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uT

Karen Carruthers, R .N . Mark Jackson, M .D. Sally McKinnon, B.S .N .Senior Technical Writer Director of Student Health Services Associate for Clinical Management

Exactis .corn Cutler Health Center Cutler Health Cente rDenver, CO University of Maine University of Main e

Orono, ME Orono, ME

Benjamin Gulli, M.D.Medical Edito r

EE*ii American College of

"' e"e Emergency Physicians '

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The procedures in this book are based on the most current recommendations of responsible medical sources . The American Academy ofOrthopaedic Surgeons and the publisher, however, make no guarantee as to, and assume no responsibility for, the correctness, sufficiency, o rcompleteness of such information or recommendations . Other or additional safety measures may be required under particular circumstances .Reviewed by the American College of Emergency Physicians .The American College of Emergency Physicians (ACEP) makes every effort to ensure that its product and program reviewers are knowledge -able content experts and recognized authorities in their fields. Readers are nevertheless advised that the statements and opinions expressed i nthis publication are provided as guidelines and should not be construed as College policy unless specifically referred to as such . The Colleg edisclaims any liability or responsibility for the consequences of any actions taken in reliance on those statements or opinions . The materialscontained herein are not intended to establish policy, procedure, or a standard of care . To contact ACEP write to: PO Box 619911, Dallas, TX75261-9911 ; call toll-free 800-798-1822, touch 6, or 972-550-0911 .

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Atner car Academy of Orthopaedic Surgeon sTELT e gency Care an Safety'. Enst Lute

Congratulations on selecting an American Academy of Orthopaedic Surgeons (AAOS) Emergency Care andSafety Institute training program! In 1971, the AAOS pioneered EMS education by publishing Emergency Careand Transportation of the Sick and Injured, the first EMS training program available . Today, the AAOS EmergencyCare and Safety Institute continues that dedication to future emergency responders and the instructors who ar epaving their way.About the AM'SThe AAOS provides education and practice management services for orthopaedic surgeons and allied health profes-sionals . The AAOS also serves as an advocate for improved patient care and informs the public about the science o forthopaedics . Founded in 1933, the not-for-profit AAOS has grown from a small organization serving less than 50 0members to the world 's largest medical association of musculoskeletal specialists . The AAOS now serves about 24,000members internationally.

About ACEPThe American College of Emergency Physicians (ACEP) was founded in 1968 and is the world's oldest and larges temergency medicine specialty organization . Today it represents more than 22,000 members and is the emergencymedicine specialty society recognized as the acknowledged leader in emergency medicine . ACEP is pleased to joinwith the AAOS to provide emergency care and safety products and training programs of exceptional quality an dvalue .

About the AAOS Emergency Care and Safety Bnstftut eThe AAOS name and training programs are recognized and respected worldwide by businesses and industries, col-leges and universities, and fire, EMS, and law enforcement agencies . The quality, affordability; and administrative easemake the AAOS Emergency Care and Safety Institute training programs appealing worldwide .Every AAOS Emergency Care and Safety Institute textbook is the center of an integrated teaching and learning sys-tem that offers instructor, student, and technology resources to better support instructors and prepare students . Th einstructor supplements provide practical, hands-on, time-saving tools like PowerPoint presentations, videos an dDVDs, and web-based distance learning resources . The student supplements are designed to help students retain th emost important information and to assist them in preparing for exams . Key components to the teaching and learningsystems are technology resources, which provide interactive exercises and simulations to help students become grea temergency responders .The Emergency Care and Safety Institute is an educational organization created for the purpose of delivering th ehighest quality training to laypeople and professionals in the areas of First Aid, CPR, AED, Bloodborne Pathogens ,and related safety and health areas . The content of the training materials used by the Emergency Care and SafetyInstitute is approved by the AAOS and ACEPtwo of the most respected names in injury, illness, and emergenc ymedical care .Documents attesting to Emergency Care and Safety Institute 's recognition of satisfactory course completion will b eissued to those who successfully meet the course objectives and criteria for passing the course . Written acknowledg-ment of a participant's successful course completion is provided in the form of a Course Completion Card, issued bythe Emergency Care and Safety Institute .

American Academy o fOrthopaedic Surgeons

American College of.iiiiiii Emergency Physicians

TABLE OF CONTENT S

Chapter 1 ntr .,duaal n 1Overview 1What Is the OHSA BloodbornePathogens Standard? 2Who Needs OSHA BBP Training? 2

Employees 2Employers and Employment Agencies 3

Why Do I Need This Manual? 5Meeting OSHA Standards 5OSHA Required Categories of Information 6The Ryan White Act 6OSHA Required Record Keeping 6Site -Specific Work Page 8Learning Activities 9

Chaff ter 2 Blo dhorne Pathogens 1 0Overview 1 0What Are Bloodborne Pathogens? 1 1Mode of Transmission ofBloodborne Pathogens 1 1OSHA Expectations Regarding Exposure 1 1Reporting Requirements 1 2What is an OccupationalExposure Incident? 12

Assessing Exposure Determination 1 3Reporting an Incident 1 3Specific Bloodborne Pathogens 1 4

Hepatitis Viruses 1 4Hepatitis B Virus 1 4HBV Immunization 1 5Hepatitis C Virus

1 7Human Immunodeficiency Virus 1 8

Site-Specific Work Page 2 0Learning Activities 2 1

Overview 2 2Engineering Controls 2 3

Labeling Regulated Waste 2 3The Needlestick Safety Prevention Act 2 4SESIP and Needleless Systems 2 4Contaminated Sharps 2 6Reusable Sharps 2 6Acceptable Sharps Containers 2 7

Work Practice Controls 29Handwashing and Handwashing Facilities 2 9Cleaning Work Surfaces 3 0Laundry 3 1

Personal Protective Equipment 32

TABLE OF CONTENTS

21

Latex Allergy 34Limited Exceptions to Using Persona lProtective Equipment 3 5

Universal Precautions

3 5Materials That Requir eUniversal Precautions 3 5Materials That Do Not Requir eUniversal Precautions 35

Body Substance Isolation -3 5Site-Specific Work Page 3 9

Exposure Control Plan Requirements .

Appendix A. OSHA Moodborne

Chapter 4 Exposure Control Plan 41{hervievv 4l

Pathogens Standard "' 43

Appendix B: Hepatitis B Vaccin e

Appendix C. Sample Exposure

ppendi*CC Tuberculosis (TS) 60ppendix E: OSHA Directory ' 64

ppendix F: Answers to End of ChapterLearning Activities ' 65

Glossary ' 66

Principal ReviewersWe wish to thank the following individuals and companies for their contributions to the various edition sof this manual .

Peggy BaumHealth and Safety AdministratorUniversity of Main eOrono, Maine

Richard CooperSEMTARye, New Hampshire

Donna GatesHealth Care and Nursing Consultant sLexington, KentuckyDavid A. Gibb sSafety Compliance SpecialistState of MaineBureau of Labor StandardsAugusta, Maine

Jon R. I rohmer, M .D .Kent County EMSChestertown, MarylandLynne Lamstein, M.S .I .H .Occupational Health SpecialistState of MaineDepartment of Labo rBureau of Labor Standard sAugusta, MaineJose Salaza rLoudoun County Fire and RescueLeesburg, VirginiaAlton Thygerson, Ph .D.Brigham Young UniversityProvo, Utah

Overvewthe Occupational Safety and Health Adminis-

tration (OSHA) is the government agenc yresponsible for ensuring a safe work environment

for every employee .Since 1992, employer implementation of th e

OSHA Bloodborne Pathogens Standard has been contin-ually guided by OSHA's interpretation of the Standard ,OSHA's citations for violations of the Standard and courtrulings specific to the Standard . Training about the risksand hazards associated with tasks involving blood andOther Potentially Infectious Materials (OPIM) hasimproved employee safety. The Standard has motivatedmanufacturers to introduce new engineering controls(e .g., needleless systems) and develop and produce a wid evariety of products that offer greater choice for worksit esafety and personal protection .

Despite the advances in engineering work practices an dpersonal protective equipment, the health risks posed b ythe handling of blood and OPIM remain very high . Therequirements of the OSHA Bloodborne Pathogen sStandard continue to be essential in maintaining safework environments for all employees engaged inhandling blood and OPIM .

Throughout this manual you will see references t oCalifornia OSHA (CalOSHA) . These notations are clearlymarked with a symbol to indicate that this interpretatio nof the standard is taken from the CalOSHA standard .Ca1OSHA has been referenced in cases where thei rinterpretation of the Standard was more stringent thanFederal OSHA, or where it was felt that their interpreta-tion or requirements could benefit others . Regardless,these notations are clearly marked so you will be able t odistinguish between the requirements of the Federa lStandard and the Ca1OSHA Standard .

The Standard requires that you learn the content o fthe Bloodborne Pathogens Standard; that you receivetraining on the categories defined within the Standard ;and that you receive site-specific training to properly

BLOODBORNE PATHOGEN S

OSHA 0loodbome I'al ogcnsReuimlonn Sedlon 1010.1030pan 1910.(Antended )Subpar) Z (Arnendcsl)1.'1'he general authority citation for subpart Z of 29 CFR par t1910 continues to read as follows and a new citation fo r1910.1030 Is adrlnl :Authority: Sams. G and 8, Occupational S lely and Health Act ,29 U.S.C, 655, 657, Secretary of Labo r's Orders Nos . 12.71 (311CFR 8754), 8.76 (41 CPR 251)5)) . or 911 (18 CFR :15736), asapplicable ; and 29 CFR pan 1911 .

Section 1910.1030 also Issued under 29 U .S.C. 853.

2. Sactlun 1910 .1030 Is added to road its follows :1910 .1030 Dloodlwme Pathogens.(a) Scope and Application

Thls section applies lo all occupmlonal exposmr' t oblood or other potentially inlecllnns materials a sdefined by paragraph (b) of this section .

(b) DetnllIon sFor purposes of Ilk section. the following shall apply;

Assismn(Sarnmry means the Ittisiaant Secretary of Labor fu rOccupational Safety and Health . or designated representative .Blowd means human blond. Minton blood components. an dproducts made from human blood .Bloodborne Pathogens means pathogenic microorganismsthat are prescnl In human blood and can cause tlise;lse Inhumans . These pathogens Include, but are not Mulled to ,Hepatitis D Virus 1101') and Ilouten IlnllntlurlellolcllcyVirus [111V).Clinical Lalvmm0 means a workplace where diagnoslic o rother screenIng procedures are perforated on blood o rother potentially Inleclious materials.Canlmnlrrated means the presence or the reasonably ankhpaled presence of blood or other potentially Infectiou smaterials on an Item or surface.Contain( netted laundry means laundry which has been soiledwith blood or other polenllally infectious materials or an ycontain sharps.Chntaminaled Sharps means any contaminated object fia tcan penetrate the skin including, but not limited to . nee'dies, scalpels, broken glass, broken cnpllli ry lobes, an d

r s, owed ends of dental wlres .

( Figure1-1) OSHA Bloodborne Pathogen Standar d

implement the requirements in your work environment .This unit provides an overview of the OSHA BloodbornePathogens Standard .

hat is the SH/ Bloodbirn ePathogens Standard ?In 1991, OSHA issued its final regulation on occupationalexposure to bloodborne pathogens (29 CFR 1910.1030) .OSHA determined that employees face a significan thealth risk as the result of occupational exposure t oblood and other potentially infectious materials (OPIM )because they may contain bloodborne pathogens . Thisstandard provides requirements for employers to follo wto ensure employee safety with regard to occupationa lexposure to bloodborne pathogens. (AFigure 1-1 )

Bloodborne pathogens include, but are not limite dto, hepatitis B virus (HBV), which causes hepatitis B ;human immunodeficiency virus (HIV), which causesacquired immunodeficiency syndrome (AIDS) ; hepatitisC virus (HCV) ; human T-lymphotrophic virus Type 1 ;and the pathogens that cause diseases such as malaria ,syphilis, arboviral infections, relapsing fever, and vira lhemorrhagic fever.

Hazards from bloodborne pathogens can be minimizedor eliminated by using a combination of engineering an dwork practice controls, personal protective clothing an dequipment, training, medical surveillance, hepatitis Bvaccination and signs and labels . Both the Standar dand CPL 2-44C became effective on March 6, 1992 .CPL 2-02 .69 became effective November 27, 200 1and cancelled CPL 2-2 .44C.

This edition of the AAOS Bloodborne Pathogen smanual continues to provide guidance specific to 29 CFR1910.1030 and later amended by PL 106-430 OccupationalExposure to Bloodborne Pathogens ; Needlesticks andother sharps injuries ; Final Rule January 19, 2001 (appen-dix B) and incorporates clarifications found in CPL 2 .69 ,OSHA interpretations, and OSHA citations .

Who Needs OSHA BBP Training ?The scope of the Standard is not limited to employee swith job classifications that may that have occupationalexposure to blood and other potentially infectious mate-rials. In the case of a warehouse employee trained in firs taid and identified by the employer as responsible fo rrendering medical assistance as part of his/her job duties,that employee is covered by the standard.. ,

The Standard includes the potential for exposure, notjust actual exposure. For example, a front desk reception-ist may not have an actual exposure to a bleeding patient ,but the potential for exposure may exist .

EmployeesAny employee who has occupational exposure to bloo dor other potentially infectious material is included withinthe scope of the Standard. This includes part time, tempo-rary, healthcare workers known as "per diem" employee sand volunteers .

OSHA jurisdiction extends only to private busines semployees in the workplace . It does not extend to studentsif they are not considered employees ; to state, county, o rmunicipal employees ; to health care professionals who aresole practitioners or partners ; and to the self-employed .

Any employee who has potential for occupational .exposure to blood or OPIM is required to receive trainin gaccording to the bloodborne pathogens standard .The following job classifications may be associated withtasks that have occupational exposure to blood or OPIM ,but the standard is not limited to employees in thesepositions . (o- Figure 1-2 )

Physicians, physician's assistants, nurses, nursepractitioners, and other healthcare employees inclinics and physicians' office s

Decooiuodnmion anemias the Ilse of physical or chemica lmeans to remove . inactivate, or destroy bloodborn epathogens on a surface or Ram die point where they are n olonger capable of Iransmilling Infectious particles and th esurface or Rent Is rendered sale fur handling, use, or disposal .Director means the Director of the National Institute IonOccupational Safety and Health, 11 .5, Department of Healthand Human Services, or designated representative .Engineering Commis means controls (e.g., sharps dislwsolcontainers. sollshemhfng needles) that Isolate or remov ethe hlnodborne pathogens heard front the workplace .Exposure Incident meats a specific eye . mouth. othermucous ntembtaue. nntiImacl skin, or parenteral contactwith blood ur other potentially Inleclious materials tha tevens from limped onimnec of an employee 's dull..

llnndawshing 1'nnblicr means a facility providing an ode- supply of n nning potable wafer. soap, and single use

towels or hot air drying nmcldnes.Licensed lleollh Cure Professional Is a person whoselegally permitted scope of practice allows hint or her t oIndependently perform the activities required by para-graph

uwtHepatiti s tttis B vaccination and p est-exposure

116' ntcans Ilclialius Il Virus .ltNnwans I loose Innnunodeficlency Virus .Ocotpalionnl &poseur means reasmuably anticipated skin ,eye. mucous membrane, or parenterl contact with blood o rother potentially infectious materials that may result fromthe performance of an employees duties .Otherlitlallliolly/ofections ectionsWedoLs means

(1) The following human body fluids: semen, vaginalsecretions, cerebrospinal fluid. synovlal fluid ,pleural fluid, lxrieardial fluid, peritoneal Itold, aeinl 'r lie fluid, saliva In dental procedures, any bodyQuid that is visibly contaminated with blood, and allbody fluids In situations where it Is difficult orimpossible to differentiate between body fluids;

(2) Any unfixed tissue or organ (other than intact skin )from a human (living or dead) ; and

(3) HIVcontalning cell or tissue cultures, organ cul-tures, and HIV- or IIBV.conlainhng culture mediumor other solutions: and blood, organs, ur nlher Ifs sues hoot experimental animals Inlecled with I1 Nor I10V.

1'omMenll means pleming mucous membranes or the ski nbarrier through such events as neodlesticks, human bites .cols. and abraslonk. .

Chapterl INTRODUCTIO N

Employees of clinical and diagnostic laboratorie s

Housekeepers in healthcare and other facilitie s

Personnel in hospital laundries or commercia llaundries that service healthcare or public safetyinstitution s

Tissue bank personnel

Employees in blood banks and plasma centerswho collect, transport, and test bloo d

Freestanding clinic employees (e .g., hemodialysisclinics, urgent care clinics, health maintenance organ -ization (HMO) clinics, and family planning clinics )

Employees in clinics in industrial, educational, andcorrectional facilities (e .g., those who collect blood,and clean and dress wounds )Employees designated to provide emergency first ai d

Dentists, dental hygienists, dental assistants an ddental laboratory technicians

Staff of institutions for the developmentally disabled

Hospice employees

Home healthcare workers

Staff of nursing homes and long-term care facilitie s

Employees of funeral homes and mortuaries

HIV and HBV research laboratory and productio nfacility worker s

(Figure1-2) All procedures should be performed tominimize splashing .

Employees handling regulated waste ; custodia lworkers required to clean up contaminated sharpsor spills of blood or OPIM

Medical equipment service and repair personnel

Emergency medical technicians, paramedics ,and other emergency medical service provider s

Fire fighters, law enforcement personnel, an dcorrectional officers

Maintenance workers, such as plumbers, i nhealthcare facilities and employees of substanc eabuse clinics

Employers and Employment AgenciesAn employment agency refers job applicants to potentialemployers but does not put these workers on the payrol lor otherwise establish an employment relationship wit hthem; thus, the employment agency is not the employerof these workers . The company that uses these workers ,e .g., a hospital, is the employer of these workers and isresponsible for providing training according to theBloodborne Pathogens Standard . CPL 2-0 .124 effectiveDecember 1999 clarifies OSHA's multiemployer citatio npolicy.

Personnel Services and Multi-EmployerWorksite GuidelinesPersonnel services firms employ medical care staff an dservice employees who are assigned to work at hospital sand other healthcare facilities that contract with the firm .

Often the employees are paid by the personnel servicesfirm, but day-to-day supervision of the work is provide dby the healthcare facility. When the host employer exer-cises day-to-day supervision over the personnel serviceworkers, they are the employees of the host employer ,as well as of the personnel service.

Under these circumstances the personnel servic efirm can be held accountable for meeting the followin gprovisions of the standard :

o providing hepatitis B vaccinations ;

managing post-exposure evaluation and follow-up ;

recordkeeping ;

providing generic training;

exercising reasonable diligence to assure that thehost workplace facility is in compliance with th eBloodborne Pathogens Standard; and

BLOODBORNE PATHOGEN S

when violations of the standard at the hos tworkplace are known by the firm, the firm take sreasonable steps to have the host employer correc tthe violation.

The host employer must comply with all provisions ofthe standard with respect to these workers i .e ., providin gappropriate engineering controls, an exposure contro lplan that is explained and available to the worker an dpersonal protective equipment in the appropriate siz eand type . With regards to Hepatitis B vaccination, post-exposure evaluation and follow-up, recordkeeping, an dgeneric training, the host employer 's obligation is to takereasonable measures to assure that the personnel servicefirm has complied with these provisions .

The shared responsibilities of both employers i sreferred to as multi-employer worksite guidelines .

Home Health ServicesThe employees of home health service companies ma yprovide health services in private homes . The employerdoes not control the private home worksite to which theemployee is sent to provide services . Therefore, the appli-cation of the bloodborne pathogens standard is restricte din the home health services industry .

This does not mean that the private home worksiteis free from bloodborne pathogen hazards . Employee sshould follow work practice guidelines and use persona lprotective equipment. Prevention of exposure is the ke yto protecting your good health .

As a result, OSHA may not cite those employersfor site-dependent provisions of the standard when th ehazard is site-specific.

OSHA has determined that the employer will not b eheld responsible for the following site-specific violation s(e .g ., violations occurring in a private home) :

housekeeping requirements, such as th emaintenance of a clean and sanitary worksite ;

the handling and disposal of regulated waste ;

o ensuring the use of personal protective equipment;

ensuring that specific work practices are followe d(e .g., handwashing with running water) ; and

ensuring the use of engineering controls .

The employer will be held responsible for all nonsite-specific requirements of the bloodborne pathogen sstandard, such as :

the non-site specific requirements of the exposurecontrol plan ;

o providing hepatitis B vaccinations;

post-exposure evaluation, and follow-up ;

recordkeeping;

providing generic training that is not workplac especific in detail and content ; and

for the provision of appropriate personal protectiv eequipment to employees .

Physicians and Healthcare Professionals in i nindependent PracticeIn applying the provisions of the bloodborne pathogen sstandard in situations involving physicians, the status o fthe physician is important. Physicians may be employer sor employees . In this situation, the assignment of respon-sibilities under the standard is similar to those in effectfor personnel services firms .

In general, professional corporations are the employersof their physician-members and must comply with th ehepatitis B vaccination, post-exposure evaluation an dfollow up, recordkeeping and site-specific training provi-sions, with respect to these physicians when they work a thost employer sites . The host employer is not responsibl efor these provisions with respect to physicians with staffprivileges, but the host employer must comply with al lother provisions of the standard in accordance with th emulti-employer worksite guidelines .

Independent ContractorsIndependent contractors are companies that provide aservice, such as radiology or housekeeping, to host employers .They provide supervisory and other personnel to carr yout the service . Both the companies and the host employersare responsible for complying with all provisions o fthe standard in accordance with the multi-employerworksite guidelines .

Other IndustriesAlthough these industries are not free from the hazard sof bloodborne pathogens, the bloodborne pathogensstandard does not apply to the construction, agriculture ,marine terminal and longshoring industries .

Good Samaritan Assistanc eEmployees who do not fall within the scope of thi sstandard may still experience a specific exposure incidentat work that is unrelated to the performance of their job

Chapter1 INTRODUCTIO N

duties . An example is "Good Samaritan" assistance, whic his voluntarily performed to an injured co-worker or amember of the public.

OSHA strongly encourage semployers to offer any employee whoexperiences an exposure incident a twork confidential medical evaluatio nincluding necessary post exposureprophylaxis and follow-up treatment.

Why o II Need T Ids Manua ?This manual provides OSHA-specific bloodbornepathogens guidelines and is used in conjunction with,and as a supplement to your worksite-specific training .You are encouraged to gather worksite-specific detail o nvarious work pages throughout the manual . Exercises atthe end of each chapter help you check what you havelearned and how it may be applied to your particula rworksite requirements .

This manual will not make you an expert in blood-borne pathogens or the treatment of bloodborne pathogen sdisease . The detail provided in the manual serves to sup-port the requirements of the OSHA Bloodborne Pathogen sStandard . The manual does give you important an dnecessary information as required by the Standard .Your instructor may expand the information accordin gto worksite specific practices . The categories of informa-tion presented in this manual must be included in anyand all training .

[Meeting OSHA Standard sThe goal of training is to educate the employee regardin ggeneral bloodborne pathogens issues, as well as how tominimize or eliminate their exposure by a combination o funiversal precautions, work practice controls, engineerin gcontrols and personal protective equipment .

Trainees must have direct access to a qualified traine rduring training. Training the employees solely by mean sof a film, video or computer CD-ROM without theopportunity for a discussion period is not acceptable an dconstitutes a violation of the Standard . The trainer mustbe familiar with the manner in which the elements in th etraining program relate to the workplace practices . Thi smay also be accomplished by having two trainers : one todiscuss generic bloodborne pathogens training and oneto discuss site-specific information . ( Figure 1- 3

All employees, at the time of initial assignment t otasks with occupational exposure to blood or OPIM, must

NFigure 1-3) Annual training is necessary to ensur eemployee safety.

receive training on the hazards associated with blood an dOPIM, and the protective measures to be taken to mini-mize the risk of occupational exposure prior to actuallyperforming any of the tasks .

Thereafter, training is provided at least annuallyand must be provided within one year of the origina ltraining that occurred prior to the initial work assign-ment . Whenever a change in an employee's responsibilities,procedures, or work situation is such that an employee' soccupational exposure is affected, additional training or, a sstated in the CPL, `retraining' must take place . Retrainin gis not the same as annual training . Training must occurwhen new equipment is brought to the worksite tha tmight affect the employee's possible exposure .

Annual training must cover topics listed in th estandard to the extent needed and must emphasizenew information or procedures . Otherwise, it does needto be an exact repetition of the previous annual trainin gincluding all the required categories of information an dother included site-specific information .

The provisions for employee training are performanc eoriented, with flexibility in training permitted to allowthe program to be tailored to the employee's backgroundand responsibilities or other site-specific needs. The cate-gories of information presented in this manual must b eincluded in any and all training.

OSHA requires that any training (including writtenmaterial, oral presentations, films, videotapes, computerprograms or audiotapes) be presented in a manne rappropriate to the employee ' s education, literacy level,and language . If an employee is only proficient in a languag eother than English, the trainer or an interpreter mustconvey the information in that language .

BLOODBORNE PATHOGEN S

It is necessary to record information about the datesof training sessions, a summary of the training contentand the names and job titles of the employees who atten dthe training .

SHRequired Categoriesof informationA. An accessible copy of the regulatory text (Appendi x

A) and an explanation of its contents (this manual )B. A general explanation of the epidemiology an d

symptoms of bloodborne disease (Chapter 2 )C. An explanation of the modes of transmission of

bloodborne pathogens (Chapter 2 )D. An explanation of the employer's Exposure Contro l

Plan and the means by which the employee can obtai na copy of the written plan (supplied by your companydirectly or through the instructor) (Chapter 4 )

E. An explanation of the appropriate methods fo rrecognizing tasks and other activities that may involveexposure to blood and other potentially infectiou smaterials (Chapter 3 )

F. An explanation of the use and limitations of method sthat will prevent or reduce exposure including appro-priate engineering controls, work practices, andpersonal protective equipment (Chapter 3 )

G. An explanation of the requirements to evaluate, selec tand use of needleless systems and sharps with engi-ineered sharps injury protections, which require semployee input, appropriate to circumstances of th eworkplace . (Chapter 3 )

H. Information on the types, proper use, location,removal, handling, decontamination, and disposa lof personal protective equipment (Chapter 3 )

I. An explanation of the basis for selection of persona lprotective equipment (Chapter 3 )

1 Information on the Hepatitis B vaccine, includin ginformation on its efficacy, safety, method of admin-istration, the benefits of being vaccinated, and thatthe vaccine and vaccination will be offered free of

charge to employees covered by the standard(Chapter 2 )

K. Information on the appropriate actions to take andpersons to contact in an emergency (exposure outsid ethe normal scope of work) involving blood or othe rpotentially infectious materials (Chapter 2)

L. An explanation of the procedure to follow if anexposure incident occurs including the method ofreporting the incident and the medical follow-up tha twill be made available (Chapter 2)

M. Information on the post-exposure evaluation an dfollow-up that the employer is required to provid efor the employee following an exposure incident(Chapter 2)

N. An explanation of the signs, labels, and/or color-coding required (Chapter 3 )

0. An opportunity for interactive questions and answer swith the person conducting the training sessio n(during and after training session )

The Ryan White ,k CtThe CDC is in the process of preparing the final listof diseases required by the passage of the Public Law101-381, the Ryan White Comprehensive AIDS Resource sEmergency Act. The Act creates a notification syste mfor emergency response employees listed as police ,fire, and EMS, who are exposed to diseases such a sM. tuberculosis, Hepatitis B or C, and HIV.

OSHA Rquired Rec rd Keepin gThere are specific changes to record keeping that must b efollowed. Changes to the exposure control plan mus toccur that demonstrate that plan has been updated t oreflect changes in technologies that reduce or eliminateexposure; annual documentation of consideration andimplementation of safer medical devises ; and, the solici-tation of input from nonmanagerial input employees.

Those subject to record keeping under 29 CFR 1904using Log of Work-Related Injuries and Illness (Form 300 )and Injury and Illness Incident Report (Form 301) mustrecord :

1. Any needlestick injury or cut from a sharp objec tthat is contaminated with another person's bloodor OPIM .

2. Any case requiring an employee to be medicallyremoved under the requirements of an OSH Ahealth standard .

Training records assist the employe rand OSHA in determining whether th etraining program adequately addresse sthe risks involved in each job.

Chapter 1 INTRODUCTIO N

3. Tuberculosis infection as evidenced by a positiv eskin test or diagnosis by a physician or othe rlicensed health care professional after exposure t oa known case of active TB .

In accordance with CPL2-0 .131 effective January 1, 2002 .Additionally, there must be a Sharps Injury Log main-

tained independently from the OSHA 300 . This log mus tbe confidential and person specific data should not b econtained on the Sharps Injury Log. At a minimum th elog must record the type and brand of the device

The employer must maintain record sin a wavy that segregates sharp sinjuries from other types of wor k -related injuries .

involved; department or area of incident; and, descrip-tion of incident . The log should be reviewed on a regula rbasis and action should be taken to correct any problem sthat are leading to needlestick or sharps injury.

BLOODBORNE PATHOGEN S

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EMPLOYEE TRAINING

Date/Time of Training

Training Location

Your Name

This bloodborne pathogens training has been conducted by :

Attach a few comments about his or her qualifications .

Name of your supervisor or other responsible person you would contact in the event of an exposure .

BBP Training materials are available at

This is : Initial training :

q Yes

q No

Retraining:

q Yes

q No

Annual training :

q Yes

q No

This training occurred during my routine work hours :

q Yes

q N o

This training occurred at no cost to me :

q Yes

q No

A copy of the Standard is included in my Bloodborne Pathogens manual :

q Yes

q No

The training materials used by the instructor are easy for me to understand :

q Yes

q No

The training materials used are in a language I understand : q Yes

q No

Terms are defined in Appendix A of my Bloodborne Pathogens manual :

q Yes

q No

My company' s Exposure Control Plan is available at :

Training records are available for 3 years and are kept by:

I may request a copy of my training record from :

Request for a copy of my training record is to be provided within 15 days :

q Yes

q No

Training records are not considered confidential :

q Yes

q No

Questions about the Standard were answered by the trainer :

q Yes

q No

My question about the OSHA Bloodborne Pathogens Standard is :

a

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earning ..

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1 . What kind of task would require training in bloodborne pathogens and OPIM safety?

T

F

2 . An explanation of the symptoms caused by bloodborne pathogens is not a site-specific topic .

T

F

3 . Information about the locations of the eye wash stations is a site-specific topic .

T

F

4 . Recommending and participating in the selection of engineering controls or personal protectiv eequipment is an example of site-specific information .

Yes No

5 . Is there any industry free from the hazards of bloodborne pathogens ?

6 . Name an industry not covered by the OSHA Bloodborne Pathogens Standard.

Yes No

7. If there is a change to my work practices that would change my exposure to bloodborne pathogens ,I would receive retraining .

Yes No

8 . I must receive training every year .

Yes No

9 . OSHA requires the use of engineering controls .

ver ieccupational exposure to blood or OPIM mean sthat you are at risk for infection from diseas ecausing organisms that may be transmitted

through direct contact with blood or OPIM. The hazardof exposure to infected blood or OPIM is not restricte dto the healthcare industry.

The likelihood of becoming infected after a singl eexposure to blood containing a disease-causing organis mdepends upon many factors . The factors most commonlyassociated with transmission of disease include the pres-ence of the organism in the source blood or OPIM ; thetype of injury or contact sustained by you (e .g ., splashor puncture wound) ; the viral level present in the sourceindividual and, your current health (e .g ., immunizedagainst Hepatitis B) .

There are many bloodborne pathogens . The likelihoo dof being exposed to a particular disease-causing organis mvaries and is affected by :

1. The geographic region where the work occurs(i .e ., certain countries and/or areas have a muc hhigher incidence of diseases caused by bloodborn epathogens) . It is estimated that 16-18 million peopl ein Central and South America are infected wit hTypanosoma curzi . This is a bloodborne pathogenparasite responsible for Chagas disease .

2. The type of work performed (e .g ., work in aresearch lab that investigates and cultures variou sviruses and bacteria may increase the risk) .

It is not possible to include every possible bloodborn epathogen in this manual; therefore, the emphasis in thissection is on I-IBV, HCV and HIV. The Standard include sany pathogenic microorganism that may be presen tin human blood or OPIM and can infect and caus edisease in persons who are exposed to blood containingthe pathogen.

Chapter 2 BLOODBORNE PATHOGEN S

Your employer should determine the inclusion o finformation about other bloodborne pathogens in you rtraining based on your geographic location and type ofpotential exposure. For example, if you work in facilitie sthat are located near or along the border with Mexicoand you might reasonably expect to have occupationa lexposure to the blood of people from Mexico or Centra lAmerica, then it might be important to learn more abou tChagas disease .

What Are B]oodb *rne Pathogens ?Bloodborne pathogens are disease-causing microorganisms(e .g ., viruses, bacteria, and parasites) that may be presen tin human blood . They may be transmitted with anyexposure to blood or OPIM .

Mode of Transmission'oodbom e Pathoge ; s

Bloodborne pathogens are transmitted when blood o rOPIM come in contact with mucous membranes or non-intact skin . Non-intact skin includes, but is not limitedto, cuts, abrasions, burns, rashes, acne, paper cuts, an dhangnails . Bloodborne pathogens may also be transmittedby blood splash or spray, handling or touching contami-nated items or surfaces and injection under the skin bypuncture wounds or cuts from contaminated sharps .(v Figure 2- 1

The majority of occupational HIV transmission ha soccurred through puncture injury. However, there hav ebeen documented HIV transmissions from non-sexual,non-percutaneous exposures to fresh blood or body fluidcontaminated with HIV. Transmission has been docu-mented to occur after contact with HIV-contaminate dblood through non-intact skin and mucous membranes .

( Figure2-1) Always wear gloves to prevent contamination .

One worker became HIV positive after a splash of HI Vcontaminated blood to the eyes . Contact with blood orOPIM should be avoided .

OSHA Expectation sRegarding ExposureThe objective of the Standard is to minimize or eliminat ethe hazard posed by exposure to blood or OPIM . However,occupational exposure to a bloodborne pathogen mayoccur.

If there is a risk of exposure or injury, it is importan tto know :

1. if there is a way to prevent infection as a result o fexposure to the pathogen (e .g ., immunization) ,

2. the symptoms caused by infection with th epathogen, as well as the natural course of th einfection ,

3. that counseling specific to the exposure incidentis available and ,

4. the post-exposure treatments and follow-up tha tmay be provided.

If you are exposed to bloodborne pathogens, aconfidential medical evaluation is to be made immediatelyavailable to you, the injured employee . The word "imme-diately" is used in the Standard to emphasize the impor-tance of prompt medical evaluation and prophylaxis .An exact time cannot be stated because the time limit o nthe effectiveness of post-exposure prophylactic measure sdoes vary depending on the infection of concern.

Medical evaluation must be confidential and protec tyour identity and test results .

Needle stick and other sharps injuries are primarily associate dwith the following activities: disposing needles ; administerin ginjections; drawing blood, including use of glass capillar ytubes ; recapping needles ; and handling trash and dirty linens .

The employer does not have a specific right to know the actua lresults of the source individual's blood testing, but must ensur ethat the information is provided to the evaluating healthcar eprofessional .

B

BLOOD BORNE PATHOGEN S

If you go for a medical evaluation the following infor-mation will be made available to the health professional .

1. A copy of the OSHA guidelines section 1910 .103 0

2. A description of how the incident occurred as i trelates to your employment

3. The results of the source individual's testin g(if available )

4. All medical records that are relevant for yourproper treatment (if treatment is necessary) ,including a copy of your Hepatitis B vaccinatio nstatus with the dates of all the Hepatitis B vaccina-tions and any medical records relative to yourability to receive the vaccination

You and your employer should expect that curren tCDC guidelines will be used to guide post-exposureprophylaxis and treatment .

It is the employer's responsibility to ensure that yourmedical records are kept confidential . Your records canno tbe disclosed without your express written consent to an yperson within or outside the workplace except as requiredby law. Your employer will have a copy of the healthcareprovider's written opinion regarding the incident .

During consultation with the health professional ,decisions will be made about the need for Hepatitis Bvaccination, and laboratory tests and information will b eprovided about available post-exposure prophylaxisand treatments .

The healthcare professional will discuss the laborator ytest results with you . A plan will be created that identifiesany necessary follow-up or treatments including initiatio nof Hepatitis B immunization, if Hepatitis B vaccine is indi-cated . Any post-exposure treatments and follow-up plan sshould be in accordance with the current CDC guidelines .

Rep rtng Requirements

hat Is an Occupationa lExpssure Include t ?An occupational exposure incident occurs if you are in awork situation and come in contact with blood or OPIM .

For OSHA 2000 record-keeping purposes, a noccupational bloodborne pathogens exposure inciden t(e .g ., needlestick, laceration, or splash) shall be classified a san injury since it is usually the result of an instantaneou sevent or exposure . (mFigure 2-2 )

Figure 2-2) An uncapped needle can cause an injury.

Confidentiality requirements must be part of any contract Wit ha health professional, health clinic, or other healthcare facilit ythat provides postexposure evaluation or follow-up treatmen tprograms .

It is possible to test the blood for antibodies specific to HBV,HBC,and HIV.

Test interpretation occurs inconsultation with your healthcar eprofessional and is beyond the scope of this training :

If you have an exposure incident to anothe rperson's blood or OPIM, immediately wash th eexposed area with warm water and soap.If the exposed area was in your mouth ,rinse your mouth with water or mouthwas h(whichever is most readily available) .

If the exposure was in your eyes, flush wit hwarm water (or normal saline if available) . Aquick rinse is probably not adequate, you wan tto irrigate the area completely with water.

Your employer will have site-specific work

Chapter2 BLOODBORNE PATHOGEN S

Once an occupational exposure to blood or otherpotentially infectious materials has occurred, the employee' sname and job classification are listed on the OSHA 20 0log. A review of the job classification should be under-taken and determination made as to which emploees, ifany, in that classification should now be covered unde rthe Standard .

Califorina OSHA requires a sharp sinjury log, which records .the date an dtime of each sharps injury resulting i nan exposure incident,as well as ;thetype and brand of device involved i nthe exposure incident.

Assessing Exposure D term natioThe employer must identify and document the jobclassifications in which all employees have occupationa lexposure and/or where some employees have an occupa-tional exposure . The exposure determination must havebeen made without taking into consideration the use o fpersonal protective clothing or equipment . The ExposureControl Plan should identify the person responsible fo rthe determination and assessment of an exposure incident.

Reorting an incidentThe goal of reporting an incident is to assure timely acces sto medical services and to identify and adopt other methodsor devices to prevent exposure incidents from recurring .

At sites where an exposure incident has occurred itshould be determined if the procedures were properl yfollowed through interviews, incident report reviews ,and, if necessary, medical records reviews .

The documentation of circumstances surrounding anincident allows identification and correction of hazards .To be useful, the documentation should contain sufficientdetail about the incident.

It is important to report the incident to your supervisor .OSHA requires you to report the following information :

date and time of the exposure incident

job classification of the exposed employe e work site location where the exposure incident

occurred ;o work practices being followe d

engineering controls in use at the time includin ga description of the device in use (e .g ., type andbrand of sharp involved in the exposure incident )

protective equipment or clothing that was use dat the time of the exposure incident

procedure being performed when the inciden toccurredyour training for the activity .

California OSHA also requires :o identifying the body part involved in the exposur e

incident . the engineering controls in use at the time if the

sharp had engineered sharps injury protectio n whether the protective mechanism was activated,

and whether the injury occurred before the protec-tive mechanism was activated, during activation ofthe mechanism or after activation of the mechanism ,if applicable

if the sharp had no engineered sharps injuryprotection, the injured employee's opinion as towhether and how such a mechanism could haveprevented the injury

the employee's opinion about whether anyother engineering, administrative or work practicecontrol could have prevented the injur y

Once an incident has been reported, your employe rwill take the following steps :

1. identify and document the source individual, an d2. obtain consent and make arrangements to have

the source individual tested as soon as possible t odetermine HIV, HCV, and HBV infectivity .

It may not be feasible to ident iState laws may vary; please check with your instructo rregarding testing and test result confidentiality laws in you r

E state .

5

OSHA requires that information onthe appropriate actions to take an dpersons to contact in an emergencyinvolving blood or OPIM be providedas part of BBP training.

BLOODBORNE PATHOGEN S

Examples of when you may be unable to identify thesource individual include needlesticks caused by unmarke dsyringes left in laundry, or those involving blood sampleswhich are not properly labeled, as well as incidents occur-ring where state or local laws prohibit such identification .

As stated before, the source individual's blood (i favailable) may be tested for HBV, HCV, and/or HIV an dthe results of the test will be made known to you . Testin gof the source individual's blood may be performed afte rconsent is obtained. It should be documented whenlegally required consent to test the blood is not obtained .

Your blood may be tested for HBV, HCV and/o rHIV only with your consent. You may refuse . Counselingand evaluation of reported illnesses are not dependen ton you choosing to have baseline HBV, HCV and HI Vserological testing .

You may choose to have your blood drawn and store dfor 90 days . If you change your mind within the 90 days ,testing will be done. The 90-day time frame allows youthe opportunity to obtain knowledge about baselineserologic testing after exposure incidents, and to participat ein further discussion, education or counseling . If youelect not to have the blood tested, the sample will b edisposed of without testing after 90 days .

Spedf k B oodb me Path B en sHepatitis VirusesHepatitis means "inflammation of the liver ." A numberof things including drugs, poisons and other toxins, andbloodborne pathogens may cause hepatitis . This sectionwill focus on two causes of viral hepatitis that are impor-tant in the United States Hepatitis B Virus (HBV) andHepatitis C Virus (HCV) .

OSHA does not require redraviwingof the source individual's blood 'specifically for HBV, HCV and HI Vtesting without the consent of th esource individual .

The employer's exposure control plan must specifi-cally address the provisions of the Standard as theyapply to first aid providers .The Exposure Control Plan must include : Provision for a reporting procedure that ensure s

that all first aid incidents involving the presenc eof blood or OPIM will be reported to theemployer before the end of the work shif tduring which the incident occurred .The report must include the names of all first ai dproviders who rendered assistance, regardless o fwhether personal protective equipment was use dand must describe the first aid incident, includ-ing time and date. The description must includ ea determination of whether or not, in addition tothe presence of blood or other potentially infec-tious materials, an "exposure incident," as define dby the standard, occurred .This determination i snecessary in order to ensure that the proper post-exposure evaluation, prophylaxis, and follow-u pprocedures required by the standard are madeavailable immediately, whenever there has bee nan "exposure incident" as defined by the standard .

A report that lists all such first aid incidents ,that is readily available, upon request, to al lemployees and to the Assistant Secretary.

o Provision for the bloodborne pathogens trainin gprogram for designated first aid providers toinclude the specifics of this reporting procedure .Provision for the full hepatitis B vaccinatio nseries to be made available as soon as possible ,but in no event later than 24 hours, to all unvac-cinated first aid providers who have rendere dassistance in any situation involving the pres-ence of blood or OPIM, regardless of whether o rnot a specific"exposure incident," as defined b ythe standard, has occurred .

Infection with one form of hepatiti sdoes not prevent infection wit hanother form of hepatitis . For exa mpiea person with an HCV infectio ninaystill :get an HBV infection .

Chapter2 BLOODBORNE PATHOGEN S

(Figure 2-3) Immunization against HBV is possible.

Hepatitis B Viru sHepatitis B virus can affect anyone. Each year, in th eUnited States, 140,000-320,000 people will becom einfected with the virus . Studies conducted by the CD Chave shown a steady decline in the incidence of HBV. Thisdecline is attributed to the widespread use of Hepatitis Bvaccine and the implementation of other preventio nmethods such as engineering and work practice controls ,personal protective equipment, and universal precautions .

Even though there has been a decline in the numberof infections with HBV, the CDC estimated that in 1994 ,1024 health care workers became infected with the virus .Sadly, it is projected that of this group, 22 persons wil lsuffer significant disease and eventually die from compli-cations related to the infection . It is estimated that 1-1 .25million Americans are chronically infected with HBV.

Prevention and controlThe hepatitis B vaccine has been available since 1982 .The vaccine does not contain any live components .The vaccine is given in a series of 3 shots .

HBV Immunizatio n

All people who have routine occupational exposure t oblood or other potentially infectious materials have th eright to receive the immunization series against Hepatiti sB at no personal expense . The standard includes tempo-rary and part-time workers and volunteers . (AFigure 2- 3

There are several reasons why you may choosenot to receive the Hepatitis B vaccine . Among the mostcommon reasons are:

1. documentation exists that you have previouslyreceived the series ,

2. antibody testing reveals that you are immune,

3. medical evaluation shows that vaccination iscontraindicated, o r

4. you are allergic to any component of the vaccine.

Exception for Hepatitis Vaccinatio nDesignated first aid providers who have occupationa lexposure are not required to be offered pre-exposur ehepatitis B vaccine if the following conditions exist:

1. The primary job assignment of the designate dfirst aid provider is not the rendering of first aid .

2. Any first aid rendered by the first aid provide ris rendered only as a collateral duty respondingsolely to injuries resulting from workplaceincidents, and generally at the location wher ethe incident occurred .

3. This provision does not apply to designated firs taid providers who render assistance on a regularbasis, for example, at a first aid station, clinic, dis-pensary; or other location where injured employeesroutinely go for such assistance, and emergency o rpublic safety personnel who are expected to rende rfirst aid in the course of their work.

Prescreening antibody testing is not required and you remployer may not make prescreening a requirement fo rreceiving the vaccine . If an employer wishes prescreening ,it must be made available to you at no cost .If you choose to have prescreening, the testing must b edone at an accredited laboratory.

The standard requires that your employer offer th evaccine at a convenient time and place to you, durin gnormal work hours . If travel is required away from th eworksite, your employer is responsible for that cost .The standard includes temporary and part-time workers .

Your employer cannot require you to pay for testin gand then reimburse you if you remain employed for aspecific time . Nor are you required to reimburse youremployer for the cost of the vaccine if you leave your job .

Immunization with Hepatitis

shoul dable within 10 working days of initial assignment to the job .

Your employer cannot require you to use your health insuranceor your family insurance to pay for the cost of the vaccine .To learn more about CDC recommendations visit .h ttp ://www .cdc .go v

BLOODBORNE PATHOGEN S

While it is OSHA's intent to have the employer remove ,as much as possible, obstacles to your acceptance of thevaccine, the term "made available" emphasizes that youmay refuse'the series by signing the Hepatitis B vaccin edeclination form (Appendix C) . If you change your mindwhile still covered under the standard at a later date, yo umay still receive the vaccine at no cost .

If your job requires you to have ongoing contact withpatients or blood and you are at ongoing risk for injurieswith sharp instruments or needlesticks, the CDC recom-mends that you be tested for antibody to Hepatitis Bsurface antigen (HBsAg), one to two months after thecompletion of the three-dose vaccination series . If youdo not respond to the primary vaccination series yo umust be re-vaccinated with a second three-dose vaccin eseries and re-tested for HBsAg. Non-responders must b emedically evaluated .

Contraindication so You should not receive the vaccine if you are sensi-

tive to yeast or any other component of the vaccine .

Consultation with a physician is required fo rpersons with heart disease, fever, or other illness.

If you are pregnant or breastfeeding an infant ,you should consult your physician before receivingthe vaccine .

Side Effects of the VaccineThe side effects of the vaccine are minimal and mayinclude localized swelling, pain, bruising, or redness a tthe injection site . The most common systemic reaction sinclude flu-like symptoms such as fatigue, weakness ,headache, fever, or malaise .

About the Vaccine sRecombivax HB provided by Merck & Company orEngerix-B by GlaxoSmithKline Biologicals are the vac-cines used to prevent infection with the hepatitis B virus .The vaccine against hepatitis B, prepared from recombi-nant yeast cultures, is free of association with humanblood or blood products . A new (1999) single-antigenhepatitis B vaccine does not contain thimerosal as a pre-servative .

The vaccine is given in three doses over a six-monthperiod; the first is given at an agreed-on date and withi nten working days of the initial assignment, the second i sgiven one month later, and the third dose is given fivemonths after the second dose . The vaccine is adminis-tered by needle into a large muscle such as the deltoid i nthe upper arm. However, for persons at risk of hemor-

rhage following intramuscular injection, the vaccine maybe administered subcutaneously.

In persons receiving the vaccine, 87 percent will devel-op immunity after the second dose of the vaccine, and 96percent will develop immunity after the third dose .

The Hepatitis B vaccine declination languag emust not be changed . Any change to the lan-guageshould be made for the sole purpose o fimproving understanding .

Clinical Features and History of Hepatitis BThe symptoms of HBV infection typically last four to sixweeks and include :

o Jaundice (your eyes or skin may turn yellow )

fatigue abdominal pain loss of appetiteo intermittent nauseao vomiting

It is expected that 70,000 to 160,000 people willdevelop symptomatic infections with HBV and 8,400to 19,000 of these people will require hospitalization .Unfortunately, each year, as many as 320 will die fromthe acute infection with HBV.

The incubation period for HBV (the time fromexposure to developing the disease) averages twelv eweeks, with a range of four weeks to six months . In themajority, 90-94% of the cases, infection with HBVresolves without further complication . However, about8,000-32,000 (6%-10%) of all the annual infections willprogress and suffer chronic infection with HBV. Overtime, chronic infection causes significant injury to th eliver. 5,000 - 6,000 deaths occur each year from chronicHBV liver disease .

Post-Exposure Prophylaxis and Follow-Upfor Hepatitis BThere is no cure for infection with HBV. Hepatitis Bvaccination is the best protection .

All decisions about post-exposure prophylaxis aremade in consultation with your health care professional .

Post-exposure treatment for HBV infection shouldbegin within 24 hours and no later than 7 days .

The post-exposure treatments available include :

Chapter2 BLOODBORNE PATHOGEN S

1. Hepatitis B immunization, an d2. the use of immune globulin, which has bee n

shown to be effective for passive immunizatio nagainst HBV if given within hours after th eexposure incident .

The decision to provide post-exposure prophylaxi stakes into account:

1. whether the source of the blood is availabl e

2. the HbsAg status of the source blood and

3. the hepatitis B vaccination and vaccine-respons estatus of the exposed employee

For any occupational exposure to blood or OPIM of aperson not previously vaccinated, hepatitis B vaccinationis recommended .

The CDC reports that for an unvaccinated person ,the risk from a single needlestick or cut exposure t oHBV infected blood ranges from 6-30% and dependson the hepatitis B e antigen (HBeAg) status of th esource blood.

Chronic HBV infection treatment options includeantiviral medications and/or liver transplantation.

Hepatitis C Viru s

Hepatitis C virus (HCV) infection is the most commonchronic bloodborne infection in the United States. HCVis transmitted primarily through large or repeated direc tpercutaneous exposures to blood .

The incidence of HCV infection has declined .

Fatigue

Abdominal pain

Loss of appetite

Intermittent nause a

Vomiting

The incubation period (the time from exposureto developing the disease) averages seven weeks (range,3-20 weeks) . Chronic infection is common, affecting mor ethan 85% of people infected . Chronic liver disease mayoccur in 70% of those infected with HCV. It is estimatedthat 8,000 to 10,000 deaths occur each year as a resul tof HCV-associated liver disease . HCV is the major caus eof liver disease requiring liver transplantation .

Post-Exposure Prophylaxis and Follow-UpThere is no cure for infection with HVC .

All decisions about post-exposure laboratory testin gand prophylaxis are made in consultation with yourhealth care professional. The test for HCV and liver func-tion tests should occur as soon as possible after exposur eand repeated at four and six months after the exposure .

Currently there is no recommendation for post-exposur eprophylaxis of HCV. Immune globulin is not effective i nproviding passive immunization against the disease .

When HCV infection is identified early, referral fo rmedical management to a specialist knowledgeable inthis disease is recommended . Limited data indicates that

Hepatitis C (HCV) has specifically been included wherever HI Vand HBV are mentioned in the regulation .

The CDC reports that the prevalence of HCV infection amon ghealth-care workers is no greater than the general population ,averaging 1%-2%,and is 10 times lower than the prevalenceof HBV infection among health-care workers .

Needle-stick injury is theonly occupational risk factor that hasbeen associated with HCV infection .

Referral to a specialist in liver disease may be necessary t oproperly manage an infection with HCV.

In follow-up studies of health-care workers who sustaine dpercutaneous exposures to blood from anti-HCV positiv epatients, the incidence of anti-HCV conversion averaged 3 .5%.

Transfusion-associated cases occurred prior to donorscreening and are now very rare. Injectable drug abus ehas consistently accounted for a substantial proportion ofHCV infections and currently accounts for 60% of HC Vtransmission in the United States .

It is estimated that 3.9 million (1 .8%) Americans

have been infected with HCV of whom 2.7 million arechronically infected. 36,000 new infections occur in th eUnited States each year.

Prevention and ControlThere is no vaccination for HCV.

Prevention recommendations are directed toward th euse of engineering and work practice controls, personalprotective equipment, and universal precautions .

Clinical Features and History of Hepatitis CMost patients (70-75%) with acute hepatitis C ar easymptomatic . Symptoms may include :

Jaundice (eyes or skin may turn yellow)

BLOODBORNE PATHOGEN S

antiviral therapy might be beneficial when started earl yin the course of the HCV infection . However, no guide-lines currently exist for the use of antiviral medication sin the acute phase of the infection .

The CDC reports that the risk for infection after aneedlestick or cut exposure to HCV-infected blood i sabout 1 .8% .

Chronic HCV infection treatment options includ eantiviral medications and liver transplantation.

Human Immunodeficiency Viru sTwo types of the human immunodeficiency virus areidentified (HIV-1 and HIV-2) . Both HIV-1 and HIV- 2are the cause of AIDS, have the same mode of transmis-sion, and are associated with opportunistic infections .

The differences between HIV-1 and HIV-2 shoul dbe noted. HIV-2 AIDS develops more slowly and may be

The CDC is aware of 56 healthcare workers in the United State swho have documented HIV seroconversion following occupa-tional exposure Of the 56 workers, 48 were exposed throug hpercutaneous injuries .Of the adults reported with AIDS in the United States throug hDecembei 1999, 22,218 had been employed in healthcare .

The CDC is also aware of 136 other cases of-HIV infection o rAIDS among healthcare workers who have not reported othe rrisk factors for HIV infection and who have reported a histor yof occupational exposureto blood, body fluids or HIV-infectedlaboratory material .

Vermont

3 . 9rir s

52 . 2Puerto Rico

Legend (rate per 100,000) :

0-4.9

(t aiJ 10.0 . 14.9

rs3' 5.0-9 .9

215 .0

(Figure 2-4) AIDS Prevalence Map

Chapter2 BLOODBORNE PATHOGEN S

The average risk for HIV infection from all types of .; ;reported percutaneous exposure to HIV infecte dblood is 0 .3% .The risk is increased in exposures involving :

deep injury to healthcare worke rvisible blood on the device causing the injur ya device previously placed in the sourc epatient's vein or arterya source patient who died as a result of AID S

within 60 days after exposure

jithin 60 days after exposure

Advances in the field of antiviral therapy and theuse o fprotease inhibitors might change the recommendations fo rtreatment and follow-up forHCV and HIV infection, therefore ,it is important to work closely withyour healthcar eprofessional and use current CDC guidelines .

All the antiviral drugs have been associated with significan tside effects . Protease inhibitors may interacfwith othe rmedications and cause serious side effects .

milder. There are few reported cases of HIV-2 in th eUnited States . HIV-2 is predominately found in Africa .Hereafter, all references to HIV mean HIV-1 .

The CDC reports that in the United States there ar e113,167 persons living with HIV infection and there are299,944 persons living with AIDS . The annual rate o finfection with HIV is 16 .5 cases per 100,000 population .

-4 Figure2-4 )Prevention and ControlThere is no vaccination for HIV.

Prevention recommendations are directed toward theuse of engineering and work practice controls, personalprotective equipment, and universal precautions .

The CDC reports that as of December 1999 ther ehave been 56 documented cases and 136 possible cases ofoccupationally acquired HIV infection among healthcareworkers.

Clinical Features and History of HIVThe only way to determine for sure whether you areinfected is to be tested . The incubation period with HI Vfrom the time of HIV infection to the development ofAIDS may take 8 to 10 years . This time varies greatlyfrom person to person .

You cannot rely on symptoms to know whether or notyou are infected with HIV. Many people who are infectedwith HIV experience no symptoms for many years . Thesymptoms of AIDS are similar to the symptoms of man yof infections and might include night sweats, weigh tloss, fever, fatigue, gland pain or swelling, and muscl eor joint pain .Postexposure Prophylaxis and Follow-Upfor HIVThere is no cure for infection with HIV.

All decisions about post-exposure laboratory testin gand prophylaxis are made in consultation with you rhealthcare professional. Testing for the HIV antibodyshould be done as soon as possible after exposure and ,thereafter, periodically for at least six months . Antibodie susually become detectable within three months of infection .

Postexposure treatment is not recommended for alloccupational exposures; 99 .7% of the exposures do no tlead to HIV infection . If treatment with antiviral medica-tions plus a protease inhibitor is recommended, treatmen tshould begin within hours of the exposure .

The CDC reports that the risk of infection after aneedlestick or cut exposure to HIV-infected blood i sabout 0 .3% .

BL'OO.DBORNE PATHOGEN S

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In addition to HBV, HBC, and HIV, the instructor also reviewed the following bloodborne pathogens .

Pathogen :

Prevention and Control:

Clinical Features and History of the Disease :

Post-Exposure Prophylaxis and Follow-up :

Pathogen :

Prevention and Control:

Clinical Features and History of the Disease :

Post-Exposure Prophylaxis and Follow-up :

Pathogen:

Prevention and Control:

Clinical Features and History of the Disease :

Post-Exposure Prophylaxis and Follow-up :

The required medical records are maintained by :

at (location)

Medical records are kept for the duration of my employment plus 30 years : q Yes q No

Medical care at my worksite is provided by :

Medical records are provided to you or to anyone having written consent from you within 15 days : q True q Fals e

The person responsible to evaluate if an exposure incident meets OSHA record keeping requirements is :

Hepatitis B vaccine is provided by at (location

The health professional 's written opinion concerning Hepatitis B immunization is limited to whether the employe e

requires the vaccine and whether the vaccine was administered . q True q Fals e

My question about Hepatitis B is :

My question: about Hepatitis C is :

My question about HIV is:

My question about another bloodborne pathogen is :

Chapter2 . 8E00 DBORNE PATHOGEN S

Actnnt es1 . For which virus is there an effective vaccine ?

a. HIVb. HCVc. HBV

T

F

2 . If you do not respond to the first HBV immunization series you may be revaccinated with asecond series .

3 . List two symptoms of hepatitis .

T

F

4. Symptoms are not helpful in diagnosing HIV infection .

T

F

5 . HIV is the virus that causes AIDS .

T

F

6 . Anti-viral medications and protease inhibitors are used in the treatment of HCV and HIV .

Yes No

7 . It is necessary to report as much detail as possible about an exposure incident.

T

F

8 . Hepatits B vaccine is offered at no cost to you .

T

F

9 . Hepatits C virus causes chronic liver disease in 70% of the people infected .

T

F

10 . A liver transplant maybe necessary to treat a chronic infection with Hepatitis C.

T

F

11 . It is possible to diagnose infection with HIV, HBV and HCV with a blood test .

Yes No 12. Infection with bloodborne pathogens occurs primarily through puncture injuries .

Yes No 13. It is necessary to learn about other bloodborne pathogens .

14 . Which virus poses the greatest risk for infection after a puncture injury ?a. Hepatitis B or Cb. HIV

T

F

15 . More than one blood test is needed to determine if there has been infection with HIV .

OverryewSHA defines four principal strategies to preventor reduce exposure to bloodborne pathogens .These strategies are used in combination to

offer you maximum protection . It is OSHA' s view thatpreventing exposures requires a comprehensive program ,including engineering controls (e .g ., needleless devices ,shielded needle devices, and plastic capillary tubes) an dproper work practices (e .g ., no-hands procedures i nhandling contaminated sharps) . If engineering and workpractice controls do not eliminate exposure, the use o fpersonal protective equipment (e.g ., eye protection )and universal precautions are required .

Your employer's Exposure Control Plan describes th eengineering controls in use at your worksite . Significantimprovements in technology are most evident in th egrowing market of safer medical devices that minimize ,control, or prevent exposure incidents . Employee partici-pation in the selection of new devices is required b yOSHA. OSHA does not advocate the use of one particu-lar device over another . An annual review of youremployer's Exposure Control Plan should includ eidentification of new safety devices . Adoption of engi-neering controls requires changes to your employer 'sExposure Control Plan and retraining in the proper us eof the control .

According to California OSHA, the use of needlelesssystems, needle devices with engineered sharps injur yprotection, and non-needle sharps with engineere dsharps injury protection is required except unde rfour conditions :

1. lack of market availability2. information that the device will jeopardiz e

patient car e3. information indicating that the device is not mor e

effective in reducing sharps injuries than the devic ecurrently used by the employer

4. lack of sufficient information to determine whethera new device on the market will effectively reduc ethe chances of a sharps injury

Chapter3 PREVENTION ( 2 3

When occupational exposure remains after usingengineering and work practice controls, employers mus tprovide personal protective equipment . Personal protectiveequipment is used to protect you from contamination o fskin, mucous membranes and puncture wounds .Universal Precautions is a strategy to structure you rapproach to working with all human blood and certai nbody fluids . All these strategies combined promote work-er safety and provide a safer working environment.

Engfineering ContrcA sEngineering controls attempt to design safety int othe tools and workspace organization . Examples includehandwashing facilities, eye stations, sharps containers ,biohazard labels, self-sheathing needles on syringes, an dneedleless IV systems .

Where engineering controls wil lreduce employee exposure either b yremoving, eliminating, or isolating thehazard, they must be used .

Your employer is responsible for the full cost o finstituting engineering and work practice controls .Your employer is also responsible for regularly examinin gand repairing and/or replacing engineering controls a soften as necessary to ensure that each control is main-tained and that it provides the protection intended .Regularly scheduled inspections are required to confirm ,for instance, that engineering controls such as safe rdevices continue to function effectively, that protectiveshields have not been removed or broken, and that physi-cal, mechanical or replacement-dependent controls ar efunctioning as intended. Your employer may assign thistask to you .

Work practice controls shall be evaluated and updatedon a regular schedule to ensure their effectiveness .

Labeling Regulated WasteWhat is Regulated Waste ?The term "regulated waste " refers to the followin gcategories of waste that require special handling ,at a minimum:

liquid or semi-liquid blood or OPIMitems contaminated with blood or OPIM an dwhich would release these substances in a liqui dor semi-liquid state if compresse d

items that are caked with dried blood or OPI Mand are capable of releasing these materials durin ghandling

contaminated sharps pathological and microbiological wastes containin g

blood or OPIM

When Is Labeling Regulated Waste Necessary ?

Labels must be provided on containers of regulate dwaste, on refrigerators and freezers that are used tostore blood or OPIM, and on containers used t ostore, dispose of, transport, or ship blood or OPIM.

Equipment that is being sent to another facilit yfor servicing or decontamination must have a labe lattached stating which portions of the equipmen tremain contaminated to warn other employees of thehazard and encourage them to use proper precautions.

Labeling Regulated Waste

Regulated waste containers are required to b elabeled with the biohazard label or color-coded t owarn employees who may have contact with the con-tainers of the potential hazard posed by their contents .

Even if your facility considers all of its waste to beregulated waste, the waste containers must still bea rthe required label or color-coding in order to protec tnew employees and employees from outside facilities .

Regulated waste that has been decontaminate dneed not be labeled or color-coded . However, youremployer Must have controls in place to determineif the decontamination process is successful .

Exceptions to Labeling RequirementsBlood and blood products that bear an identifying labe las specified by the Food and Drug Administration an dthat have been screened for HBV, HCV and HIV anti-bodies and released for transfusion or other clinical use sare exempted from the labeling requirements .

When blood is being drawn or laboratory proceduresare being performed on blood samples, then the individualcontainers housing the blood or OPIM do not have tobe labeled provided the larger container into which theyare placed for storage, transport, shipment, or disposa l(for example, a test tube rack) is labeled .

^24 \, BLOODBORNE PATHOGEN S

Biohazard LabelsBiohazard labels may be attached to bags containingpotentially infectious materials . These labels must b efluorescent orange or orange-red with letters or symbol sin a contrasting color. These are attached to any contain-er that is used to store or transport potentially infectiou smaterials . (v Figure 3-1 )

The Needlestick Safety Prevention ActThis act, effective April 2001, requires employers t oimplement new developments in control technology; torequire the employer to solicit nonmanagerial employeeswith direct patient care who are exposed to these poten-tial hazards for input in the identification, evaluation ,and selection of engineering and work practice control s

( Figure 3-1) Biohazard labels may be attached to bag scontaining potentially infectious materials .The label must befluorescent orange or orange-red in color and clearly visible .

and to maintain a log of percutaneous injuries from con-taminated sharps .

While no specific procedures for obtaining employe einput are prescribed, such methods might include infor-mal problem solving groups, participation of employee sin safety audits, workplace inspection, evaluation o fdevices, pilot testing devices, and membership on a com-mittee that consistently meets to review and audit report sof these activities .

Remember that your participation is critical in creatin ga safe work environment . Participation in these activitie sassures safer medical devices and the training to properl yuse these devices ; identification of compatibility prob -lems; and, in many instances employee contribution hasled to important decisions that result in the most appro-priate engineered sharps being selected .

SESIP and Needleless System sSharps with Engineered Sharps Injury Protection s(SESIP) means a nonneedle sharp or needle device use dfor withdrawing body fluids, accessing a vein or artery, o radministering medications or other fluids with built i nsafety features or mechanism that effectively reduces therisk of an exposure incident . ( Figure 3-2 )SESIP devices are available as :

Syringe with retractable needles

Blunt-tipped blood drawing needl e

Re-sheathing disposable scalpels Retracting finger prick lancet

SESIP shall be used for : withdrawal of body fluid s

accessing a vein or artery

adminstration of medications or fluids

any procedure for which SESIP is available

( Figure 3-2) IV needle with auto sharp injury protection .

When there is an overlap betwee nthe OSHA mandated label and th eDOT required label, the DOT label wil lbe considered acceptable on th eoutside of the transport container,

provided that the OSHA mandated label appears on any interna lcontainers that may be present .

Chapter3 . PREVENTION ( 2 5

Needles that will not become con -taminated by blood during use (suc has those used only to draw medica -tion from vials) are not required t o

have engineering controls under the standard .

Needleless systems are used for withdrawal of body flu-ids or administration of medications or fluids after th einitial venous or arterial access is established or whenevera needleless system is available . (v Figure 3- 3

It is important to note that the standardprohibits the removal of contaminated needle sfrom medical devices . When performing a blooddrawing procedure it is necessary to dispose o fthe blood tube holder with a safety needl eattached after each patient's blood is drawn.

Evaluating Safety System sYour employer must evaluate existing engineering andwork practice controls and assess the feasibility of imple-menting new safety technology yearly . There are manynew products introduced each year. Not all products maybe correct for your work environment . However, thes eproducts should be evaluated with input of nonmanager-ial employees who have patient care responsibilities .

There are many new types of needleless systems .Examples of the new types of injection equipment ,IV equipment and laboratory equipment include:

needleguard-sliding sheath/sleev e needleguards hinged recap needleless jet injection

retractable needle s needleless IV access-blunted cannulas recessed protected needle plastic blood collection tubes self-blunting needl e

lancets-laser and retractin g

retracting scalpels quick-release scalpel blade handle s

blunted suture needle s

The process for evaluating safety technology is not pre-scribed, however, it has been found that good review sinclude the following detail :

Form a multidisciplinary team that follows atimetable for completing timely evaluations .

Identify priority areas and give the highest priorit yassessement to any work area or practice in whic hpercutaneous injuries have occurred. Emphasizesafety devices with features that will have the great-est impact on preventing occupational injury .Conduct the evaluation with participants who wil lactually use the selected device .

Train the workers in the proper use o fthe device

Self-sheathing needle product sand other SESIPs, even after activa -tion must be disposed of in a sharp scontainer that conforms to th erequirements of the Standard . -

A fixed safety feature provides a barrier betwee nthe hands and the needle after use; the safet yfeature should allow or require the worker 'shands to remain behind the needle at all times.The safety feature is an integral part of th edevice, not an accessory.

The safety feature is in effect before disassembl yand remains in effect after disposal to protec tusers and trash handlers, and for environmenta lsafety.The safety feature is as simple as possible, an drequires little or no training to use effectively .

BLOODBORNE PATHOGEN S

Establish clear criteria and measures for evalu-ation including attempts to circumvent th esafety features

Conduct follow-up and obtain informal feed-back, identify problems, and offer additiona lguidance .

Monitor the use of the device to determine if addi-tional training is necessary or for any possibl eadverse effects of the device on patient care .

Your employer must document consideration an dimplementation of appropriate commercially availableand effective engineering controls designed to eliminateor minimize exposure .

There are many different evaluation forms that can b eused. The employer should maintain a file of the formsafter they are completed with the action taken regardingthe device .

Regarding safe needle systems, there are active an dpassive safety features available . An integrated system ispreferred because the safety feature is built in and is no tdependent on employee compliance .

In Case of InjuryIf you are stuck by a needle containing blood or OPIM,

OSHA recommends : an HIV test and counseling a test for HIV periodically for at least six month s practice "safe" sex stop breast-feeding get immediate evaluation of any illness

You can also call the Needlestick Hotline, which is runby the Department of Health and Human Services an dwhich offers up-to-date, free advice in an emergenc y24 hours/dayTelephone : 888-448-4911 .

Contaminated Sharp sOSHA defines contaminated sharps as any contaminate dobject that can penetrate the skin, including, but not limitedto, needles, scalpels, broken capillary tubes, and expose dends of dental wires . (Y Figure 3-4)

Contaminated needles or other contaminated sharp smust not be bent, recapped, or removed unless it can b edemonstrated that no alternative is feasible or that suc haction is required by a specific medical procedure .

If a procedure requires shearing or breaking of needles,this procedure must be