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

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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

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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.

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

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.

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.

Removal of Contaminated Needles Prior to Disposal

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

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

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

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Safer work practices in medical labs

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,


Richard E. Fairfax, Director
Directorate of Compliance Programs