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Society of Interventional Radiology: Resource and Environment Recommended Standards for IR

Published:February 06, 2017DOI:https://doi.org/10.1016/j.jvir.2016.12.1213

      Abbreviation:

      PACS (picture archival communication system)

      Introduction

      Inadequate health care resources, including staffing and equipment, can have a negative impact on patient outcomes (
      • Fridkin S.K.
      • Pear S.M.
      • Williamson T.H.
      • et al.
      The role of understaffing in central venous catheter-associated bloodstream infections.
      ,
      • Kane R.L.
      • Shamliyan T.A.
      • Mueller C.
      • et al.
      The association of registered nurse staffing levels and patient outcomes: Systematic review and meta-analysis.
      ,
      • Unruh L.
      • Joseph L.
      • Strickland M.
      Nurse absenteeism and workload: Negative effect on restraint use, incident reports and mortality.
      ,
      • Clements A.
      • Halton K.
      • Graves N.
      • et al.
      Overcrowding and understaffing in modern health-care systems: Key determinants in methicillin-resistant Staphylococcus aureus transmission.
      ). Previous work demonstrated a lack of formal consensus on recommended staffing standards in interventional radiology (IR), which led to the IR staffing document (
      • Baerlocher M.O.
      • Kennedy S.A.
      • Ward T.J.
      • et al.
      Staffing guidelines for the interventional radiology suite.
      ). There is a similar absence of recommended standards on appropriate resource and space requirements for a successful and safe IR practice. This document provides recommendations for the core requirements necessary to deliver IR services. In centers with a greater proportion of higher complexity cases and/or higher acuity patients (eg, American Society of Anesthesiologists class III, IV, or V), there may be additional requirements.
      These recommended standards are based on best available literature, including societal standards and information from national architectural firms involved with designing the IR area and periprocedural space. (“IR suite” is used throughout this text rather than “angio suite,” as it more accurately reflects the greater breadth of procedures performed in these suites; however, the equipment, including use of a power injector, is equivalent. “IR suite” refers to the actual procedural room. “IR area” includes the procedural room(s) and the adjacent IR control room(s), hallway(s) or equivalent containing additional storage space, and picture archival communication system (PACS) workstation(s). The “periprocedural area” refers to the preparatory (before the procedure) and recovery (after the procedure) patient areas.) Where information is unavailable, the document relies on expert consensus. In addition to higher acuity and patient complexity, factors such as case volume and local expertise influence the configuration of the IR and periprocedural areas. These recommended standards were written with optimal patient flow, efficiency, and safety in mind, and deviations from them should be rare. If not currently feasible, the recommendations should be addressed with future renovations or new construction. The recommendations are primarily focused on patient safety considerations (
      • Baerlocher M.O.
      • Kennedy S.A.
      • Ward T.J.
      • et al.
      Staffing guidelines for the interventional radiology suite.
      ).

       Before the Procedure and Recovery (Periprocedural Area)

       Space

      There should be adequate, dedicated space for the periprocedural area (

      The Royal Australian and New Zealand College of Radiologists. Standards of practice for diagnostic and interventional radiology. Version 10. Available at: http://www.ranzcr.edu.au/documents-download/document-library-22/document-library-25/510-ranzcr-standards-of-practice-for-diagnostic-and-interventional-radiology/file. Accessed August 18, 2015.

      ). This area should be in the near vicinity of the IR suite so as to maximize efficiency and workflow. The periprocedural area should also include adequate space for privacy during discussions (eg, to obtain a consent) and to perform a physical examination (to meet requirements of the Health Insurance Portability and Accountability Act of 1996 and the Accreditation Council for Graduate Medical Education Program Requirements for Graduate Medical Education in IR) (

      Accreditation Council for Graduate Medical Education. Program requirements for graduate medical education in vascular and interventional radiology. Revised 2016. Available at: https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/427_vascular_intervent_diag_rad_2016_1-YR.pdf. Accessed October 10, 2016.

      ). Patient bays should have structural walls, rather than curtains, as the latter does not provide adequate privacy.
      The number of patient preparatory and recovery rooms should be correlated with the number of IR suites and the volume and complexity of procedures being performed. In a typical hospital-based setting, much of the preparatory work before a procedure and routine recovery after a procedure is performed in a setting similar to an ambulatory care unit, an area separate from the actual IR suite area. In this scenario, up to 4 beds per IR suite may be necessary to complete patient preparation and full recovery of patients (
      • Baskin K.M.
      • Hogan M.J.
      • Sidhu M.K.
      • et al.
      Developing a clinical pediatric interventional practice: a joint clinical practice guideline from the Society of Interventional Radiology and the Society for Pediatric Radiology.
      ,

      ACR-SIR-SNIS-SPR practice parameter for interventional clinical practice and management. Revised 2014 (Resolution 18). Available at: http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Interventional_Clinical_Practice.pdf. Accessed August 18, 2015.

      ), but the minimum recommendation is 1.5 preparatory and 1.5 recovery bays per IR suite. This consensus panel generally supports the recommendations from an architectural firm whose primary business is designing hospitals—that is, 2.5–3.2 periprocedural rooms per IR suite (Daniel Moore, Perkins + Will Architectural Firm, personal communication April 15, 2016). The size of the patient bays will vary depending on the patient population. For patient bays, a minimum of 60 square feet of clear floor space should be provided for each patient in a lounge chair or stretcher; for individual patient cubicles, a minimum of 80 square feet with enough space for a visitor’s chair should be provided; and for single-bed rooms, a minimum of 100 square feet should be provided (
      Facilities Guidelines Institute
      Guidelines for design and construction of hospitals and outpatient facilities.
      ), again providing enough space for a visitor’s chair.
      Case volumes in IR may surge quickly and unpredictably and may not be tied to any hospital-based metric or emergency department or inpatient volumes. A contingency plan should be in place to handle sudden increases in patient referrals. This plan should include provisions for additional space, staff, and resources and may involve relying on the emergency department, intensive care unit, postanesthesia care unit, or hospital inpatient wards. In most circumstances, transfer protocols and agreements should be in place with other hospitals and facilities. For example, the contact information for both the referring and the accepting physician and the requisite medical documents and/or information to be transferred should be clear to facilitate efficient communication, as should the protocol for after the intervention and repatriation where relevant.
      IR fellowship training programs must include adequate facilities and space for the education of fellows, including sufficient study and conference space and access to computers (

      Accreditation Council for Graduate Medical Education. Program requirements for graduate medical education in vascular and interventional radiology. Revised 2016. Available at: https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/427_vascular_intervent_diag_rad_2016_1-YR.pdf. Accessed October 10, 2016.

      ).

       Recommendations

      • 1.
        Per IR suite, 3–4 preparatory and recovery rooms are recommended. If additional space is unavailable for recovery of patients for longer periods of time (ie, a short stay or ambulatory care unit for patients needing recovery for 6–36 hours), additional preparatory and/or recovery rooms may be necessary.
      • 2.
        Contingency plans must be available to handle an unexpected increase in urgent patient referrals.
      • 3.
        Transfer and post-intervention/repatriation protocols for after the intervention and repatriation between facilities should be established and clear.

       Resources and Equipment

      The preparatory and recovery areas must be located in a setting with adequate electrical, oxygen, suction, anesthesia, and emergency services. There must be appropriate temperature and humidity control, air exchange and ventilation, lighting, computer terminals, PACS access, and monitoring equipment. Access to basic and advanced resuscitation equipment as well as necessary medications and fluids and adequate support area for supplies, nutritional support, ice machines, blanket warmers, and nursing space are also required (

      ACR-SIR-SNIS-SPR practice parameter for interventional clinical practice and management. Revised 2014 (Resolution 18). Available at: http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Interventional_Clinical_Practice.pdf. Accessed August 18, 2015.

      ). Equipment and resources must comply with jurisdictional regulatory requirements and be fully operational without any known defects (

      The Royal Australian and New Zealand College of Radiologists. Standards of practice for diagnostic and interventional radiology. Version 10. Available at: http://www.ranzcr.edu.au/documents-download/document-library-22/document-library-25/510-ranzcr-standards-of-practice-for-diagnostic-and-interventional-radiology/file. Accessed August 18, 2015.

      ). The preparatory and recovery areas should be in close proximity to the physicians’ working area and IR suites in case the IR physician is required emergently for patient care.
      A scrub area that includes sinks is required. This area should be immediately adjacent to, but outside of, the IR suite.
      A patient’s clinical situation can unexpectedly deteriorate before, during, and after a procedure, occasionally requiring emergency resuscitation. Adequate capacity and infrastructure to safely manage these situations is necessary and should include the requisite monitoring and resuscitation equipment (ie, code cart) as well as emergent access for staff from other departments as necessary (

      The Royal Australian and New Zealand College of Radiologists. Standards of practice for diagnostic and interventional radiology. Version 10. Available at: http://www.ranzcr.edu.au/documents-download/document-library-22/document-library-25/510-ranzcr-standards-of-practice-for-diagnostic-and-interventional-radiology/file. Accessed August 18, 2015.

      ).
      Patient flow in the IR periprocedural areas should be under the control of the IR team and not dependent on recovery room availability related to other services, unless the area is specifically designed for this purpose and procedures, policies, and processes are established and defined to ensure adequate staffing and space needs for safe and appropriate patient care. There should be a process in place by which to monitor and optimize patient and procedure/room turnover; workflow in the IR suite should not be delayed by inadequate resources for patient care and recovery after the procedure.

       Recommendations

      • 1.
        Immediately accessible equipment to carry out resuscitations is required.
      • 2.
        A sufficient surplus of resources and equipment must be available not only to handle an expected volume of cases but also to be able to manage an unexpected increase in urgent patient referrals and acute changes in a patient’s condition.

       IR Suite and IR Area

       Space

      Appropriate space is critical to run a safe and efficient IR suite. All IR suites must have sufficient room to accommodate all required equipment and resources, as described in the next section. The IR area should contain PACS viewing systems for review of relevant images before, during, or after procedures (

      The Royal Australian and New Zealand College of Radiologists. Standards of practice for diagnostic and interventional radiology. Version 10. Available at: http://www.ranzcr.edu.au/documents-download/document-library-22/document-library-25/510-ranzcr-standards-of-practice-for-diagnostic-and-interventional-radiology/file. Accessed August 18, 2015.

      ). The ability to display PACS as well as real-time ultrasound imaging on a monitor within the IR suite is recommended, but not required. An area of 650 square feet is recommended for IR suites. At least 800 square feet is recommended for IR/operating room hybrid suites (). In some jurisdictions, there may be additional local or regional requirements. Emergency cases or cases with major adverse events can result in a sudden influx of resuscitation personnel. There must be sufficient room and access for emergency responders to adequately deliver care.

       Recommendations

      • 1.
        The IR suite and larger IR area must have sufficient space to accommodate the personnel and equipment required to ensure a safe procedural environment and manage a patient care emergency.
      • 2.
        For an IR suite, 650 square feet is recommended; for an IR/operating room hybrid suite, at least 800 square feet is recommended.

       Resources, Storage Space, and Equipment Inventory

      Similar to surgical operating rooms, IR suites must have appropriate ventilation, air exchanges, air conditioning, and electrical utilities with backup power. There must be sterile zones requiring masks and surgical caps (

      ACR-SIR-SNIS-SPR practice parameter for interventional clinical practice and management. Revised 2014 (Resolution 18). Available at: http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Interventional_Clinical_Practice.pdf. Accessed August 18, 2015.

      ). All IR suites must have appropriate lighting, preferably mobile ceiling units to conserve floor space, and radiation-mitigating shielding (some of which may be ceiling-mounted).
      IR services should have a permanent, mounted, C-arm fluoroscopy unit capable of complex, multiobliquity imaging in the room (

      ACR-SIR-SNIS-SPR practice parameter for interventional clinical practice and management. Revised 2014 (Resolution 18). Available at: http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Interventional_Clinical_Practice.pdf. Accessed August 18, 2015.

      ) and have immediate access to a modern color duplex ultrasound machine and a computed tomography (CT) scanner in certain case scenarios. In settings with a low volume and/or case complexity, a portable C-arm unit may be used if deemed safe and if it does not compromise patient safety and outcomes. In some cases, the IR suite or area may have a CT scanner. For institutions where there are a large number of CT-guided procedures performed by interventional radiologists, the presence of a dedicated CT scanner in the IR area (either separate from or within the IR suite) will improve patient access, timely patient care, and efficiency.
      A wide breadth of inventory is necessary to handle the variety of procedures performed on a daily basis within an IR suite. Some inventory may be used once a year or less, but it must be available if required for a procedure, especially if the inventory could be required emergently. Processes should be developed and managed to reduce losses associated with expired inventory by using programs such as the “first in first out” method, consignment programs, or agreements with vendors to rotate out material before expiration. However, despite implementing these types of programs, loss of inventory will occur and should be incorporated into the budgetary process, along with “par levels” for expensive supplies.
      All procedure-specific materials should be stocked and monitored ideally with a bar code system to avoid missing or out-of-stock equipment. In addition to equipment required for specific planned procedures, IR suites should have resources to convert nonarterial cases to arterial cases immediately. This need is uncommon, but it does occur. For example, estimates of hemorrhage requiring transfusion or another intervention for simple image-guided renal, hepatic, and splenic biopsies range from 0 to 8.3% (
      • Gupta S.
      • Wallace M.J.
      • Cardella J.F.
      • et al.
      Quality improvement guidelines for percutaneous needle biopsy.
      ). Equipment necessary for unexpected adverse events, including covered stents and embolization materials such as microcatheters, guide wires, coils, polyvinyl alcohol particles, and Gelfoam, should be readily available.
      All IR suites should have access to a power injector for contrast administration as well as a backup power injector. Power injectors have been demonstrated to lead to significantly superior image quality, reduced contrast agent use, and lower patient and worker radiation exposure (
      • Hayashi N.
      • Sakai T.
      • Kitagawa M.
      • et al.
      Radiation exposure to interventional radiologists during manual-injection digital subtraction angiography.
      ,
      • Layton K.F.
      • Kallmes D.F.
      • Cloft H.J.
      • Schueler B.A.
      • Sturchio B.M.
      Radiation exposure to the primary operator during endovascular surgical neuroradiology procedures.
      ). Reduced contrast agent use in particular reduces the risk of patients developing contrast-induced nephropathy and results in cost savings. Power injectors can also be used for planned vascular work or for converting nonvascular cases into vascular cases should an adverse event occur. Space and accommodations should be made available for the injector and for contrast medium warming and preparation.
      Equipment for radiation monitoring and management is also necessary. This includes the availability of radiation shielding devices, lead aprons with thyroid collars, lead glasses, and dose monitoring software that is able to record the dose and transfer the data into the patient’s medical record (in some jurisdictions, this may be mandatory). The lead aprons and thyroid shields should be checked annually to ensure that there are no cracks or defects compromising their shielding efficacy.
      Space for the storage of all necessary equipment used in the IR suites should be available (

      Accreditation Council for Graduate Medical Education. Program requirements for graduate medical education in vascular and interventional radiology. Revised 2016. Available at: https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/427_vascular_intervent_diag_rad_2016_1-YR.pdf. Accessed October 10, 2016.

      ) as well as space for processing and cleaning ultrasound probes and storing empty patient stretchers. A minimum of 50 square feet for storage of supplies per IR suite is recommended. There should also be adequate space allotted to maintain the necessary inventory for supplies that may be needed emergently. Having “in-room” rather than “down-the-hall” access to some materials (eg, coils) may be critical in some situations: a difference of several minutes in obtaining the necessary products may make the difference between life and death.
      The above-noted 50 square feet of recommended space is specifically “in-room” IR suite space. Basic and common procedural equipment (eg, needles, wires, catheters) as well as critical equipment (eg, coils) is stored within the suite. An inventory storage room in close proximity to the IR suite (ie, within the larger IR area) is also needed to store the multitude of other inventory, such as larger, nonemergent, boxed supplies (eg, inferior vena cava filter kits). Decreasing the time spent obtaining the necessary supplies to perform a procedure decreases procedure and room turnover times, which will ultimately increase productivity and improve patient safety.
      Designated space is needed for control room areas (120 square feet) for operation of the imaging equipment, image viewing and interpretation with physician workstations for post-processing, and storage of radiation safety equipment such as lead aprons and glasses that are properly apportioned to the number of staff and operators (
      Facilities Guidelines Institute
      Guidelines for design and construction of hospitals and outpatient facilities.
      ). In the case of lead aprons, adequate space is required to ensure that wrinkling or folding of the aprons does not occur.
      All equipment required for advanced cardiac life support must also be immediately accessible and ready to use at all times. All monitoring and resuscitation equipment required for safe performance of moderate sedation must be immediately accessible in the IR suite, including electrocardiogram and blood pressure monitoring equipment, pulse oximeters, an oxygen source and supplies for its administration, and suction equipment (

      The Royal Australian and New Zealand College of Radiologists. Standards of practice for diagnostic and interventional radiology. Version 10. Available at: http://www.ranzcr.edu.au/documents-download/document-library-22/document-library-25/510-ranzcr-standards-of-practice-for-diagnostic-and-interventional-radiology/file. Accessed August 18, 2015.

      ). Equipment required for carbon dioxide capnography ideally should also be available in the IR suite (
      • Waugh J.B.
      • Epps C.A.
      • Khodneva Y.A.
      Capnography enhances surveillance of respiratory events during procedural sedation: A meta-analysis.
      ,
      • Baerlocher M.O.
      • Nikolic B.
      • Silbersweig J.E.
      • et al.
      Society of Interventional Radiology position statement on recent change to the ASA’s moderate sedation standards: capnography.
      ). Suites should have the capability to automatically post procedural information into the patient’s electronic medical record and procedural report. The IR suite and broader IR area should be viewed as a seamless site of care. Although some of the equipment may not be used in every case (eg, a power injector), it must still be readily available within the IR area.

       Recommendations

      • 1.
        All equipment necessary to urgently convert a nonarterial case to an arterial case must be immediately accessible.
      • 2.
        Power injectors must be available for immediate and unexpected use, including for procedures initially intended to be nonvascular.
      • 3.
        All equipment necessary for advanced cardiac life support must be immediately accessible.
      • 4.
        PACS and access to the electronic medical record must be readily accessible, and suites should have the capability to automatically port procedural information into the electronic medical record.
      • 5.
        Storage space for devices required in the IR suite must be available, with the standard being 50 square feet of storage space per suite.
      • 6.
        Space for controlling the operation of the imaging equipment and a dedicated image-viewing and interpretation area for the interventional radiologists should be in close proximity to, if not directly in, the IR suite (ie, in the IR area).
      • 7.
        The IR suite and IR area should be viewed as a seamless site of care. Some of the equipment may not be used in every case (eg, a power injector); however, it must still be readily available within the suite.

      Conclusions

      Proper attention to the requisite spacing and resource requirements of an IR program is essential for a safe and successful practice. Although the specific needs of an IR program may vary depending on the complexity and volume of cases, budgetary constraints should not be cited as the primary reason for an inability to adhere to these recommended standards. Finally, given that IR is a growing field with innovation leading to new minimally invasive, image-guided procedures being offered, planning of an IR department should include a view to the future addition of procedure types and volumes. It is likely that more procedures will move from a traditional operating room setting to a minimally invasive, image-guided IR procedural environment.

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