Wednesday, December 26, 2012

Exposure to Blood: Treatment for the Exposure Part 2

How soon after exposure to a bloodborne pathogen should treatment start?

HBV

Postexposure treatment should begin as soon as possible after exposure, preferably within 24 hours, and no later than 7 days.

HIV

Treatment should be started as soon as possible, preferably within hours as opposed to days, after the exposure. Although animal studies suggest that treatment is less effective when started more than 24-36 hours after exposure, the time frame after which no benefit is gained in humans is not known. Starting treatment after a longer period (e.g., 1 week) may be considered for exposures that represent an increased risk of transmission.

Has the FDA approved these drugs to prevent bloodborne virus infection following an occupational exposure?

HBV

Yes. Both hepatitis B vaccine and HBIG are approved for this use.

HIV

No. The FDA has approved these drugs only for the treatment of existing HIV infection, but not as a treatment to prevent infection. However, physicians may prescribe any approved drug when, in their professional judgment, the use of the drug is warranted.

What is known about the safety and side effects of these drugs?

HBV

Hepatitis B vaccine and HBIG are very safe. There is no information that the vaccine causes any chronic illnesses. Most illnesses reported after a hepatitis B vaccination are related to other causes and not the vaccine. However, you should report to your healthcare provider any unusual reaction after a hepatitis B vaccination.

HIV

All of the antiviral drugs for treatment of HIV have been associated with side effects. The most common side effects include upset stomach (nausea, vomiting, diarrhea), tiredness, or headache. The few serious side effects that have been reported in healthcare personnel using combinations of antiviral drugs after exposure have included kidney stones, hepatitis, and suppressed blood cell production. Protease inhibitors (e.g., indinavir and nelfinavir) may interact with other medicines and cause serious side effects and should not be taken in combination with certain other drugs, such as non-sedating antihistamines, e.g., Claritin®. If you need to take antiviral drugs for an HIV exposure, it is important to tell the healthcare provider managing your exposure about any medications you are currently taking.

Can pregnant healthcare personnel take the drugs recommended for postexposure treatment?

HBV

Yes. Women who are pregnant or breast-feeding can receive the hepatitis B vaccine and/or HBIG. Pregnant women who are exposed to blood should be vaccinated against HBV infection, because infection during pregnancy can cause severe illness in the mother and a chronic infection in the newborn. The vaccine does not harm the fetus.

HIV

Pregnancy should not rule out the use of postexposure treatment when it is warranted. If you are pregnant you should understand what is known and not known regarding the potential benefits and risks associated with the use of antiviral drugs in order to make an informed decision about treatment.

Wednesday, December 19, 2012

Exposure to Blood: Treatment for the Exposure

Is vaccine or treatment available to prevent infections with blood-borne pathogens?

HBV

As mentioned above, hepatitis B vaccine has been available since 1982 to prevent HBV infection. All healthcare personnel who have a reasonable chance of exposure to blood or body fluids should receive hepatitis B vaccine. Vaccination ideally should occur during the healthcare worker's training period. Workers should be tested 1-2 months after the vaccine series is complete to make sure that vaccination has provided immunity to HBV infection. Hepatitis B immune globulin (HBIG) alone or in combination with vaccine (if not previously vaccinated) is effective in preventing HBV infection after an exposure. The decision to begin treatment is based on several factors, such as:
  • Whether the source individual is positive for hepatitis B surface antigen
  • Whether you have been vaccinated
  • Whether the vaccine provided you immunity

HCV

There is no vaccine against hepatitis C and no treatment after an exposure that will prevent infection. Neither immune globulin nor antiviral therapy is recommended after exposure. For these reasons, following recommended infection control practices to prevent percutaneous injuries is imperative.

HIV

There is no vaccine against HIV. However, results from a small number of studies suggest that the use of some antiretroviral drugs after certain occupational exposures may reduce the chance of HIV transmission. Postexposure prophylaxis (PEP) is recommended for certain occupational exposures that pose a risk of transmission. However, for those exposures without risk of HIV infection, PEP is not recommended because the drugs used to prevent infection may have serious side effects. You should discuss the risks and side effects with your healthcare provider before starting PEP for HIV.

How are exposures to blood from an individual whose infection status is unknown handled?

HBV–HCV–HIV

If the source individual cannot be identified or tested, decisions regarding follow-up should be based on the exposure risk and whether the source is likely to be infected with a bloodborne pathogen. Follow-up testing should be available to all personnel who are concerned about possible infection through occupational exposure.

What specific drugs are recommended for postexposure treatment?

HBV

If you have not been vaccinated, then hepatitis B vaccination is recommended for any exposure regardless of the source person's HBV status. HBIG and/or hepatitis B vaccine may be recommended depending on the source person's infection status, your vaccination status and, if vaccinated, your response to the vaccine.

HCV

There is no postexposure treatment that will prevent HCV infection.

HIV

The Public Health Service recommends a 4-week course of a combination of either two antiretroviral drugs for most HIV exposures, or three antiretroviral drugs for exposures that may pose a greater risk for transmitting HIV (such as those involving a larger volume of blood with a larger amount of HIV or a concern about drug-resistant HIV). Differences in side effects associated with the use of these drugs may influence which drugs are selected in a specific situation. These recommendations are intended to provide guidance to clinicians and may be modified on a case-by-case basis. Determining which drugs and how many drugs to use or when to change a treatment regimen is largely a matter of judgment. Whenever possible, consulting an expert with experience in the use of antiviral drugs is advised, especially if a recommended drug is not available, if the source patient's virus is likely to be resistant to one or more recommended drugs, or if the drugs are poorly tolerated.

Wednesday, December 5, 2012

Exposure to Blood: Risk of Infection after Exposure

What is the risk of infection after an occupational exposure?

HBV

Healthcare personnel who have received hepatitis B vaccine and developed immunity to the virus are at virtually no risk for infection. For a susceptible person, the risk from a single needlestick or cut exposure to HBV-infected blood ranges from 6-30% and depends on the hepatitis B e antigen (HBeAg) status of the source individual. Hepatitis B surface antigen (HBsAg)-positive individuals who are HBeAg positive have more virus in their blood and are more likely to transmit HBV than those who are HBeAg negative. While there is a risk for HBV infection from exposures of mucous membranes or nonintact skin, there is no known risk for HBV infection from exposure to intact skin.

HCV

The average risk for infection after a needlestick or cut exposure to HCV-infected blood is approximately 1.8%. The risk following a blood exposure to the eye, nose or mouth is unknown, but is believed to be very small; however, HCV infection from blood splash to the eye has been reported. There also has been a report of HCV transmission that may have resulted from exposure to nonintact skin, but no known risk from exposure to intact skin.

HIV

  • The average risk of HIV infection after a needlestick or cut exposure to HlV-infected blood is 0.3% (i.e., three-tenths of one percent, or about 1 in 300). Stated another way, 99.7% of needlestick/cut exposures do not lead to infection.
  • The risk after exposure of the eye, nose, or mouth to HIV-infected blood is estimated to be, on average, 0.1% (1 in 1,000).
  • The risk after exposure of non-intact skin to HlV-infected blood is estimated to be less than 0.1%. A small amount of blood on intact skin probably poses no risk at all. There have been no documented cases of HIV transmission due to an exposure involving a small amount of blood on intact skin (a few drops of blood on skin for a short period of time).

How many healthcare personnel have been infected with blood-borne pathogens?

HBV

The annual number of occupational infections has decreased 95% since hepatitis B vaccine became available in 1982, from >10,000 in 1983 to <400 in 2001 (CDC, unpublished data).

HCV

There are no exact estimates on the number of healthcare personnel occupationally infected with HCV. However, studies have shown that 1% of hospital healthcare personnel have evidence of HCV infection (about 3% of the U.S. population has evidence of infection). The number of these workers who may have been infected through an occupational exposure is unknown.

HIV

As of December 2001, CDC had received reports of 57 documented cases and 138 possible cases of occupationally acquired HIV infection among healthcare personnel in the United States since reporting began in 1985.

Friday, November 30, 2012

Exposure to Blood: If an Exposure Occurs

What should I do if I am exposed to the blood of a patient?

  1. Immediately following an exposure to blood:
    • Wash needlesticks and cuts with soap and water
    • Flush splashes to the nose, mouth, or skin with water
    • Irrigate eyes with clean water, saline, or sterile irrigants
    • No scientific evidence shows that using antiseptics or squeezing the wound will reduce the risk of transmission of a bloodborne pathogen. Using a caustic agent such as bleach is not recommended.
  2. Report the exposure to the department (e.g., occupational health, infection control) responsible for managing exposures. Prompt reporting is essential because, in some cases, postexposure treatment may be recommended and it should be started as soon as possible. Discuss the possible risks of acquiring HBV, HCV, and HIV and the need for postexposure treatment with the provider managing your exposure. You should have already received hepatitis B vaccine, which is extremely safe and effective in preventing HBV infection.

Thursday, November 15, 2012

Exposure to Blood: What Healthcare Personnel Need to Know

OCCUPATIONAL EXPOSURES TO BLOOD

Introduction

Healthcare personnel are at risk for occupational exposure to bloodborne pathogens, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Exposures occur through needlesticks or cuts from other sharp instruments contaminated with an infected patient's blood or through contact of the eye, nose, mouth, or skin with a patient's blood. Important factors that influence the overall risk for occupational exposures to bloodborne pathogens include the number of infected individuals in the patient population and the type and number of blood contacts. Most exposures do not result in infection. Following a specific exposure, the risk of infection may vary with factors such as these:
  • The pathogen involved
  • The type of exposure
  • The amount of blood involved in the exposure
  • The amount of virus in the patient's blood at the time of exposure
Your employer should have in place a system for reporting exposures in order to quickly evaluate the risk of infection, inform you about treatments available to help prevent infection, monitor you for side effects of treatments, and determine if infection occurs. This may involve testing your blood and that of the source patient and offering appropriate postexposure treatment.
How can occupational exposures be prevented?
Many needlesticks and other cuts can be prevented by using safer techniques (for example, not recapping needles by hand), disposing of used needles in appropriate sharps disposal containers, and using medical devices with safety features designed to prevent injuries. Using appropriate barriers such as gloves, eye and face protection, or gowns when contact with blood is expected can prevent many exposures to the eyes, nose, mouth, or skin.

We will discuss this very important topic as it relates to healthcare personnel as the CDC has put forth the information.

Thursday, November 8, 2012

OSHA 300 "A Log to Live By"

Health care Joint Commission article calls OSHA 300 "A Log to Live By"

The OSHA 300 form is explained and praised as a valuable analytical tool to protect health care workers in a recent article published by Joint Commission Resources. In its October article, "OSHA 300: A Log to Live By," the Joint Commission states that "properly documenting work-related injuries can reduce incidents” of worker injuries and illnesses."
The OSHA 300 Log is one of the key forms that OSHA requires hospitals and other large businesses to complete. The 300 form is "far more than recordkeeping," wrote the Joint Commission; for employers, the log "is an invaluable resource that should be integrated into monitoring and analysis" to target where workplaces are having problems with injuries and illnesses.
"Looking closer [at the 300 Log] can reveal a lot of important information, such as what tasks employees are performing when they are injured and how," said Mark Hagemann, Acting Director of OSHA's Office of Technological Feasibility, who was interviewed for the article. "You need to identify the problems so you can fix them," he said. "That's the only way to assure a culture of safety for both patients and health care workers."
An independent, not-for-profit organization, the Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. The Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care. OSHA and the Joint Commission have worked together since 2004 under an Alliance agreement to protect health care workers' health and safety.

Monday, November 5, 2012

Reporting an Exposure Incident and Medical Evaluation and follow-up

Reporting an Exposure Incident

Exposure incidents should be reported immediately to the employer since they can lead to infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or other bloodborne pathogens. When a worker reports an exposure incident right away, the report permits the employer to arrange for immediate medical evaluation of the worker. Early reporting is crucial for beginning immediate intervention to address possible infection of the worker and can also help the worker avoid spreading bloodborne infections to others. Furthermore, the employer is required to perform a timely evaluation of the circumstances surrounding the exposure incident to find ways of preventing such a situation from occurring again.
Reporting is also important because part of the follow-up includes identifying the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law, and determining the source's HBV and HIV infectivity status. If the status of the source individual is not already known, the employer is required to test the source's blood as soon as feasible, provided the source individual consents. If the individual does not consent, the employer must establish that legally required consent cannot be obtained. If state or local law allows testing without the source individual's consent, the employer must test the individual's blood, if it is available. The results of these tests must be made available to the exposed worker and the worker must be informed of the laws and regulations about disclosing the source's identity and infectious status.

Medical Evaluation and Follow-up

When a worker experiences an exposure incident, the employer must make immediate confidential medical evaluation and follow-up available to the worker. This evaluation and follow-up must be: made available at no cost to the worker and at a reasonable time and place; performed by or under the supervision of a licensed physician or other licensed healthcare professional; and provided according to the recommendations of the U.S. Public Health Service (USPHS) current at the time the procedures take place. In addition, laboratory tests must be conducted by an accredited laboratory and also must be at no cost to the worker. A worker who participates in post-exposure evaluation
and follow-up may consent to have his or her blood drawn for determination of a baseline infection status, but has the option to withhold consent for HIV testing at that time. In this instance, the employer must ensure that the worker's blood sample is preserved for at least 90 days in case the worker changes his or her mind about HIV testing.
Post-exposure prophylaxis for HIV, HBV, and HCV, when medically indicated, must be offered to the exposed worker according to the current recommendations of the U.S. Public Health Service. The post-exposure follow-up must include counseling the worker about the possible implications of the exposure and his or her infection status, including the results and interpretation of all tests and how to protect personal contacts. The follow-up must also include evaluation of reported illnesses that may be related to the exposure.

Friday, October 26, 2012

Acceptable time lapse for "annual training."

January 24, 2007

Mr. D. C. Skinner
Employer Management Technical Policy Consultant
Ohio Bureau of Workers' Compensation
One Government Center, Suite 1236
Toledo, Ohio 43604

Dear Mr. Skinner:

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). 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. You requested clarification on OSHA's interpretation of acceptable time lapse for "annual" training.

Scenario: Various OSHA standards address frequency of employee training. Some standards are very explicit on frequency, stating "no later than 12 months from the date of the previous training," while others simply state that training must be performed "at least annually."

Question: Could you please clarify OSHA's interpretation of training requirements and what is expected when training must be conducted "at least annually"?

Reply: You are correct in stating that the language may vary in certain OSHA standards. However, wherever OSHA standards require that employee training be conducted "at least annually," OSHA interprets that to mean that employees must be provided re-training at least once every 12 months (i.e., within a time period not exceeding 365 days.) This annual training need not be performed on the exact anniversary date of the preceding training, but should be provided on a date reasonably close to the anniversary date taking into consideration the company's and the employees' convenience in scheduling. If the annual training cannot be completed by the anniversary date, the employer should maintain a record indicating why the training has been delayed and when the training will be provided.

Please keep in mind that the term "at least annually" is generally regarded as indicating that circumstances which warrant more frequent training may occur. It is extremely important that employees are trained to protect themselves from all known workplace hazards, including new hazards which may result from changes in workplace practices, procedures, or tasks. For example, OSHA's bloodborne pathogens standard at 29 CFR 1910.1030(g)(2)(v), provides for "additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupation exposure." More frequent training may also be required when employee performance suggests that the prior training was incomplete or not fully understood.

Thursday, October 18, 2012

Applicability of Bloodborne Pathogens Standard to HCV (Hepatitis C Vaccination)

March 25, 1999

Dear Mr. Thorsland:

We received your letter dated December 21, 1998, addressed to the Occupational Safety and Health Administration's (OSHA's) [Office of Health Enforcement (OHE)], regarding the inclusion of the Hepatitis C Virus (HCV) under 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens. Thank you for your inquiry. Your concern was whether HCV is included as a specific bloodborne pathogen included in (f)(3), which addresses Hepatitis B vaccination (HBV) and post-exposure evaluation and follow-up procedures. Your questions are restated below, followed by OSHA's response.

  1. (Can) 'HCV' just be substituted for 'HBV' and 'HIV' in the wording of the citations (section (f)(3))?
  2. Could you please forward to us the correct policy regarding citing HCV violations under 29 CFR 1910.1030?
A number of resources are available to you that outline the definitions of bloodborne pathogens which are included in 29 CFR 1910.1030. The preamble published in the Federal Register, Vol. 58, No. 235, December 6, 1991, defines bloodborne pathogens to include "HBV, HIV, and other pathogens including hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeld-Jakob Disease, Human T-lymphotrophic virus Type I, and Viral Hemorrhagic Fever." The preamble is quoted as stating, "HBV and HIV are given as examples because they are the viruses of greatest interest and present the greatest risk. Adding additional examples to the definition would not improve the definition."

OSHA Instruction [CPL 2-2.69, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens], states "while HBV and HIV are specifically identified in the standard, the term includes any pathogenic microorganism that is present in human blood and can infect and cause disease in persons who are exposed to blood containing the pathogen. Other examples include hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeld-Jakob Disease, Human T-lymphotrophic Virus Type 1, and viral hemorrhagic fever."

Additionally, the preamble to the standard discusses the health effects of hepatitis viruses and covers the transmission and infectious nature of the hepatitis viruses, specifically hepatitis C. It addresses the fact that "parenterally transmitted non-A, non-B hepatitis is caused by at least one bloodborne virus, designated hepatitis C virus (HCV)." This is an example of and further indication that, in addition to HBV and HIV, "other bloodborne diseases, hepatitis C, delta hepatitis, syphilis, and malaria" are included in the discussion of this standard and its potential hazard in the workplace. We hope that we have given you several examples of the inclusion of HCV, as an example of a bloodborne pathogen in the standard.

With regards to your second inquiry, OSHA Instruction [CPL 2-2.69] outlines inspection and citation guidelines. Generally,citations shall be issued if work practice controls, engineering controls and personal protective equipment are not used to eliminate or minimize employee exposure to bloodborne pathogens. For post-exposure evaluation and follow-up as required in paragraph (f)(3), a citation shall be issued if a compliance officer determines that an employer did not make immediately available a confidential medical evaluation and follow-up after an exposure incident. At sites where an exposure incident has occurred, it should be determined if the procedures were properly followed through interviews, incident report review, and, if necessary, medical record reviews. Furthermore, if a compliance officer believes that an employer is not properly following accepted post-exposure procedures, or needs specific information about current accepted procedures, the Regional bloodborne pathogens coordinator should be contacted. These details and many other concerning compliance to this standard are available for your perusal in either the original standard, 29 CFR 1910.1030, and/or OSHA Instruction [CPL 2-2.69].


However, not all provisions of the bloodborne pathogens standard apply to hepatitis C. Section 1910.1030(f)(3)(ii)(A)-(C) and (f)(3)(iii) only apply to testing for HBV and HIV after an exposure incident. Section 1910.1030(e) only applies to HIV and HBV research laboratories and production facilities. Section 1910.1030(f)(1)(i),(2),(4)(i) and (5)(i) only apply to HBV (HBV vaccination, information provided to healthcare professional, and healthcare professional's written opinion). Section 1910.1030(g)(1)(ii) only applies to signs in HIV and HBV research laboratories and production facilities. Section 1910.1030(g)(2)(vii)(I) only applies to training about the HBV vaccine and (g)(2)(ix) only applies to training in HIV and HBV laboratories and production facilities. Section 1910.1030(h)(ii)(B) only applies to keeping records of an employee's HBV vaccination status.

Tuesday, October 16, 2012

29 CFR 1910.1030 Clarification of the Standard

Clarification of the Standard on Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910.1030. The guidance that follows relates to specific provisions of 29 CFR 1910.1030 and is provided to assist compliance officers in conducting inspections where the standard may be applicable:


  1. Scope and Application - 29 CFR 1910.1030(a). This paragraph defines the range of employees covered by the standard.

    1. Since there is no population that is risk free for HIV, HBV or other bloodborne disease infection, any employee who has occupational exposure to blood or other potentially infectious material will be included within the scope of this standard.
    2. Although a list is included below of a number of job classifications that may be associated with tasks that have occupational exposure to blood and other potentially infectious materials, the scope of this standard is not limited to employees in these jobs. The hazard of exposure to infectious materials affects employees in many types of employment and is not restricted to the healthcare industry. At the same time, employees in the following jobs are not automatically covered unless they have the potential for occupational exposure:

      Physicians, physician's assistants, nurses, nurse practitioners, and other healthcare employees in clinics and physicians' offices; employees of clinical and diagnostic laboratories; housekeepers in healthcare and other facilities; personnel in hospital laundries or commercial laundries that service healthcare or public safety institutions; tissue bank personnel; employees in blood banks and plasma centers who collect, transport, and test blood; freestanding clinic employees (e.g., hemodialysis clinics, urgent care clinics, health maintenance organization (HMO) clinics, and family planning clinics); employees in clinics in industrial, educational, and correctional facilities (e.g., those who collect blood, and clean and dress wounds); employees designated to provide emergency first aid; dentists, dental hygienists, dental assistants and dental laboratory technicians; staff of institutions for the developmentally disabled; hospice employees; home healthcare workers; staff of nursing homes and long-term care facilities; employees of funeral homes and mortuaries; HIV and HBV research laboratory and production facility workers; employees handling regulated waste; custodial workers required to clean up contaminated sharps or spills of blood or OPIM; medical equipment service and repair personnel; emergency medical technicians, paramedics, and other emergency medical service providers; fire fighters, law enforcement personnel, and correctional officers (employees in the private sector, or the Federal Government, or a state or local government in a state that has an OSHA-approved state plan); maintenance workers, such as plumbers, in healthcare facilities and employees of substance abuse clinics.
    3. INSPECTION GUIDELINES. The scope paragraph of this standard states that it "applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b)." The compliance officer must take careful note of the definition of "occupational exposure" in paragraph (b) in determining if an employee is covered by this standard.

      1. Part-time, temporary, and healthcare workers known as "per diem" employees are covered by this standard.
      2. OSHA jurisdiction extends only to employees in the workplace. It does not extend to students if they are not also considered employees; to state, county, or municipal employees; to health care professionals who are sole practitioners or partners, or to the self-employed. However, the 26 OSHA-approved state plans must protect state and local government workers under an "at least as effective" state standard.
      3. If an employee is trained in first aid and identified by the employer as responsible for rendering medical assistance as part of his/her job duties, that employee is covered by the standard. See the citation policy for paragraph (f)(2) of the standard below regarding designated first aid providers, who administer first aid as a collateral duty to their routine work assignments. An employee who routinely provides first aid to fellow employees with the knowledge of the employer may also fall, de facto, under this designation even if the employer has not officially designated this employee as a first aid provider.
      4. Exposure to bloodborne pathogens in shipyard operations is covered under 29 CFR 1915.1030, which states that its requirements are identical to those in 29 CFR 1910.1030.
      5. Other Industries: The bloodborne pathogens standard does not apply to the construction, agriculture, marine terminal and longshoring industries. OSHA has not, however, stated that these industries are free from the hazards of bloodborne pathogens. For industries not covered by the bloodborne pathogens standard, Section 5(a)(1) of the OSH Act provides that "each employer shall furnish to each of his employees employment and a place of employment which is free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees." The General Duty Clause should not be used to cite for violations of the bloodborne pathogens rule, but may be used to cite for failure to provide a workplace free from exposure to bloodborne pathogens. Section 5(a)(1) citations must meet the requirements outlined in the FIRM, OSHA Instruction CPL 2.103, Chapter III. Failure to implement all or any part of 29 CFR 1910.1030 should not be, in itself, the basis for a citation. Accordingly, 29 CFR 1910.1030 should not be specifically referenced in a citation.
  2. Definitions - 29 CFR 1910.1030(b). The following provides further clarifications of some definitions found in this paragraph:

    1. "Blood": The term "human blood components" includes plasma, platelets, and serosanguineous fluids (e.g., exudates from wounds). Also included are medications derived from blood, such as immune globulins, albumin, and factors 8 and 9.
    2. "Bloodborne Pathogens": While HBV and HIV are specifically identified in the standard, the term includes any pathogenic microorganism that is present in human blood or OPIM and can infect and cause disease in persons who are exposed to blood containing the pathogen. Pathogenic microorganisms can also cause diseases such as hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, adult T-cell leukemia/lymphoma (caused by HTLV-I), HTLV-I associated myelopathy, diseases associated with HTLV-II, and viral hemorrhagic fever.

      NOTE: According to the Centers for Disease Control and Prevention (CDC), hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States. (MMWR: Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease, October 16, 1998/Vol.47/No. RR-19.)

      HCV is a viral infection of the liver that is transmitted primarily by exposure to blood. Currently there is no vaccine effective against HCV. See discussion of paragraph (f)(3) below.
    3. "Exposure Incident": In this definition, "non-intact skin" includes skin with dermatitis, hangnails, cuts, abrasions, chafing, acne, etc
    4. "Engineering controls" means controls that isolate or remove the bloodborne pathogens hazard from the workplace. Examples include safer medical devices, such as sharps with engineered sharp injury protection (SESIPs) and needleless systems. These two terms were further defined in the revision to 1910.1030 mandated by the Needlestick Safety and Prevention Act.
    5. "Needleless Systems" means a device that does not use needles for: (1) the collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (2) the administration of medication or fluids; or (3) any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. "Needleless Systems" provide an alternative to needles for the specified procedures, thereby reducing the risk of percutaneous injury involving contaminated sharps. Examples of needleless systems include, but are not limited to, intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a blunt cannula or other non-needle connection, and jet injection systems that deliver subcutaneous or intramuscular injections of liquid medication through the skin without use of a needle.
    6. "Occupational Exposure": The term "reasonably anticipated contact" includes the potential for contact as well as actual contact with blood or OPIM. Lack of history of blood exposures among designated first aid personnel of a particular manufacturing site, for instance, does not preclude coverage. "Reasonably anticipated contact" includes, among others, contact with blood or OPIM (including regulated waste) as well as incidents of needlesticks. For example, a compliance officer may document incidents in which an employee observes a contaminated needle on a bed or contacts other regulated waste in order to substantiate "occupational exposure."

      NOTE: This definition does not cover "Good Samaritan" acts (i.e. voluntarily aiding someone in one's place of employment) that result in exposure to blood or other potentially infectious materials from voluntarily assisting a fellow employee, although OSHA encourages employers to offer follow-up procedures to these employees in such cases.
    7. "Other Potentially Infectious Materials" (OPIM): Coverage under this definition also extends to blood and tissues of experimental animals that are infected with HIV or HBV.
    8. "Parenteral": This definition includes human bites that break the skin, which are most likely to occur in violent situations such as may be encountered by prison and law enforcement personnel and in emergency rooms or psychiatric wards.
    9. "Sharps with Engineered Sharps Injury Protections (SESIPs)" are defined as "a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident." This term encompasses a broad array of devices that make injury involving a contaminated sharp less likely. They include, but are not limited to: syringes with guards or sliding sheaths that shield the attached needle after use; needles that retract into a syringe after use; shielded or retracting catheters used to access the bloodstream for intravenous administration of medication or fluids; intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a needle that is housed in a protective covering, blunt suture needles; and plastic (instead of glass) capillary tubes.

    For other training information regarding Bloodborne Pathogens or any other OSHA topic, please contact National Safety Compliance, Inc.

Friday, July 27, 2012

Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Part 2

    ABSTRACT
    Purpose: This instruction establishes policies and provides clarification to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard.
    Scope: This instruction applies OSHA-wide.
    References: 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens OSHA Instruction CPL 2.103, Field Inspection Reference Manual
    Cancellations: This instruction cancels CPL 2-2.44D
    State Impact: This instruction describes a Federal Program Change for which State adoption is not required (See Paragraph VI).
    Action Offices: National, Regional and Area Offices
    Originating Office: Directorate of Compliance Programs
    Contact: Office of Health Compliance Assistance (202)693-2190
    200 Constitution Avenue, Room N3603
    Washington, DC 20210

     
  1. Recording of Exposure Incidents.
  2. Multi-Employer and Related Worksites
    1. Employment Agencies.
    2. Personnel Services.
    3. Home Health Services
    4. Physicians and Healthcare professionals
    5. Independent Contractors.
  3. Federal Agency Facilities.

  1. Recording of Exposure Incidents. The new recordkeeping rule effective January 1, 2002 requires at 29 CFR 1904.8 that all employers, whether or not they are covered by the bloodborne pathogens standard, record all work-related needlesticks and cuts from sharp objects that are contaminated with another person's blood or OPIM on the 300 Log as an injury. The employee's name must not be entered on the 300 Log. [See the requirements for privacy cases in paragraphs 1904.29(b)(6) through (b)(9).] If the employee is later diagnosed with an infectious bloodborne disease, the identity of the disease must be entered and the classification must be changed to an illness. If an employee is splashed or exposed to blood or OPIM without being cut or punctured, the incident must be recorded on the OSHA 300, if it results in the diagnosis of a bloodborne illness or it meets one or more of the recording criteria of 1904.7.
  2. Multi-Employer and Related Worksites. There are a number of different types of multi-employer worksites. This paragraph addresses a few typical situations but does not address all the circumstances that occur. In addition, this paragraph deals with situations in which employees are sent out to sites that are not multi-employer worksites. Where these guidelines do not address a particular question, see CPL 2-0.124, Multi-Employer Citation Policy.

    1. Employment Agencies. An employment agency refers job applicants to potential employers but does not put these workers on the payroll or otherwise establish an employment relationship with them; thus, the employment agency is not the employer of these workers. These agencies shall not be cited for violations affecting the workers they refer. The company that uses these workers, e.g., a hospital, is the employer of these workers and shall be cited for all violations affecting them.
    2. Personnel Services. Personnel services firms employ medical care staff and service employees who are assigned to work at hospitals and other healthcare facilities that contract with the firm. Typically, the employees are on the payroll of the personnel services firm, but the healthcare facility exercises day-to-day supervision over them. In these circumstances, due to the concerns expressed by the court in American Dental Association v. Martin, 984 F.2d 823, 829-30 (7th Cir. 1993) (dictum about medical personnel services) the personnel services firm should be cited for violations of the bloodborne pathogens standard only in the following categories: (1) hepatitis B vaccinations; (2) post-exposure evaluation and follow-up; (3) recordkeeping under paragraph (h) of the standard; (4) generic training; (5) violations occurring at the healthcare facility about which the personnel services firm actually knew and where the firm failed to take reasonable steps to have the host employer (the employer using the workers, e.g., a hospital) correct the violation (see FIRM multi-employer worksite guidelines); and (6) pervasive serious violations occurring at the healthcare facility about which the personnel service firm could have known with the exercise of reasonable diligence.

      When the host employer exercises day-to-day supervision over the personnel service workers, they are the employees of the host employer, as well as of the personnel service, and thus the host employer must comply with all provisions of the standard with respect to these workers. With respect to Hepatitis B vaccination, post-exposure evaluation and follow-up, recordkeeping, and generic training, the host employer's obligation is to take reasonable measures to assure that the personnel service firm has complied with these provisions.
    3. Home Health Services. The American Dental Association v. Martin decision upheld the bloodborne pathogens standard but restricted its application in the home health services industry. These are companies whose employees provide home health services in private homes. The court held that OSHA had not adequately considered feasibility problems for such employers, where employees work at sites that the employer does not control. As a result, OSHA may not cite those employers for site-dependent provisions of the standard when the hazard is site-specific.

      In implementing this decision, OSHA determined that the employer will not be held responsible for the following site-specific violations: housekeeping requirements, such as the maintenance of a clean and sanitary worksite and the handling and disposal of regulated waste; ensuring the use of personal protective equipment; and ensuring that specific work practices are followed (e.g., handwashing with running water) and ensuring the use of engineering controls.

      The employer will be held responsible for all non-site-specific requirements of the standard, including the non-site specific requirements of the exposure control plan, hepatitis B vaccinations, post exposure evaluation and follow-up, recordkeeping, and the generic training requirements. OSHA will also cite employers for failure to supply appropriate personal protective equipment to employees.
    4. Physicians and Healthcare professionals who have established an independent practice. In applying the provisions of the standard in situations involving physicians, the status of the physician is important. Physicians may be employers or employees. Physicians who are unincorporated sole proprietors or partners in a bona fide partnership are employers for purposes of the OSH Act and may be cited if they employ at least one employee (such as a technician or secretary). Such physician-employers may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges in accordance with the multi-employer worksite guidelines of CPL 2-0.124, Multi-Employer Citation Policy. Because physicians in these situations are not themselves employees, citations may not be based on the exposure of such physicians to the hazards of bloodborne diseases.

      Physicians may be employed by a hospital or other healthcare facility or may be members of a professional corporation and conduct some of their activities at host employer sites where they have staff privileges. In general, professional corporations are the employers of their physician-members and must comply with the hepatitis B vaccination, post-exposure-evaluation and follow up, recordkeeping, and generic training provisions with respect to these physicians when they work at host employer sites. The host employer is not responsible for these provisions with respect to physicians with staff privileges, but in appropriate circumstances, may be cited under other provisions of the standard in accordance with the multi-employer worksite guidelines of CPL 2-0.124, Multi-Employer Citation Policy. The professional corporation may also be cited under other provisions of the standard for the exposure of its physicians and other workers at a host employer site in accordance with the multi-employer worksite guidelines of CPL 2-0.124, Multi-Employer Citation Policy.
    5. Independent Contractors. These are companies that provide a service, such as radiology or housekeeping, to host employers. They provide supervisory personnel, as well as rank-and-file workers, to carry out the service. These companies and the host employers are responsible for complying with all provisions of the standard in accordance with the multi-employer worksite guidelines of CPL 2-0.124, Multi-Employer Citation Policy.
  3. Federal Agency Facilities. Agencies of the Federal Government are covered by this instruction.

Tuesday, May 22, 2012

Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Part 1

Directive Number: CPL 02-02-069 (formerly CPL 2-2.69) Effective Date: November 27, 2001
Subject: Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens


ABSTRACT

Purpose: This instruction establishes policies and provides clarification to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard.
Scope: This instruction applies OSHA-wide.
References: 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens OSHA Instruction CPL 2.103, Field Inspection Reference Manual
Cancellations: This instruction cancels CPL 2-2.44D
State Impact: This instruction describes a Federal Program Change for which State adoption is not required (See Paragraph VI).
Action Offices: National, Regional and Area Offices
Originating Office: Directorate of Compliance Programs
Contact: Office of Health Compliance Assistance (202)693-2190
200 Constitution Avenue, Room N3603
Washington, DC 20210


By and Under the Authority of
John L. Henshaw
Assistant Secretary







TABLE OF CONTENTS

  1. Purpose
  2. Scope.
  3. Cancellation
  4. References.
  5. Action.
  6. Federal Program Change.
  7. Background.
  8. Inspection Scheduling, and Scope.
  9. General Inspection Procedures




  1. Purpose. This instruction establishes policies and provides clarifications to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard.
  2. Scope. This instruction applies OSHA-wide.
  3. Cancellation. This instruction cancels OSHA Instruction CPL 2-2.44D, Nov. 5, 1999.
  4. References.

    1. OSHA Instruction, CPL 2.103, September 26, 1994, Field Inspection Reference Manual (FIRM).
    2. OSHA Instruction CPL 2.111, November 27, 1995, Citation Policy for Paperwork and Written Program Violations.
    3. OSHA Instruction, CPL 2-2.30, November 14, 1980, Authorization of Review of Medical Opinions.
    4. OSHA Instruction, CPL 2-2.32, January 19, 1981, Authorization of Review of Specific Medical Information.
    5. OSHA Instruction, CPL 2-2.33, February 8, 1982, Rules of Agency Practice and Procedure Concerning OSHA Access to Employee Medical Records-Procedures Governing Enforcement Activities.
    6. OSHA Instruction, CPL 2-2.46, January 5, 1989, Authorization and Procedures for Reviewing Medical Records.
    7. OSHA Instruction, PER 8-2.4, March 31, 1989, CSHO Pre-Employment Medical Examinations.
    8. Centers for Disease Control Morbidity and Mortality Weekly Report: "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis." May 15, 1998; Vol. 47, No. RR-7.
    9. Centers for Disease Control Morbidity and Mortality Weekly Report: "Recommendations for Follow-Up of Health-Care Workers After Occupational Exposure to Hepatitis C Virus". July 4, 1997; Vol. 46, No. 26.
    10. Record Summary of the Request for Information (RFI) on Occupational Exposure to Bloodborne Pathogens due to Percutaneous Injury. May 20, 1999.
    11. Safer Needle Devices: Protecting Health Care Workers, Directorate of Technical Support, Office of Occupational Health Nursing, October 1997.
    12. Needlestick Injuries Among Health Care Workers: A Literature Review, Directorate of Technical Support, Office of Occupational Health Nursing, July, 1998.
    13. International HealthCare Worker Safety Center, #407, Health Sciences Center, University of Virginia, Charlottesville, VA 22908, EPINet, Exposure Prevention Information Network, E-mail: epinet@virginia.edu.
    14. DHHS, Public Health Service, "FDA Safety Alert: Needlestick and Other Risks from Hypodermic Needles on Secondary IV Administration Sets - Piggyback and Intermittent IV", April 16, 1992.
    15. Glass Capillary Tubes: Joint Safety Advisory About Potential Risks, OSHA/NIOSH/FDA, February, 1999 and Memorandum dated February 18, 1999, from Steve Witt to the Regional Administrators.
    16. NIOSH, "Selecting, Evaluating, and Using Sharps Disposal Containers", DHHS (NIOSH) Publication No. 97-111, January 1998.
    17. Centers for Disease Control, MMWR, October 16, 1998/Vol.47/No. RR-19 "Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease."
    18. Centers for Disease Control, American Journal of Infection Control, June 1998, Vol. 26, "Guideline for Infection Control in Health Care Personnel, 1998."
    19. Centers for Disease Control, MMWR, December 26, 1997, Vol.46, No.RR-18, Immunization of Health-Care Workers: Recommendations
    20. 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens; Final Rule, Federal Register/Vol.56, No.235/ December 6, 1991.
    21. Training for Development of Innovative Control Technology Project, "Safety Feature Evaluation Forms".
    22. 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens; Needlesticks and Other Sharps Injuries; Final Rule, Federal Register/Vol.66, No. 12/ January 18, 2001.
    23. Centers for Disease Control, MMWR, June 29, 2001, Vol.50, No.RR-11, Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis.
  5. Action. OSHA Regional Administrators and Area Directors should use the guidelines in this instruction to ensure uniform enforcement of the Bloodborne Pathogens Standard. The Directorate of Compliance Programs will provide support necessary to assist the Regional Administrators and Area Directors in enforcing the Bloodborne Pathogens Standard.
  6. Federal Program Change. This instruction describes a federal program change for which State adoption is not required. On April 19, 2001, OSHA notified the state plan states of the requirement to adopt revisions to the Bloodborne Pathogens Standard by October 18, 2001. In order to effectively enforce safety and health standards, guidance to compliance staff is necessary. Therefore, although adoption of this instruction is not required, states are expected to have standards, enforcement policies and procedures which are at least as effective as those of Federal OSHA.

    1. Preemption. A number of states have enacted state "needlestick" laws which apply to the public sector, the private sector or both. The issuance of OSHA's revised Bloodborne Pathogens Standard has raised questions as to the status of those State laws. Section 18 of the OSH Act expresses Congress' intent, as reaffirmed by the U.S. Supreme Court in Gade v. National Solid Wastes Management Assoc. [505 U.S. 19, 107 (1992)], to preempt state laws relating to issues in the private sector on which Federal OSHA has promulgated occupational safety and health standards, such as the Bloodborne Pathogens Standard, regardless of whether the requirements are more or less stringent. Preemption is a complex legal matter which can only be finally resolved by the courts when raised by an affected party. OSHA does not take any formal legal or other action with regard to preemption of state activities. However, in general, the following principles apply:

      1. State Plan States. All OSHA-approved state plans are required to incorporate "at least as effective" needlestick protection for private sector and public sector (state and local government) employment, either through a standard or a state needlestick prevention law administered under the plan. To avoid the preemptive effect of Section 18 of the OSHAct, state needlestick prevention laws applicable to the private sector must be administered under the state plan, and in accordance with the enforcement provisions of the state OSHAct.
      2. States Without State Plans. State "needlestick" laws and/or regulations in these states would not be affected by the preemptive effect of the federal Bloodborne Pathogens Standard to the extent to which they regulate the occupational safety and health conditions of public sector (state and local government) employment. (See: Section 3(5) of the OSH Act; 29 CFR Parts 1952 and 1956; 66 FR 5323.) However, state laws or programs which regulate private sector activities addressed by the federal Bloodborne Pathogens Standard, absent an OSHA-approved state plan, would be subject to challenge as preempted.
  7. Background. In September 1986, OSHA was petitioned by various unions representing healthcare employees to develop an emergency temporary standard to protect employees from occupational exposure to bloodborne diseases. The agency decided to pursue the development of a Section 6(b) standard and published a proposed rule on May 30, 1989.

    1. The agency also concluded that the risk of contracting the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) among members of various occupations within the healthcare sector required an immediate response and therefore issued OSHA Instruction CPL 2-2.44, January 19, 1988. That instruction was superseded by CPL 2-2.44A, August 15, 1988; subsequently, CPL 2-2.44B was issued February 27, 1990.
    2. On December 6, 1991, the agency issued its final regulation on occupational exposure to bloodborne pathogens (29 CFR 1910.1030). Based on a review of the information in the rulemaking record, OSHA determined that employees face a significant health risk as the result of occupational exposure to blood and other potentially infectious materials (OPIM) because they may contain bloodborne pathogens. These pathogens include but are not limited to HBV, which causes hepatitis B; HIV, which causes acquired immunodeficiency syndrome (AIDS); hepatitis C virus; human T-lymphotrophic virus Type 1; and pathogens causing malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, and viral hemorrhagic fever. The agency further concludes that these hazards can be minimized or eliminated by using a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, hepatitis B vaccination, signs and labels, and other provisions. Both the standard and CPL 2-2.44C became effective on March 6, 1992.
    3. On September 9, 1998 OSHA published a Request for Information (RFI) on engineering and work practice controls used to eliminate or minimize the risk of occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. The responses indicated that safer medical devices along with training are the most effective means of reducing injury rates. A Summary of the comments received on response to the RFI was published in March 1999. On November 5, 1999 CPL 2-2.44D was issued. It incorporated information from the RFI, past interpretations and several CDC guidelines on vaccination and post-exposure prophylaxis.
    4. On November 6, 2000 the Needlestick Safety and Prevention Act was signed into law (Public Law 106-430). It directed OSHA to revise the Bloodborne Pathogens standard to include new examples in the definition of engineering controls; to require that exposure control plans reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; to require employers to document annually in the exposure control plans consideration and implementation of safer medical devices; to require employers to solicit input from non-managerial employees responsible for direct patient care in the identification, evaluation, and selection of engineering and work practice controls; to document this input in the exposure control plan; and to require certain employers to establish and maintain a log of percutaneous injuries from contaminated sharps. OSHA published these revisions on January 18, 2001 with an effective date of April 18, 2001.
  8. Inspection Scheduling, and Scope.

    1. Inspection scheduling should be conducted in accordance with the procedures outlined in the FIRM (CPL 2.103), Chapter II, Inspection Procedures.
    2. All inspections, programmed or unprogrammed, should include, if appropriate, a review of the employer's exposure control plan and employee interviews to assess compliance with the Bloodborne Pathogens standard.
    3. Expansion of an inspection to areas involving the hazard of occupational exposure to blood or other potentially infectious materials (including on site healthcare units and emergency response or first aid personnel) should be performed when:

      1. The exposure control plan or employee interviews indicate deficiencies in complying with OSHA requirements, as set forth in 29 CFR 1910.1030 or this instruction.
      2. Relevant formal employee complaints are received which are specifically related to occupational exposure to blood or OPIM.
      3. A fatality/catastrophe inspection is conducted as the result of occupational exposure to blood or OPIM.
  9. General Inspection Procedures. The procedures given in the FIRM, Chapter II, should be followed except as modified in the following sections:

    1. Where appropriate, the facility administrator, as well as the directors of infection control, employee (occupational) health, training and education, and environmental services (housekeeping) will be included in the opening conference or interviewed early in the inspection.
    2. The facility's sharps injury log and any other file of "incident reports" that document the circumstances of exposure incidents in accordance with the provisions in the exposure control plan, and any first aid log of injuries, should be reviewed. The compliance officer should ask for any other additional records that track bloodborne incidents. The compliance officer should review the most recent Part 1904 - Recording and Reporting Occupational Injuries and Illnesses regulations prior to citing recordkeeping violations. See Paragraph X below.
    3. Compliance officers should take necessary precautions to avoid direct contact with blood or OPIM and should not participate in activities that will require them to come into contact with blood or OPIM. The CSHO should avoid direct contact with needles or other sharp instruments potentially contaminated with blood or OPIM. To evaluate such activities, compliance officers normally should establish the existence of hazards and adequacy of work practices through employee interviews and should observe them at a safe distance.
    4. On occasions when entry into potentially hazardous areas is judged necessary, the compliance officer should be properly equipped as required by the facility as well as by his/her own professional judgment, after consultation with the supervisor, who should refer to OSHA's exposure control plan for further guidance.
    5. Compliance officers should use appropriate caution when entering patient care areas of the facility. When such visits are judged necessary for determining actual conditions in the facility, the privacy of patients must be respected. Photos or videos are normally not necessary and in no event should identifiable photos be taken without the patient's consent.

Tuesday, May 8, 2012

Retraining "at least annually"

Dear Mr. Skinner:

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). 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. You requested clarification on OSHA's interpretation of acceptable time lapse for "annual" training.

Scenario: Various OSHA standards address frequency of employee training. Some standards are very explicit on frequency, stating "no later than 12 months from the date of the previous training," while others simply state that training must be performed "at least annually."

Question: Could you please clarify OSHA's interpretation of training requirements and what is expected when training must be conducted "at least annually"?

Reply: You are correct in stating that the language may vary in certain OSHA standards. However, wherever OSHA standards require that employee training be conducted "at least annually," OSHA interprets that to mean that employees must be provided re-training at least once every 12 months (i.e., within a time period not exceeding 365 days.) This annual training need not be performed on the exact anniversary date of the preceding training, but should be provided on a date reasonably close to the anniversary date taking into consideration the company's and the employees' convenience in scheduling. If the annual training cannot be completed by the anniversary date, the employer should maintain a record indicating why the training has been delayed and when the training will be provided.

Please keep in mind that the term "at least annually" is generally regarded as indicating that circumstances which warrant more frequent training may occur. It is extremely important that employees are trained to protect themselves from all known workplace hazards, including new hazards which may result from changes in workplace practices, procedures, or tasks. For example, OSHA's bloodborne pathogens standard at 29 CFR 1910.1030(g)(2)(v), provides for "additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupation exposure." More frequent training may also be required when employee performance suggests that the prior training was incomplete or not fully understood.

Thank you for your interest in occupational safety and health. We hope this provides the clarification you were seeking and apologize for any confusion the earlier documents may have caused. 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 may consult OSHA's website at
http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,

Richard E. Fairfax, Director
Directorate of Enforcement Programs

Friday, April 6, 2012

New National Emphasis Program for Nursing/Residential Care Facilities

US Labor Department's OSHA announces new National Emphasis
Program for Nursing and Residential Care Facilities

The U.S. Department of Labor's Occupational Safety and Health Administration today announced a new National Emphasis Program for Nursing and Residential Care Facilities to protect workers from serious safety and health hazards that are common in medical industries. OSHA develops national emphasis programs to focus outreach efforts and inspections on specific hazards in an industry for a three-year period. Through this NEP, OSHA will target nursing homes and residential care facilities in an effort to reduce occupational illnesses and injuries.

In 2010, according to the department's Bureau of Labor Statistics, nursing and residential care facilities experienced one of the highest rates of lost workdays due to injuries and illnesses of all major American industries. The incidence rate for cases involving days away from work in the nursing and residential care sector was 2.3 times higher than that of all private industry as a whole, despite the availability of feasible controls to address hazards. The data further indicate that an overwhelming proportion of the injuries within this sector were attributed to overexertion as well as to slips, trips and falls. Taken together, these two categories accounted for 62.5 percent of cases involving days away from work within this industry in 2010. For this NEP, OSHA will target facilities with a days-away-from-work rate of 10 or higher per 100 full-time workers.

"These are people who have dedicated their lives to caring for our loved ones when they are not well. It is not acceptable that they continue to get hurt at such high rates," said Dr. David Michaels, assistant secretary of labor for occupational safety and health. "Our new emphasis program for inspecting these facilities will strengthen protections for society's caretakers."

Health care workers face numerous serious safety and health hazards, and the NEP will provide guidance to OSHA compliance staff on the policies and procedures for targeting and conducting inspections specifically focused on the hazards associated with nursing and residential care. These hazards include exposure to blood and other potentially infectious material; exposure to other communicable diseases such as tuberculosis; ergonomic stressors related to lifting patients; workplace violence; and slips, trips and falls. Workers also may be exposed to hazardous chemicals and drugs.

The NEP directive can be viewed at http://www.osha.gov/OshDoc/Directive_pdf/CPL_03-00-016.pdf*. Information for employers and employees in nursing homes and residential care facilities, including guidance on ergonomics and workplace violence, is available at http://www.osha.gov/SLTC/nursinghome/index.html.

Tuesday, February 7, 2012

Is the CDC "Guideline for Hand Hygiene in Health-Care Settings" in compliance with OSHA BBP Standard?

March 31, 2003

Ms. Janice Zalen
Director of Special Programs
American Health Care Association
1201 L St., NW
Washington, DC 20005

Dear Ms. Zalen:

Thank you for your January 3, 2003 inquiry to the Occupational Safety and Health Administration (OSHA) regarding OSHA requirements for handwashing under the bloodborne pathogens standard [29 CFR 1910.1030]. Your question has been outlined below followed by OSHA's response.
The new Centers for Disease Control and Prevention (CDC) "Guideline for Hand Hygiene in Health-Care Settings" (Morbidity and Mortality Weekly Report, October25, 2002) supports the use of alcohol-based hand rubs as an effective means for decontaminating hands in healthcare settings. Is this consistent with the requirements for handwashing established in OSHA's bloodborne pathogens standard?
Many of CDC's hand hygiene guidelines are for infection control and patient safety, which OSHA standards do not specifically address. However, we feel that these guidelines which do address occupational exposures to blood or other potentially infectious materials (OPIM) are consistent with OSHA's bloodborne pathogens standard. In paragraph (d)(2) of OSHA's standard, the section that most appropriately addresses "handwashing" in the scenario that you describe, the following is stated:
(v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. (vi) Employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials.
OSHA interprets this to mean that when an employee is removing gloves and has had contact, meaning occupational exposure to blood or blood or other potentially infectious materials (OPIM), hands must be washed with an appropriate soap and running water. If a sink is not readily accessible (e.g., in the field) for instances where there has been occupational exposure, hands may be decontaminated with a hand cleanser or towelette, but must be washed with soap and running water as soon as feasible. If there has been no occupational exposure to blood or OPIM, antiseptic hand cleansers may be used as an appropriate "handwashing" practice.

Again, if there has been no occupational exposure to or contact with blood or OPIM (as defined in [29 CFR 1910.1030(b)]), the use of alcohol-based hand cleansers described in the CDC's October 2002 guidelines would be appropriate. The application of the standard and its specific elements must be put into place where there has been actual or reasonably anticipated exposure to blood or OPIM and does not apply if no occupational exposure exists.

OSHA has consistently relied on the findings and recommendations of the CDC in developing good work practices for those employees with occupational exposure to blood or OPIM and feels that the existing standard does not compromise or contradict the recommendations included in the CDC's most recent guidelines.

This is an official Letter of Interpretation from OSHA. You may find all the OSHA Letters of Interpretations online.

Wednesday, January 18, 2012

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.


Wednesday, January 11, 2012

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.”

Monday, January 2, 2012

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