenil;

·         naloxone.

 

2.4.3.9A             endotracheal intubation equipment to include:

 

i.               sedative(s);

ii.             paralytic agent(s); and

iii.           anesthetic agent.

 

2.4.3.10A          resuscitator bag and mask;

2.4.3.11A          non-rebreather mask;

 

2.4.3.12A          arterial blood gas kits;

2.4.3.13A          separate monitoring system for ECG and hemodynamics to include:

 

i.               pressure transducer; and

ii.             end-tidal carbon dioxide monitor.

 

2.4.4A            Monitoring equipment must be available to perform:

 

2.4.4.1A             intravascular pressure;

 

2.4.4.2A             non-invasive blood pressure;

 

2.4.4.3A             pulse oximetry;

 

2.4.4.4A             activated coagulation time (ACT) analyzer;

2.4.4.5A             electrocardiogram (ECG);

 

i.               12-lead surface ECG.

 

2.4.4.6A       capnography (CO2) monitoring is recommended for use with moderate sedation.

 

2.4.5A            Procedure table(s) must be radiolucent, motorized and have the following capabilities:

 

2.4.5.1A             height adjustable;

 

2.4.5.2A             support more than 159kg/350 lbs.;

 

2.4.5.3A             longitudinal and lateral displacement; and

 

2.4.5.4A             length and width appropriate to accommodate the patient population being treated (e.g., pediatric, adult, bariatric).

 

2.4.6A            Additional systems and applications may be used during the course of performing a cardiovascular catheterization procedure:

 

2.4.6.1A             Intracardiac echocardiography (ICE) systems using a linear phased array transducer that produces a 90-degree image longitudinal to the catheter and/or a rotational transducer to display a 360-degree image perpendicular to the catheter.

 

(See Guidelines below for further recommendations.)

2.4.6.2A             robotic navigation systems; and

 

2.4.6.3A             transthoracic echocardiography (TTE) and/or transesophageal echocardiography (TEE) (refer to 2.4.7A for additional requirements).

.

(See Guidelines below for further recommendations.)

2.4.7A            Ultrasound imaging equipment:

 

2.4.7.1A             Must meet the IAC Standards and Guidelines for Adult and/or Pediatric Echocardiography Accreditation for equipment and must include:

i.         color flow Doppler;

ii.       imaging frequencies appropriate for the structures evaluated;

iii.     Doppler frequencies appropriate for the vessel evaluated;

iv.     a visual display and capability of permanent recording of the image; and

v.       a visual display, audible output and capability for a permanent recording of the Doppler waveform and corresponding image.

 

2.4.8A            Adequate disposable supplies must be immediately available. These include U.S. Food and Drug Administration (FDA) approved catheters, wires, stents, balloons and embolic protection devices. Non-FDA approved devices may also be used as permitted by law.

 

2.4.9A            Ancillary equipment as appropriate (e.g., monitoring equipment, blood coagulation testing equipment, workstations, picture archiving communication system [PACS], radiation protection for personnel [aprons and thyroid shields, portable shield either on wheels or suspended from ceiling]).

STANDARD – Equipment and Instrumentation Quality Control

 

2.5A           There must be a comprehensive Quality Improvement (QI) program to provide a standard of measurement for system performance and the documentation of any variance thereof.

 

2.5.1A            A QI Committee should be appointed to provide oversight to the equipment and instrumentation quality control (QC).

 

2.6A           Fluoroscopic system QC testing must include a comprehensive evaluation of the system components, image performance and radiation output limits as outlined in the FDA Code of Federal Regulations (CFR) Title 21 subchapter J, Parts 1010 and 1020 and applicable FDA guidance documents.11

 

2.7A           Image quality requirements, radiation output limits, and other fluoroscopic performance requirements must also comply with the health-code regulations of the state in which the facility is located.

 

2.8A           The site-appointed qualified medical physicist must complete the performance evaluations at equipment installation and annually, unless state regulations require more frequent testing. Equipment performance evaluations are recommended semi-annually to include radiation output measurements, system quality control tests and image quality performance measurements.

 

2.9A           The site-appointed medical physicist must perform a radiation safety survey to ensure that occupational workers and members of the public are shielded according to state regulation. This must be performed prior to installation of each new angiographic imaging system. A documented radiation safety survey of the cardiovascular catheterization suite and adjacent areas that has been accepted by the State Radiation Program fulfills this requirement.

 

2.10A        A radiation safety survey must be performed on all renovated or newly constructed interventional/ cardiovascular catheterization suites and adjacent areas. This must be performed prior to first patient use. This survey must confirm that the levels of radiation protection are in conformance with the State Radiation Program.

 

2.11A        All spaces outside the procedure rooms should provide adequate protection for full time occupancy by non-radiation workers. This recommendation includes the control room.

 

2.12A        Preventive maintenance (PM) on all cardiovascular catheterization equipment listed in Standards 2.4.4.A, 2.4.5A, 2.4.6A, 2.4.7A and 2.4.8A is required according to the manufacturer’s recommendations.

 

2.13A        Preventive maintenance (PM) service is recommended periodically per the manufacturers’ recommendations for each angiographic system at the facility.

 

2.14A        Ancillary equipment (e.g., hemodynamic monitoring equipment, blood gas and coagulation testing equipment, workstations, PACS, lead aprons, suction, oxygen lines, etc.) should also be included in a PM program.

 

2.15A        The emergency response cart or kit must be checked at least monthly, with documentation to assure that all expected items are present and the supplies are not expired.

 

2.16A        There must be a process to check inventory of disposable supplies (e.g., catheters, wires, balloons, stents, embolic protection devices, contrast, and portable oxygen tank) on a regular basis to assure that these supplies are readily available during a procedure.

STANDARD – Quality Control Documentation

 

2.17A        All QC results must be documented and reviewed.

 

2.17.1A         Documentation of the physicists’ evaluation, preventive maintenance and quality control tests performed, and service records for all angiographic systems and ancillary equipment must be maintained at the facility and available for review. The reports must be signed and dated by the person(s) performing the tests.

 

2.17.2A         Results of all QC tests must be documented, archived and stored on film, in digital format, or on other suitable media according to state requirements (if applicable).

Section 2A: Facility
Guidelines

 

2.1A        The participation of an ergonomics expert in the planning should be considered as a measure to comply with Occupational Safety and Health Administration standards.

 

2.1.7A    The Guidelines for Design and Construction of Hospitals and Health Care Facilities published by the American Institute of Architects and the Facility Guidelines Institute provide space and functionality standards for cardiovascular catheterization laboratories with a goal to improve work flow in the cardiovascular catheterization environment.

 

The minimal procedural area of a complete cardiovascular catheterization laboratory (not including control room space) is 350 square feet of clear floor area.

 

There should be a minimum of 8 feet of clear space between the wall and the edges of each side of the patient table when it is positioned at the isocenter.

 

Enough clearance at the head of the bed should be allocated for anesthesia equipment on either side and sterile access to jugular vein entry sites, if employed, while allowing for free range of movement of the fluoroscopy C-arm.

 

Current electrical system regulations for health care facilities should follow Article 517 of the National Electrical Code (NEC) Handbook

 

The air flow/heating, ventilation, and air conditioning design should comply with the Guidelines for Environmental Infection Control in Health-Care Facilities Recommendations of the Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee document.

 

Lighting should include an overhead light on an articulating arm, 2 x 2 feet lighting squares to flood the main procedure area, and a dedicated workspace light for the nursing/anesthesia area.

 

2.1.7A and 2.1.8A        The ideal sound/communication system is an always-on, full-duplex, two-way intercom system.

 

Network cabling and hardware should have a minimum capability of support for gigabit Ethernet speed.

 

2.1.7.2A Hybrid rooms should be in close proximity to operating room(s) or catheterization suite(s) and located on a clear core or semirestricted corridor where scrubs, hats and masks are required.6

 

2.1.8.3A An additional 45 inches of desk space is suggested for a two-monitor reading station or single-monitor workstation.

 

2.2A and 2.3A       Electronic storage of cardiovascular catheterization data should be Health Insurance Portability 

and Accountability Act (HIPAA) compliant. Data should be maintained for at least the minimum

duration as determined by each state.

 

2.4A        Integrated data display systems provide flexibility and efficiency in data display; it is advisable to have separate backup monitors in case of failure.

 

2.4.1A    It is important to achieve the lowest possible noise signal with all recording systems.

 

2.4.6.1A     Intracardiac Echocardiography (ICE) may be useful as an adjunctive imaging modality during complex procedures.

 

2.4.6.3A     Transthoracic echocardiography and transesophageal echocardiography should be readily available for emergency use and for adjunctive imaging in selected cases.