By Enid K. Eck, RN, MPH; Barbara DeBaun, RN, BSN, CIC; and GinaPugliese, RN, MS
Thelandmark Needlestick Safety and Prevention Act, signed by President Clinton Nov.6, 2001, authorized the federal Occupational Safety and Health Administration (OSHA)to revise the 1991 Bloodborne Pathogens Standard (29 CFR 1919.1030) to mandatethe use of sharps injury prevention devices. OSHA's revised standard took effectApril 18, 2001 and includes four major components: 1) adoption of sharps injuryprevention devices, 2) maintenance of a log of all contaminated needlesticksinjuries, 3) inclusion of frontline workers in the identification, evaluation,and selection of safety devices, and 4) annual revision of the exposure controlto outline all the steps taken to select and adopt safety devices. As written,the standard applies to all worksites under federal OSHA mandate where employeesmay be exposed to blood or other potentially infectious material. The standarddoes not cover public (state and municipal) facilities unless they arespecifically covered by a separate state-run OSHA plan or have a state law thatapplies. Of 27 states that are under federal OSHA--Georgia, Maine,Massachusetts, New Hampshire, Ohio, Texas, and West Virginia--have passed needlesafety laws covering public healthcare settings. States with state OSHA plans(there are 23) have 6 months from the effective date of the federal standard (byOctober 18, 2001) to adopt a standard that is "at least as effective"as the federal standard.
If a state has a specific needle safety law with requirements above andbeyond what the federal OSHA standard requires, then the additional staterequirements must be followed. As of May 2001, 18 states have passed needlesafety laws (figure 1). For example, some states laws may require heathcarefacilities to report needlestick injury data to a state agency. If a stateneedle safety law is less protective than the federal law, the federal law'srequirements must be followed.
Effective sharps safety programs are those that address the complex, dynamicpriorities of planning, product identification, and connections with peoplealong the continuum of care and the product supply chain. Although measurableprogress can be achieved, a successful program requires ongoing review of eachcomponent of the program.
Creating an effective plan
It is important to note that the bloodborne pathogen standard is aperformance-oriented standard. This gives employers the flexibility to meet theintent of the standard based on the unique characteristics of the worksite andwhat is determined to be "appropriate." Thus, the type of workpractices, protective barriers and engineering controls (e.g., sharpssafety devices) will likely vary in each facility and depend on the types ofprocedures being performed, the risks involved, the preferences of the workers,and any other unique factors or experiences of that facility. There may be somevariation in the specific interpretations of the standard in compliancedocuments prepared for the OSHA field staff. However, what will be important isthe detailed written exposure control plan that outlines what each facility isdoing to protect its workers based on their own unique characteristics. OSHApublished the revised bloodborne pathogen standard in the January 18, 2001 issueof the Federal Register. In this published revision, OSHA included manysuggestions and ideas on how to comply. What will be important is the planreflects what is actually being done and that it is reviewed and updatedannually to reflect any changes that are made.
OSHA requires that the plan include consideration and implementation ofappropriate commercially available and effective safer medical devices. OSHAdoes note that employers should account for innovations in procedure andtechnological developments that reduce the risk of exposure incidents. This doesnot mean that we need to continually change or replace our devices as a new onecomes along. It does mean that there should be a consideration of both trends inthe injuries and exposures and a consideration of new devices if it isdetermined that a change is needed to reduce risk. OSHA also requires that theplan include the methods used for identification of devices as"candidates" for adoption, the methods used to evaluate them, andjustification for final decisions. Special notations in the plan need to includesituations where conventional devices are still needed; for example, if safetydevices are not available or a clinician judges that they interfere with theprocedure and jeopardize the safety of the patient or worker.
BBP exposure prevention: Based on your experiences
OSHA requires that a sharps injury log be kept of injuries from contaminatedneedles. The log must include information on the type and brand of deviceinvolved, the department where the incident occurred, and an explanation of howthe injury occurred. Information from the log is just one source of informationto help guide the sharps injury prevention program to determine whereinterventions are needed, that is, administrative, work practices, orengineering control (e.g., safety devices). This log will provide trendsin injuries and may identify situations that need further investigation. Forexample, if there is an increase in needlestick injuries associated withdisposal of devices in one location, it might indicate that the disposal unitsare not being replaced when they are filled or it might mean there is a defectin the box. Further investigation is needed to determine the potential cause andpreventive action required. There might be a trend in the data indicating thatthere may be an increase in the needlestick injuries for a particular type ofdevice in one group of workers. Further investigation may reveal that theworkers in a particular department have had a shortage in staff and increase inpatient load and admitted that they are not always activating the safetymechanism.
How useful are device-specific injury rates?
It is important to point out that rarely will there be enough data from asingle facility to calculate rates of injury for specific devices that arestatistically significant and can be used to determine the efficacy of onesafety device over another. So, caution must be used in interpretation of rates.For example, in a Centers for Disease Control and Prevention (CDC) study of theefficacy of phlebotomy devices compared to conventional devices, the rate ofinjury for a conventional device was 3-4 injuries per 100,000 devices used. Therate of injury for the safety devices ranged between 0.9 and 3.1 per 100,000devices. So, if you wanted to show a statistically significant reduction in therate of injury when comparing a conventional phlebotomy device to a safetydevice, you would need between 500,000 and 1.6 million devices in each group tohave statistically significant data and rule out the possibility that thedifference occurred by chance alone (alpha 0.05 and statistical power of 90using X2 Fishers exact test) If you wanted to compare the efficacy ofone safety phlebotomy device over another the number of devices in your samplewould need to be even larger. Further complicating the issue of using rates tocompare devices is the inconsistency in reporting injuries, the profound degreeof underreporting, and the variations in reporting, all of which impact theaccuracy of the data collected. For example, the underreporting of needlestickinjuries has been as high as 70% in some facilities. This makes theestablishment of a non-judgmental, "no-fault" reporting systemessential to encourage reporting. If employees are fearful of being criticizedfor being careless, they often will choose not to report injuries thus renderingthe sharps injury data incomplete and less useful.
So, although the OSHA standard requires that the brand and type of device beincluded in the log, the data should be used to look for trends and not forcalculation of injury rates by type or brand of device. So use all your injuryand exposure data as only one piece of information to guide your sharps injuryprevention program. Avoid calculation of rates to compare devices because unlessyou have huge numbers, they will rarely be able to provide an accurate pictureof what is really happening. There is also no national consensus on thedenominator to use to calculate rates for comparison purposes--some facilitieshave used the number of full time staff, number of occupied beds, or number ofdevices used.
Frontline worker input
Other sources of information to guide the identification, selection andevaluation of safety devices are interviews with frontline workers. There aremany different performance criteria and preferences of individual workers. Itwill be important to get the workers' input and gain consensus on what theybelieve will protect them from injury. You may not have agreement by all thestaff regarding the perceived safety of one particular device. The type ofprocedures being performed in a particular department or care setting will alsoguide the selection process. So you may need to provide more than one device ina particular category.
Selecting appropriate and effective devices
OSHA's revised standard calls for implementation of safer medical devicesthat are commercially available, appropriate, and effective. Each facility andworksite must determine what is an appropriate device based on the clinicalenvironment, procedures being performed, the patient population, and the needsand preferences of the frontline workers.
The effectiveness of a device is a subjective view by the workers and not anevaluation to determine efficacy of one device compared to another. OSHA hasstated that an effective safer medical device is "a device that, based onreasonable judgment, will make an exposure incident involving a contaminatedsharp less likely to occur." This "reasonable judgment" is thejudgment of the frontline workers that will be using the device. That is why thefrontline worker input into the selection process is so important. Otherconsiderations in determining the appropriateness and effectiveness of a safetydevice are summarized in Table 1.
Prevent infections with immunizations
Although the revised standard does not change the requirements for theadministration of hepatitis B vaccinations, it still remains the primary meansof preventing transmission of hepatitis B in the workplace. As such, a periodicreview of new employee health records is a prudent way to assure thatimmunization is being offered and encouraged among employees at potential riskof exposure to blood.
Establish, monitor, continually improve PEP mechanisms
Equally important is the establishment of a comprehensive post-exposuremanagement program. Healthcare workers must have immediate access to apractitioner who is capable of providing state-of-the-art, post-exposureprophylaxis (PEP) in addition to the emotional or psychological support requiredat a moment when the worker needs it most.
Development of an internal needlestick hotline or establishment of a systemwhere a core group of individuals such as nursing supervisors are trained toprovide PEP has been successfully instituted in many institutions across thecountry. PEP drug choices must be appropriate based on the risk assessment ofthe injury and source patient. Time is of the essence so it is critical that theestablished system allows for the worker, with a high-risk exposure, immediateaccess to the appropriate prophylaxis.
The exposure control plan should also include the most recent recommendationsfrom the US Public Health Services/CDC; for example, the post-exposure follow-upand tests for HCV and post HBV vaccination testing of workers at ongoing risk ofoccupational bloodborne pathogen exposures.
Exposure control: Administrative, work practice, and engineering
Administrative exposure controls can take many forms. An important initialstrategy is to educate senior management/administration about the program'soverall effectiveness, financial impact, and barriers to success. Solicitingsupport for the program initiatives is critical, particularly because of themany innate challenges in today's healthcare system.
Education of staff is one of the most challenging and potentially frustratingcomponents of the plan. We all recognize that the nationwide nursing shortagehas impacted who and how we teach them. A nursing staff of mostly full-timenurses is a thing of the past in many parts of the US. Many facilities rely onpart-timers, per diems, and travelers who work very infrequently or for shortperiods of time to provide adequate staffing. Effective education requirescreativity and flexibility that may include the development of atrain-the-trainer program (i.e., unit-based nurses that can providejust-in-time training to individuals that may have missed the opportunity toreceive orientation prior to placement or assignment).
Optimal training on devices with engineered sharps injury protection requiresactual handling of the product. Although viewing a video or observing ademonstration of a device may be somewhat useful, this approach has limitedeffectiveness as it does not afford the nurse the ability to actually experiencethe safety feature. Adequate skill development requires time and practice.
Work practice controls remain the cornerstone of a sharps injury preventionprogram, therefore it is critical to continuously evaluate your staff to assuresafe practices are taking place. This can be accomplished formally duringsafety/infection control rounds where observations are recorded and reportedback to the specific area's clinical and/or administrative manager.Specifically, workers should be observed to determine placement and utilizationof sharps containers, utilization of safety devices as intended (e.g.,activation of safety feature), evidence of two-handed recapping, and creation ofa safe work environment. This important documentation will provide evidence thata surveillance system is in place to monitor compliance with recommendedpractices.
Product evaluation process
Several authors have described effective mechanisms for assuring sharpssafety product availability. Key recommendations include:
The product evaluation oversight committee
The market availability of sharps safety devices is rapidly expanding withmajor advances in technology design and for this reason, OSHA modified itsdefinition of "engineering controls" to include as examples"safer medical devices such as sharps with engineered sharps injuryprotections and needleless systems."
This change clarified that safer medical devices are considered to beengineering controls under the standard. Sources of information on sharps safetydevices on the market include:
Frontline worker input
The revised standard requires employers to solicit input from frontline(non-managerial) healthcare workers when identifying, evaluating, and selectingsafety-engineered sharp devices. A product evaluation oversight committee canfacilitate sharps injury reduction by identifying, evaluating, and expeditingthe implementation of clinically acceptable safety products. Staff withclinical, purchasing, materials management, safety, and education expertise arehelpful to include on such a committee. As well, including administrationstakeholders within the committee addresses any financial adjustments orbudgetary considerations.
Although a formal committee may have oversight in the process, the actualinput can be obtained from frontline workers in any manner that is appropriateto the circumstances of the workplace. This frontline worker input will beneeded for identifying devices to consider, performing some type of assessmentor evaluation of the devices, and then for the final selection of device forimplementation. This input can be formal or informal and OSHA has explained itdoes not prescribe any specific procedures for obtaining worker input. Examplesthat OSHA has provided for soliciting frontline worker input are summarized inTable 2.
Regardless of the method used to solicit input from frontline workers, themethod must be documented in the exposure control plan. This should includewhich employees were involved and the process used to solicit input. Theevidence that frontline worker input was solicited could include, for example,meeting minutes, copies of documents used to request employee participation,records of responses from employees such as reports or evaluation forms, or evenenvironmental rounds forms.
Assuring product availability
Now that there is a federal mandate requiring safety-engineered sharpsdevices, product availability problems may occur. If a safety device is notavailable, for example on extended backorder for purchase, there needs to be apotential "runner-up." You should not wait to replace a conventionaldevice with a safety device until a specific product is available but ratherimplement a different safety device in the interim.
Creating the people connections
If effective people connections are not solidly in place, the best possibleplan and the most effective sharps safety products will not achieve the desiredoutcome of injury reduction. Creating effective people connections requiresconsistency, collaboration, commitment, and intensive communication.
The most important component of creating effective "peopleconnections" is establishing consistency in every part of the sharps safetyprogram. Although it would seem to be obvious, consistency of purpose assuresthat competing interests are addressed effectively. Everyone involved in thesharps injury reduction program must stay focused on the same targeted outcomereducing risks of exposure to workers by implementing devices that they preferand that they believe will protect them. There may be variety of ways to achievethis but the purpose remains the same.
Once the program purpose has been negotiated and can be consistentlysupported, consistent messages must be established so that everyone in thehealthcare setting understands the goals of the program. Clarifying eachperson's role in achieving the program goals and assuring that everyone isinformed as the program unfolds greatly facilitates program compliance andultimately injury reduction. As with any marketing strategy, creating slogans ormottoes that capture the essence of the injury reduction effort helpparticipants to remember the goal and actively engage in the effort to reduceinjuries.
Report the outcomes and successes of the injury reduction programconsistently to maintain enthusiasm and facilitate identification of potentialbarriers. Create user-friendly data displays or "storyboards" thatinclude charts, graphs, and information on successful work practiceinterventions and/or administrative controls. These tools will be an effectiveway to demonstrate to JCAHO surveyors that your facility has taken a proactiveapproach to needlestick injury prevention.
As issues or questions about the program, products or procedures areidentified it is essential that the designated sharps safety staff followthrough on whatever the issues are, reporting back to the department orindividuals that raised the concern initially. Staff tend to fill in the gaps ifthey can't count on a consistent response from the leadership of an importantprogram like sharps safety.
The revised standard requires solicitation of input from frontline employees;evidence that employee input has been sought and obtained can include minutesfrom meetings, completed evaluation forms, or copies of documents (e.g.,hospital newsletter) requesting employee participation.
Although collaboration is frequently touted as an important element of anysuccessful program, it is easier to talk about than do. Some strategies thatenhance collaboration include:
Programs as comprehensive and complex as sharps injury reduction requireinput from a wide variety of disciplines and individuals who may havehistorically been excluded or even disenfranchised. A history of exclusion isn'teasily overcome without establishing new patterns of interaction. Respect isessential to soliciting input and opinions from everyone involved.
Use interest-based negotiation strategies to assure that all stakeholders areadequately heard. Work to reach consensus, especially on areas of initialdisagreement, by identifying common goals, shared responsibility, and ownershipof the ultimate outcome(s). Although the same device may be the source ofinjuries in many different areas of clinical care, each setting has uniquefactors that contribute to such injuries e.g., patient acuity on an ICU,pace or activity in an ER, types of procedures in an OR, etc.
Provide a variety of mechanisms such as hotlines, suggestion boxes,newsletters, interactive open forums in department staff meetings to solicitsuggestions, injury reduction strategies, and successes. New employeeorientation may be an additional opportunity to emphasize the value offorwarding suggestions to individuals charged with the responsibility ofinitiating product trials. Each specialty has valuable information and expertisethat should be incorporated into injury reduction strategies. Creatively captureall the ideas possible.
The process of sharps injury reduction can be long and frustrating andmaintaining interest and commitment in the face of competing needs can beparticularly challenging. By spending time together as colleagues, the staffinvolved in the injury reduction program can gain comfort and build trust witheach other. Trusting relationships are essential when facing the challenges ofinjury reduction in the "real world."
There is no perfect product or "silver bullet" available to solveall the multifaceted challenges of reducing sharps injuries. Persistence and anunwavering commitment to resolving each and every problem as it is identifiedare critical. Problems with staff resistance to using safety products or changesin practice, product backorders, limitations in current technology, delays inproduct evaluations, and implementation all necessitate long-term commitment,and a willingness to persevere.
To assure ultimate success with injury reduction, thoughtful strategies forcontinuous improvement should be developed. Use objective measures built onreliable and readily available data. Verify the validity of all data sources toenhance stakeholder "buy-in."
Creative thinking or brainstorming potential solutions can often identify newstrategies or approaches to problems that are particularly challenging. No ideasshould be discarded until thoroughly explored and possibly piloted in limitedlocations.
Communicate with internal and external audiences
The slogan "location, location, location" conveys the primarymessage for anyone interested in selling a home or business property. In injuryreduction programs the corresponding slogan is "communication,communication, communication."
Ultimately, the success of a sharps injury prevention program depends on theimplementation of an effective communication plan. There are internal andexternal audiences that must be successfully addressed.
The internal audience includes: clinical staff and end users, administrationstakeholders, purchasing, materials managers, safety and employee healthexperts. Each member of the internal audience should be fully informed regardinginjury reduction strategies, available safety products, resource and technologygaps, and any current program challenges. Information should be conveyed in anunderstandable, focused way so that the "language" of each disciplineis incorporated into key messages. Provide mechanisms for staff to havequestions answered and problems reported.
External audiences are equally important and may include; regulatoryagencies, state and/or county departments of health services, product suppliersand distributors, labor union representatives, and the media. Each externalaudience is apt to have a different area of concern. Identify appropriatespokespersons to address each audience and assure accuracy of all informationbeing provided.
Although there are many priorities in reducing sharps injuries, there arethree elements that, if effectively addressed, can greatly enhance the successof an injury reduction program. Think of them as the three "Ps,"an effective Exposure Control Plan, assuring the availability andappropriate use of safer products and developing a team of peoplecommitted to working together to reduce sharps injuries. If any of theseelements becomes the "weakest link" then the whole program is injeopardy and rather than getting "voted off," that component should bestrengthened to more fully contribute to everyone's success.
Gina Pugliese is the director of the Safety Institution, Premier Inc.based in Chicago, Ill. She holds faculty appointments at the University ofIllinois School of Public Health and Rush University of Nursing. Barbara DeBaunis the director of infection control for California Pacific Medical Center inSan Francisco. Enid. Eck is the senior consultant for HIV and infectious diseasefor Kaiser Permanente, California.
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