Mount Sinai School of Medicine Bloodborne Pathogen Training

1. Mount Sinai School of Medicine Bloodborne Pathogen Training This training module has all of the material that is contained in the formal classroom presentations. The only component that is missing is the opportunity for you to ask specific questions about any content that is not clear to you in these presentations. Since this is a required component of the OSHA Standard 29 CFR 1910.1030, if you have any questions after reviewing this material you can call the Biosafety Officer at 241-5169, or arrange a meeting to go over this material one –on- one if you prefer. It is requested that you do not take the test as a group effort, but groups can participate in this training, studying the material together and then taking the test individually. Since evidence of training is required by OSHA and must be maintained as per the Standard, you are required to log-on and take the test at the end. Successful completion of the session and the test will satisfy the annual training requirement. Please read the text material and review the slides before attempting the tests. Hepatitis B Virus induced Cancer(from CDC) Pgh: 9/2009 edition

2. Section 1 Standard BBP Labs This section pertains to labs handling human clinical specimens and / or samples derived from such human source material. For those laboratories working with HIV, HBV, HCV and other Blood Borne Pathogens, and Large scale production, Section 2 has to be completed as well in order to meet the annual training requirements.

3. Introduction The main focus of this training session centers on Human Immunodeficiency Virus (HIV), Hepatitis B, and C Viruses (HBV, HCV), but is not limited to these viruses alone. There are many pathogens that are transmissible through human blood, body fluids and tissues that are included in this topic. OSHA’s Bloodborne Pathogen Standard, 29 CFR 1910.1030 defines specific laboratories, procedures and pathogens that fall within this regulation; the complete Standard can be found on the OSHA website: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051, or by requesting a copy from the Biosafety Officer at 241-5169. It must be remembered that this is an enforceable standard with fines accruing, with each citation, against the institution.

4. Definitions Bloodborne Pathogens “means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV)”

5. Definitions Exposure Incident “means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that result from the performance of an employee's duties”.

6. Definitions Contaminated “means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface”.

7. Definitions Other Potentially Infectious Materials “means ……. (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV”.

8. Definitions OPIM is a catch-all definition for any and all HUMAN tissues, body fluids, blood, secretions, and excretions. Urine and feces are excluded, except when contaminated by blood; for our purposes, we will also consider these materials to fall under this definition. All fluid, broth, and solid slant cultures of bloodborne pathogens should be included under this definition for our purposes with respect to complying with blood borne pathogen exposure practices.

9. Definitions Needless Systems Means a Device that does not use a needle for: • Collection of bodily fluids • Administration of medication/fluids • Any other procedure with potential percutaneous exposure to a contaminated sharp

10. Definitions Engineering Controls “… means 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.”

11. Definitions “SESIP”… Sharps with Engineered Sharps Injury Protections Non-needle sharp or a needle with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. The following illustrations show types of SESIPs

12. Self-Sheathing Needle Unprotected position Self-sheathed protected position

13. Retractable Hypodermic Not retracted, unprotected position Retracted protected position

14. Self-Blunting Needle Blunted protected position

15. Add-On Safety Device Shield attached to syringe needle

16. Add-On Safety Device Attached to syringe needle

17. Epidemiology Direct contact Contact of the skin and mucus membranes with human blood and / or body fluids is the primary exposure route. Broken skin and percutaneous inoculations are chief routes of pathogen entry into the body. This is of particular importance if there is a skin condition or abrasion that is unprotected while handling blood and / or body fluids-a spill on the site could result in an exposure incident.

18. Epidemiology Droplets generated from sprays, splatters of blood/body fluids generated from spills or certain types of laboratory activities can result in deposition on the skin, or allow introduction of blood/body fluids into eyes, nose or mouth with the possibility of further penetration of mucus membranes and conjunctiva by pathogens. Secondary contact can be made with contaminated surfaces resulting in direct contact-like exposures.

19. Epidemiology Aerosols If the droplets are fine enough, falling between 1-5 μ in diameter, the exposure that results is caused by an AEROSOL, (think of a fog) which can remain suspended for 30 minutes or more and allow inhalation of the micro-droplets deep into the alveoli of the lung. From the alveoli, many pathogens can penetrate through alveolar cells and vascular walls to enter the blood stream and disseminate to other organs in the body.

20. Epidemiology Needle-sticks, bites and scratches during animal handling, cuts or lacerations all present routes of entry if the item is contaminated or the wound is contaminated subsequently with human blood / body fluids.

21. Epidemiology Infectivity of blood all human blood is considered to be infected with abloodborne agent atanytime. Setting up an infection depends on a number of factors (next slide). With some pathogens, the stage or phase of the life cycle will determine if an infection will occur. Some examples of possible outcomes are given below:

22. ACQUIRING INFECTIONS The Establishment of an Infection in a Host Depends on (“Chain of Infection”): • the pathogen present, • its host specificity, • its contagiousness, • its virulence, • the route of exposure, • the dose received by the host (you, if you are the recipient), • the general health of the host, and • the host’s susceptibility to that pathogen.

23. Epidemiology Bacteremias - bacteria in the blood usually associated with blood sepsis or large systemic infections of organs. Viremias - virus particles in the blood; this condition could be from the lytic phase of the virus, or could be an eclipse phase where viruses are “hiding” in certain blood cells - this is specifically the case with HIV’s; Carrier states can exist where shedding will release viruses periodically over a phase or complete lifetime of a host-this is a hallmark of the Hepatitis viruses.

24. Epidemiology Parasites - actively infectious forms of the parasite in their life cycle i.e. schizonts, trophozoites, leishmania-forms, cysts, and eggs. This will vary with each parasite, but should not be discounted even though such an occurrence is rare. A case of malaria occurred in Canada when a dentist sustained a needlestick while recapping a needle….the patient had a febrile illness and had just returned from India a few days prior after visiting her relatives.

25. Epidemiology Fungi - generally not associated with blood, but Candida spp, Cryptococcus neoformans, and Sporothrix schenkii, have been associated with blood / body fluids. Yeast-forms of the Systemic Mycoses agents i.e. Histoplasma capsulatum and Blastomyces dermatitidis are infectious from blood.

26. Epidemiology Incubation periods - HIV has an incubation period as long as 6 years before signs and symptoms can be detected; HBV has a 7-26 week incubation period. During these periods individuals can look and feel “normal”. There is a possibility for a subclinical infection to occur with some agents, which can give rise to Transient or permanent carrier states with viral shedding.

27. Risk Assessment Many pathogens have been manipulated in laboratories over many years, and a substantial experience base has been accumulated in Lab – Acquired Infections (LAIs). Biosafety in Microbiological and Biomedical Laboratories, a publication of the CDC-NIH, has Agent Summary Statements giving information on the types and frequency of LAI’s occurring with a given agent. (see: http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm)

28. Risk Assessment NIH Guidelineshas Risk Group designations for many pathogens that may be used in the laboratory, assigning a Risk Group categorization based on the severity of the pathological condition produced in a healthy human in response to the agent. (see: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).

29. Risk Assessment A general rule of thumb is that many Risk Group 2 organisms fall into what are considered to be Blood Borne transmissible agents. Some of the Risk Group 3 and 4 agents are also “Blood Borne” in nature, but these are very pernicious, deadly agents and not encountered in routine medical research laboratories.

30. Risk Assessment For HUMAN blood, body fluids, tissues, from living or dead individuals, ALL CLINICAL SPECIMENS - INCLUDING YOUR OWN are considered to contain bloodborne pathogens. This is the concept behind Universal or Standard Precautions. This concept should also be extended to work with animal specimens where bloodborne zoonotic agents are present or are reasonably anticipated, i.e. Herpes B Virus of monkeys, when working with certain Non-human Primate species.

31. Risk Assessment Evaluate all of your lab practices for the potential to release droplets, aerosols, large amounts of blood if a container ruptures, or the potential for percutaneous injuries. Identify all members of your research staff who may have exposures to human blood/body fluids during their work activities. Then design out exposures by using different needles (self-sheathing), using plastic instead of glass barrels, working with sealed containers, or double-containment (bottle within a bottle). Biosafety Cabinets provide a high level of protection if used properly and maintained as per manufacturer’s instructions.

32. Risk Assessment There is no value in testing blood or body fluids: - specimens can be too early or too late for the window of detection; - sensitivity of tests may be lacking; - false negatives or positives can be detected and evaluated but what do the results mean?; - too costly and time consuming. It is much easier to consider everything of human origin as infectious and handle it accordingly. That even applies to feces and urine specimens - even though they are “exempt” if not blood-contaminated.

33. Hazard Recognition / Reduction Universal (or Standard)Precautions assumes a “worst case” scenario, and requires a certain minimum acceptable level of practice to protect oneself from an exposure.

34. Hazard Recognition / Reduction Hand washingbreaks the “hand-to-mouth and “hand-to-object” transfer of pathogens. It also removes deposited organisms after spills / splatter of contaminated droplets onto skin. Droplets are a major concern, and can be present on upper arms, backs of hands and even on the face, depending on the size and distribution of the droplets.

35. Hazard Recognition / Reduction Protective equipment such as respirators, gloves, eyewear, face shields and clothing are used to break direct and indirect contact with fluids, droplets and aerosols.

36. Hazard Recognition / Reduction Vaccinations for HBV and other pathogens for which USPHS vaccines are available. Vaccinations remove the risk of acquiring the infectious agent by immunizing the individual.

37. Hazard Recognition / Reduction Reduction of “sharps” use, substitution of self-sheathing needles, and safe disposal of sharps into puncture-proof containers reduces the risk of sustaining a puncture wound or a cut with a contaminated device. Recapping used needles must be eliminated as much as possible. If recapping must occur, a one-handed technique or use of Kelly clamps is suitable to protect against inadvertent needle sticks.

38. Hazard Recognition / Reduction Control of aerosol / droplet production through the use of a biological safety cabinet when performing activities that generate aerosols, use of screw-cap containers, use of sealed centrifuge rotors, and transporting specimens in leak-proof containers reduce the opportunity for exposure to bloodborne pathogens.

39. Hazard Recognition / Reduction Specific laboratory practices are detailed in the OSHA standard with respect to culturing and manipulating HIV, HBV and other bloodborne pathogens in research and production laboratories. Refer to Section (e) HIV and HBV Research Laboratories and Production Facilities within the standard. Note that these are not the only organisms - all bloodborne pathogens used at lab quantities or greater require the practices referenced above.

40. Hazard Recognition / Reduction

41. Biological Safety Cabinets (BSC’s)

42. Biological Safety Cabinets (BSC’s) • AKA “Tissue Culture Hoods” are a primary means for containing and controlling hazardous aerosols, splatters and splashes that may result from research activities • BSC’s must be used properly in order for the devices to protect the user from biological hazards.

43. Biological Safety Cabinets (BSC’s)Biosafety Cabinet Type II A1 / A2 A Front opening B. Sash (Fixed or Movable) C. Exhaust HEPA filter D. Supply HEPA filter E. Rear plenum (+ or - ) F. Blower Source: CDC / Primary Containment for Biohazards: Selection,Installation and Use of Biological Safety Cabinets; 2nd Edition

44. Biological Safety Cabinets (BSC’s) Proper use of a biosafety cabinet (BSC) reduces the release hazard of aerosols generated during specimen / aliquot preparations. The areas marked with blue arrows show the internal air flow patterns that entrain and carry the aerosols to HEPA filters ([VVV] areas). These filters trap and contain the infectious agent within the cabinet. As long as the cabinet’s integrity is maintained, especially the HEPA filter, there is virtually no risk

45. Biological Safety Cabinets (BSC’s)HEPA Filters- the BSC’s main safety feature HEPA Filters and ULPA Filters are challenged with 0.3 Micron, monodisperse DioctylPhthalate (DOP) aerosols Almost all breathable hazards are eliminated by BSC use- the HEPA filter effectively removing particulates (but not gases!!)

46. Hazard Recognition / Reduction Biological Safety cabinets must be used whenever release of droplets and aerosols is possible in a procedure. These cabinets are specifically required to be tested annually and certified when used with HIV, HBV, HCV etc. as specified in the regulation.

47. Hazard Recognition / Reduction Good microbiological technique as outlined in the MSSM Biosafety Manual is practiced when culturing, concentrating and manipulating these pathogens. http://www.mssm.edu/biosafety/manual/manual.pdf

48. Warning Signs and Labeling Procedures

49. Warning Signs and Labeling Procedures OSHA specifies the design and colors of the Universal Biohazard Symbol. This signage must be used when a bloodborne pathogen is cultured or handled in production quantities in a laboratory as described in Section 29 CFR1910.1030 (e).

50. Warning Signs and Labeling Procedures For laboratories working with clinical specimens of human blood, body fluids and tissues, smaller cards and labels are available for marking equipment, benches, incubators and other storage areas. Tubes without hazard markings can be stored in a larger container with a hazard symbol. Once the tube is removed, a similar warning has to be placed on the tube.