Expert consensus on standardization of clinical laboratory specimen transportation and storage

The transportation and preservation of test samples is an important stage in the whole process of testing

management. Due to its complex process, many influencing factors and difficult to standardize operation,

it is also a difficulty and pain point in laboratory management.

In order to standardize the transportation and preservation of clinical test samples, meet the requirements of sample quality control and laboratory

, and ensure the accuracy of test results, this expert consensus is formulated. The consensus elaborates on

the specific requirements of transport personnel qualifications and training, sample packaging and time

limit, sample handover and acceptance, automated logistics system, emergency response in case of

accidents, sample preservation and application, and tracks and monitors the entire transportation process

to further improve management quality and efficiency.

The transportation and preservation of test samples is an important link that affects the quality and

efficiency of inspections, an important stage in the whole process of sample management, and an

important link in the whole process of quality control.

At present, sample collection and sample testing departments are distributed in different areas. Some projects also need to be transported to third-party

laboratories or other hospital areas for testing. The collected samples need to be transported to the

corresponding testing departments manually or through the logistics system. Transfer personnel should

receive relevant biosafety knowledge training and take corresponding protective measures during the

escort process. The automated logistics system used is evaluated for results impact, biosafety, quality risk,

and operating efficiency.

The laboratory should pre-treat the samples in time and store the samples after testing according to the specifications to ensure the validity of the results.

In order to standardize the transportation and storage management of test samples, avoid sample

deterioration or failure caused by objective or subjective factors during transportation, which leads to

inaccurate test results, and avoid biological hazards and sample loss caused by sample leakage, the

Laboratory Medicine Professional Committee of the Chinese Association of Integrated Traditional Chinese

and Western Medicine organized experts to refer to relevant domestic and foreign literature and combine

clinical applications to compile this consensus to improve the management level of transportation and

storage before testing and ensure the quality and efficiency of testing.

1.Sample classification and transportation regulations

The types of clinical test samples include blood, urine, feces, cerebrospinal fluid, serous cavity effusion,

nasal/pharyngeal swabs, pathological tissues, etc.

Among them, blood samples are the most common, accounting for about 80%. According to the urgency of the test items, they can be divided into green

channel, emergency, and ordinary clinics. According to the hospital area of ​​transfer, it can be divided into

intra-hospital transfer and out-of-hospital transfer, and out-of-hospital transfer is divided into inter-

hospital transfer and entrusted sample transfer. When transporting outside the hospital, especially when

transferring across cities and provinces, if the sample is confirmed or suspected to be a highly

pathogenic pathogenic microorganism, bacteria (virus) or sample, its transportation should be handled in

accordance with the “Regulations on the Management of Transportation of Highly Pathogenic

Microorganisms, Bacteria (Virus) or Samples that Can Infect Humans”. The entry and exit management of

special items such as microorganisms, human tissues, biological products, blood and its products shall be

implemented in accordance with the “Regulations on the Management of Sanitary Quarantine of Special

Articles Entering and Leaving the Country” issued by the General Administration of Quality Supervision,

Inspection and Quarantine No. 160, which is divided into three processes: quarantine approval,

quarantine inspection, and subsequent supervision.

2.Qualification and training of transport personnel

In order to ensure that the transportation process does not affect the test results, timely delivery to the

laboratory, ensure safety during transportation and have the ability to initiate emergency treatment

measures in the event of an accident, the personnel responsible for transportation should be relatively

fixed and trained regularly. The training content includes but is not limited to the sources of various test

samples, the transportation direction of samples, the requirements for sample transportation for different

test purposes, the judgment of whether the sample collection is qualified or not, the biohazard of the

samples sent for inspection and its protection, the regulations on the transportation of biohazardous

items, the temperature control requirements of different samples, the emergency disposal and

notification procedures in the event of an accident or leakage, etc. Since the method and time of sample

transportation are affected by various factors, the test results may be erroneous. Transport personnel

must receive relevant professional training, master the methods of preservation and transportation, and

pass the corresponding assessment before they can take up their posts. They must receive regular

training every year.

Recommendation 1 Laboratory and sample transport personnel should be familiar with the types and

quantities of samples, the types and methods of transportation in the hospital, and comply with the

relevant laws and regulations on sample transfer and preservation.

Recommendation 2 Transport personnel should be relatively stable and receive regular training and

assessment on sample transportation knowledge.

III. Packaging and time limit requirements for transported samples

When clinical test samples are transported within the hospital, they should be packaged in sample bags

with biohazard labels to prevent the leakage of samples from contaminating other samples and transpor

t boxes. Non-blood specimens should be packaged separately in sample bags. The sample bag is affixed

with a barcode label indicating the packer, packing time, sample quantity, etc. The sample bag is placed in

a dedicated sample transport box. When transporting highly pathogenic microorganisms, bacteria

(viruses) or samples that can infect humans outside the hospital, the transport packaging is divided into

two categories, A and B, according to the “List of Pathogenic Microorganisms Transmitted in Humans”,

corresponding to the United Nations numbers UN2814 and UN3373 respectively, and implemented in

accordance with the “Regulations on the Transportation Management of Highly Pathogenic

Microorganisms, Bacteria (Viruses) or Samples that Can Infect Humans” .

It is advisable to use a dedicated transport box to transport samples and keep the temperature stable.

Appropriate fixtures or buffers should be placed in the transport box to reduce mechanical damage

during transportation, or to buffer the impact of vibration and pressure changes (such as traffic accidents

during transportation). The laboratory should formulate documents to specify the specifications of the

sample transport box, internal storage, anti-spill measures, external identification, contact persons, etc.

According to different transportation distances and environmental conditions, appropriate sample

transport boxes should be selected. The sample location and storage temperature during transportation

should be monitored and recorded [6], and vibration and pressure changes during transportation should

be monitored.

The test results of some test items will become unstable as the sample is placed for a longer time.

Therefore, the sample should be sent to the laboratory for testing in time after collection. Separating

serum or plasma as soon as possible is conducive to accurate and reliable test results. Different test items

have different requirements for pretreatment methods and stabilization time. The sample transportation

time limit requirements for common test items are shown in Table 1. If the transportation is carried out

over a long distance such as across hospital campuses, the collector is generally required to perform

pretreatment, such as separating serum or plasma, using special containers, etc. The transportation

principle is that the shorter the transportation time and the more suitable the temperature during

transportation, the better the quality upon arrival.

IV. Handover and acceptance of transported samples

Before transporting the sample, the collector should check the doctor’s order, check the sample quality,

and check the sample quantity again before handing it over to the transporter. The handover content

includes: delivery time, delivery temperature, sample quantity, sample integrity, etc. The handover site

should meet biosafety requirements. If the sample cannot be sent for inspection in time, the sample

should be temporarily stored in a suitable environment and storage conditions.

During manual transportation, transport should be carried out in a transfer box that meets biosafety

requirements. It is advisable to monitor the environment of the transportation process, such as

temperature, time, path, location, etc. in real time. To ensure transportation safety, the hospital

implements dedicated transportation management, closed container transportation, fixed walking routes,

handover registration, record handover time and personnel, and have emergency measures to prevent

. Keep the test tube upright during transportation, reduce shaking and vibration, prevent spillage and

contamination, and pay attention to biosafety. If there is a paper inspection application form, it should be

delivered at the same time as the sample, and the application form should be avoided from being contaminated.

Samples across hospital areas involve many people and handover points, which are prone to problems

such as extended sample transportation time and sample container damage. In addition to the key node

handover of samples within the hospital, the handover person and handover date and time should be

recorded when sending out/delivering. The laboratory should clarify the transportation time, number of

times, full-time personnel, transportation tools (such as special vehicles, electric vehicles), etc. The

transporter must confirm whether the number of samples is consistent with the inspection list, there is no

sample leakage, and it is safely delivered to the destination in a sealed container. The transportation

process must meet biosafety requirements and regularly disinfect and clean the container. Pay attention

to the sealing of the container and avoid light. When the ambient temperature rises or drops abnormally,

attention should be paid to keeping the temperature in the transfer box within the appropriate range,

such as adding ice cubes and other insulation measures in the transfer box. The transfer box can be

intelligently monitored, including location positioning and temperature monitoring. If an abnormality

occurs, the abnormal situation will be sent to the designated person. When a third-party inspection

agency transfers across cities, a management system should be established to ensure the integrity and

safety of the transportation equipment, including transportation methods, temperature control

equipment, human resources, sample containers, protective tools, etc. When necessary, drones can be

used to transport samples.

The laboratory can clarify the acceptance and rejection standards for various types of samples based on

information such as methodology. After the specimen is delivered to the laboratory, it should be checked

and accepted in time, and the receipt should be confirmed after verification. The acceptance content

includes: complete application information, correct sample type, sample quantity compliance, timely

delivery, etc. Record all received samples, including the recipient and the date and time of receipt. When

unqualified specimens are found during acceptance, they should be recorded and handled according to

the unqualified specimen management process.