Surveyors probe ultrasound device HLD practices

Nov. 24, 2021

Surveyors from the Joint Commission (TJC) are dialing up their focus on reprocessing of medical devices, including ultrasound probes, to ensure accountability and compliance with infection control standard IC.02.02.01. The standard requires Joint Commission-accredited facilities to reduce the risk of infections associated with medical equipment, devices and supplies. This heightened focus began in 2014 when TJC released a safety alert warning that high-level disinfection or sterilization (HLD) was not being properly carried out. When noncompliance increased between 2009 and 2016, TJC reissued the safety alert in May 2017.

“TJC has zeroed in on this because they said that 74% of all immediate threats of life were from improperly sterilized or high-level disinfection of devices. That’s very concerning,” said Emily Smith, BS, RDMS, VT, Clinical Marketing Specialist, CIVCO Medical Solutions, during her IAHCSMM Virtual Conference session, “A Joint Commission Survey: What You Need to Know Regarding High-Level Disinfection.”

Collaboration, documentation, training crucial

TJC recommends strong collaboration between Infection Control/Infection Prevention departments and all departmental areas responsible for high-level disinfection (HLD) and sterilization processes, said Smith. Proper disposal of those devices, and storage of the equipment after sterilization and HLD, are also being more closely eyed by TJC surveyors in recent years. She noted that important infection prevention and control information should be available to staff, standard- and transmission-based precautions and instructions for use (IFU) should be readily available and consistently followed, processes should be carefully documented, and any infection outbreaks should be properly investigated  TJC surveyors will want to ensure facilities are following evidence-based guidelines and standards, as well as manufacturers’ instructions for use (IFU), per IC.01.05.01. Multiple guidelines, standards and best practices are available, including ANSI/AAMI ST58:2014/(R) 2018, Chemical sterilization and HLD in health care facilities; the Centers for Disease Control and Prevention’ Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (updated Feb. 15, 2017); the Association of periOperative Registered Nurses’ 2016 Perioperative Standards and Recommended Practices for Sterilization; the American Institute of Ultrasound in Medicine’s (AIUM’s) Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers Between Patients, Safe Handling, and Use of Ultrasound Coupling Gel; and the Society of Diagnostic Medical Sonography’s Guidelines for Infection Prevention and Control in Sonography: Reprocessing the Ultrasound Transducer.

Although TJC surveyors are not concerned about which evidence-based guidelines a facility uses, they will look to ensure the facility sticks with the one it has chosen. “They may request a copy of this, so make sure you keep a copy close in the department—and they will expect you to show how you’re following those guidelines as well. They may ask questions about IFU for your HLD disinfectant, and they may also ask for your IFU or manual for your automated HLD system, as well as the IFU from the ultrasound manufacturers themselves.”

If there is conflicting information between the guidelines a facility uses and manufacturers’ IFU, Smith said the facility must resolve those differences by contacting the equipment and product manufacturers and also the society/group responsible for the evidence-based guidelines.

Inadequate monitoring or documentation of HLD or sterilization processes can also contribute to survey noncompliance. “Proper data logging is an essential part of the HLD process because it allows for the tracking of instruments, disinfectants, etc. for outbreak investigations,” said Smith.

 For ultrasound probes, the following should be logged for each use:

  • Instrument being processed, including serial number or some other unique identifier
  • Name of person reprocessing the items
  • Date/time disinfection process occurred
  • Type of HLD chemical and lot number, and expiration date for the HLD
  • Temperature of the HLD at the time of reprocessing
  • MRC test results (know the type, lot # and expiration date of test strips)
  • HLD submersion time and documentation of the rinse cycles (how long probes are submersed in the chemical)
  • Proper storage

Lack of employee knowledge and training on proper sterilization or HLD processes also contributes to noncompliance. Training should be required and provided any time a new employee is hired and whenever new equipment is introduced (to ensure all employees know how to clean it properly). Annual competencies should be assessed for all employees, and all must be carefully documented.

Noncompliance results when processes for sterilization or HLD are not followed properly, or when shortcuts are taken. “Know the steps that are outlined in your particular evidence-based guidelines, follow them consistently and document that you did [follow them],” said Smith, noting that this should include every step, from pre-cleaning, minimum recommended concentration (MEC) testing and HLD to rinsing, data logging and proper storage.

Surveyors will also ensure that dedicated staff members are overseeing proper processes, and they will examine reprocessing areas to ensure that probes follow a “dirty to clean to storage and use,” flow. Proper ventilation or air filtration and personal protective equipment will also likely be assessed, along with eye wash station availability.

TJC surveys are not always black and white and are often subjective, said Smith. But even when noncompliance is discovered, she said, the organization or facility will have an opportunity to resolve it. “[Surveyors] are looking for long-term compliance, so if you follow your evidence-based guidelines and IFU, you’ll do fine.”