Pediatric Immunization Refresher Immunization Documentation Massachusetts Department of Public Health Theodora Wohler, RN MPH Regional Immunization Nurses Definition of Standing Order A standing order is a written order stipulating that all persons meeting certain criteria i.e.: age or underlying medical condition - should be vaccinated Eliminates the need for individual physician s orders for each patient Standing Orders Implementation: Decide what criteria will be used to indicate patient eligibility for vaccination and for specific vaccines. Physician writes standing order. Physician meets with staff to discuss implementation of the standing order. 1
Standing Orders Each standing order must be reviewed, approved, and signed by the head physician before the order can take effect Source: GWU/SPHHS Review of Standing Orders Fall 2005 Legal Basis for Standing Orders in Massachusetts MA Board of Registration in Nursing Advisory Ruling Number: 9804 M.G.L., c. 30A, ss8 and c. 112, ss80b. Title: Administration of Immunizing Agents or Vaccines - A nurse may administer an immunizing agent or vaccine ordered from a Standing Order Protocol. Standing Orders: A standing order protocol must include: The name(s) of the immunizing agent or vaccine to be administered The dose to be administered The route or method of administration Inclusion/Exclusion criteria that the nurse will assess for before administering the immunizing agent or vaccine The signature or approval by a duly authorized prescriber either directly on the standing order or on file with the facility/agency/program providing individual or mass immunization or vaccinations 2
Standing Orders: Nursing responsibilities Being educated about storage, handling, administration, contraindications, reporting of adverse effects and documentation required Completing accurate and legible entries Relaying to the patient information on the risks and benefits of accepting or refusing the immunizing agent Understanding the method for documenting informed consent Assessing for allergy history of the patient prior to administration of the immunizing agent Being able to access and use emergency equipment Screening http://www.immunize.org/printmaterials/topic_screening.asp Documentation & Record Keeping for Immunization Accurate documentation allows Accurate documentation allows timely immunizations and helps prevent unnecessary disease 3
Federal Requirements for Documentation Date of administration of the vaccine Vaccine manufacturer and lot number Name and address of administering personnel Federal Requirements for Documentation, continued Vaccine Information Statement (VIS) publication date Date VIS given to recipient MDPH Immunization Program also recommends: site and route of administration Vaccine Administration Record for Children and Teens http://www.mass.gov/dph/imm 4
Vaccine Information Statements An Important Tool in Vaccine Risk Communication Benefit and Risk Communication Opportunities for questions should be provided before each vaccination Vaccine Information Statements (VIS) must be provided before each dose of vaccine Provider is not required by federal law to obtain a signature Who must give out these VISs All public and private providers who administer the vaccines covered by the National Childhood Vaccine Injury Act Are required by law to provide a copy of the relevant VIS to the vaccinee or his/her parent or legal representative Provider is required to document that VIS was given and its publication date 5
What is a Vaccine Information Statement A vaccine information statement is a one page two sided information sheet produced by CDC informing vaccine recipients or their parents or legal representatives of the benefits and risks of a vaccine. When must VIS be given out They must be given out at the time of each vaccination PROVIDERS SHOULD NOT CHANGE OR ALTER THE VIS DEVELOPED BY CDC Providers may add the practice s name, address, or phone number to an existing VIS Why must VIS be used It is a legal requirement of the childhood vaccine injury act of 1986 The purpose is to inform parents and vaccine recipients about the benefits and risks of vaccines 6
How to supply VIS All practices are responsible for maintaining the latest versions Available in multiple languages at CDC VIS website Spoken format also available Assign someone at your site to be responsible for updating the VIS supply Subscribe for VIS Updates from CDC www.cdc.gov/vaccines/pubs/vis/ Click on Get Email Updates Enter your email address CDC will email you when there are updates to VISs or new versions Consent forms and VIS use in School Based Programs Two options: Parental or legal representative signature for administration of each dose of vaccine in a series with acknowledgement of receipt of the VIS Signed single consent form for administration of the series which acknowledges receipt of the VIS Each additional dose requires mailing VIS home to parent noting the earlier permission for the series and the date of the next dose Important to consult with legal counsel 7
Consent forms and VIS use in School Based Programs Permission and veto statements must be kept in the medical record along with dates that the VISs were delivered Establish a system for responding to questions by telephone and mail NACCHO Toolkits Toolkits designed to reduce the burden to schools and local health departments by providing: Suggested processes (e.g., timelines, checklists, who to engage) Sample materials (e.g., sample consent forms, letters soliciting principal support) http://www.naccho.org/toolbox/ Family Education and Rights Privacy Act (FERPA) Per FERPA, school nurses can not disclose health information without authorization, including to a physician, without consent. School nurses can consider seeking consent on an annual basis from a student s parent or guardian to share information with physicians concerning immunization. 8
Vaccine Adverse Event Reporting System (VAERS) National reporting system Jointly administered by CDC & FDA Passive (depends on healthcare providers and others to report) Receives ~23,000 reports per year Vaccine Adverse Event Reporting System (VAERS) Detects new or rare events increases in rates of known side effects patient risk factors Additional studies required to confirm VAERS signals Not all reports of adverse events are causally related to vaccine Report Adverse Events to VAERS Vaccine Adverse Events Reporting System www.vaers.hhs.gov 1-800-338-2382 Report Vaccine Administration Errors to the Institute for Safe Medication Practices www.ismp.org 9
Infection Control Hand hygiene recommended between each patient alcohol-based waterless antiseptic can be used Gloves not required by Occupational Safety and Health Administration (OSHA) unless potential for exposure to blood or body fluids, open lesions on the hands, or agency policy Needle stick policies & use of Safety needles Equipment disposal NEVER detach, recap or cut a used needle place in puncture-proof container dispose as infectious medical waste Vaccine Administration Issues Aspiration not required no reports of injury because of failure to aspirate MDPH Key Resources Guidelines for Compliance with Federal and State Vaccine Administration Requirements General Protocol for Standing Orders MMWR: General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices (ACIP), December 2006 10
QUESTIONS??? Anyone? 11