Sharps Safety and OSHA Compliance: Staying on the Right Side of the Law

March 9, 2012

By Kelly M. Pyrek

Despite legislation, regulation and stepped-up oversight and education campaigns by public and private sectors, needlesticks and other sharps-related injuries persist, although with variance in the rates depending on the healthcare setting. The Occupational Safety and Health Administration (OSHA)'s Bloodborne Pathogens Standard  outlines what employers must do to protect workers who are occupationally exposed to blood or other potentially infectious materials (OPIM), and on Nov. 6, 2000, President Bill Clinton signed into law the bloodborne pathogens standard (BBP) by way of the Needlestick Safety and Prevention Act. This federal law requires the use of standard  precautions to any setting where occupational exposure to blood or other potentially infectious materials occurs.  It mandated that the 1991 Bloodborne Pathogens Standard be revised to strengthen the requirements related to the use of safety-engineered sharps devices.

Compliance with OSHA's BBP standard (found in Title 29 of the Code of Federal Regulations at 29 CFR 1910.1030) is mandatory, yet experts are concerned that in many hospitals and ambulatory surgery centers, these mandates are not being heeded. To review, the standard requires employers to:

Establish an exposure control plan. This is a written plan to eliminate or minimize occupational exposures. The employer must prepare an exposure determination that contains a list of job classifications in which all workers have occupational exposure and a list of job classifications in which some workers have occupational exposure, along with a list of the tasks and procedures performed by those workers that result in their exposure.

Employers must update the plan annually to reflect changes in tasks, procedures and positions that affect occupational exposure, and also technological changes that eliminate or reduce occupational exposure. In addition, employers must annually document in the plan that they have considered and begun using appropriate, commercially-available effective safer medical devices designed to eliminate or minimize occupational exposure. Employers must also document that they have solicited input from frontline workers in identifying, evaluating and selecting effective engineering and work-practice controls.

Implement the use of standard precautions (treating all human blood and OPIM as if known to be infectious for bloodborne pathogens).

Identify and use engineering controls. These are devices that isolate or remove the bloodborne pathogens hazard from the workplace. They include sharps disposal containers, self-sheathing needles and safer medical devices, such as sharps with engineered sharps-injury protection and needleless systems.

Identify and ensure the use of work-practice controls. These are practices that reduce the possibility of exposure by changing the way a task is performed, such as appropriate practices for handling and disposing of contaminated sharps, handling specimens, handling laundry, and cleaning contaminated surfaces and items.

Provide personal protective equipment (PPE), such as gloves, gowns, eye protection and masks. Employers must clean, repair and replace this equipment as needed. Provision, maintenance, repair and replacement are at no cost to the worker.

Make available hepatitis B vaccinations to all workers with occupational exposure. This vaccination must be offered after the worker has received the required bloodborne pathogens training and within 10 days of initial assignment to a job with occupational exposure.

Make available post-exposure evaluation and follow-up to any occupationally exposed worker who experiences an exposure incident. An exposure incident is a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or OPIM. This evaluation and follow-up must be at no cost to the worker and includes documenting the route(s) of exposure and the circumstances under which the exposure incident occurred; identifying and testing the source individual for HBV and HIV infectivity, if the source individual consents or the law does not require consent; collecting and testing the exposed workers blood, if the worker consents; offering post-exposure prophylaxis; offering counseling; and evaluating reported illnesses. The healthcare professional will provide a limited written opinion to the employer and all diagnoses must remain confidential.

Use labels and signs to communicate hazards. Warning labels must be affixed to containers of regulated waste; containers of contaminated reusable sharps; refrigerators and freezers containing blood or OPIM; other containers used to store, transport, or ship blood or OPIM; contaminated equipment that is being shipped or serviced; and bags or containers of contaminated laundry, except as provided in the standard. Facilities may use red bags or red containers instead of labels. In HIV and HBV research laboratories and production facilities, signs must be posted at all access doors when OPIM or infected animals are present in the work area or containment module.

Provide information and training to workers. Employers must ensure that their workers receive regular training that covers all elements of the standard including, but not limited to: information on bloodborne pathogens and diseases, methods used to control occupational exposure, hepatitis B vaccine, and medical evaluation and post-exposure follow-up procedures. Employers must offer this training on initial assignment, at least annually thereafter, and when new or modified tasks or procedures affect a workers occupational exposure. Also, HIV and HBV laboratory and production facility workers must receive specialized initial training, in addition to the training provided to all workers with occupational exposure. Workers must have the opportunity to ask the trainer questions. Also, training must be presented at an educational level and in a language that workers understand.

Maintain worker medical and training records. The employer also must maintain a sharps injury log, unless it is exempt under Part 1904 -- Recording and Reporting Occupational Injuries and Illnesses, in Title 29 of the Code of Federal Regulations.

Of note in these standards is the requirement (made mandatory in 2001 in a revision of the BBP standard) that employers maintain a sharps injury log and that frontline workers be included in the safety-engineered device selection process. The revised BBP standard includes:
- An expanded definition of engineering control to include devices with engineered sharps injury protection and needleless systems
- Exposure control plans that reflect changes in technology which reduce exposure to bloodborne pathogens and that document the consideration, at least annually, of devices to minimize occupational exposure
- Documentation at least annual input from frontline workers for identification, evaluation and selection of devices and other controls
- A sharps injury log of percutaneous injuries with information on the type and brand of device involved the department where the incident occurred, and an explanation of how the injury occurred. The confidential sharps injury log must include the following information: type and brand of the device causing the injury (if known); department or work areas where incident occurred; description of the events surrounding the injury including the body part affected and objects/substances involved in the exposure. The sharps injury log should be reviewed regularly and as part of the review and update of the facility's exposure control plan.

It should be kept in mind that some states have additional requirements beyond the federal law, such as the requirement for healthcare facilities to report needlestick injury data to a state agency. State laws with stricter requirements take precedence over the federal requirements; however, if a state's sharps safety law is less stringent than the federal law, the federal laws requirements must be followed.

There are still too many facilities running afoul of federal mandates, says Pamela Dembski Hart, CHSP, BS, MT(ASCP), principal of Massachusetts-based Healthcare Accreditation Resources LLC, who specializes in healthcare accreditation, safety and compliance issues, and helps institutions  identify noncompliance and areas for improvement with the BBP standard.
Dembski Hart identifies a number of common challenges with which facilities struggle:  "I see a lack of education regarding the requirements and lack of information, so they still don't know much about OSHA requirements.  If they do know about them, they may feel as though it's not something they really have to address. Also, even  if they know about them, many of the healthcare center administrators will rely on physician input  or nursing staff preferences regarding the selection of safety-engineered devices, and that may not always be the best approach. And if they do have safety devices, many facilities have never investigated them thoroughly since the purchasing decision was made by a larger organization or system which has chosen what they will purchase without adequate involvement of frontline staff -- and this goes against OSHA requirements. Many facilities do not look at the next generation of safety devices that are available, even though OSHA requires it annually."

Dembski Hart emphasizes that implementation of OSHA mandates is suboptimal, especially in outpatient facilities that have fewer staff and resources and less administrative oversight. "Many of the nurse managers in outpatient-care facilities are not trained as infection preventionists as part of their basic education and training. I think that people are misguided when they think they can just plop someone into that role. Too much pressure is being placed on these individuals; they are expected to implement OSHA requirements but they really don't understand them. Sharps safety is a separate entity to them and it is not on their infection prevention and control radar screen. There's a lot to the OSHA regulations, and it evolves. On top of having to be a clinical caregiver as well as a regulatory oversight person,  it's no wonder they feel overwhelmed. It's a lot to manage and they are not given the time to do so properly in many cases. Implementation of OSHA regulations requires proper education and time -- two things that are not always in abundance."

The solution, Dembski Hart says, lies in support from organization administrators. "I believe they need commitment from the facility's management, and support from leadership that emphasizes the importance of safety and the ramifications if clinicians do not practice safely," she says. "The challenge, especially in outpatient facilities, is that decisions are driven by the bottom line and facility administrators can be dismissive of the risks because they are so focused on issues relating to revenue and patient turnaround. In some ambulatory surgery centers, accreditation is the gold standard but often the reason they are pursuing it is to have a competitive advantage. But they need to realize that oversight that requires excellence will also improve the bottom line."

The focus must shift to costs associated with a sharps injury and the toll taken on human health, Dembski Hart adds. "The cost to purchase safety-engineered devices, as mandated by the Needlestick Safety and Prevention Act, pales in compared with the cost to manage a workplace injury," she says. "Never mind the trauma inflicted on the injured individual who was actually exposed to an infectious disease; even someone who did not actually seroconvert, there are costs associated with testing at day one, six weeks, three months and six months. That's four tests for hepatitis B, C and HIV -- it's quite an ordeal."
Although more than half of the surgeries in the U.S. are performed in ambulatory care centers, ambulatory surgery center (ASC) resources and safety oversight may lag significantly behind those of their hospital counterparts. In the past four years, OSHA has increased medical facility inspections. As a result, agents are citing more ASCs and physician offices for bloodborne pathogen standard violations. In fact, such violations make up the majority of OSHA medical facility citations in recent years.

According to a two-part series of articles published in October and November 2011 editions of the AORN Journal, the most frequent causes of bloodborne pathogen violations were outdated or nonexistent exposure control plans, poor documentation, the failure to use safety devices and the lack of free training during working hours. The violations that merited the largest fines dealt with failure to immediately remove personal protective equipment (PPE) penetrated with body fluids; failure to use safety devices; and the failure to provide workers with a free hepatitis B vaccination and follow-up.

Compliance with the bloodborne pathogen standard may seem complex; however, it is the key to providing a safe workplace for both the healthcare employee and patient, writes Dembski Hart, the author of the two-article series,  Complying With the Bloodborne Pathogen Standard: Protecting Health Care Workers and Patients, and Compliance: the Key to Bloodborne Pathogen Safety.

OSHA adopted the mandatory bloodborne pathogen standard in order to protect healthcare workers from exposure to blood, body fluids and infectious material. These infectious liquids and materials may contain bloodborne pathogens, particularly hepatitis C virus (HCV), hepatitis B virus (HBV) and HIV. While protecting workers from disease, safe practices also guard against patient exposures. In fact, in the last decade, more than 130,000 U.S. patients served at ASCs were notified of potential exposure to HBV, HCV and HIV due to unsafe injection practices and lapses in infection control. Hart describes how healthcare facilities can avoid frequent and costly OSHA violations. Facilities should develop and exposure control plans that determine safety risks and describe work practice controls. Facility managers should also solicit input from all employees to prevent needlesticks and sharp contamination and identify employees exposure risks.

Dembski Hart reports that last year, OSHA inspections and citations increased almost 10-fold in all types of healthcare facilities, including hospitals, and inspectors issued 3,674 citations, 62 percent of which were characterized as serious. In fiscal year 2010, of the $81,822 in fines issued to medical practices, 76 percent involved bloodborne pathogen-related violations. Dembski Hart also addresses under-reporting: "Although documentation of healthcare-associated infections and OSHA violations exists, healthcare worker injury reporting is not routinely documented. It is estimated that more than 800,000 injuries occur annually in the United States from needles and other sharps, and more than half of these injuries are never officially reported. Healthcare workers appear to be hesitant to report workplace injuries or exposures for a number of reasons, which may include the unavailability of written information and training regarding necessary steps of post-exposure evaluation and treatment protocols, incorrect perceptions regarding the seriousness of the incident or exposure, lack of time to fill out forms or participate in the reporting process, and fear of reprimand or embarrassment."

The day of reckoning has arrived, Dembski Hart acknowledges: "OSHA now has regional emphasis on unannounced surveys in outpatient facilities, recognizing that care has shifted significantly from acute-care hospital settings to outpatient settings and that more than 50 percent of healthcare workers are now employed in an outpatient care facility," Hart says. OSHA is also recognizing that there are additional hazards in healthcare that we didn't have 10 years ago -- everything is becoming more complex, including the devices, the patient population, procedures, and anesthetic gases -- all have changed dramatically."

Unwittingly, the unannounced OSHA surveys may be coinciding with a trend Hart says she has observed while walking through facility surveys by the Joint Commission and by the Centers for Medicare and Medicaid Services (CMS). "Frequently surveyors don't pay that close attention to OSHA regulatory compliance," Dembski Hart says. "They are focusing on infection prevention and control, and if it happens to overlap with OSHA compliance, that's great, but I have yet to see a surveyor ask about an exposure control plan specifically. They will ask for an infection prevention and control manual, and there is an overlap -- a whole section of the infection control manual should be the exposure control plan dealing with BBPs and OSHA regulatory compliance. But generally, other infection control manuals I see do not address OSHA regulatory compliance. So they will look at these infection control manuals that only contain a blurb about BBPs, but they don't check if the facility is really meeting all of the elements in it such as engineering controls,  personal protective equipment, work-practice controls, hepatitis B vaccination, identification of exposure risks, etc. What are your clinical protocols regarding compliance with the BBP standard? Do you have a cleaning and decontamination schedule? That all overlaps into OSHA's requirements. But surveyors tend to gloss over that, focusing on patient safety, which is important of course, but if you are looking at the regulations comprehensively, that involves employee safety too and they tend to not address it. There is still much disparity among surveyors regarding their attention to detail. It's such a new arena really, that it takes a lot to get that expertise -- they need more of a global perspective on how infection prevention and control and meeting the requirements of OSHA's BBP standard really do compliment each other -- but they don't quite see that yet."

The dichotomy between patient safety and healthcare worker safety is a perplexing, persistent problem at some facilities. Elise Handelman, MEd, COHN-S, a Maryland-based occupational and environmental health consultant, reminds healthcare professionals that patient safety and employee safety are mutually beneficial. "Safer devices prevent needlesticks and protect healthcare workers, and having healthy healthcare workers at the bedside is a critical need to the patient," Handelman says. "When a needlestick or other sharps injury occurs, it removes that healthcare worker from patient care either temporarily or sometimes long-term, depending upon what has occurred and the treatment required. It is beneficial for patients to be cared for by well-trained healthcare workers who use safety-engineered devices, are cautious about preventing infections in patients, and aware of their own safety needs."

Handelman continues, "There are so many variables involved with the use of safety-engineered devices. There has been a significant improvement in the variety and efficacy of these devices, but there are still facilities where we hear that the devices do not meet the needs of the clinicians.  Manufacturers are working on this; for example, with the first generation of the safety scalpel, some surgeons said this device didn't feel right in their hand and that it  wasn't the right weight, so manufacturers have redesigned the device to remedy some of those criticisms.  Device design is an area where I would love to see more nurses aggressively involved.  Getting frontline workers involved in the selection of devices is mandated by OSHA's BBP standard and  it is to everyone's benefit to do that. Just like anything else, if you can get the user's input, it's usually a more effective product. I think that when individuals are involved in making a decision, they take more ownership of it. So, creating ways for  frontline healthcare workers to be involved in the purchasing decisions may increase the use of the devices. Training with the new device is also important. Clinicians are typically short-staffed and rushed, and, especially if they haven't had any training, may be reticent to use a new device because they are not sure how it works. In addition to more formal training, peer-to-peer training on the new devices would be beneficial, as it would meet OSHA requirements and get people who are at risk involved in the change to safety-engineered devices."

Handelman says that even though OSHA regulation and the needlestick legislation have been in place for a number of years, it is a challenge to keep clinicians stirred up about compliance. Handelman says the focused OSHA inspections could help drive attention back to compliance. "OSHA has limited resources and, with few exceptions, the only time they will come into a healthcare facility is when an employee calls them to register a complaint and asks them conduct an inspection. There are some situations where OSHA will target a specific industry group like they have done in the Atlanta area where certain ASCs are being surveyed. OSHA is doing targetted inspections in those areas and have had great success in terms of reducing the rate of needlesticks. In most circumstances throughout most of the country, the OSHA inspection depends on an employee reporting noncompliance.

Once OSHA finds problems in a facility  the fines can be significant, depending on the severity of the violation," says Handelman. These fines are added to the significant costs previously alluded to by Hart, and encompass so many more adverse ramifications. As Handelman notes, "In addition to the human agony caused by a needlestick or other sharps injury, there are of course human resource issues that are time- and resource-intensive with which to deal. Another significant problem for facilities that are self-insured is increases in their insurance rates when there is an untoward event. Also, one of the things that gets the attention of the executive suite most rapidly is the potential for bad press -- if the media finds out about a significant occupational exposure, it can be very adversarial for an institution. So there are many reasons, in addition to the moral imperative, to be compliant." 

That compliance imperative may fall squarely on the shoulders of the infection preventionist who may also be wearing the occupational health hat for their facility. Handelman says she empathizes: "I spent about 20 years doing infection prevention and employee health and I know what they are up against -- it's arduous. I see infection preventionists as having been crusaders over the years, working toward compliance, and they clearly have made a difference. In general, needlesticks are being reduced at many hospitals, but that doesn't mean the job is done. We are still seeing pockets of noncompliance within the general hospital setting."

One of those settings is the operating room (OR), which Handelman says is notorious for escalating needlestick incidences. "The OR is a challenging area -- it is geographically isolated, it is somewhat culturally isolated, and it can be tough for infection preventionists to get into those areas because of those barriers," she says. "The OR is one of the areas that has actually had an increase in needlestick injuries and blood exposures whereas the rest of the hospital, in most places, has trended down slightly. It's critical to get OR personnel to look at solutions such as blunt suture needles, safety scalpels, no-hands passing of instruments; but trying to get those elements embedded into the OR is a challenge and something I think the infection control community will have to be focused on continually.  I do see more interest and awareness being raised by associations such as the American College of Surgeons which has come out with clear statements about what they expect in terms of needlestick prevention in the OR, and the Association of periOperative Registered Nurses (AORN) has also been at the forefront of sharps safety initiatives and recommended practices. So working with groups like that to create some peer pressure is an effective strategy. Another area where non-compliance can be high is the emergency department (ED), which has some unique situations with patients who are more unpredictable receiving care in urgent situations where a lot of invasive procedures are being done in a hurry."

Handelman continues, "Outpatient care -- whether it's in an ASC or home care or other non-hospital settings --  is another significant area upon which that infection preventionists must focus -- the Bureau of Labor Statistics (2010-2011) says that about 40 percent of the nation's 2.3 million registered nurses are employed outside of the hospital. When it comes to preventing sharps injuries, infection preventionists must think about strategically targeting the places where they know problems persist-- the higher-risk places like the OR, the ED, and outpatient settings.  I advise them to use their limited time and thinning resources to look at what the risks are in these areas and what devices and strategies are being used to avoid and reduce sharps injuries." 
"I really see the infection preventionist as the crusader in this fight," Handelman adds, " and they have done a marvelous job. Their challenge now is to optimize the resources that they have while strategically intervening . Everyone's belts are tightening and it's not easy. Infection preventionists are where the rubber hits the road and they are the people onsite who are really going to be able to make a difference in the occupational health of employees. They are not sitting in an office far removed from the delivery of care -- they are at the place where care is delivered and they have a huge opportunity to make an impact. They've undertaken this role with great tenacity and I think their efforts will pay off."

Keeping sharps safety at the forefront of clinicians' minds is an ongoing task that cannot be taken lightly, according to Hart, who writes in the AORN Journal article, "It is important for all employers and employees to understand that OSHA compliance is not optional. Employers have a responsibility to provide employees and patients with a safe environment, and employees have a responsibility to comply with regulations for their own protection and that of their patients. Safety compliance is an ongoing process and must be maintained to reflect and address the changes that occur in individual healthcare practices. Every effort must be made by managers and employees to demonstrate compliance with the bloodborne pathogen standard regulations."

The Future of Sharps Safety

In November 2010, the University of Virginia hosted a conference,  "10th Anniversary of the Needlestick Safety and Prevention Act: Mapping Progress, Charting a Future Path," in which experts from around the country gathered to assess the impact of the legislation, identify remaining gaps in sharps safety technology, and chart a future path that is global in scale. The conference -- sponsored by the International Healthcare Worker Safety Center and funded by a grant from National Institute for Occupational Safety and Health and the Centers for Disease Control and Prevention -- was designed to answer the questions of what the global sharps safety and medical device market will look like in another decade, how these changes will benefit those in the poorest countries around the world -- and the healthcare workers who are most at risk of infection from bloodborne pathogens.

A consensus statement and a call to action has been created by the members of the conference steering committee and includes recommendations are based on the presentations, panels and informal discussions that took place at the conference. The speakers and participants represented a broad range of stakeholders relevant to the issue of sharps safety, including clinicians, researchers, and healthcare administrators, as well as representatives from government agencies (in particular NIOSH/CDC and OSHA), professional associations, and the medical device industry. The consensus statement was released on March 8, 2012, and to read more, CLICK HERE