New Joint Commission Requirements for Fluoroscopy Services

Transcription

1 New Joint Commission Requirements for Fluoroscopy Services Melissa C. Martin, M.S., FAAPM, FACR Past President AAPM Florida Chapter Fall Meeting Orlando, FL September 14, 2018 New Requirements Effective January 1, 2019 for Critical Access Hospitals Standard EC : The critical access hospital inspects, tests and maintains medical equipment Elements of Performance for EC # 34 For Critical Access Hospital that provide fluoroscopic services: At least annually, a diagnostic medical physicist conducts a performance evaluation of fluoroscopic imaging equipment. The evaluation results, along with recommendations for correcting any problems identified, are documents. 1

2 Items that must be assessed during Annual Physics Evaluation of Fluoroscopy Units Beam Alignment and Collimation Tube Potential/kVp Accuracy Beam Filtration (Half Value Layer) High Contrast Resolution Low Contrast Detectability Maximum Exposure Rate in ALL Imaging Modes Displayed Air Kerma Rate and Cumulative Air Kerma Accuracy (When Applicable) Medical Physicists Assistants Medical Physicists conducting Performance Evaluations may be assisted with the testing and evaluation of equipment performance by individuals who have the required training and skills as determined by the physicist. This element of performance does not apply to fluoroscopy equipment used for therapeutic radiation treatment planning or delivery. 2

3 Annual Training Requirements (Standard HR ) All operators who use fluoroscopic equipment must participate in ongoing annual training (Physicians, Non Physicians, and Ancillary Personnel) on the following: Radiation Dose Optimization Techniques and Tools for Pediatric and Adult Patients Image Gently Campaign ( Safe Procedures for operation of the types of fluoroscopy equipment they will use (does not apply to fluoro equipment used for therapy treatment planning or delivery Management of Programs, Services, Sites or Departments: Standard LD An Individual must be designated to serve as the Radiation Safety Officer who is responsible for making certain that Radiologic Services are provided in accordance with law, regulation, and organizational policy. The RSO must have the necessary authority and leadership support. 3

4 Responsibilities of the Fluoroscopy RSO Monitor and Verify Compliance with established Radiation Safety Practices (including oversight of Dosimetry Monitoring) Provide Recommendations for Improved Radiation Safety Intervene as needed to STOP Unsafe Practices Implement Corrective Action. Provisions for Diagnostic Testing: Standard PC The Cumulative Air Kerma or Kerma Area Product are documented in a retrievable format. For Fluoroscopy Equipment that CANNOT DISPLAY or PROVIDE Cumulative Air Kerma or Kerma Area Product, Fluoroscopy TIME and NUMBER of IMAGES acquired are documented in a retrievable format, such as a PACS (Picture Archiving and Communication System) Does not apply to Fluoroscopy Equipment used for Radiation Therapy Treatment Planning or Delivery. 4

5 Provisions for Providing Fluoroscopic Services: Standard PC The facility identifies radiation exposure and skin dose threshold levels, that if exceeded, trigger further review and/or patient evaluation to assess for adverse radiation effects. Radiation exposure thresholds may be established based on metrics such as reference air kerma, cumulative air kerma, kerma area product, or fluoroscopy time. References for Radiation Exposure Thresholds National Council on Radiation Protection (NCRP) s Report Number 168: Radiation Dose Management for Fluoroscopically Guided Interventional Medical Procedures Food and Drug Administration s (FDA) Center for Devices for Radiological Health (CDRH) website. 5

6 NCRP Report # 168 (June 2015) This Report is intended for policymakers who can place radiation dose management requirements on those who conduct fluoroscopically guided interventional procedures. Provides recommendations and supporting information on radiation dose management for patients and medical staff during the use of fluoroscopic systems for guiding diagnostic and therapeutic medical procedures NCRP Report # 168 (June 2015) Optimizing imaging protocols; Managing procedure time; Utilizing available radiation protective equipment and dose management features; Tracking and trending radiation doses to patients and medical staff; and Credentialing and privileging physicians to use the fluoroscopic equipment for these specialized procedures 6

7 Compilation and Data Analysis: Standard PI Hospitals must review and analyze instances where the radiation exposure and skin dose threshold levels identified by the organization are exceeded. Radiation exposure thresholds may be established based on metrics such as Reference Air Kerma, Cumulative Air Kerma, Kerma Area Product, or Fluoroscopy Time. 7

8 Number and Types of FGI Procedures Number and Types of FGI Procedures 8

9 Number and Types of FGI Procedures Principle of Dose Limitation The total dose to any individual from all the regulated sources in planned situations other than medical exposure of patients should not exceed recommended limits. It is not appropriate to apply dose limits to medical exposure of patients, because such limits would often do more harm than good. Most likely, there are concurrent chronic, severe or even life threatening medical conditions that are of greater concern than the radiation exposure 9

10 Relationship of Air Kerma to Fluoroscopy Time for Non Cardiac Procedures Air Kerma at a Reference Point Fluoroscopy Time Minutes Relationship between Air Kerma and Fluoroscopy Time Fluoroscopy Time correlates poorly with other dose metrics and should be used cautiously to monitor patient irradiation during fluoroscopic procedures As shown in the previous slide, there is a factor of 10 variation in patient exposure for the same fluoroscopic procedure time. Because fluorsocopy time is such a poor indicator of patient dose, its use is generally discouraged. 10

11 Radiation Dose Monitors Real Time Display of Air Kerma or Air Kerma Area Product to the Fluoroscopy Unit Operator allows for evaluation patient radiation risk (dose) during the procedure. FDA and IEC Standards limit both of these values to a maximum deviation in accuracy to 35%. Machine Parameters as well as the type of image receptor and patient size determine the incident air kerma to the patient, radiation dose at the image receptor, and image quality. Proper adjustment of the machine parameters contribute to the optimization of the procedure. 11

12 Image Gently Campaign Step Lightly is the fluoroscopy component of the Image Gently Campaign including: a PowerPoint training presentation on application of the ALARA principle during fluoroscopy a Procedure Check List of Dose Reduction Steps for Review during each Case Dose Reduction and Quality Maintenance Steps to take Targeted Guidelines for Radiologists, Technologists, and Medical Physicists Brochures for Parents Room Design and Structural Radiation Protection Facility Design is an essential component of radiation safety and protection. TJC requires that the facility have the shielding design reports and radiation safety surveys for each room in which fluoroscopy is performed. A large control room with a generously sized leaded glass/acrylic window can serve as an observation area. An intercom between the control and procedure rooms can allow some staff to remain outside of the procedure room until they are needed. 12

13 NCRP Exposure Limits The NCRP recommends that new facilities be designed to limit exposure of occupational personnel to 50% of the maximum permissible dose or to 5 msv per year. Control areas should be shielded for non controlled personnel with full occupancy to a limit of 1 msv per year. This will allow no limits on the occupancy of ancillary personnel for observations of procedures. Flexible ceiling mounted shielding should be provided for operators of the fluoroscopic equipment to minimize their exposures. Administrative and Regulatory Concerns NCRP 168 Recommendations: Every person who operates or supervises the operation of fluoroscopy equipment SHALL have current training in the safe use of that equipment. All workers have a responsibility to use appropriate personal radiation protective equipment and dosimeters and to communicate with each other adequately to protect the safety of other staff 13

14 Technical Optimization of Use of Equipment The technical optimization of fluoroscopy equipment usage can only be achieved when well maintained and appropriate equipment is used for the procedure. Adequate resources should be provided to meet this goal. The proportional cost of equipment and its maintenance is a few percent of the total cost of performing a fluoroscopic procedure. 14

15 Summary and Conclusions Fluoroscopic procedures encompass a wide range of organ systems, procedure types and physician specialties. Volume and complexity of fluoroscopic procedures has grown significantly in the last decade. Risks to personnel performing fluoroscopic procedures has increased proportionally. Appropriate management of all occupational risks from radiation exposure must be considered. Summary and Conclusions Though infrequent, severe skin injuries to patients have occurred as a result of potentially high radiation dose procedures. The severity of skin and subcutaneous tissue injury depends on the skin dose, the portion of the patient s body exposed, and other patient sensitivity factors. Notable risk for injury to the lens of the eye from radiation exposure for physicians and other personnel working closely to the x ray beam. 15

16 Summary and Conclusions Patient radiation dose management requires active review, monitoring, and recording. Radiation dose should be continuously monitored during the procedure with adjustment of imaging technique to minimize skin dose if possible. Patient follow up should be provided if the Air Kerma exceeds 5 Gy or the DAP exceeds 500 Gy cm 2 or the fluoroscopy time exceeds 60 minutes. Documentation of patient s skin doses must be recorded in a retrievable format or in the patient s record. Thank You for Your Time and Attention Discussion Time Questions and Answers Melissa@TherapyPhysics.com