Subject: Vaccine Management and Administration (Immunization) BOARD APPROVED: 7/30/96 REVISION APPROVED: 05/03/05, 04/08/08, 04/07/09, 04/12/11 Purpose: To ensure safe and appropriate storage, handling and administration of vaccines. : All individuals who receive health care at the will be actively immunized against preventable infectious diseases in accordance with the recommendations of the Immunizations Practices advisory committee (ACIP) of the U.S. Public Health Services and the Michigan Department of Public Health Immunization program. We are currently enrolled in the Vaccine for Children Program (VFC) and the Vaccine Replacement Program (VRP) for adults. Procedure: A. Informed Consent Individuals or the responsible guardian will be informed of the benefits of immunization as well as the known risks involved with any given vaccine. An immunization questionnaire is given to the patient/parent/guardian to complete to assess for any contraindications. All vaccines will be offered according to the approved schedule for immunization for infants, children and adults. A current copy of the Vaccine Information Statement (VIS) must be made available for review and a copy given upon request to the patient/ parent/guardian for every vaccine prior to the administration of the vaccine. In addition a verbal explanation of the risks and benefits of each vaccine will be given and the opportunity to ask questions prior to the administration of a vaccine will be provided. In the event that the parent or responsible guardian is unavailable, immunization may be given to children only if the child is with an accompanying adult who is listed on the Permission to treat form. Verbal consent via telephone is an option in some instances. B. Record Keeping Request all prior immunization records from the parent/guardian/patient on arrival and verbally confirm that all immunizations were given as recorded. A MCIR record will also be printed for all children through age18 years old, who are scheduled for an appointment. This record is reviewed by the clinic assistant and provider to assess whether immunizations are needed at this visit. Individuals receiving vaccine or their guardian will be given the appropriate copy of Michigan Care Improvement Registry (MCIR). Include a notation of when the next immunization will be due. 1
Record in the medical record the following information: name of vaccine, lot #, expiration date, date vaccine given, site of vaccination, date VIS given and VIS publication date. Daily reports are run for every vaccine given and this report is used to enter all vaccine information into the MCIR system. C. Administration Administer the vaccines only after the VIS are given and reviewed with the patient/parent/guardian. Vaccines will be administered by physicians, mid-level providers, and by qualified nursing staff, including medical assistants. Nursing staff may administer vaccines for second and subsequent doses of a series where an initial physicians order has been written, based on review of the patient s immunization history, review of the chart, and assessment of the patient for any contraindications. Advise patient/parent or guardian to call the office if there are any questions or concerns following a vaccine, or call the CFH after-hours nurse line. All adverse reactions associated with vaccination must be reported to the U. S. Department of Health and Human Services. Adverse events are reported on a Vaccine Adverse Event Reporting System (VEARS) form. The form should be sent to the Michigan Department of Community Health if the event involves an MDCH vaccine or the VEARS office if it involves other vaccines. VEARS will accept all reports of suspected adverse events after the administration of any vaccine. Following immunization the parent /guardian will be given an instruction sheet. This form has instructions of what to do if the child has discomforts and when they need to call the CFH for further advice. For proper administration and dosage of injected vaccines see specific vaccine information. Always draw just the required amount for the dose in the syringe, usually 0.5 cc, using proper syringe loading techniques, i.e. Injection. Careful filling of the syringe will prevent vaccine wastage and enable use of all the doses in the vial. There is no known risk of side effects and no loss of vaccine efficacy when vaccines are given simultaneously and this practice is recommended by the ACIP. Simultaneous administrations of vaccines are also approved by the American Academy of Pediatrics. A new needle and syringe must be used for each immunization. The following should be done for each immunization: 1. Verify the patients name and DOB. 2. Wash hands and don gloves prior to administrating the vaccine. 3. Clean the site with alcohol swab. 4. Inject the syringe by using the proper technique (The infant or child should be properly restrained on a table or an adult s lap. The parent/guardian should be instructed to hold the child securely. Older children & adults preferably should be seated for immunizations). 2
5. Withdraw the needle quickly while placing alcohol swab or cotton ball just above the injection site. Place Band-Aid over the injection site. Dispose of the needle in a sharps container. D. Vaccine Charges Charges for vaccines and their administration will be in accordance with guidelines for the Michigan Department of Public Health and the Centers for Disease Control. For those immunizations that fall under the VFC and VRP program, the vaccine itself is free and a procedural charge to cover vaccine administration will be billed for each vaccine. In accordance with federal law, if a client requests that vaccine be administered without charge, the vaccine will be administered and this information will be forwarded to the appropriate patient accounts personnel. For those commercial vaccines, a procedural charge to cover the cost of vaccine and administration will be billed to the appropriate payor. E. Ordering Vaccine orders are placed on a monthly or quarterly basis depending on site and vaccine utilization. At the end of the month, a physical inventory count is done. Using this data the inventory is balanced and an Ending Inventory Report is generated. A Doses Administered Report is run, and temp logs are checked. Utilizing the above data, a vaccine order is calculated and submitted to JCHD via electronic-ordering, this is the responsibility of the Primary Vaccine Coordinator, or designee. When vaccine is received the boxes are immediately opened and temperatures are checked and vaccine is immediately placed in the refrigerator. The packing slip is checked for site identification and number of boxes expected in order. Additionally, each vaccine is checked against the packing slip for name, manufacturer, expiration date, NDC code, lot number, and number of doses. The packing slip is also compared against the order for accuracy. For VFC vaccine the packing slip should also be compared to the inventory in MCIR and for commercial vaccine the inventory must be entered into MCIR. Any errors in the order or changes in temperature range or problems in the shipment must be reported to the JCHD within 2 hours of receipt. Frozen vaccine received directly from the manufacturer is handled in the same manner, although Merck vaccines are entered manually into MCIR, not by the JCHD. NDC codes and lot # s are sent to the patient Account Manager for billing purposes. Additionally, copies of the packing slips are faxed to JCHD and kept for 3 years within the Center for Family Health. Vaccine orders from McKesson are received Monday through Thursday from 8:00 until 3:00. F. Storage and Handling All vaccine will be kept in a secure clinical or storage area in a separate refrigerator from any food substances. All vaccines will be stored according to manufacturers guidelines. 3
Temperatures are monitored twice daily by assigned clinic staff (AM/PM) and recorded on a Temperature Log Sheet posted on the refrigerator. CFH uses digital thermometer in both refrigerators and freezers and at least one refrigerator at each site also has a Sensaphone monitoring system refrigerators and freezers are monitored with certified Market Lab (continuous min/max) thermometers. See attached Thermometer and Sensaphone instructions. The instructions for the vaccine emergency plan are attached to the main refrigerator on the second floor in Pediatrics. This is a stand alone Helmer refrigerator. uses Summit stand alone refrigerators and freezers to house vaccines temporarily during working hours. All vaccines are brought to the main refrigerator for overnight storage. The refrigerators are monitored by alarms which are set at a low temperature of 36 degrees and a high temperature of 46 degrees Fahrenheit. Freezers are set at a low temperature of minus 15 degrees and a high temperature of 5 degrees. Vaccines are stored in their original boxes, in open weave baskets to allow for proper circulation. Vaccines are stored in the center of the appliance, not in the doors or against the walls of the units. Water bottles and ice packs are used, if necessary, to maintain proper temperature. Whenever the viability of a vaccine is in question due to improper storage and handling the vaccine manufacturer shall be contacted Stock rotation is done on a monthly basis. All new inventory is placed to the back and older stock is rotated forward. Vaccine inventory and expiration dates are checked weekly and the shortest dated vaccine is used first. Excess vaccine that is due to expire is used by utilizing recalls and by using single dose antigens instead of combination vaccines. The JCHD is notified when vaccine is within six months of its expiration date. Arrangements are made with JCHD for use of these vaccines if the does not anticipate being able to use these vaccines. Staff is educated yearly on how to administer vaccines, what type of vaccine to administer and how to use short dated vaccine first. Staff training includes, but is not limited to, proper techniques when administering vaccine, correct use of VFC versus Private stock vaccine, choosing appropriate vaccine for patient s age and proper documentation of vaccines administered. A written test is given to test knowledge of this training. All vaccine coming in or going out are logged into NextGen to track vaccine movement and inventory. Utmost precaution is taken to avoid power failure to vaccine containing appliances by utilizing signage on the units and on the circuit boxes to prevent accidental interruption of power. In the event of a power failure or mechanical failure, vaccine will be transported to the Jackson County Health Department, Allegiance Health System Main Pharmacy or another CFH site that has adequate space. See policy: Vaccine Emergency Plan for further instructions. Vaccine will be transported as described in the handout Transporting Refrigerated Vaccines found in the VFC Resource Book, Section III. G. Scheduling 4
All clinical staff will assess immunization status at all visits, well or sick. Adult or child patients can be scheduled anytime on the nurse schedule for immunizations. H. Wastage and Disposal Every effort will be made to use vaccines before expiration. Smaller CFH sites may transfer vaccine to the main Medical site as need to utilize all vaccine, with prior approval from the Jackson County Health Department and following proper procedure for transporting of vaccine. VFC vaccine losses will be reported to the Jackson County Health Department, manufacturers contacted immediately and instructions in section III of VFC Provider Resource Book: Vaccine Lost/Wasted/Borrowed will be followed. See policy: Vaccine Emergency Plan for further instructions. All wasted, expired or lost vaccines must be accounted for in MCIR. is aware and follows proper protocol for repayment of vaccine loss from the VFC program. Vaccines are categorized as regulated medical waste and must be disposed of in the same manner as sharps in a designated biohazard container. This policy and procedure shall be periodically reviewed and updated consistent with the requirements and standards established by the Board of Directors and by Health Center management, Federal and State law and regulations, and applicable accrediting and review organizations Responsible Parties Signature CEO Signature Board Chair Date Date 5