Specimen Handling - General Requirements

GENERAL GUIDELINES

Generally, the specimen requirements are written in a format that specifies the requested volume, storage temperature, and any special handling notes. The requested volume is an amount sufficient to allow at least two performances of the assay either singly or in duplicate. The minimum volume allows one single analysis including instrument dead volume. Storage temperature is specified as room temperature (15 - 30˚C), refrigerated (2 to 10˚C) or frozen (-20˚C or colder). When temperature is not indicated, the sample may be stored and shipped in the most convenient manner for the client.



For panels or multiple assay requests, the sample should be submitted with the physician’s priority of determination on the Test Request Form. Tests will be performed in the order of that priority. If the volume is insufficient to run all the tests requested, our Client Services department will contact the physician.

INTRODUCTION

The quality of any laboratory test result is dependent on many variables, the first of which begins with you. Your care, skill, and knowledge when preparing the patient and specimen are essential to the provision of the highest quality standards for testing and services. The patient must first be properly prepared so that the best possible specimen can be collected. Next, the actual collection of the specimen must be completed. Then, the specimen should be properly processed, packaged and transported to the laboratory in a timely manner and under environmental conditions that will not compromise the integrity of the specimen. After all of these activities take place, a quality analysis can be performed. The specimen collection and handling process can be completed by you and your staff, or by referring your patient to a Quest Diagnostics Patient Service Center. Please contact the laboratory for clarifications, if needed, prior to specimen collection.

Specific specimen requirements for each test are listed in the General Test Listing section of this directory. Specimen requirements include information such as specimen volume, collection and transport containers as well as transport temperature. If additional information is needed for the interpretation of the test results or there are specific instructions for patient preparation, they are listed along with specimen requirements. It is critical that an adequate specimen volume is submitted for analysis. The volume requested in this directory is enough for initial analysis as well as for any confirmatory tests that must be performed. If an inadequate specimen is submitted, we may not be able to perform the initial test or required confirmatory procedures.

If repeat or confirmatory tests cannot be performed, the report will indicate that the specimen quantity submitted was “QNS” (Quantity Not Sufficient) for additional testing. When serum or plasma is to be submitted for analysis, it is good practice to collect a volume of blood that is 2 to 2.5 times the volume of serum or plasma needed for the test. As an example, if 4 mL of serum or plasma is needed for a test, collect 8 to 10 mL of blood. When an inappropriate specimen or unclear test request has been submitted, you will receive notification with instructions for resolving the problem.

HEALTH AND SAFETY PRECAUTIONS

Specimens must be handled in a safe manner and according to applicable legal requirements or guidance. Information on safe specimen handling may be obtained from the U.S. Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC). In handling human specimens, the goal is to protect health care workers and ancillary staff such as transportation as well as the general public from exposures to blood and to other potentially infectious body fluids. Besides following other specimen preparation procedures included in this directory, customers should, prior to sending a specimen to Quest Diagnostics, ensure that there is no leakage from or visible contamination outside the specimen container and that there are no needles or other sharps in the package that could cause injury or pathogenic exposure to anyone handling or opening the package and inner containers. Quest Diagnostics reserves the right to refuse to accept any transports that pose a safety hazard to its employees.

PATIENT PREPARATION

Many tests require that the patient be prepared in some specific way to ensure useful results. The best analytical techniques provide results that are only as meaningful as the quality of the specimen that has been submitted for analysis. Our goal is to provide you with the most useful diagnostic information possible. If you have questions about patient preparation for any test, please consult the General Test Listing section in this directory or call Client Services for further assistance.

Fasting requirements

For the majority of tests performed on serum, plasma or whole blood, a fasting specimen is preferred. Non-fasting specimens often contain fat particles that can interfere with many analytical procedures.

Patient age

It is helpful to indicate patient age and blood type so that appropriate reference ranges can be assigned for reporting purposes. On occasion, patient age will assist the technologists in choosing the appropriate initial sample dilution for the assay.

Pediatric Specimens

Pediatric color-coded Vacutainer® tubes are provided to facilitate special handling. Special small conical tubes with screw caps are provided to prevent evaporation of small volume samples. These tubes will hold up to 1.5 mL of specimen. Standard Quest Diagnostics, Nichols Institute (SJC), CA specimen transfer tubes should be used for larger volume samples. For urine specimens, use Quest Diagnostics, Nichols Institute (SJC), CA urine vials.

We generally request 1 tube per test to avoid delays in processing and to expedite turnaround time. To minimize specimen volume requirements for small children, however, only one tube is required even when multiple tests are ordered.

For pediatric specimen tubes, wrap the label around the tube just below the screw cap so the ends of the label adhere to each other and the information stipulated above can be read.

Bright orange, self-adhesive “Pediatric Sample” labels are provided. Please place one of these labels in a blank area of the Test Request Form. The Test Request Form, properly filled out and labeled, should be folded and inserted in the pediatric specimen bag.

LABELING SPECIMENS

Each specimen submitted must have a requisition label. This label must include your account number, laboratory number and the patient’s name. Be sure that the label is securely attached. Use a ballpoint pen. Do not use a felt tip pen.

Each specimen submitted must be labeled with the patient’s name, written exactly as it appears on the test requisition (e.g., “Doe, John”), and date of collection. When using an electronically generated Quest Diagnostics test requisition, place the label lengthwise on the tube. When submitting a specimen in a transfer tube, also indicate specimen type on the label, e.g., serum, plasma, urine, etc. When ordering tests in a series (e.g., growth hormone stimulation, glucose tolerance, multiple-site renin specimens):

1. Use one Test Requisition
2. Label each specimen with the patient’s name, date and time 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

PACKAGING SPECIMENS

1. Ensure that all specimen container caps and lids are properly tightened to prevent leakage.
2. Complete the “Patient Information” and “Insurance Information” sections. Legibly print patient information and indicate with a check (in Field”#13 on the sample physician requisition) which party will be responsible for payment in the “Bill To” section of the requisition. Enter the ICD9 diagnosis codes (in Field #35) that reflect the patient’s diagnoses and provide medical justification for the tests ordered. Complete the billing information.
3. Indicate the patient’s full name on the labels in the lower portion of the test requisition.
4. Collect the specimen(s) in proper transport container. (Refer to the General Test Listing section for more information.)
5. Remove the label from the test requisition and affix to the specimen transport container. Place on the container so that the label does not cover the handwritten patient name on the container.
6. Fold the top copy (original) of the test requisition in half widthwise (top to bottom) with the patient’s name and bar code facing out. Retain the second copy for your files.
7. The specimen bag has two pouches. Place the specimen(s) in the rear pouch (printed side) and the test requisition in the front pouch (unprinted side) with the bar code visible in the bottom corner of the bag.
8. FROZEN specimens must be placed in a separate specimen bag along with a separate test requisition. Frozen specimens cannot be split for multiple tests. If more than one test is ordered on a single frozen sample, we will call you to decide which test you want performed before testing can proceed.
9. Remove the protective strip and seal the specimen bag. The protective strip must not obstruct the bar code. This will protect the test requisition from leakage and ensure that the patient information can be entered directly into the laboratory computer by laser reading the bar code.
10. If the specimen has already been classified as an “infectious substance,” inform Quest Diagnostics prior to or at time of courier pick-up so that proper transport arrangements can be made.
11. Any updates to these guidelines (or to the specimen transport supplies) will be communicated through your local Quest Diagnostics sales representative or courier.

STORING AND SECURITY OF SPECIMENS

Maintain specimens at room temperature or on cool packs, unless otherwise noted under the “Transport Temperature” or other specimen requirement in the General Test Listing section.

Quest Diagnostics will provide a “lock box” for specimens awaiting pick-up by a Quest Diagnostics courier. However, customers are responsible for the security of specimens prior to pick-up by a Quest Diagnostics courier.

TRANSPORTING SPECIMENS

Please follow the guidelines in the General Test Listing for placing specimens in the proper containers and preparing to submit them to Quest Diagnostics for testing. The following is applicable to transporting specimen packages to Quest Diagnostics, whether transported by a Quest Diagnostics courier or by a commercial carrier (e.g., UPS, commercial airlines). Please note that if you do not submit specimens through a Quest Diagnostics courier, the commercial transport of specimens (including by the Postal Service) is subject to various regulations or carrier requirements for documenting the contents of any package and for packaging and labeling. Anyone submitting specimens to Quest Diagnostics is responsible for compliance with these regulations or requirements. The outline of transportation requirements below should not be substituted for seeking expert or legal advice about regulatory compliance when applicable, especially when transporting what the U.S. Department of Transportation (DOT) considers “infectious substances” or other “hazardous material.” In some cases, employees must be trained on their knowledge of these regulations. Quest Diagnostics cannot be responsible for that training.

Needles, Sharps or Medical Waste

Do not send any needles or other breakable medical equipment. Sending medical waste as a diagnostic specimen violates the law and may create a health hazard. Properly discard of used needles or other sharps prior to transport. Please note for tests requiring the submission of syringes, the needle must be removed from the syringe and discarded and the syringe capped before sending to the laboratory.

Transportation Bag

Specimen containers should be placed in a transportation bag with the proper specimen labeling and the paperwork in the side pocket. In all cases, use of appropriate containers and packaging for specimens is important as leaking packages may pose a health hazard.

SHIPPING

1. Transported by Quest Diagnostics courier:
   • Place specimen containers in a Quest Diagnostics requisition bag.
   • Follow any other guidance provided by Quest Diagnostics for submitting specimens.
2. Transported by Commercial Carrier (e.g., FedEx, Commercial Airline) or Postal Service (the person packaging the specimens for shipment must be trained and certified):
   • Diagnostic Specimens:
     • package and document according to carrier’s instructions, including any requirements for dry ice or accompanying material, e.g., alcohol;
     • if by air carrier, follow any additional packaging and documentation requirements according to carrier’s instructions and/or those issued by the International Air Transport Association (IATA), including Packing Instruction 650;
     • if by U.S. Postal Service, package and document according to Postal Service instructions.
       
       
       
       Because some parts of the U.S. DOT regulations (49 CFR Parts 171-180) may apply depending upon whether it is transported by air or ground, and the carriers may account for the DOT rules in their instructions, check with your carrier or transportation expert about application of the DOT rules prior to submitting.
   • Infectious Substances (see note below – the person packaging the specimens for shipment must be trained and certified):
     • use infectious substance label, package and document according to carrier’s instructions, including any requirements for dry ice or accompanying material, e.g., alcohol;
     • if by air, follow any additional packaging and documentation requirements according to carrier’s instructions and/or those issued by the IATA, including Packing Instruction 602 (note that not all air carriers will accept infectious substances);
     • if by U.S. Postal Service, label, package and document according to Postal Service instructions (note that the Postal Service may not accept certain types of specimens).
       
       
       
       Packages originating outside of the United States must meet any applicable legal requirements of the country of origin and the U.S. Customs and/or CDC requirements for entry into the United States.

INFECTIOUS SUBSTANCE

Starting in 2003, both DOT and IATA changed their rules for classifying specimens for transport. Under the new rules, most specimens for clinical testing may be classified as diagnostic specimens; only certain specimens with a higher potential to transmit severe, disabling or fatal diseases must be declared and packaged as “infectious substances.” Those wishing to transport infectious substances should check with the DOT, CDC or public health authorities to determine the Risk Group of the specimen and, correspondingly, how the specimen should be packaged for transport.



For example a Risk Group 4 specimen will need to be packaged as a DOT or IATA “infectious substance.” In addition, some air carriers may not consider some specimens in other Risk Groups as suitable for air transport.

The proper packaging of specimens will expedite the timely receipt and processing by Quest Diagnostics. Quest Diagnostics and its affiliates will not be responsible for any liability attributable to the shipper’s improper actions or failure to comply with any applicable legal requirements. Quest Diagnostics reserves the right to refuse to accept any transports that do not meet legal requirements.

SUPPLIES

Certain supplies necessary to draw and submit specimens for analysis by Quest Diagnostics are provided to customers as part of our testing services. Type and quantity of items must correlate to the number of specimens submitted to Quest Diagnostics for testing. Specimen collection devices supplied by Quest Diagnostics are to be used only for the collection of specimens for processing by Quest Diagnostics. Such 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 Quest Diagnostics.