Handling Biological Samples From Subjects Known or Suspected to be Infected with the Human Immunodeficiency Virus (HIV)

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Overview
It is the policy of the Medical College that every investigator working with the Human Immunodeficiency Virus (HIV) or with blood or other biological materials from subjects with known or suspected HIV infection adhere to the safety standards and procedures published by the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) in HHS Publication 88-8395: Biosafety in Microbiological and Biomedical Laboratories: Appendix G: “May, 1999 Agent Summary Statement for Human Immunodeficiency Virus and Report on Laboratory-Acquired Infection with Human Immunodeficiency Virus” (4th edition). This summary is intended as a brief outline to assist Faculty in planning, as well as instructing employees and students. It is not meant to replace the more detailed publication referenced above, the contents of which every person working with HIV or with biological samples possibly contaminated with HIV should be fully cognizant.

Applicability
This Update applies to all personnel working with blood or other potentially infectious materials known or suspected to contain HIV.

Procedure
General Safety Considerations
The Human Immunodeficiency Virus (HIV) is known to be the cause of the acquired immunodeficiency syndrome (AIDS) and various AIDS related disease states. While transmission of the HIV virus does not occur through casual contact with infected individuals, it can be transmitted with blood or other biological materials from infected persons. The common pathways for transmission of HIV are through sexual contact involving exchange of biological fluids and through sharing of hypodermic needles by intravenous drug users. A number of cases of transmission of HIV to laboratory workers and to health care providers have been documented. These have usually involved accidental puncture wounds with contaminated needles or direct skin and/or mucous membrane exposure to blood. Because of the severity of HIV infection, it is essential that all persons working with materials known or suspected to be contaminated with HIV be fully aware of the risks involved and adhere to appropriate safety procedures.

Laboratory personnel should avoid direct contact of skin and mucous membranes with blood, blood products, excretions, secretions, tissues or other biological materials from persons known or suspected to be infected with HIV. Extreme care should also be taken to avoid accidental wounds from needles and to avoid contact of open skin lesions.

In view of the significant incidence of HIV infection among the apparently healthy population, BioSafety Level procedures must be followed when working with any human blood or other biological samples that have not been subjected to effective decontamination procedures.

Laboratory Practices and Precautions

1. Mechanical pipetting devices should be used for the manipulation of all liquids in the laboratory. Mouth pipetting is prohibited.

2. Eating, drinking, smoking, storing food, and applying cosmetics are not permitted in the work areas.

3. Specifically dedicated coats, gowns or uniforms should be worn while working with any potentially infectious materials. These garments should not be worn outside the laboratory work area. Garments should be changed at a minimum of once per week and promptly after overt contamination. Garments which are overtly contaminated should be decontaminated by autoclaving prior to disposal or laundering. When working with concentrated viral preparations, disposable garments should be used and should be appropriately disposed of immediately at the termination of a work session.

4. Gloves should be worn for those procedures which might result in direct contact with potentially infectious specimens. Gloves should be autoclaved with other laboratory waste before disposal. Gloves should be removed immediately upon leaving the work area.

5. All manipulations of potentially infectious materials should be performed carefully to minimize the creation of aerosols. Face shields and masks are required for procedures during which a “splash” hazard exists. Head and foot coverings and fluid-resistant aprons are also required for such procedures.

6. Class II biological safety cabinets and other primary containment devices (e.g., centrifuge safety cups) should be used for handling all biological materials derived from persons known or suspected to be infected with HIV.

7. Access to the laboratory should be limited to essential staff when experiments are being conducted.

8. Laboratory work surfaces should be decontaminated with an appropriate EPA – approved disinfectant following any spill of potentially infectious materials, as well as at the completion of daily work activities. In the event of a spill, Environmental Health and Safety should be notified promptly.

9. All laboratory waste should be decontaminated by autoclaving before disposal. All waste should be identified by label and an indicator showing whether or not material has been decontaminated.

10. All personnel should wash their hands with soap and water following completion of laboratory activities and before leaving the laboratory.

11. Used needles and other sharps should not be sheared, bent, broken, recapped or resheathed by hand.

12. All needles and sharps should be discarded in the rigid puncture proof containers provided in each laboratory.

Experimental Animal Studies
Experimental animals inoculated with potentially infectious materials must be maintained in approved animal facilities. The staff of the Research Animal Resource Center must be informed in advance of initiation of any studies with HIV or with biological samples from subjects known or suspected to be infected with HIV which involve the use of experimental animals.

Certification of Laboratories and Laboratory Personnel
Laboratories: Any laboratory working with HIV or with biological materials from persons known or suspected to be infected with HIV must be inspected by the Biosafety Officer, contact EHS, who will certify that the laboratory meets the physical containment levels specified in the relevant CDC-NIH guidelines and summarized above. A biohazard sign with appropriate designation will be placed on all access doors.

Laboratory Personnel: The Biosafety Officer must determine that all personnel who intend to work with HIV or with blood or other biological samples from persons known or suspected to be infected with HIV have had training in appropriate microbiological techniques and laboratory safety procedures. The Biosafety Officer must be notified by the faculty member in charge of a laboratory when new personnel are assigned to a project involving samples known or suspected to be contaminated with HIV. All personnel will be interviewed individually and provided instruction as needed by the Biosafety Officer, who will then approve them for work with HIV related materials.

Monitoring: To ensure that appropriate containment procedures and staff training are carried out, all certified laboratories will be monitored for compliance at periodic intervals by the Biosafety Officer.

A procedure for “Management of Needlesticks and Bodily Fluid Exposure” has been developed. This procedure, which was approved by the Executive Faculty Council (November 1, 1990) and General Faculty Council (November 12, 1990), is summarized below:

In case of accidental puncture or unprotected exposure of cut, burned or abraided skin or mucus membranes (eyes, mouth, etc.) to HIV cultures or to human bodily fluids (blood, pus, saliva, urine, stool, etc.), the affected area should be washed immediately with water and, if available, with an anti-microbial soap (e.g. Hibaclens or Betadine) or modified Dakin Solution (1:10 dilution of household bleach). Promptly after washing, the individual should notify their supervisor and if it is between Monday and Friday, 8:30AM and 4:30PM, go to Occupational Health Services. At other times, call the Center for Special Study (212.737-9961 or Ext. 64180). If there is no response, go to the New York Presbyterian Hospital Emergency Department.

References
HHS Publication 88-8395: Biosafety in Microbiological and Biomedical Laboratories: Appendix G: “May, 1999 Agent Summary Statement for Human Immunodeficiency Virus and Report on Laboratory-Acquired Infection with Human Immunodeficiency Virus” (4th edition).