ecently, approximately 70 thought-leaders in
sterilization gathered at the second annual Sterilization Leadership Summit
in St. Paul, MN. Sponsored by 3M, Belimed and Materials Management
Microsystems, the Summit was a unique opportunity for leaders to teach
leaders about best practices on a variety of topics vital to advancing
patient safety – including how to survive a Joint Commission inspection.
Below, I’ve shared insights gleaned from Ed Ross, a former Joint
Commission surveyor, as well as practical advice from Summit participants
who have been through the trenches.
Compliance
The Joint Commission (TJC)’s philosophy can be summed up in one word -
compliance. Surveyors want to see that facilities are in compliance with
what they say they do. Most surveyors are "process people" who do not know
all the details of what goes on day to day in the Sterile Processing
Department (SPD), therefore they look for conformity with policy and
procedures.
Healthcare professionals should let go of the mindset that that TJC is
concerned with a specific practice, such as sterilization, or with a
specific department, such as the Operating Room. They look at the big
picture. Surveyors will take the opportunity to evaluate compliance with
other things while they are reviewing processes. In decontamination and
sterilization there are two things to remember:
1. TJC will want to see all areas that perform any reprocessing such as,
decontamination, sterilization/disinfection, or sterile storage, (e.g.
Dental clinics, Labor and Delivery), and
2. They will always look at other processes while in an area (e.g. fire
extinguishers or the proper use of PPE).
TJC risk reduction tools
There are three risk reduction tools facilities can use to look at
patient safety issues. They are the Root Cause Analysis, a reactive process;
the Failure Mode Effect Analysis, a proactive process; and Tracer
Methodology, which looks at the process real time. A tracer follows a
selected patient through the continuum of care in the effort to evaluate
facility compliance to standards, and is the only risk reduction tool that
looks at the entire process.
Using the tracer methodology
The tracer is a living flow chart. It picks up on every aspect as it
follows the process throughout the organization across departments or units.
It looks for evidence of compliance, picks out process problems, and nails
down accountability. Ross encourages SPDs to conduct routine internal
sterilization tracers in order to evaluate compliance throughout their
facility. The tracer should start with 20-25 processes involving areas that
you suspect may have non-compliance with policies.
The two most common themes identified by SPD leaders were issues around
flash sterilization and loaner instrumentation.
Flash sterilization
TJC surveyors have been impressed by efforts to significantly reduce
flash sterilization. Best practices implemented by participants included
instituting procedures such as:
1. Purchasing more commonly used instrument sets;
2. Asking the OR staff to verify three things before an item can be
flashed:
a. No other like tray/item up sterile,
b. SPD called to confirm they do not have one ready,
c. Not enough turnaround time to properly reprocess;
3. Following manufacturers’ written recommendations (for many flashing is
not a validated option);
4. Posting cycle parameters for items requiring extended exposure times
by all sterilizers;
5. Cleaning and flashing only done by the experts in SPD;
6. Record keeping mandatory for each flash load to include date, time,
sterilizer identification, staff initials, parameters, items flashed and
patient name;
7. Document why implants were released before results of BI available;
and
8. Standardize policies and procedures and perform routine audits.
Loaners
Every facility needs to develop a clearly written policy for managing
loaner instrumentation. The policy should address who is responsible for
managing the loaners; how loaners are transported, checked in, processed and
traced to the patient.
Facilities need to partner with vendors to ensure loaner trays are
delivered in enough time to adequately process the items — preferably the
day before the scheduled procedure. For the successful management of loaner
instrumentation, it is imperative to get support for enforcement from
administration.
Inspections in ambulatory surgery centers
When surveying Ambulatory Surgery Centers (ASCs), TJC looks for
compliance with the same procedures as larger institutions. According to
Summit participants, TJC surveyors have looked for some of the specific
instrument reprocessing compliance issues below:
1. Clearly written policies and procedures that follow evidence based
recommendations;
2. Written infection control, and risk assessment prevention plans;
3. How the ASC maintains a clean environment;
4. Sterile storage:
a. Clear physical separation of clean and dirty items,
b. Sterilization package integrity, and
c. Shelf life or expiration dates;
5. Transportation of contaminated items;
6. Flash sterilization practices;
7. Biological Monitoring
a. Frequency should match the written policy,
b. Controls must be the same lot number as the BI; and
8. If the staff responsible for reprocessing can explain what to do if
there is a load failure.