With legislation in New York being signed into law on July 31, 2013, there are now two states that require sterile processing/central service technicians to be certified and engage in continuing education to maintain and improve their core competencies. The bill that New York Gov. Andrew Cuomo signed into law, A.878-a (Bronson)/S.697-a (Grisanti), will take effect on Jan. 1, 2015. It requires central service technicians to become certified and undergo continuing education credits. These technicians are responsible for ensuring that instrumentation and equipment used in medical and surgical procedures are properly cleaned, disinfected, inspected and sterilized prior to patient use.
"New York patients in our healthcare facilities will be safer from the spread of infections," said bill co-sponsor Sen. Mark Grisanti. "Our central service technicians are the first line of defense in maintaining quality control to prevent and control the spread of infection, And as Assemblyman Harry Bronson added, As many families know, all aspects of medicine have become more technical and require better training for all medical providers. This legislation will ensure that central service technicians have the proper training on how to clean medical equipment to prevent and control the spread of infection, and protect our families.
The International Association of Healthcare Central Service Materiel Management (IAHCSMM) has long been an outspoken advocate of state certification of CS technicians. Improperly sterilized instruments used in surgical procedures can introduce bacteria into a patient that sets up the risk for infection. IAHCSMM says that certification of CS technicians will help drive positive patient outcomes and reduce healthcare costs overall.
Central service technicians are part of the team of professionals dedicated to preventing such infections. Certification demonstrates a commitment to patient safety and quality, says Josephine Colacci, JD, director of government affairs for IAHCSMM.
In its "Certification for Central Service Technicians" document, IAHCSMM notes, " IAHCSMMs top legislative priority is to ensure that there are certified central service technicians in every healthcare facility. IAHCSMM maintains every patient has the right to receive the highest quality of care during his or her visit to a healthcare facility. Through certification, Central Service Technicians will be properly educated to assist in the challenge to reduce healthcare associated infections. Every patient deserves to have an educated, certified Central Service Technician responsible for reprocessing his or her instruments." The document adds further, " The Central Service profession continues to evolve at a rapid pace with new surgical items being introduced regularly. The processing of robotics, endoscopes, joint replacement, and related instruments and equipment requires an advanced technical knowledge that only certification will provide. Association for the Advancement of Medical Instrumentation (AAMI) standards recommends certification for individuals responsible for sterilization activities, as well as those who manage Central Service processes. Joint Commission Patient Safety goals require specific knowledge of the processing and monitoring of instrumentation and equipment to comply with their rigid quality control policies in order to prevent patient injury. To comply with these requirements, Central Service Technicians must receive ongoing, formal training, including certification, in order to perform their daily duties safely, effectively and consistently. Certification will promote healthcare quality, reduce the risk of healthcare associated infections, and ensure successful patient care. This is an issue of basic patient safety. Central Service Technicians can help prevent infections in patients. Our patients deserve the highest level of patient safety and care. Certification of Central Service Technicians will assist in achieving this goal."
The ongoing education required to maintain certification also helps CS professionals stay abreast of ever-evolving instrumentation and equipment, and industry standards and best practices.
Certification will keep technicians educated on standards-based instrument processing practices, so these professionals can perform their jobs safely and effectively, while keeping quality and patient safety at the forefront," says Wilhelmina Jones, CRCST, president of the New York State Association of Central Service Professionals.
Until now, New Jersey was the sole state in the nation to require certification. IAHCSMM will build upon this momentum to lay the foundation for certification legislation in other states. Legislation will be introduced in Pennsylvania and Massachusetts sometime this fall, and numerous other states will introduce legislation in 2014.
Today is a positive step forward for patients, Colacci says. We hope this will be the tipping point for many other states to follow.
Let's take a look at what the New York legislation requires. A central service technician cannot be employed unless the individual meets one of the following:
- has successfully passed a nationally accredited central service exam for central service technicians; and holds and maintains one of the following credentials administered by a nationally accredited central service technician credentialing organization: the certified registered central service technician credential, the certified sterile processing and distribution technician credential or a substantially equivalent credential; or
- provides evidence that the person was employed or contracted for the services as a central service technician in a healthcare facility for a cumulative period of one year, occurring within the four years immediately prior to the effective date of the legislation. Any contractor or employer of persons functioning as a central service technician on the effective date shall confirm in writing to each employee or contractor his or her employment in a capacity functioning as a central service technician in a healthcare facility as of the effective date of this section; or
- is a student or intern performing the functions of a central service technician if the student or intern is under the direct supervision of an appropriately licensed or certified healthcare professional and is functioning within the scope of the student's or intern's training.
A central service technician who does not meet these requirements will have 18 months from the date of hire to obtain the certified registered central service technician credential or the certified sterile processing and distribution technician credential.
A person who qualifies to function as a central service technician in a healthcare facility must annually complete 10 hours of continuing education credits to remain qualified to function as a central service technician.
A healthcare facility may employ or otherwise contract with a person who does not meet the requirements to function as a central service technician in a healthcare facility if:
- after a diligent and thorough effort has been made, the healthcare facility is unable to employ or contract with a sufficient number of qualified central service technicians who meet the requirements
- the healthcare facility makes a written record of its efforts and retains the record at the facility; and
- the person meets the requirements within two years of the start of employment or contracting for the performance of central service technician duties.
As we have seen, in 2005 New Jersey became the first state to mandate certification for central sterile staff. The New Jersey Department of Health mandates the following in sections 8:43G-8.2 and 8:43G-8.3:
- There shall be a full-time director or supervisor of central service.
- The director or supervisor of central services shall have two years of supervisory experience and shall be certified through a national sterile processing program recognized by the New Jersey Department of Health and Senior Services.
- All personnel involved in sterile processing shall be certified through a national sterile processing program recognized by the New Jersey Department of Health and Senior Services within three years of employment and by Aug. 2, 2009.
- Personnel involved in the use of ethylene oxide shall have the appropriate licensure from the New Jersey Department of Environmental Protection.
Regarding central service staff education and training, in N.J.A.C. 8:43G-5.9 the New Jersey Department of Environmental Protection requires the following:
- All new central service employees shall receive on-the-job training on practices and equipment unique to the hospital.
- Competency for processing tasks shall be documented annually by the employees supervisor or by the director of central services
Certification is Part of the Bigger Picture
In October 2011, the Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) held a summit to discuss key issues impacting the proper reprocessing of reusable medical devices. Coming out of this two-day stakeholders meeting were a number of perspectives from regulators, clinicians, sterile processing experts, manufacturers and medical device engineers, and from that, AAMI created a concise list of seven clarion themes to guide the ongoing agenda of quality improvement. Of these clarion themes, No. 6 -- Improve reprocessing competencies by strengthening training, education and certification -- addresses the same issues of concern that IAHCSMM has in its legislative efforts.
At the 2011 FDA/AAMI Summit, AORNs Ramona Conner and IAHCSMMs Susan Klacik joined summit presenters Marilyn Hanchett, senior director, research and clinical innovation at APIC, and Eileen Young, clinical nurse educator of Olympus America, in advocating for improved staff training and competencies. They also called for mandated certification for reprocessing staff, acknowledging that resource limitations and personnel issuesincluding adequate education, pay, and responsibilitiesare barriers to improving technicians' competencies. They emphasized that mandatory certification should provide:
A consistent, baseline education in standard practices for reprocessing reusable medical devices
Higher competency levels
Required annual continuing education
Critical thinking skills
As Young noted at the summit, It is easy to say we need certification of central sterile professionals. The obstacle is that at the state level, that is a three- to five-year process. Its not just certification, but ensuring that they remain competent. There should be a minimum two-year degree requirement and a reward system. The demand is higher than the number of trained professionalsand there are not a lot of training programs available.
In the 2011 document, "Reprocessing: Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit," AAMI outlines a number of challenges and potential solutions relating to this issue:
Challenge #1: Inadequate reprocessing knowledge among reprocessing staff and manufacturers
Provide thorough training to reprocessing staff.
Adequately train manufacturers representatives in reprocessing processes and requirements.
Ensure excellent training and educational materials.
Ensure that healthcare delivery organizations have appropriate competencies and instructional technologies to reprocess reusable medical devices.
Challenge #2: Uneven reprocessing competencies in the field
Priority action: Encourage education of reprocessing staff at the national level through a two-year degree program.
Challenge #3: High turnover and low pay for reprocessing staff
Encourage career ladders with increased compensation for additional education.
Compensate certified reprocessing staff with pay that reflects required competencies.
Association for the Advancement of Medical Instrumentation (AAMI). Reprocessing: Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit. 2011.
International Association of Healthcare Central Service Materiel Management (IAHCSMM). Certification for Central Service Technicians. Undated.
Q&A with Josephine Colacci, JD
Josephine Colacci, JD, government affairs director for IAHCSMM, provides her insights on the latest state to adopt CS technician certification legislation.
Q: How does this victory in New York help efforts in other states?
A: New Jersey was the first state to require certification of central service technicians through the regulatory process. New York is the second state to require certification of central service technicians and the only state to require it through legislation. This means that legislatures across the country will now look at the New York law as a model. The fact that we had a unanimous vote in the legislature in New York and zero opposition from other organizations gives us a lot of credibility when we are talking to legislators in other states. Legislators want to know the background surrounding the legislative efforts in other states. This is probably the number one question that we receive from legislators how many other states require this and what opposition did you receive? Now we have good answers to these questions and it can only help our efforts as we move forward in other states.
Q: Can you provide a quick update on where youll be focusing your attention next?
A: We did have legislation introduced in Connecticut this year for the first time but we were unsuccessful in getting the bill passed. We will be spending the rest of the summer and fall working with legislators and organizations to try to work out issues surrounding the language in the bill. We plan to reintroduce this legislation in Connecticut in 2014. We will have certification legislation introduced sometime this fall in Pennsylvania and Massachusetts. Pennsylvania and Massachusetts started their legislative sessions in January 2013 and they end in December 2014. This means that we will have until December 2014 to get our legislation passed through these states.
For the rest of the summer and fall, we will be working on educating legislators in Maryland, South Carolina, and Oklahoma. These states legislatures have ended for this year but will start again in January 2014. It is too early for me to tell whether or not we will have legislation introduced in these states for 2014.
Q: Are legislators and staff becoming more familiar with the importance of certification or is it still challenging to explain IAHCSMMs vision for patient safety?
A: Legislators and staff are becoming more familiar with the importance of certification. Once we explain the issue to them, they understand it. Most of them have had surgery or had family members and friends that have had surgery so that makes it real to them. One of the biggest challenges is that legislators are not familiar with what a central service technician is let alone what the job responsibilities are associated with a central service technician. As we move forward in other states, it will continue to take time to educate the legislators on simply who is a central service technician. Another big challenge is purely politics. We have to navigate the waters of a political process, which is never easy. We have a great issue but our issue will never be the number one priority for a legislature. Legislatures are dealing with a ton of bills every session and steering our bills through this process will take time.