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Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 9 of 43Management ProcedureGuidelines for Proper Specimen Collection and Factors That MayAffect the Quality of the Results: Confirm the identity of the patient either verbally and/or by hospital identificationwristband.Complete the request form.Check that the patient is appropriately prepared. This will obviously differdepending on the nature of the sample(s) being taken.To comply with the Human Tissue Act legislation (Human Tissue Act, 2004), itis the responsibility of the requester to ensure that the patient has beeninformed of, and has consented to, the tests being requested.Where patient or donor consent is required it is the responsibility of therequester to ensure the subjects of any tests have given informed consent.Unless written notice is received to the contrary, consent for investigations andthe use of any surplus sample in scheduled purposes (quality control, staffdevelopment or ethics committee approved research) will be assumed.Ensure the specimen(s) is collected correctly. It is important that the laboratoryreceive good quality samples. Guidance on sample collection especially thosesamples that are naturally eliminated from the body and hence can often becollected by the patient can be found on the website http://labtestsonline.org.uk/(further information can also be found by following the links in the specificsample types detailed below).Collect specimen before administering antimicrobial agents when possible.Check that the sample container is labelled correctly. Use sterile containers andaseptic technique to collect specimens to prevent introduction of microorganisms during invasive procedures. Only laboratory approved, CE marked,in vitro devices IVDs, must be used as primary specimen containers, nosubstitutes or improvised containers.Collect an adequate amount of specimen. Inadequate amounts of specimenmay yield false-negative results. If multiple samples are collected at the sametime ensure there is no interchange of samples.Specimens obtained using needle aspiration should be transferred to a sterilecontainer and transported to the laboratory as soon as possible. If there is onlya small volume of material in the syringe, add some sterile preservative-freesaline, mix and transfer to a sterile container. Do not send needle or syringe.All materials used in specimen collection should be disposed of safelyaccording to local protocols used in specimen collection area.See BHSCT policy TP066/11: Trust waste policy found on BHSCT website andHealth Technical Memorandum 07-01: Safe management of healthcare wastefound on DoH website.All high risk samples MUST be identified to facilitate the correct processing ofsuch samples by laboratory personnel.Any spillages or breakages occurring during sample collection must be dealtwith correctly according to a documented procedure.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date 17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 10 of 43Management ProcedureAll container tops must be firmly and properly closed, leakage adversely affectsnot only that specimen but other specimens sharing the transitThe date and time of collection should be clearly stated (24 hr clock)Fragile organisms may be affected by a delay in transport.Specimens must be kept in a cool room awaiting dispatch, not in the sunlightor near a radiator. Ensure the samples are stored under the appropriate storageconditions for the investigation required.Transit to the laboratory should be prompt and specimens must not be left inuncontrolled vehicles (hot/cold) for any prolonged period.If processing is delayed, refrigeration is preferable to storage at ambienttemperature. Delays of over 48h are undesirable.Indicate if an unusual or fragile organism is suspected as the causal agent,these may not be isolated by normal testing protocols & may require specialmedia, special isolation conditions & prolonged incubation.To minimise the risk and ensure the safety of the specimen collector, carrier,general public and the receiving laboratory, it is important that care is takenwhen collecting and handling clinical samples to ensure that the risk of infectionto staff is kept to an absolute minimum. Therefore:o Samples must always be carried in closed sealed plastic bags placed inclosed sealed boxes.o Safe working practices shall be observed at all times.o All clinical samples must be placed inside a sealed plastic bag.o Should any urgent samples be sent outside of normal laboratory hours (0900– 1715) they will be transported in sealed plastic bags.o Samples must never be carried unprotected in the open hand or given toother members of staff in this way.o Patient confidentiality must be preserved by the use of envelopes or opaqueplastic bags.o Samples must always be carried in closed boxes which are clearly markedwith a BIOHAZARD label. Samples must never be thrown into a large plasticbag and transported in this manner.o The containment of samples within motor vehicles, used to transportsamples, must be such as to restrain, retain and protect the contents in theevent of an accident.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 11 of 43Management ProcedurePackaging and Transportation of SamplesAdvice on packaging samples for transport to the LaboratoryInstructions can be found on the Belfast Trust website, or requested from thelaboratory:C-17 - Pneumatic tube transport of specimensC-18 - Road transport of specimensC-84 - BTL Transport PolicyThe manager of every Ward, Clinic, or GP which sends specimens to the Belfast TrustLaboratories must read these and must ensure their unit complies with thesedirections. The Carriage of Dangerous Goods Regulations (2011) and ADR (2017)place a clear legal responsibility on the sender and any agent they use to transportdiagnostic specimens by road. Internal transfer to the laboratories by the pneumatictube system is subject to risk assessments made under the HSAW order and theCOSHH regulations.Transportation of SamplesThere is a legal responsibility and a duty of care on anyone who dispatches clinicalmaterial (diagnostic specimens) to the Belfast Trust Laboratories. The legalresponsibility is to ensure that if required, the specimens are packaged and labelled incompliance with the relevant road transport regulations (ADR/CDG). There is a furtherlegal responsibility under COSHH regulations, since clinical materials may containinfectious agents, to ensure that the materials do not leak or injure anyone involved inthe transportation or the wider public and environment.The duty of care (to the patient) is to ensure that the transport conditions do notdamage the material being sent for testing or otherwise interfere with the validity of thetest results, and to ensure the specimen reaches the laboratory in good conditionwithin an appropriate time frame for good clinical management of the case. Specimensshould be clearly labelled and dated. Place all specimens in leak proof containers insealed plastic bags.NB: Category 3 samples should be double bagged and clearly identified. Samples from the Royal Group of Hospitals can be sent via the vacuum tubesystem (except cat 3 samples) or by hospital courier.Samples from other hospitals / GPs may be sent by the relevant dispatchsystems.Category B specimens and all other diagnostic specimens sent by DataDispatch must be packed to at least PI 650 standard. No additionaltransportation documentation is required for these specimens.Individual couriers such as the Post Office may issue their own additionalrequirements and restrictions, which must be complied with.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 12 of 43Management ProcedureAny referring Unit, Hospital, Clinic, GP Practice or Trust transporting specimens byroad (which includes postal services) should take professional advice and guidanceon the packaging and labelling of any materials they hand over for transportation.The laboratories are not responsible for nor do they have any managerial control overthe transportation of specimens between the shipper and the destination. The strongrecommendation by Belfast Trust Microbiology is that all patient Clinical Specimensshould be considered as potentially infectious and must therefore be categorised atthe very minimum as UN3373 Biological Substance Category B and be packed andlabelled according to Packing Instruction P650 in the ADR/CDG regulations. (Thepackaging standard comprises 3 layers, two leak proof layers, and a third outer rigidlayer which provides protection against impact.)If fully compliant with P650 then the package, the transport vehicle and the driver arenot subject to further specific requirements under ADR.THIS EXEMPTION MUST ALWAYS BE USEDIf the packaging is not P650 compliant then there is no exemption from the fullADR/CDG regs, and the shipper and the driver will probably be found in breach of anumber of transport regulations and liable to prosecution.All users’ will be contacted immediately if specimens are received that do not meetwith the stated packaging and transport requirements and informed as to how toeliminate recurrence.Data DispatchUnit 33,Westlink Ent Park30-50 Distillery St,BelfastBT12 5BJTel : 02890311022Criteria for Rejection of SpecimensSpecimens may be rejected immediately if: Form Received with no specimen Discrepancy between the patient details on the form and the specimen No patient details on either the request form or the specimen Specimens which have leaked and are insufficient for testing Specimens deemed unsuitable for testing by BMS or clinical scientist at thepoint of testing Specimens accompanied by a request form with insufficient information tosend out a report or to determine which test is required.If a sample is unsuitable for testing a report will be sent to the requestor giving thereason and requesting another sample.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 13 of 43Management ProcedureWhen blood cultures are received that do not meet the minimum identifier set everyeffort will be made to contact the ward/department by telephone to advise that thesample is to be rejected and a repeat sample is necessary.The laboratory may choose to process a sample that may otherwise have beenrejected by cooperating with users in clarifying the request.In the case of CSF, tissues, bronchial washes and irreplaceable fluids for TB cultureand other such samples which cannot or are extremely difficult to repeat, thelaboratory will contact the ward/department to clarify the patient identifier set. Note willbe taken as to whom communication has been made and included as a laboratorycomment on the report.In other instances, the final report will have a laboratory comment which indicates theproblem and if caution need be applied when interpreting the result.ResultsFinal reports for both routine and emergency requests can be viewed on BHSCT‘Labcentre’, the HSC ‘NIECR’ system or alternatively on cyberlab. These may beaccessed in your relevant ward or practice as soon as they are validated by laboratorypersonnel. Please make use of this facility.Please note:For BSHCT microbiology results, ‘NIECR’ may not display specimen types (or the siteof origin for a swab), pending results, or test data on patients whose examinationswhere supplied without an H&C number. For many tests results are better accessedon LabCentre browser look up where tests, results and interpretative comments aredisplayed together. Should any uncertainty exist on lookup, please contact thelaboratory for further information.For serological assays performed in-house, results are only valid whenspecimens are tested within the validated timeframe of the assay. Pleaseconsult the test repertoire table to determine the validated timeframe for testing.The issuing of results of a non-urgent nature over the phone is discouraged and mustbe kept to an essential minimum in the interests of safety as verbal reports may leadto transcription errors.If a phone enquiry is necessary, where possible consult labcentre to obtain the onscreen laboratory test request number. This is in order to validate that you areauthorised to receive the confidential laboratory report in question and will assistlaboratory staff in dealing with your enquiry more efficiently.All laboratory results should be interpreted in conjunction with the clinicalstate of the patient.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 14 of 43Management ProcedureIf inappropriate results are received, please contact the laboratory and/or repeat thespecimen.Frequency of requesting examinationsHow often a test should be repeated, if at all, should be based on a number ofcriteria: The physiological properties Biological half-life Analytical aspects Treatment and monitoring requirements Established guidanceThe Royal College of Pathologists have published advice on the minimum retestingintervals in 1F-4482-B08303CE3907020D/For further advice on the use of the services provided, please contact the laboratory.Test Repertoire:The Microbiology laboratory is a UKAS accredited testing laboratory No. 8704The test schedule listing accredited tests can be found on the UKAS ns/ . For any tests not currently on theschedule, the further information section of the repertoire table will state nonaccredited test.For a number of serological assays, the results are only valid if the sample istested within the validated time period of the assay. Where applicable, thevalidated testing period is detailed in the further information section of the testrepertoire table.Referred testsAny tests sent to a referral laboratory for testing or confirmation will be clearly markedon the result report. Details of all tests sent to referral laboratories and theaccreditation status of the referral laboratory can be found here.Service AgreementEach request accepted by the Microbiology Laboratory for examination(s) shall bedeemed an agreement by the user for the Belfast Health & Social Care Laboratoryservices, or other accredited laboratories as may be used to perform testing outsiderepertoire, to carry out the necessary testing and reporting function. It also implies anacceptance of the conditions of preparation and transport as outlined in this manual.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 15 of 43Management ProcedureThe Microbiology laboratory will endeavour to inform customers and users of theservice as soon as possible if there are: Any deviations from the agreement that may impact upon the examinationresults Any issues that arise which may impact on the quality of the service or theresults provided.Sample StabilityA delay in transport to the laboratory may affect sample quality and compromise theresults produced. It is essential that the specimens reach the laboratory as soon aspossible to allow processing before the sample quality deteriorates.The sample may be rejected if it is received after the recommended timeframe.Measurement UncertaintyThe uncertainty of measurement is available, where appropriate, for each test listed inthe repertoire table and can be obtained upon request from the Quality Officer. Seecontact details at the start of this manual.Turnaround TimesTurnaround times are from day of receipt to issue of reports in calendar days.The times shown are the typical turnaround times achieved by the laboratory, but maybe longer or shorter depending on the availability of staff and the complexity of theinvestigation.Please note: In this new version of the Microbiology user manual, the turnaround timefor some tests have been increased.If there are any comments or queries regarding this please contact the Quality Officer,contact details are available at the start of this manual.Belfast Trust LaboratoriesMicrobiology

Revision NumberAuthor/ReviewerActive DateEffective Date17.0L McCoy19/10/202019/10/2020Document NumberAuthoriserPage NumberDocument TypeMicrobiology User ManualM-3M McGimpseyPage 16 of 43Management ProcedureMicrobiology Department Repertoire of TestsFor tests not listed below, please click here for the list of tests sent to Referral Laboratories. If, however, the test or specimen type is not listed, pleasecontact the laboratory to discuss clinical requirements.BacteriologyTestAntibiotic AssaySample Type5mls Clotted blood sampleContainerYellow topbottleFurther information Gentamicin, Vancomycin, Amikacin, Tobramycin, Teicoplanin Performed inBiochemistry Laboratory Other Antibiotics Sent to reference laboratoryTurnaroundTimeSeeBiochemistryuser manualFor antibiotic guideline ranges follow the link ntibiotic%20Guideline%20Ranges%202019.pdfBlood cultureAdult – set of culture bottles8-10mls Blood in

Microbiology User Manual Belfast Trust Laboratories Microbiology Guidelines for Proper Specimen Collection and Factors That May Affect the Quality of the Results: Confirm the identity of the patient eit