OSHA PROGRAM MANUAL for Medical Facilities

About the Author Sheila Dunn, DA, MT (ASCP), holds a doctoral degree in clinical laboratory science from the Catholic University of America in Washington, DC. She has helped thousands of outpatient medical facilities comply with federal regulations such as CLIA and OSHA through her presentations at a nationwide seminar series. She has written more than 150 articles about regulatory issues and healthcare delivery systems and serves as an advisor to numerous companies. 11A

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01/2011 21825 TAB 5: BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN

Contents

Page Exposure Control Plan Introduction...... 5-1 Overview of Bloodborne Pathogens Standard Components...... 5-2 A Quick Look at Occupational Exposure...... 5-3 Industries Subject to the Bloodborne Pathogens Standard...... 5-3 Key Provisions and Effective Dates...... 5-4 Universal Precautions...... 5-4 Other Potentially Infectious Materials (OPIM)...... 5-4 Implementing Universal Precautions...... 5-5 Bloodborne Pathogens...... 5-6 Epidemiology of Bloodborne Pathogens...... 5-6 Update on AIDS in the Workplace...... 5-9 Transmission of Bloodborne Pathogens...... 5-10 Exposure Determination...... 5-10 Personnel Who Are Occupationally Exposed...... 5-10 Exposure Prone Procedures...... 5-11 Bloodborne Pathogens Exposure Determination List #1 (Form 8)...... 5-12 Other Personnel Who Could Potentially Be Occupationally Exposed...... 5-13 Bloodborne Pathogens Exposure Determination List #2 (Form 9)...... 5-14 Employees Who Are Not Occupationally Exposed...... 5-15 Restricted Access Areas...... 5-15 Engineering / Work Practice Controls...... 5-15 Biohazard Labels...... 5-16 Handwashing...... 5-16 When to Wash Hands...... 5-18 How to Wash Hands...... 5-18 Artificial Nails...... 5-18 Sharps Safety...... 5-19 What to Look for in Safety Devices...... 5-19 Contents

Sharps Evaluation Procedure...... 5-20 Use of Non-Safe Sharps...... 5-21 Phlebotomy Needles...... 5-22 Sharps Containers...... 5-22 Sharps Container Maintenance...... 5-23 Sharps Container Disposal Procedure...... 5-23 Biohazardous Waste (See Tab 8)...... Laundry...... 5-24 Personal Protective Clothing & Equipment...... 5-25 PPE Strategy...... 5-25 Locations of PPE...... 5-26 Gloves...... 5-27 When to Wear Gloves...... 5-27 How to Wear Gloves...... 5-27 Latex Allergy...... 5-28 Preventing Allergic Reactions...... 5-29 Face Protection...... 5-30 Body Protection...... 5-30 Emergency Resuscitation Equipment...... 5-31 When to Wear PPE...... 5-31 Hepatitis B Vaccine...... 5-32 Safety of the Hepatitis B Vaccine...... 5-33 Documenting Employee Hepatitis Vaccines...... 5-33 Titering Employees after the Hepatitis B Vaccination...... 5-34 How to Determine Employee Immunity...... 5-34 Testing Employees Vaccinated before the Titer Requirement...... 5-35 Types of Hepatitis B Tests...... 5-35 Interpreting Hepatitis B Test Results...... 5-36 New Employee Hepatitis B Virus Vaccination Flow Chart...... Supplement Post-exposure Evaluation & Follow-up...... 5-37 What Is an Exposure?...... 5-37 What to Do after an Occupational Exposure...... 5-37 Confidentiality of Post-exposure Procedures...... 5-42 Employee Counseling/Precautions...... 5-43 Occupational Exposure Management Resources...... 5-43 Accident Report/Sharps Injury (Form 14)...... 5-44 Post-exposure Checklist...... 5-46 Post-exposure Medical Evaluation Declination Form (Form 18)...... 5-47 Injection Safety...... 5-49 Information for Providers...... 5-49 Frequently Asked Questions: Injection Safety FAQs for Providers...... 5-50 Infection Control and Safe Injection Practices to Prevent Patient- to-Patient Transmission of Bloodborne Pathogens...... Supplement Contents

Infection Control and Safe Injection Practices to Prevent Patient-to- Patient Transmission of Bloodborne Pathogens (fingerstick, blood glucose sampling)...... Supplement Bloodborne Pathogens Resources...... 5-55 Bloodborne Pathogens Violations in Physician Practices...... 5-56

OSHA Program Manual for Medical Facilities

infection includes combination interferon and ribavirin. Treatment results in eradication only in 30% to 40% of cases. Symptoms of hepatitis B and C are: . Fever . Rash . Jaundice . Dark urine . Anorexia . Right upper quadrant pain . Nausea

Bloodborne Pathogen Incubation Period Infectivity* HIV 6-12 weeks 0.3% (percutaneous) 0.1% (mucous membrane/eyes) HBV 8-12 weeks 7-30% HCV 6-9 weeks 0-10% *Percent of those occupationally exposed expected to seroconvert

HEPATITIS D Virus, also called delta hepatitis, is an RNA virus that can cause hepatitis only when the patient has hepatitis B.

HEPATITIS E Virus is not a bloodborne pathogen, but an RNA virus that contaminates water and is endemic to third world countries.

HEPATITIS G Virus is a bloodborne virus that has been associated with non-ABCDE hepatitis.

HIV (Human Immunodeficiency Virus) is the virus that causes AIDS. Because the transmission of HIV is considerab­ly less efficient than HBV, the risk of HIV infection to employees who must handle blood and other potentially infectious materials is less than for HBV infection (i.e., HIV results in fewer serocon­versions following exposure incidents, estimated to be less than half of 1%).

HIV is a member of a group of viruses known as human retrovirus­es. HIV gradually de­ pletes the number of cells that are essential for immune function, rendering the infected individual increasingly susceptible to oppor­tunistic infections and clinical disorders. These condi­tions can be aggressive, rapidly progres­sive, difficult to treat, and less responsive to traditional modes of treatment.

Infection with HIV is identified through testing the blood for the presence of HIV anti­ bodies. Although the antibodies do not appear to defend or protect the host against HIV, they serve as markers of viral infection. Most people infected with HIV have detectable anti­bodies within 6 months of infection, with the majority generating detectable anti­ bodies between 6 and 12 weeks after exposure.

5-8 RECOMMENDED INFECTION-CONTROL AND SAFE INJECTION PRACTICES TO PREVENT PATIENT-TO-PATIENT TRANSMISSION OF BLOODBORNE PATHOGENS

Diabetes Care Procedures & Techniques . Prepare medications such as insulin in a centralized medication area; multiple dose insulin vials should be assigned to individual patients and labeled appropriately. . Never reuse needles, syringes, or lancets. . Restrict use of fingerstick capillary blood sampling devices to individual patients. Consider selecting single-use lancets that permanently retract upon puncture. . Dispose of used fingerstick devices and lancets at the point of use in an approved sharps container. . Environmental surfaces such as glucometers should be decontaminated regularly and anytime contamination with blood or body fluids occurs or is suspected. . Glucometers should be assigned to individual patients. If a glucometer that has been used for one patient must be MGD, reused for another patient, the device must be cleaned and disinfected. . Maintain supplies and equipment such as fingerstick devices and glucometers within individual patient rooms if possible. . Any trays or carts used to deliver medications or supplies to individual patients should remain outside patient rooms. Do not carry supplies and medications in pockets.

. Because of possible inadvertent contamination, unused supplies and medications taken to a patient’s bedside during fingerstick monitoring or insulin administration should not be used for another patient.

CDC. Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term--Care Facilities --- Mississippi, North Carolina, and Los Angeles County, California, 2003—2004. MMWR 2005; 54(09):220-223. RECOMMENDED INFECTION-CONTROL AND SAFE INJECTION PRACTICES TO PREVENT PATIENT-TO-PATIENT TRANSMISSION OF BLOODBORNE PATHOGENS

Hand hygiene and gloves Training and oversight . Wear gloves during fingerstick glucose . Provide a full hepatitis B vaccination series to all monitoring and during any other procedure previously unvaccinated LTC staff persons whose that involves potential exposure to activities involve contact with blood or body blood or body fluids. fluids. Check and document post-vaccination titers one to two months after completion of the . Change gloves between patient contacts. vaccination series. Change gloves that have touched potentially blood-contaminated objects or fingerstick . Establish responsibility for oversight of infection wounds before touching clean surfaces. control activities. Investigate and report any suspected case that may represent a newly . Remove and discard gloves in appropriate acquired bloodborne infection. receptacles after every procedure that involves potential exposure to blood or body fluids, . Have staff demonstrate knowledge of standard including fingerstick blood sampling. precautions guidelines and proficiency in application of these guidelines during procedures . Perform hand hygiene (i.e., hand washing with that involve possible blood or body fluid soap and water or use of an alcohol-based exposures. hand rub) immediately after removal of gloves and before touching other medical supplies . Provide staff members who assume responsibilities intended for use on other residents. involving percutaneous procedures with infection control training that includes practical demonstration of aseptic techniques and Medical management instruction regarding reporting exposures or . Review regularly the individual patients’ breaches. Direct annual retraining to all staff schedules for fingerstick blood glucose sampling members who perform procedures that involve and insulin administration and reduce the exposure to blood or body fluids. number of percutaneous procedures to the . Assesscompliance with infection control minimum necessary for appropriate medical recommendations for fingerstick glucose management of diabetes and its complications. monitoring (such as hand hygiene and glove changes between patients) by periodically . Assure that adequate staffing levels are observing personnel and tracking use of supplies. maintained to perform all scheduled diabetes care procedures, including fingerstick blood glucose monitoring. . Consider the diagnosis of acute viral hepatitis infection in LTC residents who develop an illness that includes hepatic dysfunction or elevated aminotransaminase levels (AST or ALT).

CDC. Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term--Care Facilities --- Mississippi, North Carolina, and Los Angeles County, California, 2003—2004. MMWR 2005; 54(09):220-223.

Source: Centers for Disease Control and Prevention. Reprinted with permission. Injection safety supplement, fingerstick blood glucose sampling Insert before p. 5-55 OSHA Program Manual for Medical Facilities

STEP 3. Assign an educational coordinator (write his or her name and title below) and make sure he or she follows the educational coordinator duties below.

Educational Coordinator: ______Name Title

Educational Coordinator Duties . Train all medical personnel to understand the implications of pandemic influenza and control measures (administrative, engineering, and work practice controls). . Identify staff members requiring respiratory protection and arrange for training, medical evaluation, and fit testing in time to respond to pandemic influenza. . Provide educational opportunities for staff members and patients (see Pandemic Influenza Resources on page 6-29) that are appropriate to their level of practice, language, and reading level. . Include infection control measures in your staff training programs to prevent the spread of pandemic flu. . Help staff members understand their roles in providing healthcare guidance to patients with pandemic influenza . Keep attendance records for all training programs.

STEP 4. Offer influenza vaccine (includes seasonal and H1N1 protection) to healthcare staff and keep a log of who accepted the vaccine. Use Influenza Vaccine Log located behind Tab 11: Master Record Forms (Form 25A) to record those who decline.

Administer pandemic influenza vaccines and antiviral medications according to current federal and/or state health department recommendations, including those for prioritizing administration. (See Pandemic Influenza Resources on page 6-29.)

This prioritization list will help estimate of the number of personnel and patients who would be targeted as first- and second-priority groups. It will also be used to identify staffing requirements and to determine the amount of vaccines and antivirals needed.

STEP 5. Anticipate a staffing shortage due to illness in personnel or their family members during a pandemic influenza outbreak.

Use the following procedures for handling staffing needs related to patient volume during a pandemic: . Encourage staff members to develop their own plan for the care of dependent family members (e.g., small children and seniors) in the event of community containment measures (e.g., school closings). . Calculate the minimum number and categories of staff members needed to keep the office/practice open during a pandemic influenza outbreak and use temporary staff members, if necessary, or close the office/practice. Identify your staff members in the following chart:

6-23 TAB 9: SPECIALTY SERVICES

Contents

Page About This Section...... 9-1 Working Safely with Cytotoxic Drugs...... 9-1 Effects of CD Exposure on Health...... 9-1 Safe Work Practices...... 9-2 Clothing...... 9-2 Drug Preparation & Administration...... 9-2 Sample List of Drugs that Should be Handled as Hazardous...... Supplement Selecting Biological Safety Cabinets (BSC)...... 9-3 Cleaning the Drug Preparation Area...... 9-3 Caring for Patients Receiving CDs...... 9-4 Waste Disposal...... 9-4 Spill Clean-up...... 9-4 Suggested Spill Kit Components...... 9-5 CD Receiving …………………...... 9-5 CD Storage………………………………...... 9-5 CD Transport……………………………...... 9-6 Employee Training……………………...... 9-6 Employee Medical Surveillance………...... 9-6 Employee Exposure……………………...... 9-6 Gas Cylinder Safety...... 9-7 Electrosurgical Safety (Laser, LEEPs)...... 9-9 Safe Work Practices...... 9-10 Surgical Safety…………………………...... 9-11 General PPE Indications for Surgery...... 9-11 Surgical Gowns...... 9-11 Surgical Gloves...... 9-12 Face and Eye Protection...... 9-12 Headwear...... 9-13 Shoe Covers...... 9-13 Contents

Surgical Drapes...... 9-13 Safe Sharp Strategies for the Surgical Setting...... 9-13 Scalpels...... 9-13 Suture Needles...... 9-13 Transferring Sharps Safely...... 9-14 How to Use the Neutral Zone...... 9-14 Tips for Minimally Invasive Surgeries...... 9-15 Safety Techniques for Operating on Patients Infected with Known Bloodborne Disease...... 9-15 Preventing Surgical Fires...... 9-15 Laboratory Safety...... 9-16 Laboratory Specimen Transport...... 9-17 Radiation Safety...... 9-18 Regulation of the Medical Use of Nuclear By-products...... 9-18 The “ALARA” Principle...... 9-18 Radiation Safety Guidelines for Personnel...... 9-19 Radiation Safety Policies for the Facility...... 9-19 Ionizing Radiation Exposure Limits...... 9-20 Special Precautions for Pregnant Workers...... 9-20 Low-level Radioactive Waste Disposal...... 9-21 NRC Notification, Reports, and Record...... 9-21 NRC Resources and Publications...... 9-22 Working Safely with Cryogenic Liquids...... 9-23 Precautions for Handling Liquid Nitrogen...... 9-23 Storing Liquid Nitrogen...... 9-24 Personal Protective Equipment...... 9-24 Liquid Nitrogen Disposal...... 9-24 Steps to Take if There Is Accidental Exposure...... 9-25 First Aid (cryogenic burns)...... 9-25 First Aid (anoxia)...... 9-25 Safe Vaccine Handling and Storage...... 9-26 Waste Anesthetic Gases...... 9-29 Where Exposures Occur...... 9-29 Preventing Exposures...... 9-29 Controls...... 9-30 Medical Surveillance...... 9-31 Recordkeeping...... 9-31 More Information...... 9-31 OSHA Program Manual for Medical Facilities

SPECIALTY SERVICES

About this Section

This section includes safety considerations for specialty services such as x-rays, laser and other ambulatory surgery, compressed gas handling, laboratory testing, and ad­ ministration of chemotherapy. This section may or may not be applicable to your prac­ tice. Please disregard information on any services that are not performed in your facility.

Working Safely with Cytotoxic Drugs

Cytotoxic drugs (CDs), also known as antineoplastics, are used to treat cancer. They are inherently toxic to human cell structures and pose significant short-term and long- term risks to healthcare professionals. Because they are often designed to seek out and kill growing cells, they can have serious reproductive side effects, such as fetal loss or malformation of offspring. These same anti-cancer agents also have toxic effects on healthy cells, and thus pose a health risk to those employees who are involved in their preparation, storage, administration and disposal. See below for a list of Hazardous Drugs updated July 2009 (* indicates newly added drugs).

NIOSH Hazardous Drug List for Healthcare

NIOSH has identified 157 hazardous drugs (see supplement following p. 9-2) that, if present in healthcare workplaces, may need to be included in the written hazard communication plan. It is unlikely that all the drugs identified will be present in a practice, but facilities, especially those with “inadequate resources for determining their own list of hazardous drugs, can use the list as a starter in determining when precautions are needed,” according to NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 (www.cdc.gov/niosh/docs/2010-167).

Effects of CD Exposure on Health

Short-term effects of exposure to CDs include skin injury, lightheadedness, dizziness, nausea, headache and allergic reactions. The long-term effects are more serious. Some antineoplastics are carcinogenic; that is, they can cause cancer and leukemia. Studies show they also cause birth defects (teratogens) and miscarriages, as well as chromosomal damage (mutagens).

Employee exposure is mainly through inhalation or skin contamination by droplets or dusts from CDs in the process of dissolving them, transferring them from one container to another, or manipulating them before administering to patients. These agents are

9-1 Sample List of Drugs that Should be Handled as Hazardous*

Aldesleukin Dienestrol Interferon alfa-n3 Procarbazine Alefacept Diethylstilbestrol Irinotecan HCl Progesterone Alemtuzumab Dinoprostone Leflunomide Progestins Alitretinoin Docetaxel Lenalidomide Raloxifene Altretamine Doxorubicin Letrozole Raltitrexed Amsacrine Dutasteride Leuprolide acetate Rasagiline mesylate Anastrozole Entecavir Lomustine Ribavirin Arsenic trioxide Epirubicin Mechlorethamine Risperidone Asparaginase Ergonovine/methylergonovine Medroxyprogesterone acetate Sirolimus Azacitidine Estradiol Megestrol Sorafenib Azathioprine Estramustine phosphate Melphalan Streptozocin Bacillus Calmette- Estrogen-progestin Menotropins Sunitinib malate Guerin (BCG)† combinations Mercaptopurine Tacrolimus Bexarotene Estrogens, conjugated Methotrexate Tamoxifen Bicalutamide Estrogens, esterified Methyltestosterone Temozolomide Bleomycin Estrone Mifepristone Teniposide Bortezomib Estropipate Mitomycin Testolactone Bosentan Etoposide Mitotane Testosterone Busulfan Exemestane Mitoxantrone HCl Thalidomide Capecitabine Finasteride Mycophenolate mofetil Thioguanine Carboplatin Floxuridine Nafarelin Thiotepa Carmustine Fludarabine Nelarabine Topotecan Cetrorelix acetate Fluorouracil Nilutamide Toremifene citrate Chlorambucil Fluoxymesterone Oxaliplatin Tositumomab Chloramphenicol Flutamide Oxytocin Tretinoin Choriogonadotropin alfa Fulvestrant Paclitaxel Trifluridine Cidofovir Ganciclovir Palifermin Trimetrexate glucuronate Cisplatin Ganirelix acetate Paroxetine HCl Triptorelin Cladribine Gemcitabine Pegaspargase Uracil mustard Clofarabine Gemtuzumab ozogamicin Pemetrexed Valganciclovir Colchicine Gonadotropin, chorionic Pentamidine isethionate Valrubicin Cyclophosphamide Goserelin Pentetate calcium trisodium Vidarabine Cyclosporin Hydroxyurea Pentostatin Vinblastine sulfate Cytarabine Ibritumomab tiuxetan Perphosphamide Vincristine sulfate Dacarbazine Idarubicin Pipobroman Vindesine Dactinomycin Ifosfamide Piritrexim isethionate Vinorelbine tartrate Dasatinib Imatinib mesylate Plicamycin Vorinostat Daunorubicin HCl Interferon alfa-2a Podofilox Zidovudine Decitabine Interferon alfa-2b Podophyllum resin Zonisamide Denileukin Interferon alfa-n1 Prednimustine

*These lists of hazardous drugs were used with the permission of the institutions that provided them and were adapted for use by NIOSH. The sample lists are intended to guide health care providers in diverse practice settings and should not be construed as complete representations of all of the hazardous drugs used at the referenced institutions. Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, intact medica­tions such as coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formu­lations are altered outside a ventilated cabinet (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened).

†BCG preparation should be done using aseptic techniques. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared. A separate area for the preparation of BCG suspension is recommended. All equipment, supplies, and receptacles in contact with BCG should be handled and disposed of as biohazardous. If preparation cannot be performed in a containment device, then respiratory protection, gloves and a gown should be worn to avoid inhalation or contact with BCG organisms.

Source: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010, reprinted with permission. Hazardous Drug list supplement Insert after p. 9-2

Contents

Form 11 Phlebotomy Device Evaluation…...... Use initially and whenever new safety devices are under consideration. Form 12 Generic Safety Device Evaluation……...... Use initially and whenever new safety devices are under consideration. Form 12-A Sharps Disposal Container Locations...... Use periodically to monitor compliance for sharps disposal container locations. Form 13 Sharps Evaluation Results Form...... … Use initially and whenever new safety devices are under consideration.

Bloodborne Pathogens Employee Medical Records

Form 14 Accident Report/Sharps Injury Log…...... Use when an employee injury occurs, including sharps injuries and other bloodborne pathogens exposures. Form 15 HBV Vaccination Declination Form……...... Use when an employee is given the hepatitis B vaccine or declines this vaccine. Form 16 HBV Employee Vaccination Form……...... Use when an employee is given the hepatitis B vaccine or declines this vaccine. Form 17 Post-exposure Checklist…………….…...... Use to document that all required actions were taken after a sharps injury or employee exposure to bloodborne pathogens. Form 18 Post-exposure Medical Evaluation Use to document a particular employee refusing post- Declination Form…………………...... exposure testing and treatment. Form 18-A Source Patient Testing Consent Form…….. Use to obtain consent from a source patient after an exposure incident such as a needlestick.

Hazard Communication Records

Form 19 Hazardous Substances List…….……...... Use initially to list all hazardous chemicals in your facility and when a new hazardous chemical is introduced. Form 20 MSDS Request Letter…………..……...... Use when a new hazardous chemical is intro­duced to document attempts to procure an MSDS.

TB/Infection Control Records

Form 21 TB Risk Assessment Results Form…...... Use annually.

Form 22 TST Record……………..………..……...... Use as indicated, based on your facility’s risk assessment. Form 23 TST Declination Form………….…...…...... Use when an employee declines receiving a TB skin test. Form 24 TB Exposure Log……………….…...…...... Use as indicated when employees are exposed to a known TB patient. Form 25 Influenza Vaccine Log………....………...... Use annually to vaccinate all employees.

Form 25-A Influenza Vaccine Declination Form…...... Use when an employee declines this vaccine. OSHA Program Manual for Medical Facilities

INFLUENZA VACCINE DECLINATION FORM (Seasonal and H1N1)

My employer or affiliated health facility, ______, has recommended I receive influenza vaccination in order to protect myself and the patients I serve.

I acknowledge that I am aware of the following facts:

• Influenza is a serious respiratory disease that kills an average of 36,000 persons and hospitalizes more than 200,000 persons in the United States each year. • Influenza vaccination is recommended for me and all other healthcare workers to prevent influenza disease and its complications, including death. • If I contract influenza, I will shed the virus for 24–48 hours before influenza symptoms appear. My shedding the virus can spread influenza infection to patients in this facility. • If I become infected with influenza, even when my symptoms are mild, I can spread severe illness to others. • I understand that the strains of virus that cause influenza infection change almost every year, which is why a different influenza vaccine is recommended each year. • I cannot get the influenza disease from the influenza vaccine. • The consequences of my refusing to be vaccinated could endanger my health and the health of those with whom I have contact, including

––patients in this healthcare setting ––my coworkers ––my family ––my community

Despite these facts, I am choosing to decline influenza vaccination right now for the following reasons:______

I understand that I may change my mind at any time and accept influenza vaccination, if vaccine is available.

I have read and fully understand the information on this declination form.

______Employee signature Date

______Employee printed name

Adapted from Immunization Action Coalition www.immunize.org/catg.d/p4068.pdf

Form 25-A