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Accreditation Surveys: Guidance for Meeting Reprocessing Standards
By Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT

Reprocessing of reusable medical devices is a major focal point of today’s healthcare accreditation surveys, such as those conducted by The Joint Commission (TJC) or the Centers for Medicare & Medicaid Services (CMS). As a response to reports of patients being notified of risks for infection transmission due to lapses in basic cleaning, disinfection, and sterilization of medical devices, surveyors will be looking for risk reduction and process improvements relating to sterilization and high-level disinfection (HLD). 

The Association for the Advancement of Medical Instrumentation (AAMI) posted a recent article by the director of infection prevention and control at TJC, Sylvia Garcia, MBA, RN, CIC. Garcia stated, “Reprocessing of medical equipment and devices is one of the most challenging areas related to Joint Commission Surveys.”In recent years, more than 70% of hospitals and critical-access hospitals and 60% of ambulatory organizations were cited for being noncompliant in at least one part of reprocessing.1

Education and training
The Joint Commission and CMS surveyors will likely review how the organization provides training to all personnel who reprocess medical devices upon hire and at least once a year thereafter, and when new devices or protocols are introduced. They will want to see the current documented competencies for all staff who perform any part of reprocessing (including immediate-use steam sterilization and HLD) anywhere it is performed in the organization.1The surveyors may ask if staff are certified as recommended in national guidelines and standards.Some surveyors may inquire how involved staff are with their professional associations.

Surveyors want to ensure that facilities are using current evidence-based guidelines (EBG) and staff orientation, training, and competency are conducted by personnel considered a subject matter experts (SME). Trainers should have current education on EBG, be certified, have experience in all steps of reprocessing, and be involved in their professional organization.In addition, the SME should collaborate with the infection prevention and control (IPC) professional regarding policies and procedures and ensure a traceable path to the patient and product identification in the event of a recall.

Available IFUs
Regulatory agencies and surveyors want to ensure facilities are following the manufacturers’ instructions for use (IFU) for each type of reusable device, piece of equipment and, chemical disinfectants and cleaning supplies used.1 They will want to see those IFUs readily available to staff and inspectors. Organizations have been cited for lack of quality control, not following the IFUs, and not using validated conditions (e.g., concentration, exposure times, temperatures, etc.). If there are conflicts in IFUs, the organization is required to resolve the conflict by contacting the manufacturers for acceptable applications.1   

Write policies to evidence based guidelines
According to TJC standard IC.01.05.01, facilities must use evidence-based guidelines and standards when developing infection prevention and control activities.In TJC’s October 30, 2018, webinar titled Disinfection and Sterilization: Dispelling the Myths, Garcia stated:

“Facilities should be able to articulate the source of their IC practices if they are based on multiple EBG, for example a facility might choose:

  • AORN for dress code and aseptic practices in the OR
  • AAMI for reprocessing of sterile instruments and endoscopes
  • CDC for isolation practices in oncology clinics.4

Physical design considerations
More than half of the facilities surveyed by TJC have been cited for being out of compliance related to the department design and the environment. An engineer will most likely be part of the survey team. Surveyors will possibly ask if staff know the required temperature and humidity parameters, how it gets logged each day (paper or automation), and what is the mandatory feedback if it goes out of compliance. They will inquire about risks relating to the utility systems, such as correct airflow. Staff should know if the airflow is positive or negative in each area and what they can do to maintain the appropriate pressure.3

Managing risks related to hazardous materials is another area of concern. Eyewash stations need to be in the immediate area anywhere chemicals are used. They should be plumbed, within 15-seconds travel time, and be able to irrigate both eyes hands-free for at least 15 minutes. The water should be tepid and the eyewash should have weekly inspections that are documented. Any new chemicals or products brought into the facility should be evaluated for safety prior to use.3

TJC’s updated guidance
Late last year The Joint Commission Online and TJC’s Perspectives published TJC’s key takeaways, which included:

  • “Facilites should develop and implement a process to keep instruments moist that is in accordance with the manufacturer’s IFU and the instruments and, if applicable, for related products used.
  • Manufacturer IFUs should be followed. If conflicts exist, they should be resolved by contacting manufacturers.
  • Items should be disassembled for terminal decontamination and inspection in accordance with manufacture’s IFU.
  • Instruments should be packaged for sterilization in compliance with the manufacturer’s IFU for the item, the packaging chosen, and the sterilizer used.
  • Items should be stored in a manner that meets state regulations (e.g., building code), protects them from contamination, and meets the manufacturer’s IFU.1

If you have questions about TJC’s scoring process, you can send them to:
https://www.jointcommission.org/about/contactus.aspx

Know your survey standards
Surveys are unannounced and surveyor dependent. Each site visit will be different and may not have the same focus; therefore, the best way to ensure a good survey is to know and consistently follow the accreditation standards, ensure staff are trained and educated according to current evidence-based process guidelines, and work closely with the IPC and facilities and engineers to ensure your environment is within standards. If you follow these suggestions, you should pass a survey relating to reprocessing with flying colors.

References

  • Garcia, S. The Joint Commission Provides Guidance for Meeting Infection Control Standards. AAMI News, January 2019.
  • ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, ANSI/AAMI ST79:2017. Section 4.
  • Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2017.
  • Garcia-Huchins, S. Disinfection and Sterilization: Dispelling the Myths – webinar. Available at: https://www.jointcommission.org/disinfection_and_sterilization_dispelling_myths/
    Accessed 2/2/12019

Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, is president/CEO of Seavey Healthcare Consulting and formerly the director of the SPD at The Children’s Hospital of Denver. Rose served on the AORN board of directors and is a past president ASHCSP. She received numerous awards and was named as one of the Who’s Who in Infection Prevention by Infection Control Today. Ms. Seavey is the author of Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys, published by AAMI. She serves on several AAMI committees helping to write national standards.

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