- You Have Got to Do It"
Copyright © 2007 - Sterile Processing
University, LLC - All Rights Reserved.
This in-service may not be copied or used without permission of the author.
site is best viewed at 1024x768 resolution on your monitor.
once said, "do what you document and document what you do".
Truer words were never spoken. There are many processes we document in
our daily lives however in healthcare, documentation becomes essential.
Today, we live in a litigious society, meaning, people get sued for anything
and everything. When it comes to healthcare, lawsuits are almost "assumed"
if anything goes wrong, whether it was preventable or not!
Sterile Processing personnel should be following good manufacturing practices;
these practices ensure a consistent product each and every time it is
produced. Part of the process is documentation. In addition, to track
and investigate problems, it is essential to know every individual who
took part in the processing of the device, e.g. who cleaned it, who assembled
it, who sterilized it and who distributed it. This is similar to the tracer
methodology which the Joint Commission (JC) is requiring. With tracer
methodology, the JC requires that the facility be able to fully trace
a device to the patient.
For example, in the newspaper, you read about a recall on a food product.
The company is able to tell the lot number, when the product was made,
everyone who had a part in the process, when shipped, where shipped to,
etc. This is all part of a quality system.
There are many types of documentation in sterile processing. Some do not
relate to the process it self, for example, we must document the time
we report to work and when we leave. This is required for payment of wages.
Time records can be audited by the Department of Labor, so it is important
that these records are maintained properly. Documentation can be required
for other reasons such as return from a medial leave (clearance to return),
However, in the processing area, there are many types of documentation
needed. Let's look at some of them.
Orientation - One of the most important pieces of documentation
is the Orientation Guide form. This form documents the training the employee
has received. It is proof that the employee received the training needed
to be successful in the job. Usually, each step of the way a return demonstration
is requested to make sure the employee has learned the specific task.
These forms, once completed, should be retained in the employee's file.
The Orientation Guide should also document the facility orientation date,
and all safety related training such as the date the employee reviewed
the Material Safety Data sheets , safety manual, infection control manual,
etc. In addition, a review of the dress code for the department (including
personal protective equipment required in the Decontamination Area) should
Annual Competency - This documentation is required by the Joint
Commission (JC). It requires that the facility verify specific competencies
for each employee on an annual basis. Usually several key tasks or knowledge
areas are selected and employees are questioned or asked to demonstrate
the task without error. This annual testing is important because it verifies
the competency of employees and may indicate areas of additional training
Continuing Education - With the emphasis on mandatory certification,
it is important for employees to keep careful records of their certification.
All continuing education towards re-certification should be documented.
Make sure you do not leave the Seminar without your certificate and make
sure the certificate has been approved by the certifying board. The certificate
should state the number of points approved for the program. These certificates
usually cannot be replaced especially after a year so keep them in a safe
place so you have them for re-certification when needed.
Environmental Documentation - This would include daily documentation
of the AAMI recommended temperature and humidity levels in the Decontamination,
Prep/Packaging/Sterilization and Sterile Storage areas. All environmental
cleaning should be documented as well as sterilizer cleaning.
Maintenance records - All installation documentation, including
installation testing, should be documented. All preventive maintenance
on sterilization and processing equipment should be documented and records
retained for the life of the equipment. Repairs should also be documented.
Decontamination - In the Decontamination area, in addition to the
specific training received, all items processed should be documented.
This can be accomplished with a surgical instrument tracking system or
a manual system. The manual system can be a form that is made up with
the date, shift, technician's name and then a list of devices processed.
A listing of the number and types of patient care equipment should be
documented. This documentation should include any testing performed on
Prep and Packaging - All sets assembled should be documented on
a log by person. In addition, the initials of the preparer or an ID# should
be prominently displayed on each package processed, even peel packs. If
special testing performed (e.g. verification of the integrity of insulation
on laparoscopic instruments) this should be documented. Lubrication of
drills should be documented. If sharps are routinely sharpened, have the
repair service document the date and keep a record.
Sterilization - the majority of the documentation is in the sterilization
area. This area requires the following documentation:
- All items
processed should be recorded on a log. Some facilities use a preprinted
envelope. The contents of each load should be recorded; the records
should include the number of items, a description of the items, and
the using department. In addition, the inclusion of a BI test pack should
be documented on the log form for all cycles containing BIs. This information
should be specific rather than generic - six OR Mayo scissors, not six
OR peel packs. Any PCDs included in the load should be documented as
well. All information should be written neatly and legibly. The use
of whiteout to correct errors is prohibited, because it could suggest
that the records were altered. Instead, the operator should draw a line
through the incorrect information and initial it.
- All cycles
run, including dynamic air-removal tests and aborted cycles, must be
- All sheets
from dynamic air removal tests should be saved.
- All BI
test results should be carefully documented. This includes the lot control
number of the BI vial, the lot control number of the control vial, the
time the BI was placed in thenincubator or autoreader, the time it was
removed and read, the name of the person(s) incubating or final reading
the BI, etc.
- The sterilizer
printouts should be removed (either after each cycle or at the end of
the day) and placed inside the preprinted envelope along with any CIs
run in the load. To identify the sterilizer and load, a lot control
sticker indicating the load number should be affixed to the CI or printout.
- The printout
for each cycle run (regardless of the sterilization method) must be
reviewed by the sterilizer operator and signed verifying all parameters
of the results of the chemical indicators should be documented on the
Sterilization Log Form
Lot control numbers are required so that each sterilized device can be tracked.
This information is important in the event of a sterilizer malfunction necessitating
a recall of the processed items. Each sterilizer should be labeled with
a number (e.g., #1, #2) so that sterilizers can be differentiated in the
event of a sterilizer malfunction. The lot control information, which should
include the sterilizer number, the cycle or load number, and date of sterilization,
is usually affixed to each item with a lot control label gun. It is important
to verify that the lot control information is accurate before affixing the
labels to the packages. Therefore, the CS/SPD technician should double-check
the lot control information before each cycle.
Event Related Sterility Dating - Monitoring of compliance with Event
Related Dating is recommended. Each month a different area of the facility
should be visited and the storage areas reviewed for compliance. Look for
trays that have damaged packaging or dust covers that have been removed,
stained packages, storage under sinks, etc. Note the non-compliance issues
and discuss with the manager for the area. The Sterile Processing sterile
storage area should also be monitored for compliance with cleaning of shelves
and bins, no cardboard in the area, etc. When performing monitoring, look
for expiration dates for dated items from outside manufacturers and remove
them if outdated.
Implants - All implants should be documented on the Sterilization
Log form however it is helpful to keep a separate Implant Log form to help
identify implants in the event of a recall. A sample Implant Log form
is at the end of this Inservice. Implants should not be released until
the result of the biological test is known. This is an AAMI, AORN and CDC
recommendation. However, if there is a documented emergency and an implant
must be released before the BI test result is known, this should be documented
on the Waiver form. A sample form is available in the AAMI ST-79 document.
CJD - Due to the difficulty inactivating prions, when known or suspect
patients have eye, brain or spinal cord surgery, their instruments should
receive special prion processing. This should be documented on a form similar
to the implant log to be able to quickly identify instruments and how they
Rigid Container Testing - Rigid containers require pre-purchase biological
testing as well as ongoing (annual) bi testing. The pre-purchase and annual
testing should be documented and records kept where they can be retrieved.
Some facilities copy the results from the BI record book and save them in
a file folder labeled Rigid Container testing so facilitate location of
Recalls - If there is a positive BI a recall of products processed
in the affected sterilizer, back to the last known negative BI must be performed.
The actions taken must be documented. Usually, as items from the affected
loads are retrieved, a line is placed through the description on the Sterilization
Log form. If the device cannot be located or was already used, the item
should be circled and noted (not found, already used). Any similar process
is acceptable as long as the records show who retrieved the items, what
items were retrieved and when they were retrieved.
Outside Manufacturer Recalls - Sometimes manufacturers have recalls
of their products. If the product is used within your department or dispensed
from your department, it is your department's responsibility to retrieve
the product from the various locations and return to the manufacturer per
their instructions. The same documentation as an in-house recall is needed;
when the recall notice was received, how it was received (e.g. FAX, email),
when the products were retrieved, from what locations were they retrieved
and when, where and how the recalled items were shipped back to the manufacturer.
Sample of Implant Log
Yes or No
for the Advancement of Medical Instrumentation. Comprehensive Guide
to Steam Sterilization and Sterility Assurance in Healthcare Facilities.
Basics of Sterile Processing, First Edition, Sterile Processing
University, LLC, 2006.