Infection/Disease Control HEPATITIS CONTROL PROGRAM

OPERATING PROCEDURE NO. 153-29 Florida State Hospital Chattahoochee, Florida July 8, 2009 Infection/Disease Control HEPATITIS CONTROL PROGRAM 1. Purpose: To establish consistent surveillance, reporting, control and prevention practices for hepatitis. 2. Policy: Florida State Hospital shall have an effective Hepatitis Control Program that will enable the early detection of hepatitis and prevent disease transmission from one person to another. 3. Training Requirements: All Florida State Hospital employees will be trained on this operating procedure upon hire into the position during Worksite Education and by their supervisor each time the operating procedure is revised. 4. Reference: a. Centers for Disease Control (CDC) Guidelines for Isolation Precautions in Hospitals. b. Section 60K-5.031(2) of the State Personnel Rules of the Career Service System. c. Control of Communicable Diseases in Man, by the American Public Health Association. d. Centers for Disease Control (CDC) Protection Against Viral Hepatitis: Morbidity & Mortality Weekly Report Recommendations and Reports, February 9, 1990, Volume 39, No. RR-2. e. 29 Code of Federal Regulations (CFR) Part 1910.1030 Occupational Exposure to Bloodborne Pathogens Federal Register. f. Florida Administrative Code 38I-20, Safety and Health Standards g. Centers for Disease Control (CDC) Recommendations for Prevention and Control of Hepatitis C Virus Infection and HCV-Related Chronic Disease: Morbidity and Mortality Weekly Report, October 16, 1998. Volume 47, No. RR-19. 5. Definitions: a. Hepatitis--An inflammation of the liver, usually from a viral infection. This Operating Procedure supersedes: Operating Procedure 153-29, dated March 11, 2008 Office of Primary Responsibility: Quality Assessment and Planning/Infection Control Distribution: Florida State Hospital Computer Network Users

Operating Procedure 153-29 July 8, 2009 b. Hepatitis B Carrier--An individual who carries the Hepatitis B Virus in the bloodstream and may be asymptomatic, but is capable of transmitting the infection to other susceptible individuals. c. HBsAG (Hepatitis B Surface Antigen)--An Australian antigen (HAA) which, when present in the bloodstream, is considered the marker for the presence of the Hepatitis B virus. d. H.B.I.G. (Hepatitis B Immune Globulin)--A sterile solution of human immunoglobulin used in providing passive immunization to individuals following exposure to Hepatitis B. e. Hepatitis B Vaccine (recombinant)--the recombinant vaccines are derived from HBsAg produced in yeast cells and are free of association with human blood or blood products. f. Anti-HBs (Antibody to Hepatitis B Surface Antigen)--The presence of anti-hbs in the serum indicates the person has had the Hepatitis B virus or has received the Hepatitis B Immune Globulin (HBIG) or the Hepatitis B Vaccine. g. Isolation Precautions--The Centers for Disease Control and Prevention have developed new guidelines for isolation precautions in hospitals. The revised guidelines contain two tiers of precautions a) Standard and b) Transmission based. (1) Standard Precautions: Blends the major features of universal precautions, (blood and body fluid precautions) and body substance isolation into a single set of precautions to be used for the care of all persons in hospitals. The new Standard Precautions apply to blood, all body fluids, secretions, and excretions, except sweat, whether or not they contain visible blood; non intact skin; and mucous membranes. These precautions are designed to reduce the risk of transmission of both recognized and unrecognized sources of infection in hospitals. This new terminology, Standard Precautions, will be used in place of Universal Blood and Body Fluid Precautions. (2) Transmission-Based Precautions: Reduces the disease-specific precautions into three sets of precautions based on routes of transmission. These categories are designed for documented or suspected to be infected or colonized with highly transmissible or epidemiological important pathogens for which additional precautions beyond Standard Precautions are needed to interrupt transmission to others. The three (3) types of Transmission-Based Precautions include: (a) Airborne precautions reduce the risk of airborne transmission of infectious agents such as tuberculosis and varicella viruses. (b) Droplet precautions reduce the risk of transmission of agents such as meningitis, and rubella. (c) Contact precautions are used for persons known to have serious illnesses easily transmitted by direct contact such as herpes simplex, wound or skin infections. All three (3) types of Transmission Based Precautions may be used at one time when the multiple routes of transmission are suspected in a person. Transmission Based Precautions are always used in conjunction with Standard Precautions (Florida State Hospital Operating Procedure 153-8, Medical Isolation Precautions). 2

Operating Procedure 153-29 July 8, 2009 h. Personal Protective Equipment (PPE) or Barrier Equipment--Protective equipment is to be worn by employees as barriers to prevent possible exposure to blood/body fluids, secretions, excretions (except sweat), non-intact skin, and mucous membranes. 6. General Information: a. The number of hepatitis diseases caused by different virus continues to increase as research and testing methods improve. The three (3) major types of hepatitis are A, B, and C with D and E also being diagnosed (see Attachment 1). Appropriate laboratory studies are needed for an accurate diagnoses of hepatitis. b. An individual may be exposed when blood or body fluid from an infected person (either someone who presently has hepatitis or a carrier) comes in contact with blood, body fluid, or mucous membrane of an uninfected person. The six (6) principle modes of transmission are: (1) direct percutaneous exposure, such as needlesticks; (2) percutaneous exposure, such as bites, cuts, and abrasions; (3) exposure of broken skin or mucous membranes of the mouth or eye to blood or body fluids which contains the Hepatitis virus; (4) direct exposure of mucous membranes to infective saliva or semen, such as through sexual contact; and (5) indirect transfer of infective serum or plasma through environmental surfaces; (6) perinatal exposure. c. Individuals must be aware of the modes of transmission and the appropriate precautions to be taken to prevent transmission. The Centers for Disease Control s disease specific guidelines are followed at Florida State Hospital (refer to Florida State Hospital Operating Procedure 153-8, Medical Isolation Precautions). The guideline for hepatitis is Standard Precautions. Proper handwashing and having minimal contact with blood and blood contaminated secretions/excretions by using the appropriate barrier (PPE) is of utmost importance. 7. Procedures: a. Hepatitis Screening: Resident admissions will be tested for Hepatitis A, B, and C for baseline status, need for Hepatitis B vaccination and follow up medical evaluation. b. Suspected Hepatitis: (1) Residents with signs or symptoms of hepatitis are on Standard Precautions as are all residents. Appropriate laboratory testing will be conducted for an accurate diagnosis. 3

Operating Procedure 153-29 July 8, 2009 (2) Unit medical physicians will evaluate the need for further restriction and/or medical isolation based on resident s condition and laboratory test results. (3) Residents requiring medical isolation for hepatitis and/or further diagnostic studies may be transferred to Unit 31. (4) Employees with suspected hepatitis will follow guidelines in Florida State Hospital Operating Procedure 153-9, Employee Health Services Program. c. Hepatitis A: (1) Residents with signs or symptoms of acute infection of Hepatitis A will be admitted to Unit 31. (2) Place resident in isolation using Transmission Based Precautions during the first two (2) weeks and until at least one (1) week after onset of jaundice. d. Hepatitis B/Hepatitis B Carrier: (1) Residents with signs or symptoms of acute infection of Hepatitis B will be referred to Unit 31 for evaluation. (2) Place resident on Transmission Based Precaution-Contact Transmission until resident has at least two (2) negative HBsAG (HAA) reports done at six (6) month intervals. (3) Residents who remain positive for HBsAG after clinical improvement will be considered carriers. Appropriate tests for liver function and hepatitis disease status will be done at six (6) month intervals or more frequently to determine whether antigenemia continues to persist. Residents are to be instructed regarding the disease process and modes of transmission with emphasis on eliminating further transmission. e. Preventive Treatment following possible exposure to Hepatitis: (1) Employee: Any employee who in the performance of job duties sustains a possible exposure to Hepatitis will report to the supervisor for immediate referral to the current Hospital Workers Compensation Provider. Unit Personnel will initiate the Resident/Employee Possible Blood/Body Fluid Exposure Report (Attachment 2). (2) Resident: Any resident who sustains a possible exposure to Hepatitis will be reported to the attending physician immediately. (a) Unit personnel will initiate the Resident/Employee Possible Blood/Body Fluid Exposure Report (Attachment 2). The physician will review the status of the resident exposed and take the appropriate action. The action taken will be based on the hepatitis status of the resident causing exposure and the resident exposed (Attachments 3, 4, and 5). (b) If the resident is to receive preventive treatment, it will be ordered by the attending physician and administered by the assigned nurse in the Unit. 4

Operating Procedure 153-29 July 8, 2009 (c) Unit personnel will be responsible for the scheduling and administration of Hepatitis B vaccination injections for residents. (3) All Resident/Employee Possible Blood/Body Fluid Exposure Reports (Form 180) for residents and employees are to be completed and forwarded to the Office of Quality Assessment and Planning/Infection Control and Office Of Risk Managment within 48 hours following completion. (4) The Hospital Infection Control Nurse will review each exposure report form, assess action(s) taken and complete Section III. 8. Reporting Requirements: a. The occurrence or suspected occurrence of Hepatitis is considered dangerous to public health and is a Reportable Disease governed by Chapter 64D-3 of the Florida Statutes. b. Unit personnel will be responsible to report all cases or suspected cases of residents or employees clinically ill with Hepatitis immediately by telephone to the Hospital Infection Control Nurse. c. All resident confirmed positive HBsAg(HAA) reports received by the Laboratory will be telephoned upon receipt to the Hospital Infection Control Nurse and the resident s unit nurse/doctor. Written copies from the lab will follow in the mail. d. The Hospital Infection Control Nurse will be responsible to report any cases or suspected cases of residents or employees clinically ill with Hepatitis to the Hospital Health Care Medical Service Director, Hospital Clinical Director, and the Senior Human Service Program Administrator in the Office of Quality Assessment and Planning. e. The Hospital Infection Control Nurse shall be responsible to report all cases or suspected cases within 48 hours to the Gadsden County Health Officer. 9. Mandatory Employee Compliance: a. Any employee with signs or symptoms of being clinically ill with Hepatitis is required to comply with the work restriction requirements as outlined in established Florida State Hospital Operating Procedure 153-9, Employee Health Services Program. b. Any employee with a diagnosis of being clinically ill with Hepatitis must have evidence that he/she is no longer infectious before returning to work. c. A copy of approval for the employee to return to work is to be furnished to the Office of Quality Assessment and Planning/Infection Control, upon receipt in the employee s Unit/Department. (Signed original on file in Central Health Information Services) DIANE R. JAMES Hospital Administrator 6 Attachments 1. The ABC s of Hepatitis 2. Resident/Employee Possible Blood/Body Fluid Exposure Report (Form 180) 5

Operating Procedure 153-29 July 8, 2009 3. Hepatitis B Preventative Treatment Algorithm 4. Post-Exposure Prophylaxis of HBsAg- Positive Exposures in Recipients of Hepatitis B. Vaccine 5. Hepatitis C Guidelines for Testing and Post Exposure Recommendations 6. Employee Consent for Treatment (Form 179) SUMMARY OF REVISED, ADDED, OR DELETED MATERIAL This operating procedure was revised with the following changes: deleted all references to Employee Health Clinic and inserted references to current Hospital Workers Compensation Provider; deleted employee Hepatitis B and C baseline testing in paragraph 7a(1); deleted High risk resident in paragraph 7a(2). deleted all reference to post exposure follow up by Employee Health Clinic in paragraph 7e(1)(b)-(f); deleted sentence stating Written copies from lab will follow. in paragraph 8c; added Form 180 and Office of Risk Management in paragraph 7e(3); updated attachments. 6

The ABC s of Hepatitis What is it? Incubation Period How is it Spread? Symptoms Treatment of Chronic Disease Vaccine Who is at Risk? Prevention Hepatitis A (HAV) HAV is a virus that causes inflammation of the liver. It does not lead to chronic disease. 15 to 50 days. Average 30 days Transmitted by fecal/oral route, through close person to person contact or ingestion of contaminated food and water. May have no symptoms. Adults may have light stools, dark urine, fatigue, fever and jaundice. Not applicable. Two doses of vaccine to anyone over the age of two. Household or sex contact with an infected person or living in an area with HAV outbreak. Travelers to developing countries, homosexual men, and IV drug users. Immune Globulin or vaccination. Wash hands after going to the toilet. Clean surfaces contaminated with feces, such as changing tables. Hepatitis B (HBV) HBV is a virus that causes inflammation of the liver. The virus can cause liver cell damage, leading to cirrhosis and cancer. 4 to 25 weeks. Average 8 to 12 weeks. Contact with infected blood, seminal fluid, and vaginal secretions. Sex contact, contaminated needles, tattoo/body piercing and other sharp instruments. Infected mother to newborn. Human bite. May have no symptoms. Some persons have mild flulike symptoms, dark urine, light stools, jaundice, and fever. Interferon is effective in up to 35-45% of those treated. Three doses may be given to persons of any age. Infant born to infected mother, having sex with infected persons or multiple partners, IV drug users, emergency responders and healthcare workers, homosexual men, and hemodialysis patients. Vaccination and safe sex. Clean up any infected blood with bleach/disinfectant and wear protected gloves. Do not share razors or toothbrushes. Hepatitis C (HCV) HCV is virus that causes inflammation of the liver. This infection can lead to cirrhosis and cancer. 2 to 25 weeks. Average 7 to 9 weeks. Contact with infected blood, contaminated IV needles, razors, tattoo/body piercing and other sharp instruments. Infected mother to newborn. It is not easily transmitted through sex. Hepatitis D (HDV) HDV is a virus that causes inflammation of the liver. It only infects those persons with HBV. Hepatitis E (HEV) HEV is a virus that causes inflammation of the liver. It is rare in the U.S. There is no chronic state. 4 to 26 weeks. 2 to 9 weeks. Average 40 days. Contact with infected blood, contaminated needles. Sexual contact with HDV infected person. Transmitted through fecal/oral route. Outbreaks associated with contaminated water supply in other countries. Same as HBV Same as HBV Same HBV Interferon is effective in 10-20% of those treated. Interferon with varying success. None None None Anyone who had a blood transfusion before 1990; healthcare workers, IV drug users, hemodialysis patients, infants born to infected mother, and multiple sex partners. Safe sex. Clean up spilled blood with bleach/disinfectant Wear gloves when touching blood. Do not share razors or toothbrushes IV drug users, homosexual men, and those having sex with a HDV infected person. Hepatitis B vaccine to prevent HBV infection. Safe sex. Not Applicable. Travelers to developing countries. Avoid drinking or using potentially contaminated water. Attachment 1 Operating Procedure 153-29

RESIDENT/EMPLOYEE POSSIBLE BLOOD/BODY FLUID EXPOSURE REPORT SECTION I: (COMPLETED BY UNIT/DEPARTMENT) DATE: TIME: UNIT/DEPARTMENT: WARD/POD: TYPE OF EXPOSURE: Bite Needle Stick Open Wound Mucous membrane/mouth Mucous membrane/eyes Sexual contact Other (specify) DESCRIPTION OF EXPOSURE: PREVIOUS HEPATITIS/HIV STATUS OF PERSON RECEIVING EXPOSURE: Name and Hospital Number: History of Hepatitis: Yes No History of HIV: Yes No Tested for Hepatitis: Yes No Tested for HIV: Yes No If Yes, Date/Results: If Yes, Date/Results: Rec d HBIG: Yes No Rec d HB Vaccine: Yes No Date Hep B vaccine Completed: Tested for Antibodies: Yes No Date/Results: PREVIOUS HEPATITIS/HIV STATUS OF PERSON CAUSING EXPOSURE: Name and Hospital Number: History of Hepatitis: Yes No History of HIV: Yes No Tested for Hepatitis: Yes No Tested for HIV: Yes No If Yes, Date/Results: If Yes, Date/Results: Rec d HBIG: Yes No Rec d HB Vaccine: Yes No Date Hep B vaccine Completed: Tested for Antibodies: Yes No Date/Results: SIGNATURE/PERSON COMPLETING SECTION I DATE ******************************************************************************************************************* SECTION II: (COMPLETED BY UNIT/DEPARTMENT FOR RESIDENT EXPOSURE; SUPERVISOR FOR EMPLOYEE EXPOSURES) TYPE TESTING/TREATMENT ORDERED SIGNATURE/PERSON COMPLETING SECTION II DATE ******************************************************************************************************************* SECTION III: (COMPLETED BY HOSPITAL INFECTION CONTROL NURSE) REPORT OF HOSPITAL INFECTION CONTROL NURSE SIGNATURE/PERSON COMPLETING SECTION III DATE INSTRUCTIONS: SECTION I: Completed by Unit/Department. If employee exposure, the employee should personally write the Description of Exposure, if resident exposure, the nurse or supervisor should complete the Description of Exposure. SECTION II: Completed by Unit Department if resident exposure; Supervisor if employee exposure. SECTION III: Completed by the Hospital Infection Control Nurse. GENERAL: Sections I and II are to be completed as soon as possible after exposure occurs. All completed forms are to be forwarded to the Office of Quality Assessment and Planning/Hospital Infection Control and Office of Risk Management within forty-eight (48) hours. Form 180, (Revised) Apr 09 Attachment 2 Office of Primary Responsibility: Quality Assessment & Planning/Infection Control Operating Procedure 153-29

HEPATITIS B EXPOSURE PREVENTIVE TREATMENT ALGORITHM EXPOSER AND EXPOSED KNOWN HEPATITIS STATUS EXPOSER AND/OR EXPOSED UNKNOWN HEPATITIS STATUS HAA NOT INDICATED STAT HAA NEEDED DETERMINE INDICATOR FOR TREATMENT EXPOSER POS. EXPOSED NEG. EXPOSER NEG. EXPOSED POS. EXPOSER NEG. EXPOSED NEG. EXPOSER POS. EXPOSED POS. TREAT EXPOSED TREAT EXPOSER NO TREATMENT NO TREATMENT PREVENTIVE TREATMENT REGIMEN FOR EXPOSURE HBIG (WITHIN 24 HRS. FOLLOWING EXPOSURE IF POSSIBLE AND NO LONGER THAN 7 DAYS PAST EXPOSURE) HEPATITUS B VACCINE - 3 DOSES 1st DOSE WITHIN 7 DAYS FOLLOWING HBIG 2nd DOSE ONE MONTH FOLLOWING 1st DOSE 3rd DOSE SIX MONTHS FOLLOWING 1st DOSE

POST-EXPOSURE PROPHYLAXIS OF HBsAg-POSITIVE EXPOSURES IN RECIPIENTS OF HEPATITIS B VACCINE 3 Vaccine Doses Complete Vaccine Series Test for Anti-HBS Never Tested Known Responder Known Non- Responder Within Test for 1 year HBIGx1 Positive Negative Anti-HBs 1 year vaccine booster dose x1 No Treatment Complete HBIGx1 Test for vaccine Complete Anti-HBS series vaccine Positive Negative series Positive Negative No Treatment *Adequate anti-hbs-10 SRU by RIA or positive by EIA HBIGx1 vaccine booster dose x1 No Treatment Vaccine booster dose x1 1. Partially vaccinated persons (<3 doses): Test for anti-hbs; if adequate antibody levels are present, no HBIG is necessary and the vaccine series should be completed as scheduled. If anti-hbs is low or absent, the exposed person should be given a single dose of HBIG and complete the vaccine series as scheduled. 2. Fully vaccinated persons never tested for anti-hbs; if adequate antibody levels are present, no treatment is necessary. If anti-hbs is low or absent, give one dose of HBIG immediately and one booster dose of HB vaccine. 3. Fully vaccinated persons known to have developed adequate antibody: Retest for anti-hbs only if previous testing occurred more than one year ago; if adequate antibody levels are present, no treatment is necessary. If anti- HBs is found to be low or absent, give one booster dose of HB vaccine. 4. Fully vaccinated persons known to be non-respondent: If the exposed person has been fully vaccinated, but is know to have had low or absent anti-hbs on post-vaccination testing, give one dose of HBIG immediately and one booster dose of HB vaccine. Attachment 4 Operating Procedure 153-29

Hepatitis C Guidelines for Testing and Post Exposure Recommendations A. Recommendations for testing for Hepatitis C Residents should be tested for hepatitis C virus (HCV) infection based on their risk for infection Persons who ever injected illegal drugs, including those who injected once or a few times many years ago and do not consider themselves as drug users. Persons with selected medical conditions, including persons who received clotting factor concentrates produced before 1987; persons who were ever on chronic (long-term) hemodialysis; and persons with persistently abnormal alanine aminotransferase levels. Prior recipients of transfusions or organ transplants, including persons who were notified that they received blood from a donor who later tested for HCV infection; persons who received a transfusion of blood or blood components before July 1992; and persons who received an organ transplant before July 1992. Residents/employees who should be tested routinely for HCV-infection based on a recognized exposure Healthcare, emergency medical, and public safety workers after needle sticks, sharps, or mucosal exposures (eye, mouth, nose) to HCV-positive blood. Children born to HCV-positive women. Residents who have exposure to mucosal exposure to HCV-positive blood ie: sexual contact, mucous membranes of eyes, mouth, genitals, assaultative behavior B. Postexposure follow-up of resident/employees for hepatitis C virus (HCV) infection For the source, baseline testing for anti-hcv. For the person exposed to an HCV-positive source, baseline and follow-up testing including baseline testing for anti-hcv and ALT activity; and follow up testing for anti-hcv (e.g., at 4-6 months) and ALT activity. (If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4-6 weeks.) Confirmation by supplemental anti-hcv testing of all anti-hcv results reported as positive by enzyme immunoassay. Residents who have tested positive will be referred to the Gastroenterology Clinic. Employees will be advised to see their private physicians for evaluation. Immune globulin and antiviral agents are not recommended for postexposure prophylaxis to Hepatitis C. A vaccine is not available for Hepatitis C. Attachment 5 Operating Procedure 153-29

EMPLOYEE CONSENT FOR TREATMENT NAME WORK AREA SOCIAL SECURITY NUMBER WORK PHONE DATE OF BIRTH SEX RACE WEIGHT HOME ADDRESS HOME PHONE ALLERGIES MEDICATION GIVEN \ \ LOT NUMBER EXPIRATION DATE MANUFACTURER POSSIBLE ADVERSE REACTIONS (CHECK AREA THAT APPLIES) HEPATITIS B FEVER MALAISE HEADACHE DIZZINESS NAUSEA/VOMITING MYALGIA PAIN AT INJECTION SITE LOCAL INFLAMMATION H-BIG ANAPHYLAXIS INFLUENZA FEVER MALAISE GULLAIN-BARRE ANAPHYLAXIS ERYTHEMA INDURATION SORENESS TETANUS TOXOID FEVER CHILLS MALAISE FLUSHING ACHES URTICARIA PRURITUS TACHYCARDIA HYPOTENSION ANAPHYLAXIS I HAVE BEEN INFORMED ABOUT THE MEDICATION AND ALL QUESTIONS HAVE BEEN ANSWERED TO MY SATISFACTION. I CONSENT TO RECEIVE THE ABOVE MEDICATION. SIGNATURE OF EMPLOYEE DATE AND TIME WITNESS DATE AND TIME Attachment 6 Form 179, (Revised) Oct 92 Operating Procedure 153-29 Office of Primary Responsibility: Quality Assessment & Planning/Infection Control