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Know the Score: Become aware of Increased Scrutiny

Scrutiny over processes and best-practices in Sterile Processing Departments continues to increase year after year. Do you Know the Score?

Over the past few years, Regulating bodies like The Joint Commission (TJC) have turned an ever-more investigative eye towards the workings of Sterile Processing Departments(SPD). This has resulted in increasing numbers of improperly sterilized or HLD equipment being scored non-compliant to Infection Control Standard IC.02.02.01. Do you know the score?


In a September 2018 letter to Sterile Processing and Infection Preventionists, TJC stated that, “IC.02.02.01 continues to be among the standards most cited as non-compliant.”

scoring indicator to help know your score

Taking proactive steps, TJC redefined its scoring to more precisely focus on failed processing steps that pose the greatest risk to the patient. In the letter TJC stated that they “will continue to score…as non-compliant whenever manufacture instructions are not followed.” Do you know your score or have an indication where your department might land?


Costs of failed processes for the hospital may be significant and include placing patients at risk, causing infection outbreaks, loss of accreditation or CMS status, bad publicity, lost business and litigation.


The following bullets were among the scoring revisions stated in the letter:

  • Wiping / flushing of soiled instruments is not observed during a case in the operating or procedure room, and it is clinically appropriate
  • Item that is ready for use on a patient is visibly soiled
  • There is no process for keeping used instruments moist when appropriate
  • Manufacturer instructions for products used to keep instruments moist were not followed
  • The facility policy for keeping instruments moist was not followed
  • Sharps are being transported in a manner that violates OSHA requirements (e.g., sharps not placed in puncture-resistant container that is red or labeled biohazardous)
  • Non-sharps are transported in a way that could lead to contamination of staff or other people
  • Packaged instruments awaiting sterilization are in the closed / ratcheted position
  • Items that have just undergone sterilization are on the trolley or in the sterilizer in the closed / ratcheted position
  • Items in preparation and packaging that have come through the washer or pass-through window have not been disassembled in accordance with manufacturer instructions
  • Routine sterilizer monitoring with a biologic indicator required by the state or per evidence-based guideline is not followed and recorded
  • Non-implant load is released without physical monitoring of cycle and external and internal chemical indicators
  • Implant loads are released without routine sterilizer monitoring, a biologic indicator and a type 5 integrating indicator (aka integrator)
  • Biologic indicator not read before implant release (unless allowed in emergent situations by facility policy and policy was followed)
  • Container or location of storage is visibly soiled
  • Staff is observed contaminating other high level-disinfected products
  • Storage is not consistent with the items’ intended use (e.g., items that require minimum of high-level disinfection may be stored in a way that protects from contamination even if they were sterilized)
  • Item is not stored in accordance with manufacturer instructions for use (IFU)
  • Item is not stored in accordance with facility risk assessment / policy if no guidance was provided by the item’s manufacturer IFU
  • Facility is not following manufacturer IFU for drying
  • Facility is not following manufacturer IFU for frequency of reprocessing

As you see from the list, responsibility for proper practice is shared among clinical and sterile processing personnel. It is incumbent on our profession to take the lead in facilitating a cooperative approach to correct shortcomings within our organizations. Make sure you know the score!


Read more from the PROCESS PROs in our blog section 



‘4-1-1 on Survey Enhancements: New scoring revisions for IC.02.02.01 now in effect’

Dan Johnson, Senior Consultant, Professional Services

Dan Johnson has more than 24 years of consulting experience in healthcare, manufacturing and service (14 of which with STERIS). He is a Certified Six-Sigma Black Belt and his areas of expertise include Lean Process facilitation, process design, capacity planning, management training and organizational development. Dan has been instrumental in the design and development of hospital CS management planning, workflow control and performance measurement systems. He is also certified in Production and Inventory Control by the American Production and Inventory Control Society (APICS) and holds a Master’s Degree in Operation Management from the University of Arkansas, 1986.