May 30, 2012
STERILE INSTRUMENTS IN HOSPITALS
By: James Orlando, Associate Analyst
You asked about laws requiring the certification of individuals who clean sterile instruments in hospitals. You also asked about current law regarding sterilization of hospital equipment.
Connecticut does not require the certification of central sterile supply technicians or central service technicians (i.e., staff persons responsible for cleaning, sterilizing, and decontaminating surgical instruments and related health care supplies). We also did not find any bills on this issue.
According to the International Association of Healthcare Central Service Materiel Management (IAHCSMM), one state (New Jersey) requires certification to work in central service. A few other states had bills introduced on this topic in 2012. IAHCSMM's website includes information on legislative action in other states: http://www.iahcsmm.org/GovernmentAffairs/LegislativeMap.html#pab1_4.
We have attached New Jersey's regulations to this report.
Connecticut law and regulations generally require health care facilities to be sanitary. Short-term hospitals must have an infection control program and meet other requirements. Here is a link to a 2011 OLR report on Connecticut law on hospital infection control: http://www.cga.ct.gov/2011/rpt/2011-R-0297.htm.
There are also federal requirements on infection control and sterilization. The federal Conditions of Participation for all Medicare receiving hospitals (CoPs) (all acute care hospitals in Connecticut are in this category) includes extensive infection control and prevention obligations. The CoPs (as well as the Connecticut Public Health Code) require each hospital to have a comprehensive program for prevention, control, and investigation of infections and communicable diseases that incorporates nationally recognized infection control practices or guidelines, including those from the Centers for Disease Control and Prevention, Association for Professionals in Infection Control and Epidemiology, the Society for Healthcare Epidemiology of America, and the Association of periOperative Registered Nurses. There are also various federal Occupational Safety and Health Administration regulations applicable to infection control practices.
As part of this larger process, hospitals must ensure that surgical instruments are properly sterilized. As explained in the Centers for Medicare and Medicaid Services (CMS) interpretative guidelines, the CoPs infection control regulations (42 C.F.R. § 482.42) require hospitals to have a surgical infection risk mitigation measure that demonstrates the hospital is “addressing aseptic technique practices used in surgery and invasive procedures performed outside the operating room, including sterilization of instruments.”
42 C.F.R. § 482.51 contains additional infection prevention requirements for surgical settings, including the obligation to sterilize operating room equipment.
The CMS interpretive guidelines for the CoPS regulations on infection control (42 C.F.R. § 482.42) and surgical services (42 C.F.R. § 482.51) are available at the following link: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf. The discussion of 42 C.F.R. § 482.42 starts on page 317; the discussion of 42 C.F.R. § 482.51 starts on page 357.