1. Hepatitis C Investigation Ward County

2. Hepatitis C Virus (HCV): Background Most common bloodborne infection in the United States Transmission is primarily through percutaneous blood exposure  Most infections are asymptomatic  Long incubation period: 2 weeks to 6 months Healthcare-associated exposure due to infection control lapses is an emerging route of transmission Centers for Disease Control and Prevention. http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet-BW.pdf http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet-BW.pdf PRELIMINARY FINDINGS, CONFIDENTIAL

3. Hepatitis C Outbreaks United States, 2008-2012 16 outbreaks with 160 associated cases  8 outpatient settings (42 cases; >68,000 notified)  6 hemodialysis settings (50 cases;1,353 notified)  2 owing to drug diversion (67 cases; > 19,000 notified) Centers for Disease Control and Prevention. http://www.cdc.gov/hepatitis/Outbreaks/PDFs/HealthcareInvestigationTable.pdf PRELIMINARY FINDINGS, CONFIDENTIAL

4. Hepatitis C Outbreaks: Infection Control Lapses  Syringe reuse/contaminated medication vials  Suspected syringe reuse  Failure to maintain separate clean and contaminated work spaces  Breaches in environmental cleaning/disinfection  Breaches in medication preparation  Failure to consistently change gloves and perform hand hygiene  Mode of transmission unknown or only suspected  5 of 16 HCV investigations (31%) PRELIMINARY FINDINGS, CONFIDENTIAL

5. HCV Transmisison: Challenges  HCV capable of surviving at room temperature for at least 16 hours  Blood contaminated surfaces may act as reservoir for the virus  Blood contamination may not be visible to the naked eye  There is no vaccine or prophylactic treatment for HCV PRELIMINARY FINDINGS, CONFIDENTIAL

6. First 2 cases identified in Feb 2013  Patient 1  Elevated liver enzymes  HCV AB +  Patient 2  Jaundice noticed earlier  Rt upper quadrant pain  Elevated liver enzymes  HCV AB + Third case identified in May 2013  Elevated liver enzymes  HCV AB + Identification of the Outbreak

7. In June additional blood samples were collected from 2 of the 3 original patients  Patient #3 was deceased Begin gathering background healthcare data and living information on all three patients  Further investigation identified 4 more residents meeting the acute HCV case definition; blood samples collected Samples were sent to PHL for confirmation of HCV+ status All were positive Contacted CDC regarding acute HCV in non-traditional population  Found stored blood sample on patient #3  All 7 Samples sent to CDC for quasi-species analysis Follow up

8. All 3 patients were current residents of the same LTC Facility  Notified the facility of the issue  Gathered list of all residents going back to August of 2011  This date was based on 6 month incubation period of earliest case  Matched list of residents to NDDoH’s HCV surveillance database  Eight additional matches identified Additional testing was conducted on Sept. 9  27 additional cases identified as HCV +  Samples sent to CDC for quasi-species analysis  Additional + indicated 26% of residents infected  Highest known percentage found in the literature in LTC facilities was 4% Testing done at alternate LTC Facility: ~3.6% residents were positive  One resident that was positive for the outbreak strain had previous stay at the index LTC Facility Additional Testing

9. Testing Summary NDDoH Has Tested Approx. 1,300 Individuals Since August 2013 in this Investigation  Testing Based on Associations from Data Analysis  Assisted Living Facility Screening

10. Minot HCV Investigation

11. Investigation Objectives Conduct case-finding to identify the scope of the outbreak Conduct an investigation to find risk factors associated with transmission Develop recommendations to prevent ongoing HCV transmission

12. Outbreak Case Definition Any individual who resided at skilled nursing facility A during Jan 1, 2011 – Sep 9, 2013, with evidence of HCV infection AND whose virus is related by transmission to the outbreak strain by quasispecies (QS) analysis

13. Case-Control Study: Data Collection and Analysis Study population limited to residents present on Sep 9, 2013 Chart abstraction: procedures involving percutaneous contact with blood or body fluids  Hospital inpatient encounters  Emergency department visits and transport  Outpatient clinic encounters  Skilled nursing facility procedures Frequency of exposures, crude and adjusted odds ratios calculated

14. Infection Control Assessments Focused on opportunity for bloodborne pathogen transmission in relation to percutaneous exposures Assessments  Medication handling  Disinfection of reusable medical equipment

15. INVESTIGATION FINDINGS

16. Case Characteristics CharacteristicNumber (N=50)  Sex: Female (%)  30 (60%)  Median Age (Range)  84 years (38 – 100 years)  Median Length of Residence  1.9 years Range(0.02 – 7.1 years)

17. Quasispecies Analysis HCV mutates over time QS analysis allows for comparisons of specimens and evaluates degree of molecular relatedness  Highly sensitive method to evaluate the array of molecular variance in one individual versus another individual  CDC/DVH reference lab is able to compare among all patient specimens and look at all mutations Laboratory determination when identifying a “matched” case: samples share the same viral molecular branches and therefore share the same virus

18. QuasiSpecies Results

19. Case-Control Study Design Facility A Residents (n=105) Sep 9, 2013 Non-Match Genotype n=1 EXCLUDED No blood specimen collected. Rapid Anti-HCV negative screen only (n=7) EXCLUDED RNA (+), whether Anti-HCV (+) or (-) n=31 QS Match Genotype n=30 CASES Anti-HCV (-), RNA (-) n=62 CONTROLS Anti-HCV (+), RNA (-), n=5 EXCLUDED Blood specimen collected (n=98)

20. Percutaneous Exposure Analysis ExposureNo. of Cases (%) Hemodialysis0 ( 0.0) Bronchoscopy0 (0.0) Biopsy0 (0.0) Chemotherapy0 (0.0) Cardiac Catheterization1 (3.3) Endoscopy2 (6.7) Interventional Radiology3 (10.0) Non-orthopedic surgery3 (10.0) Gastrointestinal Clinic4 (13.3) Same Day Surgery4 (13.3) Transfusion5 (16.7) Orthopedic surgery6 (20.0) Controlled Injectable Medications10 (33.0)

21. Case-Control Findings: Crude Associations Exposure No. of Cases (%) N=30 No. of Controls (%) N=62 Crude Odds Ratio 95% Confidence Intervals Phlebotomy at Facility A28 (93%)33 (53%)12.32.7 – 56.2 Any Nail Care with Nursing Staff at Facility A 11(37%)7(11%)4.551.5 – 13.4 Podiatry only at Facility A23 (77%)7 (11%)25.38.0 – 80.5

22. Procedures Performed in Podiatry Care at Facility Debridement of toenail thickness and length Slant backs “as necessary”  Also known as a partial wedge resection, the procedure is a treatment for ingrown toenails Sharp debridement of overlying, nonviable tissue

23. Limitations Incubation period for HCV difficult to define  Limitation for case-control study as arbitrary time period for exposures was chosen Unable to directly observe the principal podiatrist or phlebotomist at Facility A during the suspected transmission period Problems with chart documentation  Nail care performed by Facility A nurses  Podiatry notes

24. Recommendations Implement active serologic surveillance protocol  Has not yielded any additional cases with likely transmission within the facility since implemented. Strict adherence to Standard Precautions Consultation with a certified infection preventionist  February 2014: APIC review

25. Future Directions Additional Testing Infection Control Education

26.  HAND HYGIENE  PHLEBOTOMY  PODIATRY  NAIL CARE PREVENTING TRANSMISSION OF BLOODBORNE PATHOGENS Faye Salzer, RN Division of Disease Control

27. Hand Hygiene: The number one step in preventing transmission of disease!  Easy access to hand sanitizer for hand hygiene  Before direct contact with patients  Before donning sterile gloves  After direct contact with a patient’s skin  After contact with body fluids, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled  When moving from a contaminated body site to a clean body site during patient care  After contact with inanimate objects in the immediate vicinity of the patient  After removing gloves  When leaving patient room

28.  Hand washing with soap and water  Hands are visibly dirty or known to be contaminated  Before eating  After using the restroom  After caring for patients colonized with Clostridium difficile  Access to lotion  Hand irritation can reduce hand hygiene compliance  Education:  disease transmission  Hand hygiene-right way, right time

29.  Access to gloves  Wearing gloves when contact with blood or other potentially infectious body fluids, excretions, secretions (except sweat), mucous membranes, and non-intact skin could occur.  Removing gloves after caring for a patient — personnel should not wear the same pair of gloves for the care of more than one patient.  Changing gloves during patient care when moving from a contaminated body site to a clean body site.  Performing hand hygiene immediately after removal of gloves.  Gloves can become a mode of transmission if not used appropriately, so remove immediately after task!  Gloves are not a replacement for hand washing.

30. PHLEBOTOMY  Educate  on procedure  avoidance of contamination of equipment  Bloodborne Pathogens  Plan ahead  Availability of supplies  All supplies should be one time use  Tourniquets  Hand sanitizer  Availability of personnel protective equipment (PPE)  Right size gloves

31. PROCEDURE  Perform hand hygiene.  Don non sterile gloves.  Completely clean and use an antiseptic at the site of venipuncture and area around site.  Allow area to dry.  Do NOT touch site of venipuncture after cleaning, if palpated must re- clean area with antiseptic prior to venipuncture.  Obtain Hemostasis.  Gather and discard used supplies, making sure to discard sharps in sharps container; gloves can be put in regular garbage.  Remove gloves and perform hand hygiene.

32. SUPPLIES SHOULD NEVER BE USED ON MORE THAN ONE PERSON, ONE TIME  One patient  One needle/syringe/plastic disposable tube holder  Plastic tube holders should never be used for more than one patient.  One time  A new needle should be used if a re-stick needs to be done.  Remember, if site re-palpated, need to clean area with antiseptic again before re-sticking.

33. PODIATRY  Performed in clean room with cleanable floor and available sink for hand washing.  Garbage and sharps container readily available.  Clean towel is used for each client.  Scrubs or a lab coat are not a clean barrier for clients foot.  New gloves are to be worn for each client.  One set of sterile instruments for each client, including bandage scissors.  Hand hygiene performed between each client.

34.  Create separate clean and dirty areas to work from. Dirty instruments should not be stored near clean instruments.  Take out only supplies expected to be used during procedure.  Place creams, ointments or solutions needed in labeled cups and take to side of client.  All one use items should be disposed of immediately after using. Orange sticks, cuticle pushers, emery board, callus files, dressings, etc. If taken to side of client, they are considered dirty, as easily contaminated with gloved hand.  Instruments should be sprayed with enzymatic solution until able to clean prior to sterilizing.  Nail care area should be cleaned between patients.

35. FOOT CARE -Performed by Staff Gloves are recommended to be worn throughout the procedure to prevent exposure to bacteria, fungi and viruses.  Gloves MUST be worn if you or the client have cuts, open wounds/sores, blisters, or visibly infected skin on hands, feet, or nails.  Assess the clients feet for any areas of concern. Foot care should not be done if any areas of concern are observed and referral to physician should be arranged.  Gloves MUST be changed between clients and hands should not be washed with gloves on. If gloves are soiled, gloves should be changed.  Gloves become a mode of transmission so be aware of what you are touching.  Perform hand hygiene immediately after gloves are removed.

36.  Clean and disinfected instruments such as clippers, nippers, metal cuticle pushers, must be used for each client.  Exception: Client brings dedicated clean instruments.  Shared clippers at nurse’s station, on treatment cart, in shower room, etc. being wiped with an alcohol wipe are NOT acceptable.  Clean supplies such as emery board, file, pumice stone, orange stick, cuticle pusher, etc. should be used.  Items such as files, emery boards, pumices, or other items with coarse surfaces can not be disinfected and should be discarded after use or dedicated to one client.  Equipment and implements that are dedicated to one client cannot be stored with clean and disinfected equipment and implements that are shared among clients.

37.  Clean towels need to be used under the foot of each client and for drying the feet.  Lotions should be dispensed in an individual cup for each client unless client brings own lotion.  If ointments or anti-hemorrhagic agent (such as styptic) are used on nicks, the product needs to be applied to a clean orange stick or applicator and then applied, to prevent contamination of original product container.  All health care workers providing foot care should be aware of protocols for the prevention of transmission of blood borne pathogens.

38.  Electric nail file (such as Dremel) heads can NOT be disinfected and should not be used unless the device has the ability to use disposable heads.  The unit itself needs to be cleaned between uses with a disinfectant wipe following product recommendations as well as equipment manufacturer’s recommendations.  Only individuals trained in using these devices should be using them, as the use of this device increases the risk of cuts and nicks to the clients skin.

39. CLEANING FOOT CARE EQUIPMENT  Don gloves.  All items, including the wash basin and the container used to transport instruments, should be cleaned in warm water with a detergent to remove organic matter, then rinsed, before they are disinfected.  Any instrument taken to the side of the client, even if not used, must be reprocessed.  A brush should be used on hinged items and on dried on debris under water.  Remove gloves and perform hand hygiene.  Items should be left to air dry when possible.

40.  All re-use equipment such as clippers/nippers, and foot basins should be cleaned and disinfected, at a minimum, with a Tuberculocidal disinfectant, as recommended by the North Dakota Department of Health (NDDoH), due to high HCV disease prevalence.  With spray disinfectants, contact time can not always be guaranteed.  Any item that is known to be contaminated with blood and/or body fluids must be sterilized prior to reuse or disposed of.  The steps of cleaning and disinfecting can not be combined! Always remember these are two separate processes. During nail care, small microscopic nicks in the skin can occur, creating the possibility of contamination with a bloodborne pathogen, not visible to the naked eye. DISINFECTION

41.  Make sure to adhere to concentration and contact/dwell times of disinfectants. Approximates are not acceptable!  Follow product recommendations for storage temperature of solution and change solution as directed.  All hinged instruments must be open.  Do NOT add items once timing has begun.  Remove instruments with gloved hand or lifter.  Allow instruments to air dry on a clean towel.  instruments that have been clean and disinfected need to be kept in a clean covered container until use. Staff MUST be trained in the proper reprocessing procedure and proper use of disinfectants.

42. DECONTAMINATION USE OR STORAGE CLEANING & Rinsing DISINFECTION A monitoring process should be put in place to make sure short cuts are not taken.

43.  When planning large number foot clinics, you must ensure that you have enough instrument sets and processing time to meet the client number.  Each client having their own dedicated equipment is always best!  Dedicated Instruments that are not available for others use, at a minimum, should be cleaned with soap and water and dried between care routine.  Educate the client on importance of not sharing their nail care items with others and keeping them clean and dry.

44.  Decontamination of pedicure chairs and home foot spa tubs need to be done according to manufacturer’s instructions and state cosmetology regulations.  They are not recommended for use with large foot care clinics due to reprocessing time required.

45. Reference Sites: www.epa.gov/oppad001/chemregindex.htm www.spc.int/phs/pphsn/activities/picnet/SECTION_7.pdf www.cdc.gov/hicpac/Disinfection_Sterilization/6_0disinfection.html www.cdc.gov/hicpac/Disinfection_Sterilization/19_00glossary.html www.cdc.gov/hicpac/Disinfection_Sterilization/3_2contaminatedDevices.html www.epa.gov/opp00001/factsheets/footspa_disinfection.html www.education.nh.gov/instruction/school_health/documents/disinfectants.pdf www.infectioncontroltoday.com/articles/2001/01/general-guidelines-for-use-of-chemical- disinfecta.aspx www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/ ucm208018.htm

46. Additional Reference Sites: www.shea-online.org/Assets/files/IHI_Hand_Hygiene.pdf www.ncbi.nlm.nih.gov/books/NBK138665/ www.austincc.edu/mlt/phb/phb_equipment.html www.tpchd.org/files/library/df5e2d72be388786.pdf http://allnurses.com/foot-care-nursing/foot-care-infection-69660.html www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle- UseDevices/UCM133514 http://files.nailsmag.com/Handouts/NAILSDisinfectionChart.pdf www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a2.htm#fig

47. For more information or questions, contact Faye Salzer 701-333-8389 fsalzer@nd.gov