Wednesday, October 21, 2015

Handling of contaminated laundry in a long-term care facility

February 23, 2011

Mr. C***
Honolulu, Hawaii

Dear Mr. C***:

This is in response to your October 18, 2010, to the Occupational Safety and Health Administration (OSHA) in which you requested an interpretation of the Bloodborne Pathogens Standard, 29 CFR 1910.1030.  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.  Your questions have been paraphrased below followed by our responses.  We apologize for the delay in responding to your inquiry.

Question 1:  Other potentially infectious materials (OPIM) have been defined by the Bloodborne Pathogens Standard to include various body fluids, such as "...all body fluids in situations where it is difficult or impossible to differentiate between body fluids."   29 CFR 1910.1030(b).   Based on this definition, would soiled linen from a nursing home or long-term care facility be treated as OPIM if it consists of urine, or feces or both, without the presence of blood?

Response 1:  The linen itself is not OPIM.  The issue is whether the linen you describe is "contaminated laundry."  In paragraph (b) of the standard "contaminated laundry" is defined as "...laundry which has been soiled with blood or other potentially infectious materials or may contain sharps."  [Emphasis added]. Urine and feces not containing blood are not per se OPIM within the meaning of the standard.

Urine and feces are not the only sources of contamination that may be present on linen generated in nursing homes or other long-term care facilities.  The potential for a variety of medical conditions that may be present in the patient/resident population in these facilities (e.g., surgical wounds, bed sores, etc.) could also be potential sources of blood contamination of linen.  As well, the linen may contain sharps.  As such, it is important that employers in healthcare settings, including nursing homes or other long-term care facilities, evaluate the scope of all possible sources of exposure to housekeeping staff who handle laundry.

Question 2:  If the handling of urine and feces by the nursing staff and the housekeepers in a long-term care facility or a hospital need not be considered handling OPIM unless blood is present, would the requirement to offer the hepatitis B vaccination apply?

Response 2:  The Bloodborne Pathogens Standard requires employers to make the Hepatitis B vaccination available to "...all employees who have occupational exposure..."  [29 CFR 1910.1030(f)(1)(i)].  Determining coverage under the Bloodborne Pathogens Standard must be based on all tasks and possible sources of exposure for a given job function.  Among nursing staff and housekeepers in long-term care facilities and hospitals, a determination of the employees' potential for occupational exposure to blood or OPIM should in no way be limited to exposure to urine and feces.

Nursing staff and housekeepers in these settings perform various tasks that would be considered potential exposure sources.  For example, nursing staff often perform various patient care procedures, such as dressing wounds, which puts them at risk of exposure.  Among housekeepers, the cleaning of blood spills, exposure to exudates from wounds, surgical sites and bed sores, and to syringes or other sharps left in linen or in receptacles following in-room medical treatments are among the exposure scenarios that must be considered.  As such, the nursing staff and housekeepers in long-term care facilities and hospitals are among those who must be offered the hepatitis B vaccination.

Questions 3 & 4:  We note in other interpretations where the discussion of the BBP standard includes laundry a clear distinction between healthcare and non-healthcare settings is made.  For example, in the interpretation issued on September 17, 2004, regarding the handling of laundry in a fitness center the response stated, "...Normally laundry in a non-healthcare setting would not be covered by the bloodborne pathogens standard."  Should we take it to mean that the laundry discussed in questions 1 and 2 above should be treated as OPIM?  Also, would soiled laundry in a patient room in a hospital be considered OPIM? 

Responses 3 & 4: As stated in the response to question 1, the standard's definition of contaminated laundry would apply to the laundry generated in healthcare settings such as hospitals and long-term care facilities.  Consequently, staff members whose duties expose them to contaminated laundry from healthcare settings are considered to have an increased risk for exposure to blood and OPIM.  The Bloodborne Pathogens Standard has special provisions for the handling of contaminated laundry.  For example, employers must assure that contaminated laundry is bagged or containerized at the location where it was used, and are prohibited from allowing the sorting and rinsing of contaminated laundry at the point of use. [29 CFR 1910.1030(d)(4)(iv)(A)(1)].

Additionally, the Centers for Disease Control and Prevention (CDC) has issued infection control guidance recommending careful handling of contaminated laundry in healthcare settings as a measure to enhance patient and healthcare worker protection.  Please refer to Guidelines for Environmental Infection Control in Health-Care Facilities, MMWR 52 (RR10: 1-42; June 6, 2003) for additional information.

The State of Hawaii operates its own occupational safety and health program under a plan approved and monitored by the Federal Occupational Safety and Health Administration (OSHA).  The Hawaii Occupational Safety and Health Division (HIOSH), part of the Hawaii Department of Labor and Industrial Relations (DLIR), adopts and enforces standards and investigates safety and health concerns in workplaces in the State.

HIOSH's Bloodborne Pathogens Standard is identical to OSHA's.  For more information on the standard and HIOSH's enforcement procedures, we suggest that you contact HIOSH directly at the following address:
Hawaii Department of Labor and Industrial Relations
Hawaii Occupational Safety and Health Division
830 Punchbowl Street #425
Honolulu, HI 96813
PH: 808 586-9100
Fax: 808 586-9104

Thursday, October 15, 2015

HBV and Needlesicks in the Textile Industry

February 11, 2015

Mr. Michael J. H***
Asheville, North Carolina 28803

Dear Mr. H***:

Thank you for your September 10, 2014, letter to the Occupational Safety and Health Administration (OSHA). Your letter has been referred to the Directorate of Enforcement Programs for an answer to your specific question. You requested information about possible cases of hepatitis resulting from needlesticks from textile mill equipment. This letter constitutes OSHA's answer to your question and provides an interpretation of the coverage of OSHA's Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030, and may not be applicable to any other question not delineated within your original correspondence. Your question has been paraphrased, followed by OSHA's response.

Background: You identified a situation where an employee in a textile mill/factory reported daily needlesticks to fingers while operating the equipment. The needles on the machines are reported to be infrequently changed and the equipment is utilized by shift workers.

Question: Have there been any case reports or data related to being infected with hepatitis - in particular - from the equipment being operated and shared with others?

Response: OSHA is unaware of any case reports or data that specifically connect hepatitis infections to employees operating textile equipment. However, the underlying basis of the BBP standard is that all blood and certain body fluids are potentially infectious. [56 FR 64004, 64089 (December 6, 1991)] Thus, the standard applies to "...all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section." [29 CFR 1910.1030(a)] "Occupational exposure" is defined as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties." [29 CFR 1910.1030(b)] If employees are reasonably expected to get needlesticks from textile equipment contaminated with the blood of others, there is occupational exposure within the meaning of the standard. Employers would thus be required to protect those employees under the provisions of the standard, including, but not limited to, requirements to provide free hepatitis B vaccinations to employees with occupational exposure (paragraph (f)(2)); post-exposure (such as a needlestick) evaluation, follow-up, and post-exposure prophylaxis (where appropriate) (paragraph (f)(3)); and training (paragraph (g)(2)).
In an OSHA memorandum dated August 12, 1994, a similar situation in the garment industry was identified. There, employees sharing label tagging devices were subjected to frequent needlesticks. The issue of concern relating to the BBP standard is that these label tagging devices can retain blood on the needles and on the tool. When the label tagging devices are exchanged between employees, e.g., during shift changes, the result is a potential transmission of bloodborne pathogens.

North Carolina operates its own occupational safety and health program under a plan approved and monitored by OSHA. The North Carolina Department of Labor (NCDOL) adopts and enforces standards and investigates safety and health concerns in workplaces throughout the state, and has jurisdiction over worker safety and health in the state. State plans are required to have standards and enforcement programs that are at least as effective as OSHA's, but may have different or additional requirements. The NCDOL bloodborne pathogens standard for general industry is the same as OSHA's and must be enforced at least as effectively as OSHA enforces the BPS. For specific information regarding North Carolina's requirements for bloodborne pathogens, you may contact North Carolina DOL directly at the following address:

North Carolina Department of Labor
Occupational Safety and Health Division
111 Hillsborough Street
Raleigh, NC 27601-1092
(919) 733-7166

Thursday, October 8, 2015

Clarification of the selection and use of BBP safety devices

May 5, 2008

Dr. H***
Texas A&M University
College Station, TX

Dear Dr. H***:

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter requests OSHA's interpretation of several provisions under 29 CFR 1910.1030, the Bloodborne Pathogens standard. 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. For clarification, your specific questions are paraphrased below, followed by OSHA's responses. We apologize for the delay in providing our response.

Question 1: The OSHA Bloodborne Pathogens Standard requires employers to use engineering controls, such as appropriate "safety engineered" sharps. Can an employer select a device that is not expressly labeled by the manufacturer as a safety device and that does not have corresponding safety claims that have been cleared by the Food and Drug Administration (FDA)?

Response 1: As you know, employers are required to use engineering and work practice controls to protect employees [29 CFR 1910.1030(d)(2)(i)]. The standard defines engineering controls as ". . . controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." [29 CFR 1910.1030(b)]. With regard to safety-engineered devices used for preventing needlesticks and other sharps injuries, many circumstances would involve the use of safety-engineered devices which are expressly manufactured to replace conventional ones (i.e., sharps with safety engineered sharps injury protections, SESIPs). These devices generally bear a manufacturer's label indicating the type of safety feature along with specific instructions for use. However, the key to preventing needlesticks and other sharps injuries is the isolation or removal of the hazard, and in some circumstances, this may be achieved by completely removing the sharp (needleless technology) or substituting a safer alternative that is not necessarily labeled as such.

As an example, the use of plastic hypodermic syringes has largely replaced the use of glass syringes as an effective safer alternative. Plastic syringes are less prone to accidental breakage and, therefore, offer protection from potential percutaneous injuries from broken contaminated glass. Plastic syringes however, do not necessarily bear a legend of this safety benefit. Another example is the use of alternatives to glass capillary tubes which break easily. In a joint safety advisory on hazards associated with the use of glass capillary tubes, the FDA, NIOSH and OSHA recommended the use of capillary tubes that are not made of glass and glass capillary tubes wrapped in a puncture-resistant film. These alternatives also represent safety-engineered features in that they remove or isolate the sharps hazard.

It is important that employers perform a thorough hazard assessment and fully evaluate the feasibility and appropriateness for use of any engineering control before instituting its use [29 CFR 1910.1030(c)(1)(iv)(B)]. The substitution of a type of device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. Additionally, employers should consult device manufacturers prior to making any after-market modifications to medical devices. Unauthorized modifications to medical devices may interfere with their intended use, may violate the FDA's approval of the device, or may create a greater hazard to patients and/or employees. You may wish to contact the FDA directly for additional information on the criteria which manufacturers must meet and the specific labeling requirements for all medical devices, including those with claims of safety-engineering features or capabilities.

Question 2: May an employer make an independent judgment that a device marketed with other claims and for other purposes provides the type of safety-engineered protection anticipated by the standard? If so, what level of documentation or testing is the employer required to have to demonstrate the validity of such judgments?

Response 2: As stated in response #1, the substitution of an alternative device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. The requirement for evaluation and selection of a safety device is a performance-oriented provision which depends greatly on the specific medical device and medical procedure(s) in question. Devices must be evaluated for their ability to prevent occupational exposures to blood or other potentially infectious materials (OPIM) in each procedure. The final determination of what safer device is selected for use is a responsibility of the employer; however, when evaluating and selecting safer devices, employers must solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps [29 CFR 1910.1030(c)(1)(v)]. The input from affected employees must be factored into the employer's judgment of the appropriateness for use of a particular safety device.

With regard to the documentation needed to justify selection of safety devices, employers are required to have an exposure control plan which includes the initial exposure determination required by 29 CFR 1910.1030(c)(2) as well as the documentation of the methods of compliance, which includes implementation of engineering controls [29 CFR 1910.1030(c)(1)(ii)(A) and 1910.1030(c)(1)(ii)(B)]. The exposure control plan must be reviewed and updated annually to include documentation of the employer's consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A) and 1910.1030(c)(1)(iv)(B)]. The standard does not specify the level of detail that must be included in this documentation; however, sufficient information must be provided to substantiate the facility's judgment. As discussed in the preamble of the Final Rule, consideration and implementation of safer medical devices could be documented in the Exposure Control Plan by describing the safer devices identified as candidates for adoption; the method or methods used to evaluate devices and the results of the evaluations; and justification for selection decisions. [See 66 Federal Register 5319, under discussion of paragraph 1910.1030(c)(1)(iv).]

Question 3: OSHA has previously clarified, in the context of Group Purchasing Organizations (GPOs), that price and contractual availability cannot be the sole basis for selecting a safety device. May other contractual requirements provide a basis for selecting a particular device? For example, if a multi-product manufacturer offers a contract that has a cost basis associated with being the employer's exclusive provider of a range of medical devices, and/or offers overall volume discounts that would be impacted by selecting another manufacturer's safety device, is a decision to use the contracting supplier's safety engineering sharps devices on this basis acceptable?

Response 3: 29 CFR 1910.1030 does not address contractual arrangements between employers and device manufacturers. Therefore, the standard does not specifically preclude the use of GPOs as long as the employer is still able to meet the intent of the standard. As stated in the response to question #2, non-managerial employees involved in patient care must be afforded the opportunity to provide feedback in the evaluation and selection of safer devices. If an employer enters into an exclusive contractual arrangement with a manufacturer, the availability and variety of devices may be restricted. As technology advances, it is difficult to determine whether a safer and more appropriate device might become commercially available from a competitor of the exclusive supplier. Employees may be limited in the variety of available safety devices, particularly with regard to equipment that has few available choices. Additionally, each employer must review and update the exposure control plan annually and the annual review must include documentation of the consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A)]. Advances in technology might not be captured if an employer is bound by contract to only evaluate devices from a single manufacturer. Finally, 29 CFR 1910.1030(d)(2)(i) requires that employers eliminate or minimize, i.e., reduce to the lowest extent feasible, occupational exposure. Thus, irrespective of the arrangements used in obtaining safety devices, the determination of an employer's compliance will be based on whether the requirements of the standard are being met.

Thursday, October 1, 2015

Protections Provided by OSHA's Bloodborne Pathogens Standard

Bloodborne pathogens are infectious microorganisms present in blood that can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), the virus that causes AIDS. Workers exposed to bloodborne pathogens are at risk for serious or life-threatening illnesses.

All of the requirements of OSHA’s Bloodborne Pathogens standard can be found in Title 29 of theCode of Federal Regulations at 29 CFR 1910.1030. The standard’s requirements state what  employers must do to protect workers who are occupationally exposed to blood or other potentially
infectious materials (OPIM), as defined in the standard. That is, the standard protects workers who
can reasonably be anticipated to come into contact with blood or OPIM as a result of doing their
job duties.

In general, the standard requires employers to:
• Establish an exposure control plan. This is a written plan to eliminate or minimize occupational
exposures. The employer must prepare an exposure determination that contains a list of job  classifications in which all workers have occupational exposure and a list of job classifications in which some workers have occupational exposure, along with a list of the tasks and procedures performed by those workers that result in their exposure.

• Employers must update the plan annually to reflect changes in tasks, procedures, and positions that affect occupational exposure, and also technological changes that eliminate or reduce occupational exposure. In addition, employers must annually document in the plan that they have considered and begun using appropriate, commercially-available effective safer medical devices designed to eliminate or minimize occupational exposure. Employers must also document that they have solicited
input from frontline workers in identifying, evaluating, and selecting effective engineering and work practice controls.

• Implement the use of universal precautions (treating all human blood and OPIM as if known
to be infectious for bloodborne pathogens).

• Identify and use engineering controls. These are devices that isolate or remove the bloodborne
pathogens hazard from the workplace. They include sharps disposal containers, selfsheathing needles, and safer medical devices, such as sharps with engineered sharps-injury protection and needleless systems.

• Identify and ensure the use of work practice controls. These are practices that reduce the possibility of exposure by changing the way a task is performed, such as appropriate practices for handling and disposing of contaminated sharps, handling specimens, handling laundry, and cleaning contaminated surfaces and items.

• Provide personal protective equipment (PPE), such as gloves, gowns, eye protection, and masks. Employers must clean, repair, and replace this equipment as needed. Provision, maintenance, repair and replacement are at no cost to the worker.