February 2019
GET THE PICTURE! A review of the Imaging and Fluoroscopy Requirements
As our health care delivery system continues its journey towards improving the quality and safety of the care, treatment and services we render and striving for Zero Harm, important new requirements have developed over the past 3 years related to the provision of imaging services. This month's article will focus on the 2015 CMS Condition of Participation changes and the recent alignment of the Joint Commission standards.
The Requirements
July 1, 2018 Standard EC 02.02.01 took effect and requires an organization to manage hazardous waste and materials. Elements of Performance associated with this standard require that:
  • There must be proper shielding of the patient during fluoroscopic procedures as part of the larger approach to minimizing risk associated with using hazardous energy sources.
  • Organizations providing fluoroscopy services must review, at least quarterly, the results of dosimetry monitoring. The review should be conducted by the radiation safety officer, diagnostic medical physicist, or health physicist and assess whether staff radiation exposure levels are "as low as reasonably achievable" (ALARA) and below regulatory limits.
The most recent Joint Commission changes took effect January 1, 2019 and appear within HR 01.05.03 of the Hospital Accreditation Manual. Similar requirements also appear within the Ambulatory, Critical Access and Office-Based Surgery Accreditation Manuals.

The new elements of performance at HR 01.05.03 are specific to ongoing education and training. It is here that these new requirements now focus on INDIVIDUALS (physicians, non-physicians, ancillary personnel and staff) who use fluoroscopic or CT equipment participate in ongoing education that covers the following topics:

(1)   Radiation dose optimization techniques and tools that are addressed in the ImageGently and ImageWisely campaign for pediatric and adult studies.
(2)   Safe procedures for operation of the MRI equipment they will use to perform these tests.
Please note that the above requirements do not apply to fluoroscopy or CT used for therapeutic radiation treatment planning or delivery.
Information on ImageGently and their campaign can be found at on their website. 

Information on ImageWisely and their campaign can be found here.

Additional requirements were added in 2018 to HR 01.01.01 elements of performance 32 and 33 as follows:
  • EP 32 requires Advanced certification of technologists that perform CT studies
  • EP 33 requires Board Certificationor certain educational/experience criteria for the medical physicist that support CT services.
Evidence of these certifications should be included in the employee's employment file and their job descriptions should reflect this required qualification.

PC 01.02.15 contains more requirements and are specific to the provision of fluoroscopic procedures. When fluoroscopic procedures are performed, the organization must document the cumulative air-kerma or kerma-area product in a retrievable format. These numerical values represent the dose a patient receives during an x-ray procedure. Tracking and trending this data can provide valuable information regarding how we can reduce the amount of exposure without compromising the final picture or image.

Last but not least, LD 04.01.05 EP 25 requires the designation of a Radiation Safety Officer as of January 1, 2019.
In July 2015, CMS published Transmittal # 141 outlining the updates that were made to the State Operations Manual to address radiological and nuclear medicine services.
Key components of this transmittal that now appear in the Hospital Conditions of Participation at 482.26 and are contained within The Joint Commission standards are:
  • Provision of Radiological Services must meet professionally approved standards for safety and personnel qualifications.
  • Radiological procedures must be free from hazards for patients and personnel.
  • Staff training requirement in proper equipment use per manufacturer's instructions
  • Defined qualifications for medical physicists.
You can access the Transmittals  here.

Reduction Strategies:
  • Work with your Human Resources team to ensure that job descriptions are updated to reflect the latest job qualification/certifications. Remember, these certifications will need to be primary sourced with the issuing organization since they are now required per regulation.
  • Conduct an HR Competency session to ensure the correct information is available and primary sourced as the appropriate time.
  • Do not forget:
  • Imaging and Radiological equipment requirements that reside in the Environment of Care Chapter specifically EC 02.04.01 EP5, EP 10 and EC 02.04.03 EP18, EP 20 and EP 21 and ensure that your Environment of Care Team has the associated documentation to substantiate compliance.
  • Designation of a Radiation Safety Officer is required per Leadership Standard LD 04.01.05 EP 25. It is recommended that this designation be documented in the form of an appointment letter and recorded in the employee's employment file.


Perspectives, January 2019. The Joint Commission
The Joint Commission, Prepublication Standards, December 17, 2018
The Joint Commission Hospital Accreditation Manual January 2019
CMS Transmittal 141, Revisions to the State Operations Manual (SOM), Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals July 10, 2015


Are You Ready for an Ambulatory Survey?

Part I: Infection Prevention
Ambulatory surgery centers, office practices, hospital- based ambulatory services, and other services that may be a part of a hospital's network or may be completely independent, must meet the same infection prevention practices as hospitals. What does this mean to you? Think about hand hygiene, cleaning between patients, appropriate precautions, proper attire, cleaning, disinfection and sterilization of instruments, processing instruments, managing infectious waste, and the list goes on.
Here are tips for success
Regardless of the accrediting organization you use, the principles are the same and the care provided in ambulatory sites must meet the same requirements.
Point # 1: WASH YOUR HANDS BEFORE AND AFTER SEEING PATIENTS. The single most important way to prevent infection is also the simplest. Don't think for a minute that surveyors are the only ones watching this, your patients are very aware as well. Involve your patients by asking if they have observed staff performing hand hygiene.
Point # 2 : EDUCATE EVERYONE THAT RESISTANT ORGANISMS ARE EVERYWHERE. We know that resistant organisms are also found in the community and patients may be carriers. It is critical that patient areas and equipment are cleaned with appropriate germicides between patients. That isn't just the exam table. Remember the stethoscopes and other equipment that touch the patient and also clean them with the appropriate germicidals.
Point # 3:   PERFORM CLEANING, DISINFECTION AND STERILIZATION . When sterile instruments are needed for patients, wipe them down immediately, apply enzymatic to keep moist, reapply as needed to keep them moist with a manufacturer approved solution to prevent drying of bioburden. Instruments must be contained and transported as biohazardous to prepare them for cleaning, disinfection and sterilization for reuse. The biohazard label also prevents potential adverse outcomes for both patients and staff.
Point # 4: USE STANDARD PRECAUTIONS. WHEN? . . . Every patient - Every day, use standard precautions. If there is a concern that a patient may have something that might be contagious, isolate as quickly as possible. Preventing further potential exposure to others is the best approach until you can rule out infectious potential.
Point # 5: FOLLOW MANUFACTURER INSTRUCTIONS FOR USE (IFUs). Too often we lose sight of this important tip. It is critical for the care of our equipment, instruments and cleaning solutions. Post IFUs to make sure staff are aware and assure their competence at least annually.

Avoid Ambulatory Survey Findings
Remember that all accreditation requirements are based in Centers for Medicare and Medicaid (CMS) standards. Infection prevention has many facets to the process which can lead to a variety of requirements for improvements (RFIs) and organizations should trace frequently to assure compliance. Below are some of the most frequent RFIs:
  • Failure to perform low-level, high-level and sterilization per the IFUs
  • Store equipment, supplies and other patient items incorrectly (not per policy)
    • Mix of clean and dirty
  • Use standard precautions inconsistently
  • Lack of evidence-based guidelines to support procedures
  • Failure to use transmission-based precautions, when appropriate
  • Incomplete implementation of the infection prevention plan
  • Inconsistent management of equipment and supplies
  • Failure to assess infectious risk appropriate to your setting
  • Deficient/incomplete documentation
Examples of TJC Survey Findings:
  • Staff were observed leaving one patient room and entering another with no evidence of hand hygiene between patients
  • Soiled instruments were not prepared in a manner that prevented instruments from drying out in ambulatory areas where instruments are frequently used, such as Dental Clinics, Surgical Clinics, Podiatry, Orthopedics, ENT and office practices
  • Surgical instruments were not transported in a leak-proof, puncture-proof container
  • Facility did not follow IFUs or evidence-based guidelines for instrument management
  • Staff were not following organization's policy for managing soiled instruments
  • Office practice was not following OSHA blood borne pathogen expectations to contain sharps during transport
  • Soiled instruments received in sterile processing were dry and in a closed position
  • Preventive maintenance on sterilizers does not follow IFUs
  • Instruments released before biological indicator read
  • Endoscopes were not wiped, flushed and inspected at point of use
  • IFUs not followed for endoscope cleaning and storage
Stay Ahead of the Curve
Infection prevention is everyone's job! Look for areas, including outpatient areas, where procedures are performed and enlist staff's support in meeting IFUs and evidence-based practice guidelines for the risks in their areas. Always maintain awareness of the continuous need for standard precautions and be on the look out for situations requiring transmission-based precautions. Keep policies and procedures up to date and assure staff competence in carrying out IFUs. Impress surveyors with your implementation of infection prevention approaches and strategies that keep your patients safe in your ambulatory settings.


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