Phlebotomy Guidelines for Human Subjects Used in Teaching and Research University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 1 Table of Contents Phlebotomy Guidelines for Human Subjects Used in Teaching and Research ............................................. 1 Introduction .............................................................................................................................................. 3 Definitions ................................................................................................................................................. 4 Training Requirements.............................................................................................................................. 5 Venipucture........................................................................................................................................... 5 Capillary Source..................................................................................................................................... 5 Ethics ......................................................................................................................................................... 6 Biosafety/ Exposure Control Considerations ............................................................................................ 7 Universal Precautions ........................................................................................................................... 7 Phlebotomy Hazards ............................................................................................................................. 7 Immunizations....................................................................................................................................... 7 Personal Protective Equipment ............................................................................................................ 8 Protective and Personal Clothing Decontamination............................................................................. 8 Phlebotomy Equipment and Materials ..................................................................................................... 9 Phlebotomy Procedures.......................................................................................................................... 10 Venipuncture Procedures ................................................................................................................... 10 General Capillary Source (Fingerprick) Procedures ............................................................................ 10 Sharps Disposal (i.e. needles, razor blade, scalpels, etc.) ................................................................... 11 Incidents .................................................................................................................................................. 13 Exposure.............................................................................................................................................. 13 Spills .................................................................................................................................................... 14 References .............................................................................................................................................. 16 University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 2 Introduction These Phlebotomy Guidelines outline the recommended health and safety program for only performing fingerprick (capillary) phlebotomy on human subjects for teaching and research purposes at the University of Regina (U of R). These Phlebotomy Guidelines apply to all U of R Faculty, Staff, Students, Contractors, and Visitors engaged in capillary source phlebotomy on humans. These Phlebotomy Guidelines do not apply to phlebotomy for animals or for venous source activities, contact health.safety@uregina.ca for more information. The U of R Biosafety for Education, Research, and Community Health Program and Health and Safety Policy (GOV-100-005) provides the guidance and authority to the Phlebotomy Guidelines and forms part of the Health and Safety Management System. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 3 Definitions Canadian Society for Exercise Physiology (CSEP): The CSEP is a voluntary organization composed of professionals interested and involved in the scientific study of exercise physiology, exercise biochemistry, fitness and health. Immunization: The process by which an individual’s immune system becomes fortified against an agent. Phlebotomy: The practice of drawing or collecting blood from a venous (venipucture) or capillary blood source. Universal Precautions: Are a set of strategies developed to prevent transmission of blood and body fluid pathogens. Venipuncture: The drawing or puncture of a vein through the skin in order to withdraw blood. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 4 Training Requirements Venipucture Only trained health care professionals (physician, registered nurse, phlebotomist) are permitted to draw human blood for a venous source for teaching and research purposes. This Phlebotomy Guide does not address venipuncture activities, contact health.safety@uregina.ca for more information. Capillary Source Individuals intending to draw blood from a capillary source (fingerprick) must be appropriately trained on the procedure, the associated hazards, and protective measures. The U of R Phlebotmoy Training Program has been designed by Saskatchewan PolyTechnic (http://saskpolytech.ca). Records of training, theoretical and practical, must be maintained by the supervising researcher overseeing the work. Contact health.safety@uregina.ca for training information. CSEP-CEP Hands-on demonstration must be re-certified annually, as per the Canadian Society of Exercise Physiology (CSEP) position statement, see http://www.csep.ca/english/view.asp?x=956. The U of R Training Program successfully meets this requirement. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 5 Ethics Researchers intending to perform phlebotomy must ensure that all required ethics approvals from the Research Ethics Board (REB) are in place prior to engaging in phlebotomy on humans. The REB is responsible for the review of all ethics applications involving human subjects. For more information on the human ethics approval process and requirements, please refer to the U of R REB website, http://www.uregina.ca/research/REB/main.shtml. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 6 Biosafety/ Exposure Control Considerations Universal Precautions All individuals shall adhere to universal precaution strategies when performing phlebotomy. For information, please see: http://www.ccohs.ca/oshanswers/prevention/universa.html. Phlebotomy Hazards By its nature, phlebotomy has the potential to expose personnel to blood from other people, putting them at risk from bloodborne pathogens. These pathogens include human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus, those causing vial haemorrhagic fevers (e.g. Ebola, etc.), and dengue. Diseases such as malaria and syphilis may also be transmitted via contaminated blood. Poor infection/ exposure control practices may lead to bacterial infections. Immunizations It is the responsibility of the supervising researcher who has been granted authorization to perform phlebotomy procedures to ensure that all Faculty, Staff, and Students are offered recommended immunizations when performing phlebotomy (see Table 1 below). Personnel may formally decline immunization. Copies of all immunization records must be maintained by the supervising researcher. Contact health.safety@uregina.ca for more information. Table 1 Recommended immunizations for U of R lab faculty and staff working with human/ primary specimens Vaccine Recommendation(s) All Researchers or lab staff should be immune. Primary series if no previous immunization. Diphtheria Booster doses of Td vaccine every 10 years. (Available as Td or Tdap or Tdap-IPV. Tdap is Tetanus indicated if an adult pertussis dose is needed. Tdap-IPV is indicated if both pertussis and polio vaccinations are needed.) Hepatitis A If no evidence of immunity. (Post-immunization serologic testing within 1 to 6 months of &B completion of primary series.) Measles If no evidence of immunity, regardless of age - 2 doses. Mumps If no evidence of immunity, regardless of age - 2 doses. Pertussis A single dose of Tdap vaccine if not previously received in adulthood. Polio Rubella Primary series if no previous immunization – 3 doses. Unvaccinated Researchers and Lab staff at highest risk of exposure should be particularly targeted for primary immunization. A single lifetime booster dose for Researchers and Lab staff at highest risk of exposure. If no evidence of immunity – 1 dose. If no evidence of immunity - 2 doses. (Self-reported history of varicella or herpes zoster is not reliable for a Researcher or Lab staff to be considered immune.) For more information, please see PHAC’s Canadian Immunization Guideline, (7th Edition, 2006). Varicella University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 7 Personal Protective Equipment The minimum personal protective equipment (PPE) required when performing phlebotomy and when handling human blood are: Clean lab coat; Safety glasses; Disposal non-latex gloves (e.g. nitrile gloves); Pants; and Closed toe/heel shoes. Protective and Personal Clothing Decontamination All contaminated personal clothing items and non-disposable gowns, coveralls, and coats should be properly decontaminated to reduce risk of transmission and exposure. The risk of disease transmission from soiled linen is low, but soiled linens may carry organisms that may contaminate the air and immediate environment. It is recommended that decontamination via the U of R Laundry Service (Science Stores) be performed every 6 months, but this will vary with the type and intensity of research activity. Contact health.safety@uregina.ca for more information. 1. Do not walk into public areas with contaminated clothing. 2. Promptly don the appropriate PPE for removing contaminated clothing (i.e. gloves). 3. If soiled clothing cleaning and disinfecting procedures cannot be completed in the room that the clothing was soiled, the items must be removed and transported in strong biohazard/plastic bags. 4. Soiled clothing should be handled as little as possible and with minimum agitation. 5. Hold the soiled clothing away from your unsoiled clothing. 6. Bring the soiled clothing sealed in strong biohazard/plastic bag down to Science Stores for Laundry Servicing. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 8 Phlebotomy Equipment and Materials Areas designated for capillary phlebotomy are to include the following equipment and materials: Sink for hand washing; Soap and/or hand sanitizer; Impervious work surface; Emergency eye wash station; Chair or suitable seating; Prepackaged alcohol wipes; Clean cotton balls; Safety-engineered lancets; Absorbent waterproof paper with plastic backing/ bench-coat; Test strip and/or capillary tubes; Sterile gauze and bandages; Disinfectant (i.e. 70% ethanol, fresh 10% bleach, or pre-diluted Oxivir Tb) and supplies for decontamination; Blood & Body Fluid Spill Clean Up Kit; Paper towels; Sharps disposal container (available for purchase at Science Stores); First Aid Kit. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 9 Phlebotomy Procedures Venipuncture Procedures Only health care professional shall be permitted to draw human blood from a venous source for teaching and research purposes. Contact health.safety@uregina.ca for more information. General Capillary Source (Fingerprick) Procedures The following is a general procedure when performing human capillary source phlebotomy on fingertips. 1. Prepare all necessary materials prior to performing the procedures so that they are easily assessable. Keep work area organized and clean. 2. Wash hands thoroughly: Hand Washing Steps: 3. 4. 5. 6. 7. 8. 9. 10. 11. 1. Remove all rings and wet your hands with warm running water. 2. Use soap and produce lather, rubbing your hands for 20 seconds. 3. Scrub all surfaces of hands including backs of hands, wrists, between fingers, and under fingernails (with a nail brush if available). 4. Rinse hands in clean, warm running water for at least 10 seconds. 5. Dry hands with a clean towel. Don lab coat, safety glasses, and nitrile gloves. Set aside a second pair of gloves for cleanup procedures. If gloves have to be removed for any reason, a new pair should be used. If gloves are damaged, replace them before proceeding. Wash hands before putting on new gloves. Work over an absorbent waterproof pad (bench-coat/ absorbent paper with plastic backing). Select the non-dominant hand and ring finger tip of the volunteer. Hold the finger nail down firmly on the table surface. Select a site that is about 1/3 of the nail length from the end of the finger, slightly off centre. Wipe the fingertip with a new alcohol wipe. Allow to air dry thoroughly. Retrieve a new safety-engineering lancet. Never use a surgical blade to perform capillary source phlebotomy. Puncture the disinfected finger tip with one quick, continuous and deliberate stroke, to achieve a good low of blood and to prevent the need to repeat the puncture. Safety-engineered lancets require only gentle pressure on the side of the end of the finger. Do not puncture the skin more than once with the same lancet or sued the same site more than once. This can lead to bacterial contamination or infection. Disposal of the used lancet in the sharps disposal container. Wipe away the first drop of blood because it may be contaminated with tissue fluid or debris (sloughing skin). Squeeze out a single blood drop and transfer it to the test strip or capillary tube. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 10 12. Wipe off finger with a new cotton ball. Discard cotton ball in the sharps waste disposal container. 13. If bleeding has not completely stopped, cover wound with cotton ball, sterile gauze, or a bandage. 14. Dispose of all test strips or capillary tubes when finished in the sharps container. Once containers are ¾ full contact health.safety@uregina.ca for waste removal. 15. Disinfect the work areas with Oxivir Tb (pre-diluted solution with a contact time of 1-5 minutes) or bleach (e.g. fresh daily dilution of 10% bleach with a contact time of 15 minutes) or ethanol (dilution of 70% ethanol with a contact time of 5 minutes). Wipe area thoroughly with paper towel. 16. Remove all PPE and wash hands thoroughly. PPE may not be worn outside of phlebotomy area. The laboratory coat should be placed in plastic bags for transfer to laundry service every three months (see above). Sharps Disposal (i.e. needles, razor blade, scalpels, etc.) 1. Wear gloves, laboratory coat, closed-toe shoes, and other appropriate personal protective equipment, including face and eye protection. 2. No other items (i.e. liquids, solids) should be mixed with sharps waste. 3. Place waste in a biohazard sharps waste container available from Science Stores. Fill container no more than 75% full. 4. If applicable, put on chemical waste label and label all chemicals. 5. Contact health.safety@uregina.ca for disposal. Steps for Removing Laboratory Coat: 1. With gloves still on, unbutton coat. 2. Pull off one arm, keep coat away from body. 3. Pull off second arm, keeping coat away from body. 4. Once coat is off, hold away from body and slowly roll coat. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 5. Dispose of coat in garbage receptacle or placed in plastic bag for laundry service. Page 11 Steps for Removing Goggles: 1. Without touching face, grasp goggle with one gloved-hand. 2. Pull goggle upward away and off of head. 3. Dispose of goggle in the garbage receptacle. Steps for Removing Gloves: 1. Grasp one glove on the inside of wrist at ½ inch below band of dirty side of glove without touching the skin. 6. 2. Pull down glove, turning it inside out, and pull hand. Hold the glove with the still-gloved hand. 3. Insert fingers of ungloved hand under the cuff of the glove on the other hand (on inside of cuff). 4. Pull down glove until it is inside out, drawing it over the first glove. 5. Dispose of gloves in the garbage receptacle. Wash your hands well with hand anti-septic and/or soap and water at the nearest clean location. 17. Ensure all samples collected are stored in appropriate storage units such a refrigerator or freezer. Ensure confidentiality. _______________________________________________________________ Physician Name and Signature University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 12 Incidents Exposure If an individual performing phlebotomy has been injured or exposed to human blood (e.g. cut, pucture, exposure to eyes of mucous membranes), the following steps are to be followed by the individual. Emergency Contact Information 24 Hour Emergency (Fire, Police, Medical): 24 Hour Saskatchewan Health Hotline: Campus Security: Biosafety Officer (BSO): Health, Safety & Environment, Human Resources: 911 811 306-585-4999 306-585-5198/ 306-527-4320 306-585-4776 /306-585-5487 Medical Emergency 1. Phone 911 – Direct them to the scene of the occurrence. 2. Call Campus Security: 585-4999 3. Give First Aid, if you are qualified to do so, or get help from trained Emergency Wardens and/or Campus Security. 4. Stay with victim. Needle Stick Poke, Puncture Wound, or Percutaneous Injury 1. Remove gloves and allow the wound to bleed. 2. Immediately wash the affected area for 15 minutes with soap and warm water. 3. Notify Supervisor (if available) to obtain assistance. 4. Seek medical assistance immediately (within 1-2 hours) from a health care professional. The cause of the wound and organisms involved should be reported. 5. Details of the incident must be documented using the Incident Report Form and forwarded to Health, Safety & Environment within 24 hours. Forms can be found online atwww.uregina.ca/hr/hse or by contacting health.safety@uregina.ca or 306-585-4776. Please include the following details: a) What was the method of contact (e.g. needle stick, splash)? b) How did the exposure occur? c) What known biological agents or body fluids were you in contact with? d) What action was taken in response to the exposure to remove the contamination (e.g. hand washing)? e) What personal protective equipment was being used at the time of exposure? f) What is your immune status (e.g. Tetanus, Hepatitis A or B Virus)? Eyes or Mucous Membrane Exposure (e.g. Splash) 1. Immediately flush the affected area for 15 minutes using an eyewash or shower. 2. Notify Supervisor (if available) to obtain assistance. 3. Seek medical assistance immediately (within 1-2 hours) from a health care professional. The organisms involved should be reported. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 13 4. Details of the incident must be documented using the Incident Report Form and forwarded to Health, Safety & Environment within 24 hours. Forms can be found online www.uregina.ca/hr/hse or by contacting health.safety@uregina.ca or 306-585-4776. Please include details as listed above. Ingestion 1. Protective clothing should be removed. 2. Notify Supervisor (if available) to obtain assistance. 3. Seek medical assistance immediately (within 1-2 hours) from a health care professional. 4. Identification of the material ingested and circumstances of the incident should be reported. 5. Details of the incident must be documented using the Incident Report Form and forwarded to Health, Safety & Environment within 24 hours. Forms can be found online www.uregina.ca/hr/hse or by contacting health.safety@uregina.ca or 306-585-4776. Please include details as listed above. Spills 1. If you need to clean up a spill, obtain the Blood & Body Fluid Spill Clean Up Kit from your area. 2. The person performing the spill cleanup must first put on personal protective 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. equipment provided in the Blood & Body Fluid Spill Clean Up Kit: nitrile gloves, safety goggles, and disposable laboratory coat. Care must be taken to avoid splashing or generating aerosols during the clean up. Prepare a garbage bag inside a leak-proof, puncture-resistant waste disposal container (e.g. garbage receptacle, plastic pail, etc.) for disposal of supplies, gloves, mask, and equipment. Place the garbage receptacle close to the area of spill cleanup to minimize splashes. Cover all contaminated areas, equipment, and/or broken glass with paper towels to avoid splashing and to reduce generation of aerosols. Spray or pour disinfectant from the outside of the contaminated area and move inwards. Leave disinfectant on areas and equipment for at least 5 minute contact time. **If area is heavily contaminated with organic material (fecal material, thick secretions, vomit, etc.) allow for 10 minute contact time. Collect any sharp objects or broken glass with forceps, tongs, or broom/dust-pan and place in biohazard sharps container. Never use your hands. The spill area must be cleaned of obvious organic material (fecal matter, thick secretions, vomit, etc.) before applying a 2nd round of disinfectant. Place material and paper towels in the garbage receptacle. Absorb excess blood and body fluids with paper towels and place in garbage receptacle. Again lay paper towels over the remaining spill. Spray or pour disinfectant over the paper towels and the immediate surrounding area. Allow for a 5-minute contact time. Before exiting room, properly remove laboratory coat, goggles, and then gloves, (see above). Place disposable items into the garbage receptacle. Close bag immediately and dispose of waste by contacting Health, Safety & Environment (306-5854776) or health.safety@uregina.ca. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 14 17. If you contaminate your personal clothing items with blood and body fluids: 18. 19. 20. 21. a. Put on clean nitrile gloves. b. Remove contaminated items slowly and transport in separate, closed garbage bag. Hold the contaminated clothing away from your unsoiled clothing. Contaminated clothing should be handled as little as possible. c. Wash contaminated clothing separately in hot soapy water and dry in a hot dryer. Or have items dry-cleaned. Wash your hands very well with hand anti-septic and/or soap and water at the nearest clean location. Notify your supervisor and Health, Safety & Environment within 24 hours of incident. Complete an Incident Report Form detailing your response and forward to Health & Safety. Incident Report Forms can be found in the Blood & Body Fluid Spill Clean Up Kit. Replace Blood & Body Fluid Spill Clean Up Kit contents by contacting Health, Safety & Environment. University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 15 References Canadian Centre for Occuptional Health and Safety (CCOHS). Routine Practices. Retrieved from http://www.coohs.ca/oshansweres/prevention/universa.html Canadian Society for Exercise Physiology. 2015. Blood Sampling Position Statement. Retrieved from http://www.csep.ca/english/view.asp?x=956 Public Health Agency of Canada. 2007. Canadian Immunization Guideline, 7th Edition. University of Saskatchewan, Workplace Safety and Environmental Protection. 2011. Phlebotomy Guidelines for Human Subjects Used in Research. Retrieved from http://safetyresources.usask.ca/procedures_forms/documents/Phlebotomy%20Guidelines%20October %2014,%202011.pdf University of Regina – Phlebotomy Guidelines for Teaching and Research, 2015 Page 16