Compliance Requires Proper Disinfection and Sterilization of Instruments

Conditions of Participation from acute care and critical access hospitals require an active facility-wide infection control program for the surveillance, prevention, and control of hospital acquired infections and other infectious diseases. If an organization is observed to have egregious infection control issues that may cause or are likely to cause serious injury, harm, impairment, or death, and that threaten the health and safety of patients, there may be an immediate jeopardy citation for the failure to protect patients from harm.

Sterilization and disinfection of surgical instruments is one of many key areas to focus on to help protect patients from transmission of infectious pathogens. Hinged, ratcheted instrument pose a special concern due to the potential for pathogens within the teeth of the instrument that can transmit infection to a subsequent patient.

At time of survey, surveyors will inspect surgical instruments in peel packs and surgical instrument trays to verify proper sterilization. Ratcheted instruments such as hemostats, Kelly clamps, and scissors observed in the closed position indicate improper sterilization procedures and will result in a deficiency.  

Other issues that result in deficiencies are inadequate staff training and competency and lack of adequate oversight by the infection prevention and control professional.

Below is a summary of relevant standards.

Acute Care Hospital Standard 07.00.03 and Critical Access Hospital Standard 18.00.03: Responsibilities of the infection prevention and control professional

The infection prevention and control professional is responsible for the development and implementation of infection prevention and control policies and procedures that are based on nationally recognized guidelines to mitigate risks contributing to healthcare-associated infections. In addition, this individual is responsible to ensure competency-based training and education has been provided to the appropriate individuals on infection prevention and control guidelines, policies, and procedures.

Acute Care Hospital Standard 07.02.01 and Critical Access Hospital Standard 18.02.01: Risk mitigation measures for infection prevention

The hospital must identify activities to mitigate risks associated with infections. The hospital must have policies and procedures defining methods to prevent the transmission of infection within the hospital. The policies must be specific to the department and services provided.

Acute Care Hospital Standard 07.04.01 and Critical Access Hospital Standard 18.04.01: Decontamination and sterilization policies

Policies and procedures are based on manufacturer instructions and nationally recognized guidelines for the decontamination and sterilization techniques performed approved by the infection prevention committee.

Tips for Compliance

To maintain compliance, policies and procedures must be developed and based on nationally recognized guidelines. The policies and procedures must be approved by the infection control committee. Education, training, and competency evaluation must be provided for the individuals who are sterilizing equipment upon hire and regularly thereafter. It is highly recommended to provide education to the staff using the equipment. Instruments should not be used if they are found closed when opening blister packs or surgical instrument packs. The instruments must be re-sterilized. A monitoring process should be in place to audit sterilized instruments to ensure compliance with the defined sterilization process.

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