Sample Handling and Shipping
1. Notes on sample collection
Many factors can occur before the collection of samples that may influence the results of laboratory tests, for example: eating, physical exercise, stress, coffee, smoking, alcohol and medicines (including natural products, vitamins and nutritional supplements). Correct preparation of patients for blood sampling is a vital factor that can have a significant impact on the quality of samples and test results derived from them. It is generally recommended that smoking, eating or drinking (excluding water) is avoided for a minimum of 12 hours prior to arrival at the laboratory. Consuming alcohol or undertaking vigorous physical exercise should be avoided at a minimum of 24 hours before sample collection.
For the Service, standard clinical human venous fasting or non-fasting serum, or EDTA, citrate and heparin plasma samples are all acceptable. Nightingale recommends following for example the WHO guidelines on drawing blood (best practices in phlebotomy on applicable parts).
Nightingale’s Service is compatible with all standard clinical blood samples collections. It is recommended that the time blood and serum/plasma are stored at the room temperature is kept to a bare minimum. The separated serum/plasma Samples should be cooled down to +4°C as soon as possible. The Customer is advised to follow the blood collection tube manufacturer’s instructions for serum/plasma separation.
2. Sample storage requirements
The Samples should be delivered to Nightingale within three days of sample collection, as advised by standard practice in clinical chemistry. If the Samples are not delivered within this timescale, the serum/plasma must be frozen at -20°C and, whenever possible, further to -80°C or colder. This should occur as soon as possible and preferably on the day of collection. Long-term storage (>1 month) of the Samples must always be at -80°C or colder (e.g. using liquid nitrogen).
3. Number of Samples and Sample volume
The number of Samples analysed and the minimum biofluid volume per Sample are defined on a per project basis.
4. Sample container
Several types of vials and containers are accepted. The outer diameter of a vial must be less than 12.5 mm. Screw cap microtubes (0.5 ml, e.g., Sarstedt 72.730.005; or 2 ml, e.g., Sarstedt 72.694.006) would be the most convenient ones. Also, deep 96-well plates (e.g., Nunc U96 DeepWell PP Plate 1.3 ml Well, Nunc 260251) or 96-well format sample storage tubes with screw caps (e.g., FluidX 1.0 ml 66-32034-Z6-L) from several commercial suppliers may be used. All the sample containers within a shipment must be similar. If the Customer sends the Samples on 96-well plates or 96-well format storage tubes, locations A1 and H12 should be left open as Nightingale will use those for quality control samples. In case of any uncertainty of suitability, the Customer is advised to verify suitability from Nightingale.
5. Sample identification
Each Sample must be clearly marked with a unique identification code using a barcode or a matrix code. The Samples must also be packed in an orderly fashion. The identification code is used to identify the results of each Sample. If a barcode or matrix code is not available, the Customer should consult Nightingale for further instructions.
The Sample identification codes must be sent in a table format at the same time as the Samples; one printed list should be sent together with the Samples and the list should also be sent to Nightingale in an editable electronic format. In the table, a unique code for each Sample must be given together with the information referring to the placement of the Sample in the package. Codes and Samples must be exactly in the same order. If the identification code on the Sample (barcode or matrix code) is different than the Sample’s identification code in the list, Nightingale will use the barcode or matrix code for identification.
6. Shipping conditions
When shipping Samples that are not frozen (i.e. samples at fridge temperature), the Samples must be kept at +4°C during the shipment. This is achieved using an insulated transportation box (e.g. a Styrofoam box) and gel or ice packs. Dedicated cold packages provided by specialist couriers may also be used.
When shipping frozen Samples, it is crucial that the Samples are kept frozen before the shipping and also during the entire period of transportation. To ensure this, a sufficient amount of dry ice must be placed into the shipping packaging. Shipping should include temperature monitoring and dry ice replenishing service.
The Customer should confirm the Sample shipment schedule in writing with Nightingale before sending the shipment to ensure appropriate shipping conditions for the Samples. The Samples should never be sent prior to a bank holiday. On all occasions, the Customer is required to gain clearance from Nightingale before shipping.
The Customer should send a tracking code to Nightingale as soon as the Samples have been shipped.
7. Packing instructions
The Customer should follow the United Nations Recommendations on the Transport of Dangerous Goods Division 6.2 – Infectious substances (United Nations Packing Instruction 650, PI650). Full instructions can be found for example in WHO Guidance on regulations for the Transport of Infectious Substances http://www.who.int/ihr/publications/guidance_infectious_substances/en/.
The main points of the instructions are: The packaging must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport, including trans-shipment between transport units and between transport units and warehouses as well as any removal from a pallet or overpack for subsequent manual or mechanical handling.
The packaging must consist of three components:
1) Primary receptacle(s) (the tube, vial or other container typically made of glass or rigid plastic, including the stopper, cap or other closure elements, that is in direct contact with the specimen).
2) Leak-proof secondary packaging.
3) Rigid outer packaging.
Absorbent material must be placed between the primary receptacle and the secondary packaging. One external surface of the outer packaging clearly must show the text “BIOLOGICAL SUBSTANCE, CATEGORY B.” Adjacent to this, inside a diamond mark, must appear the text “UN 3373”.
If shipping frozen samples with dry ice, the outer packaging must be marked with the text “Dry Ice” or “Carbon dioxide, solid” and “UN 1845” and the net quantity, in kilograms, of dry ice. These markings must be accompanied by the Class 9 label for Miscellaneous Dangerous Goods.
8. Mailing address and contact information
Nightingale will provide the project specific shipping address and contact information to the The Customer after an order has been placed. The sales representative is the main point of contact throughout the entire project, and the Customer is advised to contact this representative with any possible questions and feedback.
9. Return or disposal of Remaining Sample Material
The Samples are prepared for analysis at ambient temperature. Preparation steps include mixing the Sample material gently, spinning down the serum/plasma (3200xg, 3 min, +4°C), and transferring the Sample material to measurement tubes with an automatic liquid handler. Frozen Sample material will be thawed overnight at +4°C before the Samples are prepared for analysis. For clinical Samples, all delivered Sample material that is not used for the Service, is disposed of according to Nightingale’s laboratory procedures for biomedical waste disposal. For research Samples, the potential remaining aliquot after the Sample preparation is returned to -80°C (“Remaining Sample Material”). Remaining Sample Material will be either disposed of (Option A) or returned (Option B). The Customer is required to inform Nightingale with written instructions, as to whether Nightingale should return or dispose of the Remaining Sample Material.
OPTION A: Disposal of the Remaining Sample Material
If the Customer chooses option A, Nightingale will dispose of the Remaining Sample Material according to its laboratory procedures after the performance of the NMR measurements of the Samples. By selecting this option the Customer fully understands and agrees to this procedure permanently destroying the Remaining Sample Material. In this option Nightingale also disposes of all the shipping boxes received during the Sample material delivery.
OPTION B: Return of the Remaining Sample Material
Shipping of the Remaining Sample Material should be performed by a courier chosen by Nightingale. The Customer is fully responsible for all costs related to shipping, handling and packaging the Remaining Sample Material.
There are two options for organising the shipment:
- The Customer takes care of all communication and shipping practicalities with the courier instructed by Nightingale. The Customer shall confirm the pick-up date with Nightingale before the shipping.
- If requested in writing by the Customer, Nightingale organizes the shipping. Nightingale enquires a price estimate from the courier which is forwarded to the Customer for acceptance. The actual costs may differ from the given estimate.
In case the Customer accepts the price estimate, Nightingale enquires a shipping address and contact person from the Customer. Nightingale and the Customer agree the shipping dates via email. Nightingale will confirm the Sample shipment schedule in a written form with the Customer before agreeing the shipment dates with the courier to ensure appropriate shipping conditions for the Samples. It is the Customer’s responsibility to ensure that no local bank holiday or similar will delay the delivery.
After receiving the Customers confirmation, Nightingale requests the courier to prepare the shipping and to ship the Remaining Sample material to the Customer according to the agreed dates.
After the Remaining Sample Material is delivered to the Customer, Nightingale invoices the actual shipping costs and its service fee for arranging the shipment practicalities.