Friday, December 13, 2013

Employees dealing with developmental disabled individuals

August 28, 1992
The Honorable John A. Boehner
House of Representatives
Washington, D.C. 20515

Dear Congressman Boehner:

This is in further response to your letter of July 7, on behalf of your constituent, Ms. Amy G***, requesting clarification of issues regarding the Occupational Safety and Health Administration (OSHA) regulation, 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Ms. Gerowitz's primary issue of concern is the requirement to provide personal protective equipment to employees performing certain residential services for individuals with developmental disabilities. She has stated that she feels the implementation of these requirements may, or may appear to, discriminate against individuals with developmental disabilities.

The bloodborne pathogens standard is designed to protect the nation's workers, particularly health care workers, from exposure to the Hepatitis B Virus (HBV), the Human Immunodeficiency Virus (HIV), and other bloodborne pathogens. Of the diseases caused by these viruses, Hepatitis B is the most common, with 8,700 cases per year among workers in the health care profession. Hepatitis B infection may result in serious illness, long term disability, and death. The HIV virus causes AIDS, for which there currently is no cure and which eventually results in death. These viruses, as well as other organisms that cause bloodborne diseases, are found in human blood and certain other human body fluids. Therefore, employers have a particular responsibility to ensure that employees do not come into direct contact with blood or other potentially infectious materials while performing their job.

You should note, however, that it is the employer's responsibility to determine which job classifications involve occupational exposure, and that the employer is only required to make the hepatitis B vaccine available and provide the other protections of the standard to those employees having occupational exposure. Occupational exposure is defined as reasonably anticipated exposure to blood or other potentially infectious materials as the result of performing one's job duties.

In an ambulatory residential facility, only certain employees may have jobs which involve occupational exposure, although OSHA expects an employer to take into account all potential circumstances of exposure (such as biting and contact with skin lesions or other potentially infectious secretions) when determining which, if any, employees in a facility have occupational exposure. Employees who do not have occupational exposure are not covered by the scope of this standard.

With respect to the issue raised in your constituent's letter concerning the use of personal protective equipment, the requirements of 29 CFR 1910.1030 are performance oriented. The standard requires the employer to evaluate the task and the potential contact with blood and other potentially infectious materials. Based on this determination, the employer is to select the "appropriate" personal protective equipment in accordance with paragraph (d)(3)(i) of the standard.

Of the specific examples cited in your constituent's letter, procedures such as flossing and brushing teeth, and suctioning of body fluids would be reasonably anticipated to result in potential exposure to blood or other potentially infectious materials and would, therefore, require the use of some level of personal protective equipment. It is not OSHA's position or expectation, however, that protective equipment would be required for employees assisting patients in eating under normal circumstances.

One of Ms. Gerowitz's attachments in her letter to you is a copy of a June 9 letter addressed to OSHA which delineates the concerns of the National Association of Private Residential Resources (NAPRR) regarding the application of OSHA standards to their members. OSHA's Office of Health Compliance Assistance met with Ms. Joni Fritz, Executive Director of the NAPRR, and Ms. Nancy Meng, Director of Special Projects, on April 16 to discuss the Association's concerns and to explain OSHA's enforcement policy as it relates to the bloodborne pathogens standard, the hazard communication standard, and other OSHA standards which may be applicable. This meeting clarified a number of misunderstandings regarding OSHA compliance, and the representatives of NAPRR informed us that the meeting had been extremely beneficial to them. Furthermore, in order to promote further understanding, OSHA has agreed to provide a speaker on these topics on September 15, for the NAPRR 1992 Governmental Activities Seminar.

Friday, November 15, 2013

Application of BBP Standard to Funeral & Nursing Homes

June 1, 1992



SUBJECT: Clarification of Issues under the Bloodborne Pathogens Standard Settlement Agreements

The National Funeral Directors Association (NFDA) and the American Health Care Association (AHCA), which represents nursing homes, have requested clarification on certain issues under the bloodborne pathogens standard that concern their industries. The NFDA was concerned about: (1) whether human remains would be regarded as "regulated waste;" (2) the significance of including human remains in the definition of "source individual;" and (3) the extent to which funeral home employers would be required to ensure that their workers wear personal protective equipment. The AHCA asked for clarification on the considerations that enter into the exposure determinations the employer must make under paragraph (c)(2) and on whether the records retention requirement of paragraph (h) required the employer to physically maintain employee medical records at the worksite.

The attached letters from the Acting Assistant Secretary explain OSHA's position on the points raised by NFDA and AHCA and should be consulted for guidance in enforcing the standard with respect to the above issues.


April 29, 1992

Ms. Carol J. Hendrick
Government Relations Coordinator
National Funeral Directors Association
11121 West Oklahoma Avenue
Milwaukee, WI 53208

Re: Clarification of Application of Certain Provisions of OSHA Bloodborne Pathogens Standard to Funeral Homes

Dear Ms. Hendrick:

The Occupational Safety and Health Administration's (OSHA) bloodborne pathogens standard, issued on December 6, 1991, applies to all occupational exposure to blood or other potentially infectious materials. As the National Funeral Directors Association acknowledged during the rulemaking proceeding, funeral homes are among the workplaces known to have such exposure.

In a meeting with members of my staff on February 20, you explained that you support the standard but asked for guidance on the manner in which certain of its provisions would apply to funeral homes. Your concerns included whether a dead human body would be considered "regulated waste," as that term is used in the standard, and how the inclusion of human remains in the definition of "source individual" would affect funeral homes. You also expressed concern that OSHA would require funeral home employers to ensure the use of personal protective equipment in situations in which employees' exposure to blood or other potentially infectious materials is not reasonably anticipated.

First, employees handling a body must, as you recognize, be protected against contact with blood and other potentially infectious materials. However, the standard does not include a human body within the term "regulated waste," which is defined as:

[... liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.]
Since human remains are not regulated waste under the standard, the requirements governing the containment, disposal, and labeling of regulated waste found in 29 CFR 1910.1030(d)(4)(iii)(B) & (C) and 29 CFR 1910.1030(g)(1) do not apply to a human body or to containers used to store, transport, or ship a human body. Moreover, an intact human body, whether alive or dead, is not a "specimen" of blood or other potentially infectious materials to which the containerization and labeling requirements of 29 CFR 1910.1030(d)(2)(xiii) would apply. Although the standard does not require labeling of a container holding a human body as a biohazard, nothing in this letter should be read as detracting from the need to utilize a means of containment under certain circumstances, such as decay or trauma, to contain blood or other potentially infectious materials and prevent exposure.

Second, the standard defines "source individual" to include: [any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components.]

By including human remains in this definition, OSHA intended that a specific exposure incident resulting from contact with blood or other potentially infectious materials from human remains would trigger the requirements of 29 CFR 1910.1030(f) regarding evaluation, treatment, and follow-up of an employee who suffers an exposure incident. OSHA considers the inherent risk of exposure from human remains to be similar to that from a living human being. As with living human beings, occupational exposure from human remains arises only from reasonably anticipated contact with blood or other potentially infectious materials. For the purpose of this standard, occupational exposure does not occur if contact with such material is not reasonably anticipated.

Third, with regard to the use of protective equipment, OSHA recognizes that the selection and type of personal protective equipment and the degree to which it must resist penetration are performance-based. The employer must evaluate the task and the type of exposure expected and, based on the determination, select the "appropriate" personal protective equipment in accordance with paragraph (d)(3)(i) of the standard. As OSHA stated in the preamble to the final standard (56 Fed. Reg. at 64125):
It is not the Agency's intent that employees be outfitted in all possible personal protective equipment or a "moon suit" for all tasks or procedures that they perform. The protective equipment utilized is simply to be chosen to protect against contact with blood or other potentially infectious materials based upon the type of exposure and quantity of these substances which can be reasonably anticipated to be encountered during performance of a task or procedure.
I appreciate your interest in working with OSHA to assure that employers in your industry understand their obligations under the standard. I hope this letter clarifies the specific points you have raised. Although OSHA does not now intend to develop training materials that are specific to funeral homes, should the Agency do so in the future it will afford your Association the opportunity to review such materials to assure that they accurately reflect industry practices.


Dorothy L. Strunk
Acting Assistant Secretary

April 29, 1992

Dr. Paul R. Willging
Executive Vice President
American Health Care Association
1201 L Street, N.W.
Washington, DC 20005

Dear Dr. Willging:

Thank you for your letter of March 24, which Mr. Adkins has forwarded to me, explaining the American Health Care Association's concerns over the application of the bloodborne pathogens standard to nursing homes. Your letter raises issues concerning the exposure determinations employers must make under paragraph (c)(2) of the standard and the records retention requirements of paragraph (h).

The exposure determinations required by paragraph (c)(2) are intended to identify employees who are occupationally exposed to bloodborne pathogens. "Occupational exposure" is defined as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties." The employer must fully comply with the standard with respect to all employees who perform tasks and procedures in which occupational exposure occurs. However, employees who do not perform such tasks and procedures are not considered occupationally exposed under the standard.

Paragraph (c)(2) requires each employer with employees exposed to bloodborne pathogens to make an exposure determination listing:
(A) job classifications in which all employees have occupational exposure;

(B) job classifications in which some, but not all, employees have occupational exposure; and

(C) the tasks and procedures, or groups of closely related tasks and procedures, in which occupational exposure occurs in the job classifications in which some, but not all, employees have occupational exposure.
These determinations must be made without taking into account the use of personal protective equipment.

For the job classifications in which some, but not all, employees have occupational exposure, each employer must designate that employees who perform the specific tasks and procedures that subject them to occupational exposure are within the scope of the standard. Employees within the same job category that the employer designates as "non-exposed," and therefore outside the scope of the standard, should be trained to identify the circumstances that can lead to exposure and to defer such tasks to employees designated to perform them. For example, an employee who handles linens soiled with feces, nasal secretions, sputum, sweat, tears, urine, vomitus, or saliva (other than saliva from dental procedures) that are not contaminated with visible blood would not be occupationally exposed during that task, for these substances are not "other potentially infectious materials" as defined in the standard unless they are contaminated with visible blood. See 56 Fed. Reg. at 64103 (adopting June 1988 CDC guidelines to determine the body fluids defined as "other potentially infectious materials"). But if that employee were to handle, for example, linens soiled with urine that did contain visible blood or for which the presence of blood would be reasonably anticipated because the particular patient has a medical condition that typically leads to blood in the urine, the employee would be occupationally exposed. The employee should therefore be instructed to defer all tasks involving visible blood contamination or reasonably anticipated blood contamination to employees designated to perform tasks involving exposure to blood or other potentially infectious materials.

Where an employer determines that some employees in a job classification have occupational exposure and others do not, the compliance officer will verify that employees who are designated as exposed are the only ones who perform tasks and procedures that will cause exposure. If the compliance officer does not find evidence demonstrating that employees designated as non- exposed are performing tasks and procedures that cause occupational exposure, the employer shall be deemed in compliance with respect to those employees.

With respect to the standard's recordkeeping provisions, you have asked for a reduction of the 30-year retention requirement and for clarification about whether it is permissible for the records to be kept at a location other than the worksite. OSHA believes that the 30-year retention period is necessary and not overly burdensome. With respect to the location of records, paragraph (h) requires employers to establish and maintain for each employee medical records that include hepatitis B vaccination status and evaluation and follow-up of exposure incidents. The records need not be kept at the place of employment but must be maintained in a manner that makes them accessible to OSHA. See 56 Fed. Reg. at 64169. Some employers may contract with the healthcare professional or professionals that perform the vaccination or post-exposure evaluation and follow-up to maintain the records. If the employer does not retain possession of the records, the employer must assure that the records are available to OSHA and make them accessible by identifying where the records are kept and how they may be accessed by OSHA. One way in which this can be accomplished is by maintaining a statement in each employee's record identifying the location where that employee's records are kept and how OSHA may access the records.

I hope that this letter adequately answers your concerns.


Dorothy L. Strunk
Acting Assistant Secretary

[Corrected 2/20/2004]

Tuesday, November 5, 2013

Clarification of Training Requirement

Stuart, Florida 34995

Dear Ms. G***:

This is in response to your letter of February 24, addressed to Dan Mick, Office of the Solicitor. You requested clarification concerning a training requirement in 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens".

Section (g)(2)(vii)(N) of the standard states that there must be "an opportunity for interactive questions and answers with the person conducting the training session". The Occupational Safety and Health Administration (OSHA) [CPL 2-2.69, "Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens"] has interpreted that language to mean that if a generic program is used (even an interactive computer program), it must be supplemented with the site-specific information required by the standard and a person must be accessible for interaction with trainees.

Whether or not the use of telephone access for the question and answer period would meet OSHA requirements would depend on such factors (assuming competency of the trainer) as accessibility and the ratio of trainers answering the phone to number of employees calling with questions. The requirement may be satisfactorily fulfilled without the trainer being physically present in the room with the employee.

Because many of these requirements are performance based, compliance officers will determine, on a case-by-case basis, whether the training that has been provided is effective and adequate. This is accomplished through observation of work practices and employee interviews to determine that the training (including written material, oral presentations, film, videos, computer programs, and audiotapes) is presented in a manner that is appropriate to the employees' education, literacy level, and language.

We hope this information is responsive to your concerns. Thank you for your interest in worker safety and health.


Monday, October 28, 2013

Post-Exposure Follow-Up

Post-Exposure Follow-up

Potential Hazard
  • No post-exposure follow-up made available after a needlestick/sharps injury to help document injury or offer medically indicated post-exposure prophylaxis.
Possible Solutions
  • Employer should ensure that a Post-Exposure Evaluation and Follow-up is in place to handle needlestick/sharps injuries.
  • Employer should provide a confidential medical evaluation and follow-up to the exposed employee, immediately following the report of an exposure incident [29 CFR 1910.1030(f)(3)]. It is recommended that the follow-up include identifying injury patterns and accident analysis to determine if other training, procedures, or safer needle devices should be used to prevent future accidents.

    • Post-exposure evaluation and follow-up should include:

  • Maintain a log of injuries from contaminated sharps [29 CFR 1910.1030(h)(5)].

  • The National Institute for Occupational Safety and Health (NIOSH) recommends that if an employee experiences a needlestick/sharps injury or is exposed to blood or other body fluid during the course of work that the following steps be taken immediately:

    • Wash needlestick and cuts with soap and water.
    • Flush splashes to the nose, mouth, or skin with water.
    • Irrigate eyes with clean water, saline, or sterile irrigates.
    • Report the incident to your supervisor.
    • Seek medical treatment immediately.
  • Questions about appropriate medical treatment for occupational exposures to blood is available 24 hours from the Clinicians' Post Exposure Prophylaxis Hotline (PEPline) (1-888-448-4911).

Thursday, October 24, 2013

Bloodborne Infectious Diseases: HIV/AIDS, Hepatitis B & Hepatitis C

National Institute for Occupational Safety and Health (NIOSH) Workplace Safety and Health Topic

Exposures to blood and other body fluids occur across a wide variety of occupations. Health care workers, emergency response and public safety personnel, and other workers can be exposed to blood through needlestick and other sharps injuries, mucous membrane, and skin exposures. The pathogens of primary concern are the human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Workers and employers are urged to take advantage of available engineering controls and work practices to prevent exposure to blood and other body fluids.

Universal Precautions for Preventing Transmission of Bloodborne Infections

 There are two tiers of Healthcare Infection Control Practices Advisory Committee (HICPAC)/CDC precautions to prevent transmission of infectious agents, Standard Precautions and Transmission-Based Precautions. Standard Precautions are intended to be applied to the care of all patients in all healthcare settings, regardless of the suspected or confirmed presence of an infectious agent. Implementation of Standard Precautions constitutes the primary strategy for the prevention of healthcare-associated transmission of infectious agents among patients and healthcare personnel. Transmission-Based Precautions are for patients who are known or suspected to be infected or colonized with infectious agents, including certain epidemiologically important pathogens, which require additional control measures to effectively prevent transmission. Since the infecting agent often is not known at the time of admission to a healthcare facility, Transmission-Based Precautions are used empirically, according to the clinical syndrome and the likely etiologic agents at the time, and then modified when the pathogen is identified or a transmissible infectious etiology is ruled out. Examples of this syndromic approach are presented in Table 2. The HICPAC/CDC Guidelines also include recommendations for creating a Protective Environment for allogeneic HSCT patients.

The specific elements of Standard and Transmission-Based Precautions are discussed in Part II of this guideline. In Part III, the circumstances in which Standard Precautions, Transmission-Based Precautions, and a Protective Environment are applied are discussed. See Tables 4 and 5 for summaries of the key elements of these sets of precautions.

Standard Precautions

Standard Precautions combine the major features of Universal Precautions (UP) 780, 896 and Body Substance Isolation (BSI) 640 and are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. Standard Precautions include a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which healthcare is delivered (Table 4). These include: hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; and safe injection practices. Also, equipment or items in the patient environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents (e.g. wear gloves for direct contact, contain heavily soiled equipment, properly clean and disinfect or sterilize reusable equipment before use on another patient).

The application of Standard Precautions during patient care is determined by the nature of the HCW-patient interaction and the extent of anticipated blood, body fluid, or pathogen exposure. For some interactions (e.g., performing venipuncture), only gloves may be needed; during other interactions (e.g., intubation), use of gloves, gown, and face shield or mask and goggles is necessary. Education and training on the principles and rationale for recommended practices are critical elements of Standard Precautions because they facilitate appropriate decision-making and promote adherence when HCWs are faced with new circumstances 655, 681-686. An example of the importance of the use of Standard Precautions is intubation, especially under emergency circumstances when infectious agents may not be suspected, but later are identified (e.g., SARS-CoV, N. meningitides). The application of Standard Precautions is described below and summarized in Table 4. Guidance on donning and removing gloves, gowns and other PPE is presented in the Figure. Standard Precautions are also intended to protect patients by ensuring that healthcare personnel do not carry infectious agents to patients on their hands or via equipment used during patient care.

Friday, October 18, 2013

Hazard Recognition

The CDC estimates that 5.6 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and others. All occupational exposure to blood or other potentially infectious materials (OPIM) place workers at risk for infection with bloodborne pathogens. OSHA defines blood to mean human blood, human blood components, and products made from human blood. Other potentially infectious materials (OPIM) means: (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. The following references aid in recognizing workplace hazards associated with bloodborne pathogens.

Bloodborne Pathogens Standard

As mandated by the Needlestick Safety and Prevention Act, OSHA revised the Bloodborne Pathogens Standard [29 CFR 1910.1030], effective April 18, 2001. Definitions for bloodborne pathogens, other potentially infectious materials (OPIM), and occupational exposure are found in 29 CFR 1910.1030(b).

Potential Hazard
  • Employee exposure to blood and OPIM [29 CFR 1910.1030(b)] due to ineffective Exposure Control Plan (ECP).
Possible Solutions
  • Identify employees who have occupational exposure to blood or OPIM [29 CFR 1910.1030(b)], and then establish and implement a written Exposure Control Plan (ECP), designed to eliminate or minimize employee exposure [29 CFR 1910.1030(c)(1)].

  • Exposure Control Plan requirements include:
    • Documenting an annual review and update of the written plan that reflects changes in technology for safer medical devices. [29 CFR 1910.1030(c)(1)(iv)(A)] Employers must also document consideration and implementation of the safer medical devices annually. [29 CFR 1910.1030(c)(1)(iv)(B)]

    • Employer must get input for the devices from those responsible for direct patient care. [29 CFR 1910.1030(c)(1)(v)] This input must also be documented.
  • Employer should ensure that the Exposure Control Plan (ECP) is accessible to all employees. [29 CFR 1910.1030(c)(1)(iii)] They should also review and update it at least yearly. [29 CFR 1910.1030(c)(1)(iv)]

  • Employer should ensure that employees with occupational exposure to bloodborne pathogens receive appropriate training, at no cost to employee, and during working hours. [29 CFR 1910.1030(g)(2)(i) and 29 CFR 1910.1030(g)(2)(vii)]

Friday, October 11, 2013

Quick Reference Guide Part 3

  • Does the revised Bloodborne Pathogens standard apply to medical or dental offices that have fewer than 10 employees?

    OSHA's Bloodborne Pathogens standard applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials (OPIM), regardless of how many workers are employed. However, the offices and clinics of medical doctors and dentists are exempt from the requirement to keep a log of occupational injuries and illnesses and thus exempt from maintaining a sharps injury log. (See Appendix A to Subpart B of 29 CFR Part 1904.) All other applicable provisions of the Bloodborne Pathogens standard still apply.

  • What information do I need to include in my written Exposure Control Plan (ECP)? How often do I need to update it?

    The required elements of an ECP are:
    • The exposure determination which identifies job classifications with occupational exposure and tasks and procedures where there is occupational exposure and that are performed by employees in job classifications in which some employees have occupational exposure;
    • The procedures for evaluating the circumstances surrounding exposure incidents;
    • A schedule of how other provisions of the standard are implemented, including methods of compliance, HIV and HBV research laboratories and production facilities requirements, hepatitis B vaccination and post-exposure evaluation and follow-up, communication of hazards to employees, and recordkeeping;
      Methods of compliance include:
      • Universal Precautions;
      • Engineering and work practice controls, e.g., safer medical devices, sharps disposal containers, hand hygiene;
      • Personal protective equipment;
      • Housekeeping, including decontamination procedures and removal of regulated waste.

    • Documentation of:
      • the annual consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure, and
      • the solicitation of non-managerial healthcare workers (who are responsible for direct patient care and are potentially exposed to injuries from contaminated sharps) in the identification, evaluation, and selection of effective engineering and work practice controls.

    The ECP must be reviewed and updated at least annually, and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure.

  • Are employers responsible for providing sharps containers for employees who are diabetic and need insulin shots in a non-healthcare related facility?

  • The employer would not be required to provide a sharps container to an employee using insulin syringes for personal therapeutic reasons. To eliminate potential exposures to other workers, however, the employer could require that the employee provide his or her own workplace sharps container.

  • What does OSHA currently accept as "appropriate" disinfectants to prevent the spread of HIV and HBV

    OSHA's position is that EPA-registered tuberculocidal disinfectants, diluted bleach solutions and EPA-registered disinfectants that are labeled as effective against both HIV and HBV as well as Sterilants/High-Level Disinfectants cleared by the FDA, meet the requirement in the standard and are "appropriate" disinfectants to clean contaminated surfaces, provided that such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended.

    It is important to emphasize the EPA-approved label section titled "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 AND HBV OF SURFACES\OBJECTS SOILED WITH BLOOD\BODY FLUIDS." These instructions require:

    • that personal protective equipment be provided for the worker performing the task;
    • that all the blood must be cleaned up thoroughly before applying the disinfectant;
    • that the disposal of the infectious waste be in accordance with federal, state, or local regulations; and
    • that the surface be left wet with the disinfectant for 30 seconds for HIV-1 and for 10 minutes for HBV.

  • Is a Hepatitis B (HBV) post-vaccination titer required?

    29 CFR 1910.1030(f)(1)(ii)(D) takes into consideration the changing nature of medical treatment relating to hepatitis B. OSHA requires use of the U.S. Public Health Service (USPHS) guidelines current at the time of the evaluation or procedure. The most current guidelines regarding hepatitis B is the Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis in MMWR, Vol. 50, No.11, June 29, 2001. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration, as recommended in the guidelines. Employees who have ongoing contact with patients or blood and are at ongoing risk for percutaneous injuries must be tested for antibody to hepatitis B surface antigen, one to two months after the completion of the three-dose vaccination series. Employees who do not respond to the primary vaccination series must be revaccinated with a second three-dose vaccine series and retested. Non-responders to the second series must be medically evaluated.

  • Are workers who administer the vaccines in emergency situations (e.g., in a pandemic response) covered by the Bloodborne Pathogens standard

    The Bloodborne Pathogens standard covers all workers in the private sector as well as civilian employees of federal entities. State and local government employees are covered if they are in one of the 25 states and two territories that operate their own OSHA-approved state plans. In the remaining jurisdictions, where Federal OSHA has authority, hospitals operated by state, territorial or local governments are required to provide the protection of the Bloodborne Pathogens standard to their employees with enforcement by the Centers for Medicare and Medicaid Services (42 U.S.C. 1395cc(a)(1)(V) and (b)(4)).

    Additionally, the CDC recommends that all vaccination clinics comply with the Bloodborne Pathogens standard's provisions.

  • Where can I get information about what is expected of me?

    There are several resources available for employers and employees with regard to occupational exposures to blood and OPIM. First is the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030). Also available are CPL 2-2.69 (November 2001) Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, and many other related documents. This information can be found on OSHA's Bloodborne Pathogens and Needlestick Prevention Web Page. You may access additional information, such as information from OSHA's Consultation and State Plan State Offices, via OSHA's website or by phone at 1-800-321-OSHA (6742). CDC and the National Institute for Occupational Safety and Health (NIOSH), a CDC agency, also have documents related to the prevention of occupational exposure to blood and OPIM available.

Monday, October 7, 2013

Quick Reference Guide Part 2

  1. Do the Bloodborne Pathogens standard and the Needlestick Safety and Prevention Act apply to me?

    OSHA's Bloodborne Pathogens standard, including its 2001 revisions, applies to all employers who have an employee(s) with occupational exposure (i.e., reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials (OPIM) that may result from the performance of the employee's duties). These employers must implement the requirements set forth in the standard. Some of the new and clarified provisions in the standard apply only to healthcare settings, but other provisions, particularly the requirements to update the Exposure Control Plan and to keep a sharps injury log, apply to non-healthcare as well as healthcare settings.

  2. What does the standard say about the use of safer medical devices?

    The standard states, "engineering and work practice controls shall be used to eliminate or minimize employee exposure." The 2001 revision defines engineering controls as "controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." Employers who have employees exposed to contaminated sharps must consider and implement appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure. Also, employees with occupational exposure must be trained in the use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices and personal protective equipment. Therefore, training must include instruction on any new techniques and practices associated with new engineering controls.

  3. If I've never had an employee experience a needlestick, do I still need to use safer devices?

    Yes. OSHA standards are intended to be implemented as a means to prevent occupational injuries and illnesses. To most effectively avoid percutaneous injuries from contaminated sharps, employers must implement engineering controls, including safer medical devices, so that employees have them available to use.

  4. How many non-managerial employees do I need to include in the process of choosing safer medical devices?

    Small medical offices may want to seek input from all occupationally exposed employees when making their decisions. Larger facilities are not required to request input from all exposed employees; however, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, emergency department, etc.). Regardless of the number chosen, in order to be included in the process the workers must be responsible for direct patient care and be potentially exposed to injuries from contaminated sharps. The solicitation of employees who have been involved in the input and evaluation process must be documented in the Exposure Control Plan.

  5. Does OSHA have a list of available safer medical devices?

    No. OSHA does not approve or endorse any product. It is the employer's responsibility to identify and implement appropriate, commercially available and effective safer medical devices for the specific medical procedures being conducted.

  6. What if a safer option is not available for the medical device that I use?

    A key element in choosing a safer medical device, other than its appropriateness to the procedure and its effectiveness, is its availability on the market. If there is no safer option to the medical device that you are using for a particular procedure, you are not required to adopt a device different from the one currently being used. During your annual review of devices, you must consider new or prospective safer options and document this fact in your written Exposure Control Plan. With advances in medical technology, more devices are becoming available for different procedures. If no engineering control is available, work practice controls shall be used and, if occupational exposure still remains, personal protective equipment must also be used.

  7. Do I have to keep a sharps injury log? Does it have to be confidential?

    If, as an employer, you are required to maintain a log of occupational injuries and illnesses under 29 CFR Part 1904, you must also establish and maintain a sharps injury log for recording percutaneous injuries from contaminated sharps. The sharps injury log must contain, at a minimum, the type and brand of device involved in the injury (if known), the department or work area where the exposure incident occurred, and an explanation of how the incident occurred. The log must be recorded and maintained in a manner that protects the confidentiality of the injured worker (e.g., removal of personal identifiers).

Thursday, September 26, 2013

Quick Reference Guide

  1. What is the Bloodborne Pathogens standard?

    OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) as amended pursuant to the Needlestick Safety and Prevention Act of 2000, prescribes safeguards to protect workers against the health hazards caused by bloodborne pathogens. Its requirements address items such as exposure control plans, universal precautions, engineering and work practice controls, personal protective equipment, housekeeping, laboratories, hepatitis B vaccination, post-exposure follow-up, hazard communication and training, and recordkeeping. The standard places requirements on employers whose workers can be reasonably anticipated to contact blood or other potentially infectious materials (OPIM), such as unfixed human tissues and certain body fluids.

  2. What is the Needlestick Safety and Prevention Act?

    The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress required modification of OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA's requirement for employers to identify, evaluate and implement safer medical devices such as needleless systems and sharps with engineered sharps protections. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in identifying, evaluating and choosing effective engineering and work practice controls. These are workers who are responsible for direct patient care and be potentially exposed to injuries from contaminated sharps.

  3. How does the Needlestick Safety and Prevention Act apply to OSHA's Bloodborne Pathogens standard?

    The Act directed OSHA to revise its Bloodborne Pathogens standard (29 CFR 1910.1030). OSHA published the revised standard in the Federal Register on January 18, 2001; it took effect on April 18, 2001. The requirement to implement the use of engineering controls, which includes safer medical devices, has been in effect since 1992.

  4. How does the standard affect states that operate their own federally-approved occupational safety and health programs?

    States and territories that operate their own OSHA-approved state programs are required to adopt a Bloodborne Pathogens standard that is at least as effective as the Federal OSHA standard.

  5. Does the standard apply to public sector (state and local government) employees?

    The 25 states and two territories that operate OSHA-approved state plans are required to enforce an "at least as effective" standard in the public sector. In the remaining states where Federal OSHA has jurisdiction, hospitals in the public sector are required to comply with the Bloodborne Pathogens standard with enforcement by the Centers for Medicare and Medicaid Services (42 U.S.C. 1395cc(a)(1)(V) and (b)(4)).

Wednesday, September 18, 2013

Biohazard labeling - red container, not biohazard label?

December 15, 1992
Ms. Elaine T***
Ciba-Corning Diagnostics Limited
Sudbury, England CO10 6XD

Dear Ms. T***,

This is in response to your letter of September 22 and to provide you with written confirmation of phone conversations you have had with a member of my staff. You requested an interpretation of the acceptability of your company's biohazard label under the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, the Occupational Exposure to Bloodborne Pathogens Standard. We apologize for the delay in this written response.

The bloodborne pathogens standard requires that the biohazard label be affixed to containers of regulated waste and other containers used to store, transport, or ship blood or other potentially infectious materials; a red container may be substituted for the biohazard label. The design and coloring of the warning label which you submitted appears to be consistent with the requirements of 1910.1030(g)(1)(i)(B) and (C) which require that the biohazard symbol and legend be in a contrasting color to a fluorescent orange or orange-red background.

We hope this information is responsive to your concerns and thank you for your interest in worker safety and health.


Roger A. Clark,
Directorate of Compliance Programs

Wednesday, September 4, 2013

Applicability for companion-sitters in private homes

April 17, 1997

Patricia O****

Dear Ms. O***:

Thank you for your letter of February 13, concerning the applicability of the Bloodborne Pathogens Standard, 29 CFR 1910.1030, for employees who work as companion-sitters in private homes was discussed in detail during a telephonic conversation with a member of my staff, Wanda Bissell, on April 2. This letter will serve to highlight that discussion and reiterate the Occupational Safety and Health Administration's (OSHA) policies on providing the Hepatitis B vaccine.

The companion-sitter occupation is described by you as a "non-health care" service. You provided a list of tasks that employees perform when working as a companion-sitter, personal care attendant and homemaker for the elderly, ill, or disabled persons, such as bathing, feeding, cooking, assisting with walking, light housekeeping, running errands, and providing transportation. You have stated that these workers do not change bandages, nor do they give intravenous injections; however, there may be contact with blood when the employee handles bloody stool or urine or inserts suppositories. The description of a routine day seems to rarely include contact with blood or other potentially infectious materials (OPIM). However, as part of their collateral duties, these employees are expected to provide first aid.

OSHA policy states that designated first aiders are covered under the scope of the standard, however, failure to provide the Hepatitis B vaccine pre-exposure to persons who render first aid only as a collateral duty will be considered a de minimis violation carrying no penalty, provided certain conditions are met. These conditions include the requirement that employers institute a reporting procedure for all first aid incidents involving the presence of blood or OPIM and offer the vaccine to any employee who has rendered first aid in such an incident regardless of the occurrence of an actual "exposure incident" as defined by the standard. All other requirements of the Bloodborne Pathogens standard continue to apply to designated first aiders. This policy does not apply to employees who render medical assistance or emergency response activities on a regular basis.

Friday, August 30, 2013

"Freehand" piercing without forceps or other engineering controls.

December 8, 2005

Mr. David V***
Mr. Kris L***

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs regarding the applicability of OSHA's bloodborne pathogens standard (29 CFR 1910.1030) to the "freehand" body piercing technique. Your question is 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 question not delineated within your original correspondence.

Scenario: A "freehand" piercing technique is one where the practitioner uses his or her hands as the piercing instrument instead of piercing forceps. In this procedure, the practitioner's fingers are placed in close proximity to the cutting edge of the needle as it exits the piercing site.

Question: Does OSHA view the practice of "freehand" piercing without the use of forceps and a receiving tool (cork or tube) as safe for the practitioner performing the procedure?

Reply: The practice of "freehand" piercing without the use of forceps or other available engineering and work practice controls to prevent contact with the used end of the piercing needle violates 29 CFR 1910.1030(d)(2)(i), an important provision of the bloodborne pathogens standard which requires that engineering and work practice controls shall be used to eliminate or minimize employee exposure.

In a previously published letter of interpretation, OSHA wrote:

"When an employee has exposure to a contaminated sharp and engineering controls (e.g., sharps with engineered safety features) are not available, hazard control is primarily gained through the implementation of work practices. In order to best protect an employee from an injury with a contaminated needle, minimal manipulation of the needle serves as means of control." [
Vidra, 8/19/03]

Friday, August 23, 2013

Safety needles with self-infuse bleeding products

Dear Mr. D****:

Thank you for your inquiry to the Occupational Safety and Health Administration. Your letter was forwarded to OSHA's Directorate of Enforcement Programs (DEP) for a response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenarios or questions not delineated within your original inquiry. You had specific questions regarding the applicability of OSHA's bloodborne pathogens standard, 29 CFR 1910.1030 to the use of needles with self-infuse bleeding products. Your questions are restated below followed by OSHA's responses.

Scenario: A hemophilia home healthcare company supplies bleeding products to patients nationwide. Many patients with bleeding disorders self-infuse their products while other patients have professional nursing services provide in-home assistance with venipuncture and infusion.

Question 1: Does OSHA's bloodborne pathogens standard, 29 CFR 1910.1030, require that safety needles be sent to patients who self-infuse?

Reply 1: No. Your company is not required to send safety needles to persons who self-infuse bleeding products or who self-inject any other medication. The Occupational Safety and health Act of 1970 (OSH Act) only protects employees. 29 USC §653(a) states that the OSH Act applies to employment.

Question 2: Does OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030, require us to provide safety needles when an outside party (e.g., home healthcare professional) uses our products to infuse a patient in his/her home?

Reply 2: The standard applies to employers having employees with occupational exposure to blood or other potentially infectious materials (OPIM). During a phone conversation with a member of our staff, you mentioned that your company, a pharmacy which supplies medical products and equipment, does not employ nor contract with in-home healthcare professionals to assist patients in infusing bleeding products. Since your company does not have employees with occupational exposure to blood or OPIM, you do not have a responsibility under OSHA's Bloodborne Pathogens Standard to supply your customers with safety-engineered sharps.

However, it is advisable that patients who rely on the services of healthcare professionals to be supplied with sharps with engineered sharps injury protections (SESIPs) and/or needleless devices for the protection of healthcare workers.

Thursday, August 15, 2013

Who should not get the Hepatitis B Vaccine?

Who should not get hepatitis B vaccine?
  • Anyone with a life-threatening allergy to yeast, or to any other component of the vaccine, should not get hepatitis B vaccine. Tell your provider if you have any severe allergies.
  • Anyone who has had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose.
  • Anyone who is moderately or severely ill when a dose of vaccine is scheduled should probably wait until they recover before getting the vaccine.
Your doctor can give you more information about these precautions.

Note: You might be asked to wait 28 days before donating blood after getting hepatitis B vaccine. This is because the screening test could mistake vaccine in the bloodstream (which is not infectious) for hepatitis B infection.

Wednesday, August 7, 2013

FDA, NIOSH and OSHA Joint Safety Communication

FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel

Date Issued: May 30, 2012
Audience: Surgeons, Operating Room Supervisors, Perioperative Nurses, Hospital Administrators, Hospital Risk Managers, Occupational Health & Safety Managers, Infection Preventionists, Surgeon Educators, Surgical Residents, Medical School Administrators/Faculty, and other Personnel
Medical Specialties: General Surgery, Urology, Obstetrics/Gynecology, Orthopedics, Anesthesiology, Surgical Technology, and any specialty that includes surgery of the muscle or fascia
Purpose: The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) strongly encourage health care professionals to use blunt-tip suture needles as an alternative to standard suture needles when suturing fascia and muscle to decrease the risk of needlestick injury.
Blunt-Tip Suture Needles:
Image of Blunt-tip Suture Needle. Blunt-tip suture needles (Figure 1), which are not as sharp as standard (sharp-tip) suture needles, are designed to penetrate muscle and fascia and reduce the risk of needlesticks. Blunt-tip suture needles are regulated by the FDA and have been marketed in the U.S. for more than 25 years.
Summary of Problem and Scope:
Needlestick injuries continue to occur in surgical settings when suturing muscle and fascia, despite the availability of safety-engineered devices, such as blunt-tip suture needles, and the endorsement of their use by professional organizations.
Needlestick injuries have the potential to expose health care personnel to bloodborne viruses, such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Of the estimated 384,000 needlestick injuries occurring in hospitals each year, 23 percent occur in surgical settings.1 Published literature indicates that while needlestick injury rates have been decreasing among non-surgical health care providers, this has not been the case among those who work in surgical settings. According to a 2010 article published in the Journal of the American College of Surgeons and citing data from a 1998 study, more than half of needlestick injuries involving suture needles occur during the suturing of fascia or muscle.2
Benefits of Using Blunt-Tip Suture Needles:
Published studies show that using blunt-tip suture needles reduces the risk of needlestick injuries from suture needles by 69 percent.3 Although blunt-tip suture needles currently cost some 70 cents more than their standard suture needle counterparts, the benefits of reducing the risk of serious and potentially fatal bloodborne infections for health care personnel support their use when clinically appropriate.
A 2007 report suggests that the slight difference in costs of blunt- and sharp-tip suture needles is balanced by the economic savings associated with needlestick injury prevention. This report, which assessed the costs of managing occupational exposures to blood and body fluids, concluded that the cost of managing a needlestick injury can range from $376 to $2,456 per reported incident.4 In addition, personnel who receive needlestick injuries may experience anxiety and a loss of productivity as they await the results of blood tests.
Government Agencies and Professional Organizations Endorse the Use of Blunt-Tip Suture Needles:
The OSHA Bloodborne Pathogens standard, revised on Jan.18, 2001 in response to the Needlestick Safety and Prevention Act of 2000, requires the use of safer devices, such as blunt-tip suture needles, when clinically appropriate, to reduce the risk of needlestick injury and subsequent pathogen transmission to personnel. The revised standard requires employers, with input from non-managerial direct patient care employees, to consider and implement available appropriate and effective safer medical devices designed to eliminate or minimize occupational exposure.
In 2007, OSHA and NIOSH issued a joint Safety and Health Information Bulletin emphasizing OSHA's requirement and NIOSH's recommendation to use blunt-tip suture needles, when clinically appropriate, to decrease needlestick injuries to surgical personnel.
The American College of Surgeons (ACS) recommends the universal adoption of blunt-tip suture needles as the first choice for the closure of fascia and muscle. This statement is endorsed by the Association of periOperative Registered Nurses, American Association of Nurse Anesthetists, American Association of Surgical Physician Assistants, American Society of Anesthesiologists, American Society of PeriAnesthesia Nurses, and Association of Surgical Technologists.
In addition, the 2011 Viral Hepatitis Action Plan issued by the U.S. Department of Health and Human Services recommends the use of blunt-tip suture needles, when clinically appropriate, to help reduce device-related needlestick exposures among health care personnel.
The FDA, NIOSH, and OSHA strongly encourage health care professionals in surgical settings to use blunt-tip suture needles to suture muscle and fascia, when clinically appropriate, to reduce the risk of needlestick injury and subsequent pathogen transmission to surgical personnel.
Reporting Occupational Needlestick Injuries:
When an employee reports a sharps injury to their employer, the OSHA Bloodborne Pathogens standard requires the employer to record the injury, make immediately available to the employee a confidential medical evaluation and provide follow-up, and investigate and document the circumstances and type of device involved. The employer can use this information to assist in preventing similar injuries in the future. Needlestick injuries must be documented as required in OSHA’s Recordkeeping standard (29 CFR 1904.8).
In addition, OSHA’s Bloodborne Pathogens standard (29 CFR 1910.1030(h)(5)) states that any employer required to keep occupational injuries and illnesses records under 29 CFR 1904 must maintain a sharps injury log to record needlestick injuries. The sharps injury log should contain, at a minimum, the following information:
  • Type and brand of device involved in the incident;
  • Department or work area where the exposure incident occurred; and
  • Explanation of how the incident occurred.
Furthermore, prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with suture needles (sharp and blunt), we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Additional information about types of needlestick adverse events to report to the FDA is available at Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers and Importers.
To help the FDA learn as much as possible about the adverse events associated with suture needles, please include the following information in your reports, if available:
  • Manufacturer's name
  • Device name (needle brand name)
  • Type of needle (blunt or sharp)
  • Type of suture
  • Date device was manufactured
  • Distributor's name
  • Details of adverse event and medical and/or surgical interventions (if required)
    • Date the event occurred
    • Location of the event
    • Nature of the injury and associated health outcome
    • Status of the device
    • Can the FDA contact the reporter for further follow-up
Contact Information:If you have questions about OSHA’s Bloodborne Pathogens standard and its requirement to use safer devices to prevent needlestick injuries, contact OSHA’s Directorate of Technical Support and Emergency Management at 1-800-321-6742 or 202-693-2300.

Friday, August 2, 2013

Testing and Public Health Management of Persons with Chronic Hepatitis B Virus Infection

On September 19, 2008, CDC published updated and expanded guidelines for testing for chronic Hepatitis B virus (HBV) infection and recommendations for public health evaluation and management for chronically infected persons and their contacts. Serologic testing for Hepatitis B surface antigen (HBsAg) is the primary way to identify persons with chronic infection with HBV infection.
Testing for HBsAg now is recommended for:
  • persons born in geographic regions with HBsAg prevalence of 2%
  • US born persons not vaccinated as infants whose parents were born in geographic regions with HBsAg prevalence of ≥8%
  • injection-drug users
  • men who have sex with men
  • persons with elevated ALT/AST of unknown etiology
  • persons with selected medical conditions who require immunosuppressive therapy
Testing continues to be recommended for:
  • pregnant women
  • infants born to HBsAg-positive mothers
  • household contacts and sex partners of HBV-infected persons
  • persons who are the source of blood or body fluid exposures that might warrant postexposure prophylaxis (e.g., needlestick injury to a health care worker)
  • persons infected with HIV

Tuesday, July 30, 2013

Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians


May 10, 2013 / 62(18);362-365

On May 7, 2013, this report was posted as an MMWR Early Release on the MMWR website (
In the United States, an estimated 4.1 million persons have been infected with hepatitis C virus (HCV), of whom an estimated 3.2 (95% confidence interval [CI] = 2.7–3.9) million are living with the infection (1). New infections continue to be reported particularly among persons who inject drugs and persons exposed to HCV-contaminated blood in health-care settings with inadequate infection control (2).
Since 1998, CDC has recommended HCV testing for persons with risks for HCV infection (3). In 2003, CDC published guidelines for the laboratory testing and result reporting of antibody to HCV (4). In 2012, CDC amended testing recommendations to include one-time HCV testing for all persons born during 1945–1965 regardless of other risk factors (1).
CDC is issuing this update in guidance because of 1) changes in the availability of certain commercial HCV antibody tests, 2) evidence that many persons who are identified as reactive by an HCV antibody test might not subsequently be evaluated to determine if they have current HCV infection (5), and 3) significant advances in the development of antiviral agents with improved efficacy against HCV (6). Although previous guidance has focused on strategies to detect and confirm HCV antibody (3,4), reactive results from HCV antibody testing cannot distinguish between persons whose past HCV infection has resolved and those who are currently HCV infected. Persons with current infection who are not identified as currently infected will not receive appropriate preventive services, clinical evaluation, and medical treatment. Testing strategies must ensure the identification of those persons with current HCV infection.
This guidance was written by a workgroup convened by CDC and the Association of Public Health Laboratories (APHL), comprising experts from CDC, APHL, state and local public health departments, and academic and independent diagnostic testing laboratories, in consultation with experts from the Veterans Health Administration and the Food and Drug Administration (FDA). The workgroup reviewed laboratory capacities and practices relating to HCV testing, data presented at the CDC 2011 symposium on identification, screening and surveillance of HCV infection (7), and data from published scientific literature on HCV testing. Unpublished data from the American Red Cross on validation of HCV antibody testing also were reviewed.
Changes in HCV Testing Technologies
Since the 2003 guidance was published (4), there have been two developments with important implications for HCV testing:
  1. Availability of a rapid test for HCV antibody. The OraQuick HCV Rapid Antibody Test (OraSure Technologies) is a rapid assay for the presumptive detection of HCV antibody in fingerstick capillary blood and venipuncture whole blood. Its sensitivity and specificity are similar to those of FDA–approved, laboratory-conducted HCV antibody assays (8). In 2011, a Clinical Laboratory Improvements Amendments waiver was granted to the test by FDA. The waiver provides wider testing access to persons at risk for HCV infection, permitting use of the assay in nontraditional settings such as physician offices, hospital emergency departments, health department clinics, and other freestanding counseling and testing sites.
  2. Discontinuation of RIBA HCV. The Chiron RIBA HCV 3.0 Strip Immunoblot Assay (Novartis Vaccines and Diagnostics) that was recommended (4) for supplemental testing of blood samples after initial HCV antibody testing is no longer available. As a result, the only other FDA-approved supplemental tests for HCV infection are those that detect HCV viremia.
Identifying Current HCV Infections
In 2011, FDA approved boceprevir (Victrelis, Merck & Co.) and telaprevir (Incivek, Vertex Pharmaceuticals) for treatment of chronic hepatitis C genotype 1 infection, in combination with pegylated interferon and ribavirin, in adult patients with compensated liver disease. Boceprevir and telaprevir interfere directly with HCV replication. Persons who complete treatment using either of these drugs combined with pegylated interferon and ribavirin are more likely to clear virus (i.e., have virologic cure), compared to those given standard therapy based on pegylated interferon and ribavirin (9). Viral clearance, when sustained, stops further spread of HCV and is associated with reduced risk for hepatocellular carcinoma (10) and all-cause mortality (11). Other compounds under study in clinical trials hold promise for even more effective therapies (6).
Because antiviral treatment is intended for persons with current HCV infection, these persons need to be distinguished from persons whose infection has resolved. HCV RNA in blood, by nucleic acid testing (NAT), is a marker for HCV viremia and is detected only in persons who are currently infected. Persons with reactive results after HCV antibody testing should be evaluated for the presence of HCV RNA in their blood.
Benefits of Testing for Current HCV Infection
Accurate testing to identify current infection is important to 1) help clinicians and other providers correctly identify persons infected with HCV, so that preventive services, care and treatment can be offered; 2) notify tested persons of their infection status, enabling them to make informed decisions about medical care and options for HCV treatment, take measures to limit HCV-associated disease progression (e.g., avoidance or reduction of alcohol intake, and vaccination against hepatitis A and B), and minimize risk for transmitting HCV to others; and 3) inform persons who are not currently infected of their status and the fact that they are not infectious.
Recommended Testing Sequence
The testing sequence in this guidance is intended for use by primary care and public health providers seeking to implement CDC recommendations for HCV testing (1,3,4). In most cases, persons identified with HCV viremia have chronic HCV infection. This testing sequence is not intended for diagnosis of acute hepatitis C or clinical evaluation of persons receiving specialist medical care, for which specific guidance is available (12).
Testing for HCV infection begins with either a rapid or a laboratory-conducted assay for HCV antibody in blood (Figure). A nonreactive HCV antibody result indicates no HCV antibody detected. A reactive result indicates one of the following: 1) current HCV infection, 2) past HCV infection that has resolved, or 3) false positivity. A reactive result should be followed by NAT for HCV RNA. If HCV RNA is detected, that indicates current HCV infection. If HCV RNA is not detected, that indicates either past, resolved HCV infection, or false HCV antibody positivity.
Initial Testing for HCV Antibody. An FDA-approved test for HCV antibody should be used. If the OraQuick HCV Rapid Antibody Test is used, the outcome is reported as reactive or nonreactive. If a laboratory-based assay is used, the outcome is reported as reactive or nonreactive without necessarily specifying signal-to-cutoff ratios.
Testing for HCV RNA. An FDA-approved NAT assay intended for detection of HCV RNA in serum or plasma from blood of at-risk patients who test reactive for HCV antibody should be used. There are several possible operational steps toward NAT after initial testing for HCV antibody:
  1. Blood from a subsequent venipuncture is submitted for HCV NAT if the blood sample collected is reactive for HCV antibody during initial testing.
  2. From a single venipuncture, two specimens are collected in separate tubes: one tube for initial HCV antibody testing; and a second tube for HCV NAT if the HCV antibody test is reactive.
  3. The same sample of venipuncture blood used for initial HCV antibody testing, if reactive, is reflexed to HCV NAT without another blood draw for NAT (13).
  4. A separate venipuncture blood sample is submitted for HCV NAT if the OraQuick HCV Rapid Antibody Test for initial testing of HCV antibody has used fingerstick blood.

Friday, July 19, 2013

Occupational Risk Statistics of HBV, HCV, HIV

Estimated incidence of acute Hepatitis B, U.S. 1978-1995

 Occupational risk of Hepatitis C:
  • HCV - major cause of chronic liver disease
  • No vaccine
  • No effective post-exposure prophylaxis
  • 85% of HCV infected people develop chronic infection
Occupational risk of HIV:
  • Risk after needlestick - 1 in 300
  • Exposures from needlesticks or cuts cause most infections
HCWs with occupationally acquired HIV/AIDS infection: