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


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


  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.

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