The OSHA lowdown on occupational exposure to bloodborne pathogens.
"Have you beard about the 'new' OSHA standard?" "Do you know you have to write a new Exposure Control Plan?" "I heard video training programs. are no longer acceptable."
These and other myths about compliance directive 2-2.44D (Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogen Standard) have been rampant since the directive went into effect on Nov. 5, 1999.  Not since the original Bloodborne Pathogen Standard was published on Dec. 6, 1991, has such controversy surrounded a document.
The new compliance document is not a new OSHA standard, but rather a guideline for OSHIA Compliance Officers (GO) to help them determine whether violations exist. It is a vast improvement over its predecessor and clarifies what has been hearsay in many circles. The following highlights aim to clarify what is reviewed during an OSHA on-site inspection.
Regarding compliance officers
The CO will begin by holding a conference with the facility administrator and the directors of infection control, employee (occupational) health, training, education, and environmental services (housekeeping). He or she will review incident reports as well as all OSHA 200 logs.
The CO will then observe work entailing exposure to blood or other body fluids and talk to groups of employees to evaluate exposure risk. If the CO must enter a hazard area, be prepared to provide whatever personal protective equipment (PPE) is required under the exposure control plan of your facility. If you don't, serious fines will be levied.
Full time, part-time, temporary, and "per diem" employees are covered under the Bloodborne Pathogen Standard. Temporary agencies that supply staff to healthcare facilities are responsible for assuring that their employees are offered the hepatitis B vaccine, for keeping records on each employee that document post-exposure evaluation and follow-up, and for providing some generic training. Any facility that hires such temporary employees should ascertain that the agency being used complies with these requirements.
OSHA says that a facility is not responsible for violations committed by employees while they are in patients' homes (eg, home health workers and phlebotomists who draw homebound patients). This includes violations concerning the use of PPE, specific work practices, and the use of engineering controls. The facility, however, must provide PPE and hepatitis B testing to such employees.
Incorporated physicians who have one or more employees in their practice, including themselves, must abide by the OSHA standards. However, physicians who have staff privileges but who are not employed by a facility are not covered by the OSHA standard when in the facility. Also, OSHA does not cover students if they are not official employees, sole practitioners, partners, or anyone in the facility that is self-employed.
So how do you protect students, for example, who are working alongside employed staff? You have an ethical obligation to provide the same level of protection to students that you do for your employees. You can do so by enforcing standard operating procedures (SOPs), dress code, etc. and by regarding them with the same level of concern that you apply to visitors to the laboratory, such as repair technicians.
An adequate exposure control plan
The exposure control plan must identify tasks and procedures in which occupational exposure may occur, as well as the individuals at risk of being exposed. The plan must be updated every 12 months or whenever new tasks and procedures involving potential exposure are added or existing ones are modified. If an employee wants to review the plan, the facility must make it available within 15 working days of the request. Practically speaking, the exposure control plan should be part of the facility's safety manual and should be available to all employees on all shifts in every department.
To get a true picture of the exposure risk associated with a particular task, assess risk as if the task were to be performed without any engineering controls, PPE, or other safety measures. Document in your exposure control plan the procedures for handling exposure incidents, and provide proof that they have been implemented. The plan must be continuously updated to reflect technologic changes that eliminate or reduce exposure to bloodborne pathogens as well as the latest scientific knowledge and information pertaining to bloodbome pathogens. This compliance directive makes specific reference to the use of effective engineering controls to reduce needlestick and other sharps injuries.
OSHA has always required employers to use engineering and work practice controls, but the current directive places even more emphasis on their employment in an effort to eliminate, or at least reduce, occupational exposure. It is OSHA's view that preventing exposures requires a comprehensive program, including engineering controls (eg, needleless devices, shielded needle devices, and plastic capillary tubes) and proper work practices (eg, no-hands procedures in handling contaminated sharps).
Even though the FDA clears medical devices for marketing, it is the responsibility of the employer to document that a given device works for employees. Using an evaluation tool for documentation is one way to do this. Observation of employees using the device with appropriate documentation is another.
With regard to safety devices for needles, a fixed safety feature for needles provides a barrier between the hands and the needle after use. The safety feature must be an integral part of the device, not an accessory, and must be as simple as possible to use, requiring little or no training.
If the CO finds that an employer is using an engineering control, but believes an alternative device would be more effective, the CO should document how the device was being used. It is then up to the employer to provide written documentation of why the safety device was selected and to justify its use and performance. The CO will then consult with the Regional Bloodborne Pathogens Coordinator to determine if a violation exists. OSHA's website (www.osha.gov) has several needle device evaluation tools at the end of the directive that can be printed for use by facilities (see Figure 1, page 15).
Employers must provide readily accessible handwashing facilities to employees. Handwashing with soap and at least tepid running water must be performed as soon as is feasible, particularly in cases of gross contamination, in order to adequately flush contaminated material from the skin. Alternative handwashing methods can be used as interim measures when soap and water are not available. In such cases, the employer must provide either antiseptic hand cleaner and clean cloth/paper towels or antiseptic towelettes. When such alternatives are used, employees must wash their hands (or other affected area) with soap and running water as soon as is feasible.
Employers must ensure that employees wash their hands immediately after removing gloves or other PPE. There is no requirement for handwashing upon leaving the work area unless contact with blood or body fluids has occurred or gloves/PPE have been removed.
Employees must have direct access to handwashing facilities. Employees who must surmount obstacles, such as doorways or stairs, may touch surfaces and contaminate them. Employees must be adequately trained in handwashing procedures. This includes a 15-second scrub with soap (preferably liquid) and a thorough rinse with tepid water with the hands held downward (see Figure 2, below, left). Hand cream is allowed as long as it is not petroleum-based; petroleum-based products can adversely affect glove integrity.
A regular schedule of inspecting engineering controls must be maintained. Items that are broken must be fixed or replaced as soon as they are discovered.
Although not new, the prohibition of shearing or breaking contaminated sharps is reiterated in the compliance directive with a warning to place dirty needles into an accessible sharps container. If a needle must be recapped for medical reasons, then it must be done using the single handed scoop technique in which the hand holding the needle scoops up the needle cap from a flat surface.
The primary concern in the transportation of clinical specimens via pneumatic tube is leakage of the specimen into the carrier and potentially into the tube system. Some systems have virtually eliminated breakage by means of padded inserts for carriers or by soft delivery of the carrier. Leakage generally results from improper packaging and/or the use of primary containers that do not prevent leaks during transport.
All employees who might open a carrier must be trained to regard the contents as potentially biohazardous. They must wear gloves when removing specimens from the system in case the specimen leaked during transport, and they must be trained on how to decontaminate the carrier if a leak occurs.
Personal protective equipment (PPE)
A task analysis is mandatory to determine what type of PPE is required. In a laboratory, for example, a lab coat and gloves would be routine for most situations. If you work around closed tube sampling devices, face PPE would not necessarily be needed unless you expect sprays and splashes of blood or other body fluids to occur. Employees must remove PPE and wash their hands before going to any nonwork areas, such as the break room, cafeteria, or restroom facilities.
Although OSHA does not mandate or even recommend any particular brand of lab coat, the directive makes reference to the American Society for Testing and Materials (ASTM) and its requirements for fabric used in PPE. According to the ASTM, a spray rating determines whether the fabric absorbs or repels fluids upon contact. Hospital surgical attire that is considered fluid-proof must have a spray rating of 100. Cotton lab coats customarily have a spray rating of 0. This means if cotton lab coats are splashed or sprayed, the blood or other body fluid will soak through to the clothing or skin of the employee.
The air porosity test determines the breathability of the material or how hot it feels on the employee. Hospital surgical attire that is considered fluid proof has an air porosity of 1; cotton lab coats have an air porosity of 25. This means the cotton lab coat is cooler than the fluid-proof fabric required for hospital surgical attire.
The Suter hydrostatic resistance to fluid pressure is 850 for surgical attire and 60 for a cotton coat. This means a large spill of blood or other body fluid would be repelled by the hospital surgical attire, but would easily penetrate the cotton lab coat.
For optimum employee protection, a wise choice is a lab coat with a spray rating of 90 or above, an air porosity of 10 or higher, and a Suter rating of 340 or above (see Table 1, below). These ratings should be stated by the manufacturer and remain through the fabric's washings.
Another feature you may want to consider for your lab coats is knitted cuffs. These allow gloves to be worn over them, thus eliminating exposure to the wrist, which is an especially vulnerable area for splashes and sprays. And, finally, antistatic properties prevent computer and equipment power outages due to static electricity. The cost of providing and cleaning PPE is borne by the employer.
Scrubs purchased by the employer as part of PPE must be paid for by the facility; however, scrubs purchased by the employee as work clothes need not be paid for by the employer. Employees must be trained to roll soiled pullover scrubs up over their heads to avoid contact with blood or other body fluids on the fabric.
Studies have shown that gloves provide a barrier, but that neither vinyl nor latex procedure gloves are completely impermeable. Thus, handwashing after glove removal is required. Contaminated disposable (single-use) gloves must be replaced as soon as is practical or feasible. Disposable gloves may not be washed and reused. Plastic film food handling gloves ("cafeteria" or "baggie" gloves) are not appropriate for use in exposure-related tasks. OSHA will fine an employer and possibly the employee for not wearing proper PPE, including wearing the wrong size glove. Employers will also be cited if they do not provide alternative gloves for employees who are allergic to latex.
Gloves are usually not necessary when administering intramuscular or subcutaneous injections as long as bleeding that could result in hand contact with blood or body fluids is not anticipated. The original standard stated that gloves were optional during phlebotomy procedures for employees of volunteer donor blood collection centers, and the new compliance directive has not changed that. However, the directive specifically states that phlebotomy conducted in other settings, such as hospitals or plasmapheresis centers, requires the use of gloves during the procedures.
Employees are not required to change PPE when traveling from one hospital lab area to another, provided the connecting hallway is considered to be a work area. The use of PPE with phlebotomy is often confusing. In a 1993 fact sheet published by OSHA, gloves are considered the primary PPE required by phlebotomists. Therefore, the lab coat or scrubs worn when collecting blood may be considered a uniform and not subject to PPE restrictions if splashes and sprays are not reasonably anticipated during the course of phlebotomy collection. This procedure has not changed with the new directive.
A lot of controversy exists over whether employers must provide prescription eyewear for employees. The answer is "no" as long as side shields, goggles, and/or protective face shields are available.
Environmental contamination is an effective mode of transmitting HBV. The Centers for Disease Control and Prevention (CDC) states that HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles. Household bleach, which is 5.25 sodium hypochlorite diluted 1:10, is an appropriate disinfectant. Contact time for bleach is generally considered to be the time it takes the product to air dry. Solutions of bleach should not be stored in glass containers, but rather in the plastic material in which the bleach product is packaged. Work areas should be disinfected at the end of the shift or the end of analysis or before leaving the work area for break or meals.
EPA-registered tuberculocides, sterilants, or products registered against HIV/HBV are also acceptable forms of disinfecting surfaces. Sterilants and tuberculocides must be prepared according to the package label in order to be effective. Lists of these EPA Registered Products are available from the National Antimicrobial Information Network at (800) 447-6349 or its website at www.ace.orst.edu/info/nain/lists.htm.
The concern with regulated waste is not so much the amount of blood, but whether it might be dripping or difficult to contain. For example, 10 mls of blood on a bed sheet would dissipate into a large area and dry; however, a 1O-ml tube of blood that breaks must be picked up; its sharp and dripping nature would require placement in a regulated waste container. Waste containers must have the required biohazard symbol or color-coding even if all waste in the facility is considered biohazardous. Disposal of regulated waste falls under state and local regulations as well as under the EPA.
Sharps containers can be made of anything as long as they are leak-proof and puncture-resistant on the sides and bottom. The National Institute for Occupational Safety and Health (NIOSH) publication, Selecting, Evaluating and Using Sharps Disposal Containers  is a good resource.
Self-sheathing needle products must be disposed in a sharps container. Duct tape may be used to secure a sharps container lid, but tape is not acceptable if it serves as the lid itself. If a sharps container has an unwinder for the needle, it must be located so that the needle can be removed using a single-handed technique.
Laundries must have a sharps container because of the number of sharps found in bed linen.
Compliance officers will inspect sharps containers to see if they are overfilled and to check the number of recapped needles they contain. Some COs have been known to look into sharps containers, count the number of recapped needles found, and fine the facility based on that number.
Labels must be provided on containers of regulated waste, on refrigerators and freezers that are used to store blood and other body fluids, and on containers used to store, transport, or ship blood or other body fluids. Where there is overlap between the OSHA-mandated label and the DOT-required label, the DOT label will be considered acceptable on the outside of the transport container, provided that the OSHA-mandated label appears on any internal containers and includes the term "BIOHAZARD".
Employees must be trained prior to being placed in positions where occupational exposure may occur. Annual retraining for these employees must be provided within one year of their original training and must emphasize new information or procedures. The retraining does not have to be an exact replica of previous training. Trainers are required to keep accurate records of training sessions, including the names and titles of the employees who attend.
Trainees must have direct access to a qualified trainer during training. This may be via a telephone hotline. The use of an electronic mail system (email) to answer employee questions is not considered direct access to a qualified trainer. The CO will verify the competency of trainers based on the completion of specialized courses, degree programs, or work experience. Credentialing organizations (eg, ASCP) now provide specialized certification examinations for individuals responsible for safety in the laboratory. This would document trainer competence.
Other important information in the directive includes:
* OSHA defers to the CDC guidelines.  The CO will see if the employer knows the contents of the CDC guidelines and may even request proof of attendance at seminars where training about the CDC guidelines was given as well as knowledge of CDC web pages.
* Biosafety cabinets Class I or II must be certified annually and have an inward face velocity of 75 linear feet per minute.
* An eyewash must supply a 15-minute stream of tepid water. The hands must be free to hold the eyelids open to aid in the complete flushing of the eyes. The American National Standards Institute (ANSI) requires that eyewashes be checked weekly.
* Areas where food and drink are consumed must be separated from places where lab analyses are performed so that splashes and aerosols cannot contaminate food or drink.
* Teeth and gallstones or kidney stones may be given to patients and are not subject to the containerization and labeling provisions of the Standard.
* Body Substance Isolation and Standard Precautions are acceptable as alternative wording for Universal Precautions.
* Equipment being shipped for repair or other reasons must be decontaminated first. If that is not possible, the outer shell must be cleaned and disinfected, and a label must be placed on the equipment indicating exposure to bloodborne pathogens.
Ms. Gille is Administrative coordinator at Barnes-Jewish Hospital, BJC Health System, St. Louis, MO, and a member of MLO's Management Q&A board.
(1.) OSHA Compliance Directive 2-2.44D.
(2.) Selecting, Evaluating and Using Sharps Disposal Containers. DHHS (NIOSH) Publication No 97-111. January 1998.
(3.) CDC Prevention Guidelines Database.
Table 1 Material Spray rating Air porosity Suter test Cotton/polyester blend 0 (failed) 25 60 (65% cotton/35%/ polyester) Ideal lab coat fabric 90 (passed) 10 340 Surgical fluid-proof fabric 100 (optimal) 1 850
The following questions are examples that can be used for an evaluation of safety features on a vacuum tube blood collection system:
1. Can the safety feature be activated using a one-handed technique?
2. Does the safety feature interfere with normal use of this product?
3. Does the safety product require more time to use than a nonsafety device?
4. Does the safety feature work well regardless of the size of the person's hand?
5. Does the safety feature operate reliably?
6. When the safety feature is activated, does a clear and unmistakable audible (eg, a click) or visible (eg, blunted or covered) change occur?
7. Is the exposed sharp blunted or covered after use and prior to disposal?
8. Does the product need extensive training to be operated correctly?
1. Turn on faucet
2. Adjust temperature (must be at least tepid) and flow of water.
3. Wet hands.
4. Soap hands.
5. Work up lather using vigorous friction for at least 15 seconds.
6. Include areas between the fingers and around nail beds.
7. Rinse hands, holding hands downward.
8. Dry hands using paper towel.
9. Turn off faucet using the paper towel used to dry hands.
10. Discard paper towel in wastebasket.
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|Author:||Gile, Terry Jo|
|Publication:||Medical Laboratory Observer|
|Date:||Jun 1, 2001|
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