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Mount Sinai School of Medicine Bloodborne Pathogen Training This training module has all of the material that is contained in the formal classroom presentations.

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Presentation on theme: "Mount Sinai School of Medicine Bloodborne Pathogen Training This training module has all of the material that is contained in the formal classroom presentations."— Presentation transcript:

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 , if you have any questions after reviewing this material you can call the Biosafety Officer at , 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. OSHAs Bloodborne Pathogen Standard, 29 CFR defines specific laboratories, procedures and pathogens that fall within this regulation; the complete Standard can be found on the OSHA website: , or by requesting a copy from the Biosafety Officer at 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 Retracted protected position Not retracted, unprotected 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 a bloodborne agent at any time. 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 hosts 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 HIVs; 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 LAIs occurring with a given agent. (see: )

28 Risk Assessment NIH Guidelines has 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 manufacturers 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 washing breaks 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 (BSCs)

42 AKA Tissue Culture Hoods are a primary means for containing and controlling hazardous aerosols, splatters and splashes that may result from research activities BSCs must be used properly in order for the devices to protect the user from biological hazards.

43 Biological Safety Cabinets (BSCs) 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 (BSCs) 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 cabinets integrity is maintained, especially the HEPA filter, there is virtually no risk

45 Biological Safety Cabinets (BSCs) HEPA Filters- the BSCs 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.

48 Warning Signs and Labeling Procedures

49 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 CFR (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.

51 Warning Signs and Labeling Procedures All stocks and cultures must be clearly labeled with the agent name and hazard. Refer specifically to Section (g) of the OSHA Standard for specific practices. A collection of tubes can be marked with a label on the outside of the over-container. However, once a tube is removed for use, it must be labeled as a Blood-borne pathogen.

52 Spills, Exposure Reporting and Vaccinations A spill of human blood, body fluids or contact with tissue on unprotected skin or mucus membranes is considered an exposure incident by OSHA. Report the incident to your supervisor and to the Biosafety Officer at X Supervisors must keep information on their employees exposure and any devices involved in the exposure incident.

53 Spills, Exposure Reporting and Vaccinations In responding to biological spills, f ollow the spill procedures outlined in the MSSM Biosafety Manual and Spill Procedures booklet. A copy is available at: -download it before you need it! Call the Biosafety Officer at for assistance with a spill clean-up

54 Spills, Exposure Reporting and Vaccinations Any needlesticks, lacerations or other puncture wounds caused by sharps while working with human source specimens, require immediate attention in the MSMC Employee Health Service (Jack Martin Fund Clinic for Students) or Emergency Department (after hours and weekends), whether the sharp is contaminated or not. These incidents also must be reported to the Needlestick Coordinator (X #) and the Biosafety Officer (X45169) as required by OSHA.

55 Spills, Exposure Reporting and Vaccinations Report the incident to your supervisor and call the General Page number 41300, and punch in " 4118 " for the Needle Stick Coordinator. A log of all injuries, body fluid exposures and type of Sharp involved must be maintained by the MSMC Needle Stick Coordinator. Depending on whether you are an employee or student, go to Employee Health Service or the Jack Martin Fund Clinic, respectively. After hours report to the Emergency Department.

56 Spills, Exposure Reporting and Vaccinations Documentation of the route (s) of exposure, and the circumstances under which the exposure incident occurred; For an incident involving a clinical specimen identification and documentation of the source individual should be included, unless the MSMC establishes that identification is not feasible or prohibited by state or local law-this would require consent of the source individual.

57 Spills, Exposure Reporting and Vaccinations The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented.

58 Spills, Exposure Reporting and Vaccinations Any and all physicians reports, and ancillary reports generated as a result of an exposure incident must be retained for the length of the employees service plus an additional thirty years after separation from MSSM.

59 Spills, Exposure Reporting and Vaccinations Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations (HIPAA) concerning disclosure of the identity and infectious status of the source individual. Collection and testing of source individuals blood for HBV and HIV serological status; The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained.

60 Spills, Exposure Reporting and Vaccinations If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. Post-exposure prophylaxis will be provided, when medically indicated, as recommended by the U.S. Public Health Service Counseling and evaluation of reported illnesses will be made available to the employee.

61 Spills, Exposure Reporting and Vaccinations MSSM shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR and this record shall include: –The name and social security number of the employee –A copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination –A copy of all results of examinations, medical testing, and follow- up procedures –The employer's copy of the healthcare professional's written opinion –A copy of the information provided to the healthcare professional

62 Spills, Exposure Reporting and Vaccinations MSSM shall ensure that employee medical records required by OSHAs BBP Standard are kept confidential and not disclosed or reported without the employee's express written consent to any person within or outside the workplace except as may be required by law. MSSM shall maintain the records required by the BBP Standard for at least the duration of MSSM employment plus 30 years.

63 Spills, Exposure Reporting and Vaccinations If you are an MSSM employee, and you work directly with human blood, body fluids, tissues or other specimens, or occasionally come into contact with these materials, Hepatitis B Vaccination is available to you at no cost. The vaccinations are provided through the MSMC Employee Health Service

64 Spills, Exposure Reporting and Vaccinations You may decline to be vaccinated, but in order to do so you must formally decline by completing a declination statement and placing it in your MSMC Employee file You can change your mind later and accept vaccination, again at no personal cost to you

65 Spills, Exposure Reporting and Vaccinations I understand that due to my occupational exposure to blood or other potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me. _________________________________________ Signed Sample Declination Form _________ Date

66 Spills, Exposure Reporting and Vaccinations Sharps injury log The MSMC Needle Strick Coordinator maintains a sharps injury log for the recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log is recorded and maintained in such manner as to protect the confidentiality of the injured employee. The sharps injury log contains: The type and brand of device involved in the incident, The department or work area where the exposure incident occurred, An explanation of how the incident occurred

67 Conclusion It is your responsibility as an employee to read and understand the contents of the OSHA Standard. This presentation is not a substitute for becoming familiar with the Standard, which is available at: Specific hands-on training can be arranged with the Biosafety Officer in your laboratory by calling

68 Conclusion Faculty members and Principal Investigators are reminded that specific Standard Operating Procedures prepared in written format should be available at all times to their research and support staff working with production amounts or large quantities of bloodborne pathogens. All new employees and transient individuals working on bloodborne pathogen projects should demonstrate the required level of training and knowledge before working directly with pathogenic agents, as required in the standard.

69 Congratulations…. You have successfully completed the training session and all you need to do is take the exam. We will see you again within one year of this session, if you pass.

70 Section 2 HIV and HBV Research Laboratories and Production Facilities

71 Section 2: HIV and HBV Research Laboratories and Production Facilities (e)(1) (OSHA Bloodborne Standard) This paragraph applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard.

72 Research Laboratories and Production Facilities Standard Microbiological Practices. All regulated waste shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens Laboratory doors shall be kept closed when work involving HIV or HBV is in progress.

73 Research Laboratories and Production Facilities Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms.

74 Research Laboratories and Production Facilities When other potentially infectious materials or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this standard. (Next Slide)

75 Research Laboratories and Production Facilities

76 All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench.

77 Research Laboratories and Production Facilities Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered.

78 Research Laboratories and Production Facilities Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable.

79 Research Laboratories and Production Facilities Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens.

80 Research laboratories and production facilities shall meet the following criteria: Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary.

81 Research Laboratories and Production Facilities Vacuum Line Protection A. Flask with Disinfectant B. Back – up Flask C. HEPA In-line filter D. Vacuum Connection

82 Research Laboratories and Production Facilities Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials.

83 Research Laboratories and Production Facilities Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly autoclaved or decontaminated before reuse or disposal by placing in a puncture-resistant plastic container.

84 Research Laboratories and Production Facilities All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. An SOP has to be available describing the correct procedures. A spill or accident that results in an exposure incident shall be immediately reported to the Principal Investigator, laboratory director the MSMC NeedleStick Coordinator ( #) and to the MSSM Biosafety Officer,

85 Research Laboratories and Production Facilities A specific biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. All lab personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them as a matter of their employment.

86 Research Laboratories and Production Facilities Containment Equipment Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols.

87 Research Laboratories and Production Facilities Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually.

88 Research Laboratories and Production Facilities Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area. An individual should not have to walk through doors to access the sink or eyewash An autoclave for decontamination of regulated waste shall be available, ideally within the suite.

89 HIV and HBV Production Facilities The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes-change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area.

90 HIV and HBV Production Facilities The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area.

91 HIV and HBV Production Facilities Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area.

92 HIV and HBV Production Facilities Access doors to the work area or containment module shall be self-closing. An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area.

93 HIV and HBV Production Facilities A ducted exhaust-air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area).

94 Training Requirements Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix). The essential components are specified in the next slides

95 Training Requirements Additional Initial Training for Employees in HIV and HBV Laboratories and Production Facilities. Employees in HIV or HBV research laboratories and HIV or HBV production facilities shall receive the following initial training in addition to the training requirements set forth in section 1.

96 Training Requirements The Principal Investigator shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV. The Principal Investigator shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV.

97 Training Requirements The Principal Investigator shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. The Principal Investigator shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated.

98 Training Requirements Training records shall include the following information: The dates of the training sessions; The contents or a summary of the training sessions; The names and qualifications of persons conducting the training; The names and job titles of all persons attending the training sessions. Training records shall be maintained for 3 years from the date on which the training occurred.

99 Labels Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E), (F) and (G). Labels required by this section shall include the following legend:

100 Labels

101 These labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color. Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal.

102 Labels Red bags or red containers may be substituted for labels. Containers of blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of paragraph (g). Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal are exempted from the labeling requirement.

103 Labels Labels required for contaminated equipment shall be in accordance with this paragraph and shall also state which portions of the equipment remain contaminated. Regulated waste that has been decontaminated need not be labeled or color-coded.

104 Signs The employer shall post signs at the entrance to work areas specified in HIV and HBV Research Laboratory and Production Facilities, which shall bear the following legend:

105 Signs (Name of the Infectious Agent) (Special requirements for entering the area) (Name, telephone number of the laboratory director or other responsible person.) These signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color.

106 Know your Enemy!!


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