Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program

Contents:

INFORMATION ABOUT THE WORKBOOK

Introduction

Occupational exposure to bloodborne pathogens from needlesticks and other sharps injuries is a serious problem, but it is often preventable. The Centers for Disease Control and Prevention (CDC) estimates that each year 385,000 needlesticks and other sharps-related injuries are sustained by hospital-based healthcare personnel (1). Similar injuries occur in other healthcare settings, such as nursing homes, clinics, emergency care services, and private homes. Sharps injuries are primarily associated with occupational transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), but they may be implicated in the transmission of more than 20 other pathogens (2,3).

Overview of the Program Plan

An effective sharps injury prevention program includes several components that must work in concert to prevent healthcare personnel from suffering needlesticks and other sharps-related injuries. This program plan is designed to integrate into existing performance improvement, infection control, and safety programs. It is based on a model of continuous quality improvement, an approach that successful healthcare organizations are increasingly adopting. We can describe this model in a variety of terms, but the underlying concept is that of a systematic, organization-wide approach for continually improving all processes ( Processes Performance Improvement) involved in the delivery of quality products and services. The program plan also draws on concepts from the industrial hygiene profession, in which prevention interventions are prioritized based on a hierarchy of control strategies. The plan has two main components:

• Organizational steps for developing and implementing a sharps injury prevention program. These include a series of administrative and organizational activities, beginning with the creation of a multidisciplinary working team. The steps are consistent with other continuous quality improvement models in that they call for conducting a baseline assessment and setting priorities for development of an action plan. An ongoing process of review assesses and modifies the plan's effectiveness as needed.
• Operational processes. These activities form the backbone of the sharps injury prevention program. They include creating a culture of safety, reporting injuries, analyzing data, and selecting and evaluating devices.

Information Provided

The workbook includes several sections that describe each of the organizational steps and operational processes. A toolkit of forms and worksheets is included to help guide program development and implementation. The workbook also contains:

• A comprehensive overview of the literature on the risks and prevention of sharps injuries in healthcare personnel;
• A description of devices with sharps injury prevention features, and factors to consider when selecting such devices; and
• Internet links to Websites with relevant information on sharps injury prevention.

How to Use the Workbook

The workbook presents a comprehensive program for sharps injury prevention. The information can be used to:

• Help healthcare organizations design, launch, and maintain a prevention program, and
• Help healthcare organizations enhance or augment current activities if a program is already in place.

The principles may also be broadly applied to the prevention of all types of blood exposures.

Target Audience

The audience for this information includes healthcare administrators, program managers, and members of relevant healthcare organization committees. However, not all parts or activities will be relevant to every healthcare organization. CDC encourages healthcare organizations to use whatever they find helpful and necessary for their sharps injury prevention program. The sample forms and worksheets in the toolkit may also be adapted according to users' needs. Some sample tools (e.g., those for baseline assessment) are designed to be used only once, whereas others (e.g., healthcare worker surveys) are designed for periodic use.

Value of the Workbook to Healthcare Organizations

This workbook contains a practical plan to help healthcare organizations prevent sharps injuries. Once implemented, the program will help improve workplace safety for healthcare personnel. At the same time, it may help healthcare facilities meet the worker safety requirements for accrediting organizations, as well as the following federal and state regulatory standards:

• Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards for surveillance of infection, environment of care, and product evaluation;
• Center for Medicare and Medicaid Services (CMS) compliance with the Conditions for Medicare and Medicaid Participation;
• Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) and its related field directive, Inspection Procedures for the Occupational Exposure to Bloodborne Pathogens Standard (CPL 2-2.44, November 5, 1999) requiring use of engineered sharps injury prevention devices as a primary prevention strategy ( http://www.osha.gov/SLTC/bloodbornepathogens/index.html/);
• State OSHA plans that equal or exceed federal OSHA standards for preventing transmission of bloodborne pathogens to healthcare personnel;
• State-specific legislation that also requires the use of devices with engineered sharps injury prevention features and, in some cases, specific sharps injury reporting requirements (http://www.cdc.gov/niosh/ndl-law.html/); and
• Federal Needlestick Safety and Prevention Act (PL 106-430), (November 6, 2000), which mandates revision of the 1991 OSHA Bloodborne Pathogens Standard to require the use of engineered sharps injury prevention devices. Details may be found at: PL 106-430

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OVERVIEW: RISKS AND PREVENTION OF SHARPS INJURIES IN HEALTHCARE PERSONNEL

Introduction

Prevention of percutaneous injuries and other blood exposures is an important step in preventing the transmission of bloodborne viruses to healthcare personnel. Epidemiologic data on sharps injury events, including the circumstances associated with occupational transmission of bloodborne viruses, are essential for targeting and evaluating interventions at the local and national levels. The CDC estimates that each year 385,000 needlesticks and other sharps-related injuries are sustained by hospital-based healthcare personnel; an average of 1,000 sharps injuries per day (1). The true magnitude of the problem is difficult to assess because information has not been gathered on the frequency of injuries among healthcare personnel working in other settings (e.g., long-term care, home healthcare, private offices). In addition, although CDC estimates are adjusted for it, the importance of underreporting must be acknowledged. Surveys of healthcare personnel indicate that 50% or more do not report their occupational percutaneous injuries (4-7).

Bloodborne Virus Transmission to Healthcare Personnel

Injuries from needles and other sharp devices used in healthcare and laboratory settings are associated with the occupational transmission of more than 20 pathogens (2,3,8-10). HBV, HCV, and HIV are the most commonly transmitted pathogens during patient care (Table 1).

Hepatitis B Virus

National hepatitis surveillance provides yearly estimates of HBV infections in healthcare personnel. These estimates are based on the proportion of persons with new infections who report frequent occupational blood contact. CDC estimated that 12,000 HBV infections occurred in healthcare personnel in 1985 (11). Since then, the number has declined steadily, down to an estimated 500 in 1997 (12).  The decline in occupational HBV-more than 95%-is due largely to the widespread immunization of healthcare personnel. Although universal precautions also help reduce blood exposures and HBV infections in healthcare personnel (13-15), the extent of their contribution cannot be precisely quantified.

Most healthcare personnel today are immune to HBV as the result of pre-exposure vaccination (16-21). However, susceptible healthcare personnel are still at risk for needlestick exposure to an HBV-positive source. Without postexposure prophylaxis, there is a 6%-30% risk that an exposed, susceptible healthcare worker will become infected with HBV (22-24). The risk is highest if the source individual is hepatitis B e antigen positive, a marker of increased infectivity (22).

Hepatitis C Virus

Before the implementation of universal precautions and the discovery of HCV in 1990, an association was noted between employment in patient care or laboratory work and acquiring acute non-A, non-B hepatitis (25). One study showed an association between anti-HCV positivity and a history of accidental needlestick exposures (26).

The precise number of healthcare personnel who acquire HCV occupationally is not known. Healthcare personnel exposed to blood in the workplace represent 2% to 4% of the total new HCV infections occurring annually in the United States (a total that has declined from 112,000 in 1991 to 38,000 in 1997) (27, CDC, unpublished data). However, there is no way to confirm that these are occupational transmissions. Prospective studies show that the average risk of HCV transmission following percutaneous exposure to an HCV-positive source is 1.8% (range: 0% -7%)  (28-33), with one study indicating that transmission occurred only from hollow-bore needles compared with other sharps (28)

A number of case reports also document occupational HCV transmission to healthcare personnel (34-40). All except two involve percutaneous injuries: one case of HCV and another of HCV and HIV transmission via splash to the conjunctiva (39, 40). To date, no transmission in healthcare personnel has been documented through intact or non-intact skin HCV blood exposure.  However, one case of HIV and HCV transmission from a nursing home patient to a health care worker is thought to have occurred through a non-intact skin exposure (41).

Human Immunodeficiency Virus

The first case of HIV transmission from a patient to a healthcare worker was reported in 1986 (42). Through December, 2001, CDC had received voluntary reports of 57 documented and 138 possible episodes of HIV transmission to healthcare personnel in the United States ( http://www.cdc.gov/ncidod/hip/BLOOD/hivpersonnel.htm/).

In prospective studies of healthcare personnel,  the average risk of  HIV transmission after a percutaneous exposure is estimated to be approximately 0.3% (10).

In a retrospective case-control study of healthcare personnel with percutaneous exposure to HIV, the risk for HIV infection was found to be increased with exposure to a larger quantity of blood from the source person as indicated by a) a device visibly contaminated with the patient's blood, b) a procedure that involves placing a needle directly in the source patient's vein or artery, or c) a deep injury (43).  Of the 57 documented cases of HIV transmission to healthcare personnel in the United States, most involve exposure to blood through a percutaneous injury, usually with a hollow-bore needle that was in a blood vessel (vein or artery) (CDC, unpublished data).

The average risk for occupational HIV transmission after a mucous-membrane exposure is estimated to be 0.09% (44).  Although episodes of HIV transmission after skin exposures are documented (45), the average risk for transmission has not been precisely quantified but is estimated to be less than the risk  mucous-membrane exposures (46).

Cost of Needlestick Injuries

Although occupational HIV and hepatitis seroconversion is relatively rare, the risks and costs associated with a blood exposure are serious and real. Costs include the direct costs associated with the initial and follow-up treatment of exposed healthcare personnel, which are estimated to range from $500 to $3,000 depending on the treatment provided (47). Costs that are harder to quantify include the emotional cost associated with fear and anxiety from worrying about the possible consequences of an exposure, direct and indirect costs associated with drug toxicities and lost time from work, and the societal cost associated with an HIV or HCV seroconversion; the latter includes the possible loss of a worker's services in patient care, the economic burden of medical care, and the cost of any associated litigation.

Epidemiology of Needlesticks and Other Sharps-related Injuries

Data on needlesticks and other sharps-related injuries are used to characterize the who, where, what, when, and how of such events. Aggregated surveillance data from the National Surveillance System for Health Care Workers (NaSH) are used here to provide a general description of the epidemiology of percutaneous injuries. Similar statistics from hospitals participating in the Exposure Prevention Information Network (EPINet) system, developed by Dr. Janine Jagger and colleagues at the University of Virginia, may be found on the International Health Care Worker Safety Center website http://www.med.virginia.edu/epinet/soi01.html.

Who is at Risk of Injury?

Data from NaSH show that nurses sustain the highest number of percutaneous injuries. However, other patient-care providers (e.g., physicians, technicians), laboratory staff, and support personnel (e.g., housekeeping staff), are also at risk (Figure 1). Nurses are the predominant occupational group injured by needles and other sharps, in part because they are the largest segment of the workforce at most hospitals. When injury rates are calculated based on the number of employees or full-time equivalent (FTE) positions, non-nursing occupations sometimes have a higher rate of injury (Table 2).

Where, When and How Do Injuries Occur?

Although sharp devices can cause injuries anywhere within the healthcare environment, NaSH data show that the majority (40%) of injuries occur on inpatient units, particularly medical floors and intensive care units, and in operating rooms (Figure 2).  Injuries most often occur after use and before disposal of a sharp device (41%), during use of a sharp device on a patient (39%), and during or after disposal (16%).(CDC unpublished data) There are many possible mechanisms of injury during each of these periods as shown in NaSH data on hollow-bore needle injuries (Figure 3).

What Devices Are Involved in Percutaneous Injuries?

Although many types of sharps injure healthcare personnel, aggregate data from NaSH indicates that six devices are responsible for nearly eighty percent of all injuries (Figure 4).  These are:

• Disposable syringes (32%)
• Suture needles (19%)
• Winged steel needles (12%)
• Scalpel blades (7%)
• Intravenous (IV) catheter stylets (6%)
• Phlebotomy needles (3%)

Overall, hollow-bore needles are responsible for 59% of all sharps injuries in NaSH.

Device-related factors also influence percutaneous injury risks. A 1988 article by Jagger et al. (52) demonstrates that devices requiring manipulation or disassembly after use (such as needles attached to IV tubing, winged steel needles, and IV catheter stylets) were associated with a higher rate of injury than the hypodermic needle or syringe.

Importance of Hollow-bore Needle Injuries

Of particular concern are injuries from hollow-bore needles, especially those used for blood collection or IV catheter insertion. These devices are likely to contain residual blood and are associated with an increased risk for HIV transmission (43). Of the 57 documented cases of occupational HIV transmission to healthcare personnel reported to CDC through December 2001, 50 (88%) involve a percutaneous exposure. Of these, 45 (90%) were caused by hollow-bore needles, and half of these needles were used in a vein or an artery (CDC, unpublished data). Similar injuries are seen in occupational HIV transmission in other countries (53).

Although two scalpel injuries (both in the autopsy setting) caused HIV seroconversions (CDC, unpublished data), solid sharps, such as suture needles, generally deliver a smaller blood inoculum, especially if they first penetrate gloves or another barrier (54). Therefore, these devices theoretically pose a lower risk for HIV transmission. Similar descriptive data are not available for the types of devices or exposures involved in the transmission of HBV or HCV.        

Sharps Injuries in the Operating Room

Among NaSH hospitals, the operating room is the second most common environment in which sharps injuries occur, accounting for 25% of injuries overall(CDC, unpublished data). However, the epidemiology of sharps injuries in the operating room differs from that in other hospital locations. Observational studies of operative procedures have recorded some type of blood exposure to healthcare personnel in 7% to 50% of exposures; in 2% to 15% of exposure, the event is a percutaneous injury-usually from a suture needle (55-59). Aggregate data from nine hospitals on injuries among operating room staff also reflect the importance of suture needles, which in this study account for 43% of the injuries (60).

Injury Prevention Strategies

Historical Perspective and Rationale for a Broad-Based Strategy for Preventing Sharps Injuries

In 1981, McCormick and Maki first described the characteristics of needlestick injuries among healthcare personnel and recommended a series of prevention strategies, including educational programs, avoidance of recapping, and better needle disposal systems (48). In 1987, CDC's recommendations for universal precautions included guidance on sharps injury prevention, with a focus on careful handling and disposal of sharp devices (61). Several reports on needlestick prevention  published between 1987 and 1991 focused on the appropriate design and convenient placement of puncture-resistant sharps disposal containers and the education of healthcare personnel on the dangers of recapping, bending, and breaking used needles (62-68). Most of these studies documented only limited success of specific interventions to prevent disposal-related injuries and injuries due to recapping (51,64-67). Greater success in decreasing injuries was reported if the intervention included an emphasis on communication (62,68).

Universal (now standard) precautions is an important concept and an accepted prevention approach with demonstrated effectiveness in preventing blood exposures to skin and mucous membranes (13,14). However, it focuses heavily on the use of barrier precautions (i.e., personal protective practices) and work-practice controls (e.g., care in handling sharp devices) and by itself could not be expected to have a significant impact on the prevention of sharps injuries. Although personal protective equipment (e.g., gloves, gowns) provide a barrier to shield skin and mucous membranes from contact with blood and other potentially infectious body fluids, most protective equipment is easily penetrated by needles.

Thus, although strategies used to reduce the incidence of sharps injuries (e.g., rigid sharps disposal containers, avoidance of recapping) a decade or more ago remain important today, additional interventions are needed.

Current Prevention Approaches

In recent years, healthcare organizations have adopted as a prevention model the hierarchy of controls concept used by the industrial hygiene profession to prioritize prevention interventions. In the hierarchy for sharps injury prevention, the first priority is to eliminate and reduce the use of needles and other sharps where possible. Next is to isolate the hazard, thereby protecting an otherwise exposed sharp, through the use of an engineering control. When these strategies are not available or will not provide total protection, the focus shifts to work-practice controls and personal protective equipment.

Since 1991, when OSHA first issued its Bloodborne Pathogens Standard (69) to protect healthcare personnel from blood exposure, the focus of regulatory and legislative activity has been on implementing a hierarchy of control measures.  This has included giving greater attention to removing sharps hazards through the development and use of engineering controls. By the end of 2001, 21 states had enacted legislation to ensure the evaluation and implementation of safer devices to protect healthcare personnel from sharps injuries ( http://www.cdc.gov/niosh/ndl-law.htm).  Also, the federal Needlestick Safety and Prevention Act signed into law in November, 2000 (Current Prevention Approaches) authorized OSHA's recent revision of its Bloodborne Pathogens Standard to more explicitly require the use of safety-engineered sharp devices. (http://www.osha.gov/SLTC/bloodbornepathogens/ index.html)

Alternatives to Using Needles. Healthcare organizations can eliminate or reduce needle use in several ways. The majority (~70%) of U.S. hospitals (70) have eliminated unnecessary use of needles through the implementation of IV delivery systems that do not require (and in some instances do not permit) needle access. (Some consider this a form of engineering control described below.) This strategy has largely removed needles attached to IV tubing, such as that for intermittent ("piggy-back") infusion, and other needles used to connect and access parts of the IV delivery system. Such systems have demonstrated considerable success in reducing IV-related sharps injuries (71-73). Other important strategies for eliminating or reducing needle use include:

• Using alternate routes for medication delivery and vaccination when available and safe for patient care, and
• Reviewing specimen collection systems to identify opportunities to consolidate and eliminate unnecessary punctures, a strategy that is good for both patients and healthcare personnel.

Engineering Controls. Engineering controls remove or isolate a hazard in the workplace. In the context of sharps injury prevention, engineering controls include sharps disposal containers and needles and other sharps devices with an integrated engineered sharps injury prevention feature. The emphasis on engineering controls has led to the development of many types of devices with engineered sharps injury prevention features (74-78) and there are suggested criteria for the design and performance of such devices (52). These criteria propose that the safety feature should accomplish the following:

• Provide a rigid cover that allows the hands to remain behind the needle,
• Ensure that the safety feature is in effect before disassembly and remains in effect after disposal,
• Be an integral part of the device,
• Be simple and obvious in operation, and
• Be cost effective.

Moreover, features designed to protect healthcare personnel should not compromise patient care (79).

Relatively few studies are published that systematically assess the effectiveness of safety devices in reducing percutaneous injuries (other than those involving needle-free IV systems), despite the proliferation of these devices (Table 3). Reports that are available show considerable variation in study methodology, measurement of outcomes, and efficacy. Also, there are apparent differences in efficacy by type of device.

Table 3. Effectiveness of devices with sharps injury prevention features and other sharps injury prevention measures

 * PI = percutaneous injuries

In 1998, OSHA published a Request for Information in the Federal Register on "engineering and work practice controls used to minimize the risk of occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps." There were 396 responses to this request; several respondents provided data and anecdotal information on their experiences with safety devices.  (http://www.osha.gov/html/ndlreport052099.html)

Research suggests that no single safety device or strategy works the same in every facility. In addition, no standard criteria exist for evaluating safety claims, although all major medical device manufacturers market devices with safety features. Therefore, employers must develop their own programs to select the most appropriate technology and evaluate the effectiveness of various devices in their specific settings.

Work-practice Controls. With the current focus on engineered technology, there is little new information on the use of work-practice controls to reduce the risk of sharps injuries during patient care. One exception is the operating room. Work-practice controls are an important adjunct for preventing blood exposures, including percutaneous injuries, in surgical and obstetrical settings because the use of exposed sharps cannot be avoided.  Operating room controls include:

• Using instruments, rather than fingers, to grasp needles, retract tissue, and load/unload needles and scalpels;
• Giving verbal announcements when passing sharps;
• Avoiding hand-to-hand passage of sharp instruments by using a basin or neutral zone;
• Using alternative cutting methods such as blunt electrocautery and laser devices when appropriate;
• Substituting endoscopic surgery for open surgery when possible; and
• Using round-tipped scalpel blades instead of sharp-tipped blades (85-88). 

The use of blunt suture needles, an engineering control, is also shown to reduce injuries in this setting (89). These measures help protect both the healthcare provider and patient from exposure to the other's blood (90).

Multi-component Prevention Approaches

Experts agree that safety devices and work practices alone will not prevent all sharps injuries (85, 90-95). Significant declines in sharps injuries also requires:

• Education,
• A reduction in the use of invasive procedures (as much as possible),
• A secure work environment, and
• An adequate staff-to-patient ratio.

One report detailed a program to decrease needlestick injuries that involves simultaneous implementation of multiple interventions:

• Formation of a needlestick prevention committee for compulsory in-service education programs;
• Out-sourcing of replacement and disposal of sharps boxes;
• Revision of needlestick policies; and
• Adoption and evaluation of a needleless IV access system, safety syringes, and a prefilled cartridge needleless system (94).

This strategy showed an immediate and sustained decrease in needlestick injuries, leading researchers to conclude that a multi-component prevention approach can reduce sharps injuries.

Organizational Factors

Some industrial sectors are finding that a strong safety culture correlates with: productivity, cost, product quality, and employee satisfaction (96).  Organizations with strong safety cultures consistently report fewer injuries than organizations with weak safety cultures. This happens not only because the workplace has well-developed and effective safety programs, but also because management, through these programs, sends cues to employees about the organization's commitment to safety. The concept of institutionalizing a culture of safety is relatively new for the healthcare industry and there is limited literature on the impact of such efforts. However, a  recent study in one healthcare organization linked measures of safety culture with both employee compliance with safe work practices and reduced exposure to blood and other body fluids, including reductions in sharps-related injuries (97).

System analysis strategies, used by many healthcare organizations to improve patient safety, also can be applied to the prevention of sharps-related injuries to healthcare personnel.  These strategies include the following:

• Defining "Sentinel Events" and performing a "Root Cause Analysis" to determine their underlying cause.
• Applying "Failure Mode Analysis" to a problem pre-event to systematically identify how to prevent it from occurring.

Detailed information on these and other systems approaches to patient safety may be found at http://www.patientsafety.gov.

Healthcare Personnel Acceptance

Healthcare personnel have difficulties changing long-standing practices. This observation is borne out by studies conducted in the years following implementation of universal precautions, when observed compliance with recommended practices was not satisfactory (98-103). The same holds true for devices with safety features-healthcare organizations have difficulty convincing healthcare personnel to adopt new devices and procedures (94). Psychosocial and organizational factors that slow the adoption of safety practices include:

• Risk-taking personality profile,
• Perceived poor safety climate in the workplace, and
• Perceived conflict of interest between providing optimal patient care and protecting oneself from exposure (102). Personnel most readily change their behavior when they think that:
• They are at risk.
• The risk is significant.
• Behavior change will make a difference.
• The change is worth the effort (104).

A few authors have applied research methods and behavior-change models from other disciplines to study the acceptability of infection-control strategies (105,106). English used an adult learner model to evaluate needle injuries in hospital personnel and found that knowledge of correct procedures, provision of safe equipment, and proper management predicted compliance with needlestick-prevention precautions (105). Others consider the use of the Health Belief Model to help understand the reluctance to adopt preventive behaviors to decrease sharps injuries, and they suggest that cognitive approaches and behavior modification strategies be incorporated into an overall program to prevent sharps injuries (98, 100). Other models, including the Theory of Reasoned Action and the Theory of Planned Behavior, are recommended when considering a theoretical based intervention for improving practice (98). Further research on how these models will affect sharps injury prevention is needed.

The Need for Guidance

According to the authors of the American Hospital Association injury prevention guide (95), facilities that have adopted or are adopting safety technologies find the process to be complex and exacting. Successful injury prevention programs require:

• Comprehensive reporting of injuries,
• Meticulous follow-up,
• Thorough education in use of the new devices, and
• Accurate evaluation of effectiveness.

Also, although most healthcare organizations recognize the need for an interdisciplinary approach to this complex undertaking, "... few are prepared for the difficulties in attempting to change behavior, the complex logistics of supplies and equipment in a modern hospital, or the methodological and analytical rigors of documenting the impact of safety devices" (93).

In November, 1999, CDC/NIOSH issued the NIOSH Alert: Preventing Needlestick Injuries in Healthcare Settings to guide employers and healthcare personnel on strategies for preventing sharps injuries. CDC is providing this workbook, which compliments the  CDC/NIOSH Alert, to assist healthcare organizations in their programmatic efforts to improve healthcare personnel safety.

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ORGANIZATIONAL STEPS

This section describes a series of organizational steps that are designed to ensure that a sharps injury prevention program:

• Is integrated into existing safety programs,
• Reflects the current status of an institution's prevention activities, and
• Targets appropriate areas for performance improvement.

Processes Performance Improvement

Although the program focuses on preventing sharps injuries, it is based on principles that can be applied to the prevention of all types of blood exposures.

Step 1. Develop Organizational Capacity

The proposed model is an institution-wide program (i.e., encompassing all aspects of an organization, whether a small private practice or a complex medical center) in which responsibility is held jointly by members of a multidisciplinary leadership team that is focused on eliminating sharps injuries to healthcare personnel. Representation of staff from across disciplines ensures that needed resources, expertise, and perspectives are involved. The responsibility and authority for program coordination should be assigned to an individual with appropriate organizational and leadership skills. Representation from senior-level management is important to provide visible leadership and demonstrate the administration's commitment to the program. The team should also include persons from clinical and laboratory services who use sharp devices, as well as staff with expertise in infection control, occupational health/industrial hygiene, inservice training or staff development, environmental services, central service, materials management, and quality/risk management, as available. Regardless of the type or size of the organization, a multidisciplinary approach is essential to identify health and safety issues, analyze trends, implement interventions, evaluate outcomes, and make recommendations to other organizational components.

Model for a Leadership Team

Although the leadership team should include a small core group of clinical staff, other staff from areas such as radiology, anesthesiology, respiratory therapy, surgery, hemodialysis, intensive care, pediatrics, and other units might be invited to participate in a particular discussion or as part of an ad hoc subcommittee.

In this first step, the leadership team should outline how it plans to achieve the goal of injury reduction or elimination. The team should determine which of the facility's standing committees will contribute to the process and how these committee's will exchange information. Committees might include:

• Infection Control
• Quality Improvement
• Occupational Health and Safety
• Value Analysis
• Materials Management/Product Evaluation

In some organizations, one of these committees might be charged with oversight of the sharps injury prevention program. However, each committee should become involved in designing the sharps injury prevention program. For example, the Occupational Safety and Health or Infection Control committees might provide monthly reports on sharps injuries. In turn, the leadership team might work with the Occupational Safety and Health or Infection Control committees to improve the quality of information collected to better meet performance improvement goals.

Step 2. Assess Program Operation Processes

The proposed program model includes five operational processes, each of which is discussed in detail in subsequent sections of the workbook. These include:

1. Institutionalize a culture of safety in the work environment,
2. Implement procedures for reporting and examining sharps injuries and injury hazards,
3. Analyze sharps injury data for prevention planning and measuring performance improvement,
4. Selection of sharps injury prevention devices (e.g., devices with safety features), and
5. Education and training of healthcare personnel on sharps injury prevention.

The team should conduct a baseline assessment of each of these processes to determine where improvements are needed.

Toolkit Resource for This Activity:

Assessing the Culture of Safety

This assessment determines how safety, particularly sharps injury prevention, is valued in the organization and what processes are in place to promote a safe work environment for the protection of patients and healthcare personnel. Key elements of an organizational safety culture and suggestions for improving safety awareness are discussed in Operational Processes, Institutionalize a Culture of Safety in the Work Environment. As part of a baseline assessment, the team should assess the following:

• Organization leadership's commitment to safety;
• Strategies used to report injuries and to identify and remove injury hazards;
• Feedback systems to improve safety awareness; and
• Methods to promote individual accountability for safety.

The team should also explore the data sources (e.g., written or observational surveys, incident reports) that are used or could be used to measure safety culture performance improvement. As part of the baseline assessment and as a possible mechanism for measuring performance improvement, the team might consider using the following tool to survey staff about their perceptions of a safety culture in the organization.

Toolkit Resource for This Activity:

Assessing Procedures for Sharps Injury Reporting

Most healthcare organizations have procedures for reporting and documenting employee needlesticks and other percutaneous injuries. The team should assess whether these procedures are adequate for data collection and analysis and determine the data sources that can be used to assess improvements in injury reporting.

As part of the baseline assessment, the team should consider using the following tool to assess the completeness of sharps injury reporting. (Although postexposure management is not included in the model for a sharps injury prevention program, the survey tool does include questions that can be used to assess worker satisfaction with the postexposure management process.) Periodic repeat surveys (e.g., every few years) can be used to measure improvements in reporting compliance.

Toolkit Resource for This Activity:

Assessing Methods for the Analysis and Use of Sharps Injury Data

Data on sharps injuries need to be analyzed and interpreted so it will be meaningful for prevention planning. This part of the assessment determines how these data are compiled and used in the organization. See Operational Processes, Analyze Sharps Injury Data, for a discussion of how to perform simple data analysis.

Assessing the Process for Identifying, Selecting, and Implementing Engineered Sharps Injury Prevention Devices

Because an important goal of this workbook is to provide information and guidance on the implementation of devices with engineered sharps injury prevention features, a model approach for the evaluation of these devices is included in Operational Processes, Selection of Sharps Injury Prevention Devices. This baseline assessment considers who is involved and how decisions are made. As with other program functions, it is important to determine the data sources (e.g., product evaluation committee reports, lists of manufacturers contacted, device lists) that can be used to measure process improvement. A similar process assessment of methods for identifying and implementing other prevention interventions (e.g., changes in work practices, policies, and procedures) also could be included in this baseline assessment.

Assessing Programs for the Education and Training of Healthcare Personnel on Sharps Injury Prevention

Most healthcare institutions have a plan for providing employee education and training on bloodborne pathogen prevention at the time of hire, as well as on an annual basis. The implementation of a sharps injury prevention program is an opportune time to reassess the quality of these efforts and to identify other education and  training opportunities. As with other processes, it is necessary to identify the data (e.g., staff development reports, curriculum changes, training) that can be used to assess improvements in educating and training healthcare personnel.

Step 3. Prepare a Baseline Profile of Sharps Injuries and Prevention Activities

After assessing program operations, the next step is to develop a baseline profile of injury risks in the institution. This information, along with the information gleaned from the baseline assessment, will be used to develop an intervention action plan.

Toolkit Resource for This Activity:

Toolkit Resource for This Activity:

Using data currently available in the organization and the tools provided in this workbook, develop a profile of how injuries are occurring and a list of current prevention strategies. The following questions may help guide the development of this profile, but other questions may be added.

• What occupational groups most frequently sustain sharps injuries?
• Where do sharps injuries most frequently occur?
• What devices are most commonly involved in sharps injuries?
• What circumstances or procedures contribute to sharps injuries?
• What sharps injuries pose an increased risk for bloodborne virus transmission?
• Has the organization taken steps to limit the unnecessary use of needles by healthcare personnel? If so, how has this been done?
• What devices with engineered sharps injury prevention features have been implemented?
• Is there a list of recommended work practices to prevent sharps injuries?
• What communication tools have been used to promote safe sharps handling techniques?
• Is there a policy/procedure for determining the appropriate location of sharps containers?
• Who is responsible for removing/replacing sharps containers?

Step 4.     Determine Intervention Priorities

Not all problems can be addressed at once, so healthcare organizations must decide which sharps injury problems should receive priority attention. Baseline information on sharps injuries, along with the weaknesses identified in the assessment of program operation processes, should be used to determine priority areas.

Sharps Injury Prevention Priorities

The following approaches can be used alone or in combination to create a list of initial priorities for intervention:

• Determine priorities based on injuries that pose the greatest risk for bloodborne virus transmission (e.g., focus initially on preventing injuries associated with vascular access)
• Determine priorities based on the frequency of injury with a particular device (e.g., focus on injuries associated with hypodermic or suture needles)
• Determine priorities based on a specific problem contributing to a high frequency of injuries (e.g., focus on sharps handling and/or disposal)

Toolkit Resource for This Activity:

Program Process Improvement Priorities

Leadership teams might consider selecting one problem in each of the processes or focus only on one of the processes for performance improvement. Give priority to those areas that will have the greatest impact on improving the overall operation of the program.

Step 5. Develop and Implement Action Plans

An intervention action plan provides a road map for charting the course, monitoring progress, and measuring performance improvements in a sharps injury prevention program. Two intervention action plans are proposed:

• The first focuses on implementing and measuring interventions to reduce specific types of injuries.
• The second measures improvements that are the result of the program processes.

Action Plan to Reduce Injuries

Set Targets for Injury Reduction. Based on the list of priorities, set targets for reducing specific types of injuries over a designated period (e.g., six months, one year). These targets should provide reasonable expectations based on the interventions available and the degree to which they are likely to be successful.

Specify Interventions. For each problem targeted for intervention, apply one or more of the following strategies:

• Substitute a non-sharp alternative for performing a procedure
• Implement a device with an engineered sharps injury prevention feature
• Recommend a change in work practice
• Change a policy or procedure
• Provide targeted education of healthcare personnel

The intervention action plan should reflect each strategy used and describe the steps, time line, and responsibility for implementation.

Identify Indicators of Performance Improvement. Indicators are tools for measuring progress; they tell when a goal is reached. The following can be used to measure the impact of an intervention on injuries:

• Changes in the frequency of certain types of injuries
• Frequency of compliance with the use of a newly implemented engineering control
• Changes in injury rates, e.g., device-specific or occupational

Once the indicators are identified, the team will need to decide:

• How frequently indicators will be monitored (e.g., monthly, quarterly, semiannually, annually), and
• How and by whom they will be reported.

Toolkit Resource for This Activity:

Action Plan to Measure Program Performance Improvement

The baseline profile will identify the strengths and weaknesses of the organization's sharps injury prevention activities. With this information, the team can create a list of priorities for performance improvement and then decide how to accomplish the necessary tasks. When writing this part of the action plan, the team should be sure that the areas for process improvement are clear and measurable. To increase the likelihood of success, only a few improvements should be taken on at a time.

Step 6. Monitor Program Performance

The one questions asked repeatedly during the assessment of operational processes is: What data can be used to measure performance improvement for each process? Once identified, data from each of these processes should be used to monitor overall program performance. In addition, as with any planning function, a checklist of activities and a timeline for implementation should be developed to monitor progress. The team should consider developing a monthly or quarterly schedule for reviewing performance improvement. Not all areas targeted for improvement need to be reviewed at each team meeting. By spreading these over the year, the team can spend more time on each issue. If the desired objectives are not being met, the team should redesign the plan accordingly.

The process of designing, implementing, and evaluating a sharps injury prevention program is continuous. At least once a year, the team should reassess the processes for avoiding injuries.

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OPERATIONAL PROCESSES

The following section describes five operational processes that are viewed as essential elements of any sharps injury prevention program. Toolkit resources to assess, implement, or evaluate these processes are included in the appendices.

Institutionalize a Culture of Safety in the Work Environment

Introduction

Many strategies to reduce sharps injuries focus on individual- or job/task-level improvements (e.g., implementing appropriate safety devices, using safe work practices).  However, this particular strategy considers sharps injury prevention in the context of a broader organizational perspective of safety, namely institutionalizing a culture of safety to protect patients, personnel, and others in the healthcare environment. The following describes safety culture concepts and discusses why having a safety culture is important to the success of a sharps injury prevention program.

Safety Culture Concepts. From an organizational perspective, culture refers to those aspects of an organization that influence overall attitudes and behavior. Examples include:

• Leadership and management style
• Institution mission and goals
• Organization of work processes

An organizational culture is the accepted norms that each place of work establishes for day-to-day tasks. It is shown to be strongly associated with workers' perceptions of job characteristics and organizational functioning (107).

A culture of safety is the shared commitment of management and employees to ensure the safety of the work environment. A culture of safety permeates all aspects of the work environment. It encourages every individual in an organization to project a level of awareness and accountability for safety. Employees perceive the presence of a culture of safety based on multiple factors, including:

• Actions taken by management to improve safety,
• Worker participation in safety planning,
• Availability of written safety guidelines and policies,
• Availability of appropriate safety devices and protective equipment,
• Influence of group norms regarding acceptable safety practices, and
• Socialization processes around safety that personnel experience when they first join an organization.

All of these factors serve to communicate the organization's commitment to safety.

Value of Institutionalizing a Culture of Safety to Healthcare Organizations. Most of our knowledge about safety culture comes from the manufacturing sector and heavy-industry work settings, where it was first studied. Critical determinants of the successful safety programs in early research include:

• Management's involvement in safety programs,
• High status and rank for safety officers,
• Strong safety training and safety communications programs,
• Orderly plant operations, and
• An emphasis on recognizing individual safe performance rather than a relying on punitive measures.

The concept of institutionalizing a culture of safety is relatively new for the healthcare industry and much of the focus is on patient safety. However, recent studies in some healthcare organizations link measures of safety culture to:

• Employee compliance with safe work practices, and
• Reduced exposure to blood and other body fluids, including reductions in sharps-related injuries (94, 96).

Safety culture is also relevant to patient care and safety. According to an Institute of Medicine (IOM) report, To Err is Human (109), medical errors represent one of the nation's leading causes of death and injury. The report estimates that 44,000 to 98,000 deaths occur in U.S. hospitals each year. Although the report acknowledges that causes of medical error are multifaceted, the authors repeatedly emphasize the pivotal role of safety culture. Thus, whereas the focus of this workbook is on healthcare personnel safety, strategies related to safety culture also have important implications for the health and welfare of patients.

Strategies for Creating a Culture of Safety

To create a culture of safety, organizations must address those factors known to influence employees' attitudes and behavior. Organizations must also direct measures to reduce hazards in the environment. Although many factors influence a culture of safety, this workbook emphasizes those that are believed to be the major determinants of a safety culture.

Ensure Organizational Commitment. Organizations can use three important strategies to communicate their involvement in and commitment to safety:

• Include safety-related statements (e.g., zero tolerance for unsafe conditions and practices in the healthcare environment) in statements of the organization's mission, vision, values, goals, and objectives;
• Give high priority and visibility to safety committees, teams, and work groups (e.g., occupational health, infection control, quality assurance, pharmacy, and therapeutics), and ensure direct management involvement in the evaluation of committee processes and impact
• Require action plans for safety in ongoing planning processes. (e.g., an action plan for improving the culture of safety for sharps injury prevention could be one element in an overall safety culture initiative.)

Management can also communicate a commitment to safety indirectly by modeling safe attitudes and practices. Healthcare professionals in positions of leadership send important messages to subordinates when they:

• Handle sharp devices with care during procedures,
• Take steps to protect co-workers from injury, and
• Properly dispose of sharps after use.

Similarly, managers should address sharps hazards in a non-punitive manner as soon as they are observed and discuss safety concerns with their staff on a regular basis. This will positively reflect the organization's commitment to safety and build safety awareness among staff.

Involve Personnel in the Planning and Implementation of Activities That Promote a Safe Healthcare Environment. Involving personnel from various areas and disciplines while planning and implementing activities improves the culture of safety and is essential to the success of such an initiative. Those personnel who participate on committees or teams created to institutionalize safety serve as conduits of information from and to their various work sites. They also legitimize the importance of the initiative in the eyes of their peers.

Encourage Reportingand Removal of Sharps Injury Hazards. Another strategy for institutionalizing a culture of safety is to create a blame-free environment for reporting sharps injuries and injury hazards. Healthcare personnel who know that management will discuss problems in an open and blame-free manner are more likely to report hazards. Healthcare organizations can also actively look for sharps injury hazards by performing observational rounds and encouraging staff to report near misses and observed hazards in the work place. (See Implement Procedures for Reporting Sharps Injuries and Injury Hazards.) Once identified, hazards should be investigated as soon as possible to determine the contributing factors, and actions should be taken to remove or prevent the hazard from occurring in the future.

Develop Feedback Systemsto Increase Safety Awareness. A number of communication strategies can provide timely information and feedback on the status of sharps injury prevention in the organization. One strategy incorporates findings from hazard investigations, ongoing problems with sharps injuries, and prevention improvements into articles in the organization's newsletter, staff memoranda, and/or electronic communication tools. It is important to communicate the value of safety by providing feedback when the problem is first observed and commending improvements. Another strategy is to create brochures and posters that enhance safety awareness. Such materials can reinforce prevention messages and highlight management's commitment to safety.

Promote Individual Accountability. Promoting individual accountability for safety communicates a strong message about the organization's commitment to a safe healthcare environment. In order for accountability to be an effective tool, all levels in the organization must comply. An organization can promote individual accountability for safe practices in general-and sharps injury prevention in particular-in many ways. One way is to incorporate an assessment of safety compliance practices in annual performance evaluations; for managers and supervisors, this might include evaluating methods used to communicate safety concerns to their subordinates. Organizations might also consider having staff sign a pledge to promote a safe healthcare environment. This could be incorporated into hiring procedures and/or as part of an organization-wide safety campaign.

Measuring Improvements in the Safety Culture

Data from four possible sources can measure how improvements in safety culture affect sharps injury prevention:

• Staff surveys on perceptions of a safety culture in the organization and reporting of blood and body- fluid exposures (Appendices A-2 and A-3),
• Sharps injury reports (Appendix A-7),
• Hazard reports (Appendix A-9-1), and
• Observational hazard assessment reports (Appendix A-9-2).

Each of the above tools can demonstrate changes over time that serve to indicate improvements in the safety culture.  For example, decreased frequency of selected items on a blood exposure report form can  reflect an increased safety consciousness (e.g., improperly discarded sharps, collisions between personnel that result in a sharps injury). Also, periodic (e.g., every few years) personnel surveys on perceptions of safety and exposure reporting are likely to reflect positive changes in the organization's commitment to safety. Hazards will also decrease as problems are addressed and corrected. If no improvements are detected, the sharps injury prevention leadership team should reassess its strategies and revise the performance improvement action plan.

Additional information on implementing a culture of safety is available at the following Websites:

• http://www.patientsafety.gov/

Implement Procedures for Reporting and Examining  Sharps Injuries and Injury Hazards

Introduction

Most healthcare organizations have procedures to report and document employees' exposures to blood and body fluids. However, many organizations have or are initiating procedures to identify hazards or near misses that could lead to sharps injuries and other adverse events. The latter is a proactive way to intervene to prevent injuries before they happen. Quality data on both reported injuries and injury hazards are important sources of information for prevention planning. Obtaining this information requires that healthcare personnel understand what to report and how to report in addition to being motivated to follow the reporting procedures. Both activities require forms to record relevant data as well as a central repository for the collected information. This section:

• Discusses how to establish an effective process for reporting process and
• Identifies the information that is essential in order to identify risks and plan prevention strategies.

Develop an Injury Reporting Protocoland Documentation Method

Characteristics of a Reporting Protocol. Every healthcare organization should have a written protocol that describes where and how healthcare personnel should seek medical evaluation and treatment after an occupational exposure to blood or body fluids, including percutaneous injury. To ensure timely medical treatment, the protocol should encourage prompt reporting and describe procedures for the rapid provision of medical care during all work hours (day, evening, and night shifts). In some cases, this will require designating different places for exposure evaluation and care. The reporting system should ensure that records of exposed employees and non-employees (e.g., students, per diem staff, volunteers) are maintained in a confidential manner. Exposure reports should be maintained in a designated area (e.g., occupational health, infection control) for purposes of follow-up and record keeping.

Characteristics of a Report Form. In the past, healthcare organizations typically used one report form to document any type of incident involving a patient or employee (e.g., fall, medication error, sharp injury). Although this type of form may provide descriptive information, it generally does not collect sufficient details to analyze injuries or measure prevention improvement.

Several organizations, including CDC, have developed forms to collect detailed information on sharps injuries reported by healthcare personnel. These forms can serve multiple purposes:

• Collecting descriptive information to help monitor sharps injuries and the impact of prevention interventions,
• Providing information to guide the medical exposure management, and
• Providing documentation for meeting regulatory requirements.

To effectively monitor injuries for sharps injury prevention planning purposes, minimal data needs include:

• Name and/or identification number of healthcare worker;
• Date, time, and work location of the injury;
• Occupation of the worker;
• Type of device involved in the injury, and presence or absence of an engineered sharps injury prevention feature on the device involved;
• Purpose or procedure for which the sharp device was being used; and
• When and how the injury occurred.

Regulatory requirement also dictate what information must be collected. Federal OSHA and some state laws or regulations now require a record of the brand and manufacturer of any device involved in an injury to a worker. Devices with engineered sharps injury prevention features  are designed specifically to prevent injuries to healthcare personnel.  Incident reports that involve these devices must include adequate information on these devices to be able to ascertain whether the injury was due to:

• Design flaw,
• Manufacturing defect,
• Device failure,
• Operator error (e.g., failure to activate the safety feature), or
• Other circumstances (e.g., movement of the patient that precluded use of the safety feature).

As with any medical product, if the device or equipment is potentially defective, the lot number and information about the defect should be reported to the Food and Drug Administration. (Healthcare organizations should also review new OSHA procedures for maintaining a sharps injury log, included in the recently revised Bloodborne Pathogens Standard [CFR 1910.1030 (h)] that took effect on April 18, 2001, and for using OSHA Forms 300 Log of Work-Related Injuries and Illnesses and 301 Injury and Illness Incident Report that were required for use by January 1, 2002. Both the log and the individual report forms record many kinds of occupational injuries.)

A sample form for recording information on blood and body-fluid exposures  is included in the toolkit. This form is similar to those used by hospitals participating in NaSH and EPINet. It demonstrates the level of data that some facilities are collecting and using to monitor blood exposures and the effect of prevention interventions. Healthcare organizations may download and print this form for use in their sharps injury prevention program. (Other organizations may have or be developing similar forms.)  In the near future, the CDC's National Healthcare Safety Network (NHSN) will be available to healthcare facilities that wish to enter exposure data into a web-based reporting system.

Toolkit Resource for This Activity:

Develop a Process for Hazard Reporting

Toolkit Resource for This Activity:

Develop a Process for Examining Factors That Led to Injury or "Near Misses"

While data on needlesticks are important for examining outcomes, it is also very important to examine the processes and systems that have led to these outcomes. There are several quality improvement tools that can assist in analyzing the processes and systems that contribute to sharps injuries or "near misses." These include:

Process maps or flow chartsare used to describe, step-by-step, the process which is being examined, e.g., sharps disposal, phlebotomy.

Fishbone or cause-and-effect diagrams can be used to identify, explore, and graphically display all of the possible contributors to a problem.  The "bones" of these diagrams are usually divided into at least four areas of "cause": 1) people; 2) equipment; 3) environment; and 4) communication.

Affinity diagramsare used so a team may creatively generate multiple issues or ideas and then summarize the natural groupings in order to understand the underpinnings of a problem and identify possible solutions.

The following Websites from non-healthcare settings are useful for individuals who want to learn more about these tools and consider applying them to sharps injury prevention.

Root Cause Analysis (RCA)is a process for identifying the basic or causal factors that underlie variations in expected performance.  This process is being used widely in healthcare settings to identify factors that lead to adverse patient outcomes or are associated with a "sentinel event" (e.g., medication errors, laboratory errors, falls). The RCA concept also can be applied to sharps injury prevention. For this reason, it is discussed in greater detail than the quality improvement tools mentioned above.

The key to the RCA process is asking the question "why?" as many times as it takes to get down to the "root" cause(s) of an event.

• What happened?
• How did it happen?
• Why did it happen?
• What can be done to prevent it from happening in the future?

The Veterans Administration National Center for Patient Safety has provided a list of triage and triggering questions for root cause analysis for each event under investigation (http://www.va.gov/ncps/toos/html). These questions focus on the relationship between the event and the following possible factors:

• Patient assessment
• Staff training or competency
• Equipment
• Work environment
• Lack of information (or misinterpretation of information)
• Communication
• Appropriate rules/policies/procedures-or lack thereof
• Failure of a barrier designed to protect the patient, staff, equipment or environment
• Personnel or personal issues

For each "YES" response, additional questions about why each of these factors occurred leads to a determination of whether it is a "root cause" of the event, and whether there is a need for further action.  From this, a team may develop a specific action plan and outcome measures in response to the event investigated. A sample form and completed examples are provided to illustrate the RCA process.  This may be a particularly useful approach for those healthcare facilities with very few occupational sharps injuries, in which case a single needlestick might be considered a sentinel event that triggers an investigation.

An RCA event can be investigated by one individual, but it will need to involve the principles associated with the event and a team of individuals who will interpret the findings and assist in developing an action plan. The keys to the success of RCA are:

• Sensitivity to the affected individuals,
• Openness to uncovering the root causes,
• Not assigning culpability, and
• Support for changes that will lead to improved worker safety.

A sample form for performing RCA is provided in the toolkit. An example of a completed form also is provided.

Toolkit Resource for This Activity:

Resources for additional information on RCA include:

• http://www.va.gov/ncps/tools.html
• http://www.rootcauseanalyst.com
• http://www.sentinelevent.com

Analyze Sharps Injury Data

Introduction

Sharps injury data must be compiled and analyzed if it is to be used for prevention planning. This section describes:

• How to compile data from injury and hazard reports.
• How to perform simple and complex analyses.

Compiling Sharps Injury Data

Data on sharps injuries can be compiled by hand or with a computerized database. The latter facilitates multiple types of analyses (e.g., line lists, frequency lists, cross-tabulations). In small healthcare organizations (e.g., private medical or dental offices) or those where fewer than 10 injuries are reported in a given year, a computerized system might not be practical. Alternatively, these facilities might participate in a professional organization's regional or state data collection network that allows several facilities to contribute descriptive data (with confidential individual identifiers removed) on injuries. (Although such networks are not known to be available, it is possible that they will be developed in the future.) The advantage of having small organizations of similar purpose (e.g., medical or dental offices) contribute to a larger data collection pool is so that aggregate data can enhance the understanding of the frequency of sharps injuries and identify unique injury risks associated with these work sites.

Injury data can be analyzed with very simple statistical tools, such as frequency distributions and cross-tabulation. Large databases can perform more sophisticated analyses (e.g., multivariate analysis).

Analyzing Sharps Injury Data

The first step in the analysis of data is to generate simple frequency lists, by hand or computer, on the variables that make up the following data elements:

• Occupations of personnel reporting injuries;
• Work locations (e.g., patient units, operating room, procedure room) where reported injuries occur;
• Types of devices (e.g., hypodermic needles, suture needles) involved in reported injuries;
• Types of procedures (e.g., phlebotomy, giving an injection, suturing) during which injuries occur;
• Timing of occurrence of injuries (e.g., during use, after use/before disposal, during/after disposal); and
• Circumstances of injuries (e.g., during use of the device in a patient, while cleaning up after a procedure, as a result of improper disposal of a device).

Once frequencies are tabulated, a cross-tabulation of variables provides a more detailed picture of how injuries occur. This is most easily performed in a computerized database, but it can be done by hand. For example, simple cross-tabulations using occupation and device variables might reveal differences in the types of devices involved in injuries among persons in different occupations. Cross-tabulations can also assess whether certain procedures or devices are more often associated with injuries.  The example below shows that nurses are more frequently injured by hypodermic needles and physicians by winged steel needles.  Nurses and phlebotomists report the same number of injuries from phlebotomy needles. Armed with this information, it is then possible to seek additional information that might explain these differences in injuries for each occupation.

Hypothetical example, using a grid with one variable (e.g., occupation) in the horizontal axis and another variable (e.g., device) in the vertical axis shows differences in occupational injuries by type of device. Other variables (e.g., procedure, injury circumstances, etc.) can be cross-tabulated to better understand injury risks.

Calculating Injury Incidence Rates

However, many factors, including improved reporting of injuries, can influence changes in incidence rates. Depending on the denominator(s) used, a facility may be viewed favorably or negatively. A recent report compared sharps injury rates in 10 Midwestern facilities that differed in size and scope of operation. It found considerable variation depending on the selection of the denominator (110). Therefore, the calculation of injury rates should be considered as one of many tools available to monitor sharps injury trends within a facility, but should be carefully used for inter-facility comparisons.

Calculating injury incidence rates requires reliable and appropriate numerators and denominators. Numerators derive from information collected on the injury report form; denominators must be obtained from other sources (e.g., human resources figures, purchasing records, cost center data). The numerator and denominator must reflect a common opportunity for exposure. For example, when calculating injury incidence rates among nursing personnel, the denominator should ideally reflect only those nurses whose job responsibilities expose or potentially expose them to sharp devices.

Selecting Denominators for Calculating Occupation-specific Injury Rates. Denominators sometimes used to calculate occupation-specific incidence rates include:

• Number of hours worked
• Number of FTE positions
• Number of healthcare personnel

Of these, "number of hours" worked is probably the most accurate and easiest to obtain, especially if part-time and per diem staff are included. Human resources and/or financial departments should be able to provide these numbers. For some complex healthcare organizations (e.g. university teaching centers) and for some occupations (e.g., attending physicians, radiologists, and anaesthesiologists provided through contract), obtaining denominators might be more difficult. If the analysis does not use the same denominator to calculate occupation-specific rates, comparisons among occupational groups are invalid.

Adjusting Occupation-specific Injury Rates for Underreporting. Although rates can be adjusted for underreporting, this step is not essential, nor is it necessarily useful, particularly for small facilities. For facilities that are interested in adjusting, the most reliable source of information is data from a survey of healthcare personnel in the facility (Appendix A-3). For example, if the survey finds considerable disparities in reporting among occupational groups (e.g., phlebotomists reporting 95% of their injuries and physicians only 10%), then adjustment of occupation-specific rates is appropriate to accurately reflect differences among occupational groups. Guidance for performing these calculations is included in the Toolkit.

Toolkit Resource for This Activity:

Calculating Procedure- and Device-specific Injury Rates. Procedure- and device-specific injury rates are also useful for defining injury risks and measuring the impact of interventions. Although the frequency of injuries is often higher with some procedures or devices, a calculation of rates can yield a different picture. For example, a 1988 study by Jagger et al. (52) found that, although the highest proportion of injuries involved the hypodermic needle/syringe, this type of device was also the most frequently used. When injury rates were calculated based on the number of devices purchased, results show that needles attached to IV tubing had the highest rate of injury, followed by phlebotomy needles, IV stylets, and winged steel needles.

Ideally, the denominators for calculating procedure- and device-specific rates are based on the actual number of procedures performed or devices used. However, it is often difficult to obtain this information. For calculating device-specific injuries, the number of devices purchased or stocked may be used as a surrogate.

Using Control Charts for Measuring Performance Improvement

Control charts are graphical statistical tools that monitor changes in a particular set of observations over time and in real time. They are now used by many healthcare organizations as a quality improvement tool for a variety of patient-care activities and events, including healthcare-associated infections, and they can be applied to the observation of sharps injuries in healthcare personnel. In concept, control charts indicate whether certain events are an exception. Over a period of time, they can also demonstrate performance improvement.

This tool is applicable and useful only to healthcare organizations with a large amount of data on sharps injuries. A minimum of 25 data points is generally needed before it is possible to make a reliable interpretation. A discussion of methods for creating and interpreting control charts is beyond the scope of this workbook. The following Website and references are provided for those who are interested in pursuing this statistical technique: http://www.isixsigma.com/st/control_charts/ (111,112).

Calculating Institutional Injury Rates

In several published studies, investigators calculate institution-wide rates of sharps injuries using a variety of denominators (e.g. number of occupied beds, number of inpatient days, number of admissions). Facility-wide information can help calculate national estimates of injuries among healthcare personnel (1). But at the institutional level, this information has limited use and is difficult to interpret. It indicates only whether a rate is changing, not why. Also, safety improvements may be masked by improved reporting. For purposes of measuring performance improvement, the basic calculations described above will prove most reliable.

Benchmarking

Benchmarking compares an institution's performance with that of similar organizations. At the present time, there is limited information for sharps injuries benchmarking. Benchmarking data from NaSH and EPINet are not yet available. As the prevention of sharps injuries in healthcare personnel is an important public health priority, and increasing numbers of facilities are collecting and reporting data on sharps injuries, resources for benchmarking will likely emerge soon.

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Selection of Sharps Injury Prevention Devices

Introduction

The process of selecting engineered sharps injury prevention devices gives healthcare organizations a systematic way to determine and document those devices that will best meet their needs. The selected devices must be acceptable for clinical care and provide optimal protection against injuries. The selection process includes collecting information that will allow the organization to make informed decisions about which devices to implement. The more this process can be standardized across clinical settings, the more information can be used to compare experiences among healthcare facilities.

Key Steps in the Product Evaluation Process

A key feature of the process is an in-use product evaluation. A product evaluation is not the same as a clinical trial. Whereas a clinical trial is a sophisticated scientific process requiring considerable methodological rigor, a product evaluation is simply a pilot test to determine how well a device performs in the clinical setting. Although the process does not need to be complex, it does need to be systematic (79). This workbook outlines an 11-step approach for selecting a product for implementation. The model is most relevant to hospitals, but it can be adapted in other healthcare settings.(Guidance for the evaluation of dental devices may by found at http://www.cdc.gov/OralHealth/infection_control/forms.htm.)

Step 1. Organize a Product Selection and Evaluation Team

Healthcare organizations should designate a team to guide processes for the selection, evaluation, and implementation of engineered sharps injury prevention devices. Many institutions already have product evaluation committees that may be used