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									 Blood Center Name                                                          Template Version: V02
 Address
 City, State, Zip
                                    SPI User Account Management
                                       Standard Operating Procedure (SOP)
 Effective Date:                                 SOP Version:                              Page 1 of 8




PRINCIPLE

The application, “System for Plasma Identification” (SPI), is a web based application which can be
accessed through the website link https://www.spi-link.com. SPI is used for tracking plasma
shipments from the moment they leave the center, to the time the plasma is pooled at the
fractionator site (CSL Behring AG).
The Blood Bank may only use SPI after a successful validation, and the specific release of the
Blood Bank by authorization of CSL Behring AG (“Go Live”). Once the Blood Bank is
authorized by CSL Behring AG, the Blood Bank may use SPI to send, release, and track shipment
data, instead of sending paper shipment packing slips and cover sheets to CSL Behring AG. The
Blood Bank is also authorized to use SPI to enter Post Donation Information (PDIs) for units,
instead of sending Post Donation Information via fax to CSL Behring AG.

This SOP for the Blood Bank is one of a set of SOPs that are required for using SPI. The diagram
below shows an overview of the Blood Bank SPI process, and the relevance of this SOP within
this process, marked by the box.


       User Account Management Plasma Shipping Process                                              Post Donation
SOP:                                                     User Access    Plasma Shipping Process
                                                                                                     Information



                                   Go to Website and                         QA Release and
          Set Up/Manage SPI                                                                         Enter any PDI’s in
                                   Upload Shipments      Login to SPI       Send Shipments in
            User Accounts*                                                                                 SPI
                                       (XML files)                                SPI



               Step 0                   Step 1              Step 2               Step 3                  Step 4



After a Blood Bank is validated and released by CSL Behring AG, the “Center Administrator” SPI
user account is released to the relevant, trained person at the Blood Bank, who is responsible for
the creation and administration of SPI user accounts for Blood Bank staff. The Centre
Administrator account details (username and password) are forwarded directly from CSL Behring
AG.

Only authentic Blood Bank staff may be granted access to SPI by the Center Administrator.

Only trained Blood Bank staff may be granted access to SPI by the Center Administrator.
 Blood Center Name                                                  Template Version: V02
 Address
 City, State, Zip
                            SPI User Account Management
                               Standard Operating Procedure (SOP)
 Effective Date:                         SOP Version:                         Page 2 of 8


SCOPE

This SOP describes the procedures required to be carried out by the Blood Bank SPI Center
Administrator for the management of Blood Bank staff user accounts.

The procedures described in this SOP are:

    -   Create new user accounts for Blood Bank staff.
    -   Deactivate existing user accounts.
    -   Terminate roles for Blood Bank staff.
    -   Add new roles for Blood Bank staff.
    -   Unlock user accounts for Blood Bank staff.
    -   Reset passwords for Blood Bank staff.


PROCEDURE: CREATE NEW USER ACCOUNTS

Note: Any PC that is used to access SPI must have completed an Installation Qualification
(IQ).

    1. Login to the SPI. (Refer to the Center SOP User Access on how to login to SPI)

    2. Go to >Local Admin > Staff Members
Blood Center Name                                                       Template Version: V02
Address
City, State, Zip
                                SPI User Account Management
                                   Standard Operating Procedure (SOP)
Effective Date:                              SOP Version:                         Page 3 of 8


   3. Enter the details of the new staff member.




                  a) Company – Mark this field with your mouse by clicking inside the Company
                       field. Next, click on the List of Values      icon and select your Blood Bank
                       company name from the list. Click OK, to add your company name in the
                       Company field.
                  b)   Company Type – This is automatically populated after entering the company
                       name.
                  c)   Last Name – Type in the last name of the person, using a CAPITAL letter for
                       the first letter in their name.
                  d)   First Name - Type in the first name of the person, using a CAPITAL letter for
                       the first letter in their name.
                  e)   Username – Enter a username that will distinguish this person from any other
                       person. (NOTE: SPI controls that only unique usernames are used.)
                  f)   Birth Date – The birth date of the person may be optionally entered.
                  g)   Language – Enter the preferred language of the person.
                  h)   Gender – Enter the gender of the person.
                  i)   Email Address – Enter the email address of the person (NOTE: Email
                       addresses will ensure that the person will receive direct communications
                       from CSL Behring AG.)
                  j)   Remarks –Rremarks can be optionally entered in this field.
                  k)   Effective Date – This is automatically provided by SPI.
                  l)   Authorization Method – Enter the Password or Digital Signature authorization
                       method (NOTE: Unless digital signatures (with graphic tablets) were used
 Blood Center Name                                                         Template Version: V02
 Address
 City, State, Zip
                                  SPI User Account Management
                                      Standard Operating Procedure (SOP)
 Effective Date:                                SOP Version:                           Page 4 of 8

                       during CSL Behring AG’s validation of the Blood Bank, Password should
                       be selected.)

    4. In the Roles list, enter the appropriate roles that the person requires. This will depending on
       their responsibilities within the Blood Bank:

                   a) Mark the Role field by clicking the mouse in this field.
                   b) Click on the List of Values         icon, and select the appropriate role for this
                      person from the list.
                   c) Click OK, to add the role in the Role list. Repeat until all appropriate roles have
                      been entered in the list for this person. The table below lists the selection of
                      available roles, and what each role allows:

                   Roles                          Description
                   All Center Staff               Should be assigned to all center users
                   Center Shipping Manager        Responsible for shipment authorization and can also perform
                                                  XML Electronic Delivery Note (EDN) uploads.
                   Center PDI Manager             Responsible for entering, opening and acknowledging PDI’s.
                   Center Shipper                 Can only perform XML Electronic Delivery Note (EDN) uploads.
                   Center QA Release              Responsible for center QA release (Refer to Center Quality
                                                  Agreement with CSL Behring AG.). Can add and remove
                                                  individual units, test kits and supplies to and from a shipment.
                   Center Administrator           Responsible for user account management.

                   NOTE: The Effective Date is automatically provided by SPI, after each role
                   has been entered.

    5. Click on the Save icon             to save this new staff account record in SPI.


PROCEDURE: DEACTIVATE EXISTING USER ACCOUNTS

User accounts are deactivated for staff members who have terminated their employment with the
Blood Bank, or should not access SPI. State other reasons for deactivation, and include timeframe
of “ASAP”.

    1. Go to > Local Admin > Staff Members.




    2. Find the account that requires deactivating:

                   a) Click on the EnterQuery            icon
Blood Center Name                                                     Template Version: V02
Address
City, State, Zip
                              SPI User Account Management
                                 Standard Operating Procedure (SOP)
Effective Date:                            SOP Version:                         Page 5 of 8

                  b) Type the Last Name, or First Name or Username of the person’s account
                     (NOTE: the Wildcard ‘%’ can be used to assist with searches. E.g. Typing
                     ‘Mur%’ will return all accounts with last names starting with ‘Mur’.
                     Navigate through all the records using the Previous /Next Record
                     icons.)
                  c) Click on the Execute Query      icon.


   3. Enter the current date in the Termination Date field for every role:.




   4. Click on the Save icon       .

   5. Enter the current date in the upper Termination Date field:
 Blood Center Name                                                    Template Version: V02
 Address
 City, State, Zip
                              SPI User Account Management
                                 Standard Operating Procedure (SOP)
 Effective Date:                           SOP Version:                         Page 6 of 8




     6. Click on the Save icon      . The user account deactivation will be effective at midnight on
        the day of the termination date.


PROCEDURE: TERMINATE ROLES

1.      Execute step 3 in the Procedure Deactivate Existing Staff User Accounts in this SOP.

        NOTE: Roles cannot be reactivated after they have been terminated. The role must be
        re-added to the list, as a new role.

PROCEDURE: ADD NEW ROLES

1.      Execute step 4 of the Procedure Creating New Staff User Accounts in this SOP.


PROCEDURE: UNLOCK USER ACCOUNTS

Users requiring access to the system should be confirmed as authentic users before unlocking
accounts.

     1. Go to >Local Admin > Staff Members
Blood Center Name                                                     Template Version: V02
Address
City, State, Zip
                              SPI User Account Management
                                 Standard Operating Procedure (SOP)
Effective Date:                            SOP Version:                         Page 7 of 8


   2. Find the relevant user account

                  a) Click on the EnterQuery       icon
                  b) Type the Last Name, or First Name or Username of the person’s account
                     (NOTE: the Wildcard ‘%’ can be used to assist with searches. E.g. Typing
                     ‘Mur%’ will return all accounts with last names starting with ‘Mur’.
                     Navigate through all the records using the Previous /Next Record
                     icons.
                  c) Click on the Execute Query      icon.
 Blood Center Name                                                   Template Version: V02
 Address
 City, State, Zip
                             SPI User Account Management
                               Standard Operating Procedure (SOP)
 Effective Date:                         SOP Version:                          Page 8 of 8



    4. To unlock the account, click on the Password Lockout checkbox to unmark it.



PROCEDURE: RESET PASSWORDS
Users requiring access to the system should be confirmed as authentic users before resetting
passwords.
    1. Follow steps 1 and 2 from Procedure: Unlocking Staff User Accounts in this SOP.

    2. Click on the Change Password button.

    3. Enter the new password in the New Password field, and confirm the password by re-
       entering it in the Confirm Password field. Click OK.

    4. Click OK again to confirm the transaction.


NOTES:
The password is valid for three months from the last password change. The expiration of the
password is verified by the system. After three failed attempts to enter a correct password,
the account will be locked. Only Center Administrators are responsible for unlocking
accounts or resetting passwords for their Blood Bank staff.



REFERENCES
System for Plasma Identification (SPI) Center Operations Manual.
Center Quality Agreement with CSL Behring AG.




Authored by: CSL Behring AG
Date:        March, 2007

                                            Approvals
                     Name:                              Signature:                      Date:

								
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