Document RpVgGEagoN5Z64LbNLmqMdMME

hkAG - V-O 7 fi,R fifi& - M - 0 3 Site Manual fo r DuPont PFOA Screening This site manual contains instructions and forms to support collecting, processing, and Page Sample Collection Supplies..................................................................................................2 Sample Processing Procedures...... ......................................................................................3 Sample Pracessingfor the PFOA Assay............... ........................................... .......... ........ 3 Packing and Shipping Frozen Samples................................................................................ 5 PFOA Sample Collection Record.................................................. .....................................6 Sample Collection Supply Reorder Form ..... ...................................................... ...............7 Shipping Notification Form .... ...........................................................................................8 Advion BioSciences contact: Mr. David Hardwick Director of Laboratory Operations Advion BioSciences, Inc. 15 Catherwood Road Ithaca, NY 14850 4 June 2002 Company Sanitized. Does not contain TSCACRi DUPONT SM.DOC 000067 Sample Collection Supplies Sample collection supplies, sufficient for 24 subjects, are provided for each PFOA screening session. Supplies are labeled with the company name, study identification, and the expected month and year of screening. Because PFOA can be present in very low levels on some of the supplies, all supplies are tested at Advion before shipment. To minimize the possibility o f extraneous contamination, please use only the materials supplied and discard unused supplies after each screening session. Supplies include: 1. Tubes Tubes are provided for collecting samples for PFOA analysis. Blood from the patient is drawn into red-top Vacutainer tubes. Processed samples are transferred into polypropylene tubes. Each tube has an area to apply a label. 2. Labels Blue paper labels are to be applied to the red-top Vacutainer tubes. W hite nylon barcode labels are to be applied to the 12 x 75 mm screw-cap polypropylene sample tubes and have an area to write the subject ID, collection time, and collection date. 3. Needles Needles are included for drawing blood. Needles are pre-tested by lot to determine their acceptability for use in this project. 4. Needle H olders Needle holders are provided for sample collection. 5. T ransfer Pipettes Polypropylene transfer pipettes are provided to transfer the processed serum into the screwcap sample tubes. Transfer pipettes are pre-tested by lot to determine their acceptability for use in this project 6. Plastic Bags Large and small zip-lock bags are provided to protect tubes and Sample Collection Records from leakage duping transport back to Advion, 7. Site M anual This Site Manual is included with your Sample Collection Supplies. Make copies o f the Sample Collection Record (page 6) as needed for each day that samples are drawn. IM PO R T A N T ; W hen all subjects have been recruited and blood sam ples collected, discard all rem aining supplies. New supplies will be shipped for th e subsequent screening session. Page 2 DUPONTSM.DOC CofflpahySanitized. Does c-vtta'rt T5CA CBI 000068 Sample Processing Procedures During each screening session, samples will be collected for PFOA analysis. Please use the procedure listed below for sample processing. Sample Processing for the PFOA Assay Equipment and Supplies Required 4-mL (red-top) glass Vacutainer blood collection tubes (supplied) 21 -gauge needles (supplied) Needle holders (supplied) Polypropylene tubes (12 x 75 nun) with caps (supplied) Centrifuge Transfer pipettes (supplied) --20 10 C freezer Labels (supplied) Procedures 1. Draw Wood into a 4-mL (red-top) glass Vacutainer blood collection tube using the 21- gaugeneedfes supphedrLabel the Vaeutainer -with the blue paper label provided. 2. Allow blood to clot for 15 minutes (or until thoroughly clotted) at room temperature. 3. Centrifuge the blood sample for 15 minutes at 3000 rpm. 4. Remove the serum using the transfer pipettes provided and transfer the serum into a 12 x 75 mm polypropylene tube. Cap the tube tightly. 5. Label the sample with the w hite nylon barcode label provided. Write the patient ID, date, and time on the label using a Sharpie permanent marker. Do not use ballpoint pen. Example ofPFOA sample label Company Sanitized. Does not contain TSCA QBI Page3 DUPONTSM.DOC 000069 (Continued) Sample Processing for the PFOA Assay 6. Enter the last five digits o f the barcode that appears on the white nylon label on the PFOA Sample Collection Record (page 6). Enter the date and 24-hour clock tim e of sam pling on the same page. 7. Freeze im m ediately a t -20 C. Please hold samples at -20 C and ship all accumulated samples at the end o f each visit. If additional shipments are required, please contact Advion in advance. 8. When ready, ship the sample set overnight on dry ice to Advion BioSciences. See Shipping Instructions for more details. I f ^ p a i i y Sanitized. Does not contain TSCA CBl Page 4 DUPONT SM.DOC 000070 Packing and Shipping Frozen Samples Prior to shipping the first set o f samples call the courier (FedEx) to set up an account, if this has not been done previously. This will facilitate scheduling pick-ups even though your account will not he billed for the transportation of the samples. Request information on local service schedules and the latest time o f day to arrange for pick-up. Important: Please hold samples at -20 C and ship all accumulated samples at the end of each screening session. If additional shipments are required, please contact Advion in advance. Ship samples to Advion BioSciences via FedEx overnight delivery. Your supplies include shipping Airbills pre-addressed to Advion BioSciences. Please write in your address and shipping information. Samples should be shipped on Monday, Tuesday, or Wednesday, only. Package the frozen, processed samples as follows: 1. Put all samples in a zip-lock bag. 2. Place a copy o f all applicable Sample Collection Records in a second large zip-lock bag. 3. Place the zip-lock bags containing the frozen samples and the Sample Collection Records in the insulated shipping container provided by Advion. 4. Pack the samples with at least 10 pounds o f dry ice and replace the foam lid. 5. Seal the shipping box securely. 6. Complete the FedEx Airbill and place the "Dry Ice" sticker on the box. Fill in the amount of dry ice in kg (10 lbs = 4.5 kg). 7. Telephone your local FedEx service to arrange for pickup. 8. When the agent arrives, sign the Airbill and keep the sender's copy. Maintain your copy, as this begins the audit trail that documents the shipping process. 9. Complete the Shipping Notification Form and fax the form to Advion BioSciences. Nationally observed holidays may cause shipment delivery delays. Contact Advion BioSciences for holiday pick-up and delivery schedules. Company Sanitized. Dom not contain TSCA CBI Page5 DUPONT SM.DOC 000071 P F O A Sample Collection Record Study: PFOA Screening S ite No.: 1 1! 111 D ate o f Sam pling: 1 1 II I I II I 1 1 j 1___ 1___ 1 1___ !___ 1___ J 1 1 1 1 1 Day Month Year PFOA Sample Collection: Subject Initials 24-HOUR CLOCK TIME <HH:MM) BARCODE (enter lastfive digits) L L U L L R J J 4140042U J U L L J COMMENTS) I l 1 1 U J :L U 4140042LL LJ i J LI. LJ 1 1 1--I I I 4140042L L L.J...LJ I I I ) L L L L U 4140042LL. L 1..LJ LU J LLLUJ LLL1 ' L L L U J 1 11 1 1 1 H 1 1 41400421, .1...I. .1 i J 41400421 1 1 I I i 41400421 I I 1 1 1 L I . 1_.1 li 11 1 1 H i 1 4140042L L L 1. 1J i 1 h i 1 1 4140042LJ ..L. L L I iM i 11U 1 1 11 Comments: L U 'L U L U :L U Ll h jj 4140042L U L U ..i 41400421_L. L.L..LJ 4140042L i l. i ..I... I Date: SamplesCollectedby: Make copies as needed for different sampling days and additional subjects. Once completed, please make a copy of this form. Send one copy with the set of samples when shipped. Retain originals. Page 6 DUPONTSM.DOC Company Sanitized. P o es not contain TSCA CBI 000072 Sample Collection Supply Reorder Form Please use this form to reorder sam ple collection kits from Advion BioSciences. Instructions: 1. Complete the reorder 2. Fax to the attention o: 3. Orders may also be phoned in t< Requested By: Study#: PFOA Screening Date Requested: Investigator's Name: Telephone Number: Date Supplies Needed: ALL INFORMATION ABOVE IS REQUIRED TO COMPLETE ORDER Additional Supplies S u p p lie s 4-mL red-top Vaeutainer tubes 21 Gauge Needles Needle Holders Transfer Pipettes Blue paper Vaeutainer labels Barcoded Sample Labels* FedEx Airbills Dry Ice Shipping Labels Shipping Containers Q uantity Needed __________ Please contact Advion to discuss details. Please allow 5 to 7 days for delivery of kits and supplies. Company Sanitized. Does not contain TSCA CBI Page 7 DUPONT SM.DOC 000073 15 Catherwood R oad, Ithaca, NY 14850 Shipping Notification Form When shipping samples, please complete this form and return by fax to Advion BioScicnces at 607-266-0749. FAX TRANSMISSION COVER SHEET TO: NAME: COMPANY: PHONE: FAX: TOTAL PAGES TRANSMITTED INCLUDING COVER: FROM: Investigator's Name: Site Number: Location/Address: _______ _ _____ _ . Telephone Number: Fax Number: Compound or Project: Ship Date: FedEx Tracking Numbers): Number of Shipping Containers: Number of Samples Shipped: Contact at Shipping Site: Email Address: __________ _ _________ PFOA Screening __ _____________ ______. ___________ __ . ________________ CONFIDENTIALITY NOTE: The information contained in the facsimile m essage is privileged and confidential information intended only for the use of the individual or entity named below, if the reader of this m essage is not the intended recipient, you are hereby notified that any dissemination, distribution or copy of this telecopy is strictly prohibited. Ifyou have received this telecopy in error, please immediately notify us by telephone and return the original m essage to us at the address above via the United States Postal Service. Thanh you.__________________ _________ Company SanHlzed. D oes not contain TSCA CBI Pages DUPONTSM.DOC 000074