Bloodborne Pathogens Exposure Control Plan - Oakland University

Oakland University

Bloodborne Pathogens Exposure Control Plan

MAY 1992

(Revised 1993, 1994, 1996, 1999, 2000, 2001 and 2004)

Office of Environmental Health and Safety

Department of Risk Management and Contracting Rochester, Michigan 48309-4401

(248) 370-4196

Oakland University

Bloodborne Pathogens Exposure Control Plan

for

DEPARTMENT: ___________________________

MAY 1992 [Revised 1993, 1994, 1996, 1997, 2000 and 2001]

Office of Environmental Health and Safety Graham Health Center

(248) 370-4196

Oakland University Bloodborne Pathogens Exposure Control Plan

TABLE OF CONTENTS 1.0 About this Written Exposure Control Plan ................................................................................. 1

1.1 The Written Exposure Control Plan Includes ........................................................ 1 2.0 Program Administration ............................................................................................................... 2 TABLE 1 - Individuals Responsible for Implementing the ECP in their Departments. ................. 3 3.0 Employee Exposure Determination.............................................................................................. 4 TABLE 2 - Job Classifications for which ALL employees Risk Occupational Exposure.............. 4 TABLE 3 - Job Classifications for which SOME employees Risk Occupational Exposure........... 5 4.0 Methods of Controlling Exposure to BBPs.................................................................................. 5 4.1 Universal Precautions ............................................................................................ 5 4.2 Work Practice Controls.......................................................................................... 5 4.3 Engineering Controls ............................................................................................. 5 TABLE 4 - Tasks Which May Present BBP Exposure and Associated PPE/Engineering Ctrls..... 6 5.0 Biohazardous Waste ...................................................................................................................... 9 5.1 Contaminated Sharps ............................................................................................. 9 5.2 Contaminated Laundry .......................................................................................... 9 5.3 Biohazard bags, hampers and sharp safes.............................................................. 9 6.0 Contaminated Equipment ........................................................................................................... 10 7.0 Cleaning Up Spills........................................................................................................................ 10 7.1 Washable Surfaces............................................................................................... 10 7.2 Non-Washable Surfaces....................................................................................... 10 8.0 Hepatitis B Vaccinations ............................................................................................................. 12 8.1 “Pre-Exposure” Vaccinations .............................................................................. 10 8.2 “Post-Exposure” Vaccinations............................................................................. 11 9.0 Exposure Incident Response and Follow-up ............................................................................. 13 9.1 Exposure Incident - First Response ..................................................................... 13 9.2 Post-Exposure Evaluation and Follow-up ........................................................... 13 10.0 Employee Training....................................................................................................................... 12 10.1 When and How Often .......................................................................................... 12 10.2 Who Conducts Training....................................................................................... 12 10.3 Elements of Training ........................................................................................... 13 11.0. Record Keeping ............................................................................................................................ 13 11.1 Training Records.................................................................................................. 13 11.2 Medical Records .................................................................................................. 13 11.3 Exposure Incident Evaluation Records................................................................ 14 12.0 Conditions for Laboratories Working with HIV and Hepatitis Viruses ................................ 14 12.1 Working in HIV and Hepatitis Viruses “Production Facilities” .......................... 14 12.2 Working in HIV and Hepatitis Virus “Research Laboratories”........................... 15 APPENDICES ........................................................................................................................................... 21 Blank Forms Completed Departmental Forms Universal Precautions and OSHA Bloodborne Pathogens Standard

Oakland University BBP ECP Revised April 2004

1.0 ABOUT THIS WRITTEN EXPOSURE CONTROL PLAN This Exposure Control Plan is intended to serve as OU’s guide to the OSHA Standard 1910.1030, “Occupational Exposure to Bloodborne Pathogens”, which requires, as a central component, the development and issuance of an Exposure Control Plan (ECP). The information contained in this publication is not considered a substitute for the OSH Act or any provisions of OSHA standards. It provides general guidance on the OSHA Bloodborne Pathogens Standard, but should not be considered the legal authority for compliance with OSHA requirements. Rather, the reader should consult the OSHA standard in its entirety and/or OU’s Office of Environmental Health and Safety (OEHS) for specific compliance requirements. 1.1 The Written Exposure Control Plan includes: • Determination of employee exposure • Methods of controlling exposure, including: Universal Precautions and work practice controls

• Engineering Controls and Personal Protective Equipment

• Biohazardous Waste

• Contaminated Equipment

• Cleaning up Spills • Hepatitis B vaccination • Exposure Incident Response and Follow-up

• Employee Training • Record keeping

• Conditions for working with HIV or a Hepatitis virus in the laboratory Employees covered by the bloodborne pathogens standard receive an explanation of this ECP during their initial training sessions. It will also be reviewed in their annual refresher training. All employees have an opportunity to review this plan at any time during their work shifts by contacting the responsible persons identified in Table 1 (Section 2.0). If requested, those individuals will provide their employees with a copy of the ECP free of charge and within 15 days of the request The responsible persons identified in Table 1 (Section 2.0) are responsible for reviewing the ECP annually, or more frequently if necessary, to identify 1) any new or modified tasks and procedures which affect occupational exposure and 2) any new or revised job classifications that present occupational exposure.


2.0 PROGRAM ADMINISTRATION The individuals found in Table 1 below are currently responsible for the implementation of the ECP in their respective departments. These individuals are responsible to: • Maintain and provide all necessary personal protective equipment (PPE), engineering controls

(e.g., sharps containers), labels, and red bags as required by the standard • Ensure that all medical actions required are performed and that appropriate employee health

and OSHA records are maintained • Ensure that all training is provided and documented • Ensure that the written ECP is available to employees, OSHA, and NIOSH representatives; • Review the ECP (and request updates as necessary from the Office of EH&S) at least

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

TABLE 1 Individuals Responsible for Implementing ECP in their Departments

Department Position(s) Employee Name(s) (as of Feb. 2005)

Telephone Extension(s)

Athletics Head Athletic Trainer Asst. Dir. Facilities & Ops

Tom Ford Eric Stephan

3189 4050

Biological Sciences Laboratory Manager Michael Poosch 3556

Campus Cleaning Supervisors Herb Lucre, Wendy Tyrell 2168

Campus Recreation Asst. Dir., Campus Progs. Asst. Dir., Aquatics

Mila Padgett Dan Plamondon

4910 4533

Chemistry Assistant Laboratory Manager

Marcee Daly 2330

Eye Research Institute Asst. to the Director Paulette Realy 2390

Graham Health Center Coordinator Joanne Talarek 4375

Grounds/Vehicle Maint. Supervisor Randy Drewry 2413

Lab Animal Mgmt Svcs Manager Cliff Snitgen 4441

Lowry Early Childhood Ctr Director Tiffany Wright 4100

Meadow Brook Hall Facility Operations Manager Kim Zelinski 3140

Electrical and Plumbing Foreman Dan Niezurawski 4438

Oakland Center Asst. Director Operations Rich Zizek 3245

Oakland University BBP ECP Revised April 2004 Page 2 of 19


TABLE 1 Individuals Responsible for Implementing ECP in their Departments

Department Position(s) Employee Name(s) (as of Feb. 2005)

Telephone Extension(s)

Police Department Lieutenant Mel Gilroy 3339

Residence Halls Custodial & Maintenance Mgrs

Frank Moss Karen Pipitone

4061 3570

School of Education Coor of Field Svcs. Sherrill Karppinen 3083

School of Health Sci

Director Exercise Science Assoc. Professor, Exer Sci Assoc. Professor, Exer Sci Program Dir., Med Lab Sci

Brian Goslin Charles Marks Robert Jarski Lynne Williams

4140 4539 4191 4040

School of Nursing Interim Associate Dean Nursing Laboratory Mgr Admin Project Coordinator

Diane Norris Patricia Ketcham Joann Burrington

4484 4066 4065

All Sci and Res Depts. Laboratory Compliance Manager (Office of EH&S)

Domenico Luongo 4314

3.0 EMPLOYEE EXPOSURE DETERMINATION Table 2 below identifies those OU job classifications (i.e., positions) for which ALL employees who hold those positions risk occupational exposure to Bloodborne Pathogens (without regard to the use of personal protective clothing or equipment):

TABLE 2 Job Classifications for which ALL* employees Risk Occupational Exposure

Job Classification Department(s)

Clinical Faculty School of Nursing

Coach Athletics Campus Recreation

Custodian Campus Cleaning Meadow Brook Hall Oakland Center Residence Halls

Equipment Room Attendant Athletics Campus Recreation

First Responder (Lifeguards, Facility Supervisors)

Athletics Campus Recreation

Grounds keeper Grounds Maintenance Meadow Brook Hall


TABLE 2 Job Classifications for which ALL* employees Risk Occupational Exposure

Job Classification Department(s)

Laboratory Compliance Manager (OEHS) All Sci and Res Depts.

Nursing Laboratory Manager School of Nursing

Child Care Worker/Teacher Lowry Child Care Center

Medical Assistant Nurse Practitioner Nurse, Registered

Graham Health Center

Phlebotomist/Venipuncturist School of Health Sciences (Med Lab Sci and Exer Sci)

Physician Graham Health Center

Plumber Mechanical Maintenance Residence Halls

Police Officer Police Department

Student Intern Health Sciences (Med Lab and Exercise Sciences) School of Education School of Nursing

Trainer Athletics Campus Recreation

Vehicle Maintenance Personnel Grounds Maintenance Department

* regardless of whether part- or full-time, permanent or temporary Table 3 below identifies those OU job classifications for which SOME employees who hold those positions risk occupational exposure to Bloodborne Pathogens (and some may not), without regard to the use of personal protective clothing and equipment:

TABLE 3 Job Classifications for Which SOME Employees Risk Occupational Exposure

Job Classification Department

Directors, Managers and Supervisors All Departments listed in Table 1 (Section 2.0)

“Laboratory” Personnel [Includes Faculty, Instructors (adjunct, associate, part-time, temporary or visiting), Lab Technicians, Researchers, Research Assistants, Research Technicians, PIs, Graduate Assistants, and Graduate Students]

Biological Sciences Chemistry Eye Research Institute Health Sciences (Med Lab Sci and Exercise Sci) Laboratory Animal Management Services

Student Employees Athletics Campus Recreation Residence Halls All laboratory sciences listed in box above


4.0 METHODS OF CONTROLLING EXPOSURE TO BBPS 4.1 Universal Precautions: All OU employees will utilize “Universal Precautions”:

guidelines developed by the Center for Disease Control wherein all human blood or other potentially infectious body fluids are treated as if known to be infectious. A copy of these Universal Precautions is included in the Appendices of this document.

4.2 Work Practice Controls: In addition to personal protective equipment and engineering

controls, “work practice controls” will be used to prevent or minimize exposure to bloodborne pathogens. These include the following: • Following tasks which present exposure to BBPs, hands are always washed with soap

and water immediately after removing personal protective equipment. • Following an “exposure incident” (i.e., unprotected skin or mucous membrane

contact with human blood or other potentially infectious materials, OPIM), the exposed area is washed with soap and water (or, in the case eyes, flushed with an eyewash) for 15 minutes.

• Contaminated needles are never recapped, but are placed instantly into sharps safes • Eating, drinking, smoking, applying cosmetics or lip balm, and/or handling contact

lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure.

• Food and drink shall never be kept in/on refrigerators, freezers, shelves, cabinets, counter-tops or benches where human blood or other OPIM are present.

• All procedures involving blood or OPIM shall be performed in a manner as to minimize splashing, spraying, splattering, and generation of droplets.

• Mouth pipetting/suctioning of blood or OPIM is prohibited. 4.3 Engineering Controls 4.3.1 Regulatory Overview: As of the April 18, 2001 amendments to the OSHA Bloodborne

Pathogens Standard (revised in conformance with the requirements of the “Needlestick Safety and Prevention Act”), the term “Engineering controls” is defined as those “appropriate, commercially available, and effective controls which isolate or remove the bloodborne pathogens hazard from the workplace”. Examples provided in the Standard include the following: 1) devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens, such as blunt suture needles and plastic or mylar-wrapped glass capillary tubes; 2) safer medical devices such as sharps with engineered sharps injury protection or needleless systems; and 3) approved sharps disposal containers.

These amendments further require OU to solicit input its employees responsible for

direct patient care in the identification, evaluation, and selection of engineering (and work practice) controls; annually update its BBP Exposure Control Plan to reflect the university has implemented any/all new developments in control technology; and establish and maintain a log of injuries from contaminated sharps (two types of log found in the Appendices of this document).

4.3.2 Engineering and Personal Protective Controls used at OU: In accordance with the

(original and more recent) engineering control requirements of the BBP Standard, and following several months of soliciting input from OU health care and lab research employees regarding selection of engineering controls, Table 4 below documents the specific tasks that present occupational exposure to BBPs on campus, and the associated engineering controls and personal protective equipment used in each unit on campus.

TABLE 4 Tasks which May Present BBP Exposure and the PPE/Engineering Used to Control

(in alpha order by dept.)

Department Tasks Which May Present Occupational Exposure

PPE and Engineering Controls Used

Location of PPE and Engineering Controls

Athletics First Aid, Lactate Testing, Uniform & towel handling/cleaning

Sharps Safes, Gloves, Gggles, Biohaz bags/hampers.

Training Room, Aquatic Operations Office, Equipment Room

Biological Sciences Dissection of Human Eyes for Tissue Culture in 301 DHE, and Primary and SV40 Transformed Human Cells Lines used in Tissue Culture in 304B and 304C.

Gloves, Masks, Goggles, Biohazard Bags and Hampers, Sharps Safes, Biohazard Signs (posted at entrances to labs), Biohazard Labels, Autoclave, and Lab coats

Each and every laboratory that handles biohazardous agents contains these items (except for the autoclaves which are located centrally in 320 SEB and lab coats issued to employees)

Campus Cleaning Restroom clean, trash removal, lab cleaning, GHC cleaning, cleaning up after injuries involving blood

Gloves, Biohazard Bags/ Hampers, Goggles, and Sharps Safes

Campus Cleaning Supervisors’ Office, GHC, and Custodial Carts

Campus Recreation First Aid, Lactate Testing, uniform & towel handling/cleaning, cleaning up after blood/OPIM incidents

Gloves, Sharps Safes, Goggles, Biohazard Bags/Hampers

Training Room, Aquatic Operations Office, Equipment Room

Chemistry Purification of lymphocytes from blood of human volunteers in 208 and 210 SEB.

Gloves, Goggles, Sharps Safes, Gloved Laminar Flow Hood, Lab Coats, biohazard bags/boxes

208 and 210 SEB (laminar flow hood in 210 SEB)

Education, School of Student Interns assist with child injuries (e.g., first aid/CPR)

As appropriate based on judgements of Host Facilities

Host Facilities supply onsite

Eye Research Institute Dissection of Human Eye Tissue and Culture in 427 DHE and Processing of Human Eye Tissue Cells in Room 419 DHE.

Gloves, Goggles, Biosafety Cabinet, Biohazard Bags/Hampers, Biohazard Signs (posted at entrances to labs), Biohazard Labels

Every laboratory that handles biohazardous agents contains these items

Graham Health Center Drawing Blood, Handling Lab Specimens (e.g., blood, urine, etc.), Minor Office Surgeries, Office Procedures, Cleaning exam/trt rms.

“BD Eclipse” blood collection needles”, Gloves, Masks, Sharps Safes, Biohazard Bags/Hampers, Goggles, Lab Coats, Gowns

Exam/Treatment Rooms

Grounds Maintenance ----------------------------- Vehicle Maintenance

Litter Pick-up, Trash Container Bag Removal, Trash Removal/ -------------------------------------------- Cleaning vehicles contaminated with blood or OPIM

Gloves and Hand-held litter tool, Biohazard Bags/Hampers ------------------------------------- Gloves, goggles

BGM Building

Health Sciences - Exercise Science

CPR/First Aid performed by Student Interns at Host Facilities; venipuncture and finger-sticks performed in rm 207 HHS or occasionally in the field

Hosts deem appropriate PPE for interns; PPE for VeniPunc includes “BD Eclipse” blood collection needles, gloves, sharp safes, goggles, lab coats and biohaz bags/hampers

Host Facilities supply PPE onsite for interns; on-site PPE for venipuncture located in Room 207 HHS, or taken to field sites where tasks are being performed

Health Sciences - Medical Laboratory Sciences

Phlebotomy Instruction, Hematology Instruction, Clinical Analysis (instructional purposes), Washing lab glassware, Venipuncture and Urinalysis

“BD Eclipse” blood collection needles, Gloves, Wrap-around Goggles, Biohazard Bags/Hampers, Biohazard Labels, Lab coats

Phlebotomy Classrooms and carts, 310 HHS and 373 HHS, and Lab coats issued to employees



TABLE 4 Tasks which May Present BBP Exposure and the PPE/Engineering Used to Control

(in alpha order by dept.) Department Tasks Which May Present

Occupational Exposure PPE and Engineering

Controls Used

Location of PPE and Engineering Controls

Laboratory Animal Management Services (LAMS)

Assisting med personnel using sharps (including surgery), handling infectious animals

Gloves, Masks, Goggles, Biohazard Bags and Hampers, Sharps Safes, Biohazard Signs (posted at entrances to labs), Biohazard Labels, Autoclave, Bleach/Ethanol (for wiping down BSC2), and Lab coats

Biomedical Research Support Facility

Lowry Early Childhood Center

First Aid, CPR, cleaning up blood, injections, and bites.

Gloves, CPR Masks, Goggles, Biohazard Bags & Hampers, and Sharps Safes.

Kitchen and Custodial Closet

Meadow Brook Hall Cleaning Restrooms, Emptying Trash, Groundskeeping

Gloves, Goggles, Sharps Safes, Biohazard Bags/Hampers

Telephone Supply Room at MBH

Mechanical Maint Plumbing and pipefitting in high risk areas (e.g., & restrms and labs)

Gloves, Goggles Police and Support Services Bldg

Nursing, School of Clinical Instruct and Patient care at off-site health care facilities

Provided by off-site facilities Off-site

Oakland Center Restroom clean, trash removal, Cleaning up after injuries involving blood, Trash Compaction

Gloves, Masks, Goggles, Bleach, Biohazard Bags/Hampers, Sharps Safes

OC Maintenance Shop and each custodial cart (except for hampers which are maintained in Shop)

Police Department Accident Investigation, Treating Injured Persons, Processing Injured Victims or Injured Suspects, Subject or Vehicle Searches, Crime Scene Investigations, Evidence Processing, CPR/First Aid, Apprehending Suspects in High Risk Grps who are Resisting Arrest, Delivering Babies, Crowd Control

Gloves, Masks, Goggles, Biohazard Bags/Hampers, Sharps Safes, Biohazard Labels/Signs, CPR masks (with valves)

Police Station and all Officer/Patrol Units have all of these items (except for biohazard labels and hampers, which are only located in the Station)

Residence Halls Clean and Maintenance

Trash Removal, Restroom Cleaning, Cleaning up after Injuries Involving Blood, Plumbing in high risk areas (e.g., & restrms and labs)

Gloves, Biohazard Bags/ Hampers, Goggles, Sharps Safes

Custodial Carts and assigned rooms


4.3.3 Rules Governing Engineering Controls and Personal Protective Equipment 4.3.3.1 Selection: These responsible persons listed in Table 1 (Section 2.0) are required to

consult with their staffs to identify what engineering controls and personal protection equipment are necessary on an ongoing basis through employee communication, observation and annual EH&S training sessions. EH&S will also help to ensure effective implementation of these recommendations.

4.3.3.2 Maintenance: Sharps disposal containers are inspected, maintained and replaced by the

responsible persons identified in Table 1 (Section 2.0) as needed to prevent overfilling. 4.3.3.3 Training: Training in the use of the appropriate PPE for the tasks or procedures

employees will perform is provided by the responsible persons (or their designees) identified in Table 1 (Section 2.0).

4.3.3.4 All employees using PPE are required to observe the following precautions:

• Wash hands immediately or as soon as feasible after removal of gloves or other PPE

• Remove PPE after it becomes contaminated, and before leaving the work area

• Used PPE may be disposed of in the red biohazard bags available in each department • Wear appropriate gloves when it can be reasonably anticipated that there may be hand

contact with blood or OPIM, and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured, contaminated, or if their ability to function as a barrier is compromised

• Utility gloves may be decontaminated for reuse if their integrity is not compromised;

discard utility gloves if they are cracking, peeling, tearing, puncturing, or deterioration

• Never wash or decontaminate disposable gloves for reuse

• Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets of blood or OPIM pose a hazard to the eye, nose, or mouth

• Remove immediately or as soon as feasible any garment contaminated by blood or

OPIM, in such a way as to avoid contact with the outer surface 4.3.3.5 Exceptions to Use: If an employee decides against using personal protective equipment

under rare and extraordinary circumstances (e.g., would have prevented delivery of health care or public safety services, or would have posed increased hazard to safety of employee), the employee is required to complete a PPE Use Exception Form (found in the Appendices of this document) and submit it to his/her supervisor. This form is then carefully reviewed by the employee, his/her supervisor, and the Office of EH&S to determine whether changes could be instituted to prevent such occurrences in the future.


5.0 Biohazardous Waste 5.1 Contaminated sharps are managed as follows:

• Broken glassware which may be contaminated is picked up using mechanical means, such as a brush and dust pan.

• All contaminated sharps are discarded immediately or as soon as possible into “Sharps

Safes”, which are available in the locations identified in Table 4 (of this Section 5.0). 5.2 Contaminated laundry is managed as follows:

• Sent out to those laundry facilities in the area willing and able to handle Biohazardous laundry. The Graham Health Center or EH&S can provide the name(s) of current facilities who perform this function.

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

bags and hampers are available in the locations identified in Table 4.

• Handled as little as possible by OU employees, and never taken home for laundering. 5.3 Biohazard Bags, Hampers and Sharps Safes containing biohazardous waste are...

• Maintained upright at all times • Replaced routinely and not overfilled, and • Closed prior to removal to prevent spillage or protrusion of contents during handling • Transported to the Office of EH&S when full as follows:

o An "OU Medical Waste Internal Tracking Form" (Print Shop - order #001623) shall be completed for each "drop-off" (regardless of the number of containers), and brought (with the waste) to the Office of Environmental Health and Safety, in the Graham Health Center.

o An individual from the Office of Environmental Health and Safety will review the manifest, keep two copies, and issue the bearer a key to the Phoenix Cage (located in the basement of the Graham Health Center).

o At the time of drop-off, departments may also pick up empty biohazard hampers and/or bags from the Phoenix Cage as needed. The Biohazard hampers and bags are available at no charge; sharp safes can be ordered from most custodial/safety suppliers.

o Once every two weeks, Stericycycle® shall remove the hampers/sharp safes from the Phoenix Cage, and transport them first to the BFI Medical Treatment Center in Toledo, Ohio (for high-temperature decontamination), and then to the Vienna Junction Sanitary Landfill, in Erie Michigan, for land disposal as non-hazardous waste.


6.0 CONTAMINATED EQUIPMENT Responsible persons identified in Table 1 (Section 2.0) will ensure warning labels are affixed to, or red bags are used for, all biohazardous waste and/or contaminated equipment. If labels are not available in the department, the responsible person may contact the Office of Environmental Health and Safety for assistance in obtaining one. Employees are to notify their supervisors and/or the Office of Environmental Health and Safety if they discover regulated waste containers, refrigerators containing blood or OPIM, contaminated equipment, etc. without proper biohazard labels. 7.0 CLEANING UP SPILLS 7.1 Washable Surfaces: Contaminated equipment, floors, surrounding surfaces etc. shall be

cleaned up (in such a manner that spreading, splashing, etc. the material is prevented) while wearing gloves and goggles, and using a ratio of ¼⎟2½ cups of bleach for every 1 gallon of water, allowing10 minutes for disinfection to occur; after which any/all contaminated waste is placed in the proper biohazard receptacles. Broken glassware must be picked up using mechanical devices ONLY such as brush/dust pan, tongs, forceps, etc.

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

“Zgoop”), let dry, and area vacuumed. Germicidal carpet shampoo is then applied and the area vacuumed again. Broken glassware must be picked up using mechanical devices ONLY such as brush/dust pan, tongs, forceps, etc.

8.0 HEPATITIS B VACCINATION Included in new employee and annual refresher BBP exposure control training will be comprehensive information regarding hepatitis B vaccinations, including its safety, benefits, efficacy, methods of administration, and availability at no cost to the employees. Training in this regard includes, but is not limited to, the following information: 8.1 Pre-Exposure Vaccinations: The hepatitis B vaccination series shall be made available

at no cost to all “eligible” employees in Tables 2 and 3 (i.e.,those employees for whom exposure to BBPs is a primary function of their job descriptions ), after training and within 10 days of initial assignment.

8.1.1 Contraindications to Vaccination: Vaccinations are encouraged unless:

1) documentation exists that the employee has previously received the series, 2) antibody testing (i.e., a “titer”) reveals that the employee is immune, or 3) medical evaluation shows that the vaccination is contraindicated.

8.1.2 Declining the Vaccination: If an employee chooses to decline vaccination, the

employee must sign a “Hepatitis B Declination Form” (blank form found in the Appendices of this document). Employees who decline may request and obtain the vaccination at a later date at no cost to themselves (assuming their occupational responsibilities continue to present risk of exposure). Declination Forms are kept in the OEHS. Vaccinations are provided at OU’s Graham Health Center or the employee’s facility of choice.


8.1.3 Health Care Professional Written Opinion: Prior to vaccination, the Health Care Professional shall provide a written opinion, indicating that (based on consultation) the employee presents no medical contra-indications to vaccination.

8.2 Post-Exposure Vaccinations: For those employees for whom exposure to BBPs

(generally via first-aid/CPR activities) is a collateral function of their job descriptions (e.g., coaches, trainers, day care professionals, etc.), the hepatitis B vaccination is not offered free of charge until AFTER these employees are involved in an incident where human blood or OPIM is present (regardless of whether an exposure incident occurred); these vaccinations are highly effective if administered within 1 to 7 days of the incident.

9.0 EXPOSURE INCIDENT RESPONSE AND FOLLOW-UP 9.1 Exposure incident - First Response

Should an “exposure incident” occur (i.e., unprotected skin, eye or mucous membrane contact human blood or OPIM), the employee shall contact the responsible person identified in Table 1 (Section 2.0) from his/her department and/or the Officeof EH&S. Following IMMEDIATE first aid (cleaning the wound with soap and water, flushing eyes or other mucous membrane for 15 minutes), this person shall perform the following activities:

• Ensure that employee goes to a hospital emergency room WITHIN 2 hours of the

incident in order to obtain anti-viral drugs and baseline blood testing. NOTE: If the employee does not give consent for HIV serological testing during collection of blood for baseline testing, the baseline blood sample must be preserved for ∃ 90 days; if the exposed employee elects to have the baseline sample tested during this waiting period, testing shall be performed ASAP.

• Ensure that, when it is convenient and reasonable, employee documents several

pieces of critical information (preferably in time to show to treating physician), using OU’s Exposure Incident Report Form (found in the Appendices of this Document). This Exposure Incident Report Form requests the following information (and shall also be used by the Office of Environmental Health and Safety to evaluate the circumstances of the incident, generate ideas for prevention, modify the ECP, etc.):

o engineering controls in use at the time o work practices followed o a description of the activity that preceded the exposure incident o protective equipment or clothing that was used at the time of the incident o location of the incident o procedure being performed when the incident occurred o route of exposure

• Identify and document the source individual (unless the employer can establish that

identification is infeasible or prohibited by state or local law).


• Obtain consent (using a consent form found in the Appendices of this document) and make arrangements to have the source individual tested as soon as possible to determine HIV, HCV, and HBV infectivity; and document that the source individual's test results were conveyed to the employee's health care provider.

• Ensure that the exposed employee is provided with the source individual's test results

and with information about applicable disclosure laws and regulations concerning the identity and infectious status of the source individual (e.g., confidentiality laws).

9.2 Post-Exposure Evaluation and Follow-up 9.2.1 Supervisory Responsibilities: Responsible persons identified in Table 1 (Section 2.0)

are required to ensure that any/all health care professionals responsible for follow-up care (following an exposure incident and initial testing/treatment) are provided:

• A copy of the (completed) Exposure Incident Report Form;

• A copy of OSHA’s Bloodborne Pathogens Standard;

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

• Relevant employee medical records, including vaccination status.

9.2.2 Written Opinions: The employee should then receive a copy of Health Care

Professional(s) written opinion within 15 days after completion of the evaluation. 9.2.3 Follow-up Care: Any/all follow-up testing, treatment, counseling, etc. shall be funded

by Oakland University (department); employees shall bear none of the cost whatsoever. 10.0 EMPLOYEE TRAINING 10.1 When and How Often: All employees who have occupational exposure to bloodborne

pathogens receive training before they conduct any activities which could pose exposure to BBPs, and annually thereafter.

10.2 Who Conducts Training: BBP Exposure Control Training for new employees and

annual refresher training is conducted by responsible persons identified in Table 1 (Section 2.0) or a qualified designee(s). These “trainers” were all trained and examined by representatives of Environmental Health and Safety (or a qualified designee), and have had a reasonable amount of hands-on experience understanding, applying and implementing the OSHA BBP Standard.

10.3 Elements of Training: Included in the training is/are the epidemiology, symptoms, and transmission of bloodborne pathogen diseases. In addition, the training program covers, at a minimum, the following elements: • copy and explanation of the standard • detailed information on HBV, HCV and HIV (signs, symptoms, treatments, etc.) • explanation of OU’s ECP and how to obtain a copy • explanation of methods to recognize tasks and other activities that may involve

exposure to blood and OPIM, including what constitutes an exposure incident • explanation of the use/limitations of engineering controls, work practices and PPE • explanation of the types, uses, location, removal, handling, decontamination, and

disposal of PPE • explanation of the basis for PPE selection • information on the hepatitis B vaccine, including information on its efficacy, safety,

method of administration, benefits of being vaccinated, and that the vaccine will be offered free of charge

• information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM

• explanation of the procedure to follow if an exposure incident occurs • information on the post-exposure evaluation and follow-up that the employer is

required to provide for the employee following an exposure incident • explanation of signs, labels and color coding required by the standard and used at OU • an opportunity for interactive questions and answers with the trainer.

11.0 RECORD KEEPING 11.1 Training Records: Training records are completed for each employee upon completion

of training. These documents will be kept for at least three years in the Office of Environmental Health and Safety. Training records include for each employee a Declaration Form which documents the following:

• the employee name • the date of the training sessions • the contents or a summary of the training sessions • the name and qualifications of persons conducting the training • whether the employee accepted or declined the Hep B vaccination (separate Hep B

Declination Form provided to all who decline).

Employee training records are provided upon request to the employee or the employee's authorized representative within 15 working days. Such requests should be addressed to the Office of Environmental Health and Safety.

11.2 Medical Records: Medical records are maintained for each employee with occupational

exposure in accordance with 29 CFR 1910.20, "Access to Employee Exposure and Medical Records." OU’s Human Resources Department is responsible for maintenance of the required medical records for at least the duration of employment plus 30 years.


11.3 Exposure Incident Evaluation Records: Once an exposure incident (and the associated Exposure Incident Report Form) has been evaluated, and any Program modifications put into place, these records are maintained in the Office of Environmental Health and Safety.

12.0 CONDITIONS FOR LABS WORKING WITH HIV AND HEPATITIS VIRUSES 12.1 Working in HIV and Hepatitis Virus "production facilities".

"Production facility" is defined by OSHA as a facility engaged in industrial-scale, large-volume or high concentration production of HIV or Hepatitis Viruses. These activities are not currently (as of this July 2000 printing) permitted at OU.

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

in the culture, production, concentration, experimentation and manipulation of HIV or Hepatitis Viruses”. Does NOT apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues or organs).

12.2.1 Minimum Requirements for laboratories engaging in HIV or Hepatitis Virus Research

• Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area.

• An autoclave for decontamination of regulated waste shall be available. • All regulated waste shall either be incinerated or decontaminated by a method such as

autoclaving known to effectively destroy bloodborne pathogens.

12.2.2 Special Practices

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

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

• Access to the work area shall be limited to authorized persons. Written policies and

procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas.

• When other potentially infectious materials or infected animals are present in the work

area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors.

• All activities involving other potentially infectious materials shall be conducted in

biological safety cabinets or other physical-containment devices within the containment module; never on the open bench.



• Laboratory coats, gown, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animals rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered.

• Special care shall be taken to avoid skin or mucous membrane contact with other potentially infectious materials - Use gloves and goggles.

• Before disposal, all waste from work areas and from animals rooms shall be decontaminated by a method, e.g., autoclaving, known to effectively destroy BBPs.

• Vacuum lines shall be protected with liquid disinfectant traps and high efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary.

• Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units shall be used for the injection or aspiration of other potentially infectious materials.

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

• All spills shall be immediately contained and cleaned up by professional staff properly trained/equipped to handle potentially concentrated infectious materials.

• A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person.

• Employees are required to reference the Oakland University Biosafety Manual for instructions on practices and procedures for work with HIV or Hepatitis viruses, and follow these procedures. Additionally, an application for use with any infectious agents (excluding clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues or organs) must be submitted to the Oakland University Biosafety Committee; and activities may not commence until the Committee has approved the research activities in writing.

12.2.3 Signs The PI or laboratory supervisor shall complete and post the following sign(s) (available

in the Office of EH&S) at the entrance to all HIV and/or Hepatitis virus research labs: 12.2.4 Containment Equipment

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

• Biological safety cabinets shall be certified upon installation, whenever they are

moved and at least annually. 12.2.5 Training Requirements.

• Additional initial training for employees in HIV, HBV or HBC research laboratories shall receive the following initial training in addition to the general training described in Section 11.0.

• Employees must demonstrate proficiency in standard microbiological practices and

techniques and operations specific to the facility before being allowed to work with HIV, HBV or HBC.

• Employees must have prior experience in the handling of human pathogens or tissue

cultures before working with HIV, HBV or HCV, or ...

• Employees (through their supervisors, the OEHS or the OGCSR) must arrange for a training program if/when they have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. Employees may not participate in work activities involving infectious agents until proficiency has been demonstrated.


APPENDICES

BLANK FORMS: • Sharps Injury Log (Type I for Non-Laboratories)

• Sharps Injury Log (Type II for Laboratories) • Training and Hep B Declaration Form

• Hep B Declination Form

• Hepatitis B Vaccination - Status Form • Exposure Incident Report Form

• Post-Exposure Incident Checklist

• Sharps Injury Log (Type I)

• Sharps Injury Log (Type II)

• Blood Draw Consensus Form - Source Individual

• PPE Exception Form

• Research Activities Involving Direct Manipulation of Bloodborne Pathogens - Report Form

COMPLETED FORMS (WHERE APPLICABLE - DEPT. SPECIFIC): • Pre-exposure Hepatitis B Vaccination - Status Form

• Completed Hepatitis B Declaration/Declination Forms

• Exposure Incident Report Form

• Post-Exposure Incident Checklist

• Blood Draw Consensus Form - Source Individual

• PPE Exception Form

• Research Activities Involving Direct Manipulation of Bloodborne Pathogens - Report Form

UNIVERSAL PRECAUTIONS OSHA BLOODBORNE PATHOGENS STANDARD

Oakland University Graham Health Center

Sharps Injury Log Page _____

Date of Incident

Name of Injured Job Title of Injured

Type of Needle Involved

Describe how Needle stick

Occurred

Steps taken Immediately After Stick

Steps taken to Avoid Future Needle sticks

BBP TRAINING AND HBV VACCINATION DECLARATION FORM

Oakland University Training Date Department ____________________________________ Name Job Classification __________________________ TRAINING: I hereby certify that I have received training in bloodborne pathogens exposure control. This training included providing me a copy of the BBP Exposure Control Standard, and an explanation of the following: OU’s Exposure Control Plan and how to obtain a copy; details regarding transmission, signs, symptoms and prognoses of common BBP viruses (i.e., HBV, HCV and HIV); common methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident, the use and limitations of engineering controls, work practices and personal protective equipment (PPE); the types, uses, location, removal, handling, decontamination and disposal of PPE; the basis for PPE selection; the hepatitis b vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine is offered free of charge under certain circumstances; the appropriate actions to take and persons to contact in an emergency involving blood or OPIM; the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available; information on the post-exposure evaluation and follow-up that OU is required to provide me following an exposure incident; the signs and labels and/or color-coding required by the BBP Standard and OU. I further certify that I was provided ample opportunity for interactive questions and answers with the person(s) conducting the training session. The training was provided to me by “qualified” personnel as follows: General information regarding BBP viruses and exposure control was provided to me by OU’s Office of Environmental Health and Safety, either in person or via a handout generated by the Officeof EH&S and provided me by my supervisor. This EH&S training staff has had extensive formal training in, and experience with, interpreting and implementing the BBP Standard, and designing and providing training in this area. Site-specific information, regarding BBP exposure control in my department as it relates to the occupational activities I perform, was subsequently provided me by my supervisor (who received his/her guidance, training and handouts directly from the Office of EH&S). HEPATITIS B VACCINATION: While the HBV vaccine is well tolerated by most people, and provides significant protection against acquiring HBV-related illnesses, vaccination has some inherent risks (including, but not limited to, swelling, reddening, post injection soreness, body fatigue, headache, muscle or joint soreness), as well as some medical contra-indications (including, but not limited to, high blood pressure, allergies to yeast/mold, pregnancy), so I understand that my health care professional (in conference with myself) shall decide and document whether it is safe for me to obtain the HBV vaccination. I have read each option below and understand each of them. I have selected ONE option by placing a Τ. I also understand that I may change my mind at any time. Finally, if I select Option 2. below, I understand that I

ust also complete a SEPARATE Hepatitis b Declination form. m 1. ______ I would like to have OU pay for my HBV vaccination series; I understand that MIOSHA requires me

to begin the immunization process within 10 calendar days of accepting this vaccination. 2. ______I decline to have OU pay for my HBV vaccinations because (place a Τ in appropriate blank below).

________ a) I have already been immunized;

OR ________ b) I would like OU to pay for the antibody test (i.e., “titer”) performed before deciding; OR ________ c) cost of said immunization is 100% funded by another source (e.g., medical insurance); OR _

I understand that if I select this Option, I must also complete a separate Hepatitis B Declination Form 3. _____ Based on my OU job classification (identified above), my “PRIMARY” occupational duties do not

present “reasonably anticipated exposure to blood or OPIM”, and I am therefore not eligible to receive “pre-exposure” hepatitis b vaccination funding. I understand, however, that should I be involved in any occupational incident that involves human blood or OPIM (regardless of whether “exposure” occurs), I am then eligible to receive (at no cost) an accelerated series of hepatitis b vaccinations, which should begin within 24 hours, but up to 7 calendar days, after the incident. Note: Those who are required, encouraged and/or allowed to provide first-aid on campus as a “collateral” job responsibility (for example, athletic coaches) would select this Option.

SIGNED: DATE: ______________

[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 Oakland University - School of Nursing

Training Date Name __________________________________ TRAINING: I hereby certify that I have received training in bloodborne pathogens exposure control. This training included providing me a copy of the BBP Exposure Control Standard, and an explanation of the following: OU’s Exposure Control Plan and how to obtain a copy; details regarding transmission, signs, symptoms and prognoses of common BBP viruses (i.e., HBV, HCV and HIV); common methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident, the use and limitations of engineering controls, work practices and personal protective equipment (PPE); the types, uses, location, removal, handling, decontamination and disposal of PPE; the basis for PPE selection; the hepatitis b vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine is offered free of charge under certain circumstances; the appropriate actions to take and persons to contact in an emergency involving blood or OPIM; the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available; information on the post-exposure evaluation and follow-up that OU is required to provide me following an exposure incident; the signs and labels and/or color-coding required by the BBP Standard and OU. I further certify that I was provided ample opportunity for interactive questions and answers with the person(s) conducting the training session. The training was provided to me by “qualified” personnel as follows: General information regarding the BBP Exposure Control Standard, transmission and signs/symptoms of common BBP Viruses (e.g., HBV, HCV and HIV) was provided to me by either in person, and/or via live instruction, video-tape, or handout, by a Nursing Department faculty member (in conjunction with OU’s Office of Environmental Health and Safety). The Office of EH&S training staff has had extensive formal training in, and experience with, interpreting and implementing the BBP Standard; likewise Nursing Department faculty members, based on the nature of their nursing educations, are naturally well versed in BBP Exposure Controls. I further understand that the responsibility for site-specific training (as it relates to the actual duties I perform at my site(s) of employment) is/was the responsibility of similarly qualified nursing administrators/supervisors at the facilities at which I perform these duties. HEPATITIS B VACCINATION: While the HBV vaccine is well tolerated by most people, and provides significant protection against acquiring HBV-related illnesses, vaccination has some inherent risks (including, but not limited to, swelling, reddening, post injection soreness, body fatigue, headache, muscle or joint soreness), as well as some medical contra-indications (including, but not limited to, high blood pressure, allergies to yeast/mold, pregnancy), so I understand that my health care professional (in conference with myself) shall decide and document whether it is safe for me to obtain the HBV vaccination. I have read each option below and understand each of them. I have selected ONE option by placing a Τ. I also understand that I may change my mind at any time. Finally, if I select Option 2. below, I understand that I must also complete a SEPARATE “Hepatitis b Declination Form”. 1. ____I would like to have OU pay for my HBV vaccination series; I understand that MIOSHA requires me to begin the

immunization process within 10 calendar days of accepting this vaccination series. 2. _____I decline to have OU pay for my HBV vaccinations because (place a Τ in appropriate blank below).

_____ a) I have already been immunized; OR _____ b) I would like OU to pay for the antibody test (i.e., “titer”) performed before deciding; OR _____ c) cost of said immunization is 100% funded by another source (e.g., medical insurance); OR _____ d) personal reasons I understand that if I select Option 2., I must also complete a separate Hepatitis B Declination Form: 3. ______Based on my OU job classification (identified below), my occupational duties do not present “reasonably anticipated

exposure to blood or OPIM”, and I am therefore not eligible to receive “pre-exposure” hepatitis b vaccination funding. I understand, however, that should I be involved in any occupational incident that involves human blood or OPIM (regardless of whether “exposure” occurs), I am then eligible to receive an accelerated series of hepatitis b vaccinations, which should begin within 24 hours (but up to 7 days) after the incident.

SIGNED: DATE: ______________________________ J ob Classification [PLEASE CHECK ONE]:

_____ Learning Resources Lab Instructor _____ Clinical Instructor _____ Other (specify here) ________________________________

HBV VACCINATION DECLINATION FORM

I understand that, due to my occupational exposure to blood or other potentially infectious materials, I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that my declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials (OPIM) and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me. Name (printed) ______________________________________ Department _________________________________________ Job Classification ____________________________________ Signature ____________________________________________________________________________ [Requires signature of Legal Guardian if under age 18 - print words “legal guardian” next to signature if applicable] Social Security Number (REQUIRED BY MIOSHA) __________________________

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

"PRE-EXPOSURE" HEPATITIS B VACCINATION STATUS FORM

Department ______________________________________________________

ELIGIBLE EMPLOYEE

NAME

ACCEPTED/ DECLINED

VACCINATION and DATE DECIDED

DATES VACCINE

RECEIVED #1/#2/#3

ADMINISTERING HEALTH

CARE FACILITY

EXPOSURE INCIDENT REPORT FORM

Date of Incident Time of Incident _________________________ Job site/location: Name of Employee____________________________ Job Description (Description of General Duties): ________________________________________ Potentially Infectious Material Involved (e.g. blood etc.) _________________________________ Source of Potentially Infectious Material (e.g. needle-stick, cut, bite etc.) ____________________ Circumstances Surrounding Exposure Incident (e.g. work being performed etc.) _______________ _______________________________________________________________________________ Route of Exposure (e.g. under-the-skin, unprotected skin, eyes, nose, mouth) _________________ _______________________________________________________________________________ How Exposure Occurred (e.g. equipment malfunction, human error, etc.) ____________________ _______________________________________________________________________________ Personal Protection Equipment Worn at Time of Incident ________________________________ _______________________________________________________________________________ _______________________________________________________________________________ Actions Taken at Time of Incident (e.g. soap/water clean-up, reporting to supervisor etc.) _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ Recommendations for Avoiding Repetition: ___________________________________________ _______________________________________________________________________________ _______________________________________________________________________________

POST-EXPOSURE INCIDENT CHECKLIST

The following steps must be taken, and information provided, in the event of an employee's exposure to blood or other potentially infectious material. Date of Exposure Incident _______________________________

ACTIVITY COMPLETION

• Contaminated area was washed with soap and water (or eyewash if the eye) for at least 15 minutes.

____________

• Employee transported to emergency room within 2 hours of incident for anti-viral drugs (following washing/flushing described above).

____________

• Employee furnished with documentation regarding exposure incident. ____________

• The following documentation was forwarded to a Healthcare Professional who is evaluating employee:

o Bloodborne Pathogens Standard

o Exposure Incident Report

o Employee’s medical records

____________

____________

____________

• Source Individual:

o Identified OR it was determined that ID was not feasible (circle one)

o Authorization to collect blood requested

o Blood tested OR authorization refused (circle one)

____________

____________

____________

• Source individual’s blood results given to exposed employee ____________

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

Authorization to Have Blood Drawn and Analyzed for Presence of Viral Infection

Source Individual Consent Form

1. Individual's Name

S ocial Security Number Date of Birth

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

for the presence of viral (i.e., HBV or HIV) infection. 3. I understand that the results of this analysis shall be made available to the individual who has been

exposed to my blood (in addition to his/her health care provider), and maintained in that individual's CONFIDENTIAL medical records on file at OU.

4. I agree that a photocopy or facsimile of this authorization shall be as valid as the original. __________________________________________________ _________________________ Signed (source individual) Date ____________________________________________________ _________________________ Parent or guardian (if individual is under 18 years of age) Date

PPE EXCEPTION FORM

Name of Individual Completing Form On (date) __________________________ I voluntarily and knowingly chose against wearing Personal Protective Equipment (PPE) even though I was aware that the task I was performing introduced a risk of exposure to Bloodborne Pathogens. In my judgement, in this specific instance, obtaining/using PPE would have (check one): _____ prevented the delivery of health care or public safety services; _____ posed an increased hazard to the safety of a victim, myself or coworker(s); or ______ other, explain in next paragraph. Description of task I was performing, and detailed reason for choosing against PPE:

______________________________________________________________________________________

__________________________________________________________________________________

Suggestions for avoiding this situation in the future: _________________________________________________________________________________ _________________________________________________________________________________ Signed Date Co-Signed Employee Supervisor Date

RESEARCH ACTIVITIES INVOLVING DIRECT MANIPULATION OF

BLOODBORNE PATHOGENS REPORT FORM

Department:

“MANIPULATION” PROCEDURE(S)

(e.g. assay, culture, centrifuge, etc.)

BLOODBORNE PATHOGENS

BEING MANIPULATED

LOCATION(S) PERFORMED

REC’D OU BIOSAFETY

COMMITTEE APPROVAL (Date and PI

signature)

* “Manipulation” includes, but is not limited to, culturing, assaying, centrifuging, handling, pipetting etc. of infectious organisms carried in human blood.

"UNIVERSAL” BLOOD AND BODY FLUID

PRECAUTIONS

+ OSHA BLOODBORNE PATHOGEN

STANDARD [29 CFR 1910.1030]

OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. - 1910.1030

Standard Number: 1910.1030 Standard Title: Bloodborne pathogens. SubPart Number: Z SubPart Title: Toxic and Hazardous Substances (a) Scope and Application. This section applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section. (b) Definitions. For purposes of this section, the following shall apply: "Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative. "Blood" means human blood, human blood components, and products made from human blood. "Bloodborne Pathogens" means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). "Clinical Laboratory" means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. "Contaminated" means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. "Contaminated Laundry" means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. "Contaminated Sharps" means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. "Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy

bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. "Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative. "Engineering Controls" means controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace. "Exposure Incident" means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. "Handwashing Facilities" means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines. "Licensed Healthcare Professional" is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up. "HBV" means hepatitis B virus. "HIV" means human immunodeficiency virus. "Occupational Exposure" means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.

"Other Potentially Infectious Materials" (OPIM) means (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. "Parenteral" means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions. "Personal Protective Equipment" is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. "Production Facility" means a facility engaged in industrial-scale, large-volume or high concen. produc. of HIV or HBV. "Regulated Waste" means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. "Research Laboratory" means a laboratory producing or using research-laboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities.

"Source Individual" means any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the

employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of

drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components.

"Sterilize" means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. "Universal Precautions" is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. "Work Practice Controls" means controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique). (c) Exposure Control. (c)(1) Exposure Control Plan. (c)(1)(i) Each employer having an employee(s) with occupational exposure as defined by paragraph (b) of this section shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure. (c)(1)(ii) The Exposure Control Plan shall contain at least the following elements: (c)(1)(ii)(A) The exposure determination required by paragraph (c)(2), (c)(1)(ii)(B) The schedule and method of implementation for paragraphs (d) Methods of Compliance, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, (g) Communication of Hazards to Employees, and (h) Recordkeeping, of this standard, and (c)(1)(ii)(C) The procedure for the evaluation of circumstances surrounding exposure incidents as required by paragraph (f)(3)(i) of this standard. (c)(1)(iii) Each employer shall ensure that a copy of the Exposure Control Plan is accessible to employees in

accordance with 29 CFR 1910.1020(e). (c)(1)(iv) The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure. (c)(1)(v) The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying. (c)(2) Exposure Determination. (c)(2)(i) Each employer who has an employee(s) with occupational exposure as defined by paragraph (b) of this section shall prepare an exposure determination. This exp. determ. shall contain the following: (c)(2)(i)(A) A list of all job classifications in which all employees in those job classifications have occupational exposure; (c)(2)(i)(B) A list of job classifications in which some employees have occupational exposure, and (c)(2)(i)(C) A list of all tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(B) of this standard. (c)(2)(ii) This exposure determination shall be made without regard to the use of personal protective equipment. (d) Methods of Compliance. (d)(1) General. Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid

types is difficult or impossible, all body fluids shall be considered potentially infectious materials. (d)(2) Engineering and Work Practice Controls. (d)(2)(i) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used. (d)(2)(ii) Engineering controls shall be examined and maintained or replaced on a regular schedule to ensure effectiveness. (d)(2)(iii) Employers shall provide handwashing facilities which are readily accessible to employees. (d)(2)(iv) When provision of handwashing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible. (d)(2)(v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. (d)(2)(vi) Employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials. (d)(2)(vii) Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is prohibited. (d)(2)(vii)(A) Contaminated needles and other contaminated sharps shall not be bent, recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.

(d)(2)(vii)(B) Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique. (d)(2)(viii) Immediately or as soon as possible after use, contaminated

reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be: (d)(2)(viii)(A) puncture resistant;

(d)(2)(viii)(B) labeled or color-coded in accordance with this standard; (d)(2)(viii)(C) leakproof on the sides and bottom; and

(d)(2)(viii)(D) in accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps. (d)(2)(ix) Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. (d)(2)(x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. (d)(2)(xi) All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. (d)(2)(xii) Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited. (d)(2)(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. (d)(2)(xiii)(A) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility.

(d)(2)(xiii)(B) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard. (d)(2)(xiii)(C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics. (d)(2)(xiv) Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. (d)(2)(xiv)(A) A readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to the equipment stating which portions remain contaminated. (d)(2)(xiv)(B) The employer shall ensure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. (d)(3) Personal Protective Equipment. (d)(3)(i) Provision. When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye

protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used. (d)(3)(ii) Use. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. When the employee makes this judgement, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future. (d)(3)(iii) Accessibility. The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided. (d)(3)(iv) Cleaning, Laundering, and Disposal. The employer shall clean, launder, and dispose of personal protective equipment required by paragraphs (d) and (e) of this standard, at no cost to the employee (d)(3)(v) Repair and Replacement. The employer shall repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employee.

(d)(3)(vi) If a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible. (d)(3)(vii) All personal protective equipment shall be removed prior to leaving the work area.

(d)(3)(viii) When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. (d)(3)(ix) Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may

have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in paragraph (d)(3)(ix)(D); and when handling or touching contaminated items or surfaces. (d)(3)(ix)(A) Disposable (single use) gloves such as surgical or examination

gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. (d)(3)(ix)(B) Disposable (single use) gloves shall not be washed or decontaminated for re-use. (d)(3)(ix)(C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised. (d)(3)(ix)(D) If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall: (d)(3)(ix)(D)(1) Periodically reevaluate this policy; (d)(3)(ix)(D)(2) Make gloves available to all employees who wish to use them for phlebotomy; (d)(3)(ix)(D)(3) Not discourage the use of gloves for phlebotomy; and (d)(3)(ix)(D)(4) Require that gloves be used for phlebotomy in the following circumstances: [i] When the employee has cuts, scratches, or other breaks in his or her skin; [ii] When the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and [iii] When the employee is receiving training in phlebotomy. (d)(3)(x) Masks, Eye Protection, and Face Shields. Masks in combination with eye protection devices, such as

goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. (d)(3)(xi) Gowns, Aprons, and Other Protective Body Clothing. Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. (d)(3)(xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, orthopaedic surgery). (d)(4) Housekeeping. (d)(4)(i) General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. (d)(4)(ii) All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. (d)(4)(ii)(A) Contaminated work surfaces shall be decontaminated with an appropriate disinfectant

after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning. (d)(4)(ii)(B) Protective coverings, such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift. (d)(4)(ii)(C) All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. (d)(4)(ii)(D) Broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps. (d)(4)(ii)(E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. (d)(4)(iii) Regulated Waste. (d)(4)(iii)(A) Contaminated Sharps Discarding and Containment. (d)(4)(iii)(A)(1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: [a] Closable;

[b] Puncture resistant; [c] Leakproof on sides and bottom; and [d] Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. (d)(4)(iii)(A)(2) During use, containers for contaminated sharps shall be: [a] Easily accessible to personnel and located as close as is feasible to the

immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries); [b] Maintained upright throughout use; and [c] Replaced routinely and not be allowed to overfill. (d)(4)(iii)(A)(3) When moving containers of contaminated sharps from the area of use, the containers shall be:

[a] Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping; [b] Placed in a secondary container if leakage is possible. The second container shall be: [i] Closable; [ii] Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and

[iii] Labeled or color-coded according to paragraph (g)(1)(i) of this standard. (d)(4)(iii)(A)(4) Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury. (d)(4)(iii)(B) Other Regulated Waste Containment. (d)(4)(iii)(B)(1) Regulated waste shall be placed in containers which are: [a] Closable; [b] Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; [c] Labeled or color-coded in accordance with paragraph (g)(1)(i) this standard; and [d] Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. (d)(4)(iii)(B)(2) If outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container shall be: [a] Closable; [b] Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; [c] Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and [d] Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. (d)(4)(iii)(C) Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. (d)(4)(iv) Laundry. (d)(4)(iv)(A) Contaminated laundry shall be handled as little as possible with a minimum of agitation. (d)(4)(iv)(A)(1) Contaminated laundry shall be bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use.

(d)(4)(iv)(A)(2) Contaminated laundry shall be placed and transported in bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. When a facility utilizes Universal Precautions in the handling of all soiled laundry, alternative labeling or color-coding is sufficient if it permits all employees to recognize the containers as requiring compliance with Universal Precautions. (d)(4)(iv)(A)(3) Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior. (d)(4)(iv)(B) The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. (d)(4)(iv)(C) When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i). (e) HIV and HBV Research Laboratories and Production Facilities. (e)(1) This paragraph applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard. (e)(2) Research laboratories and production facilities shall meet the following criteria: (e)(2)(i) Standard Microbiological Practices. All regulated waste shall either be incinerated or

decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. (e)(2)(ii) Special Practices (e)(2)(ii)(A) Laboratory doors shall be kept closed when work involving HIV or HBV is in progress. (e)(2)(ii)(B) Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area.

(e)(2)(ii)(C) Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms. (e)(2)(ii)(D) When other potentially infectious materials or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this standard. (e)(2)(ii)(E) All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench (e)(2)(ii)(F) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. (e)(2)(ii)(G) Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable. (e)(2)(ii)(H) Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. (e)(2)(ii)(I) Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary. (e)(2)(ii)(J) Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture-resistant container and autoclaved or decontaminated before reuse or disposal. (e)(2)(ii)(K) All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. (e)(2)(ii)(L) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person. (e)(2)(ii)(M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them. (e)(2)(iii) Containment Equipment. (e)(2)(iii)(A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. (e)(2)(iii)(B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. (e)(3) HIV and HBV research laboratories shall meet the following criteria: (e)(3)(i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area. (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: (e)(4)(i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes-change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area. (e)(4)(ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. (e)(4)(iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area. (e)(4)(iv) Access doors to the work area or containment module shall be self-closing. (e)(4)(v) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area. (e)(4)(vi) A ducted exhaust-air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area). (e)(5) Training Requirements. Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix). (f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up. (f)(1) General. (f)(1)(i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident. (f)(1)(ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are: (f)(1)(ii)(A) Made available at no cost to the employee; (f)(1)(ii)(B) Made available to the employee at a reasonable time and place; (f)(1)(ii)(C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional; and (f)(1)(ii)(D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f). (f)(1)(iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee. (f)(2) Hepatitis B Vaccination. (f)(2)(i) Hepatitis B vaccination shall be made available after the employee has received the training required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. (f)(2)(ii) The employer shall not make participation in a prescreening program a prerequisite for receiving hepatitis B vaccination.

(f)(2)(iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employer shall make available hepatitis B vaccination at that time. (f)(2)(iv) The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in Appendix A. (f)(2)(v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (f)(1)(ii). (f)(3) Post-exposure Evaluation and Follow-up. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements: (f)(3)(i) Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred; (f)(3)(ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law; (f)(3)(ii)(A) The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented. (f)(3)(ii)(B) When the source individual is already known to be infected with HBV or HIV, testing for the source individual's known HBV or HIV status need not be repeated. (f)(3)(ii)(C) Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. (f)(3)(iii) Collection and testing of blood for HBV and HIV serological status; (f)(3)(iii)(A) The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained. (f)(3)(iii)(B) If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. (f)(3)(iv) Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service; (f)(3)(v) Counseling; and (f)(3)(vi) Evaluation of reported illnesses. (f)(4) Information Provided to the Healthcare Professional. (f)(4)(i) The employer shall ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination is provided a copy of this regulation. (f)(4)(ii) The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information: (f)(4)(ii)(A) A copy of this regulation; (f)(4)(ii)(B) A description of the exposed employee's duties as they relate to the exposure incident; (f)(4)(ii)(C) Documentation of the route(s) of exposure and circumstances under which exposure occurred; (f)(4)(ii)(D) Results of the source individual's blood testing, if available; and (f)(4)(ii)(E) All medical records relevant to the appropriate treatment of the employee including vaccination status which are the employer's responsibility to maintain.

(f)(5) Healthcare Professional's Written Opinion. The employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the completion of the evaluation. (f)(5)(i) The healthcare professional's written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination. (f)(5)(ii) The healthcare professional's written opinion for post-exposure evaluation and follow-up shall be limited to the following information: (f)(5)(ii)(A) That the employee has been informed of the results of the evaluation; and (f)(5)(ii)(B) That the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. (f)(5)(iii) All other findings or diagnoses shall remain confidential and shall not be included in the written report. (f)(6) Medical Recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section. (g) Communication of Hazards to Employees. (g)(1) Labels and Signs. (g)(1)(i) Labels. (g)(1)(i)(A) Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E), (F) and (G).

Bloodborne Pathogens Exposure Control Plan - Oakland University

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