Removal of Contaminated Needles Prior to Disposal

December 19, 2011
MEMORANDUM FOR:	MARTHE B. KENT, REGIONAL ADMINISTRATOR
FROM:	THOMAS GALASSI, DIRECTOR DIRECTORATE OF ENFORCEMENT PROGRAMS
SUBJECT:	Removal of Contaminated Needles Prior to Disposal

This is in response to your Regional Office's request for clarification on the Agency's enforcement policy concerning the practice of uncapping used/contaminated needles prior to disposal. In the situation you presented, it was asked whether the Bloodborne Pathogens standard (29 CFR 1910.1030) permitted employers (e.g., medical and/or dental practitioners) to remove contaminated needles from caps/sheaths before disposing of the needles following medical or dental procedures.

As you are aware, the standard strictly prohibits bending, recapping, or removal of contaminated sharps unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. [29 CFR 1910.1030(d)(2)(vii)(A)] The scenario you described clearly does not meet either of these exceptions. In the case of the first exception (i.e., one in which there is no feasible alternative), the obvious alternative is that the needle with the cap attached can be placed directly into the sharps container. In the case of the second (i.e., one in which there is a medical or dental need for the removal of the needle), it is evident that at the point of disposal, the medical or dental procedure has already been completed and thus the prohibited activity is not medically necessary. This activity is one which requires additional manual manipulation, which unnecessarily exposed employees to a greater risk of injury and would NOT be permitted under this provision of the Bloodborne Pathogens standard.

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Safer work practices in medical labs

The CDC has produced guidelines that reinforce a common-sense approach to biosafety in day-to-day laboratory activities.

“Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories” address safe work practices in human and animal diagnostic laboratory, including microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance. The following is an introduction to this publication:

This report offers guidance and recommends biosafety practices specifically for human and animal clinical diagnostic laboratories and is intended to supplement the 5th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL-5), developed by CDC and the National Institutes of Health (1). This document was written not to replace existing biosafety guidelines, but to 1) improve the safety of activities in clinical diagnostic laboratories, 2) encourage laboratory workers to think about safety issues they might not previously have considered or addressed, and 3) encourage laboratorians to create and foster a culture of safety in their laboratories. Should any of the guidelines provided herein conflict with federal, state, or local laws or regulatory requirements, the laboratorian should defer to the federal, state, or local requirements. This culture of safety is also supported by the Clinical and Laboratory Standards Institute (2). Work in a diagnostic laboratory entails safety considerations beyond the biological component; therefore, these guidelines also address a few of the more important day-to-day safety issues that affect laboratorians in settings where biological safety is a major focus.

The US Bureau of Labor Statistics estimates that there are approximately 500,000 human and animal diagnostic lab workers, and that “any of these workers who have chronic medical conditions or receive immunosuppressive therapy would be at increased risk for a laboratory-acquired infection (LAI) after a laboratory exposure.” But post exposure infection risks are unknown because of the difficulty in determining the source or mode of transmission and non national surveillance system is available.

Bacteria account for more than 40% of LAI, with more than 37 species “as etiologic agents,” says the report, but other microbes also present risks. For example, “Hepatitis B has been the most frequent laboratory-acquired viral infection, with a rate of 3.5–4.6 cases per 1000 workers, which is two to four times that of the general population,” according to the report. “Any laboratorian who collects or handles tubes of blood is vulnerable.”

Also, LAI surveys have found that laboratory staff “were three to nine times more likely than the general population to become infected with Mycobacterium tuberculosis.”

Acceptability of using a straight needle instead of a safety needle?

Thank you for your March 28, 2001 letter to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded from OSHA's Milwaukee Area Office to the Directorate of Compliance Programs in Washington, DC for a response to your specific questions regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) to the withdrawal of medications from a vial in a clinical setting. Your question is outlined below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.

The pharmacy and nursing staff (of our facility) use large bore needles to withdraw medication from a vial and then remove that needle, placing a smaller gauge safety needle on the syringe to administer the medication to the patient.

Do we have to use a safety needle to withdraw the medication from the vial even though it will not have contact with the patient?

In the situation that you describe, the practices your facility uses are compliant with the Bloodborne Pathogens standard and no further controls would be required. The standard applies to all occupational exposure to blood or other potentially infectious materials (OPIM). Therefore, during a procedure where there is no exposure to blood or OPIM, such as withdrawing medication or pharmaceuticals from a vial, it would not be necessary to implement the use of engineering controls.

If, during this procedure, the same needle used to withdraw the medication is also used to administer it to a patient through injection, OSHA would require the use of an appropriate engineering control (e.g., safer medical device, sharp with engineered sharps injury protection). As you have stated, you use a straight needle to withdraw the medication from the vial and then switch to a "safety" needle for administration; this is acceptable.

Sincerely,


Richard E. Fairfax, Director
Directorate of Compliance Programs

Employer responsibilities for supplying contract employees

My company supplies contract employees to healthcare facilities. What are my responsibilities under the Bloodborne Pathogens standard?

OSHA considers personnel providers, who send their own employees to work at other facilities, to be employers whose employees may be exposed to hazards. Because your company maintains a continuing relationship with its employees, but another employer (your client) creates and controls the hazard, there is a shared responsibility for assuring that your employees are protected from workplace hazards. The client employer has the primary responsibility for such protection, but the "lessor employer" likewise has a responsibility under the Occupational Safety and Health Act. In the context of OSHA's standard on Bloodborne Pathogens, 29 CFR 1910.1030, your company would be required, for example, to provide the general bloodborne pathogens training outlined in the standard; ensure that employees are provided with the required vaccinations; and provide proper follow-up evaluations following an exposure incident. Your clients would be responsible, for example, for providing site-specific training and personal protective equipment, and would have the primary responsibility regarding the control of potential exposure conditions. The client, of course, may specify what qualifications are required for supplied personnel, including vaccination status. It is certainly in the interest of the lessor employer to ensure that all steps required under the standard have been taken by the client employer to ensure a safe and healthful workplace for the leased employees. Toward that end, your contracts with your clients should clearly describe the responsibilities of both parties in order to ensure that all requirements of the standard are met.

Hepatitis B Vaccinations continued!

Any workers who have reasonably anticipated contact with blood or Other Potentially Infectious Materials (OPIM) during performance of their jobs are considered to have occupational exposure and to be at risk of being infected. Workers infected with HBV face a risk for liver ailments which can be fatal, including cirrhosis of the liver and primary liver cancer. A small percentage of adults who get hepatitis B never fully recover and remain chronically infected. In addition, infected individuals can spread the virus to others through contact with their blood and other body fluids.

An employer must develop an exposure control plan and implement use of universal precautions and control measures, such as engineering controls, work practice controls, and personal protective equipment to protect all workers with occupational exposure. In addition, employers must make hepatitis B vaccination available to these workers. Hepatitis B vaccination is recognized as an effective defense against HBV infection.

What to do if an employee declines the vaccination.

Employers must ensure that workers who decline vaccination sign a declination form. The purpose of this is to encourage greater participation in the vaccination program by stating that a worker declining the vaccination remains at risk of acquiring hepatitis B. The form also states that if a worker initially declines to receive the vaccine, but at a later date decides to accept it, the employer is required to make it available, at no cost, provided the worker is still occupationally exposed.

Are employers required to provide an HBV vaccination?

HBV Vaccination

The standard requires employers to offer the vaccination series to all workers who have occupational exposure. Examples of workers who may have occupational exposure include, but are not limited to, healthcare workers, emergency responders, morticians, first-aid personnel, correctional officers and laundry workers in hospitals and commercial laundries that service healthcare or public safety institutions. The vaccine and vaccination must be offered at no cost to the worker and at a reasonable time and place. The hepatitis B vaccination is a non-infectious, vaccine prepared from recombinant yeast cultures, rather than human blood or plasma. There is no risk of contamination from other bloodborne pathogens nor is there any chance of developing
HBV from the vaccine.

The vaccine must be administered according to the recommendations of the U.S. Public Health Service (USPHS) current at the time the procedure takes place. To ensure immunity, it is important for individuals to complete the entire course of vaccination contained in the USPHS recommendations.

The great majority of those vaccinated will develop immunity to the hepatitis B virus. The vaccine causes no harm to those who are already immune or to those who may be HBV carriers. Although workers may desire to have their blood tested for antibodies to see if vaccination is needed, employers cannot make such screening a condition of receiving vaccination and employers are not required to provide prescreening.

Employers must ensure that all occupationally exposed workers are trained about the vaccine and vaccination, including efficacy, safety, method of administration, and the benefits of vaccination. They also must be informed that the vaccine and vaccination are offered at no cost to the worker. The vaccination must be offered after the worker is trained and within 10 days of initial assignment to a job where there is occupational exposure, unless the worker has previously received the vaccine series, antibody testing has revealed that the worker is immune, or the vaccine is contraindicated for medical reasons. The employer must obtain a written opinion from the icensed healthcare professional within 15 days of the completion of the evaluation for vaccination. This written opinion is limited to whether hepatitis B vaccination is indicated for the worker and if the worker has received the vaccination.

Are there exceptions for PPE use by healthcare workers?

One way the employer can protect workers against exposure to bloodborne pathogens, such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), the virus that causes AIDS, is by providing and ensuring they use personal protective equipment, or PPE. Wearing appropriate PPE can significantly reduce risk, since it acts as a barrier against exposure. Employers are required to provide, clean, repair, and replace this equipment as needed, and at no cost to workers.

A worker may choose, temporarily and briefly, under rare and extraordinary circumstances, to forego use of personal protective equipment. It must be the worker’s professional judgment that using the personal protective equipment would prevent the delivery of health care or public safety services or would pose an increased hazard to the safety of the worker or coworker. When such a situation occurs, the employer is required to investigate and document the circumstances to determine if there is a way to avoid it from happening again in the future. Employers and workers should be aware that this is not a blanket exemption to the requirement to use PPE. OSHA expects that this will be an extremely rare occurrence.