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WS/T 640-2018 English PDF

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WS/T 640-2018: Specimen collection and transport in clinical microbiology
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WS/T 640-2018	579	Add to Cart	5 days	Specimen collection and transport in clinical microbiology	Valid

Similar standards

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Basic data

Standard ID: WS/T 640-2018 (WS/T640-2018)
Description (Translated English): Specimen collection and transport in clinical microbiology
Sector / Industry: Health Industry Standard (Recommended)
Classification of Chinese Standard: C59
Word Count Estimation: 25,294
Date of Issue: 2018-12-11
Date of Implementation: 2019-06-01
Regulation (derived from): State-Health-Communication (2018) No.23
Issuing agency(ies): National Health Commission

WS/T 640-2018: Specimen collection and transport in clinical microbiology

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Specimen collection and transport in clinical microbiology ICS 11.020 C 50 WS People's Republic of China Health Industry Standard Collection and transfer of clinical microbiological test specimens Published on.2018 - 12 - 11 2019 - 06 - 01 implementation National Health and Wellness Committee of the People's Republic of China

Content

Foreword...II 1 Scope...1 2 Normative references...1 3 Terms and Definitions...1 4 General principles for specimen collection, transfer and handling... 2 5 Collection, transfer and processing of clinical common specimens...10 References...21

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Peking University People's Hospital, China-Japan Friendship Hospital, Anhui Provincial Hospital, Beijing Medical University affiliated to Capital Medical University Hospital, Beijing Hospital, Beijing Dangyangliu Hospital. The main drafters of this standard. Wang Hui, Liu Yingmei, Zhang Zheng, Ma Yuling, Su Jianrong, Hu Yunjian, Ning Yongzhong, Wang Xiaojuan. Collection and transfer of clinical microbiological test specimens

1 Scope

This standard specifies the technical requirements for the collection and transfer of clinical microbiology (virology, bacteriology and mycology) specimens. This standard applies to all levels of medical institutions and clinical microbiology laboratories for clinical microbiological testing.

2 Normative references

The following documents are indispensable for the use of this document. For dated references, only the dated version applies to this document. Pieces. For undated references, the latest edition (including all amendments) applies to this document. WS/T 348 Guide to the collection and handling of urine specimens WS/T 499 Lower Respiratory Tract Infection Bacterial Culture Operation Guide WS/T 442 Clinical Laboratory Biosafety Guide WS/T 503 Clinical Microbiology Laboratory Blood Culture Practices

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Microbiological Specimen Microbiological specimens in this document refer to clinical virological, bacteriological and mycological tests (including smear microscopy, culture, antigens, antibodies and fractions). Specimens used in sub-technologies, etc.). 3.2 Emergency check specimen STAT Specimens that require immediate treatment as the disease may endanger the patient's life. 3.3 Sampling swab Sampling swab The swab used to collect specimens containing pathogenic microorganisms consists of two parts. 1 Smudge stick. the handle is often made of plastic or aluminum rod, and the handle is one. The end is a sampling head with adsorption. The sampling head material includes cotton wool, synthetic polyester fiber, polyamide fiber, rayon and foam polyurethane. Ester, etc.; 2 Handle. Located at the other end of the handle, it can also be used as a cap for a transfer device (container or tube). 3.4 Transit Transport The process of transporting specimens from the sampling location to the inspection site is divided into internal transport (such as internal sample delivery using manual or pneumatic transmission) And external transport (such as using an external sample delivery method such as a car, airplane or train). 3.5 Transfer container A container for holding a transport medium and for inspecting a specimen. The container should be sterile, free of disinfectants and preservatives, non-polluting, and well sealed. Transparent for easy viewing from the outside. When the sampling device has a sealing function and can effectively protect the sample from contamination, it can be transported as a transport container. Send the specimen. 3.6 Transport medium A liquid or semi-solid medium used to protect and maintain specimens during transport (from the time the specimen is collected to the laboratory) Integrity. Transport media generally do not promote microbial proliferation, but they are guaranteed to survive. For the bacterium, it can be used for separation and culture. The medium is used as a transport medium (such as sheep blood agar or chocolate agar). 3.7 Set of blood culture Blood was drawn from a puncture site, and aerobic and anaerobic blood culture flasks were separately injected for aerobic and anaerobic culture, respectively. 4 General principles for specimen collection, transshipment and handling 4.1 Specimen Collection Manual The laboratory shall establish a manual for the collection of clinical microbiological examination specimens of the institution, and the information provided in the manual includes (but is not limited to) Column content. a) inspection items; b) inspection method; c) indications; d) the specimen collection site; e) specimen type; f) the device/container and transport medium required for specimen collection and transport; g) specimen collection method; h) the volume or quality of the specimen; i) transit time limits and storage conditions; j) the method of identification of the specimen; k) repeat the test frequency; l) biosafety protection information; m) Clinical data to be obtained. 4.2 Application for inspection 4.2.1 Sample Collection According to the application of the test item, the laboratory shall establish an application procedure for clinical microbiological examination. Inspection request form Information includes (but is not limited to) the following. a) the name of the patient; b) patient gender; c) the age of the patient or the date of birth; d) patient unique identifier, such as medical record number; e) visiting wards and wards; f) verify the name of the applicant; g) inspection of the applicant's department; h) type of specimen; i) specimen collection site; j) inspection items; k) the date and time of specimen collection; l) special methods used to collect specimens (where applicable); m) clinical diagnosis and main clinical manifestations; n) special culture requirements or suspected pathogens (where applicable); o) whether the patient is taking anti-microbial drugs and specific types; p) Telephone number of the patient and the test applicant (where applicable). 4.2.2 Selection of bacteriological and mycological test items. a) sterile body fluid specimens, tissue specimens, sputum specimens, Bronchoalveolar lavage fluid (BALF), Urine specimens and pus specimens should be selected for direct smear staining microscopy and culture; b) Cerebrospinal fluid specimens suspected of cryptococcal infection. it is advisable to select ink staining, cryptococcal capsular polysaccharide antigen test and cryptococcal culture; c) Specimens suspected of mycobacterial infection. acid-fast staining, mycobacterial culture and mycobacterial nucleic acid testing should be selected at the same time; d) Specimens suspected of anaerobic infections. Gram staining and anaerobic culture should be selected at the same time. When aerobic bacteria cannot be excluded, aerobic should be done at the same time. to cultivate; e) Specimens suspected of Nocardia infection. Gradient staining, weak acid-fast staining and culture should be selected at the same time; f) Specimens suspected of invasive fungal infections. 10% KOH tableting, fungal culture and fungal antigen testing should be selected at the same time. Another Lactic acid phenol cotton dye or fluorescent staining. 4.2.3 The specimen collection manual issued by the laboratory should give a clear description of the cultivation requirements of special bacteria to ensure that the medical personnel are on the collection target. This is clearly identified, and the special training requirements in the inspection application form include (but are not limited to) the following. a) prolong the culture time, for example. blood specimens suspected infections caused by Bartonella, Brucella, Francis, etc., respiratory markers This infection is caused by Noca bacteria, etc.; b) Select a dedicated medium. For example, a suspected mycobacterial infection in the blood should be selected for a dedicated mycobacterial culture flask; c) Special gas and temperature environmental requirements. For example. Neisseria meningitidis and Neisseria gonorrhoeae require CO2 environment, Campylobacter and secluded The Helicobacter pylori culture requires a micro-aerobic environment; suspected biphasic fungal infection should be selected at both 25 °C and 37 °C. to cultivate. d) Anaerobic culture should be performed for specific infections. For example. closed abscess such as liver abscess, peritonitis, abdominal infection and diabetic foot infection. The characteristic manifestations of anaerobic infection include. 1 local gas production is one of the important indications; 2 infection occurs near the mucosa; 3 deep trauma, such as gunshot wounds, secondary infections after a human or animal bite; 4 secretions have stench or dark red blood or under ultraviolet light Red fluorescence is emitted, or sulfur particles are present in the pus. 4.3 Selection of specimens 4.3.1 The laboratory specimen collection manual should describe in detail the type of specimen and clinical indications for the pathogen test of infectious diseases. The pathogen should be included. Includes, but is not limited to, viruses, bacteria, and fungi. 4.3.2 Selecting the type of specimen must consider the symptoms of infection, the immune status of the patient, the severity of the patient's disease, and the risk of receiving an invasive examination. Disease, suspicious pathogen characteristics and dissemination ability and affected organs and infection sites and other factors. 4.3.3 The types of specimens suitable for common bacteria and anaerobic bacteria test are shown in Tables 1 to 2. Table 1 Specimen types suitable/not suitable for common bacterial culture in specific anatomical parts Specimens suitable for general bacterial culture in anatomical parts are not suitable for specimens cultured in common bacteria Lower respiratory tract fistula, BALF, protective brush, intratracheal aspirate saliva, oropharyngeal secretion, nasopharynx sinus drainage Middle urinary tract urine, direct catheterization, suprapubic bladder puncture urine, cystoscopy or its Urine collected during surgery, urine in urine of infants and young children Urine, catheter tip in the catheter collection bag Superficial wound pus aspirate, subcutaneous pus swab surface swab or specimen contaminated with surface material Deep wound pus, necrotic tissue, or specimens from deep tissue contaminated with surface material Fresh faeces in the gastrointestinal tract, excretions collected during endoscopy, rectal swabs (in specific cases) Collecting 2 to 4 sets of blood samples from different venous puncture points before use of venous blood anti-microbial drugs Specimens of ulcers or acne tissue and aspirate contaminated by surface materials Table 2 Specimen types suitable or not suitable for anaerobic culture Specimens suitable for anaerobic culture are not suitable for anaerobic culture specimens Extract (with syringe), bronchoscope protective brush, BALF, endotracheal aspirate, tracheal incision secretion Sinus (extraction) Nasopharyngeal swabs, sinus irrigation or swabs cannot be used as a pathogenic diagnosis of sinusitis Urine (pubic urinary bladder urine) urine (exhausted or exported from the catheter) Posterior sacral puncture fluid, tubal fluid or tissue (suction/biopsy specimen), placenta Tissue (through caesarean section), intrauterine device (for actinomycetes), Vestibular gland secretion Perineal swab, cervical secretions, lochia, vaginal or vulvar secretions, forefront Glandular fluid or semen, urethral secretions Culture of C. difficile fecal specimen rectal swab Blood, bone marrow, surgery (intraoperative extraction or tissue) Eye specimen (stones such as lacrimal duct/conjunctiva, aqueous humor, anterior chamber fluid (puncture), glass Glass body lotion (intraoperative collection) 4.4 Collection timing, parts and methods of specimens 4.4.1 Collect specimens before or after the initial treatment, in order to assess the therapeutic effect or after treatment The phase of the evaluation can be sampled. 4.4.2 The first specimen should be collected as soon as possible at the onset of the disease. 4.4.3 Contamination of skin or mucosal colonization flora around the infected site and near the infected site should be avoided. 4.4.4 For sites with multiple bacterial colonizations, appropriate methods should be chosen to test specific pathogens and prevent non-pathogenic colonization. Pollution. 4.4.5 For the detection of respiratory viruses, flocked swabs should be used to collect nasopharyngeal specimens. 4.4.6 Ordinary swab specimens should not be used for anaerobic culture. 4.4.7 In addition to blood specimens, all other specimens should be Gram-stained prior to anaerobic culture (except for C. difficile culture). 4.4.8 Sterile body fluids (such as pleural effusion, synovial fluid, pericardial fluid and cerebrospinal fluid) should be placed in sterile tubes or contain anticoagulants (note some anticoagulants) For the inhibition of some bacteria, if used, you need to inform the clinical impact of the inspection of the sterile tube, you can also inject a certain amount (best 10 mL) of the sample is added to the blood culture bottle for enrichment culture; when the bacterial or fungal infection is suspected, all the sterility except the blood sample The liquid specimens should be subjected to Gram stain microscopy. 4.4.9 Surgical specimens should be sent to liquid or tissue for smear and culture. Swab specimens are for special cases only. 4.4.10 When collecting venous blood, blood culture specimens should be collected first, and specimens for other tests should be collected. 4.4.11 See the WS/T 503 for the timing of blood specimen collection, WS/T 499 for the timing of sputum collection, and WS/T 348 for the timing of urine specimen collection. 4.4.12 It is not advisable to send or receive the tip of the catheter for culture. 4.4.13 For fungal culture, deep specimens or tissue specimens should be collected. 4.4.14 When performing serological tests on viruses, it is advisable to select different collection times and antibody types according to different viruses; Toxic-specific IgM antibodies; for convalescent patients, double serum is collected between 2 and 4 weeks after acute onset and after onset, and IgG is tested. antibody. 4.4.15 Bedside sampling may be considered under special circumstances (if anaerobic infections are suspected). 4.4.16 Specimen collection must comply with biosafety regulations. 4.5 Specimen Collection 4.5.1 Collect sufficient quantities of specimens for routine bacteriological testing, at least 0.5 mL or 0.5 g (except for special specimens). When sent When the specimen is insufficient in volume, communicate with the clinic and select the priority test item according to the doctor's advice. Cerebrospinal fluid specimens usually range from 2 mL to 5 mL; pleural fluid And ascites 10 mL; BALF 10 mL ~ 20 mL (≥ 5 mL); pus 2 mL ~ 5 mL; amniotic fluid, bile, joint puncture, pericardium, Pleural effusion, synovial fluid greater than 1 mL; peritoneal dialysis solution 50 mL; anterior chamber fluid greater than 0.1 mL, vitreous lotion greater than 1 mL. 4.5.2 Collect sufficient quantities of specimens for virological testing, especially liquid specimens (such as cerebrospinal fluid and blood), and strictly follow the clinical criteria Quasi-process operation. Cerebrospinal fluid specimens are usually 2 mL to 5 mL, and blood is 3 mL to 5 mL; 4.5.3 It is advisable to collect large volumes of specimens for routine mycological testing. 4.6 Specimen identification The label should be made of a material that will remain adhered to the refrigerator. The label is attached to the container instead of the container lid. The information provided on the label to Less include (but not limited to) the following. a) patient name, patient unique identifier; b) the date and time of collection of the specimen; c) inspection items; d) type of specimen; e) Urgently check the corresponding label of the specimen (where applicable). 4.7 Specimen transport 4.7.1 The specimen collection manual should clearly state the special transport methods for certain inspection items to ensure that medical personnel and specimen transport personnel are Accurate information about specimen collection and transfer can be obtained prior to specimen collection. 4.7.2 The transfer of specimens should be carried out by trained personnel. When transporting specimens by pneumatic transmission, confirm the violent shock and temperature in advance. Other factors do not affect the test results. 4.7.3 After the specimen is collected, the transportation link should be reduced, the laboratory should be delivered within the specified time, and the transit time should be shortened as much as possible. 4.7.4 Specimens for bacteriological examination. a) Specimens for general bacteriological examination. should be sent to the laboratory within 2 hours. If the transfer time exceeds 2 h, it is advisable to use the transfer culture. Nutrient or transport under refrigeration; in general, specimens used for bacterial culture should not be stored for more than 24 h at room temperature; Specimen specimens should not be refrigerated and transported; specimens for molecular diagnosis only should be refrigerated or cryopreserved (-70 °C or less, to avoid Repeated freezing and thawing). b) Body fluid specimens (< 1 mL) or tissue specimens (< 1 cm3) with a small amount of specimen. should be sent to the laboratory within 30 min. in general Specimens or specimens collected in preservation medium can be stored for 24 h. c) Specimens that may isolate sensitive bacteria from the surrounding environment. they are sent immediately after collection. Bacteria that are sensitive to the surrounding environment, such as pertussis Special bacteria, Shigella, Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae and anaerobic bacteria. d) Specimens that may be isolated from low temperature sensitive bacteria. should not be refrigerated after collection, such as cerebrospinal fluid, genital tract, eye, middle ear and breathing Road specimen. Low temperature sensitive bacteria such as Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae and Streptococcus pneumoniae. e) Specimens for anaerobic culture. transport at room temperature, specimens with a small amount of specimens should be sent to the laboratory within 30 minutes after collection. Specimens are isolated from the air as much as possible during transport. 4.7.5 Specimens for virological testing. a) Specimens for viral nucleic acid testing. sent to the laboratory within 2 h to 4 h after collection. Blood specimens are shipped at room temperature, other specimens Transport at 2 °C ~ 8 °C; if the transport time exceeds 24 h, the specimen should be stored and transported at -70 °C or lower. b) Specimens for virus culture and antigen testing. should be stored in the appropriate virus transfer solution (VTM) or other phase during transport Should be in the buffer. c) Liquid specimens. such as amniotic fluid, blood, cerebrospinal fluid, urine and BALF can be directly sent for inspection, generally do not need to use VTM to transport. 4.7.6 Specimens for fungal culture (except for hair,......

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