November 26, 2001

Steve Berman, MD, FAAP
President
American Academy of Pediatrics (AAP)
141 Northwest Point Blvd
Elk Grove Village, IL 60007-4000

Dear Dr. Berman:

Thank you for your July 25, 2001 letter to the Occupational Safety and Health Administration (OSHA) regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) to the administration of childhood vaccinations. We appreciated the opportunity to clarify the American Academy of Pediatrics' (AAPs') concerns over the phone. Since your letter does not ask specific interpretive questions, a member of your staff requested that we address each of your suggested "remedies" for their compliance with the standard. Your suggestions are restated below, followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenario not delineated within your original response.

AAP Scenario:   The American Academy of Pediatrics (AAP) is deeply concerned that the mandated use of safe sharps threatens the success of our nation's childhood immunization program.

AAP Suggestion 1:   Exempt injections for vaccine delivery from mandated safe sharps to allow comparable studies on sharps injuries and the effectiveness of sharps with engineered sharps injury protection (SESIPs) to be conducted in ambulatory healthcare facilities where childhood immunizations are provided.

OSHA Response 1:   OSHA does not generally grant exemptions from the Bloodborne Pathogens Standard. The standard applies to all occupational exposure to blood or other potentially infectious materials (OPIM) and requires an employer to determine where those exposures are reasonably anticipated. The exposure determination must then be documented and appropriate controls put in place to eliminate or minimize those hazards. The controls implemented include engineering and work practice controls, personal protective equipment, and employee training.

It would be particularly inappropriate to grant an exemption to the requirement in 29 CFR 1910.1030(d)(2)(i) to implement engineering controls, which include SESIPs after the Congress unanimously passed and the President signed the Needlestick Safety and Prevention Act (P.L. 106-430). The very purpose of that Act was to make sure that SESIPs are used as part of an overall bloodborne pathogens program to reduce accidental sharps injuries. Congress found that, "depending on the type of device used and the procedure involved, 62 to 88 percent of sharps injuries can potentially be prevented by the use of safer medical devices," on the basis of CDC findings in March 2000. They also found that the modification of the Bloodborne Pathogens Standard is appropriate to set forth in greater detail its requirement that employers identify, evaluate, and make use of effective safer medical devices.

As your letter illustrates and according to the International Health Care Worker Safety Center at the University of Virginia (EPINet database), needlesticks occurring from syringes used for intramuscular/subcutaneous injections pose a risk to those administering the injections. Data collected from several hospitals indicate that needlesticks occurring from this type of procedure account for the highest number of needlesticks (17%), along with those from devices used for drawing venous blood samples (EPINet, 1998). Therefore, when performing IM/subcutaneous injections (e.g., vaccinations, administration of medication) evaluation and selection of SESIPs are required.

AAP Suggestion 2:   Stand by the previous interpretation of the standard, which permitted employees and front-line employees to conduct their own risk assessments (based on the facility's history of past injuries and its comparison to sharps injuries in similar settings using similar sharps devices) and to customize their decision to switch to SESIPs. Should the work group agree that the existing work practice controls have proven sufficient to prevent sharps injuries, or that the engineering controls available would not have prevented the kinds of previous sharps injuries, then the adoption of the SESIP would be optional.

OSHA Response 2:   Implementing engineering and work practice controls where there is reasonably anticipated occupational exposure to blood or OPIM has always been a requirement of the standard and has not changed. Soliciting input from non-managerial employees responsible for patient care regarding the evaluation of engineering controls (e.g., SESIPs, needleless systems) is a requirement of the revised standard (January 2001).

Non-managerial employees responsible for direct patient care must have input in employer decisions about which engineering controls to adopt, not whether or not to adopt them. The standard does not give the employer the option to forgo appropriate, commercially available, and effective engineering controls. If the employer determines, through device evaluation, that no available devices are appropriate for a specific procedure, that decision must be documented in the Exposure Control Plan (ECP). If the employer feels that a particular device is cumbersome or awkward, employees may need additional practice or training until they feel comfortable using a new and different device. Whether or not an engineering control is chosen for a specific procedure, an annual review of devices is required and that review must be documented in the ECP.

Again, if appropriate and effective safer options are commercially available for specific medical procedures where there is reasonably anticipated exposure to blood or OPIM, they must be used. Appropriateness and effectiveness should be based on employee feedback, industry feedback, pilot programming, and/or practical use. Engineering and work practice controls that the employer determines to be appropriate, after non-managerial employee input, must be documented in the employer's Exposure Control Plan (ECP). Of course, if using a safer medical device compromises either patient safety or medical integrity, its use would not be required.

Please keep in mind that the Bloodborne Pathogens Standard and several other new OSHA standards are written in performance-oriented language, giving the employer the opportunity to implement the controls which best suit the safety of his or her employees.

The Centers for Disease Control and Prevention (CDC) and General Accounting Office (GAO) recommend, and OSHA requires, that the use of safer medical devices be combined with a comprehensive program including reducing the use of unnecessary needles, modifying procedures where appropriate, implementing safe work practices, employee training, promoting safety awareness in the workplace, and then evaluating the effectiveness of these measures. Where the use of safer medical devices is not appropriate, it is especially important that the other components of the program be in place.

Our compliance directive, CPL 2-2.44D [CPL 2-2.69], Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens (soon to be updated), provides several internet links to websites that have information and tips on evaluating engineering controls. We encourage you to look at them as aids for your evaluation.

(Correction 3/15/02)

The purpose of the Occupational Safety and Health (OSH) Act is to prevent the first injury or illness from occurring. No proof of specific prior instances of exposure is required to trigger OSH Act obligations [Mineral Industries, Etc. v. OSHRC, 639 F.2d 1289, 1294 (5th Cir. 1981)]. Thus, a facility's past sharps injury rates does not affect compliance with the standard. As mentioned previously, sharps injuries during the administration of vaccinations do occur. It is our mission to prevent these injuries.

AAP Suggestion 3:  Delaying application of safe sharps for immunization procedures to allow "payors" time to reallocate funding resources and providers time to renegotiate contracts with medical supply vendors and "payors." This would help vaccine providers to secure adequate reimbursement for additional vaccine administration costs associated with switching to SESIPs. This delay would also help small medical groups by allowing them to purchase SESIPs after hospitals and other high volume purchasers may have caused the prices of such devices to decline.

OSHA Response 3:  The requirement to use engineering and work practice controls (29 CFR 1910.1030(d)(2)) has been part of the standard since it was originally promulgated in December 1991 and has already been actively enforced since November 1999.

We will not further delay enforcement of any section of the standard. The revised standard was published in January 2001, became effective April 2001, and enforcement of the new provisions (i.e., the solicitation of input from non-managerial employees and maintaining a sharps injury log) began in July 2001 (October 2001 in OSHA state-plan states). OSHA inspections to determine compliance with this standard are performed mostly on the basis of employee complaints. During an OSHA inspection, if an OSHA compliance safety and health officer determines that an employer has not evaluated and implemented appropriate engineering and work practice controls, a citation would likely be issued.

With regard to the cost of purchasing safer medical devices, you may find that the cost is less prohibitive than anticipated. According to the November 17 GAO Report, Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals, to which you also refer in your letter, "the greatest dollars savings resulting from a needlestick reduction program would be the reduced cost of treating healthcare workers who have sustained needlesticks... these costs include medical treatment costs for healthcare workers who become infected after sustaining a needlestick; wages and time lost by these workers; emotional distress suffered by injured workers, their colleagues, and family members; reduced quality of life and while rare, lives lost." Some cost estimates for individual needlesticks range from $200 to $3,000 per injury according to both GAO and the International Health Care Worker Safety Center (University of Virginia). Most people find that the benefits of preventing an exposure incident far outweigh the costs of safer devices.

Additionally, if an employee had an exposure incident with a contaminated sharp, post-exposure follow-up is required. Through evaluation of the incident, an occupational health practitioner may determine that prophylaxis is not appropriate; however, follow-up still needs to be provided and paid for by the employer regardless of the type of device or the associated risk of transmission.

AAP Suggestion 4:  Explore ways to make SESIP purchased in high volume at government discounts available to pediatricians through programs such as the "Vaccine for Children Program," State Medicaid program, and bulk purchase programs from private sources.

OSHA Response 4:  While this may be a good suggestion for minimizing cost, we are not able to comment; this issue is outside of OSHA's jurisdiction.

AAP Suggestion 5:  Phase in the implementation of the Needlestick Safety and Prevention Act (NPSA) requirements. First, target healthcare workers in high-risk setting who use sharps in high-risk procedures. Second, target procedures more likely involved in exposure to blood or OPIM. Third, include sharps used in vaccine injections.

Response 5:  With regard to phasing in the enforcement of the new provisions of the standard (i.e., solicitation of input from non-managerial employees and maintaining a sharps injury log), this was already done in the period between January and July 2001 (October 2001 for OSHA state-plan states). OSHA is not targeting any industry or facility with regard to compliance with the Bloodborne Pathogens Standard. As mentioned previously, most OSHA inspections are complaint-driven. If an OSHA office were to receive a complaint regarding exposure to blood or OPIM, an inspection might result, regardless of the size or function of the facility.

Again, every process or procedure that may result in occupational exposure to blood or OPIM must be addressed and appropriate controls implemented. Though this has been a requirement since 1991, we recognize that evaluation and implementation of appropriate engineering controls can be a time-intensive task. That is why an employer is required to document his or her actions in the ECP, so that if an OSHA inspection did occur, the written plan can be consulted.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Compliance Assistance at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Compliance Programs

cc:  National Institute for Occupational Safety and Health, Cincinnati, OH
Centers for Disease Control and Prevention, Atlanta, GA