What should the phlebotomist do if the urine specimen Cannot be delivered to the laboratory within one hour?

Ship frozen serum samples to McKesson BioServices at least once every three months. Make shipments by mid- February, May, August, and November to ensure McKesson has sufficient time to log in the blood samples before the database consolidation at the end of the month. A quarterly shipping of blood specimens by the CC is required. CCs may make more frequent shiipments at the CC’s discretion. All CCs must ensure that frozen samples are shipped on a quarterly basis to McKesson BioServices regardless of the number of samples in the freezer.

Ship on a Monday, Tuesday or Wednesday. Do not ship on a day before a McKesson BioServices holiday. McKesson BioServices holidays are: New Year's Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas.

Samples must be frozen at least two hours at −70°C before packing them for shipment. If the blood samples were drawn on the same day you plan to ship them to McKesson, to help with freezing, leave the lid off the freezer box until it is ready to be packed for shipment. If the insulated shipping container is not filled, stuff newspapers to stabilize the freezer boxes.

Ship the fiberboard shipping box with frozen samples to McKesson BioServices by day or overnight courier to ensure receipt at McKesson BioServices within 24 hours.

There is no minimum number of cryovials to include in a shipment; ship all frozen cryovials regardless of the number of specimens that have been frozen and stored within the last collection period. However, CCs must follow current International Air Transport Association (IATA) regulations. As of January 1997, IATA Dangerous Goods Regulations have changed. The maximum allowable volume of diagnostic specimens allowed in a shipping container has increased from 500 ml to 4 liters (4000 ml). You can send up to 16 freezer boxes in the large shipping container. Include all the blood aliquots you have drawn and frozen.

Form 104 - Frozen Specimen Shipment has been replaced with the McKesson BioServices form Notification of WHI Shipment. CCs use this form to record shipping information and to order blood collection and shipping supplies. The CC is responsible for faxing the Notification of WHI Shipment form (Figure 11.7A) to McKesson when the CC sends a blood shipment. Upon receiving the blood shipment, McKesson will complete the “Confirmation of Receipt” section of the Notification of WHI Shipment form and send it to the CC. If the required WHI Notification of Shipment form is not sent to McKesson by the CC, then McKesson cannot return a Confirmation of Receipt.

Two options may be used for ensuring blood samples are sent to McKesson when a participant has her blood drawn while she is visiting another CC:

• One option is to perform the blood draw and processing at the visiting CC and return the completed Form 100 – Blood Collection and Processing and frozen blood samples to the permanent CC.
• The second option is to perform the blood draw and processing at the visiting CC, return the completed Form 100 – Blood Collection and Processing to the permanent CC and ship the frozen blood samples directly to McKesson.

The option that you select to use should be a mutually agreeable process by both the “permanent CC” and the “visiting CC.” Note that the work scope for the permanent CC is the same for both options. The work scope for the visiting CC is dependent on the option choice.

Figure 11.7ANotification of WHI Shipment

The permanent CC has responsibility for the following:

• Complete as much of the visit as possible by phone and/or mail.
• Create a new employee ID in WHILMA and give it the employee name “other CC.”
• Apply a participant ID label, complete the employee ID (“other CC”), visit type and visit year. Clip a set of blood labels to the Form 100 – Blood Collection and Processing.
• Send the Form 100 – Blood Collection and Processing to the visiting CC that will perform the blood draw along with a self-addressed envelope to facilitate the form’s return.

The visiting CC has responsibility for the following:

• Perform the blood draw. Record the name of the staff person drawing the blood alongside the “drawn by” box.
• Process and freeze the blood samples. Record the name of the staff person processing the blood alongside the “processed by” box.
• Return the completed Form 100 – Blood Collection and Processing, including CBC results, applicable for the OS AV3, to the permanent CC in the self-addressed envelope (or enclose it in an airtight plastic bag in the shipping container along with the blood samples).
• Ship the frozen blood samples to the permanent CC to ship to McKesson.
• Phone, FAX or email the permanent CC to advise of the shipment.

The permanent CC has responsibility for the following:

• Complete as much of the visit as possible by phone and/or mail.
• Create a new employee ID in WHILMA and give it the employee name “other CC.”
• Apply a participant ID label, complete the employee ID (“other CC”), visit type and visit year. Clip a set of blood labels to the Form 100 – Blood Collection and Processing.
• Send the Form 100 – Blood Collection and Processing to the visiting CC that will perform the blood draw along with a self-addressed envelope to facilitate the form’s return.

The visiting CC has responsibility for the following:

• Perform the blood draw. Record the name of the staff person drawing the blood alongside the “drawn by” box.
• Process and freeze the blood samples. Record the name of the staff person processing the blood alongside the “processed by” box.
• Return the completed Form 100 – Blood Collection and Processing, including CBC results, applicable for the OS AV3, to the permanent CC in the self-addressed envelope.
• Email McKesson to notify them that additional blood samples from another CC will be included in the routine monthly shipment of blood. Include the permanent CC’s two digit ID number in the email.
• Place a note on the top of the styrofoam cover, on the insulating portion of the shipping box, indicating that the shipment contains blood samples from another CC.
• Place a note on the top of the freezer box indicating that blood samples from another CC are included in the freezer box.
• Ship the blood samples to McKesson with the routine monthly shipment.

Pack the freezer storage boxes of frozen blood and urine samples in the shipping boxes as follows:

(The shipping box is composed of an inner styrofoam insulating portion and an outer fiberboard shell).

1. On the day of shipment, complete the Notification of WHI Shipment form to provide shipment information and/or to request supplies from McKesson. FAX the form to McKesson at 301-838-9753 and retain a copy for your records.
2. Wrap the freezer storage boxes containing the WHI samples in absorbent material (paper towels, wadding, etc.).
3. Place the freezer storage boxes in a plastic bag, either self-sealed zip-lock bag or secured with a waterproof seal. Remove as much of the air from the bag as possible and seal.
4. If you are using the smaller shipping box, place a minimum of 5–8 1bs of dry ice nuggets on the bottom. Place a maximum of 5 freezer storage boxes on top of the dry ice layer and then scatter the remaining 5–8 lbs. of dry ice nuggets around the freezer storage boxes. A minimum of 10 lbs. of dry ice and a maximum of 16 lbs. of dry ice can be used for the small shipping box. This will allow the package to remain frozen for 48 hours in case the shipment is delayed.
5. If you are using the larger shipping box, place a 8–10 lbs. of dry ice nuggets on the bottom. Place a maximum of 16 boxes on top of the dry ice layer and then scatter the remaining 8–10 lbs. of dry ice nuggets around the freezer storage boxes. A minimum of 16 lbs. of dry ice and a maximum of 20 lbs. of dry ice can be used for the large shipping box. This will allow the package to remain frozen for 48 hours in case shipment is delayed.
6. Stuff any empty space in the shipping box with newspaper or absorbent material.
7. Place the styrofoam cover on the insulating portion of the shipping box with the Notification of Shipment Form taped to the top. DO NOT TAPE the styrofoam cover to allow the dry ice gas to escape. Close and tape the outer fiberboard shell of the shipping box by sealing the top and corners of the box with waterproof tape to keep as much cool air as possible from escaping. Do not use scotch or masking tape.
8. Attach the airbill holder to the front of the box. Place the following labels on the top of the shipping box, so that none of the labels touch each other.
   LabelLocation on Fiberboard Box

   Clinical Center's return address label	Top, upper left corner
   McKesson BioServices address label	Top, lower right corner
   Black-and-white class “9” label	Top, under Return address
   Priority overnight label (optional)	Top, upper right corner
   Diagnostic specimen label	Anywhere on top
   Keep Frozen label (optional)	Anywhere on top

   See Figure 11.8 - Frozen Specimen Shipping Labels to see sample labels and placement of the labels on top of the fiberboard shipping box. You must follow the current federal regulations of labeling or face a possible fine of up to $10,000 if proper labels are not in compliance.

9. Write in the amount of dry ice placed in the box on the black-and-white class “9” label. Record the weight in pounds or kilograms. Federal Express occasionally changes the weight units on the label. Record the weight in the units requested on the label. You can use the table below to convert from one unit to the other. Federal Express will return shipments which do not show the weight of dry ice.
   PoundsKilograms

   10	4.4
   11	4.8
   12	5.3
   13	5.7
   14	6.2
   15	6.6
   16	7.3
   17	7.7
   18	8.2
   19	8.6
   20	9.1

10. Complete the Federal Express airbill supplied by McKesson BioServices. It will already be partially completed. Enter:
    • The date of the shipment.
    • Weight of dry ice (in pounds or kilograms), as requested.
    • Number of packages and total weight of shipment.

    As with the dry ice label, record the weight requested on the label. Federal Express supplies the airbills to McKesson BioServices, and sometimes requests the weight in pounds and other times in kilograms.

    Insert the airbill in the airbill holder. See Figure 11.9 - Federal Express Airbill for Frozen Specimens.

11. To delay thawing, place the box in the −70°C freezer to wait for pick up. You don't need to do this if you pack the box within 2–3 hours of pickup and you hold the box in a controlled temperature area (for example, at room temperature and not over 80°F).
12. Notify McKesson BioServices via email (or phone if email is not possible) the day you ship the specimens. In the message, include:
    • The CC name.
    • The date of the shipment.
    • The date of expected arrival (same day or next day).
    • The airbill number from the Federal Express label.

Figure 11.8Frozen Specimen Shipping Labels

Figure 11.9Federal Express Airbill for Frozen Specimens

McKesson BioServices personnel will complete the Confirmation of Receipt section of the Notification of WHI Shipment form upon arrival of the shipment at the repository.

The McKesson BioServices staff will record:

• Date shipment arrived.
• Number of boxes received.
• Condition of the total shipment, for example, “thawed.”

If McKesson BioServices staff do not receive the shipment on the expected day, they will trace the shipment using the airbill number.

McKesson BioServices will include a packing slip when sending blood collection and other supplies to the CC.