Specimen Collection and Handling

Health and Safety Precautions

Proper universal precautions should be used at all times during specimen collection and handling. Collection gloves, protective eye wear and lab coats should be worn throughout the specimen handling, collection, and preparation for shipment. Special care and attention should be paid during venipuncture.

Supplies

One Pharma Lab will provide certain supplies necessary to collect and submit specimens for analysis submitted for testing.

Specimen collection tools supplied by One Pharma Lab are to be used only for the collection of specimens processed by One Pharma Lab. Supplies are not to be used to store or dispose of biological materials, including sharp instruments, or for any activity not connected with the collection of specimens for processing by the central laboratory.

Please make sure you have selected the correct sampling kit, check the following:

· Protocol (XXXXX)

· Kit Visit Type (Screening, Study Exit (EOS), Unscheduled)

· Expiration Date*

*In the event that your kits are about to expire:

1. Order new kits using the supply order form

2. Expired specimen collection supplies should be destroyed per local regulations

Please note: testing will be cancelled if expired tubes are received. Study collection kits include (2) additional labels. If any of the contents in the collection kit(s) are broken, damaged, expired or un-useable, please return the unused tubes for a replacement kit(s).

Proper Identification of Specimens

Specimen Labels

All specimens should be labeled at the time of collection with at least two (2) Subject identifiers that must also appear on the requisition.

1. The Subject’s unique ID code is always required.

a. This should include 2 letters and 6-digit ID (__ ­­­__ __ __ __ __ __ __)

2. The second Subject identifier will be one of the following:

▪ Subject’s three letter initials. If the Subject has only two initials, the first and third initial should be separated by a hyphen, e.g. A-B

▪ Subject Date of Birth (DDMMYYYY)

NOTE: Location-based identifiers are NOT acceptable, e.g. hospital room number or street address

Each specimen must have a securely affixed label with the following information prior to shipping:

▪ The Subject’s unique ID code written exactly as it appears on the test requisition (e.g., S2-##)

▪ A second Subject identifier as noted above

If the label is hand-written, use a ballpoint pen. Do not use a felt tip pen.

When submitting a specimen in a container other than the tube used to draw the sample (e.g., transfer vials), also indicate specimen type on the label (e.g., serum, plasma, urine).

Test Requisition

Specimens must be accompanied by a paper requisition, prepared either by hand or printed from an electronic ordering system. At a minimum, the requisition should contain the following information:

▪ Adequate Subject identification information (as noted in the previous section)

▪ Subject gender

▪ Subject date of birth

▪ Name and address of the Principal Investigator ordering the test

▪ Test(s) requested

▪ Visit ID

▪ Date of specimen collection

▪ Source and type of specimen and time of collection

Complete the “Subject Study Information” sections on the requisition. Select the tests to be performed. Legibly print Subject information.

When ordering tests in a series:

1. Use one test requisition.

2. Label each specimen with the Subject’s unique ID code, date and time of collection, or site (if applicable).

3. Write the number of specimens on the test requisition.

4. Submit all specimens within a series together in one specimen bag.

*** Improperly labeled specimens will be rejected. ***

Unsuccessful Collection

Failure to draw blood may be due to needle inserted incorrectly or vacuum lost in tube:

a. If you suspect the needle is not properly inserted, gently and carefully reposition. Withdraw slightly, reposition, reinsert.

b. If you suspect vacuum in tube is lost, change tubes. Always have extra tubes within reach.

Needles, Sharps, or Medical Waste

Do not send any needles or other sharp or breakable objects. Do not send medical waste as a diagnostic specimen since it may violate the law and create a health hazard. Properly discard used needles or other sharps prior to transport. Please note that for tests requiring the submission of syringes, the needle must be removed and the syringe capped before sending to the laboratory. Ensure that there is no leakage or visible contamination on the specimen container.

Phlebotomy

Most blood specimens can be obtained using routine venipuncture phlebotomy techniques; however, there are some exceptions. The use of a tourniquet can cause stress and is not recommended in some cases. Subjects should be instructed not to clench their fist(s) just prior to or during the phlebotomy procedure as this may alter some of the Subject’s laboratory results, such as the concentration of potassium in serum. The Subject’s posture (sitting, standing or supine), or the time of day of phlebotomy can be important factors for some tests (e.g., therapeutic drug monitoring and hormone tests). If in doubt, please call Client Services at 1-800-XXX-XXXX before scheduling the Subject’s phlebotomy.

Eclipse™ Blood Collection Device Instructions

General Instructions

1. Employing Universal Precautions, protective gloves and eye wear must be worn during this procedure.

2. Carefully remove the “clear” needle cover.

3. Thread the Eclipse™ needle into the vacutainer® tube holder.

4. Prepare venipuncture site with antiseptic.

5. Place the Subject’s arm downwards.

6. Remove the “black” protective cover and perform venipuncture procedure.

7. Collect samples into appropriate collection tube(s) per the study protocol.

8. After needle has been removed from the collection site, gently close the needle safety guard. (never attempt to re-cap a needle)

9. Dispose of all sharps in biohazard containers approved for sharps disposal.

Serum and Whole Blood Collection

Draw blood in the color-coded Vacutainer® tube indicated for the procedure requested. For serum or plasma, draw approximately 2 ½ times the requested volume. For serum, allow the blood to clot with the tube in an upright position for at least 30 minutes at room temperature, but not longer than 2 hours before centrifugation. For plasma and whole blood, fill the Vacutainer with the maximum volume specified on the tube whenever possible to eliminate dilution from the anticoagulant or preservative and immediately mix the blood by gently and thoroughly inverting the tube five to ten times. The Vacutainer should not be shaken. Separate plasma by centrifugation. Transfer the serum, plasma, or whole blood to a plastic transport tube. To prevent injury and exposure to potentially infectious material, do not ship frozen serum, plasma, or whole blood in glass tubes or SST (glass or plastic) tubes.

Whole Blood

The most common test using anticoagulated whole blood are the Complete Blood Count (CBC) and blood film morphology, which should be collected using a lavender-top (EDTA) plastic Vacutainer. Other tests may require anticoagulants such as heparin (green-top) or sodium citrate (light blue-top) tube. Follow instructions for the individual test.

Collect an adequate volume of blood. Fill the tube with the maximum volume specified on the tube, since partial filling will results in distortions caused by the osmolality of the anticoagulant. Under-filled or overfilled blood collection tubes will not be accepted for testing.

Immediately mix the blood thoroughly with the anticoagulant additives by gently inverting eight (8) times, or four (4) times when using light blue-top (sodium citrate) tubes. Incomplete mixing or delay in mixing after phlebotomy will result in microscopic partial clotting of the sample, which can cause spuriously low platelet counts.

Maintain the specimen at room temperature or on cold packs, as specified, before submitting to our laboratory, unless instructed otherwise by the specimen requirement information or by the laboratory. Never freeze whole blood unless it is specifically instructed in the specimen requirement instructions.

If you store cold packs in the freezer, be sure to allow sufficient time for them to warm to refrigerator temperature before placing whole blood specimens near them. To minimize the risk of hemolysis, do not place whole blood specimens in direct contact with cold packs.

Serum

For most analyses performed on serum other than therapeutic drug monitoring, we recommend the use of plastic Serum Separator Tubes (SST®s) or plain red-top tubes. Please check individual specimen requirements for restrictions. SSTs should not be used to collect specimens for drug testing. (See Therapeutic Drug Monitoring or Toxicological Analysis in this section.)

1. Perform venipuncture.

2. Collect a volume of blood that is 2-2 ½ times the volume of serum needed for the test in an appropriate collection tube. Fill the tube with the maximum volume specified on the tube, since partial filling will result in higher serum concentration of tube additives, which are known to alter the results of some tests.

3. Immediately mix by inverting the tube gently no less than eight (8) times and no more than ten (10) times. Less than five inversions will result in incomplete clotting and incomplete separation of red cells from serum. Hemolysis of even a small number of red cells remaining above the gel in contact with serum will spuriously elevate results of tests, such as serum potassium.

4. Do not remove the stopper at any time. Do not centrifuge immediately after drawing blood. Allow the blood to clot with the tube in an upright position at room temperature for at least 30 minutes, but no longer than 2 hours before centrifugation.

5. Centrifuge for at least 15 minutes at 1250 to 1600 RCF (relative centrifuge force) within 2 hours of collection. Centrifuges supplied by us produce between 1450 (fixed-angle rotor) and 1600 RCF (horizontal rotor) when operating within the instrument manufacturer’s specifications. This equates to 3200 and 3380 +/- 50 RPM (revolutions per minute), respectively. If using other centrifuges, determine RCF by referring to the following formula:

6. Transfer the clear serum to a properly labeled plastic screw-cap vial. Attach the label from the lower portion of the test requisition, if applicable.

7. Write “SERUM”: on the plastic screw-cap vial label and on the test requisition.

Common Causes of Unacceptable Blood Specimens and Inaccurate Test Results

Hemolysis

Hemolysis occurs when the membrane surrounding red blood cells is disrupted and hemoglobin and other intracellular components escape into the serum or plasma. Hemolyzed serum or plasma varies in color from faint pink to bright red, rather than the normal straw color. Grossly or moderately hemolyzed specimens may necessitate a new sample for some tests. Even slight hemolysis that may not be obvious upon visual examination of the serum, or plasma, may significantly alter certain test results (e.g. serum potassium, serum LD).

Hyperbilirubinemia

Icteric serum or plasma varies in color from dark to bright yellow, rather than the normal straw color. Icterus may affect certain test results and might necessitate a new sample to assure results of diagnostic value.

Turbidity (Lipemia)

Eating prior to blood collection produces a transient presence of fatty substances (lipids) in the blood resulting in turbid, cloudy or milky serum. Moderately or grossly lipemic specimens may alter certain test results.

Quantity Not Sufficient (QNS)

Samples that are Quantity Not Sufficient (QNS) do not meet the minimum volume requirement to perform the test or group of tests ordered and will be cancelled as QNS. Samples noted as QNS will be required to be recollected and resubmitted.