Quality in — quality out

We’ve all heard the expression — if it’s not clean it’s not sterile — but the decontamination process is no simple task. It begins in the operating room (OR) where OR staff are responsible for proper pre-cleaning of instruments before they are sent to the central sterile/sterile processing department (CS/SPD). Once in the CS/SPD, there are a variety of factors that influence whether or not an instrument can truly be cleaned — including the detergent and water used for decontamination and the adequacy (or inadequacy) of the equipment and work space itself.

A major complaint among CS/SPD professionals is that OR staff fail to follow these guidelines resulting in instruments returning to the CS/SPD caked with dried blood, tissue and other matter. In his consulting practice, Charles J. Ciullo, CSPDT, CSPDS, has worked at or visited facilities where dirty instruments have sat from 8:00 a.m. till after noon before arriving at the CS/SPD for decontamination.

“When met with the situation of grossly soiled instruments being sent to decontamination in a facility in which I’m consulting, I have taken to arming myself and those with whom I’m consulting with as many industry standards documents as possible to plead their case when meeting with surgical services on the subject,” said Ciullo. “I tend to start with the AORN and AST documents, because they are written for preoperative nurses and surgical technicians and also because I still come across professionals who want to know ‘who Amy is and does she work here’ when referencing AAMI.”

Tanya Cambise, CHL, CRCST, RVT, Sterile Processing Manager for Presbyterian Healthcare Services, points out how nurses and scrub techs in the OR require decontamination training just as much as CS/SPD techs. She recommends that during the orientation process, new OR staff spend time in the CS/SPD so they gain a clear understanding of all the steps required to process instruments. She also suggests that the CS/SPD provide OR staff with frequent in-services where they can reinforce the proper processes for instrument pre-cleaning and post-procedure transport.

Bob Marrs, Director of Aesculap Consulting Services & Field Operations, acknowledges that OR staff can become frustrated at CS/SPD staff’s attempts to teach them proper instrument handling post procedure and recommends CS/SPD professionals refer back to the standards when making their case for proper pre-cleaning.

“I always tell folks that when you’re looking at issues like this see what the standards and best practices recommend first because it’s easier to say to OR staff ‘hey don’t be frustrated with me, be frustrated with AORN, AAMI or whatever organization is making the recommendations for these practices,’” said Marrs. “Furthermore, the CS/SPD can point out to OR staff that heavily soiled instruments can take double or triple the time to process so it’s in the OR’s best interest to pre-clean them. These standards and recommended practices are in place to guide facilities with development of departmental policies and procedures but most importantly to enhance patient care.”

According to Ferriero, “Pictures are worth 1,000 words.” When he worked as a CS/SPD manager, he would task his decontamination coordinator with taking pictures of “bad” case carts that would arrive for processing and then work with OR leadership to track these back to the specific OR and the staff would be held accountable for not following the policy.

Sharon Reinhard, Marketing Director for Haemo-Sol International, points out how use of specially formulated detergents is an important part of the decontamination and disinfection process, particularly when tackling soiled instruments that are left to sit after use.

The decontamination area itself”Sometimes instruments are not cleaned immediately after use; the debris becomes dried and hard, making the job of decontaminating difficult. In this case, soaking in an enzymatic detergent allows enzymes to break down and release the bond of the biofilm and debris, allowing for easy removal,” said Reinhard. “Taking the time to soak, scrub and rinse may seem like an extra step, but this is not the place to cut corners. Investing the time to clean with detergents will ensure thorough decontamination and sterilization, as well as protect costly instruments.”

In its Guideline for Disinfection and Sterilization in Healthcare Facilities, the Centers for Disease Control and Prevention (CDC) recommend physical barriers separate the decontamination area from the other sections to contain contamination on used items, and the airflow pattern contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas.⁴

In reality, many CS/SPD professionals are performing decontamination in less than ideal conditions using inadequate equipment. Cambise explains how inadequate space and/or equipment creates bottlenecks in the process. When a CS/SPD does not have the capacity to process the OR’s volume of instruments, backlogs occur in decontamination as dirty instruments await sink, ultrasonic or washer space.

“The decontamination space needs to be large enough to support the work that is done on a daily basis,” said Cambise. “Overall the space needs to be large enough to keep cleaning tasks separate from the sorting activities and the personal protective equipment (PPE) area. The space itself should be conducive to LEAN practices that help prevent bottlenecks.”

At the University of Iowa Hospitals and Clinics (UIHC), recent CS/SPD improvements have been driven by leadership to best meet the demands of new technology and a focus on quality, explains Courtney Mace Davis, MBA, the health system’s Manager of Central Sterilizing Services. In addition to standardizing and optimizing workflows, UI Hospitals and Clinics has made short-term physical improvements to its CS/SPD department (e.g., lights, paint, height-adjustable work stations, computers installed at every work station) with the goal of completely remodeling the department within the next three years.

“The industry as a whole is struggling with inadequate resources for several reasons,” said Davis. “In the past, sterile processing departments by nature have not received the credit for the incredible work they do. Admittedly, it is more appealing to provide financial resources for items that are experienced more first hand by patients and others in healthcare organizations. What you are seeing now is the beginning of a shift in how the healthcare world thinks about sterile processing. A renewed sense of value is beginning with attention being placed on the role of sterile processing departments and the functionality of how they are a large part in improving patient safety and care.”

According to Weston “Hank” Balch, CRCST, CIS, CHL, Director of Sterile Processing Operations for Jewish Hospital & University of Louisville Hospital, a must-have for any decontamination process improvement model is a quality assurance component geared toward strategic sampling of instrument trays (especially new trays) as they come out of decontamination into the assembly area.

“This can be done by a Q/A technician and used to gather data on process breakdowns related to particular trays, staff members or processing equipment,” said Balch. “The program could be as simple as visual inspection and documentation of problem trays prior to assembly or as complex as utilizing continual testing of ATP (adenosine tri-phosphate) or other protein testing levels of manually cleaned instruments. This information could then be used to direct staff education, guide discussion on changes in chemistry and make data-driven arguments to facility leadership for better processing equipment.”

Water quality

If a CS/SPD department’s water is safe enough to drink it must be safe enough to process instruments right? Wrong. Determining the type of water to use for instrument decontamination is complex and challenging. The quality of tap water varies widely from hospital to hospital. It can contain naturally occurring elements (e.g., calcium, magnesium, copper, aluminum), additives (e.g., fluoride) and potentially dangerous microorganisms, bacteria and viruses (e.g., Cryptosporisium, E. coli, Coliform). Using poor quality water can hinder decontamination, corrode instruments and even make patients sick.

Furthermore, it is not just a matter of “good water” but also compatible water. CS/SPD staff must ensure the type of water is compatible with the instruments, equipment and detergent with which it is used. Manufacturer instructions for use (IFU) are valuable resources for determining the right type of water to use at each stage of the process, as are the ANSI/AAMI TIR34:2014 water quality guidelines.

“Water is so vitally important to the life of your instrumentation,” said Marrs. “When conducting evaluations we often find hospitals don’t have the water quality they need at each stage of the process. For example, the final rinse in three basin sinks for manual cleaning and washer decontaminators should be with deionized or reverse osmosis water — which essentially removes all of the elements that might be in the water from the instruments before they go to the autoclave. When a hospital is having significant corrosion issues with their instruments, one of the primary culprits is inadequate water quality. It will have a significant impact on the life of the instruments.”

Ciullo urges CS/SPD professionals to have their cleaning chemistry supplier perform an initial test on the department’s water so they can dose their chemistry accordingly. For departments that have a reverse osmosis or deionization system, he recommends the company that installed the system test the CS/SPD’s potable and purified water initially and after preventive maintenance to make sure the purified water is “up to snuff.”

“Since the quality of both potable and purified water is subject to change, I typically recommend facilities check their water quality at least weekly using a simple water test system — either a dip strip or a water test meter — that tests for pH and total dissolved solids at a minimum,” said Ciullo. “If any variance is found that might impact either detergent dosing or rinsing you should notify either your washer or purification technician so the proper adjustments can be made.”

Dave Geddis, President of ultrasonic equipment manufacturer, Geddis Inc., comments on the need for water/cleaner compatibility, stating:

“We are always asked whether our enzyme cleaner, SurgiSoak, is pH neutral, which it is,” said Geddis. “The more important question is ‘what is the quality of the water you are using?’ With our SurgiSoak, as with most concentrates, CS/SPD staff must mix one ounce of the solution to one gallon of water. A gallon is 128 ounces. Therefore, the pH of the water is the most important question by far.”

IFUs and staff education

A CS/SPD can have state-of-the-art equipment, perfect water quality and superb support from the OR but none of that matters if the staff members aren’t properly trained and following IFUs.

“The instrument IFU should always be your guide for teaching and training staff on instrument decontamination,” said Ferriero. “If the IFUs aren’t clear, utilize your vendors as a resource. They should be your resource and will provide support for their products.”

Ciullo notes how laminated wall instructions and spiral bound books can be extremely helpful for staff when they are tasked with decontaminating difficult to clean complex specialty instruments. He points out how instrument manufacturers are often happy to supply these types of resources.

Balch explains how many instrument tracking systems already allow users to upload photos, videos, and other documents to specific instrument trays. He suggests adding the ability to immediately display step-by-step cleaning instructions on a wide screen TV in the decontamination area to provide instant, readable and facility-centered cleaning instructions to CS/SPD teams.

Lastly, Davis points out the need for CS/SPD to have standard processes for decontamination that are based on IFUs, industry standards and evidence-based literature. Standardized workflows, coupled with quality monitoring, can reduce risks associated with cleaning.

“Defects can occur by either manual or mechanical reprocessing so you need to create systems that seek to reduce risk and monitor overall quality for improved patient safety,” said Davis. “Furthermore, ongoing review through process audits and metrics will support the use or identify the need for cleaning method adjustments.”

References:

1. The Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013.

2. Standards of Practice for the Decontamination of Surgical Instruments, Association of Surgical Technologists (AST) http://www.ast.org/uploadedFiles/Main_Site/Content/
About_Us/Standard_Decontamination_%20Surgical_Instruments_.pdf.

3. Recommended Practices for the Care and Cleaning of Surgical Instruments and Powered Equipment, Association of periOperative Registered Nurses (AORN), AORN Journal, January 1997,http://www.aornjournal.org/article/S0001-2092(06)63033-0/fulltext.

4. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Centers for Disease Control and Prevention (CDC), http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf.