CDC COVID-19 VACCINATION PROGRAM
PROVIDER AGREEMENT, REDISTRIBUTION AND REPORTING FORM
Provider Enrollment, Redistribution and Reporting Form
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The COVID-19 Provider Enrollment form was successfully updated.
Provider Enrollment
Redistribution
Reporting
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Submitter's Email:
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Submitter's Last Name:
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Submitter's Last Name:
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Submitter's Email:
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Access Code:
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4 digit number that will be used retrieve your form
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Access Code:
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Access Code from the Admin Screen
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Only Providers contacted by the DOH are authorized to edit an already submitted form. Please contact
Portal ADMIN Support Rep
if you are unable to edit the form. Please include your location name, address, Submitter’s Last Name if available to better serve your query.
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Submitter's Last Name:
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Submitter's Email:
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Please enter the below information for all Locations listed below.
1. Is the vaccination site open to the public? Public sites will be listed on the ourshot.in.gov vaccination map.
2. If open to the public, what is the registration website and/or phone number?
This form will auto save every 5 seconds so you can return and continue from where you left off if you are unable to complete it in a single session. To complete the form, it will need to be “Submitted”.
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Please complete Sections A and B of this form as follows: The Centers for Disease Control and Prevention (CDC) greatly appreciates your organization’s (Organization) participation in the CDC COVID-19 Vaccination Program. Your Organization’s chief medical officer (or equivalent)
and
chief executive officer (or chief fiduciary)—collectively, Responsible Officers—must complete and sign the
CDC COVID-19 Vaccination Program Provider Requirements and Legal Agreement (Section A). CDC COVID-19 Vaccination Program Provider Profile Information
(Section B) must be completed for each vaccination Location covered under the Organization listed in Section A.
Submitter Information
Submitter's Last Name:
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Submitter's Email:
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Access Code:
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4 digit number that will be used retrieve your form
Section A
- Provider Requirements and Legal Agreement
Section B
- Provider Profile Information
Submitter Information
Organization Identification
Responsible Officers
Agreement Requirements
Sign -Chief Medical Officer
Sign -Chief Executive Officer
Official Use
Organization Identification
Organization’s Legal Name:
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Number of affiliated vaccination locations covered by this agreement:
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Organization Phone:
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Email:
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must be monitored and will serve as dedicated contact method for the COVID-19 Vaccination Program
State:
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Organization Street address 1:
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Organization Street address 2:
Organization Zip:
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Organization City:
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Organization County:
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Responsible Officers
For the purposes of this agreement, in addition to Organization, Responsible Officers named below will also be accountable for compliance with the conditions specified in this agreement. The individuals listed below must provide their signature after reviewing the agreement requirements.
Chief Medical Officer (or Equivalent) Information
Licensure Number must be entered first before completing other fields
Licensure Number:
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Required for Licensed with Prescriptive Authority only should be listed (no RNs)
Last Name:
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First Name:
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Middle Initial:
Title:
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Required for Licensed with Prescriptive Authority only should be listed (no RNs)
Telephone number:
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Email:
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State:
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Street address 1:
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Street address 2:
Zip:
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City:
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County:
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Chief Executive Officer (or Chief Fiduciary) Information
Last Name:
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First Name:
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Middle Initial:
Title:
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Telephone number:
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Email:
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State:
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Street address 1:
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Street address 2:
Zip:
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City:
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County:
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Agreement Requirements
I understand this is an agreement between Organization and CDC. This program is a part of collaboration under the relevant state, local, or territorial immunization’s cooperative agreement with CDC. To receive one or more of the publicly funded COVID-19 vaccines (COVID-19 Vaccine), constituent products, and ancillary supplies at no cost, Organization agrees that it will adhere to the following requirements:
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Organization must administer COVID-19 Vaccine in accordance with all requirements and recommendations of CDC and CDC’s Advisory Committee on Immunization Practices (ACIP).
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2
Within 24 hours of administering a dose of COVID-19 Vaccine and adjuvant (if applicable), Organization must record in the vaccine recipient’s record and report required information to the relevant state, local, or territorial public health authority. Details of required information (collectively, Vaccine-Administration Data) for reporting can be found on CDC’s website.
2
Organization must submit Vaccine-Administration Data through either (1) the immunization information system (IIS) of the state and local or territorial jurisdiction or (2) another system designated by CDC according to CDC documentation and data requirements.
2
Organization must preserve the record for at least 3 years following vaccination, or longer if required by state, local, or territorial law. Such records must be made available to any federal, state, local, or territorial public health department to the extent authorized by law.
3
Organization must not sell or seek reimbursement for COVID-19 Vaccine and any adjuvant, syringes, needles, or other constituent products and ancillary supplies that the federal government provides without cost to Organization.
4
Organization must administer COVID-19 Vaccine regardless of the vaccine recipient’s ability to pay COVID-19 Vaccine administration fees or coverage status. Organization may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient. Organization may not seek any reimbursement, including through balance billing, from the vaccine recipient.
5
Before administering COVID-19 Vaccine, Organization must provide an approved Emergency Use Authorization (EUA) fact sheet or vaccine information statement (VIS), as required, to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative.
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Organization’s COVID-19 vaccination services must be conducted in compliance with CDC’s Guidance for Immunization Services During the COVID-19 Pandemic for safe delivery of vaccines.
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7
Organization must comply with CDC requirements for COVID-19 Vaccine management. Those requirements include the following:
a) Organization must store and handle COVID-19 Vaccine under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with the manufacturer’s package insert and CDC guidance in CDC’s Vaccine Storage and Handling Toolkit
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, which will be updated to include specific information related to COVID-19 Vaccine;
b) Organization must monitor vaccine-storage-unit temperatures at all times using equipment and practices that comply with guidance located in CDC’s Vaccine Storage and Handling Toolkit
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;
c) Organization must comply with each relevant jurisdiction’s immunization program guidance for dealing with temperature excursions;
d) Organization must monitor and comply with COVID-19 Vaccine expiration dates; and
e) Organization must preserve all records related to COVID-19 Vaccine management for a minimum of 3 years, or longer if required by state, local, or territorial law.
8
Organization must report the number of doses of COVID-19 Vaccine and adjuvants that were unused, spoiled, expired, or wasted as required by the relevant jurisdiction.
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Organization must comply with all federal instructions and timelines for disposing COVID-19 vaccine and adjuvant, including unused doses.
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10
Organization must report moderate and severe adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS).
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11
Organization must provide a completed COVID-19 vaccination record card to every COVID-19 Vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative. Each COVID-19 Vaccine shipment will include COVID-19 vaccination record cards.
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a) Organization must comply with all applicable requirements as set forth by the U.S. Food and Drug Administration, including but not limited to requirements in any EUA that covers COVID-19 Vaccine.
b) Organization must administer COVID-19 Vaccine in compliance with all applicable state and territorial vaccination laws.
This agreement expressly incorporates all recommendations, requirements, and other guidance that this agreement specifically identifies through footnoted weblinks. Organization must monitor such identified guidance for updates. Organization must comply with such updates.
By signing this form, I certify that all relevant officers, directors, employees, and agents of Organization involved in handling COVID-19 Vaccine understand and will comply with the agreement requirements listed above and that the information provided in sections A and B is true.
The above requirements are material conditions of payment for COVID-19 Vaccine-administration claims submitted by Organization to any federal healthcare benefit program, including but not limited to Medicare and Medicaid, or submitted to any HHS-sponsored COVID-19 relief program, including the Health Resources & Services Administration COVID-19 Uninsured Program. Reimbursement for administering COVID-19 Vaccine is not available under any federal healthcare program if Organization fails to comply with these requirements with respect to the administered COVID-19 Vaccine dose. Each time Organization submits a reimbursement claim for COVID-19 Vaccine administration to any federal healthcare program, Organization expressly certifies that it has complied with these requirements with respect to that administered dose.
Non-compliance with the terms of Agreement may result in suspension or termination from the CDC COVID-19 Vaccination Program and criminal and civil penalties under federal law, including but not limited to the False Claims Act, 31 U.S.C. § 3729 et seq., and other related federal laws, 18 U.S.C. §§ 1001, 1035, 1347, 1349.
By entering Agreement, Organization does not become a government contractor under the Federal Acquisition Regulation.
Coverage under the Public Readiness and Emergency Preparedness (PREP) Act extends to Organization if it complies with the PREP Act and the PREP Act Declaration of the Secretary of Health and Human Services.
7
Signature:
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(Submitter Signature required.)
1
https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
2
https://www.cdc.gov/vaccines/programs/iis/index.html
3
https://www.cdc.gov/vaccines/pandemic-guidance/index.html
4
https://www.cdc.gov/vaccines/hcp/admin/storage-handling.html
5
The disposal process for remaining unused COVID-19 Vaccine and adjuvant may be different from the process for other vaccines; unused vaccines must remain under storage and handling conditions noted in Item 7 until CDC provides disposal instructions; website URL will be made available.
6
https://vaers.hhs.gov/reportevent.html
7
See Pub. L. No. 109-148, Public Health Service Act §§ 319F-3 and 319F-4, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e; 85 Fed. Reg. 15,198, 15,202 (March 17, 2020).
Chief Medical Officer (or Equivalent)
Last Name:
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First Name:
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Middle Initial:
Signature:
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Entering the name in this field constitutes to signing the form and agreeing to the terms and conditions set in this provider agreement
Date:
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Chief Executive Officer (or Chief Fiduciary)
Last Name:
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First Name:
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Middle Initial:
Signature:
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Entering the name in this field constitutes to signing the form and agreeing to the terms and conditions set in this provider agreement
Date:
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Official Use Only
VTrckS ID for this Organization, if applicable:
Vaccines for Children (VFC) PIN, if applicable:
Other PIN (e.g., state, 317):
IIS ID, if applicable:
Unique COVID-19 Organization ID (Section A):
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*The jurisdiction’s immunization program is required to create a unique COVID-19 ID for the organization named in Section A that includes the awardee jurisdiction abbreviation (e.g., an organization located in Georgia could be assigned “GA123456A”). This ID is needed for CDC to match Organizations (Section A) with one or more Locations (Section B). These unique identifiers are required even if there is only one location associated with an organization.
Go to Section B
LocationId
IsVFCPresent
Location Name
Location Address
Active
Approve for VAX
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Organization Identification
Primary Vaccine Coordinator
Backup Vaccine Coordinator
Open To Public?
Shipment Address
Administered Address
Days Available
Provider Type
Administer Settings
Patients Served
Vaccination Capacity
Population Served
Report Data?
Storage Capacity
Storage Details
Providers
Official Use
Please complete and sign this form for your Organization location. If you are enrolling on behalf of one or more other affiliated Organization vaccination locations, complete and sign this form for each location. Each individual Organization vaccination location must adhere to the requirements listed in Section A.
Organization Identification for Individual Locations
Organization Location Name:
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Will another Organization location order COVID-19 vaccine for this site?
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Yes Provide Organization name:
No
Contact Information for Location's Primary COVID-19 Vaccine Coordinator
Last Name:
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First Name:
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Middle Initial:
Telephone:
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Email:
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Contact Information for Location's Back-up COVID-19 Vaccine Coordinator
Last Name:
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First Name:
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Middle Initial:
Telephone:
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Email:
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Open To Public?
1. Is the vaccination site open to the public? Public sites will be listed on the ourshot.in.gov vaccination map.
2. If open to the public, what is the registration website and/or phone number?
Is this Location open to public?:
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Yes
No
Website:
Phone:
Organization Location Address for Receipt of COVID-19 Vaccine Shipments
State:
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Street address 1:
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Street address 2:
Zip:
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City:
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County:
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Telephone:
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Fax:
Organization Address of Location where COVID-19 Vaccine will be Administered (If Different From Receiving Location)
Copy Address if Same as Receiving Location
State:
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Street address 1:
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Street address 2:
Zip:
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City:
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County:
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Telephone:
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Fax:
Days and Times Vaccine Coordinators are Available for Receipt of COVID-19 Vaccine Shipments
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Providers should be on site with appropriate staff to receive vaccine at least one day per week, other than Monday, and for at least four consecutive hours during that day.
Monday
Tuesday
Wednesday
Thursday
Friday
Official Use Only
VTrckS ID for this location, if applicable:
Vaccines for Children (VFC) PIN, if applicable:
IIS ID, if applicable:
Unique COVID-19 Organization ID (from Section A):
Unique Location ID:
*
Comments:
*The jurisdiction’s immunization program is required to create an additional unique Location ID for each location completing Section B. The number will include the awardee jurisdiction abbreviation. For example, if an organization (Section A) in Georgia (e.g., GA123456A), has three locations (main location plus two additional) completing section B, they could be numbered as GA123456B1, GA123456B2, and GA123456B3
COVID-19 Vaccination Provider Type for this Location (Select One)
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Setting(s) where this Location will Administer COVID-19 Vaccine ( Select all that apply)
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Approximate Number of Patients/Clients Routinely Served by this Location
Number of children 18 years of age and younger:
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Unknown
(Enter “0” if the location does not serve this age group.)
Number of adults 19 – 64 years of age:
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Unknown
(Enter “0” if the location does not serve this age group.)
Number of adults 65 years of age and older:
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Unknown
(Enter “0” if the location does not serve this age group.)
Number of unique patients/clients seen per week, on average:
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Unknown
Not applicable (e.g., for commercial vaccination service providers)
Reset
Influenza Vaccination Capacity for this Location
Number of influenza vaccine doses administered during the peak week of the 2019–20 influenza season:
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Unknown
(Enter “0” if no influenza vaccine doses were administered by this location in 2019-20).)
Population(s) Served by this Location (Select all that apply)
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Does your Organization currently report vaccine administration Data to the State, Local, or Territorial Immunization Information System (IIS), CHIRP?
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Yes
No
Not Applicable
List your Organization name exactly as it appears on CHIRP ( Required if you choose "Yes" above):
List your Facility name exactly as it appears on CHIRP ( Required if you choose "Yes" above):
List a user at your facility who has access to CHIRP :
Is your facility enrolled in Vaccines for Children (VFC) program ? :
Yes
No
If “No,” please explain planned method for reporting vaccine administration data to the jurisdiction’s IIS or other designated system as required:
If “Not applicable,” please explain:
Estimated number of 10-Dose MultiDose Vials (MIVs) your Location is able to store during peak vaccination periods (e.g, During back-to-school or Influenza vaccine season) at the following temperatures
Refrigerated (2°C to 8°C):
*
No Capacity
Approximately
additional 10-dose MDVs
Frozen (-15° to -25°C):
*
No Capacity
Approximately
additional 10-dose MDVs
Ultra-frozen (-60° to -80°C):
*
No Capacity
Approximately
additional 10-dose MDVs
Storage Unit details for this Location
Skip this section if the Children (VFC) program box above is checked “Yes” and includes the required VFC program PIN.
I don't have a Storage Unit
Storage and Handling Indiana
Instructions: Please provide actual pictures for every unit (not Internet pictures). Refer to the “Storage and Handling Indiana” link for more information.
1. 2 pictures: Make and model inside pictures of refrigerator and another picture outside of refrigerator
2. 2 pictures: Make and model inside pictures of your freezer and another picture outside of freezer
3. Picture of make and model of 24/7 temperature monitoring device
4. Picture of Current Certificate of Calibration of 24/7 monitoring device
Storage Unit
Storage Type:
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--Select--
FREEZER
REFRIGERATOR
ULTRA-FREEZER
Storage Make/Model:
*
Inside Picture
*
Outside Picture
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Temperature Monitoring Device Picture
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Certificate of Calibration Picture
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I attest that each unit listed will maintain the appropriate temperature range indicated above: (please sign and date)
Sign:
*
Medical/pharmacy director or location’s vaccine coordinator signature
Date:
*
Providers practicing at this Facility
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Instructions: List below
only licensed healthcare providers at this location who have prescribing authority
or will have oversight of the handling or administration of COVID-19 vaccine; i.e., Advance Practice Nurse ( NP), ANP, DDS, DO, DPM, DVM, FNP, MD, PA, PNP, RPh --- no RNs. Only those with direct involvement with COVID-19 vaccine should be listed.
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