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84 May 2008 MANAGING INFECTION CONTROL Education & Training Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one (1) contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one (1) contact hour for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 96. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. Objectives After completion of this self-study activity, the learner will be able to: 1. Describe the Association for the Advancement of Medical Instrumentation Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/ AAMI ST79:2008 approach to monitoring quality in steam sterilization. 2. Define the four components of the Plan-Do- Check-Act (PDCA) cycle. 3. Identify key tools used to collect your team’s ideas and organize them to facilitate problem solving. 4. Discuss the importance of customer feedback to successful continuous quality improvement monitoring. We Can Do Continual Quality Process Improvement! Monitoring steam sterilization quality using continuous quality improvement methods by Cynthia Hubbard, RN, BS

Education & Training We Can Do Continual Quality Process ...multimedia.3m.com/mws/media/525839O/quality-process-improvement... · 6. Dr. W. Edwards Deming was an American pioneer

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84 May 2008 MANAGING INFECTION CONTROL

Education & Training

Many thanks to the team at 3M Health Care for workingwith Managing Infection Control to provide the followingaccredited course. IAHCSMM has awarded one (1) contact pointfor completion of this continuing education lesson towardIAHCSMM recertification. The CBSPD has preapproved thisinservice for one (1) contact hour for a period of five (5) yearsfrom the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Providerapproved by the California Board of Registered Nurses, CEP5770 for one (1) contact hour. This form is valid up to five (5)years from the date of publication. Instructions for submittingresults are on page 96.

Managing Infection Control and 3M Health Care will beworking collaboratively to provide continuing education coursesin monthly editions of Managing Infection Control.

ObjectivesAfter completion of this self-study activity,

the learner will be able to:1. Describe the Association for the Advancement

of Medical Instrumentation Comprehensiveguide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2008 approach to monitoringquality in steam sterilization.

2. Define the four components of the Plan-Do-Check-Act (PDCA) cycle.

3. Identify key tools used to collect your team’s ideas and organize them to facilitateproblem solving.

4. Discuss the importance of customer feedbackto successful continuous quality improvementmonitoring.

We Can Do Continual QualityProcess Improvement!Monitoring steam sterilization quality using continuous quality improvement methodsby Cynthia Hubbard, RN, BS

Test QuestionsTrue or False. Circle the correct answer.

1. There is a sequential nature to the steps in medical devicesterile processing. If you take one out of order, skip a stepaltogether, or perform it inadequately, unsatisfactoryresults will occur.True False

2. Continuous quality improvement (CQI) programsencourage a participative style of management andemployees are encouraged and supported to evaluate andrecommend changes in their work.True False

3. The outcome of monitoring steam sterilization processesagainst a predetermined level of quality is that the truecauses of problems can be identified.True False

4. Today’s approach to process quality includes having a planned, systematic, objective and ongoing process forverifying compliance with procedures.True False

5. Brainstorming is a group decision-making techniquedesigned to generate a large number of creative ideas andevaluate their practicality.True False

6. Dr. W. Edwards Deming was an American pioneer of the quality management approach who introduced statistical process control techniques into the Japanesemanufacturing environment.True False

7. The application of the PDCA cycle can be used to verifythe effectiveness of automated equipment, but is not effective for manual processes.True False

8. Once you know what a process looks like, you will alsoknow where the waste and/or rework occur.True False

9. Use of continuous quality improvement (CQI) is recom-mended as a tool to objectively monitor our processes andensure that the outcome meets standards.True False

10. As you update procedures it is important to think of themas a set of specifications that are only the starting point foryour quality improvement efforts.True False

IntroductionEvery work process, from communications to validation,

can be improved in some manner. The Association for theAdvancement of Medical Instrumentation Comprehensiveguide to steam sterilization and sterility assurance in health

care facilities, ANSI/AAMI ST79:2008 endorses use of continuous quality improvement (CQI) methods to create andmaintain the highest quality for hospital steam sterilization. To achieve the best results, you must include all aspects ofdecontamination, preparation and packaging, sterilization,quality control, sterile storage and product distribution in your CQI review process.1 CQI programs include data measuring tools that can be used to improve the quality ofsterile processing products and decrease customer complaintsand costs.

In addition to monitoring the quality of our sterilization-related processes we also care about the quality of the serviceswe provide, as delays are costly and customer complaints add considerable stress to our workplace. Feedback fromcustomers is a necessary part of the CQI process and promotesan interdisciplinary approach to problem solving.1

Factors in Successful Sterilization Many factors influence successful sterilization in the

hospital environment; of special significance is the sequentialnature of the process. If one step, such as decontamination, ismissed, or inadequately performed, unsatisfactory results willoccur, even though the product or device is subsequentlysubjected to steam sterilization. Since we are dealing with a microscopic enemy, the pressures of increasing workloads,inventory shortages, turn-around time, complex deviceconstruction and the idiosyncrasies of human behavior, thereare many details that must be considered as you design a quality monitoring system. It is easy for processes to fallshort of quality expectations, even in the best of situations.2

CQI in Sterile ProcessingANSI/AAMI ST79:2008 recommends using a documented

quality process so you can objectively measure criteria andreduce the gap between perceived and actual results. Usingregular audits of the quality process and activities provide datathat your team can use in problem analysis and resolution ofsterilization-related issues. Monitoring the system with a teamapproach provides the better feedback and commitment by all involved.1

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ANSI/AAMI ST79:2008 recommendsusing a documented qualityprocess so you can objectivelymeasure criteria and reduce the gap between perceived andactual results.

Because quality systems for sterility assurance involvepre- and post-sterilization processing functions and controls, inaddition to the sterilization process itself, all of the operationaland environmental factors must be included in the CQIprogram. Continuous quality and productivity improvement insterilized products and service to users and patients can beachieved by: Systematically identifying and using best practices; Applying quality enhancement strategies; Assessing customer needs and satisfaction; Using process measurement and evaluation tools; Assessing the outcomes and measuring performance

results; Collaborating in a positive manner with users and

customers.3

Practical Application Measure criteria and document the quality process

to learn actual results not perceived results.

Who Makes CQI Work?In a CQI environment, everyone in the organization

(staff, managers, physicians, nurses, technicians, volunteers)is responsible for helping to make quality improvements. Our leaders and managers drive the CQI effort by theircomplete commitment and involvement in learning what isbest for, and expected by, the patients. They also help thevarious hospital employees make those expectations a realityby funding the time allocation that continuous qualityimprovement requires.1

Frontline employees, such as operating room (OR)nurses, technicians and other service staff, work day-to-daywith all the systems and processes in the hospital. There is a tremendous opportunity (if we work in a culture that rewardsour initiative) to act on any problems and strive to makeimprovements in our daily work tasks. And, if we use a process improvement like CQI, in which systematic effortsare made to understand every aspect of a process in order to reduce rework, variations in quality and outcome, and needless complexity, we can consistently meet or exceedcustomer expectations.1

The first step in operational improvement is to be sure that you are doing the right things in the right way. When weincorporate best practices from organizations such as AAMIand the Association of periOperative Registered Nurses(AORN) into our policies and procedures we have the assuranceof monitoring our results against up-to-date standards for all ofthe components of steam sterilized medical devices.

And, unless you know what a process looks like, you willnot know where the waste and/or rework occur. Improvement

can sometimes begin with performance measures or indicatorsthat tell you performance is not up to par. This can be customeror employee feedback (qualitative data), or financial reports,defect rates, etc. (quantitative data).4

Problem Solving You know something needs to change when: customers

are complaining, something’s wrong and needs to be fixed, orstaff members are angry and frustrated. And, you’ve workedhard to create a credible vision of what you want this change tolook like in the future. But are you 100 percent sure that you’reright … and, are you absolutely certain that your solution willwork perfectly, in every way?

When the consequences of getting things wrong aresignificant, such as when non-sterile surgical instruments getdistributed, it often makes sense to run a well-crafted pilotproject. This way, if the pilot doesn’t deliver the expectedresults, you get the chance to fix, fine tune and improve thingsbefore you fully commit your reputation and costly resources.

So, how do you make sure that you get this right, not just this time but every time? One solution is to have a reliableprocess to follow when you need to make a change or solve a problem. Since everyone’s time is valuable, you want an easy-to-use, credible process that ensures the right planning, testing and accurate feedback before you commit to implementation.

While there are a variety of options used by hospitals tomonitor quality (check with your organization to see if a certain CQI program has been established for use at your

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Figure 1. Plan-Do-Check-Act (PDCA) Cycle

the terms used are not clear or language that is not understood. The more clearly written the procedures are,the better your set of specifications will be and the higherthe compliance with your desired outcomes.

Practical Application Written procedures provide specification used

to improve the quality of a process.

The PDCA Approach“Plan, Do, Check (or Study) and Act” are the four

components of this popular tool used for problem solvingand improvements to established systems.

PLANThis first component establishes the objectives and

processes necessary to deliver the end-product and/orservice in accordance with the specifications for theprocess, end-product and/or service. When you are usingthe PDCA process to problem solve, analyze what youintend to improve, looking for areas that hold opportunitiesfor the changes that are needed. Start by establishing yourobjectives and state them clearly.

For example, an objective may be to analyze if eliminating recalls by running a biological indicator in anappropriate process challenge device (BI PCD) in eachsteam sterilization load and quarantining for one to threehours. The desired result would be improved patientoutcomes (fewer infections), and cost savings while delivering the same standard of care for each patient.

DOImplement the processes. Carry out the change or test,

preferably on a small scale. Note that you will have to trainstaff in the new procedure and inform the customers ofyour plan and their role, before you change the process.

CHECK or STUDYMonitor and evaluate the processes and results against

your objectives and specifications, then report theoutcome. What were the results? What was learned? Whatwent wrong? This is a crucial step in the PDCA cycle. Afteryou have implemented the change for a short time, youmust determine how well it is working. Is it really leadingto improvement in the way you had hoped? For the mostobjective reporting decide on several measures with whichyou can monitor the level of improvement.4 This part of thecycle uses data analysis/display tools, described later underthe heading of “Tools and Methodology.”

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facility), many find the “Plan-Do-Check-Act (PDCA) Cycle” tobe a reliable tool that can be used independently when you needto design effective improvements (see Figure 1 on page 87).

PDCA is also called the Shewhart Cycle, the Deming Cycleor Deming Wheel, after its proponent, Dr. W. Edwards Deming.Walter Andrew Shewhart developed the original concept in the 1930s; advocating that experiments and quality controlshould be planned to deliver results in accordance with the specifications you set up for the product or service. Dr. Demingwas an American pioneer of the quality management approachwho introduced statistical process control techniques for manufacturing to the Japanese, who used them with great successafter WWII.5 Later in Dr. Deming’s career, he modified PDCA to“Plan, Do, Study and Act” (PDSA) to better describe hisapproach to the third part of the concept.6

Variations of Shewhart and Deming’s concepts have beenused in more recent methodology and approaches to qualityimprovement. For example, in Six Sigma Programs, the PDSAcycle is called “Define, Measure, Analyze, Improve, Control”(DMAIC). Six Sigma is a disciplined, data-driven methodologyfor eliminating defects (driving towards six standard deviationsbetween the mean and the nearest specification limit) in anyprocess—from manufacturing to transactional and from productto service. At many organizations Six Sigma simply means ameasure of quality that strives for near perfection.7 DMAIC is animprovement system for existing processes which are fallingbelow specification and need incremental improvement.8

Practical Application Use the Plan-Do-Check-Act process to ensure

actions taken will supply the expected results.

The Role of SpecificationsIn the past year everyone has been busy updating sterile

processing procedures to be compatible with the ANSI/AAMIST79:2006 recommended practices for steam sterilization andthe updated AORN recommended practices for packaging andsterilizing. As you update procedures it is important to think ofthem as a set of specifications that are only the starting point foryour quality improvement efforts.

For example, when reviewing procedures for chemicaldisinfection, it is vital to your future quality monitoring efforts to update all of the product, safety and procedural details.Specify all key components such as dilution, MRC (minimumrecommended concentration), MEC (minimum effective concen-tration), temperature, PPE (personnel protective equipment),evaporation, light, pH, time, temperature, etc., so there is noguess work on the part of technicians. It is tempting to just say“follow the directions on the bottle,” but this leads to errors when

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Data analysis may be new to somemembers of the CQI team. Training will benecessary in statistical methods and tools, butstress the benefits of working with the dataversus using supposition, or opinion. Manypeople relate to the world in a visual way andfind it is easier to understand study resultswhen they are displayed in pictorial format.Graphs and charts can be used as a visualsummary to discuss the actual results andcompare them to the predicted results.

It is common in a pilot project that theresults are not exactly as expected; maybeyour theory was partially correct, but didn’thave all the insight that this study brought outinto the open. The data patterns might helpyour team learn something new, to develop anew theory about change in your department,identify retraining issues, or better under-stand process improvement for the nextphase, etc. It could be that the issue of defectswas not addressed in your plan and someobservations may indicate that the defect ratemay have increased. Study that data, too; itmay lead you in a new direction.6.9

ACTApply actions to the outcome. This

means reviewing all steps (Plan, Do, Check/Study, Act) and modifying the process toimprove it before its next implementation.The “Act” in PDCA is meant to be inter-preted to have a different meaning than to“Do.” “Act” is meant to apply actions to the outcome for necessary improvement. Inother words “Act” means “Improve.” Adoptthe change, abandon it, or run through thecycle again.4

After planning a change, implementingand monitoring it, your team must decidewhether it is worth continuing that particularchange. If it consumed too much of yourtime, was difficult to maintain to, or even led to no improvement, you may consideraborting the change and planning a new onewith a better focus. However, if the changeled to a desirable improvement or outcome,you may consider expanding the trial to adifferent area, or slightly increasing yourcomplexity. This sends you back into thePlan phase and can be the beginning of what is termed the “ramp of improvement.”4

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The Ramp of Improvement Left is a schematic representation of the

use of the PDCA cycle in the improvementprocess (see Figure 2). As each full PDCAcycle comes to completion, a new andslightly more complex project can be under-taken. This rolling-over feature is integral tothe continual improvement process.10 Thus,improvements are always on the minds ofworkers and the goals of improvement arenot short-lived, but become an integral partof our attitude toward our jobs.

Practical Application Use the Plan-Do-Check-Act tool

to determine if the change in theprocess is worth continuing.

Tools and MethodologyPeople respond to processes that bring

out their ideas and problem-solvingcreativity. If you can make it fun, too, they are more likely to set time aside for theCQI process and be active participants. It is necessary to sort out the facts from the emotion of conflict or complaints. Listed below are a few traditional qualitymonitoring tools that can be used to enhancethe continuous quality improvement processand the constructiveness of your problem-solving experience.

BrainstormingThis tool is used to simply list all ideas

put forth by a group in response to a givenproblem or question. In 1939, a team led by advertising executive Alex Osborncoined the term “brainstorm.” According to Osborn, “Brainstorm means using thebrain to storm a creative problem and to do so in commando fashion, each stormeraudaciously attacking the same objective.”Creativity is encouraged by not allowingideas to be evaluated or discussed untileveryone has run dry. Any and all ideas areconsidered legitimate and often the most far-fetched are the most fertile. Structuredbrainstorming produces numerous creativeideas about any given “central question.”

Figure 2. Plan-Do-Check-Act Ramps of Improvement

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Done right, it taps the human brain’s capacity for lateralthinking and free association.11 Brainstorms help answerspecific questions such as: What opportunities face us this year? What factors are constraining performance in our

department? What could be causing problems like wet packs, positive

BI’s, dirty instruments?

What can we do to solve problems like contaminated peelpacks, instrument damage or failure of staff to use theappropriate PPE?

Affinity DiagramThis tool is used to organize a large number of ideas

into their natural relationships. This method taps a team’screativity and intuition. It was created in the 1960s by Japanese

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anthropologist Jiro Kawakita. When you are confronted with many facts or ideas in apparent chaos; when issues seem too large and complex to grasp or when group consensusis necessary, use this tool to get concepts and ideas sorted into categories.

Using an affinity diagram is very helpful after a brainstorming exercise or when you are analyzing verbal data,such as survey results. For example, when the problem yourteam is studying is inconsistent quality of instrument cleaning,you might group the ideas you picked up from brainstorminginto people issues, equipment issues, schedule issues, instrumentissues, transport issues, etc. on the affinity diagram.4

Ishikawa DiagramThis tool is also called a cause-and-effect, fishbone

diagram or root cause analysis. The inventor of the tool, Kaoru Ishikawa, first used the technique in the 1960s. TheIshikawa diagram, like most quality tools, is a visualizationand knowledge organization tool (see Figure 3). Simplycollecting the ideas of a group in a systematic way facilitatesthe understanding and ultimate diagnosis of the problem. Keys to its successful use include: Take care to identify causes rather than symptoms. Post diagrams to stimulate thinking and get input from

other staff.

Post-it notes can be used to construct Ishikawa diagrams.Sources of variation can be rearranged to reflect appro-priate categories with minimal rework.

Ensure that the ideas placed on the Ishikawa diagram areprocess variables, not special-caused problems such astampering, etc.

Review any quick fixes and rephrase them, if possible, so that they are process variables.4

Flow ChartThis tool provides a pictorial representation of a process.

By breaking the process down into its constituent steps, flowcharts can be useful in identifying where errors are likely to be found in the system. A typical flowchart is theorganizational chart that shows reporting relationships in yourhospital. But, you could apply this technique to identifying the flow of instruments in the reprocessing cycle if you are problem solving issues in the turnaround of fast-trackinstrument sterilizing.4

Check SheetThis tool is a simple data collection form consisting of

multiple categories and definitions. Data is entered on the formwith a simple tally mark each time one of the categories occurs.Its only purpose is to facilitate the collection of data so it can

Figure 3. Ishikawa Fishbone Diagram

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subsequently be analyzed. Create a straightforward check sheet by simplymaking a list of items that you expect will appear in a process and then marka check beside each item when it appears. This type of data collection can beused for almost anything, from checking off the occurrence of particulartypes of defects to the counting of expected items (e.g., the number of timesthe telephone rings before being answered).4

Run Charts This tool is often known as a line graph outside the quality management

field, and is used to display process performance over time. Upward and downward trends, cycles, and large aberrations may be spotted andinvestigated further. In a run chart, events, shown on the y axis, are graphedagainst a time period on the x axis.4 For example; a run chart in sterileprocessing might plot the number of wet packs/sterilizer by time of day. The results might show that there are more wet packs in the morning than at8 p.m. By investigating this phenomenon you could unearth the causes andcorrect the situation.

Run charts can also be used to track improvements that have been putinto place, checking to determine their success. For each line in the runchart, specific calculations are required to understand the results. Thefollowing are typically used:

Mean = the average of all the data points in the series. Maximum = the maximum value in the series. Minimum = the minimum value in the series. Sample Size = the number of values in the series. Range = the maximum value minus the minimum value. Standard Deviation = Indicates how widely data is spread

around the mean.

Pareto DiagramThis is a bar graph used to arrange information in such a way that

priorities for process improvement can be established. Pareto diagrams arenamed after Vilfredo Pareto, an Italian sociologist and economist, whoinvented this method of presenting information toward the end of the 19thcentury. The chart is similar to the histogram (a graphical display of tabu-lated frequencies) or a bar chart, except that the bars are arranged indecreasing order from left to right along the abscissa (see Figure 4 on page94). The fundamental idea behind the use of Pareto diagrams for qualityimprovement is that the first few contributing causes to a problem (aspresented on the diagram) usually account for the majority of the result.Thus, targeting these major causes for elimination generally results in themost cost-effective improvement scheme and best customer reaction.4

Practical Application Use CQI tools in a fun way to help solve problems by sorting

out facts from emotion.

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Designing the CQI ProgramLet’s review some of the elements

to be considered in designing yourcontinuous quality improvement programfor Sterile Processing. ANSI/AAMIspecifically highlights these key elementsfor monitoring: decontamination, rigidsterilization container systems, flash sterilization, and the functional areas forproduct and process. Remember that theprogram you design should assess allcomponents of the sterilization processfor their ongoing ability to achieve thedesired outcome of consistency in deliv-ering sterile products to the patient.1

The core steps in continuousimprovement start with forming a teamthat has knowledge of the system (orprocess) needing improvement (includea cross-section of technicians, users,

Education & Training

Figure 4. Pareto Diagram

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management, etc.). The team then defines a clear aim. It is critical that the team understand the needs of the people whoare served by the system (or process). Then they can work toidentify and define measures of success; brainstorm potentialchange strategies for producing improvement; plan, collect anduse data for facilitating effective decision making; and applythe scientific method to test and refine changes.12

ANSI/AAMI ST79:2008 further states that evaluating and monitoring the effectiveness of the process of sterilizingmust be an ongoing effort and is critical to maintaining controlover, and determining methods for improving, your productsand processes.1

When it comes to product use ANSI/AAMI ST79:2008 alsorecommends that you incorporate four types of performancemeasures into your ongoing evaluation: Internal evaluations: Use them to audit the quality of

the finished products, such as: instrument packs, orproduct recalls after positive BIs.1

End-user feedback: Use a formal, documented system tolog, investigate, and resolve complaints and/or productfailures. A procedure should also be established to investigate and resolve serious and or repeat problems.1

Supplier testing: When products, supplies or equipmentprovided by an outside manufacturer raise concerns in the hospital environment a request and response from

Most problems are found in processes, not in people. CQI does notseek to blame, but ratherto improve processes.

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vendors is required. All details ofthe investigation and resolution ofthe issues should be kept on file.1

Repair records: Review of instru-ment repair records may showpatterns that can be investigatedand corrected.1

SummaryPatient safety, practicality and

cost-effectiveness must all be consid-ered in monitoring quality. Using CQI planning and implementation isrecommended by ANSI/AAMI ST79:2008 and it stresses monitoring thoseelements that are the most significant to your success in delivering sterileproducts to the patient. Quality can bedefined as meeting our specificationsand meeting or exceeding the expecta-tions of our customers.

Most problems are found inprocesses, not in people. CQI does notseek to blame, but rather to improveprocesses. Unintended process varia-tions can lead to unwanted variations inoutcomes. It is possible to achievecontinual improvement through small,incremental changes using the scientificmethod. By incorporating best practicesinto policy and procedures we establishup-to-date specifications from which to monitor our process outcomes.Continuous quality improvement ismost effective when it becomes anatural part of the way everyday workis done … by everyone.12

ANSI/AAMI ST79: 2008 also notesthat the single most important issue for those charged with implementing

Nursing CE Application FormThis inservice is approved by the California Board of Registered Nurses, CEP

5770 for one (1) contact hour. This form is valid up to one year from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add the last 4 digits of your social security number or your nursing license number.4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS.6. Submit this form and the answer sheet to: 3M Sterilization Assurance, Attn HC4160 RR Donnelly Fulfillment Services 585 Hale Ave N., Oakdale, MN 55128-99357. For questions or follow-up, contact [email protected]. Participants who score at least 70% will receive a certificate of completion

within 30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________________________________________________________

Mailing Address______________________________________________________

City, State, Country, Zip _______________________________________________

Daytime phone ( )__________________________________________

Position/Title_______________________________________________________

Social Security or Nursing License Number ________________________________

Date application submitted _____________________________________________

Signature __________________________________________________________Offer expires May 2013

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU InformationCEU Applicant Name _________________________________________________

Address___________________________________________________________

City____________________________ State________ Zip Code ______________

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for one (1) contact hour for a period of five (5) years fromthe date of publication. Successful completion of the lesson and post test must bedocumented by facility management and those records maintained by the individualsuntil recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD.

For additional information regarding Certification contact: CBSPD, 121 StateHwy 31N, Suite 500, Flemington, NJ 08822 or call 908-788-3847 or visit the Web siteat www.sterileprocessing.org.

IAHCSMM has awarded one (1) Contact Point for completion of this continuingeducation lesson toward IAHCSMM recertification.

<05/08>

1. T2. T3. T4. T5. F

6. T7. F8. T9. T10. T

ANSWERS

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a CQI program is accurate data collection using the facilityplan for documenting process monitoring and product performance. Performance improvement plans, when needed,should be implemented based upon the assessment data.Trending data for the number of BI tests, BI failures for eachsterilizer, education compliance, sterilizer maintenance, abilityto locate recalled items and completeness of test records are allexamples of key measures to be used to assess the effectivenessof your QA monitoring program.1 ✛

References1. Association for the Advancement of Medical Instrumentation

ANSI/AAMI Comprehensive guide to steam sterilization and sterilityassurance in health care facilities, Section 11 Quality processimprovement. ANSI/AAMI ST79:2008 in preparation.

2. Hubbard C. Why is Quality so Illusive? Managing Infection Control.2007;9:86-97.

3. http://adminfin.csusb.edu/cqi/whatcqi.html4. http://mot.vuse.vanderbilt.edu/mt322/library.htm5. http://www.mindtools.com6. http://deming.eng.clemson.edu 7. http://www.isixsigma.com/sixsigma 8. http://en.wikipedia.org/wiki/PDCA

9. http://www.skymark.com/resources/tools/run_charts.asp 10. http://www.dartmouth.edu11. http://www.skymark.com/resources/tools/brainstorming.asp12. www.fpm.iastate.edu/worldclass/cqi.asp

Cynthia (Hunstiger) Hubbard is a published author andprogram presenter. Her nursing experience includes ER andoccupational health nursing at Saint Mary’s Hospital MayoClinic in Rochester, Minn. She was assistant director of materials management and a central service director/sterileprocessing manager in Minnesota and Washington. Cynthia’soutpatient experience includes GI, cardiology and communityhealth. For 11 years Cynthia was a senior consultant withLerch Bates Hospital Group of Littleton, Colo., on national andinternational design projects related to materials and wastemanagement, transport and sterile processing. A graduate ofSaint Mary’s School of Nursing, she has a BS from the Collegeof St. Francis. Cynthia is a Fellow Member and served on theASHCSP Board of Directors. She is a recipient of the ASHCSPThomas Samuels and Educator of the Year awards.

Copyright©2008/Workhorse Publishing L.L.C./All Rights Reseved. Reprint with permission from Workhorse Publishing L.L.C.

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