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This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 98
Implementing a Quality Service Management System
[Reprinted from Communiqué: January/February 2008]

Central Service personnel and their healthcare peers often talk about quality. They know it is important, and they understand that it is a concept against which they are frequently evaluated. What is quality, why is it important, and how should the management of quality standards be integrated into “the way things are done” in Central Service operations? Answers to these questions are among the topics discussed in this self-study lesson.

Objective 1: Define the term, quality.

Quality can be defined as “the consistent delivery of products and services according to established standards.”¹ All Central Service departments should emphasize the establishment of quality goals, and it is important to establish and implement procedures to attain them. Adherence to these standards can, then, help to assure the delivery of safe and functional medical products and devices to customers for patient use. Quality is difficult to attain, however, and it involves an ongoing, multi-disciplinary team approach to be successful.

Objective 2: Detail the five components of a quality management system.

There are five components that are integral to the development of every quality management system.

• Component 1: A Central Service quality management system requires measurable goals for service excellence. It is critical that these goals be identified and defined to describe the expected level of service, and they then can provide a benchmark against which actual service delivery can be evaluated. The best-written goal statements will fail, however, unless Central Service Managers consider the need for well-trained, competent, and committed staff members to work towards the same outcomes. Therefore, their input is important when service goals are developed. Central Service personnel will likely have very useful ideas about goal statements, and they are needed to deliver service to customers. The best service goals are, then, “our goals” (those of all department staff), not “their goals” (those of management alone).

• Component 2: Quality control indicators must be in place to measure the degree to which a desired goal is attained. How will the desired outcomes of delivering consistent quality and service to Central Service customers (stakeholder peers who also help to define, implement, and maintain quality) be determined? The answer(s) should be addressed in measurable indicators. For example, if one quality service goal is to have zero complaints about the completeness of instrument sets, the number of complaints generated can (and should) be measured. Then, as the number of complaints declines towards zero, this quality service indicator will suggest that the desired goal is being better attained.

• Component 3: Policies and procedures must be in place to, respectively, require adherence to quality standards and to indicate how quality goals can best be achieved. These tools are critical to the quality assurance efforts necessary for consistently delivering quality products. Customers expect reliable services and products that function in the same manner every time. Deviations from what is expected can create mistrust and erode customer confidence, and may lead to less-than-desired outcomes for patients. Whenever products and services inconsistently meet standards, there can be dramatic consequences for all stakeholders. Therefore, quality systems must always meet the desired standards.

• Component 4: Processes must be in place to measure actual performance, and to compare it to expected performance (that which has been expressed in quality goals). The old saying, “If you cannot measure it, you
  cannot manage it,” is true! Measurements of quality for medical devices and instruments have been established in the healthcare industry and should be followed to help ensure patient safety.² Also, managers of healthcare facilities can establish additional measurement tools to address specific concerns relating to their own quality assurance goals.

• Component 5: Process improvement and implementation strategies are required, and must be ongoing. Deviations from expected outcomes can be studied through a process known as root cause analysis. Corrective actions should be taken to re-establish quality with process interventions and improvements. Action plans should be developed and implemented to address identified shortfalls in quality or service. The quality management system described above must be an ongoing process, a continual loop of goals to establish standards, quality control indicators, policies and procedures, measurement, and improvement. As seen in Figure 1, which reviews the five components in a quality management system, quality never ends.

Objective 3: Describe steps helpful in the development and implementation of a quality management system.

Now that we have explained the components of a quality management system, we will learn how to develop and implement a program. The first step involves careful planning. A top-to-bottom evaluation can help determine the effectiveness of current procedures. This evaluation process should consider all aspects of how products, goods, and services are currently processed and delivered. An extensive study of the equipment in use, the workplace environment, the condition of instrument sets, relevant policies and procedures, and the abilities and knowledge of Central Service staff should be included in this evaluation.

The goals of your healthcare facility and those expressed in the 2007 National Patient Safety Goals published by The Joint Commission2 are other important considerations as a quality management system is established. For example, National Patient Safety Goal #7 is: “Reduce the risk of healthcare-associated infections.” The Central Service department is instrumental in efforts to prevent surgical infections because its personnel are responsible for expertly cleaning, decontaminating, and sterilizing the medical devices used on patients. A central focus of this goal is the expectation that all Central Service staff members wash their hands when crossing back and forth between contaminated and clean work areas. The staff is also essential in helping prevent non-sterile items from being presented as “sterile” in the operating room or other patient care areas. These goals should be shared with all employees to achieve a common commitment to quality and to coordinate efforts. Central Service personnel should be part of a multi-disciplinary team that defines quality and the expectations for its delivery.

After the initial evaluation review is complete, problem areas can be identified. Action plans can then be developed to address any deficiencies that have been noted, and Central Service managers can take advantage of these “golden opportunities” for quality enhancement.

The second step in the development of a quality management system directly involves the Central Service employees. They must be well-versed about applicable policies and procedures and established standards of care. Managers should routinely conduct staff evaluations, with consideration given to each employee’s level of competency in core areas. Regular updates, evaluations, and in-service training are important. Managers must keep staff updated about industry trends and knowledgeable about changes that affect standards. Consideration should also be given to conducting basic Central Service classes, and to promoting specialty certification in instrumentation or other Central Service specialties. Enrichment through education is a critical element in the development and maintenance of a quality staff.

The third step in developing a quality management system relates to infrastructure requirements. Unfortunately, there is often an identified need to address facility or equipment shortcomings. This may be one of the most difficult steps to address because of the budgetary constraints confronting healthcare facilities today. Without adequate resources, however, it is not possible to provide products of consistent quality. Customers can be your strongest ally in providing support to gain the equipment or the environmental changes required to consistently produce quality outcomes.

Implementation and measurement are the next steps necessary to gain the benefits of a quality management system. The best written and thought-out plans will not produce desired quality levels unless they are implemented. Central Service managers and their staff should work hard to move toward their stated goals. First, address the most pressing needs that are critical to patients and staff (example: an improvement plan to reduce decontamination and sterilization errors).

Consider steps that can be easily implemented. Quick successes can provide encouragement and present evidence that the implementation of a quality management system is an achievable goal. Steps that can be undertaken without the active involvement of other departments are typically easier to implement than those requiring interdepartmental activities. One example is to adjust Central Service staffing levels to meet workload demands and, in the process, to reduce tray errors and unavailable instrumentation caused by production backups. Both of these issues relate to the National Patient Safety Goals, discussed above, and they concern the need to reduce the processing errors that affect patient care, to prevent surgical site infections, and to improve the overall quality of care delivered by your facility.

After these steps have been taken, it is possible to re-measure outcomes and compare them with earlier results and the quality management goals that have been defined. Examples of quality control indicators to be used include a decrease in infection rates, a reduction in the number of instruments found with bioburden after reprocessing, and a reduced need for flash sterilization.

Change does not always come quickly, and it may take several months to see tangible results. As you evaluate your department’s progress toward quality, share the results with all your stakeholders. Celebrate success and address failures with appropriate strategies.

Objective 4: Explain how ANSI/AAMI ST79 can be used as an established quality standard.

You have learned that the evaluation of a quality management system should compare departmental outcomes with established industry standards as well as the facility’s own expectations. National and local standards should be consulted in efforts to identify and meet compliance and regulatory issues. The “gold standard” for Central Service has been developed by the Association for the Advancement of Medical Instrumentation (AAMI), working in conjunction with the American National Standards Institute (ANSI). ANSI/AAMI ST79 3 details the requirements for the safe handling, processing, decontamination, and sterilization of medical instruments and devices. This standard should be consulted and used as a template for defining, measuring, delivering, and evaluating quality.

ANSI/AAMI ST79 revises several earlier standards and combines them into one document. Every Central Service manager and staff member should review this document, as it pertains to all processes performed by their department, including the following important areas:

• Cleaning and decontamination
• Handling and processing of medical devices and instrumentation
• Use of process indicators with sterilization
• Sterilization
• Disinfection
• Packaging, transport, and storage of sterile products
• Environmental controls
• Staff and patient safety

Although AAMI is a voluntary organization, its Recommended Practices and Standards are considered a major resource of healthcare guidelines, and non-compliance is cited by regulatory organizations that inspect healthcare facilities. ANSI/AAMI ST79 provides an excellent resource for all Central Service managers that should be used as quality management systems are planned, implemented, and evaluated, and for many other purposes.

Objective 5: Review sample corrective actions that can minimize deviations from standards.

Imagine that a Central Service manager has received numerous complaints, including feedback on quality assurance forms from surgical services about an insufficient number of available instrument sets, other sets that were not processed in a timely manner, and still other sets that were either incomplete or did not meet quality standards.

With cooperation from the director of Surgical Services, the Central Service manager forms an ad hoc committee of surgical and Central Service staff to discuss the issues related to the complaints and to formulate action plans to address them. This committee serves, in effect, as a quality management team whose members are to identify, observe, and measure the issues affecting instrument set production.

Let us assume that the delays in instrument set reprocessing are found to be caused by frequent washer malfunctions, which are affecting the quality and quantity of work produced. Sets are not completed in a timely fashion because the assembly and sterilization processes are being delayed. As a result, sets that are needed urgently are being taken by surgery staff to be flash-sterilized because they are not fully processed (sterilized) when needed.

Available records indicate that the washer is more than ten years old, and it has thousands of recorded cycles. The team recommends that the washer be replaced, and an approved instrument washer vendor is asked to make a comprehensive site visit and present a proposal for a new washer.

To build a case for the new washer, the team agrees to record washer breakdowns and obtain copies of the unit’s service history. These relevant facts are presented to facility administrators, along with equipment service life expectancy information (benchmarks) from the original equipment manufacturer. Customer impact statements and Central Service staff observations are also included to build a strong argument for the purchase of a washer.

After administrative discussion, there is consensus for approval and purchase of a new unit. Arrangements are made with the vendor to deliver a new washer and remove the older one. The vendor installs and tests the new unit and finds it to be working within the manufacturer’s specifications. Mandatory in-service training about the use and cleaning of the new washer is scheduled and it is placed into service.

The concept of a quality management system continues as the team monitors washer performance, sets reprocessing goals, records achievements, and reports findings that compare the quality and quantity outputs to earlier benchmarks. The new washer will have adequately addressed the problem to the extent that there is a reduction in flash sterilization incidents, and in related instrument set complaints from surgical customers.

In Conclusion

Attaining quality management goals requires the efforts of all Central Service employees. Quality is a concern of all stakeholders within the healthcare facility, and it should be viewed as a shared goal. Patients deserve quality outcomes, and they are becoming active and informed participants in their own care. Therefore, Central Service departments should be vigilant to industry trends and aware of improvements to address changes within the field. Education and the ongoing use of a quality management system are key to attaining and maintaining the high standards that are necessary for desired patient outcomes.

Endnotes

1. From: Central Service Technical Manual. Seventh Edition. Chicago, IL. International Association of Healthcare Central Service Materiel Management. 2007. (See Chapter 20.)
2. The Joint Commission. 2008 National Patient Safety Goals. For further information, go to: jcipatientsafety.org
3. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ANSI/AAMI ST79. 2006.

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