The time to outsource the SPD; Humidity standards

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Q There seems to be a lot of talk about outsourcing the sterile processing department lately but I don’t understand or see how taking surgical instruments out of the hospital and transporting them 50 miles away for reprocessing could be effective or improve services. Perhaps I am naïve but I fail to see any advantage to outsourcing when most hospitals seem to have enough problems processing instruments within their own hospital.

A A misconception of outsourcing is that it involves providing services from a remote location; this is often not the case. Outsourcing is a strategic action of utilizing outside resources to perform activities traditionally handled by internal staff and resources. Therefore outside resources and experts may be contracted to manage and/or staff an onsite operation. Outsourcing is by no means a new concept; it has been employed for many years by some of the most prestigious and successful corporations. Successful and profitable businesses direct their full attention on their primary business activity and to what they do best.

The business of a hospital is medical treatment and patient care. Many hospitals have found that by utilizing outsource services they are relieved of the need to invest time, labor, and material resources into the management of sterile processing thus allowing them to focus great attention and valuable resources into direct patient-care activities and quality enhancements. The functions of CPD involve production and manufacturing of sterile goods, which requires specialized skills, expertise and the application of proven industrial standards for proficiency. Many changes in the dynamics of the external environs, social, economic, political, scientific, and technological have presented great challenges to the healthcare system, which have also affected a hospital’s ability to provide quality reprocessing services.

There are many advantages to outsourcing but let’s first take a look at what outsourced service may consist of:

• Full department onsite management on an interim or long-term basis
• Total staffing of onsite department which is usually on a long term contract basis
• Interim management may be contracted to institute and facilitate a fast track action plan for critical issues or to compensate for staff shortages or needed expertise
• Outsourcer ownership and maintenance of surgical instrumentation and processing equipment
• Financing of internal facility renovations, and needed equipment
• Complete offsite reprocessing and sterilization of surgical instrumentation on a short or long term basis
• Combination of onsite and offsite processing options where only selected instruments may be processed of site
• Management and or technical consulting services for staff mentoring, special projects etc.
• Education and staff development services
• Specialized tailored programs designed to meet client unique needs

A hospital can therefore contract for specified outsourced services choosing only those required.

Advantages to contracting outsource services include the following:

• Outsourcer goal is to succeed and to exceed clients expectations
• Basically you are hiring an entire company’s expertise and resources
• Rapid response and implementation of process improvement initiatives which circumvents budget cycles and internal politics — sterile processing success is the only priority of the outsource company.
• Rapid response to technological changes, pending how contacts are written the outsourcer fulfills needs for required instrumentation and new technology
• Application of proven industrial protocols and standards
• Reduction of fixed cost, many fixed cost will become variable, since you normally pay for what is used
• Accurate account of real cost which will provide a competitive marketing advantage and placement
• Better control of service quality- outsourcer must meet quality and service expectations or financial penalties may be imposed
• Strong promising career path for CS staff

Q I am the clinical administrator for an ambulatory surgery center located in southern Florida. The summer months will soon be here and we will be dealing with excessively high temperatures and humidity. It seems that every year the OR staff complains that the humidity is a threat to the sterility maintenance of sterile goods in storage. They insist that standards of practice require that humidity levels in the OR and sterile storage need to be kept below 20 percent. I understand that may be the case for an acute care hospital, however, such standards do not apply to ambulatory surgery centers. I want to be able to assure our staff that our sterile goods are not in jeopardy of contamination can you provide any information or guidelines relative to humidity impact on sterile integrity if RH goes above 60 percent or even 70 percent?

A First and foremost the same standards, regulations and guidelines, relative to sterilization and reprocessing that apply to the acute care setting also apply to ambulatory surgery centers. The Association for the Advancement of Medical Instrumentation (AAMI) in 2017 published the latest edition of AAMI ST79. It’s a comprehensive guide to steam sterilization and sterility assurance for healthcare facilities. This document and its published standards are followed by most Healthcare organizations. They are also a source of reference and expectation of most accrediting entities. In the current document there is no longer one specific temperature or humidity range. Healthcare organizations must now identify which version of ASHRAE 170 will be used based on when the 37 HVAC system was initially installed or last upgraded. They must also establish and have a protocol and policy in place to monitor and document the systems compliance and performance within sterile processing. AAMI ST79 states, “The effect of the HVAC system parameters falling out of range is a variable. A small variance for a short period of time may not be of clinical concern, whereas a large variance for a longer period of time may have clinical significance. A risk assessment provides necessary information to guide appropriate response measures” Packaging materials, and techniques may have an effect on its response to humidity levels therefore the manufacturer(s) also should provide guidance.