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| Phone: | (800) 444-9111 |
| Fax: | (512) 225-1261 |
| Hours of Operation: | Monday - Friday 8:30 a.m. - 6:00 p.m. CST Saturday 8:00 a.m. - 5:00 p.m. CST |
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Specimen Collection Guidelines
The quality of laboratory testing is dependent on many variables, with one being the quality of the specimen submitted. The specimens should be properly collected, labeled, packaged and transported to the laboratory in a timely manner. These steps, when correctly followed, will maintain sample integrity and are prerequisites for accurate testing.
Specimen Collection Preparation
Prior to collecting a patient specimen, review the specimen requirements listed in the test menu section of our website, listed under Products and Services. Note the proper specimen type to be collected, amount of sample necessary for testing, tube type, and special storage and/or shipping instructions.
The use of plastic transport tubes or Esoterix supplied tubes is preferred. A complete listing of collection tubes is given below. Glass tubes are not acceptable for frozen specimens as they may shatter when frozen. Tube tops must be sufficiently secured to prevent leaking during transport. The specimen container should be properly identified with the patient's full name, date, time of collection and specimen type.
A properly completed test requisition form must accompany each specimen. It is important that the patient's sex, age and/or birth date be indicated so that age-adjusted normal values can be provided. It is also important that the test requisition clearly indicates the client name and account number.
CLIA regulations require that we receive a physician or designee's signature when additional tests are ordered, or if test requests are changed after receipt of the original request form.
Place all specimens for a single patient in an individual specimen bag containing absorbent material. Temperature specific specimen bags are available from Esoterix designating ambient, refrigerated or frozen temperatures.
Fold and insert the requisition in the side sleeve of the specimen bag so that the Esoterix Logo and top portion of the requisition are displayed.
If a test requires multiple specimens at different temperatures, a copy of the requisition with each specimen is preferred. Please denote "Split Specimen" or "Duplicate Requisition" on each copy of the requisition. Include copies of packing slips or shipping manifests along with specimens.
Specimen Collection Tubes
Green-Top Tube (Sodium Heparin)
Tube contains Sodium Heparin as an anticoagulant. This tube is used for preparing heparinized plasma, whole blood and bone marrow specimens.
Note: Tube should be inverted several times immediately after blood collection in order to prevent blood coagulation
Lavender-Top Tube (EDTA)
Tube contains EDTA as an anticoagulant. This tube is used for preparing EDTA plasma, whole blood and bone marrow specimens.
Note: Tube should be inverted several times immediately after blood collection in order to prevent blood coagulation.
Light Blue-Top Tube (Sodium Citrate)
Tube contains sodium citrate as an anticoagulant. This tube is used for preparing citrated plasma for coagulation studies.
Note:Tube should be inverted several times immediately after blood collection in order to prevent blood coagulation. It is also important to completely fill the tube with blood since the ratio of anticoagulant to blood is critical for certain coagulation studies.
Red-Top Tube
Tube does not contain an anticoagulant. This tube is used for collecting serum or clotted whole blood specimens.
Tiger-Top Tube (Serum Separator)
Tube does not contain an anticoagulant, but does contain a clot activator and serum separator gel. This tube is used for collecting serum.
Yellow-Top Tube (ACD)
Tube contains acid citrate dextrose as an anticoagulant. This tube is used for the collection of whole blood for special studies.
Royal Blue-Top Tube
There are two types of tubes; one contains the anticoagulant EDTA and the other does not contain an anticoagulant. These tubes are used for preparing whole blood or serum for trace element studies.
Special Collection Instructions
Coagulation Services:
Coagulation Special Collection Procedures (126 KB)
Endocrinology Services:
Specimen Storage
Each specimen should be stored at the required temperature and condition. Improper storage of the specimen will affect the integrity and may cause erroneous analysis.
Specimen storage ranges are as follows:
| Ambient (room temperature) |
+18 - 26ºC |
| Refrigerated (cool pack) |
+2 - 8ºC |
| Frozen (dry ice) |
-20ºC or colder |
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Specimen Transport
Shipper's Responsibility
Federal regulations require that specimens be properly prepared and packaged before they are shipped. Esoterix provides specimen shippers that should only be used for shipping specimens to Esoterix. These specimen shippers meet overnight carrier and postal regulations.
The International Civil Aviation Organization (ICAO) and International Air Transport Association (IATA) have established guidelines that must be followed by the shipper and air carriers when packaging and transporting patient clinical specimens by air. Please visit the IATA website for additional documentation regarding the latest IATA shipping regulations at: www.iata.org
Please note that your test referral department is considered the 'shipper' when packaging clinical specimens sent to outside reference laboratories, and this department's staff must understand and follow the established regulations set forth by the above mentioned associations. Specimens not properly packaged are likely to be delayed and/or returned to your office by the overnight or commercial air carrier. Esoterix will not be held responsible for any liability attributable to the shipper's improper actions for failure to comply with shipping regulations.
- Shipper must comply with any applicable regulations set forth by the countries of origin and destination. Violation of these regulations may be in breach of national laws and can be subject to civil or criminal penalties.
- Shipper must properly identify, classify, package, mark, label, and document contents of the shipment in accordance with the laws and regulations of the countries of origin, transit, and destination.
- Shipper must notify Esoterix of the shipping details for tracking purposes. Shipment details including tracking number and carrier should be called into 800-444-9111, option 3, or faxed to 512-225-1261.
- Shipper must provide such information to his employees as will enable them to carry out their responsibilities with regard to the transport law and regulations pertaining to the items being shipped.
- Shipper's personnel involved in the preparation of the packages for the transport of clinical specimens must have received training to enable them to carry out their responsibilities. Personnel sending Biological Substances Category B specimens must know about the requirements to send Biological Substances Category B specimens. Personnel who send Category A Infectious Substances must be trained in the shipment of Category A Infectious Substance specimens. Records of this training must be maintained and individuals recertified every 3 years.
Definitions of Category A Infectious Substance, Biological Substance Category B, and Exempt Human Specimen.
Infectious substances are substances which are known to contain, or are reasonably expected to contain, pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals. Patient specimens are those collected directly from humans, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.
While the vast majority of work performed by Esoterix will be Exempt Human Specimen, please review the following classifications to determine which category your shipment falls under. Category A and B specimens may require additional shipping labels and special shipping procedures.
- Category A Infectious Substances are infectious substances in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. Human Category Infectious Substances must be assigned to identification number UN2814. Assignment to UN2814 must be based on the known medical history or symptoms of the source patient, endemic local conditions, or professional judgment concerning the individual circumstances of the source human.
- Biological Substances Category B are infectious substances that are not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Biological Substances Category B specimens transported for diagnostics or investigational purposes. Human Biological Substances Category B specimen must be assigned to identification number UN3373.
- Exempt Human Specimen are those that have a minimal likelihood of containing infectious pathogens. The proper classification for the vast majority of work performed by Esoterix will be Exempt Human Specimen.
Clinical Specimens
Shippers of patient clinical specimens are required to include the following when packing specimens for transport:
- A leak proof primary receptacle (specimen tube).
- A leak proof secondary packaging (specimen bag - properly sealed) with biohazard labeling.
- Either the primary or secondary package must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95kPa.
- Absorbent material (desiccant) placed between the primary receptacle and the secondary packaging.
- Sturdy outside packaging constructed of corrugated fiberboard (cardboard), wood, metal, or plastic. The exterior package must be capable of passing a drop test of at least 1.2 meters.
Esoterix's primary receptacles and specimen shippers meet the requirements listed above.
Exempt Human Specimen Packaging Instructions
- Primary receptacles shall be packaged in secondary packaging in such a way that, under normal conditions, they cannot be punctured or leak their contents into the secondary packaging. Secondary packaging shall be secured in outer packaging with suitable cushioning material.
- If multiple, fragile primary receptacles are placed in a single secondary packaging; they shall either be individually wrapped or separated to prevent contact between them.
- Absorbent material shall be placed between the primary receptacle(s) and the secondary packaging in sufficient quantity to absorb the entire contents of the primary receptacle(s).
- Separate specimens by temperature type (ambient, refrigerated, or frozen) and place in the appropriate specimen shipper. Frozen Specimens must be shipped using dry ice with dry ice placed outside the secondary packaging. The outer packaging must permit the release of carbon dioxide gas to prevent the buildup and rupture of the packaging.
- Include a packing slip or shipping manifest in each specimen shipper.
- Seal the specimen shipper with packing tape.
- Complete the air waybill including the senders and recipient's complete names, addresses, and phone numbers.
- The specimen shipper should be marked Exempt Human Specimen. The specimen shippers Esoterix provides are pre-labeled with this classification. A DRY ICE label must be affixed to the outside of the shipping container when shipping with dry ice.
When packaging specimens that must remain frozen, a minimum of 5 lbs. (2.5 Kg) dry ice should be included.
Biological Substances Category B Packaging Instructions
The packaging instructions for Exempt Human Specimen can be applied with the exception of the box markings applicable to the specimen classification. For Biological Substances Category B specimen the proper classification will be Biological Substances Category B and must be accompanied by UN3373 label.
If you are using an Esoterix provided specimen shipper for Biological Substances Category B specimen you must place a label with Biological Substances Category B along with a diamond shaped box with UN3373 over all areas where Exempt Human Specimen appears. Esoterix will supply you with this label.
Infectious Substances Category A Packaging Instructions
The proper shipping classification for Category A Infectious Substances will be Category A Infectious Substances and must be accompanied by a UN2814 label for humans.
As the shipper you are responsible for reviewing specimens to determine if they are considered infectious before submitting to Esoterix or handing them to an Esoterix courier. You must determine whether a specimen is infectious based upon your knowledge of the specimen being submitted.
Esoterix will supply you with the appropriate materials and labels to ship Category A specimens via Federal Express. You should contact Esoterix Client Services (800-444-9111) to request packaging for the shipment of these types of specimens. Instructions for the use of these supplies will be included. All individuals shipping Category A specimens must be trained according to regulations set forth by IATA.
Ambient Specimen Preparation and Shipping Procedure
Refrigerated Specimen Preparation and Shipping Procedure
Frozen Specimen Preparation and Shipping Procedure
Packing Slip or Shipping Manifest
The following information should be included on all packing slips or manifests:
- Name and Address of shipper
- Temperature of the specimen
- Name of receiving lab, Esoterix
- Number of bags within the specimen shipper
FedEx Airbills
It is critical that specimens sent to Esoterix via FedEx on Friday be marked for "SATURDAY Delivery". Specimens shipped Friday and not marked for Saturday delivery will be held by FedEx for delivery until Monday thus putting the specimen's viability at risk. |