exposure control plan bloodborne pathogens and other ... with index 4-2… · the laboratories...

State of Maryland

Maryland Department of Health Laboratories Administration

1770 Ashland Avenue Baltimore, Maryland 21205

Exposure Control Plan

Bloodborne Pathogens and Other Potentially Infectious Materials

Fifth Edition, version 5.1 April 2018

ii

State of Maryland Maryland Department of Health

Laboratories Administration Annual Review/Approval of Document

The Laboratories Administration Exposure Control Plan for Bloodborne Pathogens and Other Potentially Infectious Materials will be reviewed on an annual basis. The annual review is required to verify the Plan’s effectiveness, and will be documented using this form. The document entitled “Exposure Control Plan for Bloodborne Pathogens and Other Potentially Infectious Materials” has been reviewed and approved for use in Maryland Department of Health, Laboratories Administration, effective _____________________. Date effective _________________________________ ____________________

Rachel V. Michael Date approved Safety and Security Office

_________________________________ ____________________

Robert A. Myers, Ph.D. Date approved Director, Laboratories Administration

MDH Laboratories Administration Exposure Control Plan, 5th Edition, version 5.1

iii Revision History

Exposure Control Plan

REVISION COMMENTS DATE

First Edition In 1992, Occupational Safety and Health Administration (OSHA) established Occupational Exposure to Bloodborne Pathogens standards requiring all Laboratories to create an Exposure Control Plan 29 CFR 1910.1030 [56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992; 57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996; 66 FR 5325 Jan., 18, 2001; 71 FR 16672 and 16673, April 3, 2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33608, June 8, 2011; 76 FR 80740, Dec. 27, 2011; 77 FR 19934, April 3, 2012.].

3/1992

Second Edition Revised and updated. 3/25/2008 Third Edition Revised and updated. 10/2009 Third Edition 3.1 Revised and updated. 1/15/2013 Fourth Edition Revised and update for the

1770 Ashland Avenue Facility. 7/1/2015

Fourth Edition Reviewed. 5/20/2016 Fifth Edition Revised and updated to include

State of Maryland’s new health care provider to WorkPro and Occupational Medical Services (OMS) effective April 1, 2017.

4/1/2017

Fifth Edition 5.1 Reviewed and updated to reflect Department of Health & Mental Hygiene name was changed to Maryland Department and addition of the Biological Spill Clean-Up Standard Operating Procedure.

4/1/2018


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TABLE OF CONTENTS PAGE

1.0 FORMAL POLICY STATEMENT ....................................................... 6

2.0 EXPOSURE DETERMINATION .......................................................... 2

3.0 OCCUPATIONAL EXPOSURE AND POST-EXPOSURE FOLLOW-UP ................................................................................................. 4

4.0 ENGINEERING AND WORK PRACTICE CONTROLS ................. 6 4.1 STANDARD PRECAUTIONS/UNIVERSAL PRECAUTIONS ..........................6 4.2 HANDWASHING .................................................................................................6 4.3 CONTAMINATED NEEDLES AND SHARPS ....................................................7 4.4 SHARPS CONTAINERS: .....................................................................................7 4.5 BIOLOGICAL SAFETY CABINETS ...................................................................7 4.6 FOOD AND DRINK ..............................................................................................7 4.7 PIPETTING ...........................................................................................................8 4.8 SPECIMEN HANDLING ......................................................................................8 4.9 ACCESS TO THE LABORATORIES ...................................................................9 4.10 STANDARD OPERATING PROCEDURES ........................................................9

5.0 PERSONAL PROTECTIVE EQUIPMENT (PPE) ........................... 10 5.1 PPE OVERVIEW .................................................................................................10 5.2 GLOVES ..............................................................................................................11 5.3 LABORATORY COATS ....................................................................................11 5.4 EYE PROTECTION ............................................................................................12

6.0 ANTISEPTICS/DISINFECTANTS ..................................................... 12

7.0 HOUSEKEEPING/SPILL CLEANUP ................................................ 13 7.1 CLEANING AND DECONTAMINATING ........................................................13 7.2 PROTECTIVE COVERINGS ..............................................................................13 7.3 EQUIPMENT.......................................................................................................13 7.4 SPECIMENS ........................................................................................................14 7.5 SELECT AGENTS AND TOXINS ......................................................................14

8.0 LAUNDRY ............................................................................................. 15

9.0 SIGNS AND LABELS ........................................................................... 15

10.0 WASTE DISPOSAL ............................................................................ 16


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TABLE OF CONTENTS PAGE

11.0 TRAINING ........................................................................................... 16

12.0 HEPATITIS B VACCINATION AND FOLLOW-UP ..................... 18

13.0 RECORD-KEEPING .......................................................................... 19 13.1 MEDICAL RECORD ..........................................................................................19 13.2 SAFETY TRAINING RECORD .........................................................................19

14.0 GLOSSARY ......................................................................................... 21

15.0 REFERENCES ..................................................................................... 26

16.0 APPENDICES ...................................................................................... 28


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1.0 FORMAL POLICY STATEMENT This Exposure Control Plan is designed to eliminate or minimize occupational employee exposure to bloodborne pathogens. The Laboratories Administration is committed to providing a safe working environment and believes employees have a right to know about health hazards associated with their work. So that employees can make knowledgeable decisions about any personal risks of employment, this Exposure Control Plan is established to include policies, procedures, and responsibilities designed to develop awareness in employees of potentially infectious materials in the workplace and to train employees in appropriate, safe working conditions. The Exposure Control Plan is reviewed and updated annually by the Laboratory Safety and Security Committee. It may also be updated when necessary to reflect new or modified tasks that affect occupational exposure. It is available for all employees in the Office of each Division Chief.

Laboratory safety is the responsibility of all employees. Each employee will have access to pertinent safety information and appropriate personal protective equipment through their supervisory staff. All employees must familiarized themselves with their lab unit’s standard operating procedures and manuals. When safety concerns arise, employees are encouraged to contact their supervisors.

A training program has been designed for the benefit and protection of all laboratory employees. Necessary information is available to inform the employee how best to handle potentially infectious materials.


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2.0 EXPOSURE DETERMINATION

All Laboratories Administration job classifications are assessed for occupational exposure to bloodborne pathogens. This determination by job classification includes employee exposure level (EEL) to blood and other potentially infectious material (BOPIM), and the associated job tasks. BOPIM may include: 1. Human blood, human blood components, and products made from

human blood. 2. Human body fluids such as: amniotic fluid, cerebrospinal fluid,

pleural fluid, pericardial fluid, peritoneal fluid, saliva, semen, synovial fluid, vaginal secretions, and any body fluid that is visibly contaminated with blood.

3. Animal blood, animal blood components, animal tissue and products made from animal blood.

Employee Exposure Level to BOPIM: 1. Routinely exposed. 2. Not usually exposed, but may be under certain conditions.

Tasks with Occupational Exposure to BOPIM: 1. Phlebotomy, 2. Specimen registration BOPIM, 3. Specimen preparation and testing BOPIM, 4. Handling infectious wastes, 5. Cleaning and/or decontamination of work areas where BOPIMs are

handled, including spills; 6. Report processing in proximity to BOPIM or handling reports that

could have been contaminated with BOPIM; 7. Cleaning and/or repair of instruments used in BOPIM testing; and 8. Handling contaminated laundry.

The following table lists the Laboratories Administration’s job classifications, employee exposure level (EEL), and tasks with potential occupational exposure to BOPIM.


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Table of Job Classifications with Occupational Exposure to Bloodborne Pathogens as Determined by 29 CFR 1910.1030 (NEE=No Employees Exposed) (A - Routinely exposed) (EEL=Employee Exposure Level) (B - Not usually exposed, but may be under certain conditions)

Division Job Classification EEL Tasks Administrative Office NEE NEE -- Fiscal Administration NEE NEE -- Office of Laboratory Emergency Preparedness and P.H. Lab Scientist A 1,2,3,4,5,6,8 Response Office Secretary NEE Drug Control NEE -- Management Information System Data Processing Programmer

Analyst Supervisor B 6

Computer Network Specialist B 6 Data Processing Programmer

Analyst B 6

Computer Information System Specialist

B 6

Registration and Reports Office Service Clerk A 2,5,6,8 Office Service Clerk Lead A 2,5,6,8 Office Manager B 2,5,6,8 Office Supervisor B 2,5,6,8 Preparation Laboratory P.H. Lab Assistant A 4,8 Outfit Laboratory NEE -- -- Newborn and Childhood Screening P.H. Lab Scientist A 3,4,5,6,8 P.H. Lab. Tech. A 3,4,5,6,8 P.H. Lab Assistant A 3,4,5,6,8 Office Service Clerk B 2,5,6,8 Office Secretary NEE Molecular Biology P.H. Lab Scientist A 3,4,5,6,8 P.H. Lab Tech. A 3,4,5,6,8 P.H. Lab Assistant A 3,4,5,6,8 Office Secretary NEE Public Health Microbiology P.H. Lab Scientist A 2,3,4,5,6,8 P.H. Lab Tech. A 2,3,4,5,6,8 P.H. Lab Assistant A 3,4,5,6,8 Office Service Clerk B 2,5,6,8 Office Secretary NEE Virology/Immunology P.H. Lab Scientist A 3,4,5,6,8 P.H. Lab Tech. A 3,4,5,6,8 P.H. Lab Assistant A 3,4,5,6,8 Office Secretary NEE Environmental Microbiology P.H. Lab Scientist A 3,4,5,6,8 P.H. Lab Tech A 3,4,5,6,8 P.H. Lab Assistant A 3,4,5,6,8 Office Secretary NEE Environmental Chemistry P.H. Lab Scientist A 3,4,5,6,7,8 P.H. Lab Tech A 3,4,5,6,7,8 P.H. Lab Assistant A 3,4,5,6,7,8 Office Secretary NEE Quality Assurance, Safety &Training P.H. Lab Scientist A 1,2,3,4,5,6,7,8 P.H. Lab Tech A 1,2,4,5,6,8 P.H. Lab Assistant A 2,4,5,6,8 Maintenance Mechanic B 7


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3.0 OCCUPATIONAL EXPOSURE AND POST-EXPOSURE FOLLOW-UP

High-risk exposures involve patient's blood or body fluids introduced through intact skin or splashed onto mucous membranes or broken or abraded skin of the employee. Any employee sustaining a high-risk exposure notifies his/her Supervisor immediately. Emergency counseling and treatment are available at WorkPro and Occupational Medical Services (OMS) locations. High-risk exposures from patients known to be HIV-positive or patients at risk of being HIV-positive are handled as emergencies. Post-exposure prophylaxis should be initiated as soon as possible, preferably within hours rather than days of exposure. Following a report of an exposure incident, each employee receives a confidential medical evaluation and follow-up, including at least the following elements:

1. Documentation of the route(s) of exposure and the

circumstances under which the exposure occurred.

2. Identification and documentation of the source individual are undertaken, unless identification is not feasible or prohibited by state or local law.

3. After obtaining consent from the source individual, the blood is

tested as soon as possible to determine hepatitis B virus (HBV) and HIV infectivity. Documentation that legally required consent cannot be obtained is needed, if consent is not obtained. When the source individual's consent is not required by law, the source individual's blood, if available, is tested and the results documented.

4. When the source individual is already known to be infected with

HBV or HIV, testing for the source individual's known HBV or HIV status is not repeated.


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5. Results of the source individual's testing are made available to

the exposed employee, and the employee is informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual.

6. The exposed employee's blood is collected as soon as feasible

and tested after consent is obtained. If the employee consents to the collection of a baseline blood specimen but does not give consent at that time for HIV serologic testing, the sample is preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, the testing is done as soon as feasible.

7. Follow-up of the exposed employee, including antibody or

antigen testing, counseling, illness reporting, and safe and effective post-exposure prophylaxis, is conducted according to standard recommendations for medical practice.

8. The Laboratories Administration provides the following

information to the evaluating physician: • A copy of 29 CFR 1910.1030 (Bloodborne Pathogen

Standard) dated December 6, 1991 and its appendices, if necessary; and

• A description of the affected employee's duties as they relate to the employee's occupational exposure.

• Documentation concerning the routes of entry and circumstances under which the exposure incident occurred.

• Results of source individual’s blood testing, if available. • All other relevant medical records including vaccination

status which employer maintains.

9. For each evaluation under this section, the employee will receive a copy of the evaluating physician's written opinion via mail within 15 working days after the evaluation is completed. The written opinion will be limited to the following information: • The physician's recommended limitations on the employee's

ability to receive HBV. MDH Laboratories Administration Exposure Control Plan, 5th Edition, version 5.1

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• A statement that the employee has been informed of the

results of the medical evaluation and that the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials that require further evaluation or treatment.

• Specific findings or diagnoses that relate to the employee's

ability to receive HBV vaccination. Any other findings and diagnoses remain confidential and are not included in the written report.

4.0 ENGINEERING AND WORK PRACTICE CONTROLS 4.1 STANDARD PRECAUTIONS/UNIVERSAL PRECAUTIONS Because few laboratory tasks are without potential exposure to infectious materials, general precautions for handling all such materials have been adopted to minimize exposure. Standard precautions are observed throughout the laboratory to prevent contact with blood and other potentially infectious materials. All body fluids are considered potentially infectious. Engineering controls are examined, maintained, and replaced on a regular schedule to ensure their effectiveness. This includes an annual inspection and certification of biological safety cabinets. All personal protective equipment is removed as soon as possible if overtly contaminated and decontaminated before laundering. Laboratory surfaces are made of impervious materials to facilitate disinfection.

4.2 HANDWASHING Employees wash their hands immediately (or as soon as possible) after removing gloves or other personal protective equipment and after hand contact with blood or other potentially infectious materials. Hands are washed between all patient contacts; before eating, drinking, smoking, applying cosmetics, and changing contact lenses; and after using lavatory


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facilities. Facilities for handwashing are provided and are separate from those used for washing equipment or for waste disposal. Where this option is not available, thorough cleaning of the sink and surrounding area with an intermediate disinfectant after chemical and/or biohazard waste disposal is required before handwashing is allowed. Antiseptic hand cleaner, disinfectant towelettes or waterless hand cleaners are used whenever clean running water is not available; however, they are not used as a substitute for handwashing. Hands are washed with soap and water as soon as possible. Wearing gloves does not mean you do not have to wash your hands!

4.3 CONTAMINATED NEEDLES AND SHARPS Used needles and other sharps are not bent, broken, recapped, or resheathed by hand. Contaminated needles are not sheared or broken. Used needles are not removed from disposable syringes. Sharps are placed in sharps containers as soon as possible after use.

4.4 SHARPS CONTAINERS

• Used for disposal of needles and sharps. • Located near testing personnel point of use. • Are puncture resistant, have leak-proof sides and bottoms, and are

labeled or color-coded to indicate a biohazard, may be gasketed, and are maintained upright throughout their use.

• Replaced routinely and not allowed to overfill. • Closed prior to being moved to prevent spillage of contents during

handling. • Reusable containers are not opened, emptied or cleaned in a manner

that exposes employees to risk of percutaneous injury.

4.5 BIOLOGICAL SAFETY CABINETS Biological safety cabinets (BSCs) are certified when installed, whenever they are moved, and at least annually.

4.6 FOOD AND DRINK Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a potential for occupational exposure. Food and drink are not stored in refrigerators,


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freezers, or cabinets, or on shelves, countertops, or benchtops where blood or other potentially infectious materials are stored or in other areas of possible contamination.

4.7 PIPETTING Mechanical pipetting devices are used for all liquids. Mouth pipetting/suctioning is prohibited. Pipette tips are disposed of in biohazard containers. Needles are not used for sampling unless no alternative exists (e.g., blood culture bottles).

4.8 SPECIMEN HANDLING All specimens from patients are kept in clean and dry outside containers with a secure lid. All specimens are transported in a secondary container (e.g., impervious plastic bag) that prevents leakage during handling, processing, storage, transport, or shipping. The container is labeled or color-coded appropriately. If the specimen could cause a puncture, then a secondary container that is puncture-resistant is used. All procedures involving blood or other potentially infectious materials are performed to minimize splashing, spraying, spattering, and generating droplets of these substances (e.g., blood specimens) are opened using a gauze square to minimize contamination of skin and clothing, or plastic shields or boxes are used to reduce splashing. Specimens are centrifuged with the lid firmly latched to reduce the risk of infection by spattering. Safety cups with lids are used when infectious aerosols are possible. These safety cups should be opened in a biological safety cabinet to prevent exposure to a broken or damaged centrifuge tube. Unfixed or unstained slides are considered infectious and treated appropriately. All specimens and samples will be transported throughout the building in secondary leak proof container, such as a Nalgeen BioTransport Container. Specimens and samples shall only be transported using elevators #3 and #4.


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4.9 ACCESS TO THE LABORATORIES The Laboratories Administration Security Plan and Manual, Section II -Physical Access, outlines the authorized personnel allowed in the MDH, Laboratories Administration Central Lab, at 1770 Ashland Avenue, Baltimore, MD 21205. All visitors (e.g. other state, federal and county employees, contractors, non-routine couriers, employees’ relatives, vendors, service technicians, etc.) with legitimate business to conduct with the Laboratories Administration may gain access by:

• Presenting and turning over their current government-issued photo

ID (i.e., driver’s license) to Forest City Security Officer posted at the Lobby;

• Verifying visitor has a Visitor Clearance Sheet, Appendix A. • Signing-in at Lobby Security Desk on arrival; • Obtaining and visibly wearing a dated “visitor’s” badge; • Waiting for an escort from the lab or office to be visited; and • Signing out at Lobby Security Desk and retrieving their

government-issued photo ID on departure.

Service and maintenance personnel are not permitted to enter a biohazard area until the laboratory's safety requirements are reviewed, the instrument to be serviced is decontaminated, and appropriate personal protective equipment is available. Access to restricted areas, such as Radiation Lab, Rabies Animal Room, and Biosafety Level 3 labs, must have Director, or designee approval. Access to Biological Select Agent and Toxin program areas, is strictly prohibit without authorization from Principle Investigator (PI), Responsible Official/Alternate Responsible Official (RO/ARO), and/or Director. 4.10 STANDARD OPERATING PROCEDURES Standard operating procedures (SOPs) are further delineated and maintained in the following laboratory sections or units:


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4.10.1 Phlebotomy Tourniquets used for phlebotomy are recommended for single patient use and after use, are disposed of, given high-level disinfection, or sterilized. Employees use gloves during tourniquet procedures. Needle holders (e.g., Vacutainer) for use with evacuated blood tubes can be reused unless they are visibly contaminated. However, these devices are preferably discarded or disinfected after use with each patient. 4.10.2 Hematology Liquid waste from automatic cell analyzers is considered contaminated and must be decontaminated before disposal. 4.10.3 Microbiology Due to the highly infectious nature of tuberculosis, all live Mycobacterium tuberculosis (TB) cultures and clinical specimen are handled in a Class II Biological Safety Cabinet within a BSL-3 laboratory, utilizing BSL-3 practices and PPE. After surface decontamination, heat killed and chemically inactivated TB isolates, as well as heat fixed and stained slides, may be worked in the BSL-2 laboratory. All heat killed TB isolates should only be opened within a Class II Biological Safety Cabinet. QuantifFERON testing is performed on the open bench in the BSL-2 laboratory with universal precautions.

5.0 PERSONAL PROTECTIVE EQUIPMENT (PPE) 5.1 PPE OVERVIEW Personal protective equipment (e.g., gloves, laboratory coat, or eyewear) is required to be worn by all outside service and maintenance as well as lab personnel when there is a potential exposure to blood and body fluids. Lab coat and safety glasses, or goggles, are required PPE in lab areas, including write-up areas. This equipment is provided by the laboratory and located in each lab. PPE in appropriate sizes is readily available to employees. All PPE is assigned based on the task assessment, which does not allow blood or other potentially infectious materials to pass through to or otherwise reach the employee's work clothes (e.g., scrubs), street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the time that the protective


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equipment is used. PPE is provided at no cost to the employees, and is inspected repaired and replaced as needed.

5.2 GLOVES Employees are required to wear disposable medical, single-use gloves when they have the potential for direct skin contact with blood and infectious materials, mucous membranes, and non-intact skin when touching or handling contaminated items or surfaces. Gloves are removed inside out aseptically and are replaced as soon as possible when visibly soiled, torn, or punctured or any time their ability to function as a barrier is compromised. They are not washed in disinfectant for reuse. Hypoallergenic gloves, glove liners, or powder-free gloves are provided to employees who are allergic to the regularly provided gloves. [Note: Employees with contact dermatitis caused by gloves may find protective skin creams helpful in preventing further irritation.]

5.3 LABORATORY COATS Knee-length laboratory coats with long sleeves are to be worn only in the laboratory area and are to be closed (e.g., buttoned, snapped) to protect clothing. Aprons are worn in addition to the laboratory coat when the laboratory coat cannot provide adequate protection (e.g., during pregnancy). Aprons are not substitutes for laboratory coats but serve as additional protection. Lab coats required in laboratory work area. Lab coats shall not worn in offices, restrooms, administrative areas and hallways, conference rooms, visitor elevators #1 and #2, or in break rooms where food or drink are consumed. Laboratory coats are provided by the employer at no cost to the employee. Soiled but not overtly contaminated laboratory coats are placed in a designated area on each floor and laundered weekly by an outside laundry service at no cost to the employee. Visibly contaminated laboratory coats are autoclaved prior to cleaning by the laundry service. Laboratory coats are repaired and replaced as needed by the employer at no cost to the employee.


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5.4 EYE PROTECTION Masks and eye protection or chin-length face shields are worn to prevent splashes, sprays, spatter, or droplets of blood or infectious materials if there is a potential for eye, nose, or mouth contamination. This equipment is located in each laboratory. Eyewear must meet OSHA standards and is available in various sizes to accommodate the wearer. Eye protection is required in laboratory work spaces. Tinting of lenses is not recommended. Side shields may be attached permanently or may be detachable. Eyewear is provided by the employer upon employment at no cost to the employee. Replacement and repair caused by normal wear and tear are also the employer's responsibility. Prescription lenses or replacement because of loss are the responsibility of the employee. Eyewear should be appropriately cleaned before using and whenever splashes or contamination are visible. When not in use, eyewear should be kept in a sanitizing cabinet or decontaminated and put in an individual case in the employee's locker. 6.0 ANTISEPTICS/DISINFECTANTS Antiseptics and disinfectants are used throughout the laboratory in a variety of ways. Antiseptics are chemical germicides formulated for use on skin or tissue. Disinfectants are agents that inactivate viruses, bacteria, and fungi on surfaces. Hospital disinfectants used are registered by the Environmental Protection Agency (EPA) and are classified as high-, intermediate-, or low-level depending on their ability to kill germs. The following are examples only and do not exclude other uses:

Disinfectants Effective in Inactivation of HIV and HBV

Minimum

Concentration Contact Time Disinfectant (percent) (minutes)

Isopropyl Alcohol 70% 5-30

Household bleach (Sodium hypochlorite 5.25%) 10% 10-30

(1:10 of 5.25%) MDH Laboratories Administration Exposure Control Plan, 5th Edition, version 5.1

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Lysol 2% - 10% 10-30

Heat 98°C 2

7.0 HOUSEKEEPING/SPILL CLEANUP 7.1 CLEANING AND DECONTAMINATING The Laboratory determines and implements an appropriate written schedule for cleaning and decontaminating. All equipment and work surfaces are decontaminated with an appropriate disinfectant (e.g., a freshly prepared 1 to 10 solution of bleach or other intermediate-level disinfectant is used):

• After completing procedures, • When surfaces are overtly contaminated, • Immediately after any spill of blood or other potentially infectious

materials, and • At the end of the workshift.

7.2 BIOSAFETY LEVEL 3 BSL-3 lab space must decontaminate after any spill or lab accident that may result in a possible. Routine BSL-3 lab space decontamination should be performed as part of the SOP. (Refer to current Biosafety Level 3-Standard Operating Procedure and Bioquell Decon Standard Operating Procedure.) All biohazardous waste is autoclaved before leveling the BSL-3 lab.

7.3 PROTECTIVE COVERINGS Protective coverings, such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift.

7.4 EQUIPMENT Equipment at risk to be contaminated with blood or other potentially infectious materials is decontaminated routinely, before servicing or


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shipping, and is decontaminated as necessary according to manufacturers' recommendations. All bins, pails, cans, and similar receptacles intended for reuse that have a potential for becoming contaminated with blood or other potentially infectious materials are inspected and decontaminated immediately (or as soon as possible) upon visible contamination and after use.

7.5 SPECIMENS AND BIOLOGICAL SPILLS Specimens of blood or other potentially infectious materials are placed in a closable, leakproof container and labeled or color-coded before being stored or transported, i.e., Nalgeen Bio-Transport Container. If outside contamination of the primary container is likely, then a second leakproof container that is labeled or color-coded is placed over the outside of the first and closed to prevent leakage during handling, storage, or transport. If puncture of the primary container is likely, it is placed in a secondary container that is leakproof and puncture-resistant. Broken glassware that may be contaminated is not picked up directly with the hands. It is handled by using mechanical means, such as a brush and dustpan, tongs, or forceps. Spills of body fluids are decontaminated as soon as possible by following the Laboratories Administration Biological Spill Clean-up Standard Operating Procedure, Appendix D. 7.6 SELECT AGENTS AND TOXINS In the event of a release/spill, occurs in an area working with Select Agents, inform the immediate supervisor, the SSO (443-681-3792), the Principle Investigator(s) (PI), and the Responsible Official (RO). The PI, RO, and SSO will investigate the release/spill and determine what actions are needed beside the immediate clean-up outlined in Section 2.6 of the Laboratories Administration’s Laboratory Safety Manual and also Select Agent and Toxins Biosafety Plan. The Biosafety Level 3 (BL3) laboratory may require gas decontamination by hydrogen peroxide vapor. For additional information, refer to the Laboratories Administration’s Biological Agent Incident Response Plan (BAIRP).


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8.0 LAUNDRY

Contaminated laundry is placed and transported in containers that are labeled with the biohazard symbol. These containers are stored in a designated area. Whenever laundry is overtly contaminated, it should be placed in a biohazard bag and autoclaved prior to laundering. Cleaning, laundering and repairing laboratory coats are done by the laundry service at no cost to the employee. Laboratory laundry handlers should wear protective gloves and other appropriate personal protective equipment to prevent occupational exposure during handling or sorting. Clean laboratory coats are stored separately from laboratory coats in use.

9.0 SIGNS AND LABELS Signs bearing the following illustration are posted at the entrance of laboratories and technical work areas. These areas are potentially biohazardous or may contain other infectious materials.

(Special requirements for entering the area)

These labels and signs are fluorescent orange or orange-red, or predominantly so, with lettering or symbols in a contrasting color. Warning labels are affixed to: • Containers of regulated infectious waste, • Refrigerators and freezers containing blood and other potentially

infectious materials, and • Other containers used to store, transport, or ship blood or other potentially

infectious materials. Labels are either an integral part of the container or are affixed as closely as feasible to the container by string, wire, adhesive, or other methods that


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prevent them from being lost or unintentionally removed. Red bags or red containers may be substituted for labels. Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment, or disposal are exempt from the labeling requirement. Labels are required for contaminated equipment state which portions of the equipment remain contaminated. Regulated waste that has been decontaminated is not labeled or color-coded.

10.0 WASTE DISPOSAL Infectious waste is handled according to procedures established in the Laboratory Safety Manual, Section 9.0, Waste Disposal.

11.0 TRAINING All employees with occupational exposure to bloodborne pathogens participate in a training program at no cost to the employee and that is held during working hours. Training is provided at the time of initial employment and annually thereafter. Additional training is offered whenever new or modified tasks or procedures affect the employee's occupational exposure. Material appropriate in content and vocabulary to educational level, literacy, and language background of employees is used. The training program contains the following elements:

1. A copy of the OSHA standard and an explanation of its contents; (29 CFR Part 1910.1030, pages 64175-64182).

2. A general explanation of the epidemiology and symptoms of

bloodborne diseases.

3. An explanation of the modes of transmission of bloodborne pathogens.

4. An explanation of the Laboratories Administration’s Exposure

Control Plan and a means by which the employee can obtain a copy of the written plan.


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5. An explanation of the appropriate methods for recognizing tasks

and other activities that may involve exposure to blood and other potentially infectious materials.

6. An explanation of the use and limitations of methods that will

prevent or reduce exposure, including appropriate engineering controls, work practices, and personal protective equipment.

7. Information on the types, proper use, location, removal, handling,

decontamination, and disposal of personal protective equipment.

8. An explanation of the basis for selecting personal protective equipment.

9. Information on the hepatitis B vaccine, including information on its

efficacy, safety, method of administration, and benefits. The vaccination will be offered free of charge.

10. Information on the appropriate actions to take and the people to

contact in an emergency involving blood or other potentially infectious materials.

11. An explanation of the procedure to follow if an exposure incident

occurs, including the method of reporting the incident and the medical follow-up that will be made available. Also information on the medical counseling that the employer is providing for exposed individuals.

12. An explanation of the signs, labels, and/or color-coding required.

13. An opportunity for interactive questions and answers with the

person(s) conducting the training session. Persons conducting the training are knowledgeable in the subject as it relates to the Laboratories Administration.

Adherence to recommended protective measures is monitored regularly by the employee’s supervisor. When monitoring reveals a failure to follow


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recommended precautions, counseling and retraining are provided and, if necessary, appropriate disciplinary action is considered. The Laboratory Safety Officer is responsible for providing this training program annually.

12.0 HEPATITIS B VACCINATION (HBV) AND FOLLOW-UP The Laboratories Administration makes HBV available to all employees. HBV is requirement for staff who have the potential occupational exposure due to their job duties. The Laboratories Administration provides post-exposure follow-up for all employees with an occupational exposure incident. All medical evaluations and procedures are performed by or under the supervision of a licensed physician or another licensed health-care professional and all laboratory tests are performed at no cost to the employee. All evaluations, procedures, vaccinations, and post-exposure management are provided to the employee at a reasonable time and place at no cost to the employee and according to standard recommendations for medical practice. HBV vaccination and information is offered during the new employee’s safety orientation. The Laboratories Administration SSO coordinates with HR to ensure HBV vaccination will be available at the employee’s start date, or within ten working days of initial assignment to all employees occupationally exposed to blood or other potentially infectious materials. Unless the employee has a previous HBV vaccination or unless antibody testing has revealed that the employee is immune or the vaccine is contraindicated for medical reasons. Participation in a prescreening program is not a prerequisite for receiving HBV vaccination. If the employee initially declines HBV vaccination but at a later date while still covered under the standard decides to accept the HBV vaccine, the vaccine is provided at that time. Should a booster dose(s) be recommended at a future date, such booster dose(s) will be provided according to standard recommendations for medical practice at no cost to the employee. Any


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employee who declines HBV vaccination must sign the statement in Appendix C. HBV antibody testing is made available to an employee who desires such testing before deciding whether to receive HBV vaccination. If the employee is found to be immune to HBV by virtue of adequate antibody titer, then HBV vaccine need not be offered to that employee. 13.0 RECORD-KEEPING

13.1 MEDICAL RECORD The Laboratories Administration is required to maintain an OSHA 300 Log and Sharps Injury Log for each facility. Medical records are kept for each employee in the office of the Laboratory Safety Officer and include the following: • Employee name • Employee Social Security number • Hepatitis B vaccination record/eligibility • Results of physical exams, testing, and follow-up procedures related to

vaccination and past exposures • Medical consultation, physical, and written opinion report (if

necessary because of exposure).

All medical records are kept confidential and not disclosed without the employee’s written consent. Medical records are kept for the duration of employment plus 30 years.

13.2 SAFETY TRAINING RECORD Training records are kept on all laboratory employees by the Laboratory Safety Officer for 3 years and include: • Dates of training sessions • Contents or a summary of training • Names and qualifications of instructors, attendance roster, including

names and job titles. • All records are kept and transferred in accordance with

29 CFR 1910.1020.


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Training records are made available to MOSH and NIOSH Inspectors. If the Laboratories Administration ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the Laboratories Administration will notify the area's OSHA Director and transfer the records to the Director within 3 months.


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14.0 GLOSSARY BIOSAFETY LEVEL (BSL) Associated risks with microorganisms (e.g.): • BSL-1 - This level is suitable for work involving well-characterized

agents not known to consistently cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment. (e.g., Escherichia coli )

• BSL-2 - This level is similar to Biosafety Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It includes various bacteria and viruses that cause only mild disease to humans, or are difficult to contract via aerosol in a lab setting. (e.g., Hepatitis B Virus)

• BSL-3 - This level is required for work with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation. It includes various bacteria and viruses that can cause severe to fatal disease in humans, but for which vaccines or other treatment exist. (e.g., Eastern equine encephalitis, Bacillus anthracis, Coxiella burnetii)

• BSL-4 - This level is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available. (e.g., Ebola)

BLOOD Human blood, human blood components, and products made from human blood. BLOODBORNE PATHOGENS Microorganisms that are present in human blood and that can cause disease in humans. These pathogens include hepatitis B virus (HBV), hepatitis C Virus (HCV) and human immunodeficiency virus (HIV). CLINICAL LABORATORY A workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.


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CONTAMINATED Marked by the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. CONTAMINATED LAUNDRY Laundry that has been soiled with blood or other potentially infectious materials or that may contain sharps. CONTAMINATED SHARPS Any contaminated object that can penetrate the skin, including, but not limited to: needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. DECONTAMINATION The use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. ENGINEERING CONTROLS Devices or equipment for isolating or removing hazards from the workplace (e.g. sharps disposal containers). EXPOSURE INCIDENT A specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from an employee performing his or her duties. HANDWASHING FACILITIES Locations that provide an adequate supply of running potable water, soap, and single-use towels. HBV Hepatitis B virus HCV Hepatitis C virus HEPA FILTERS High-efficiency particulate air filters HIV Human immunodeficiency virus LICENSED HEALTH-CARE PROFESSIONAL A person who is legally permitted scope of practice allows him or her to independently perform the


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activities required for hepatitis B vaccination and post-exposure evaluation and follow-up. OCCUPATIONAL EXPOSURE Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from employees performing their duties. OTHER POTENTIALLY INFECTIOUS MATERIALS

1. The following body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with blood.

2. Any unfixed tissue or organ (other than intact skin) from a human (living or dead). 3. Any unfixed tissue or organ (other than intact skin) from an animal (living or dead).

3. HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-contaminated culture media or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

PARENTERAL Exposure occurring as a result of piercing the skin barrier (e.g., subcutaneous, intramuscular, intravenous routes) through such events as needle sticks, bites, cuts, and abrasions. PERSONAL PROTECTIVE EQUIPMENT Specialized clothing or equipment worn by an employee to protect against a hazard. REGULATED WASTE Liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.


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RESEARCH LABORATORY A laboratory producing or using small but significant amounts of HIV. Research laboratories may produce high concentrations of HIV but not in the volume found in production facilities. SELECT AGENT Select agents / toxins are agents that HHS considers to have the potential to pose a severe threat to human health. A list of these agents are found in the select agent regulations (42 CFR 73, 7 CFR 331 and 9 CFR 121). SHARPS Any object that can penetrate the skin, including, but not limited to, needles, scalpels, and broken capillary tubes. SOPs Standard operating procedures SOURCE INDIVIDUAL Any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients, clients in institutions for the developmentally disabled, trauma victims, clients of drug and alcohol treatment facilities, residents of hospices and nursing homes, human remains, and individuals who donate or sell blood or blood components. STERILIZE To use a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores. STANDARD PRECAUTIONS combine the major features of Universal Precautions (UP) and Body Substance Isolation (BSI) and are based on the principle that all blood, body fluids, secretions, excretions except sweat, non-intact skin, and mucous membranes may contain transmissible infectious agents. TB A disease caused by the organism Mycobacterium tuberculosis. TOXINS Select agents / toxins are agents that HHS considers to have the potential to pose a severe threat to human health. A list of these agents are found in the select agent regulations (42 CFR 73, 7 CFR 331 and 9 CFR 121).


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UNIVERSAL PRECAUTIONS as defined by CDC, are a set of precautions designed to prevent transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other bloodborne pathogens when providing first aid or health care. Under universal precautions, blood and certain body fluids of all patients are considered potentially infectious for HIV, HBV and other bloodborne pathogens. WORK PRACTICE CONTROLS Mandated procedures or policies that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., by prohibiting recapping of needles using a two-handed technique).


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15.0 REFERENCES The following references were used in preparing this plan.

1. Brown P et al. Sodium Hydroxide Decontamination of Creutzfeldt - Jakob disease Virus. New England Journal of Medicine, 1984; 310(11):727. 2. Centers for Disease Control. Biosafety in Microbiological and Biomedical Laboratories (BMBL), Fifth edition, 2007 3. Centers for Disease Control. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post exposure Prophylaxis. Morbidity & Mortality Weekly Report (MMWR), September 30, 2005; 54(RR09);1-17 4. Centers for Disease Control. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Post exposure Prophylaxis. Morbidity & Mortality Weekly Report (MMWR), June 29, 2001; 50(RR11);1-42 5. Centers for Disease Control. Recommendations for Prevention of HIV Transmission in Health-Care Settings. Morbidity & Mortality Weekly Report, August 1987; 36(supplement no. 2s):35-185. 6. Forseter G. et al. Blood Contamination of Tourniquets Used in Routine Phlebotomy. American Journal of Infection Control, 1990; 18(6):386-390.

7. Maryland Department of Health and Mental Hygiene - Laboratories Administration, Biological Agent Incident Response Plan (BAIRP), rev Feb 2008 8. Maryland Department of Health and Mental Hygiene - Laboratories Administration, Laboratory Safety Manual, Third Edition,


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9. Maryland Department of Health and Mental Hygiene - Laboratories Administration, Security Manual and Plan, Second Edition, 10. Maryland Occupational Safety and Health (MOSH). Bloodborne Pathogens Exposure Control Plan, Compliance Guide. April, 2001. 11. National Committee for Clinical Laboratory Standards. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Second Edition, NCCLS Approved Standard H3-A2. Villanova, PA: NCCLS, 1991. 12. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids and Tissue, NCCLS Tentative Guideline M29-T2. Villanova, PA: NCCLS, 1991. 13. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards, NCCLS Proposed Guideline 117-P. Villanova, PA: NCCLS, 1991. 14. Occupational Safety and Health Administration (Department of Labor). Occupational Exposure to Bloodborne Pathogens; Final Rule. Federal Register, 29 CFR Part 1910.1030, 56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992; 57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996; 66 FR 5325 Jan., 18, 2001; 71 FR 16672 and 16673, April 3, 2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33608, June 8, 2011; 76 FR 80740, Dec. 27, 2011; 77 FR 19934, April 3, 2012. 15. Rutala WA. APIC Guideline for Selection and Use of Disinfectants. American Journal of Infection Control, 1990; 18(2): 99-117. 16. Weinstein SA et al. Blood Contamination of Reusable Needle Holders. Paper presented at the 18th Annual Educational Conference of the Association for Practitioners in Infection Control, Nashville, Tennessee, May 1991.


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16.0 APPENDICES A. Research Laboratory B Request Form for Hepatitis B Vaccine C. Waiver Form for Hepatitis B Vaccine D. Biological Spill Clean-up Standard Operating Procedure


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Appendix A RESEARCH LABORATORY Additional requirements for research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV include the following:

• All regulated waste is either incinerated or decontaminated by autoclaving, which is known to effectively destroy bloodborne pathogens.

• Laboratory doors are kept closed when work involving HIV is in

progress.

• Contaminated materials that are to be decontaminated at a site away from the work area are placed in a durable, leakproof, labeled, or color-coded container, which is closed before being removed from the work area.

• Access to the work area is limited to authorize personnel only. Only

persons who have been advised of the potential biohazard, who meet all specific entry requirements, and who comply with all entry and exit procedures are allowed to enter the work areas and animal rooms. A list of such persons is located at Division of Virology/Immunology Office.

• When potentially infectious materials are present in the work area or

containment module, a hazard warning sign that displays the universal biohazard symbol is posted on all access doors.

• All activities involving other potentially infectious materials are

conducted in biological safety cabinets that have been certified annually or in other physical containment devices within the containment module. No work is conducted in open vessels on the open bench.


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• Laboratory coats, gowns, smocks, uniforms, or other appropriate

protective clothing are used in the work area. Protective clothing is not worn outside the work areas and overtly contaminated protective clothing is decontaminated before being laundered.

• Special care is taken to avoid skin contamination when making hand

contact with other potentially infectious materials. Gloves are worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable.

• All waste from work areas is either incinerated or decontaminated by

autoclaving before disposal.

• Vacuum lines are protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters. Both are checked routinely and maintained or replaced as necessary.

• Spills and accidents that result in an exposure incident are immediately

reported to the Laboratory Supervisor or other responsible person according to the Laboratory Safety Manual. Spills are immediately contained and cleaned.

• A Laboratory Safety Manual is issued to all Laboratories

Administration employees and is provided in each Division Chief’s Office. Personnel are advised of potential hazards, required to read instructions on practices and procedures, and required to follow them. Documentation of compliance is in Laboratory Safety Office.

• 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, and sealed centrifuge rotors, are used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols.

• BSC are certified when installed, whenever they are moved, and at

least annually.


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• HIV research laboratories contain a sink for hand washing, an eye wash facility, and an autoclave for decontaminating infectious laboratory waste.

• Employees in HIV research laboratories receive the following training

in addition to the training required in the standard.

Employees are trained in and 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. This training or proficiency is documented.

Employees are experienced in the handling of human pathogens or

tissue cultures before working with HIV or HBV. A training program is provided to employees who have no prior

experience in handling human pathogens. Initial work activities do not include handling infectious agents. These employees are assigned a progression of work activities as they learn techniques and develop proficiency. Employees participate in work activities involving infectious agents only after proficiency has been demonstrated.


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Appendix B


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Appendix C


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Appendix D Biological Spill Clean-Up Standard Operating Procedure


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