Staying in Compliance by Following Policies

February 15, 2019

By Sylvia Garcia, MBA, RN, CIC

The Joint Commission provides an approach for writing policies that promote compliance with infection control standards. There are many sources of infection prevention and control standards which often make infection preventionists (IPs) struggle to choose the best references for their infection control plans policies, and practices. Review of infection control-related survey findings indicate that organizations are frequently scored out of compliance because they are not following their own policy.  

Joint Commission commends organizations for striving to follow best practices and incorporating them into their policies.  An example of this would include facilities that perform biological indicator testing of steam sterilizers daily or with every load.  This means that if there is a positive biologic it is possible to prevent use of instruments until the validity of the positive can be resolved and next steps are taken. A definite win for patient safety.

However, facilities often add requirements to their policies that have no foundation.  These may seem like good ideas but are often unachievable or unsustainable – for example: a facility writing a policy that says OR staff must remove all bioburden prior to transporting soiled instruments from the operating room (OR).  

Following is an approach that infection control professionals can follow to ensure policies are based on requirements and chosen evidence-based guidelines. This detailed approach will help facilities meet requirements. The Joint Commission surveyors have been trained to follow the same approach when surveying compliance with standards.

1. Regulation 
If a regulation exists, follow its direction in creating facility policies.  Infection control policies cannot conflict with law and regulation. For example, some states specify in their department of health licensing requirements that manufacturer instructions must be available to staff members in all areas performing reprocessing or the minimum frequency of biologic monitoring of sterilizers. 

2. CMS 
If a facility is deemed accredited to qualify for CMS, then it must meet conditions for participation (CfPs), conditions for coverage (CfCs) and Quality, Safety, Oversight or QSO letters. Information can be found by visiting the following links: Cops and CfCs and policy and oversight memos to states. Facilities who are deemed need to ensure that policies do not conflict with CMS requirements.

For example: S&C: 14-44-Hospital/CAH/ASC directs surveyors to look for evidence that all personnel who perform immediate use steam sterilization (IUSS) are trained and competent to correctly follow the manufacturer’s IFUs regarding IUSS with respect to each instrument, sterilizer(s), container(s) and cleaning supplies they are using for IUSS. 

3. Manufacturer Instructions for Use 
Healthcare organizations must follow the manufacturer instructions for use (IFU) for equipment, supplies and products used and are required to resolve any conflicts that may exist. When there are conflicts, the organization must resolve these. For example: If a manufacturer indicates varying cycle parameters must be met to sterilize a variety of instruments, but the organization’s sterilizer is set to only one of those parameters, then the he organization must contact the instrument manufacturer to determine if it is acceptable to use that parameter. If it is not acceptable, the organization must contact the sterilizer to determine if the parameters of the sterilizer can meet the various requirements.If it does not the policy direct individuals responsible for sterilization to an alternative location where the parameters can be met.

4.    Evidence-based Guidelines or National Standards
In an absence of clear requirements and recommendations provided by state regulation, conditions of participation (CoP) or IFUs, the next step for healthcare organizations is to review evidence-based guidelines or national standards. A facility can choose which evidence-based guidelines or national standards (EBGs) it follows and should be prepared to discuss (not required in writing) the process that it uses to determine which it has chosen to follow. It is important for infection control professionals who are writing policies based on EBGs to have a system for updating so that the policies are current.

For example: The organization cannot find direction on how to store an endoscope after high level disinfection. They have reviewed their state health department regulations, the CoPs, and the manufacturer instructions for use and all state to store in a manner that prevents contamination. They chose to follow AAMI ST91(2015) which states “…The endoscope should be hung vertically with the distal tip hanging freely in a well-ventilated, clean area, following the endoscope manufacturer’s written IFU for storage.” And then provides some additional detail and a rationale. This provides the facility with direction to store the endoscopes that have been high level disinfected in this manner and it is incorporated into their policy.

5. Position Statements
In the absence of regulation, CoPs, manufacturer instruction, evidence-based guidelines, or national standards, healthcare organizations may then consider position statements and other documents as guidance for developing infection control-related policies. For example: Many ophthalmology practices follow recommendations from the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses which re-enforce following manufacturer IFUs but additionally provide guidance to prevent Toxic anterior segment syndrome (TASS).  This information can be incorporated into facility policy.

Organizations have experienced adverse accreditation decisions because they are surveyed in accordance with their policies.  

To review, implementing policy that requires wiping all the bioburden off instruments at point of use may not lead to a successful outcome.  While it may sound acceptable as a concept, it is important to ask how this impacts staff during a long cardiac case when a chest retractor has been “drying” in the incision for eight hours of surgery?  OR staff do not have the equipment necessary to remove the bioburden.  A review of regulations, CoPs, and manufacturer instructions may provide guidance.  If an organization’s regulations fail to provide guidance, then it is time to check the EBGs.

Using a hospital in New Jersey as an example, let’s look at the basis for a policy about handing soiled instruments in the OR.  First, we review at regulations.  New Jersey implements regulation which requires by incorporation that facilities follow current Association for the Advancement of Medical Instrumentation (AAMI) standards. When AAMI standards are reviewed it states that instruments should be wiped during the procedure and instruments with lumens should be flushed. Prior to transport items should be prepared in a way that maintains moisture and provides three examples. The facility must also follow OSHA regulations which require that the contaminated reusable sharps shall be placed in containers that are puncture resistant; labeled with a biohazard label or color-coded red and leakproof on the sides and bottom. The facility is deemed, so the CoPs for Hospitals are reviewed and state that items must be thoroughly cleaned and visually inspected for soil according to manufacturer instructions prior to sterilization. Manufacturer instructions for the instruments indicate that the soiled instrument should be kept moist and gives the option of using a pre-treatment gel or a moistened towel. The hospital now had the information to write a policy that is compliant with standards.

An example of a policy statement based on the information could be: During use, the orthopedic instruments are wiped and flushed to remove gross contamination that could interfere with the procedure. At the end of the procedure, all used instruments will be placed in a container that is puncture resistant and leakproof on sides and bottom and be covered with a moist towel for transport to decontamination. A biohazard label is affixed to the cover of the transport cart if multiple containers are transported on the same cart or the individual container if it will be transported independently.

Most facilities will find that there is no requirement to completely remove all visible bioburden in the operating room for most instruments, instead regulations and CoPs recommend following manufacturer instructions and most manufacturer instruction recommend keeping the item moist until it can be cleaned.  In developing their policies, infection control professionals should follow the standard approach and include input from leadership and staff who will implement the policies. If recommended processes are followed, facilities can explain it to the surveyor and should do well on survey.

Surveys are meant to identify deviations from regulations, CoPs, EBGs and standards that are promulgated to keep patients and staff safe.  

Organizations with questions about the survey scoring process can contact The Joint Commission’s  Standards Interpretation Group for further information.

Sylvia Garcia, MBA, RN, CIC, is director of infection prevention and control within the Division of Healthcare Improvement at the Joint Commission. Garcia has more than 30 years of experience in infection control in hospital and long-term care settings, as well as eight years of clinical microbiology experience.