Vaccine Storage & Handling and VFC Compliance j A day in the life of a Vaccine Coordinator (following all Immunization Program requirements) Massachusetts Department of Public Health Immunization Program 1 Presenter Disclosure I, Kathleen Shattuck, 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 no relationships to disclose. I may discuss the use of vaccines in a manner not approved by the U.S. Food and Drug Administration. But in accordance with ACIP recommendations. 2 Our Practice: DPH Pediatrics Sara, RN Vaccine Coordinator Responsible for vaccine supply and training other staff on appropriately handling vaccine supply. Dr. Shaw Medical Director Responsible for complying with the Standards for Child and Adolescent Immunization Practices, and ACIP immunization schedule, dosage and contraindications. Michael, MA Back-up Vaccine Coordinator Responsible for the responsibilities of the Vaccine Coordinator when the Vaccine Coordinator is not available. 3 1
Our Practice: DPH Pediatrics Sara, RN Vaccine Coordinator The Vaccine Coordinator and Back-up must receive an annual educational training covering VFC requirements including proper vaccine storage and handling. This requirement can be met by: VFC compliance site visit Webinar training (live or recorded) In-person training Conferences (i.e. Immunization Updates and MIAP) Michael, MA Back-up Vaccine Coordinator Sara and Michael both attended the VFC Training break-out session at MIAP in October, 2016. They have their training certificates on file. 4 Some history 5 Annual Enrollment In December, DPH Pediatrics completed their annual enrollment in the MIIS. Signing as the Medical Director, Dr. Shaw acknowledged that she is responsible for Following the requirements outlined in the Agreement to Comply with Federal and State Requirements for Vaccine Administration. Complying with ACIP recommended immunization schedule. Providing the MDPH with an accurate Practice Profile. Identifying a Vaccine Coordinator and back-up, who will be responsible for all vaccine storage and handling. Reporting any change in the Vaccine Coordinator or back-up to the MDPH within ten (10) days. 6 2
Updating Standard Operating Procedure (SOP) After enrolling, Sara used the template provided on the MDPH website to update and customize DPH Pediatrics SOP, including Proper storage and handling of vaccines Vaccine receiving Procedure for vaccine relocation in the event of power or equipment failure Vaccine ordering and inventory control Handling damaged or expired vaccines Protocols for response and documentation when vaccine is stored out of temperature range 7 Updating SOP To complete the SOP update, Sara had all staff who handle or administer vaccines read the updated SOP and sign and date the last page. posted the SOP on the vaccine refrigerator. had a new staff member who started in March read and sign the SOP as part of their training. will update the SOP annually or with any changes. 8 Vaccine Storage Unit DPH pediatrics bought a new pharmaceutical-grade refrigerator to store their vaccines in 2015 when they heard it would be required in 2016. This unit consistently maintains refrigerator temperature 2 C to 8 C (35 F and 46 F), as required for vaccine storage They have an existing, stand-alone freezer for their frozen vaccines. This unit consistently maintains freezer temperature -50 C and -15 C (-58 F and +5 F) for varicella, MMR and MMRV vaccine storage. 9 3
Pharmaceutical grade units Although there is no specific description of a pharmaceutical refrigerator, they should have the following characteristics: Internal fans to circulate air throughout the unit, eliminating pockets of cold air Wire racks to allow better air flow No storage bins or shelves on door Typically have a narrow operating range (less than 2 Celsius degrees or 3 Fahrenheit degrees) Pharmaceutical grade refrigerators are currently required for all primary storage units. In 2018 all refrigerators used to store vaccines must be pharmaceutical grade. All freezers must be stand-alone units. If the Immunization Program identifies that your storage units do not meet these requirements your ability to order vaccines may be limited. 10 Our day Monday, arrival Sara arrives in the morning and Presses the Read button on the data loggers, checking the current temperature and the minimum and maximum temperatures from the weekend, following the infographic Fulfills the requirement to document temperature with time, initials and min/max temp 11 Monday, arrival 12 4
A bit about data loggers NIST certified, calibrated digital data loggers are required for all vaccine storage units at pediatric providers (any site that administers vaccines to those <19 years of age) Data loggers must have a detachable temperature probe in a buffered material (like glycol). The data logger must record the minimum and maximum temperature each day. Providers must still physically acknowledge the high/low temperatures at least twice daily. 13 MDPH Provides Fridge-tag2L Logger NIST certified; no software required; easy to install and use MDPH will provide data loggers for all vaccine storage units Measures the temperature of a 5 ml glycol solution Data logger reports have pdf and txt files to allow temperature monitoring in 5-minute intervals Minimum and maximum temperatures being measured more closely reflect the temperature of the vaccine and with more sensitivity to temperature fluctuations 14 Back to Sara, Monday morning Sara also conducts a vaccine inventory every Monday morning. Ensures an adequate supply of vaccine (privately purchased and statesupplied) for all patients. 15 5
Sara, Monday morning Sara also ensures her vaccines are rotated and monitors expiration dates. She also checks her inventory in the MIIS, which shows which vaccines will expire soonest. She knows she ll need to transfer any vaccines 2-3 months prior to expiration, and can complete the transfer in the MIIS. 16 Expired or damaged vaccine Any expired or damaged vaccine must be appropriately noted on an Expired/Damaged Vaccine Return Request Form within 6 months after the expiration date and Immediately removed from the refrigerator; labeled Do Not Use ; and packaged for return to McKesson. Any expired, damaged or contaminated vaccine must be reported in the MIIS when completing your next order. 17 Sara, Monday morning Sara organizes her vaccines and ensures thermometer is well placed Keep vaccines in original manufacturer packaging Don t remove individual vials Place vaccine boxes in trays Organize vaccines by type, state/private, for quick retrieval to minimize time door open Avoid over-filling refrigerator and hindering air circulation Do not store vaccines on the bottom shelf or near vents Water bottles/cold packs in the refrigerator and ice packs in the freezer stabilize temperature according to manufacturer 18 6
Sara, Monday morning Sara makes sure privately purchased vaccines (used for patients 19 years of age and over) are clearly labeled and separate from state supplied vaccines. Sara knows they can only use state-supplied vaccine for those children determined eligible as defined in the most recent versions of the: Childhood Vaccine Availability Table 19 Reminder about borrowing Vaccine borrowing should be exceedingly rare and only to avoid a missed opportunity. Providers may not borrow state-supplied vaccine for an adult patient. If a provider borrows state-supplied vaccine, a Vaccine Borrowing Report Form must be completed. A copy of the invoice for the privately purchased vaccine must be kept on file. Borrowing reports must be available for review during a site visit. 20 Back to Sara, Monday morning After conducting inventory Sara downloads temp logs from the data logger (she does this once a month and with every order) She reviews the temp logs again to identify any trends Logs into the MIIS to upload her temp logs once a month and with every order. Sara knows she has to keep her temp logs for at least 3 years and uploading them saves them for her. 21 7
Sara uses the MIIS to Enroll each year Report vaccine usage Transfer vaccines Order vaccines Upload temp logs each month 22 Reviewing temp logs 23 Reviewing temp logs Events - records the time the Read button is pressed. Documents that the temperature has been reviewed. There should be two times for each day the office is open. Avg. Temp. records the average temp. measured each day. Ideally should be around 5 C. 24 8
Reviewing temp logs Lower Alarm Limit shows status (ok or ALARM), the minimum temp., time below the limit (2 C), and the earliest time that day an alarm was triggered. Upper Alarm Limit shows status (ok or ALARM), the maximum temp., time above the limit (8 C), and the earliest time that day an alarm was triggered. 25 Adjusting Temps in Vaccine Storage Units If Sara notes that the refrigerator is running on the cold side, or is slowly becoming colder, she knows she needs to take action. However, Sara knows to never adjust the refrigerator temperature control with vaccine in the unit. She would remove refrigerated vaccine to another refrigerator before adjusting temperature. Then she would wait until she have successive readings of the same temperature one hour apart before returning vaccine to the unit. If she had questions, she would call the Vaccine Management Unit. 26 Order Could be Arriving About a week ago Sara placed a vaccine order in the MIIS. Before she placed her order, Sara used the Refrigerator Count Worksheet, which she printed from the MIIS, to record the inventory she had that day. Then she reported her inventory and usage for each vaccine by lot number and expiration date. She uploaded temp logs for each unit just before placing her order. Let office staff know a shipment would be coming. 27 9
Order Could be Arriving Then, she entered her order into the MIIS. Doses Administered by age and vaccine Refrigerator Count Calculated total doses administered Count Off By Upload temp logs 28 First patient of the morning Dr. Shaw sees a 12-month old for a well child visit. She sees the baby and talks with her parents, providing copies of the Vaccine Information Statements (VISs) for MMR Varicella PCV13 29 VISs All providers are required to provide a copy of the relevant, current edition of the VIS produced by the CDC before administering a doses of vaccine (NCVIA: 42 U.S.C. Section 300aa-26). Copies of the most recent VIS can be found at www.immunize.org/vis or on the CDC website at www.cdc.gov/vaccines/hcp/vis/ Sign up to receive emails when VISs are updated at www.cdc.gov/vaccines/hcp/vis. 30 10
VISs www.cdc.gov/vaccines/hcp/vis 31 First patient of the morning Sara checks VFC eligibility for the child Vaccines for Children (VFC) eligibility criteria Birth through 18 years of age: Enrolled in Medicaid Without health insurance Under-insured and seen at federally qualified community health center American Indian (Native American) or Alaska Native This child has Mass Health, she is VFC eligible 32 First patient of the morning Sara prepares and administers the vaccines to the child, then documents the vaccines in the chart, including documenting VFC eligibility. 33 11
Mid-morning, a vaccine shipment arrives The receptionist alerts Sara that her vaccine shipment has arrived. Sara immediately Opens the box Checks the temperature monitors Verifies the packing list matches the order Puts the vaccines away. Refrigerated vaccines in the refrigerator, frozen vaccines in the freezer! This follows Sara s protocol Alert office staff to expect vaccine shipment within 2 weeks after vaccine order is approved When shipment arrives, open the box immediately Check the temperature monitors if there is a problem, call McKesson or Merck immediately Verify packing list matches your vaccine order if there is a problem, call the Vaccine Unit immediately at 617-983-6828 Place vaccines in appropriate storage units. Maintain packing lists for at least 3 years 34 Sara s process for receiving vaccine shipments Late morning, a call from billing Sara takes a call from DPH Pediatrics billing department. They are updating their policies and want to make sure the amount they can charge for a vaccine administration fee for non- Medicaid VFC-eligible children has not changed. Sara consults the Guidelines for Federal and State Requirements for Vaccine Administration from the MDPH Immunization Program website and confirms the fee is $23.29. The Guidelines also state Providers may not bill for the cost of any state-supplied vaccines. Providers may not deny state-supplied vaccine to an established patient due to the inability to pay the administration fee. 35 Guidelines for Compliance All vaccine storage and handling and VFC requirements and recommendations are detailed in the Guidelines for Compliance with Federal and State Vaccine Administration Requirements. Available on our website: www.mass.gov/dph/imm and click on Vaccine Management 36 12
Early Afternoon a question A new receptionist at DPH Pediatrics pulls Michael aside She s wondering if she can take a dose of PCV13 vaccine for her mother. Her mother is home bound and should have a dose of PCV13. A home health nurse has offered to administer the vaccine, but says she can t obtain it. She suggests to account for the dose, they could document as administered to her young daughter. While Michael is sympathetic to the medical challenges of his colleague s mother, He explains that state-supplied vaccine can only be used for children determined eligible as defined in the Childhood Vaccine Availability table, in their practice setting. Taking state-supplied vaccine for use in this way and falsifying documentation is fraudulent and could be very serious. 37 Fraud (as defined by CDC) Fraud is as an intentional deception or misrepresentation made by a person with the knowledge that it could result in some unauthorized benefit to him/herself or some other person. Improper use of VFC vaccine may constitute fraud and is punishable by law (Medicaid regulation: 42 CFR 455.2 and applicable state law). 38 Abuse (as defined by CDC) Abuse is provider practice that is inconsistent with sound fiscal, business, or medical practices and result in unnecessary cost to the Medicaid program, and/or including: actions that result in unnecessary cost to the immunization program, or a health insurance company, or a patient, or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care. 39 13
Mid-afternoon Dr. Shaw gets a call from the father of a 5-year old patient. He reports his daughter has redness and pain at the site of a vaccine she received. The child was in the office and received DTaP vaccine 3 days ago. Dr. Shaw responds that this is a known possible side effect and it is expected to resolve on its own. Dr. Shaw tells the father she will report this to the Vaccine Adverse Event Reporting System, VAERS. She reports online at vaers.hhs.gov, but knows she can also call 800-822-7967 to report adverse events. 40 Late Afternoon Michael alerts Sara that he heard the alarm on a data logger. Upon inspection, the freezer has gone out of range. Sara immediately downloads the temperature log to see all of the details on the temperature excursion. Michael quarantines the vaccines and labels them Do Not Use until it can be determined if the vaccines have been damaged. Sara uploads the temp logs to the MIIS and calls the MDPH Vaccine Unit at 617-983-6828 right away to report the out of range temperature. 41 Temp logs from excursion Upper Alarm Limit shows ALARM, with a maximum temp of -8.7 C, with 1h 10min out of range with an alarm triggered time 17:33h (4:33pm) 42 14
Documentation of excursion Sara follows instructions from the vaccine unit. She know she has to document her follow-up on the temperature excursion, so she uses the Temperature Troubleshooting document on the MDPH website. Sara documents the out of range temperature and the date, time, name of the person she talked with at the vaccine unit, as well as the steps she was told to take and the outcome. Sara files the log. She know her practice is required to keep this documentation. 43 Documentation Sara files her documentation of the temperature excursion in a binder. Sara knows there is other documentation that she must keep for the Immunization Program, fortunately she keeps other documentation in the MIIS or DPH Pediatrics EHR. Accurate record of all vaccines received from MDPH: type, manufacturer lot number expiration date total doses This information is on the packing list from McKesson and Merck Temperature logs Patient Eligibility Screening documentation All records must be maintained for at least 3 years 44 MDPH Immunization Program Website www.mass.gov/dph/imm 45 15
Before leaving for the day Sara checks the temperatures in both units, paying extra attention to the freezer. She follows the infographic and pressed the Read button. She also makes sure the doors of each unit are securely closed. She knows if vaccine doors are accidentally left ajar it can damage vaccines and the practice may be required to pay restitution. 46 Restitution MDPH will require providers to make restitution for any doses of federal or state-purchased vaccines that have been lost due to the provider s failure to properly receive, store, or use vaccines if: 1st incident and the total loss is over $10,000 2nd incident (or greater) regardless of total value Due to a failure to immediately open a vaccine shipment from McKesson or Merck resulting in damaged vaccine regardless of total value. Due to a failure to store refrigerated vaccine in a refrigerator or failure to store frozen vaccine in a freezer. 47 Before leaving for the day Sara glances at her calendar and sees that her site visit from the Immunization Program is scheduled for next week. She knows her site will be assessed for compliance with VFC and other federal requirements in accordance with MDPH guidelines. If any problems are identified with VFC compliance, the site will be entered into an educational follow-up process in accordance with CDC guidelines. At the end of the visit she will receive a Provider Follow-up Plan summarizing the results of the site visit which both MDPH and Medical Director (or staff authorized to sign on behalf of the organization) must sign. 48 16
Another day is done Thanks to Dr. Shaw, Michael and, especially, Sara, DPH Pediatrics has a well run vaccine program, in compliance with all MDPH Immunization Program requirements and guidelines. 49 And thanks to you To all of the Medical Directors, Back-up Vaccine Coordinators, RNs, MAs, other office staff involved with immunizations at provider offices and, especially, to Vaccine Coordinators, Thank you for all you do to take care of vaccines and, in turn, take care of your patients and protect them from vaccine preventable diseases! 50 Please Call Us With Any Questions Please contact the Vaccine Management Unit at 617-983-6828 with any issue relating to vaccine availability, storage, or handling. Please contact the MIIS Help Desk at 617-983-4335 with any questions regarding the registry. 51 17