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Bloodborne Pathogens Exposure Control Plan - Oakland University

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<strong>Oakland</strong> <strong>University</strong><br />

<strong>Bloodborne</strong> <strong>Pathogens</strong><br />

<strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong><br />

MAY 1992<br />

(Revised 1993, 1994, 1996, 1999, 2000, 2001 and 2004)<br />

Office of Environmental Health and Safety<br />

Department of Risk Management and Contracting<br />

Rochester, Michigan 48309-4401<br />

(248) 370-4196


<strong>Oakland</strong> <strong>University</strong><br />

<strong>Bloodborne</strong> <strong>Pathogens</strong><br />

<strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong><br />

for<br />

DEPARTMENT: ___________________________<br />

MAY 1992<br />

[Revised 1993, 1994, 1996, 1997, 2000 and 2001]<br />

Office of Environmental Health and Safety<br />

Graham Health Center<br />

(248) 370-4196


<strong>Oakland</strong> <strong>University</strong><br />

<strong>Bloodborne</strong> <strong>Pathogens</strong> <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong><br />

TABLE OF CONTENTS<br />

1.0 About this Written <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong>................................................................................. 1<br />

1.1 The Written <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> Includes ........................................................ 1<br />

2.0 Program Administration............................................................................................................... 2<br />

TABLE 1 - Individuals Responsible for Implementing the ECP in their Departments. ................. 3<br />

3.0 Employee <strong>Exposure</strong> Determination.............................................................................................. 4<br />

TABLE 2 - Job Classifications for which ALL employees Risk Occupational <strong>Exposure</strong>.............. 4<br />

TABLE 3 - Job Classifications for which SOME employees Risk Occupational <strong>Exposure</strong>........... 5<br />

4.0 Methods of <strong>Control</strong>ling <strong>Exposure</strong> to BBPs.................................................................................. 5<br />

4.1 Universal Precautions ............................................................................................ 5<br />

4.2 Work Practice <strong>Control</strong>s.......................................................................................... 5<br />

4.3 Engineering <strong>Control</strong>s ............................................................................................. 5<br />

TABLE 4 - Tasks Which May Present BBP <strong>Exposure</strong> and Associated PPE/Engineering Ctrls..... 6<br />

5.0 Biohazardous Waste ...................................................................................................................... 9<br />

5.1 Contaminated Sharps ............................................................................................. 9<br />

5.2 Contaminated Laundry .......................................................................................... 9<br />

5.3 Biohazard bags, hampers and sharp safes.............................................................. 9<br />

6.0 Contaminated Equipment........................................................................................................... 10<br />

7.0 Cleaning Up Spills........................................................................................................................ 10<br />

7.1 Washable Surfaces............................................................................................... 10<br />

7.2 Non-Washable Surfaces....................................................................................... 10<br />

8.0 Hepatitis B Vaccinations ............................................................................................................. 12<br />

8.1 “Pre-<strong>Exposure</strong>” Vaccinations .............................................................................. 10<br />

8.2 “Post-<strong>Exposure</strong>” Vaccinations............................................................................. 11<br />

9.0 <strong>Exposure</strong> Incident Response and Follow-up ............................................................................. 13<br />

9.1 <strong>Exposure</strong> Incident - First Response ..................................................................... 13<br />

9.2 Post-<strong>Exposure</strong> Evaluation and Follow-up ........................................................... 13<br />

10.0 Employee Training....................................................................................................................... 12<br />

10.1 When and How Often .......................................................................................... 12<br />

10.2 Who Conducts Training....................................................................................... 12<br />

10.3 Elements of Training ........................................................................................... 13<br />

11.0. Record Keeping............................................................................................................................ 13<br />

11.1 Training Records.................................................................................................. 13<br />

11.2 Medical Records .................................................................................................. 13<br />

11.3 <strong>Exposure</strong> Incident Evaluation Records................................................................ 14<br />

12.0 Conditions for Laboratories Working with HIV and Hepatitis Viruses ................................ 14<br />

12.1 Working in HIV and Hepatitis Viruses “Production Facilities” .......................... 14<br />

12.2 Working in HIV and Hepatitis Virus “Research Laboratories”........................... 15<br />

APPENDICES........................................................................................................................................... 21<br />

Blank Forms<br />

Completed Departmental Forms<br />

Universal Precautions and OSHA <strong>Bloodborne</strong> <strong>Pathogens</strong> Standard<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP Revised April 2004


1.0 ABOUT THIS WRITTEN EXPOSURE CONTROL PLAN<br />

This <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> is intended to serve as OU’s guide to the OSHA Standard<br />

1910.1030, “Occupational <strong>Exposure</strong> to <strong>Bloodborne</strong> <strong>Pathogens</strong>”, which requires, as a central<br />

component, the development and issuance of an <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> (ECP).<br />

The information contained in this publication is not considered a substitute for the OSH Act or<br />

any provisions of OSHA standards. It provides general guidance on the OSHA <strong>Bloodborne</strong><br />

<strong>Pathogens</strong> Standard, but should not be considered the legal authority for compliance with OSHA<br />

requirements. Rather, the reader should consult the OSHA standard in its entirety and/or OU’s<br />

Office of Environmental Health and Safety (OEHS) for specific compliance requirements.<br />

1.1 The Written <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> includes:<br />

• Determination of employee exposure<br />

• Methods of controlling exposure, including: Universal Precautions and work practice controls<br />

• Engineering <strong>Control</strong>s and Personal Protective Equipment<br />

• Biohazardous Waste<br />

• Contaminated Equipment<br />

• Cleaning up Spills<br />

• Hepatitis B vaccination<br />

• <strong>Exposure</strong> Incident Response and Follow-up<br />

• Employee Training<br />

• Record keeping<br />

• Conditions for working with HIV or a Hepatitis virus in the laboratory<br />

Employees covered by the bloodborne pathogens standard receive an explanation of this ECP<br />

during their initial training sessions. It will also be reviewed in their annual refresher training.<br />

All employees have an opportunity to review this plan at any time during their work shifts by<br />

contacting the responsible persons identified in Table 1 (Section 2.0). If requested, those<br />

individuals will provide their employees with a copy of the ECP free of charge and within 15<br />

days of the request<br />

The responsible persons identified in Table 1 (Section 2.0) are responsible for reviewing the<br />

ECP annually, or more frequently if necessary, to identify 1) any new or modified tasks and<br />

procedures which affect occupational exposure and 2) any new or revised job classifications that<br />

present occupational exposure.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP Revised April 2004


2.0 PROGRAM ADMINISTRATION<br />

The individuals found in Table 1 below are currently responsible for the implementation of the<br />

ECP in their respective departments. These individuals are responsible to:<br />

• Maintain and provide all necessary personal protective equipment (PPE), engineering controls<br />

(e.g., sharps containers), labels, and red bags as required by the standard<br />

• Ensure that all medical actions required are performed and that appropriate employee health<br />

and OSHA records are maintained<br />

• Ensure that all training is provided and documented<br />

• Ensure that the written ECP is available to employees, OSHA, and NIOSH representatives;<br />

• Review the ECP (and request updates as necessary from the Office of EH&S) at least<br />

annually, and/or whenever necessary to include new or modified tasks and procedures.<br />

TABLE 1<br />

Individuals Responsible for Implementing ECP in their Departments<br />

Department Position(s) Employee Name(s) (as<br />

of Feb. 2005)<br />

Telephone<br />

Extension(s)<br />

Athletics<br />

Head Athletic Trainer<br />

Asst. Dir. Facilities & Ops<br />

Tom Ford<br />

Eric Stephan<br />

3189<br />

4050<br />

Biological Sciences Laboratory Manager Michael Poosch 3556<br />

Campus Cleaning Supervisors Herb Lucre, Wendy Tyrell 2168<br />

Campus Recreation<br />

Chemistry<br />

Asst. Dir., Campus Progs.<br />

Asst. Dir., Aquatics<br />

Assistant Laboratory<br />

Manager<br />

Mila Padgett<br />

Dan Plamondon<br />

4910<br />

4533<br />

Marcee Daly 2330<br />

Eye Research Institute Asst. to the Director Paulette Realy 2390<br />

Graham Health Center Coordinator Joanne Talarek 4375<br />

Grounds/Vehicle Maint. Supervisor Randy Drewry 2413<br />

Lab Animal Mgmt Svcs Manager Cliff Snitgen 4441<br />

Lowry Early Childhood Ctr Director Tiffany Wright 4100<br />

Meadow Brook Hall Facility Operations Manager Kim Zelinski 3140<br />

Electrical and Plumbing Foreman Dan Niezurawski 4438<br />

<strong>Oakland</strong> Center Asst. Director Operations Rich Zizek 3245<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 2 of 19<br />

Revised April 2004


TABLE 1<br />

Individuals Responsible for Implementing ECP in their Departments<br />

Department Position(s) Employee Name(s) (as<br />

of Feb. 2005)<br />

Telephone<br />

Extension(s)<br />

Police Department Lieutenant Mel Gilroy 3339<br />

Residence Halls<br />

Custodial & Maintenance<br />

Mgrs<br />

Frank Moss<br />

Karen Pipitone<br />

4061<br />

3570<br />

School of Education Coor of Field Svcs. Sherrill Karppinen 3083<br />

School of Health Sci<br />

School of Nursing<br />

All Sci and Res Depts.<br />

Director Exercise Science<br />

Assoc. Professor, Exer Sci<br />

Assoc. Professor, Exer Sci<br />

Program Dir., Med Lab Sci<br />

Interim Associate Dean<br />

Nursing Laboratory Mgr<br />

Admin Project Coordinator<br />

Laboratory Compliance<br />

Manager (Office of EH&S)<br />

Brian Goslin<br />

Charles Marks<br />

Robert Jarski<br />

Lynne Williams<br />

Diane Norris<br />

Patricia Ketcham<br />

Joann Burrington<br />

4140<br />

4539<br />

4191<br />

4040<br />

4484<br />

4066<br />

4065<br />

Domenico Luongo 4314<br />

3.0 EMPLOYEE EXPOSURE DETERMINATION<br />

Table 2 below identifies those OU job classifications (i.e., positions) for which ALL employees<br />

who hold those positions risk occupational exposure to <strong>Bloodborne</strong> <strong>Pathogens</strong> (without regard to<br />

the use of personal protective clothing or equipment):<br />

TABLE 2<br />

Job Classifications for which ALL* employees Risk Occupational <strong>Exposure</strong><br />

Clinical Faculty<br />

Coach<br />

Custodian<br />

Job Classification<br />

Equipment Room Attendant<br />

First Responder (Lifeguards, Facility<br />

Supervisors)<br />

Grounds keeper<br />

School of Nursing<br />

Athletics<br />

Campus Recreation<br />

Campus Cleaning<br />

Meadow Brook Hall<br />

<strong>Oakland</strong> Center<br />

Residence Halls<br />

Athletics<br />

Campus Recreation<br />

Athletics<br />

Campus Recreation<br />

Grounds Maintenance<br />

Meadow Brook Hall<br />

Department(s)<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 3 of 19<br />

Revised April 2004


TABLE 2<br />

Job Classifications for which ALL* employees Risk Occupational <strong>Exposure</strong><br />

Job Classification<br />

Department(s)<br />

Laboratory Compliance Manager (OEHS)<br />

Nursing Laboratory Manager<br />

Child Care Worker/Teacher<br />

Medical Assistant<br />

Nurse Practitioner<br />

Nurse, Registered<br />

Phlebotomist/Venipuncturist<br />

Physician<br />

Plumber<br />

Police Officer<br />

Student Intern<br />

Trainer<br />

Vehicle Maintenance Personnel<br />

All Sci and Res Depts.<br />

School of Nursing<br />

Lowry Child Care Center<br />

Graham Health Center<br />

School of Health Sciences (Med Lab Sci and Exer Sci)<br />

Graham Health Center<br />

Mechanical Maintenance<br />

Residence Halls<br />

Police Department<br />

Health Sciences (Med Lab and Exercise Sciences)<br />

School of Education<br />

School of Nursing<br />

Athletics<br />

Campus Recreation<br />

Grounds Maintenance Department<br />

* regardless of whether part- or full-time, permanent or temporary<br />

Table 3 below identifies those OU job classifications for which SOME employees who hold<br />

those positions risk occupational exposure to <strong>Bloodborne</strong> <strong>Pathogens</strong> (and some may not),<br />

without regard to the use of personal protective clothing and equipment:<br />

TABLE 3<br />

Job Classifications for Which SOME Employees Risk Occupational <strong>Exposure</strong><br />

Job Classification<br />

Department<br />

Directors, Managers and Supervisors All Departments listed in Table 1 (Section 2.0)<br />

“Laboratory” Personnel<br />

[Includes Faculty, Instructors (adjunct,<br />

associate, part-time, temporary or visiting), Lab<br />

Technicians, Researchers, Research Assistants,<br />

Research Technicians, PIs, Graduate Assistants,<br />

and Graduate Students]<br />

Biological Sciences<br />

Chemistry<br />

Eye Research Institute<br />

Health Sciences (Med Lab Sci and Exercise Sci)<br />

Laboratory Animal Management Services<br />

Student Employees<br />

Athletics<br />

Campus Recreation<br />

Residence Halls<br />

All laboratory sciences listed in box above<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 4 of 19<br />

Revised April 2004


4.0 METHODS OF CONTROLLING EXPOSURE TO BBPS<br />

4.1 Universal Precautions: All OU employees will utilize “Universal Precautions”:<br />

guidelines developed by the Center for Disease <strong>Control</strong> wherein all human blood or other<br />

potentially infectious body fluids are treated as if known to be infectious. A copy of<br />

these Universal Precautions is included in the Appendices of this document.<br />

4.2 Work Practice <strong>Control</strong>s: In addition to personal protective equipment and engineering<br />

controls, “work practice controls” will be used to prevent or minimize exposure to<br />

bloodborne pathogens. These include the following:<br />

• Following tasks which present exposure to BBPs, hands are always washed with soap<br />

and water immediately after removing personal protective equipment.<br />

• Following an “exposure incident” (i.e., unprotected skin or mucous membrane<br />

contact with human blood or other potentially infectious materials, OPIM), the<br />

exposed area is washed with soap and water (or, in the case eyes, flushed with an<br />

eyewash) for 15 minutes.<br />

• Contaminated needles are never recapped, but are placed instantly into sharps safes<br />

• Eating, drinking, smoking, applying cosmetics or lip balm, and/or handling contact<br />

lenses are prohibited in work areas where there is a reasonable likelihood of<br />

occupational exposure.<br />

• Food and drink shall never be kept in/on refrigerators, freezers, shelves, cabinets,<br />

counter-tops or benches where human blood or other OPIM are present.<br />

• All procedures involving blood or OPIM shall be performed in a manner as to<br />

minimize splashing, spraying, splattering, and generation of droplets.<br />

• Mouth pipetting/suctioning of blood or OPIM is prohibited.<br />

4.3 Engineering <strong>Control</strong>s<br />

4.3.1 Regulatory Overview: As of the April 18, 2001 amendments to the OSHA <strong>Bloodborne</strong><br />

<strong>Pathogens</strong> Standard (revised in conformance with the requirements of the “Needlestick<br />

Safety and Prevention Act”), the term “Engineering controls” is defined as those<br />

“appropriate, commercially available, and effective controls which isolate or remove the<br />

bloodborne pathogens hazard from the workplace”. Examples provided in the Standard<br />

include the following: 1) devices designed to reduce the risk of percutaneous exposure to<br />

bloodborne pathogens, such as blunt suture needles and plastic or mylar-wrapped glass<br />

capillary tubes; 2) safer medical devices such as sharps with engineered sharps injury<br />

protection or needleless systems; and 3) approved sharps disposal containers.<br />

These amendments further require OU to solicit input its employees responsible for<br />

direct patient care in the identification, evaluation, and selection of engineering (and<br />

work practice) controls; annually update its BBP <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> to reflect the<br />

university has implemented any/all new developments in control technology; and<br />

establish and maintain a log of injuries from contaminated sharps (two types of log<br />

found in the Appendices of this document).<br />

4.3.2 Engineering and Personal Protective <strong>Control</strong>s used at OU: In accordance with the<br />

(original and more recent) engineering control requirements of the BBP Standard, and<br />

following several months of soliciting input from OU health care and lab research<br />

employees regarding selection of engineering controls, Table 4 below documents the<br />

specific tasks that present occupational exposure to BBPs on campus, and the associated<br />

engineering controls and personal protective equipment used in each unit on campus.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 5 of 19<br />

Revised April 2004


TABLE 4<br />

Tasks which May Present BBP <strong>Exposure</strong> and the PPE/Engineering Used to <strong>Control</strong><br />

(in alpha order by dept.)<br />

Department<br />

Tasks Which May Present<br />

Occupational <strong>Exposure</strong><br />

PPE and Engineering<br />

<strong>Control</strong>s Used<br />

Location of PPE and Engineering<br />

<strong>Control</strong>s<br />

Athletics<br />

First Aid, Lactate Testing, Uniform<br />

& towel handling/cleaning<br />

Sharps Safes, Gloves, Gggles,<br />

Biohaz bags/hampers.<br />

Training Room, Aquatic Operations<br />

Office, Equipment Room<br />

Biological Sciences<br />

Dissection of Human Eyes for<br />

Tissue Culture in 301 DHE, and<br />

Primary and SV40 Transformed<br />

Human Cells Lines used in Tissue<br />

Culture in 304B and 304C.<br />

Gloves, Masks, Goggles,<br />

Biohazard Bags and Hampers,<br />

Sharps Safes, Biohazard Signs<br />

(posted at entrances to labs),<br />

Biohazard Labels, Autoclave,<br />

and Lab coats<br />

Each and every laboratory that handles<br />

biohazardous agents contains these<br />

items (except for the autoclaves which<br />

are located centrally in 320 SEB and<br />

lab coats issued to employees)<br />

Campus Cleaning<br />

Restroom clean, trash removal, lab<br />

cleaning, GHC cleaning, cleaning<br />

up after injuries involving blood<br />

Gloves, Biohazard Bags/<br />

Hampers, Goggles, and Sharps<br />

Safes<br />

Campus Cleaning Supervisors’ Office,<br />

GHC, and Custodial Carts<br />

Campus Recreation<br />

First Aid, Lactate Testing, uniform<br />

& towel handling/cleaning, cleaning<br />

up after blood/OPIM incidents<br />

Gloves, Sharps Safes,<br />

Goggles, Biohazard<br />

Bags/Hampers<br />

Training Room, Aquatic Operations<br />

Office, Equipment Room<br />

Chemistry<br />

Purification of lymphocytes from<br />

blood of human volunteers in 208<br />

and 210 SEB.<br />

Gloves, Goggles, Sharps<br />

Safes, Gloved Laminar Flow<br />

Hood, Lab Coats, biohazard<br />

bags/boxes<br />

208 and 210 SEB (laminar flow hood<br />

in 210 SEB)<br />

Education, School of<br />

Student Interns assist with child<br />

injuries (e.g., first aid/CPR)<br />

As appropriate based on<br />

judgements of Host Facilities<br />

Host Facilities supply onsite<br />

Eye Research Institute<br />

Dissection of Human Eye Tissue<br />

and Culture in 427 DHE and<br />

Processing of Human Eye Tissue<br />

Cells in Room 419 DHE.<br />

Gloves, Goggles, Biosafety<br />

Cabinet, Biohazard<br />

Bags/Hampers, Biohazard<br />

Signs (posted at entrances to<br />

labs), Biohazard Labels<br />

Every laboratory that handles<br />

biohazardous agents contains these<br />

items<br />

Graham Health Center<br />

Drawing Blood, Handling Lab<br />

Specimens (e.g., blood, urine, etc.),<br />

Minor Office Surgeries, Office<br />

Procedures, Cleaning exam/trt rms.<br />

“BD Eclipse” blood collection<br />

needles”, Gloves, Masks,<br />

Sharps Safes, Biohazard<br />

Bags/Hampers, Goggles, Lab<br />

Coats, Gowns<br />

Exam/Treatment Rooms<br />

Grounds Maintenance<br />

-----------------------------<br />

Vehicle Maintenance<br />

Litter Pick-up, Trash Container Bag<br />

Removal, Trash Removal/<br />

--------------------------------------------<br />

Cleaning vehicles contaminated<br />

with blood or OPIM<br />

Gloves and Hand-held litter<br />

tool, Biohazard Bags/Hampers<br />

-------------------------------------<br />

Gloves, goggles<br />

BGM Building<br />

Health Sciences -<br />

Exercise Science<br />

CPR/First Aid performed by Student<br />

Interns at Host Facilities;<br />

venipuncture and finger-sticks<br />

performed in rm 207 HHS or<br />

occasionally in the field<br />

Hosts deem appropriate PPE<br />

for interns; PPE for VeniPunc<br />

includes “BD Eclipse” blood<br />

collection needles, gloves,<br />

sharp safes, goggles, lab coats<br />

and biohaz bags/hampers<br />

Host Facilities supply PPE onsite for<br />

interns; on-site PPE for venipuncture<br />

located in Room 207 HHS, or taken to<br />

field sites where tasks are being<br />

performed<br />

Health Sciences -<br />

Medical Laboratory<br />

Sciences<br />

Phlebotomy Instruction,<br />

Hematology Instruction, Clinical<br />

Analysis (instructional purposes),<br />

Washing lab glassware,<br />

Venipuncture and Urinalysis<br />

“BD Eclipse” blood collection<br />

needles, Gloves, Wrap-around<br />

Goggles, Biohazard<br />

Bags/Hampers, Biohazard<br />

Labels, Lab coats<br />

Phlebotomy Classrooms and carts, 310<br />

HHS and 373 HHS, and Lab coats<br />

issued to employees<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 6 of 19<br />

Revised April 2004


Department<br />

TABLE 4<br />

Tasks which May Present BBP <strong>Exposure</strong> and the PPE/Engineering Used to <strong>Control</strong><br />

(in alpha order by dept.)<br />

Tasks Which May Present<br />

Occupational <strong>Exposure</strong><br />

PPE and Engineering<br />

<strong>Control</strong>s Used<br />

Location of PPE and Engineering<br />

<strong>Control</strong>s<br />

Laboratory Animal<br />

Management Services<br />

(LAMS)<br />

Assisting med personnel using<br />

sharps (including surgery), handling<br />

infectious animals<br />

Gloves, Masks, Goggles,<br />

Biohazard Bags and Hampers,<br />

Sharps Safes, Biohazard Signs<br />

(posted at entrances to labs),<br />

Biohazard Labels, Autoclave,<br />

Bleach/Ethanol (for wiping<br />

down BSC2), and Lab coats<br />

Biomedical Research Support Facility<br />

Lowry Early Childhood<br />

Center<br />

First Aid, CPR, cleaning up blood,<br />

injections, and bites.<br />

Gloves, CPR Masks, Goggles,<br />

Biohazard Bags & Hampers,<br />

and Sharps Safes.<br />

Kitchen and Custodial Closet<br />

Meadow Brook Hall<br />

Cleaning Restrooms, Emptying<br />

Trash, Groundskeeping<br />

Gloves, Goggles, Sharps<br />

Safes, Biohazard<br />

Bags/Hampers<br />

Telephone Supply Room at MBH<br />

Mechanical Maint<br />

Plumbing and pipefitting in high<br />

risk areas (e.g., & restrms and labs)<br />

Gloves, Goggles<br />

Police and Support Services Bldg<br />

Nursing, School of<br />

Clinical Instruct and Patient care at<br />

off-site health care facilities<br />

Provided by off-site facilities<br />

Off-site<br />

<strong>Oakland</strong> Center<br />

Restroom clean, trash removal,<br />

Cleaning up after injuries involving<br />

blood, Trash Compaction<br />

Gloves, Masks, Goggles,<br />

Bleach, Biohazard<br />

Bags/Hampers, Sharps Safes<br />

OC Maintenance Shop and each<br />

custodial cart (except for hampers<br />

which are maintained in Shop)<br />

Police Department<br />

Accident Investigation, Treating<br />

Injured Persons, Processing Injured<br />

Victims or Injured Suspects, Subject<br />

or Vehicle Searches, Crime Scene<br />

Investigations, Evidence Processing,<br />

CPR/First Aid, Apprehending<br />

Suspects in High Risk Grps who are<br />

Resisting Arrest, Delivering Babies,<br />

Crowd <strong>Control</strong><br />

Gloves, Masks, Goggles,<br />

Biohazard Bags/Hampers,<br />

Sharps Safes, Biohazard<br />

Labels/Signs, CPR masks<br />

(with valves)<br />

Police Station and all Officer/Patrol<br />

Units have all of these items (except<br />

for biohazard labels and hampers,<br />

which are only located in the Station)<br />

Residence Halls Clean<br />

and Maintenance<br />

Trash Removal, Restroom Cleaning,<br />

Cleaning up after Injuries Involving<br />

Blood, Plumbing in high risk areas<br />

(e.g., & restrms and labs)<br />

Gloves, Biohazard Bags/<br />

Hampers, Goggles, Sharps<br />

Safes<br />

Custodial Carts and assigned rooms<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

Page 7 of 19<br />

Revised April 2004


4.3.3 Rules Governing Engineering <strong>Control</strong>s and Personal Protective Equipment<br />

4.3.3.1 Selection: These responsible persons listed in Table 1 (Section 2.0) are required to<br />

consult with their staffs to identify what engineering controls and personal protection<br />

equipment are necessary on an ongoing basis through employee communication,<br />

observation and annual EH&S training sessions. EH&S will also help to ensure effective<br />

implementation of these recommendations.<br />

4.3.3.2 Maintenance: Sharps disposal containers are inspected, maintained and replaced by the<br />

responsible persons identified in Table 1 (Section 2.0) as needed to prevent overfilling.<br />

4.3.3.3 Training: Training in the use of the appropriate PPE for the tasks or procedures<br />

employees will perform is provided by the responsible persons (or their designees)<br />

identified in Table 1 (Section 2.0).<br />

4.3.3.4 All employees using PPE are required to observe the following precautions:<br />

• Wash hands immediately or as soon as feasible after removal of gloves or other PPE<br />

• Remove PPE after it becomes contaminated, and before leaving the work area<br />

• Used PPE may be disposed of in the red biohazard bags available in each department<br />

• Wear appropriate gloves when it can be reasonably anticipated that there may be hand<br />

contact with blood or OPIM, and when handling or touching contaminated items or<br />

surfaces; replace gloves if torn, punctured, contaminated, or if their ability to function<br />

as a barrier is compromised<br />

• Utility gloves may be decontaminated for reuse if their integrity is not compromised;<br />

discard utility gloves if they are cracking, peeling, tearing, puncturing, or deterioration<br />

• Never wash or decontaminate disposable gloves for reuse<br />

• Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets<br />

of blood or OPIM pose a hazard to the eye, nose, or mouth<br />

• Remove immediately or as soon as feasible any garment contaminated by blood or<br />

OPIM, in such a way as to avoid contact with the outer surface<br />

4.3.3.5 Exceptions to Use: If an employee decides against using personal protective equipment<br />

under rare and extraordinary circumstances (e.g., would have prevented delivery of health<br />

care or public safety services, or would have posed increased hazard to safety of<br />

employee), the employee is required to complete a PPE Use Exception Form (found in<br />

the Appendices of this document) and submit it to his/her supervisor. This form is then<br />

carefully reviewed by the employee, his/her supervisor, and the Office of EH&S to<br />

determine whether changes could be instituted to prevent such occurrences in the future.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


5.0 Biohazardous Waste<br />

5.1 Contaminated sharps are managed as follows:<br />

• Broken glassware which may be contaminated is picked up using mechanical means,<br />

such as a brush and dust pan.<br />

• All contaminated sharps are discarded immediately or as soon as possible into “Sharps<br />

Safes”, which are available in the locations identified in Table 4 (of this Section 5.0).<br />

5.2 Contaminated laundry is managed as follows:<br />

• Sent out to those laundry facilities in the area willing and able to handle Biohazardous<br />

laundry. The Graham Health Center or EH&S can provide the name(s) of current<br />

facilities who perform this function.<br />

• Placed in leak-proof, labeled or color-coded containers before transport. Biohazard<br />

bags and hampers are available in the locations identified in Table 4.<br />

• Handled as little as possible by OU employees, and never taken home for laundering.<br />

5.3 Biohazard Bags, Hampers and Sharps Safes containing biohazardous waste are...<br />

• Maintained upright at all times<br />

• Replaced routinely and not overfilled, and<br />

• Closed prior to removal to prevent spillage or protrusion of contents during handling<br />

• Transported to the Office of EH&S when full as follows:<br />

o An "OU Medical Waste Internal Tracking Form" (Print Shop - order<br />

#001623) shall be completed for each "drop-off" (regardless of the number of<br />

containers), and brought (with the waste) to the Office of Environmental<br />

Health and Safety, in the Graham Health Center.<br />

o An individual from the Office of Environmental Health and Safety will review<br />

the manifest, keep two copies, and issue the bearer a key to the Phoenix Cage<br />

(located in the basement of the Graham Health Center).<br />

o At the time of drop-off, departments may also pick up empty biohazard<br />

hampers and/or bags from the Phoenix Cage as needed. The Biohazard<br />

hampers and bags are available at no charge; sharp safes can be ordered from<br />

most custodial/safety suppliers.<br />

o Once every two weeks, Stericycycle® shall remove the hampers/sharp safes<br />

from the Phoenix Cage, and transport them first to the BFI Medical Treatment<br />

Center in Toledo, Ohio (for high-temperature decontamination), and then to<br />

the Vienna Junction Sanitary Landfill, in Erie Michigan, for land disposal as<br />

non-hazardous waste.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


6.0 CONTAMINATED EQUIPMENT<br />

Responsible persons identified in Table 1 (Section 2.0) will ensure warning labels are affixed to,<br />

or red bags are used for, all biohazardous waste and/or contaminated equipment. If labels are<br />

not available in the department, the responsible person may contact the Office of Environmental<br />

Health and Safety for assistance in obtaining one.<br />

Employees are to notify their supervisors and/or the Office of Environmental Health and Safety<br />

if they discover regulated waste containers, refrigerators containing blood or OPIM,<br />

contaminated equipment, etc. without proper biohazard labels.<br />

7.0 CLEANING UP SPILLS<br />

7.1 Washable Surfaces: Contaminated equipment, floors, surrounding surfaces etc. shall be<br />

cleaned up (in such a manner that spreading, splashing, etc. the material is prevented)<br />

while wearing gloves and goggles, and using a ratio of ¼⎟2½ cups of bleach for every 1<br />

gallon of water, allowing10 minutes for disinfection to occur; after which any/all<br />

contaminated waste is placed in the proper biohazard receptacles. Broken glassware<br />

must be picked up using mechanical devices ONLY such as brush/dust pan, tongs,<br />

forceps, etc.<br />

7.2 Non-Washable Surfaces (e.g., carpets): Sanitary absorbent agents shall be used (e.g.,<br />

“Zgoop”), let dry, and area vacuumed. Germicidal carpet shampoo is then applied and<br />

the area vacuumed again. Broken glassware must be picked up using mechanical devices<br />

ONLY such as brush/dust pan, tongs, forceps, etc.<br />

8.0 HEPATITIS B VACCINATION<br />

Included in new employee and annual refresher BBP exposure control training will be<br />

comprehensive information regarding hepatitis B vaccinations, including its safety, benefits,<br />

efficacy, methods of administration, and availability at no cost to the employees. Training in this<br />

regard includes, but is not limited to, the following information:<br />

8.1 Pre-<strong>Exposure</strong> Vaccinations: The hepatitis B vaccination series shall be made available<br />

at no cost to all “eligible” employees in Tables 2 and 3 (i.e.,those employees for whom<br />

exposure to BBPs is a primary function of their job descriptions ), after training and<br />

within 10 days of initial assignment.<br />

8.1.1 Contraindications to Vaccination: Vaccinations are encouraged unless:<br />

1) documentation exists that the employee has previously received the series, 2) antibody<br />

testing (i.e., a “titer”) reveals that the employee is immune, or 3) medical evaluation<br />

shows that the vaccination is contraindicated.<br />

8.1.2 Declining the Vaccination: If an employee chooses to decline vaccination, the<br />

employee must sign a “Hepatitis B Declination Form” (blank form found in the<br />

Appendices of this document). Employees who decline may request and obtain the<br />

vaccination at a later date at no cost to themselves (assuming their occupational<br />

responsibilities continue to present risk of exposure). Declination Forms are kept in the<br />

OEHS. Vaccinations are provided at OU’s Graham Health Center or the employee’s<br />

facility of choice.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


8.1.3 Health Care Professional Written Opinion: Prior to vaccination, the Health Care<br />

Professional shall provide a written opinion, indicating that (based on consultation) the<br />

employee presents no medical contra-indications to vaccination.<br />

8.2 Post-<strong>Exposure</strong> Vaccinations: For those employees for whom exposure to BBPs<br />

(generally via first-aid/CPR activities) is a collateral function of their job descriptions<br />

(e.g., coaches, trainers, day care professionals, etc.), the hepatitis B vaccination is not<br />

offered free of charge until AFTER these employees are involved in an incident where<br />

human blood or OPIM is present (regardless of whether an exposure incident occurred);<br />

these vaccinations are highly effective if administered within 1 to 7 days of the incident.<br />

9.0 EXPOSURE INCIDENT RESPONSE AND FOLLOW-UP<br />

9.1 <strong>Exposure</strong> incident - First Response<br />

Should an “exposure incident” occur (i.e., unprotected skin, eye or mucous membrane<br />

contact human blood or OPIM), the employee shall contact the responsible person<br />

identified in Table 1 (Section 2.0) from his/her department and/or the Officeof EH&S.<br />

Following IMMEDIATE first aid (cleaning the wound with soap and water, flushing eyes<br />

or other mucous membrane for 15 minutes), this person shall perform the following<br />

activities:<br />

• Ensure that employee goes to a hospital emergency room WITHIN 2 hours of the<br />

incident in order to obtain anti-viral drugs and baseline blood testing. NOTE: If the<br />

employee does not give consent for HIV serological testing during collection of blood<br />

for baseline testing, the baseline blood sample must be preserved for ∃ 90 days; if the<br />

exposed employee elects to have the baseline sample tested during this waiting<br />

period, testing shall be performed ASAP.<br />

• Ensure that, when it is convenient and reasonable, employee documents several<br />

pieces of critical information (preferably in time to show to treating physician), using<br />

OU’s <strong>Exposure</strong> Incident Report Form (found in the Appendices of this Document).<br />

This <strong>Exposure</strong> Incident Report Form requests the following information (and shall<br />

also be used by the Office of Environmental Health and Safety to evaluate the<br />

circumstances of the incident, generate ideas for prevention, modify the ECP, etc.):<br />

o engineering controls in use at the time<br />

o work practices followed<br />

o a description of the activity that preceded the exposure incident<br />

o protective equipment or clothing that was used at the time of the incident<br />

o location of the incident<br />

o procedure being performed when the incident occurred<br />

o route of exposure<br />

• Identify and document the source individual (unless the employer can establish that<br />

identification is infeasible or prohibited by state or local law).<br />

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Revised April 2004


• Obtain consent (using a consent form found in the Appendices of this document) and<br />

make arrangements to have the source individual tested as soon as possible to<br />

determine HIV, HCV, and HBV infectivity; and document that the source individual's<br />

test results were conveyed to the employee's health care provider.<br />

• Ensure that the exposed employee is provided with the source individual's test results<br />

and with information about applicable disclosure laws and regulations concerning the<br />

identity and infectious status of the source individual (e.g., confidentiality laws).<br />

9.2 Post-<strong>Exposure</strong> Evaluation and Follow-up<br />

9.2.1 Supervisory Responsibilities: Responsible persons identified in Table 1 (Section 2.0)<br />

are required to ensure that any/all health care professionals responsible for follow-up care<br />

(following an exposure incident and initial testing/treatment) are provided:<br />

• A copy of the (completed) <strong>Exposure</strong> Incident Report Form;<br />

• A copy of OSHA’s <strong>Bloodborne</strong> <strong>Pathogens</strong> Standard;<br />

• Results of the source individual's blood test (when possible); and<br />

• Relevant employee medical records, including vaccination status.<br />

9.2.2 Written Opinions: The employee should then receive a copy of Health Care<br />

Professional(s) written opinion within 15 days after completion of the evaluation.<br />

9.2.3 Follow-up Care: Any/all follow-up testing, treatment, counseling, etc. shall be funded<br />

by <strong>Oakland</strong> <strong>University</strong> (department); employees shall bear none of the cost whatsoever.<br />

10.0 EMPLOYEE TRAINING<br />

10.1 When and How Often: All employees who have occupational exposure to bloodborne<br />

pathogens receive training before they conduct any activities which could pose exposure<br />

to BBPs, and annually thereafter.<br />

10.2 Who Conducts Training: BBP <strong>Exposure</strong> <strong>Control</strong> Training for new employees and<br />

annual refresher training is conducted by responsible persons identified in Table 1<br />

(Section 2.0) or a qualified designee(s). These “trainers” were all trained and examined<br />

by representatives of Environmental Health and Safety (or a qualified designee), and<br />

have had a reasonable amount of hands-on experience understanding, applying and<br />

implementing the OSHA BBP Standard.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


10.3 Elements of Training: Included in the training is/are the epidemiology, symptoms, and<br />

transmission of bloodborne pathogen diseases. In addition, the training program covers,<br />

at a minimum, the following elements:<br />

• copy and explanation of the standard<br />

• detailed information on HBV, HCV and HIV (signs, symptoms, treatments, etc.)<br />

• explanation of OU’s ECP and how to obtain a copy<br />

• explanation of methods to recognize tasks and other activities that may involve<br />

exposure to blood and OPIM, including what constitutes an exposure incident<br />

• explanation of the use/limitations of engineering controls, work practices and PPE<br />

• explanation of the types, uses, location, removal, handling, decontamination, and<br />

disposal of PPE<br />

• explanation of the basis for PPE selection<br />

• information on the hepatitis B vaccine, including information on its efficacy, safety,<br />

method of administration, benefits of being vaccinated, and that the vaccine will be<br />

offered free of charge<br />

• information on the appropriate actions to take and persons to contact in an emergency<br />

involving blood or OPIM<br />

• explanation of the procedure to follow if an exposure incident occurs<br />

• information on the post-exposure evaluation and follow-up that the employer is<br />

required to provide for the employee following an exposure incident<br />

• explanation of signs, labels and color coding required by the standard and used at OU<br />

• an opportunity for interactive questions and answers with the trainer.<br />

11.0 RECORD KEEPING<br />

11.1 Training Records: Training records are completed for each employee upon completion<br />

of training. These documents will be kept for at least three years in the Office of<br />

Environmental Health and Safety. Training records include for each employee a<br />

Declaration Form which documents the following:<br />

• the employee name<br />

• the date of the training sessions<br />

• the contents or a summary of the training sessions<br />

• the name and qualifications of persons conducting the training<br />

• whether the employee accepted or declined the Hep B vaccination (separate Hep B<br />

Declination Form provided to all who decline).<br />

Employee training records are provided upon request to the employee or the employee's<br />

authorized representative within 15 working days. Such requests should be addressed to<br />

the Office of Environmental Health and Safety.<br />

11.2 Medical Records: Medical records are maintained for each employee with occupational<br />

exposure in accordance with 29 CFR 1910.20, "Access to Employee <strong>Exposure</strong> and<br />

Medical Records." OU’s Human Resources Department is responsible for maintenance of<br />

the required medical records for at least the duration of employment plus 30 years.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


11.3 <strong>Exposure</strong> Incident Evaluation Records: Once an exposure incident (and the associated<br />

<strong>Exposure</strong> Incident Report Form) has been evaluated, and any Program modifications put<br />

into place, these records are maintained in the Office of Environmental Health and<br />

Safety.<br />

12.0 CONDITIONS FOR LABS WORKING WITH HIV AND HEPATITIS VIRUSES<br />

12.1 Working in HIV and Hepatitis Virus "production facilities".<br />

"Production facility" is defined by OSHA as a facility engaged in industrial-scale, largevolume<br />

or high concentration production of HIV or Hepatitis Viruses. These activities<br />

are not currently (as of this July 2000 printing) permitted at OU.<br />

12.2 Working in HIV and Hepatitis Virus “Research Laboratories” (i.e., laboratories “engaged<br />

in the culture, production, concentration, experimentation and manipulation of HIV or<br />

Hepatitis Viruses”. Does NOT apply to clinical or diagnostic laboratories engaged solely<br />

in the analysis of blood, tissues or organs).<br />

12.2.1 Minimum Requirements for laboratories engaging in HIV or Hepatitis Virus Research<br />

• Each laboratory shall contain a facility for hand washing and an eye wash facility<br />

which is readily available within the work area.<br />

• An autoclave for decontamination of regulated waste shall be available.<br />

• All regulated waste shall either be incinerated or decontaminated by a method such as<br />

autoclaving known to effectively destroy bloodborne pathogens.<br />

12.2.2 Special Practices<br />

• Lab doors shall be kept closed when work involving HIV, HBV or HCV is in progress.<br />

• Contaminated materials that are to be decontaminated at a site away from the work<br />

area shall be placed in a durable, leakproof, labeled or color-coded container that is<br />

closed before being removed form the work area.<br />

• Access to the work area shall be limited to authorized persons. Written policies and<br />

procedures shall be established whereby only persons who have been advised of the<br />

potential biohazard, who meet any specific entry requirements, and who comply with<br />

all entry and exit procedures shall be allowed to enter the work areas.<br />

• When other potentially infectious materials or infected animals are present in the work<br />

area or containment module, a hazard warning sign incorporating the universal<br />

biohazard symbol shall be posted on all access doors.<br />

• All activities involving other potentially infectious materials shall be conducted in<br />

biological safety cabinets or other physical-containment devices within the<br />

containment module; never on the open bench.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


• Laboratory coats, gown, smocks, uniforms, or other appropriate protective clothing<br />

shall be used in the work area and animals rooms. Protective clothing shall not be<br />

worn outside of the work area and shall be decontaminated before being laundered.<br />

• Special care shall be taken to avoid skin or mucous membrane contact with other<br />

potentially infectious materials - Use gloves and goggles.<br />

• Before disposal, all waste from work areas and from animals rooms shall be<br />

decontaminated by a method, e.g., autoclaving, known to effectively destroy BBPs.<br />

• Vacuum lines shall be protected with liquid disinfectant traps and high efficiency<br />

particulate air (HEPA) filters or filters of equivalent or superior efficiency and which<br />

are checked routinely and maintained or replaced as necessary.<br />

• Hypodermic needles and syringes shall be used only for parenteral injection and<br />

aspiration of fluids from laboratory animals and diaphragm bottles. Only needlelocking<br />

syringes or disposable syringe-needle units shall be used for the injection or<br />

aspiration of other potentially infectious materials.<br />

• Extreme caution shall be used when handling needles and syringes. A needle shall not<br />

be bent, sheared, replaced in the sheath or guard, or removed from the syringe<br />

following use. The needle and syringe shall be promptly placed in a puncture-resistant<br />

container and autoclaved or decontaminated before reuse or disposal.<br />

• All spills shall be immediately contained and cleaned up by professional staff properly<br />

trained/equipped to handle potentially concentrated infectious materials.<br />

• A spill or accident that results in an exposure incident shall be immediately reported to<br />

the laboratory director or other responsible person.<br />

• Employees are required to reference the <strong>Oakland</strong> <strong>University</strong> Biosafety Manual for<br />

instructions on practices and procedures for work with HIV or Hepatitis viruses, and<br />

follow these procedures. Additionally, an application for use with any infectious<br />

agents (excluding clinical or diagnostic laboratories engaged solely in the analysis of<br />

blood, tissues or organs) must be submitted to the <strong>Oakland</strong> <strong>University</strong> Biosafety<br />

Committee; and activities may not commence until the Committee has approved the<br />

research activities in writing.<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP<br />

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Revised April 2004


12.2.3 Signs<br />

The PI or laboratory supervisor shall complete and post the following sign(s) (available<br />

in the Office of EH&S) at the entrance to all HIV and/or Hepatitis virus research labs:<br />

12.2.4 Containment Equipment<br />

• Certified biological safety cabinets (Class I, II, or III) or other appropriate<br />

combinations of personal protection or physical containment devices, such as special<br />

protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and<br />

containment caging for animals, shall be used for all activities with OPIM that pose a<br />

threat of exposure to droplets, splashes, spills or aerosols.<br />

• Biological safety cabinets shall be certified upon installation, whenever they are<br />

moved and at least annually.<br />

12.2.5 Training Requirements.<br />

• Additional initial training for employees in HIV, HBV or HBC research laboratories<br />

shall receive the following initial training in addition to the general training described<br />

in Section 11.0.<br />

• Employees must demonstrate proficiency in standard microbiological practices and<br />

techniques and operations specific to the facility before being allowed to work with<br />

HIV, HBV or HBC.<br />

• Employees must have prior experience in the handling of human pathogens or tissue<br />

cultures before working with HIV, HBV or HCV, or ...<br />

• Employees (through their supervisors, the OEHS or the OGCSR) must arrange for a<br />

training program if/when they have no prior experience in handling human pathogens.<br />

Initial work activities shall not include the handling of infectious agents. A<br />

progression of work activities shall be assigned as techniques are learned and<br />

proficiency is developed. Employees may not participate in work activities involving<br />

infectious agents until proficiency has been demonstrated.


APPENDICES<br />

BLANK FORMS:<br />

• Sharps Injury Log (Type I for Non-Laboratories)<br />

• Sharps Injury Log (Type II for Laboratories)<br />

• Training and Hep B Declaration Form<br />

• Hep B Declination Form<br />

• Hepatitis B Vaccination - Status Form<br />

• <strong>Exposure</strong> Incident Report Form<br />

• Post-<strong>Exposure</strong> Incident Checklist<br />

• Sharps Injury Log (Type I)<br />

• Sharps Injury Log (Type II)<br />

• Blood Draw Consensus Form - Source Individual<br />

• PPE Exception Form<br />

• Research Activities Involving Direct Manipulation of <strong>Bloodborne</strong> <strong>Pathogens</strong> - Report<br />

Form<br />

COMPLETED FORMS (WHERE APPLICABLE - DEPT. SPECIFIC):<br />

• Pre-exposure Hepatitis B Vaccination - Status Form<br />

• Completed Hepatitis B Declaration/Declination Forms<br />

• <strong>Exposure</strong> Incident Report Form<br />

• Post-<strong>Exposure</strong> Incident Checklist<br />

• Blood Draw Consensus Form - Source Individual<br />

• PPE Exception Form<br />

• Research Activities Involving Direct Manipulation of <strong>Bloodborne</strong> <strong>Pathogens</strong> - Report<br />

Form<br />

UNIVERSAL PRECAUTIONS<br />

OSHA BLOODBORNE PATHOGENS STANDARD<br />

<strong>Oakland</strong> <strong>University</strong> BBP ECP Revised April 2004


<strong>Oakland</strong> <strong>University</strong><br />

Graham Health Center<br />

Sharps Injury Log<br />

Page _____<br />

Date of<br />

Incident<br />

Name of Injured<br />

Job Title of<br />

Injured<br />

Type of Needle<br />

Involved<br />

Describe how<br />

Needle stick<br />

Occurred<br />

Steps taken<br />

Immediately<br />

After Stick<br />

Steps taken to<br />

Avoid Future<br />

Needle sticks


Training Date<br />

BBP TRAINING AND HBV VACCINATION DECLARATION FORM<br />

<strong>Oakland</strong> <strong>University</strong><br />

Department ____________________________________<br />

Name Job Classification __________________________<br />

TRAINING: I hereby certify that I have received training in bloodborne pathogens exposure control. This<br />

training included providing me a copy of the BBP <strong>Exposure</strong> <strong>Control</strong> Standard, and an explanation of the<br />

following: OU’s <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> and how to obtain a copy; details regarding transmission, signs, symptoms<br />

and prognoses of common BBP viruses (i.e., HBV, HCV and HIV); common methods to recognize tasks and other<br />

activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident, the use<br />

and limitations of engineering controls, work practices and personal protective equipment (PPE); the types, uses,<br />

location, removal, handling, decontamination and disposal of PPE; the basis for PPE selection; the hepatitis b<br />

vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated,<br />

and that the vaccine is offered free of charge under certain circumstances; the appropriate actions to take and<br />

persons to contact in an emergency involving blood or OPIM; the procedure to follow if an exposure incident<br />

occurs, including the method of reporting the incident and the medical follow-up that will be made available;<br />

information on the post-exposure evaluation and follow-up that OU is required to provide me following an<br />

exposure incident; the signs and labels and/or color-coding required by the BBP Standard and OU. I further<br />

certify that I was provided ample opportunity for interactive questions and answers with the person(s)<br />

conducting the training session.<br />

The training was provided to me by “qualified” personnel as follows: General information regarding BBP<br />

viruses and exposure control was provided to me by OU’s Office of Environmental Health and Safety, either in<br />

person or via a handout generated by the Officeof EH&S and provided me by my supervisor. This EH&S training<br />

staff has had extensive formal training in, and experience with, interpreting and implementing the BBP Standard,<br />

and designing and providing training in this area. Site-specific information, regarding BBP exposure control in my<br />

department as it relates to the occupational activities I perform, was subsequently provided me by my supervisor<br />

(who received his/her guidance, training and handouts directly from the Office of EH&S).<br />

HEPATITIS B VACCINATION: While the HBV vaccine is well tolerated by most people, and provides<br />

significant protection against acquiring HBV-related illnesses, vaccination has some inherent risks (including, but<br />

not limited to, swelling, reddening, post injection soreness, body fatigue, headache, muscle or joint soreness), as<br />

well as some medical contra-indications (including, but not limited to, high blood pressure, allergies to yeast/mold,<br />

pregnancy), so I understand that my health care professional (in conference with myself) shall decide and document<br />

whether it is safe for me to obtain the HBV vaccination.<br />

I have read each option below and understand each of them. I have selected ONE option by placing a Τ. I also<br />

understand that I may change my mind at any time. Finally, if I select Option 2. below, I understand that I<br />

must also complete a SEPARATE Hepatitis b Declination form.<br />

1. ______ I would like to have OU pay for my HBV vaccination series; I understand that MIOSHA requires me<br />

to begin the immunization process within 10 calendar days of accepting this vaccination.<br />

2. ______I decline to have OU pay for my HBV vaccinations because (place a Τ in appropriate blank below).<br />

________ a) I have already been immunized;<br />

OR<br />

________ b) I would like OU to pay for the antibody test (i.e., “titer”) performed before deciding;<br />

OR<br />

________ c) cost of said immunization is 100% funded by another source (e.g., medical insurance); OR<br />

I understand that if I select this Option, I must also complete a separate Hepatitis B Declination Form<br />

_<br />

3. _____ Based on my OU job classification (identified above), my “PRIMARY” occupational duties do not<br />

present “reasonably anticipated exposure to blood or OPIM”, and I am therefore not eligible to receive “preexposure”<br />

hepatitis b vaccination funding. I understand, however, that should I be involved in any<br />

occupational incident that involves human blood or OPIM (regardless of whether “exposure” occurs), I am<br />

then eligible to receive (at no cost) an accelerated series of hepatitis b vaccinations, which should begin<br />

within 24 hours, but up to 7 calendar days, after the incident. Note: Those who are required, encouraged<br />

and/or allowed to provide first-aid on campus as a “collateral” job responsibility (for example, athletic<br />

coaches) would select this Option.<br />

SIGNED:<br />

DATE: ______________<br />

[Requires signature of Legal Guardian if under age 18 - print words “legal guardian” next to signature if applicable]


BBP TRAINING AND HBV VACCINATION DECLARATION FORM<br />

<strong>Oakland</strong> <strong>University</strong> - School of Nursing<br />

Training Date Name __________________________________<br />

TRAINING: I hereby certify that I have received training in bloodborne pathogens exposure control. This training included<br />

providing me a copy of the BBP <strong>Exposure</strong> <strong>Control</strong> Standard, and an explanation of the following: OU’s <strong>Exposure</strong> <strong>Control</strong><br />

<strong>Plan</strong> and how to obtain a copy; details regarding transmission, signs, symptoms and prognoses of common BBP viruses (i.e.,<br />

HBV, HCV and HIV); common methods to recognize tasks and other activities that may involve exposure to blood and OPIM,<br />

including what constitutes an exposure incident, the use and limitations of engineering controls, work practices and personal<br />

protective equipment (PPE); the types, uses, location, removal, handling, decontamination and disposal of PPE; the basis for<br />

PPE selection; the hepatitis b vaccine, including information on its efficacy, safety, method of administration, the benefits of<br />

being vaccinated, and that the vaccine is offered free of charge under certain circumstances; the appropriate actions to take and<br />

persons to contact in an emergency involving blood or OPIM; the procedure to follow if an exposure incident occurs, including<br />

the method of reporting the incident and the medical follow-up that will be made available; information on the post-exposure<br />

evaluation and follow-up that OU is required to provide me following an exposure incident; the signs and labels and/or colorcoding<br />

required by the BBP Standard and OU. I further certify that I was provided ample opportunity for interactive questions<br />

and answers with the person(s) conducting the training session.<br />

The training was provided to me by “qualified” personnel as follows: General information regarding the BBP <strong>Exposure</strong><br />

<strong>Control</strong> Standard, transmission and signs/symptoms of common BBP Viruses (e.g., HBV, HCV and HIV) was provided to me by<br />

either in person, and/or via live instruction, video-tape, or handout, by a Nursing Department faculty member (in conjunction<br />

with OU’s Office of Environmental Health and Safety). The Office of EH&S training staff has had extensive formal training in,<br />

and experience with, interpreting and implementing the BBP Standard; likewise Nursing Department faculty members, based on<br />

the nature of their nursing educations, are naturally well versed in BBP <strong>Exposure</strong> <strong>Control</strong>s. I further understand that the<br />

responsibility for site-specific training (as it relates to the actual duties I perform at my site(s) of employment) is/was the<br />

responsibility of similarly qualified nursing administrators/supervisors at the facilities at which I perform these duties.<br />

HEPATITIS B VACCINATION: While the HBV vaccine is well tolerated by most people, and provides significant protection<br />

against acquiring HBV-related illnesses, vaccination has some inherent risks (including, but not limited to, swelling, reddening,<br />

post injection soreness, body fatigue, headache, muscle or joint soreness), as well as some medical contra-indications (including,<br />

but not limited to, high blood pressure, allergies to yeast/mold, pregnancy), so I understand that my health care professional (in<br />

conference with myself) shall decide and document whether it is safe for me to obtain the HBV vaccination.<br />

I have read each option below and understand each of them. I have selected ONE option by placing a Τ. I also understand that<br />

I may change my mind at any time. Finally, if I select Option 2. below, I understand that I must also complete a<br />

SEPARATE “Hepatitis b Declination Form”.<br />

1. ____I would like to have OU pay for my HBV vaccination series; I understand that MIOSHA requires me to begin the<br />

immunization process within 10 calendar days of accepting this vaccination series.<br />

2. _____I decline to have OU pay for my HBV vaccinations because (place a Τ in appropriate blank below).<br />

_____ a) I have already been immunized; OR<br />

_____ b) I would like OU to pay for the antibody test (i.e., “titer”) performed before deciding; OR<br />

_____ c) cost of said immunization is 100% funded by another source (e.g., medical insurance); OR<br />

_____ d) personal reasons<br />

I understand that if I select Option 2., I must also complete a separate Hepatitis B Declination Form:<br />

3. ______Based on my OU job classification (identified below), my occupational duties do not present “reasonably anticipated<br />

exposure to blood or OPIM”, and I am therefore not eligible to receive “pre-exposure” hepatitis b vaccination funding. I<br />

understand, however, that should I be involved in any occupational incident that involves human blood or OPIM (regardless<br />

of whether “exposure” occurs), I am then eligible to receive an accelerated series of hepatitis b vaccinations, which should<br />

begin within 24 hours (but up to 7 days) after the incident.<br />

SIGNED:<br />

Job Classification [PLEASE CHECK ONE]:<br />

_____ Learning Resources Lab Instructor<br />

_____ Clinical Instructor<br />

_____ Other (specify here) ________________________________<br />

DATE: ______________________________


HBV VACCINATION DECLINATION FORM<br />

I understand that, due to my occupational exposure to blood or other potentially infectious<br />

materials, I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given<br />

the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I<br />

decline hepatitis B vaccination at this time. I understand that my declining this vaccine, I<br />

continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to<br />

have occupational exposure to blood or other potentially infectious materials (OPIM) and I<br />

want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no<br />

charge to me.<br />

Name (printed) ______________________________________<br />

Department _________________________________________<br />

Job Classification ____________________________________<br />

Signature ____________________________________________________________________________<br />

[Requires signature of Legal Guardian if under age 18 - print words “legal guardian” next to signature if applicable]<br />

Social Security Number (REQUIRED BY MIOSHA) __________________________<br />

[Wording direct from 29 CFR’s Appendix to Section 1910.1030-Hepatitis B Vaccine Declination (Mandatory)]


"PRE-EXPOSURE" HEPATITIS B VACCINATION<br />

STATUS FORM<br />

Department ______________________________________________________<br />

ELIGIBLE<br />

EMPLOYEE<br />

NAME<br />

ACCEPTED/<br />

DECLINED<br />

VACCINATION<br />

and DATE DECIDED<br />

DATES<br />

VACCINE<br />

RECEIVED<br />

#1/#2/#3<br />

ADMINISTERING<br />

HEALTH<br />

CARE FACILITY


EXPOSURE INCIDENT REPORT FORM<br />

Date of Incident<br />

Job site/location:<br />

Time of Incident _________________________<br />

Name of Employee____________________________<br />

Job Description (Description of General Duties): ________________________________________<br />

Potentially Infectious Material Involved (e.g. blood etc.) _________________________________<br />

Source of Potentially Infectious Material (e.g. needle-stick, cut, bite etc.) ____________________<br />

Circumstances Surrounding <strong>Exposure</strong> Incident (e.g. work being performed etc.) _______________<br />

_______________________________________________________________________________<br />

Route of <strong>Exposure</strong> (e.g. under-the-skin, unprotected skin, eyes, nose, mouth) _________________<br />

_______________________________________________________________________________<br />

How <strong>Exposure</strong> Occurred (e.g. equipment malfunction, human error, etc.) ____________________<br />

_______________________________________________________________________________<br />

Personal Protection Equipment Worn at Time of Incident ________________________________<br />

_______________________________________________________________________________<br />

_______________________________________________________________________________<br />

Actions Taken at Time of Incident (e.g. soap/water clean-up, reporting to supervisor etc.)<br />

_______________________________________________________________________________<br />

_______________________________________________________________________________<br />

_______________________________________________________________________________<br />

Recommendations for Avoiding Repetition: ___________________________________________<br />

_______________________________________________________________________________<br />

_______________________________________________________________________________


POST-EXPOSURE INCIDENT CHECKLIST<br />

The following steps must be taken, and information provided, in the event of an employee's exposure to<br />

blood or other potentially infectious material.<br />

Date of <strong>Exposure</strong> Incident _______________________________<br />

ACTIVITY<br />

• Contaminated area was washed with soap and water (or eyewash if the eye) for<br />

at least 15 minutes.<br />

• Employee transported to emergency room within 2 hours of incident for antiviral<br />

drugs (following washing/flushing described above).<br />

• Employee furnished with documentation regarding exposure incident.<br />

• The following documentation was forwarded to a Healthcare Professional who<br />

is evaluating employee:<br />

o <strong>Bloodborne</strong> <strong>Pathogens</strong> Standard<br />

o <strong>Exposure</strong> Incident Report<br />

o Employee’s medical records<br />

COMPLETION<br />

____________<br />

____________<br />

____________<br />

____________<br />

____________<br />

____________<br />

• Source Individual:<br />

o Identified OR it was determined that ID was not feasible (circle one)<br />

o Authorization to collect blood requested<br />

o Blood tested OR authorization refused (circle one)<br />

____________<br />

____________<br />

____________<br />

• Source individual’s blood results given to exposed employee ____________<br />

• Employee informed than any/all follow-up care shall be at no cost to him/her ____________


Authorization to Have Blood Drawn and<br />

Analyzed for Presence of Viral Infection<br />

Source Individual Consent Form<br />

1. Individual's Name<br />

Social Security Number<br />

Date of Birth<br />

2. I authorize_______________________(Name of Health Care Facility) to draw and analyze my blood<br />

for the presence of viral (i.e., HBV or HIV) infection.<br />

3. I understand that the results of this analysis shall be made available to the individual who has been<br />

exposed to my blood (in addition to his/her health care provider), and maintained in that individual's<br />

CONFIDENTIAL medical records on file at OU.<br />

4. I agree that a photocopy or facsimile of this authorization shall be as valid as the original.<br />

__________________________________________________<br />

Signed (source individual)<br />

_________________________<br />

Date<br />

____________________________________________________<br />

Parent or guardian (if individual is under 18 years of age)<br />

_________________________<br />

Date


PPE EXCEPTION FORM<br />

Name of Individual Completing Form<br />

On (date) __________________________ I voluntarily and knowingly chose against wearing<br />

Personal Protective Equipment (PPE) even though I was aware that the task I was performing<br />

introduced a risk of exposure to <strong>Bloodborne</strong> <strong>Pathogens</strong>.<br />

In my judgement, in this specific instance, obtaining/using PPE would have (check one):<br />

_____ prevented the delivery of health care or public safety services;<br />

_____ posed an increased hazard to the safety of a victim, myself or coworker(s); or<br />

______ other, explain in next paragraph.<br />

Description of task I was performing, and detailed reason for choosing against PPE:<br />

______________________________________________________________________________________<br />

__________________________________________________________________________________<br />

Suggestions for avoiding this situation in the future:<br />

_________________________________________________________________________________<br />

_________________________________________________________________________________<br />

Signed<br />

Co-Signed Employee Supervisor<br />

Date<br />

Date


RESEARCH ACTIVITIES INVOLVING DIRECT MANIPULATION OF<br />

BLOODBORNE PATHOGENS<br />

REPORT FORM<br />

Department:<br />

“MANIPULATION”<br />

PROCEDURE(S)<br />

(e.g. assay, culture,<br />

centrifuge, etc.)<br />

BLOODBORNE<br />

PATHOGENS<br />

BEING MANIPULATED<br />

LOCATION(S)<br />

PERFORMED<br />

REC’D OU<br />

BIOSAFETY<br />

COMMITTEE<br />

APPROVAL<br />

(Date and PI<br />

signature)<br />

* “Manipulation” includes, but is not limited to, culturing, assaying, centrifuging, handling, pipetting<br />

etc. of infectious organisms carried in human blood.


"UNIVERSAL”<br />

BLOOD AND BODY FLUID<br />

PRECAUTIONS<br />

+<br />

OSHA BLOODBORNE PATHOGEN<br />

STANDARD<br />

[29 CFR 1910.1030]


Page 31 of 19


OSHA Regulations (Standards - 29 CFR)<br />

<strong>Bloodborne</strong> <strong>Pathogens</strong>. - 1910.1030<br />

Standard Number: 1910.1030<br />

Standard Title: <strong>Bloodborne</strong><br />

pathogens.<br />

SubPart Number: Z<br />

SubPart Title: Toxic and Hazardous<br />

Substances<br />

(a) Scope and Application. This<br />

section applies to all occupational<br />

exposure to blood or other potentially<br />

infectious materials as defined by<br />

paragraph (b) of this section.<br />

(b) Definitions. For purposes of this<br />

section, the following shall apply:<br />

"Assistant Secretary" means the<br />

Assistant Secretary of Labor for<br />

Occupational Safety and Health, or<br />

designated representative.<br />

"Blood" means human blood, human<br />

blood components, and products made<br />

from human blood.<br />

"<strong>Bloodborne</strong> <strong>Pathogens</strong>" means<br />

pathogenic microorganisms that are<br />

present in human blood and can cause<br />

disease in humans. These pathogens<br />

include, but are not limited to,<br />

hepatitis B virus (HBV) and human<br />

immunodeficiency virus (HIV).<br />

"Clinical Laboratory" means a<br />

workplace where diagnostic or other<br />

screening procedures are performed<br />

on blood or other potentially<br />

infectious materials.<br />

"Contaminated" means the presence<br />

or the reasonably anticipated presence<br />

of blood or other potentially infectious<br />

materials on an item or surface.<br />

"Contaminated Laundry" means<br />

laundry which has been soiled with<br />

blood or other potentially infectious<br />

materials or may contain sharps.<br />

"Contaminated Sharps" means any<br />

contaminated object that can penetrate<br />

the skin including, but not limited to,<br />

needles, scalpels, broken glass, broken<br />

capillary tubes, and exposed ends of<br />

dental wires.<br />

"Decontamination" means the use of<br />

physical or chemical means to<br />

remove, inactivate, or destroy<br />

"Source Individual" means any<br />

individual, living or dead, whose<br />

blood or other potentially infectious<br />

materials may be a source of<br />

occupational exposure to the<br />

bloodborne pathogens on a surface<br />

or item to the point where they are<br />

no longer capable of transmitting<br />

infectious particles and the surface<br />

or item is rendered safe for<br />

handling, use, or disposal.<br />

"Director" means the Director of<br />

the National Institute for<br />

Occupational Safety and Health,<br />

U.S. Department of Health and<br />

Human Services, or designated<br />

representative.<br />

"Engineering <strong>Control</strong>s" means<br />

controls (e.g., sharps disposal<br />

containers, self-sheathing needles)<br />

that isolate or remove the<br />

bloodborne pathogens hazard from<br />

the workplace.<br />

"<strong>Exposure</strong> Incident" means a<br />

specific eye, mouth, other mucous<br />

membrane, non-intact skin, or<br />

parenteral contact with blood or<br />

other potentially infectious<br />

materials that results from the<br />

performance of an employee's<br />

duties.<br />

"Handwashing Facilities" means a<br />

facility providing an adequate<br />

supply of running potable water,<br />

soap and single use towels or hot<br />

air drying machines.<br />

"Licensed Healthcare<br />

Professional" is a person whose<br />

legally permitted scope of practice<br />

allows him or her to independently<br />

perform the activities required by<br />

paragraph (f) Hepatitis B<br />

Vaccination and Post-exposure<br />

Evaluation and Follow-up.<br />

"HBV" means hepatitis B virus.<br />

"HIV" means human<br />

immunodeficiency virus.<br />

"Occupational <strong>Exposure</strong>" means<br />

reasonably anticipated skin, eye,<br />

mucous membrane, or parenteral<br />

contact with blood or other<br />

potentially infectious materials that<br />

may result from the performance of<br />

an employee's duties.<br />

employee. Examples include, but<br />

are not limited to, hospital and<br />

clinic patients; clients in<br />

institutions for the developmentally<br />

disabled; trauma victims; clients of<br />

"Other Potentially Infectious Materials"<br />

(OPIM) means (1) The following human<br />

body fluids: semen, vaginal secretions,<br />

cerebrospinal fluid, synovial fluid, pleural<br />

fluid, pericardial fluid, peritoneal fluid,<br />

amniotic fluid, saliva in dental procedures,<br />

any body fluid that is visibly contaminated<br />

with blood, and all body fluids in<br />

situations where it is difficult or<br />

impossible to differentiate between body<br />

fluids; (2) Any unfixed tissue or organ<br />

(other than intact skin) from a human<br />

(living or dead); and (3) HIV-containing<br />

cell or tissue cultures, organ cultures, and<br />

HIV- or HBV-containing culture medium<br />

or other solutions; and blood, organs, or<br />

other tissues from experimental animals<br />

infected with HIV or HBV.<br />

"Parenteral" means piercing mucous<br />

membranes or the skin barrier through<br />

such events as needlesticks, human bites,<br />

cuts, and abrasions.<br />

"Personal Protective Equipment" is<br />

specialized clothing or equipment worn by<br />

an employee for protection against a<br />

hazard. General work clothes (e.g.,<br />

uniforms, pants, shirts or blouses) not<br />

intended to function as protection against a<br />

hazard are not considered to be personal<br />

protective equipment.<br />

"Production Facility" means a facility<br />

engaged in industrial-scale, large-volume<br />

or high concen. produc. of HIV or HBV.<br />

"Regulated Waste" means liquid or semiliquid<br />

blood or other potentially infectious<br />

materials; contaminated items that would<br />

release blood or other potentially<br />

infectious materials in a liquid or semiliquid<br />

state if compressed; items that are<br />

caked with dried blood or other potentially<br />

infectious materials and are capable of<br />

releasing these materials during handling;<br />

contaminated sharps; and pathological and<br />

microbiological wastes containing blood or<br />

other potentially infectious materials.<br />

"Research Laboratory" means a laboratory<br />

producing or using research-laboratoryscale<br />

amounts of HIV or HBV. Research<br />

laboratories may produce high<br />

concentrations of HIV or HBV but not in<br />

the volume found in production facilities.<br />

drug and alcohol treatment facilities;<br />

residents of hospices and nursing homes;<br />

human remains; and individuals who<br />

donate or sell blood or blood components.


"Sterilize" means the use of a physical<br />

or chemical procedure to destroy all<br />

microbial life including highly<br />

resistant bacterial endospores.<br />

"Universal Precautions" is an<br />

approach to infection control.<br />

According to the concept of Universal<br />

Precautions, all human blood and<br />

certain human body fluids are treated<br />

as if known to be infectious for HIV,<br />

HBV, and other bloodborne<br />

pathogens.<br />

"Work Practice <strong>Control</strong>s" means<br />

controls that reduce the likelihood of<br />

exposure by altering the manner in<br />

which a task is performed (e.g.,<br />

prohibiting recapping of needles by a<br />

two-handed technique).<br />

(c) <strong>Exposure</strong> <strong>Control</strong>.<br />

(c)(1) <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong>.<br />

(c)(1)(i) Each employer having an<br />

employee(s) with occupational<br />

exposure as defined by paragraph (b)<br />

of this section shall establish a written<br />

<strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong> designed to<br />

eliminate or minimize employee<br />

exposure.<br />

(c)(1)(ii) The <strong>Exposure</strong> <strong>Control</strong> <strong>Plan</strong><br />

shall contain at least the following<br />

elements:<br />

(c)(1)(ii)(A) The exposure<br />

determination required by paragraph<br />

(c)(2),<br />

(c)(1)(ii)(B) The schedule and method<br />

of implementation for paragraphs (d)<br />

Methods of Compliance, (e) HIV and<br />

HBV Research Laboratories and<br />

Production Facilities, (f) Hepatitis B<br />

Vaccination and Post-<strong>Exposure</strong><br />

Evaluation and Follow-up, (g)<br />

Communication of Hazards to<br />

Employees, and (h) Recordkeeping, of<br />

this standard, and<br />

(c)(1)(ii)(C) The procedure for the<br />

evaluation of circumstances<br />

surrounding exposure incidents as<br />

required by paragraph (f)(3)(i) of this<br />

standard.<br />

(c)(1)(iii) Each employer shall ensure<br />

that a copy of the <strong>Exposure</strong> <strong>Control</strong><br />

<strong>Plan</strong> is accessible to employees in<br />

(d)(2)(vii)(B) Such bending,<br />

recapping or needle removal must be<br />

accomplished through the use of a<br />

mechanical device or a one-handed<br />

technique.<br />

(d)(2)(viii) Immediately or as soon as<br />

possible after use, contaminated<br />

accordance with 29 CFR<br />

1910.1020(e).<br />

(c)(1)(iv) The <strong>Exposure</strong> <strong>Control</strong><br />

<strong>Plan</strong> shall be reviewed and updated<br />

at least annually and whenever<br />

necessary to reflect new or<br />

modified tasks and procedures<br />

which affect occupational exposure<br />

and to reflect new or revised<br />

employee positions with<br />

occupational exposure.<br />

(c)(1)(v) The <strong>Exposure</strong> <strong>Control</strong><br />

<strong>Plan</strong> shall be made available to the<br />

Assistant Secretary and the<br />

Director upon request for<br />

examination and copying.<br />

(c)(2) <strong>Exposure</strong> Determination.<br />

(c)(2)(i) Each employer who has an<br />

employee(s) with occupational<br />

exposure as defined by paragraph<br />

(b) of this section shall prepare an<br />

exposure determination. This exp.<br />

determ. shall contain the following:<br />

(c)(2)(i)(A) A list of all job<br />

classifications in which all<br />

employees in those job<br />

classifications have occupational<br />

exposure;<br />

(c)(2)(i)(B) A list of job<br />

classifications in which some<br />

employees have occupational<br />

exposure, and<br />

(c)(2)(i)(C) A list of all tasks and<br />

procedures or groups of closely<br />

related tasks and procedures in<br />

which occupational exposure<br />

occurs and that are performed by<br />

employees in job classifications<br />

listed in accordance with the<br />

provisions of paragraph (c)(2)(i)(B)<br />

of this standard.<br />

(c)(2)(ii) This exposure<br />

determination shall be made<br />

without regard to the use of<br />

personal protective equipment.<br />

(d) Methods of Compliance.<br />

(d)(1) General. Universal<br />

precautions shall be observed to<br />

prevent contact with blood or other<br />

potentially infectious materials.<br />

Under circumstances in which<br />

differentiation between body fluid<br />

reusable sharps shall be placed in<br />

appropriate containers until<br />

properly reprocessed. These<br />

containers shall be:<br />

(d)(2)(viii)(A) puncture resistant;<br />

types is difficult or impossible, all body<br />

fluids shall be considered potentially<br />

infectious materials.<br />

(d)(2) Engineering and Work Practice<br />

<strong>Control</strong>s.<br />

(d)(2)(i) Engineering and work practice<br />

controls shall be used to eliminate or<br />

minimize employee exposure. Where<br />

occupational exposure remains after<br />

institution of these controls, personal<br />

protective equipment shall also be used.<br />

(d)(2)(ii) Engineering controls shall be<br />

examined and maintained or replaced on a<br />

regular schedule to ensure effectiveness.<br />

(d)(2)(iii) Employers shall provide<br />

handwashing facilities which are readily<br />

accessible to employees.<br />

(d)(2)(iv) When provision of handwashing<br />

facilities is not feasible, the employer shall<br />

provide either an appropriate antiseptic<br />

hand cleanser in conjunction with clean<br />

cloth/paper towels or antiseptic towelettes.<br />

When antiseptic hand cleansers or<br />

towelettes are used, hands shall be washed<br />

with soap and running water as soon as<br />

feasible.<br />

(d)(2)(v) Employers shall ensure that<br />

employees wash their hands immediately<br />

or as soon as feasible after removal of<br />

gloves or other personal protective<br />

equipment.<br />

(d)(2)(vi) Employers shall ensure that<br />

employees wash hands and any other skin<br />

with soap and water, or flush mucous<br />

membranes with water immediately or as<br />

soon as feasible following contact of such<br />

body areas with blood or other potentially<br />

infectious materials.<br />

(d)(2)(vii) Contaminated needles and other<br />

contaminated sharps shall not be bent,<br />

recapped, or removed except as noted in<br />

paragraphs (d)(2)(vii)(A) and<br />

(d)(2)(vii)(B) below. Shearing or breaking<br />

of contaminated needles is prohibited.<br />

(d)(2)(vii)(A) Contaminated needles and<br />

other contaminated sharps shall not be<br />

bent, recapped or removed unless the<br />

employer can demonstrate that no<br />

alternative is feasible or that such action is<br />

required by a specific medical or dental<br />

procedure.<br />

(d)(2)(viii)(B) labeled or color-coded in<br />

accordance with this standard;<br />

(d)(2)(viii)(C) leakproof on the sides and<br />

bottom; and


(d)(2)(viii)(D) in accordance with the<br />

requirements set forth in paragraph<br />

(d)(4)(ii)(E) for reusable sharps.<br />

(d)(2)(ix) Eating, drinking, smoking,<br />

applying cosmetics or lip balm, and<br />

handling contact lenses are prohibited<br />

in work areas where there is a<br />

reasonable likelihood of occupational<br />

exposure.<br />

(d)(2)(x) Food and drink shall not be<br />

kept in refrigerators, freezers, shelves,<br />

cabinets or on countertops or<br />

benchtops where blood or other<br />

potentially infectious materials are<br />

present.<br />

(d)(2)(xi) All procedures involving<br />

blood or other potentially infectious<br />

materials shall be performed in such a<br />

manner as to minimize splashing,<br />

spraying, spattering, and generation of<br />

droplets of these substances.<br />

(d)(2)(xii) Mouth pipetting/suctioning<br />

of blood or other potentially infectious<br />

materials is prohibited.<br />

(d)(2)(xiii) Specimens of blood or<br />

other potentially infectious materials<br />

shall be placed in a container which<br />

prevents leakage during collection,<br />

handling, processing, storage,<br />

transport, or shipping.<br />

(d)(2)(xiii)(A) The container for<br />

storage, transport, or shipping shall be<br />

labeled or color-coded according to<br />

paragraph (g)(1)(i) and closed prior to<br />

being stored, transported, or shipped.<br />

When a facility utilizes Universal<br />

Precautions in the handling of all<br />

specimens, the labeling/color-coding<br />

of specimens is not necessary<br />

provided containers are recognizable<br />

as containing specimens. This<br />

exemption only applies while such<br />

specimens/containers remain within<br />

the facility. Labeling or color-coding<br />

in accordance with paragraph (g)(1)(i)<br />

is required when such<br />

specimens/containers leave the<br />

facility.<br />

(d)(3)(vi) If a garment(s) is penetrated<br />

by blood or other potentially<br />

infectious materials, the garment(s)<br />

shall be removed immediately or as<br />

soon as feasible.<br />

(d)(3)(vii) All personal protective<br />

equipment shall be removed prior to<br />

leaving the work area.<br />

(d)(2)(xiii)(B) If outside<br />

contamination of the primary<br />

container occurs, the primary<br />

container shall be placed within a<br />

second container which prevents<br />

leakage during handling,<br />

processing, storage, transport, or<br />

shipping and is labeled or colorcoded<br />

according to the<br />

requirements of this standard.<br />

(d)(2)(xiii)(C) If the specimen<br />

could puncture the primary<br />

container, the primary container<br />

shall be placed within a secondary<br />

container which is punctureresistant<br />

in addition to the above<br />

characteristics.<br />

(d)(2)(xiv) Equipment which may<br />

become contaminated with blood or<br />

other potentially infectious<br />

materials shall be examined prior to<br />

servicing or shipping and shall be<br />

decontaminated as necessary,<br />

unless the employer can<br />

demonstrate that decontamination<br />

of such equipment or portions of<br />

such equipment is not feasible.<br />

(d)(2)(xiv)(A) A readily observable<br />

label in accordance with paragraph<br />

(g)(1)(i)(H) shall be attached to the<br />

equipment stating which portions<br />

remain contaminated.<br />

(d)(2)(xiv)(B) The employer shall<br />

ensure that this information is<br />

conveyed to all affected employees,<br />

the servicing representative, and/or<br />

the manufacturer, as appropriate,<br />

prior to handling, servicing, or<br />

shipping so that appropriate<br />

precautions will be taken.<br />

(d)(3) Personal Protective<br />

Equipment.<br />

(d)(3)(i) Provision. When there is<br />

occupational exposure, the<br />

employer shall provide, at no cost<br />

to the employee, appropriate<br />

personal protective equipment such<br />

as, but not limited to, gloves,<br />

gowns, laboratory coats, face<br />

shields or masks and eye<br />

(d)(3)(viii) When personal<br />

protective equipment is removed it<br />

shall be placed in an appropriately<br />

designated area or container for<br />

storage, washing, decontamination<br />

or disposal.<br />

(d)(3)(ix) Gloves. Gloves shall be<br />

worn when it can be reasonably<br />

anticipated that the employee may<br />

protection, and mouthpieces, resuscitation<br />

bags, pocket masks, or other ventilation<br />

devices. Personal protective equipment<br />

will be considered "appropriate" only if it<br />

does not permit blood or other potentially<br />

infectious materials to pass through to or<br />

reach the employee's work clothes, street<br />

clothes, undergarments, skin, eyes, mouth,<br />

or other mucous membranes under normal<br />

conditions of use and for the duration of<br />

time which the protective equipment will<br />

be used.<br />

(d)(3)(ii) Use. The employer shall ensure<br />

that the employee uses appropriate<br />

personal protective equipment unless the<br />

employer shows that the employee<br />

temporarily and briefly declined to use<br />

personal protective equipment when, under<br />

rare and extraordinary circumstances, it<br />

was the employee's professional judgment<br />

that in the specific instance its use would<br />

have prevented the delivery of health care<br />

or public safety services or would have<br />

posed an increased hazard to the safety of<br />

the worker or co-worker. When the<br />

employee makes this judgement, the<br />

circumstances shall be investigated and<br />

documented in order to determine whether<br />

changes can be instituted to prevent such<br />

occurrences in the future.<br />

(d)(3)(iii) Accessibility. The employer<br />

shall ensure that appropriate personal<br />

protective equipment in the appropriate<br />

sizes is readily accessible at the worksite<br />

or is issued to employees. Hypoallergenic<br />

gloves, glove liners, powderless gloves, or<br />

other similar alternatives shall be readily<br />

accessible to those employees who are<br />

allergic to the gloves normally provided.<br />

(d)(3)(iv) Cleaning, Laundering, and<br />

Disposal. The employer shall clean,<br />

launder, and dispose of personal protective<br />

equipment required by paragraphs (d) and<br />

(e) of this standard, at no cost to the<br />

employee<br />

(d)(3)(v) Repair and Replacement. The<br />

employer shall repair or replace personal<br />

protective equipment as needed to<br />

maintain its effectiveness, at no cost to the<br />

employee.<br />

have hand contact with blood, other<br />

potentially infectious materials, mucous<br />

membranes, and non-intact skin; when<br />

performing vascular access procedures<br />

except as specified in paragraph<br />

(d)(3)(ix)(D); and when handling or<br />

touching contaminated items or surfaces.<br />

(d)(3)(ix)(A) Disposable (single use)<br />

gloves such as surgical or examination


gloves, shall be replaced as soon as<br />

practical when contaminated or as<br />

soon as feasible if they are torn,<br />

punctured, or when their ability to<br />

function as a barrier is compromised.<br />

(d)(3)(ix)(B) Disposable (single use)<br />

gloves shall not be washed or<br />

decontaminated for re-use.<br />

(d)(3)(ix)(C) Utility gloves may be<br />

decontaminated for re-use if the<br />

integrity of the glove is not<br />

compromised. However, they must be<br />

discarded if they are cracked, peeling,<br />

torn, punctured, or exhibit other signs<br />

of deterioration or when their ability<br />

to function as a barrier is<br />

compromised.<br />

(d)(3)(ix)(D) If an employer in a<br />

volunteer blood donation center<br />

judges that routine gloving for all<br />

phlebotomies is not necessary then the<br />

employer shall:<br />

(d)(3)(ix)(D)(1) Periodically<br />

reevaluate this policy;<br />

(d)(3)(ix)(D)(2) Make gloves<br />

available to all employees who wish<br />

to use them for phlebotomy;<br />

(d)(3)(ix)(D)(3) Not discourage the<br />

use of gloves for phlebotomy; and<br />

(d)(3)(ix)(D)(4) Require that gloves<br />

be used for phlebotomy in the<br />

following circumstances:<br />

[i] When the employee has cuts,<br />

scratches, or other breaks in his or her<br />

skin;<br />

[ii] When the employee judges that<br />

hand contamination with blood may<br />

occur, for example, when performing<br />

phlebotomy on an uncooperative<br />

source individual; and<br />

[iii] When the employee is receiving<br />

training in phlebotomy.<br />

(d)(3)(x) Masks, Eye Protection, and<br />

Face Shields. Masks in combination<br />

with eye protection devices, such as<br />

[b] Puncture resistant;<br />

[c] Leakproof on sides and bottom;<br />

and<br />

[d] Labeled or color-coded in<br />

accordance with paragraph (g)(1)(i) of<br />

this standard.<br />

(d)(4)(iii)(A)(2) During use,<br />

containers for contaminated sharps<br />

shall be:<br />

[a] Easily accessible to personnel and<br />

located as close as is feasible to the<br />

goggles or glasses with solid side<br />

shields, or chin-length face shields,<br />

shall be worn whenever splashes,<br />

spray, spatter, or droplets of blood<br />

or other potentially infectious<br />

materials may be generated and<br />

eye, nose, or mouth contamination<br />

can be reasonably anticipated.<br />

(d)(3)(xi) Gowns, Aprons, and<br />

Other Protective Body Clothing.<br />

Appropriate protective clothing<br />

such as, but not limited to, gowns,<br />

aprons, lab coats, clinic jackets, or<br />

similar outer garments shall be<br />

worn in occupational exposure<br />

situations. The type and<br />

characteristics will depend upon the<br />

task and degree of exposure<br />

anticipated.<br />

(d)(3)(xii) Surgical caps or hoods<br />

and/or shoe covers or boots shall be<br />

worn in instances when gross<br />

contamination can reasonably be<br />

anticipated (e.g., autopsies,<br />

orthopaedic surgery).<br />

(d)(4) Housekeeping.<br />

(d)(4)(i) General. Employers shall<br />

ensure that the worksite is<br />

maintained in a clean and sanitary<br />

condition. The employer shall<br />

determine and implement an<br />

appropriate written schedule for<br />

cleaning and method of<br />

decontamination based upon the<br />

location within the facility, type of<br />

surface to be cleaned, type of soil<br />

present, and tasks or procedures<br />

being performed in the area.<br />

(d)(4)(ii) All equipment and<br />

environmental and working<br />

surfaces shall be cleaned and<br />

decontaminated after contact with<br />

blood or other potentially infectious<br />

materials.<br />

(d)(4)(ii)(A) Contaminated work<br />

surfaces shall be decontaminated<br />

with an appropriate disinfectant<br />

immediate area where sharps are<br />

used or can be reasonably<br />

anticipated to be found (e.g.,<br />

laundries);<br />

[b] Maintained upright throughout<br />

use; and<br />

[c] Replaced routinely and not be<br />

allowed to overfill.<br />

(d)(4)(iii)(A)(3) When moving<br />

containers of contaminated sharps<br />

from the area of use, the containers<br />

shall be:<br />

after completion of procedures;<br />

immediately or as soon as feasible when<br />

surfaces are overtly contaminated or after<br />

any spill of blood or other potentially<br />

infectious materials; and at the end of the<br />

work shift if the surface may have become<br />

contaminated since the last cleaning.<br />

(d)(4)(ii)(B) Protective coverings, such as<br />

plastic wrap, aluminum foil, or<br />

imperviously-backed absorbent paper used<br />

to cover equipment and environmental<br />

surfaces, shall be removed and replaced as<br />

soon as feasible when they become overtly<br />

contaminated or at the end of the workshift<br />

if they may have become contaminated<br />

during the shift.<br />

(d)(4)(ii)(C) All bins, pails, cans, and<br />

similar receptacles intended for reuse<br />

which have a reasonable likelihood for<br />

becoming contaminated with blood or<br />

other potentially infectious materials shall<br />

be inspected and decontaminated on a<br />

regularly scheduled basis and cleaned and<br />

decontaminated immediately or as soon as<br />

feasible upon visible contamination.<br />

(d)(4)(ii)(D) Broken glassware which may<br />

be contaminated shall not be picked up<br />

directly with the hands. It shall be cleaned<br />

up using mechanical means, such as a<br />

brush and dust pan, tongs, or forceps.<br />

(d)(4)(ii)(E) Reusable sharps that are<br />

contaminated with blood or other<br />

potentially infectious materials shall not be<br />

stored or processed in a manner that<br />

requires employees to reach by hand into<br />

the containers where these sharps have<br />

been placed.<br />

(d)(4)(iii) Regulated Waste.<br />

(d)(4)(iii)(A) Contaminated Sharps<br />

Discarding and Containment.<br />

(d)(4)(iii)(A)(1) Contaminated sharps shall<br />

be discarded immediately or as soon as<br />

feasible in containers that are:<br />

[a] Closable;<br />

[a] Closed immediately prior to removal or<br />

replacement to prevent spillage or<br />

protrusion of contents during handling,<br />

storage, transport, or shipping;<br />

[b] Placed in a secondary container if<br />

leakage is possible. The second container<br />

shall be:<br />

[i] Closable;<br />

[ii] Constructed to contain all contents and<br />

prevent leakage during handling, storage,<br />

transport, or shipping; and


[iii] Labeled or color-coded according<br />

to paragraph (g)(1)(i) of this standard.<br />

(d)(4)(iii)(A)(4) Reusable containers<br />

shall not be opened, emptied, or<br />

cleaned manually or in any other<br />

manner which would expose<br />

employees to the risk of percutaneous<br />

injury.<br />

(d)(4)(iii)(B) Other Regulated Waste<br />

Containment.<br />

(d)(4)(iii)(B)(1) Regulated waste shall<br />

be<br />

placed in containers which are:<br />

[a] Closable;<br />

[b] Constructed to contain all contents<br />

and prevent leakage of fluids during<br />

handling, storage, transport or<br />

shipping;<br />

[c] Labeled or color-coded in<br />

accordance with paragraph (g)(1)(i)<br />

this standard; and<br />

[d] Closed prior to removal to prevent<br />

spillage or protrusion of contents<br />

during handling, storage, transport, or<br />

shipping.<br />

(d)(4)(iii)(B)(2) If outside<br />

contamination of the regulated waste<br />

container occurs, it shall be placed in<br />

a second container. The second<br />

container shall be:<br />

[a] Closable;<br />

[b] Constructed to contain all contents<br />

and prevent leakage of fluids during<br />

handling, storage, transport or<br />

shipping;<br />

[c] Labeled or color-coded in<br />

accordance with paragraph (g)(1)(i) of<br />

this standard; and<br />

[d] Closed prior to removal to prevent<br />

spillage or protrusion of contents<br />

during handling, storage, transport, or<br />

shipping.<br />

(d)(4)(iii)(C) Disposal of all regulated<br />

waste shall be in accordance with<br />

applicable regulations of the United<br />

States, States and Territories, and<br />

political subdivisions of States and<br />

Territories.<br />

(d)(4)(iv) Laundry.<br />

(d)(4)(iv)(A) Contaminated laundry<br />

shall be handled as little as possible<br />

with a minimum of agitation.<br />

(d)(4)(iv)(A)(1) Contaminated<br />

laundry shall be bagged or<br />

containerized at the location where it<br />

was used and shall not be sorted or<br />

rinsed in the location of use.<br />

(d)(4)(iv)(A)(2) Contaminated<br />

laundry shall be placed and<br />

transported in bags or containers<br />

labeled or color-coded in<br />

accordance with paragraph (g)(1)(i)<br />

of this standard. When a facility<br />

utilizes Universal Precautions in<br />

the handling of all soiled laundry,<br />

alternative labeling or color-coding<br />

is sufficient if it permits all<br />

employees to recognize the<br />

containers as requiring compliance<br />

with Universal Precautions.<br />

(d)(4)(iv)(A)(3) Whenever<br />

contaminated laundry is wet and<br />

presents a reasonable likelihood of<br />

soak-through of or leakage from the<br />

bag or container, the laundry shall<br />

be placed and transported in bags<br />

or containers which prevent soakthrough<br />

and/or leakage of fluids to<br />

the exterior.<br />

(d)(4)(iv)(B) The employer shall<br />

ensure that employees who have<br />

contact with contaminated laundry<br />

wear protective gloves and other<br />

appropriate personal protective<br />

equipment.<br />

(d)(4)(iv)(C) When a facility ships<br />

contaminated laundry off-site to a<br />

second facility which does not<br />

utilize Universal Precautions in the<br />

handling of all laundry, the facility<br />

generating the contaminated<br />

laundry must place such laundry in<br />

bags or containers which are<br />

labeled or color-coded in<br />

accordance with paragraph<br />

(g)(1)(i).<br />

(e) HIV and HBV Research<br />

Laboratories and Production<br />

Facilities.<br />

(e)(1) This paragraph applies to<br />

research laboratories and<br />

production facilities engaged in the<br />

culture, production, concentration,<br />

experimentation, and manipulation<br />

of HIV and HBV. It does not apply<br />

to clinical or diagnostic laboratories<br />

engaged solely in the analysis of<br />

blood, tissues, or organs. These<br />

requirements apply in addition to<br />

the other requirements of the<br />

standard.<br />

(e)(2) Research laboratories and<br />

production facilities shall meet the<br />

following criteria:<br />

(e)(2)(i) Standard Microbiological<br />

Practices. All regulated waste shall<br />

either be incinerated or<br />

decontaminated by a method such as<br />

autoclaving known to effectively destroy<br />

bloodborne pathogens.<br />

(e)(2)(ii) Special Practices<br />

(e)(2)(ii)(A) Laboratory doors shall be kept<br />

closed when work involving HIV or HBV<br />

is in progress.<br />

(e)(2)(ii)(B) Contaminated materials that<br />

are to be decontaminated at a site away<br />

from the work area shall be placed in a<br />

durable, leakproof, labeled or color-coded<br />

container that is closed before being<br />

removed from the work area.


(e)(2)(ii)(C) Access to the work area shall be limited to authorized persons. Written policies and<br />

procedures shall be established whereby only persons who have been advised of the potential<br />

biohazard, who meet any specific entry requirements, and who comply with all entry and exit<br />

procedures shall be allowed to enter the work areas and animal rooms.<br />

(e)(2)(ii)(D) When other potentially infectious materials or infected animals are present in the work<br />

area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall<br />

be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this<br />

standard.<br />

(e)(2)(ii)(E) All activities involving other potentially infectious materials shall be conducted in<br />

biological safety cabinets or other physical-containment devices within the containment module. No<br />

work with these other potentially infectious materials shall be conducted on the open bench<br />

(e)(2)(ii)(F) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall<br />

be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work<br />

area and shall be decontaminated before being laundered.<br />

(e)(2)(ii)(G) Special care shall be taken to avoid skin contact with other potentially infectious<br />

materials. Gloves shall be worn when handling infected animals and when making hand contact with<br />

other potentially infectious materials is unavoidable.<br />

(e)(2)(ii)(H) Before disposal all waste from work areas and from animal rooms shall either be<br />

incinerated or decontaminated by a method such as autoclaving known to effectively destroy<br />

bloodborne pathogens.<br />

(e)(2)(ii)(I) Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency<br />

particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked<br />

routinely and maintained or replaced as necessary.<br />

(e)(2)(ii)(J) Hypodermic needles and syringes shall be used only for parenteral injection and<br />

aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or<br />

disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the<br />

injection or aspiration of other potentially infectious materials. Extreme caution shall be used when<br />

handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or<br />

removed from the syringe following use. The needle and syringe shall be promptly placed in a<br />

puncture-resistant container and autoclaved or decontaminated before reuse or disposal.<br />

(e)(2)(ii)(K) All spills shall be immediately contained and cleaned up by appropriate professional staff<br />

or others properly trained and equipped to work with potentially concentrated infectious materials.<br />

(e)(2)(ii)(L) A spill or accident that results in an exposure incident shall be immediately reported to<br />

the laboratory director or other responsible person.<br />

(e)(2)(ii)(M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated<br />

at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be<br />

required to read instructions on practices and procedures, and shall be required to follow them.<br />

(e)(2)(iii) Containment Equipment.<br />

(e)(2)(iii)(A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations<br />

of personal protection or physical containment devices, such as special protective clothing, respirators,<br />

centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for<br />

all activities with other potentially infectious materials that pose a threat of exposure to droplets,<br />

splashes, spills, or aerosols.<br />

(e)(2)(iii)(B) Biological safety cabinets shall be certified when installed, whenever they are moved<br />

and at least annually.<br />

(e)(3) HIV and HBV research laboratories shall meet the following criteria:<br />

(e)(3)(i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is<br />

readily available within the work area.<br />

(e)(3)(ii) An autoclave for decontamination of regulated waste shall be available.


(e)(4) HIV and HBV production facilities shall meet the following criteria:<br />

(e)(4)(i) The work areas shall be separated from areas that are open to unrestricted traffic flow within<br />

the building. Passage through two sets of doors shall be the basic requirement for entry into the work<br />

area from access corridors or other contiguous areas. Physical separation of the high-containment<br />

work area from access corridors or other areas or activities may also be provided by a double-doored<br />

clothes-change room (showers may be included), airlock, or other access facility that requires passing<br />

through two sets of doors before entering the work area.<br />

(e)(4)(ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so<br />

that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being<br />

sealed to facilitate decontamination.<br />

(e)(4)(iii) Each work area shall contain a sink for washing hands and a readily available eye wash<br />

facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door<br />

of the work area.<br />

(e)(4)(iv) Access doors to the work area or containment module shall be self-closing.<br />

(e)(4)(v) An autoclave for decontamination of regulated waste shall be available within or as near as<br />

possible to the work area.<br />

(e)(4)(vi) A ducted exhaust-air ventilation system shall be provided. This system shall create<br />

directional airflow that draws air into the work area through the entry area. The exhaust air shall not<br />

be recirculated to any other area of the building, shall be discharged to the outside, and shall be<br />

dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be<br />

verified (i.e., into the work area).<br />

(e)(5) Training Requirements. Additional training requirements for employees in HIV and HBV<br />

research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix).<br />

(f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up.<br />

(f)(1) General.<br />

(f)(1)(i) The employer shall make available the hepatitis B vaccine and vaccination series to all<br />

employees who have occupational exposure, and post-exposure evaluation and follow-up to all<br />

employees who have had an exposure incident.<br />

(f)(1)(ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis<br />

B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis,<br />

are:<br />

(f)(1)(ii)(A) Made available at no cost to the employee;<br />

(f)(1)(ii)(B) Made available to the employee at a reasonable time and place;<br />

(f)(1)(ii)(C) Performed by or under the supervision of a licensed physician or by or under the<br />

supervision of another licensed healthcare professional; and<br />

(f)(1)(ii)(D) Provided according to recommendations of the U.S. Public Health Service current at the<br />

time these evaluations and procedures take place, except as specified by this paragraph (f).<br />

(f)(1)(iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory<br />

at no cost to the employee.<br />

(f)(2) Hepatitis B Vaccination.<br />

(f)(2)(i) Hepatitis B vaccination shall be made available after the employee has received the training<br />

required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees<br />

who have occupational exposure unless the employee has previously received the complete hepatitis B<br />

vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is<br />

contraindicated for medical reasons.<br />

(f)(2)(ii) The employer shall not make participation in a prescreening program a prerequisite for<br />

receiving hepatitis B vaccination.


(f)(2)(iii) If the employee initially declines hepatitis B vaccination but at a later date while still<br />

covered under the standard decides to accept the vaccination, the employer shall make available<br />

hepatitis B vaccination at that time.<br />

(f)(2)(iv) The employer shall assure that employees who decline to accept hepatitis B vaccination<br />

offered by the employer sign the statement in Appendix A.<br />

(f)(2)(v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health<br />

Service at a future date, such booster dose(s) shall be made available in accordance with section<br />

(f)(1)(ii).<br />

(f)(3) Post-exposure Evaluation and Follow-up. Following a report of an exposure incident, the<br />

employer shall make immediately available to the exposed employee a confidential medical<br />

evaluation and follow-up, including at least the following elements:<br />

(f)(3)(i) Documentation of the route(s) of exposure, and the circumstances under which the exposure<br />

incident occurred;<br />

(f)(3)(ii) Identification and documentation of the source individual, unless the employer can establish<br />

that identification is infeasible or prohibited by state or local law;<br />

(f)(3)(ii)(A) The source individual's blood shall be tested as soon as feasible and after consent is<br />

obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall<br />

establish that legally required consent cannot be obtained. When the source individual's consent is not<br />

required by law, the source individual's blood, if available, shall be tested and the results documented.<br />

(f)(3)(ii)(B) When the source individual is already known to be infected with HBV or HIV, testing for<br />

the source individual's known HBV or HIV status need not be repeated.<br />

(f)(3)(ii)(C) Results of the source individual's testing shall be made available to the exposed<br />

employee, and the employee shall be informed of applicable laws and regulations concerning<br />

disclosure of the identity and infectious status of the source individual.<br />

(f)(3)(iii) Collection and testing of blood for HBV and HIV serological status;<br />

(f)(3)(iii)(A) The exposed employee's blood shall be collected as soon as feasible and tested after<br />

consent is obtained.<br />

(f)(3)(iii)(B) If the employee consents to baseline blood collection, but does not give consent at that<br />

time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of<br />

the exposure incident, the employee elects to have the baseline sample tested, such testing shall be<br />

done as soon as feasible.<br />

(f)(3)(iv) Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public<br />

Health Service;<br />

(f)(3)(v) Counseling; and<br />

(f)(3)(vi) Evaluation of reported illnesses.<br />

(f)(4) Information Provided to the Healthcare Professional.<br />

(f)(4)(i) The employer shall ensure that the healthcare professional responsible for the employee's<br />

Hepatitis B vaccination is provided a copy of this regulation.<br />

(f)(4)(ii) The employer shall ensure that the healthcare professional evaluating an employee after an<br />

exposure incident is provided the following information:<br />

(f)(4)(ii)(A) A copy of this regulation;<br />

(f)(4)(ii)(B) A description of the exposed employee's duties as they relate to the exposure incident;<br />

(f)(4)(ii)(C) Documentation of the route(s) of exposure and circumstances under which exposure<br />

occurred;<br />

(f)(4)(ii)(D) Results of the source individual's blood testing, if available; and<br />

(f)(4)(ii)(E) All medical records relevant to the appropriate treatment of the employee including<br />

vaccination status which are the employer's responsibility to maintain.


(f)(5) Healthcare Professional's Written Opinion. The employer shall obtain and provide the<br />

employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the<br />

completion of the evaluation.<br />

(f)(5)(i) The healthcare professional's written opinion for Hepatitis B vaccination shall be limited to<br />

whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such<br />

vaccination.<br />

(f)(5)(ii) The healthcare professional's written opinion for post-exposure evaluation and follow-up<br />

shall be limited to the following information:<br />

(f)(5)(ii)(A) That the employee has been informed of the results of the evaluation; and<br />

(f)(5)(ii)(B) That the employee has been told about any medical conditions resulting from exposure to<br />

blood or other potentially infectious materials which require further evaluation or treatment.<br />

(f)(5)(iii) All other findings or diagnoses shall remain confidential and shall not be included in the<br />

written report.<br />

(f)(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in<br />

accordance with paragraph (h)(1) of this section.<br />

(g) Communication of Hazards to Employees.<br />

(g)(1) Labels and Signs.<br />

(g)(1)(i) Labels.<br />

(g)(1)(i)(A) Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers<br />

containing blood or other potentially infectious material; and other containers used to store, transport<br />

or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E), (F)<br />

and (G).

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