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The American Biological Safety Association (ABSA) is an organization of biological safety practitioners who work in a variety of academic, governmental, healthcare and private work environments. We have many members in the United States, Canada, and in other countries. We are recognized as a leading authority in the field of biological safety. We appreciate the invitation to review your most recent revision to your guideline M29-A2, Protection of Laboratory Workers from Occupationally-Acquired Infections. Please consider these general comments: Your practice of keeping these documents active through a three year review process is evident with the inclusion of current information on prions and latex allergy issues. The Occupational Safety and Health Administration (OSHA) issued a number of new requirements regarding needles and sharps safety earlier this year. The Centers for Disease Control and Prevention (CDC) also issued a safety alert on this subject in 1999. These changes are reflected in sections in your document. In order to provide proper focus to these major changes, it may be helpful to describe them in a section or preamble early on in the document with a note that further details are to follow in the text of the document. There are a number of references for the need to post items with the universal biohazard symbol. These references should also reference the need to include the word, "Biohazard" in order to provide full communication of the hazard present and to better address the applicable labeling requirements. Our specific comments follow the sections of your guideline, and they are as follows:3 .Definitions You provide definitions of an "aerosol" and "airborne transmission" in this section. You note that an aerosol is, "a system of particles dispersed in a gas, smoke, or fog. Mycobacterium tuberculosis (TB) cultures are tested in clinical laboratories, and they pose the risk of airborne infections through the inhalation of respirable aerosols. In this context, the aerosol definition should be reflective that aerosols are respirable particles that can be retained in the lungs. You note that airborne transmission is, "infectious agents are carried by or through the air, usually in small droplets. However, later in section 5.2.4, you note that aerosols are invisible particles, which are typically less than 10 microns in diameter. Small droplets are generally not considered to be respirable. The airborne transmission definition should be reflective of infectious agents that can be transmitted through retention in the lungs of a respirable infectious aerosol. May we suggest rewording this definition to define airborne transmission as the spread of infection by inhalation of respirable size particles containing infectious agents. This would provide consistency and clarity needed for the development of information to follow in the document. You have good definitions for "needleless system" and "sharps with engineered sharps injury protections". It shows early on that you have a document with current pertinent information from OSHA and the CDC. The definition of "medical waste" is inclusive of "infectious waste" (well defined in these definitions) and of "non-medical waste". In order to better make this distinction, the use of the term "regulated medical waste" is suggested. It would be defined as "Materials generated as a result of diagnosis and treatment of patients that requires special handling. This may include 'Infectious Wastes'." 5.2 Lab Transmission There is a statement regarding the types of fluids from which HIV has been isolated. We recommend adding to the next statement, "Only blood, bloody body fluids, or concentrated virus solutions have been implicated in the laboratory transmission of HIV to date." You also may want to mention that although the OSHA Bloodborne Pathogen Standard identifies only certain fluids that have been epidemiologically linked to HIV transmission, it also includes any body fluid that contains blood. The CDC Standard Precautions recommend precautions with all body fluids except sweat. Tables 2 and 4: the data is that recorded through June, 2000, not June, 1999. 6. Protection Techniques In the text following this heading, there is a listing of the hierarchy of controls identified in the original OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030). The listing includes standard precautions. The reference should be to "universal precautions". In the text of the OSHA Bloodborne Pathogens Standard, there is no definition for standard precautions. There is no reference to it in the text of the standard itself that follows the definitions section. We appreciate the later definitions of both Universal Precautions and Standard Precautions. 6.1 Handwashing When water is not available, proper guidance is given regarding alternative means of cleaning hands on an interim basis. It needs to be clear that these interim measures do not substitute for washing of hands in soap and water. This must still be done as soon as possible in these situations when soap and water becomes available. 6.2.1 Gloves Your document indicates that gloves are meant to help prevent exposures to healthcare providers who procure specimens. Employees who are to collect blood specimens from patients are to wear gloves that are recognized as medical devices by the Food and Drug Administration (FDA). FDA issues a 510(k) number to the glove manufacturer, which enables them to label their product, "patient examination gloves". Gloves, which meet this requirement, would be the appropriate standard of care for the gloves used by employees who would handle and test specimens from patients. This should be noted in your document. Also consider adding to the list of appropriate glove use (6.2.1.3) the correct protective measures to be taken for ensuring that a healthcare provider's hands are adequately protected if they have a cut or if their skin is otherwise compromised, such as with dermatitis. The cut or broken skin should be covered with a water resistant bandage and gloves worn while handling clinical specimens. The NCCLS draft document states, "It is the opinion of this subcommittee that used gloves should be discarded as biohazardous wastes. Minimally contaminated materials such as gloves, gauze, or band-aids are not always designated as regulated medical wastes by state regulations or by OSHA, and pose almost no risk of bloodborne pathogen transmission. We would ask that a general statement about proper disposal of all disposables in laboratories be referred to the local state medical waste regulations. 6.2.1.1 Latex Hyperse nsitivity The American Society of Testing and Materials (ASTM) in ASTM D 3578-00a recommends that latex gloves should contain no more than 200 micrograms/decimeter squared of water extractable protein in order to be considered low protein. This limit should be noted in the recommendation for the selection of low protein gloves. 6.2.2 Facial Protection The first paragraph states, "Facial barrier protection should be used if there is a reasonably anticipated potential for spattering or splashing blood or body substances. We would suggest that a biological safety cabinet, splashguard, or other engineering control be the preferred method of facial protection. If these are not available, then a full "plastic face shield best provides facial protection unless there is the potential for respirable aerosols containing airborne pathogens. Then the statement, "Splashguards may serve as an acceptable alternative to plastic face shields" can be deleted. Paragraph 3 states, "If face shields are not used, a personal respirator and eye protection should be used. The preceding commentary in this section deals with protection against splashes and spattering of facial mucous membrane surfaces. A personal respirator is meant to primarily provide protection against respirable infectious aerosols. Its reference here could cause some confusion, especially since readers are being referred to section 10 for further information regarding protection against airborne pathogens such as TB. The sentence should reference the use of a face covering that protects the facial mucous membrane surfaces, such as a fluid-resistant surgeon's mask. The last statement, "The prevention of transmission of Mycobacterium tuberculosis is discussed in detail in Section 10" is an unnecessary statement under the facial protection section. 6.4.1.1 Disinfectants and Sterilants A useful example under the FDA approved chemicals for the laboratory would be the antiseptics or antimicrobial handwashing agents. Table 7: please complete the right hand side of the table ("Activity Level") for the Sterilants, or fill in as N/A.