Implementing Standing Orders Protocols Making a Difference in Immunization Rates Litjen (L.J.) Tan, MS, PhD Chief Strategy Officer Immunization Action Coalition Co-Chair National Adult and Influenza Immunization Summit
Disclosure I have been asked to disclose any significant relationships with commercial entities that are either providing financial support for this program or whose products or services are mentioned during my presentations. I have nothing to disclose. I may discuss use of vaccines in a manner not approved by the U.S. Food and Drug Administration, but in accordance with ACIP recommendations.
Outline Standing Orders Protocols (SOPs) Why implement? What are SOPs and who recommends them? What are common barriers to implementing SOPs? How do SOPs benefit medical practices? Are SOPs effective? Essential components of SOPs Implementing SOPs into your system or practice Phase 1: Build Support of Leadership Phase 2: Develop Materials and Strategies Phase 3: Make it Happen Sustaining the Program
Why Implement Standing Orders?
Standing Orders A Proven Intervention to Improve Immunization Rates 1,2 The goal of using standing orders is to increase vaccination coverage by: Reducing missed opportunities in your health care setting Routinizing vaccination by making it a program rather than relying on an individual clinician s order for each dose of vaccine Empowering nurses (or other legally qualified individuals) to manage your vaccination program Improving efficient use of clinician time by freeing clinicians from active roles in immunization 1. The Community Guide. Community Preventive Services Task Force (available at: http://www.thecommunityguide.org/vaccines/standingorders.html) Public Health Rep. 2014;129(2):115-123. 2. Yonas, et al. J Healthcare Quality.2012;34:34-42.
What Are Standing Orders?
Standing Orders What Are They? Written protocols, approved by a physician or other authorized practitioner, that authorize nurses, pharmacists or other health care personnel (where allowed by state law) to: Assess a patient s need for vaccination Administer the vaccine without a clinician s direct involvement with the individual patient at the time of the interaction www.thecommunityguide.org/findings/vaccination-programs-standing-orders
Who Recommends Use of Standing Orders? The Community Preventive Services Task Force recommends standing orders to increase vaccination coverage among adults and children on the basis of strong evidence of effectiveness. www.thecommunityguide.org/findings/vaccination-programs-standing-orders
Who Recommends Use of Standing Orders? The Advisory Committee on Immunization Practices (ACIP) recommends standing orders for all vaccines. CDC. MMWR. 2000;49(RR-1):1-26.
Who Recommends Use of Standing Orders? Centers for Medicare and Medicaid Services (CMS) www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter03-02.pdf
Why Aren t Standing Orders Used? Lack of standing orders implementation may be due to: Weak or no organizational support Gaps in staff education, training, and perceived benefit Logistical difficulties Concern that vaccination would interfere with scheduled treatments or procedures Small size of the clinical support staff relative to providers Personnel concerns about additional workload www.thecommunityguide.org/findings/vaccination-programs-standing-orders Zimmerman et al. Am J Prev Med 2011; 40(2):144-8. Yonas, et al. J Healthcare Quality.2012;34:34-42.
Why Aren t Standing Orders Used? Lack of standing orders implementation may be due to: Concerns about legal ramifications Staff reluctance to administer vaccines without a physician s order Our workshop participants indicated a common challenge was a lack of resources www.thecommunityguide.org/findings/vaccination-programs-standing-orders Zimmerman et al. Am J Prev Med 2011; 40(2):144-8. Yonas, et al. J Healthcare Quality.2012;34:34-42.
Barriers to the Use of Standing Orders Yonas et al. J Healthcare Quality 2012;34:34-42
Vaccine Injury Compensation Program Established by National Childhood Vaccine Injury Act (1986) Provides no-fault compensation for specified injuries that are temporally related to specified vaccinations Program has greatly reduced the risk of litigation for both providers and vaccine manufacturers Covers most routinely recommended vaccines, including those administered to adults, with a couple of exceptions: Pneumococcal Polysaccharide Zoster www.hrsa.gov/vaccinecompensation/index.html
How Do Standing Orders Benefit Medical Practices?
Standing Orders in Clinical Practice Efficiency Clinician time is not required to assess vaccination needs and issue verbal or written orders to vaccinate Nurses (or others) take charge of vaccination program Increased number of patients seen = increased income stream, increased economies of scale Patient safety Improved vaccine coverage, less vaccine-preventable disease Decrease opportunities for VPD transmission in your health care setting
Do Standing Orders Improve Vaccination Rates?
Are Standing Orders Effective? Based on a 2015 review of 35 studies (1997-2012) that examined standing orders either alone or combined with other activities*, the Community Prevention Services Task Force found: Used alone, standing orders increased adult vaccination coverage by a median of 16 percentage points (range: 9% to 29%) Used in combination with other interventions,* standing orders increased adult vaccination coverage by a median of 27 percentage points (range: 13% to 40%) Standing orders increased vaccination rates among children by a median of 28 percentage points * Such as expanding access in health care settings, client reminder and recall systems, clinic-based education, provider education, provider reminder and recall systems, or provider assessment plus feedback www.thecommunityguide.org/sites/default/files/assets/vaccination-standing-orders.pdf
Are Standing Orders Effective? (cont.) Based on a 2015 review of 35 studies (1997-2012) that examined standing orders either alone or combined with other activities, the Community Prevention Services Task Force found: Standing orders were effective in increasing vaccination rates when implemented in a range of clinical settings, among various providers and patient populations Standing orders were effective for vaccine delivery to children (universally recommended vaccinations) and adults (influenza and pneumococcal) www.thecommunityguide.org/sites/default/files/assets/vaccination-standing-orders.pdf
Electronic Standing Orders Work! Study looked at the implementation of an electronic standing orders into the workflow of primary care practice A customized health maintenance template provided SOs for immunization, along with other measures for screening and diabetes. The study showed a median improvement of 8% to 17% in immunizations in participating practices. Best improvement associated with: Established policies and education for staff about new roles Continued reinforcement (staff input, quarterly performance reports). Bulletin boards emphasized the importance of the measures to staff and patients. Variable interest levels by staff and physicians resulted in greater difficulty with implementation Nemeth, Lynne, et al JABFM. 2012; 25,5. 594-604
Impact of Standing Orders on Adolescent Vaccination Rates, Denver Health, 2013 Vaccine National (2013) Colorado (2013) Denver Health (2013) Tdap 86.0 87.1 95.9 MCV4 77.8 73.6 93.5 HPV Females >1 57.3 58.2 89.0 HPV Females >3 37.6 39.1 66.0 HPV Males >1 34.6 33.5 89.3 HPV Males >3 13.9 9.9 52.5 Kempe, A. 2015. National Foundation for Infectious Diseases Clinical Vaccinology Course Farmer, A.M. 2016. Pediatrics 138(5):e20152653.
What are the Components of a Standing Orders Protocol?
www.immunize.org/catg.d/p3074.pdf
Standing Orders Templates for All Routine Vaccines are Available www.immunize.org/standing-orders
Essential Components of SOPs A comprehensive standing order should include these elements: Who is targeted to receive the vaccine How to determine if a patient needs or should receive a particular vaccination (e.g., indications, contraindications and precautions) Provision of any federally required information (e.g., Vaccine Information Statement) Procedures for preparing and administering the vaccine (e.g., vaccine name, schedule for vaccination, appropriate needle size, vaccine dosage, route of administration)
Essential Components of SOPs (cont.) A comprehensive standing order should include these elements: How to document vaccination in the patient record A protocol for the management of any medical emergency related to the administration of the vaccine How to report possible adverse events occurring after vaccination Authorization by a physician or other authorized practitioner
Implementing Standing Orders in Your System and/or Practice
www.immunize.org/catg.d/p3067.pdf IAC s Standing Orders Implementation Guidance
Three Phases of Standing Orders for Immunization Implementation Phase 1: Build Support of Leadership Phase 2: Develop Materials and Strategies Phase 3: Make It Happen
Phase 1: Build Support of Leadership STEP 1: Discuss the benefits of implementing standing orders protocols with the leadership (medical director, clinicians, clinic manager, lead nurses) in your medical setting It is critical that leadership support the use of standing orders from the beginning of your program
Be Prepared To Illustrate Why Standing Orders Will Benefit Your Practice Consider determining the vaccination rate in your practice prior to meeting with Upper Management Measured rates are inevitably less (sometimes much less) than perceived rates Lower-than-expected vaccination rates will support your request to develop a standing orders program
Leadership Agreement is Critical Medical Director This person is either responsible for signing the standing orders protocols or supervises the clinician who signs them, so it is critical that he/she agrees with the need for standing orders and supports their use
Leadership Agreement is Critical (cont.) Clinicians Determine which clinician will review and sign the standing orders protocols in the practice Identify issues that might lead to any resistance among other providers Nurse Leaders Involve nurse leaders in the planning from the start Nurses (or perhaps pharmacists) are the key players in implementing and carrying out standing orders programs
Discussion with State Health Authorities and Others Consult with your state immunization program and state medical or nursing boards to determine who is legally qualified to vaccinate using standing orders under your state law Some practices may want to check with their legal counsel
Phase 1: Build Support of Leadership STEP 2: Identify the person who will take the lead and be in charge of your standing orders program. In most practices, the lead person will be a nurse, nurse practitioner, or physician assistant The lead person must be an influential leader who has medical knowledge, understands the standing orders protocol, and is able to answer questions about them from other staff members
Phase 1: Build Support of Leadership The lead person must be motivated to protect patients by improving the vaccination levels in your practice a true Immunization Champion The Immunization Champion should have a thorough knowledge of vaccine issues
Essential Tools for Immunization Champions 2018 ACIP Immunization Schedules & Footnotes Children and Adolescents Adults www.cdc.gov/vaccines/schedules/index.html
Essential Tools for Immunization Champions ACIP s General Best Practices Guidelines for Immunization www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
Phase 1: Build Support of Leadership STEP 3: Reach agreement about which vaccine(s) your practice will administer using standing orders It may be best to start using standing orders only for influenza vaccine if you have not implemented standing orders previously When staff are trained and know how standing orders work, you can expand their use to additional vaccines
Phase 2: Develop Materials and Strategies STEP 4: Create standing orders protocols for the vaccine(s) you want to administer IAC s standing orders templates www.immunize.org/standing-orders Have the standing order(s) reviewed (annually) and signed by the medical director or clinician responsible for the program
Phase 2: Develop Materials and Strategies STEP 5: Hold a meeting to explain your new standing orders program to all staff members It is crucial that all staff understand the program because they will all be involved directly or indirectly To get buy-in from staff, you will need to explain why you are starting this program Review how standing orders work and the specific protocols and procedures with all staff members who will be involved
Handy Visual Aid to Use During the Staff Meeting
Phase 2: Develop Materials and Strategies STEP 6: Determine the role staff members will play in implementing and using standing orders Think through the physical movement of people through your office Where will each step will occur Assessment (Receptionist? In exam room? Self-assessment?) Screening (Use contraindications checklist? Program into EMR?) Administration (Give VIS beforehand!) Documentation Who will perform each step of the process
Establish a Line of Consultation Screening questionnaire will generate false positive results Are you sick today? Do you have any allergies? Establish a culture that encourages questions from staff without negative ramifications Clinician may need to be involved in some cases
Logistics Administration Who is legally authorized to administer vaccines? Who will prepare the vaccine? Where will vaccination occur?
Logistics Documentation Ensure the patient s personal record is updated and given to the patient Where will vaccine administration information be recorded? For example: EMR Paper document in medical chart State/local immunization information system or registry? If you don t use an EMR and don t already have a medical record chart form for vaccination, you can use the IAC s record forms www.immunize.org/catg.d/p2023.pdf
Personal Record Cards available for purchase on IAC website www.immunize.org/shop
Phase 2: Develop Materials and Strategies STEP 7: Determine your standing orders operational strategy Review your existing vaccination services logistics Are there ways to improve patient vaccination and flow?
Sample Work Flow Patient checks in with receptionist who checks for vaccine indication Patient is taken to exam room or other designated location Yes Consult or defer No Vaccinate! If yes receptionist provides screening questionnaire and VIS for each vaccine Nurse (or other staff) reviews eligibility, questionnaire, and answers patient questions Vaccine and VIS entered into EMR and IIS and patient provided personal copy of record Patient completes questionnaire and reviews VIS in waiting room Contraindications to vaccination?
Vaccination Services Logistics Changes to Consider Consider expanding your vaccination services when using standing orders: Offer vaccinations on a walk-in basis Hold vaccination clinics on evenings or weekends Offer express service for vaccination during regular office hours for both patients with appointments and those who are walk-ins
Phase 2: Develop Materials and Strategies STEP 8: Identify strategies and publicize the program to your patients: Review your current methods for contacting patients (e.g., appointment reminders, laboratory results, prescriptions, online communications, text messaging, etc.) Can these methods also be used to tell patients about their need for vaccination and the availability of a convenient new program?
Phase 2: Develop Materials and Strategies STEP 8 (cont.): Identify strategies and publicize the program to your patients: Implement a reminder/recall system Most Immunization Information Systems can do this Your state/local health department can assist
Materials You Will Need On Hand A copy of the signed standing orders protocol for each vaccine you plan to use Contraindication screening checklists to help you determine if there is any reason not to vaccinate your patients Vaccine Information Statements for all vaccines you plan to administer
Materials You Will Need On Hand Vaccine administration record forms, if you don t use an electronic medical record and don t already have a medical record chart form Information on how to report vaccinations to your state/local immunization information system (registry) A personally held vaccination record card or a printed copy of the vaccine administered, including the date it was given
Phase 3: Make It Happen STEP 9: Start Vaccinating! Make sure the nursing and medical staff have all the tools they need to run a successful vaccination program: Storage and handling of vaccines Vaccine administration techniques Strategies to avoid vaccine administration errors Documentation requirements for administering vaccines Materials to help answer questions of vaccine-hesitant patients
www.immunize.org/clinic
Phase 3: Make It Happen STEP 10: Review your progress when you start your program and periodically: It will take a little practice to optimize the operation of your system Monitor closely and maintain good lines of communication when the program begins Check in with staff each week until it is running well, then every few months until the end of influenza vaccination season
Phase 3: Make It Happen STEP 10 (cont.): Review your progress at the end of influenza season Compare the number of doses of vaccine you gave this season with a season before your standing orders program was put in place Hold a staff meeting to get input from everyone involved in the program to find out what went right and how the program could be improved for next season Consider whether you are ready to expand your use of standing orders to additional vaccines
Sustaining the program Some issues to consider: Data extraction/data quality needs to be maintained in order to continue to show return on investment Incentivize immunization champions, develop a system to ensure that knowledge is not with just one person Integrate fully with the state IIS to maximally leverage your EMR for provider assessment, patient reminder recall, integration of clinical decision support Code and bill accurately to maximize gains from your standing orders program Sustainability is particularly important in adult immunization practices and additional interventions will be necessary to expand and sustain adult vaccination coverage
Conclusion Standing Orders Protocols for Immunization Are endorsed by major vaccine policy-making institutions Reduces missed opportunities for vaccinating patients Improves vaccine coverage levels in a variety of settings Empowers staff Provides more efficient use of clinician expertise Reduces vaccine administration errors by routinizing process, rather than ad hoc implementation Protects your patients and community from vaccine preventable diseases
IAC Resources Immunization Action Coalition www.immunize.org Email questions: admin@immunize.org IAC Express free weekly emails - www.immunize.org/subscribe Standing Orders Templates - www.immunize.org/standing-orders
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