The Newcastle upon Tyne Hospitals NHS Foundation Trust. Sample Acceptance and Rejection Policy

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The Newcastle upn Tyne Hspitals NHS Fundatin Trust Sample Acceptance and Rejectin Plicy Versin.: 3.7 Effective Frm: 22 December 2015 Expiry Date: 22 December 2017 Date Ratified: 18 December 2015 Ratified By: Labratry Medicine Bard 1 Intrductin 1.1 Submissin f a request and specimen(s) t NUTH Labratries cnstitutes a cntract between the service user (n behalf f the patient) and the service prvider (NUTH Medical Labratries) t perfrm investigatins. Bth parties are required t fulfil their bligatins under this plicy t ensure that the quality f the supprt diagnstic testing remains fcused n the patient. 1.2 This dcument sets ut the Trust s plicy fr submitting specimens t the Labratry fr diagnstic tests and investigatins. It is intended t ensure the safety f the patient and t cnfirm the crrect investigatin is perfrmed n the right sample. Labratry members f staff are nt permitted t endanger the patient by wrking utside the plicy. 1.3 The plicy applies t all samples and tissue specimens that are taken frm a patient in any clinical area f the Trust and labelling is regarded as a frmal identificatin prcedure. 1.4 Accurate identificatin details n labratry samples are vital fr patient safety. It is the respnsibility f the persn requesting a labratry investigatin (i.e. medical, nursing and phlebtmy staff etc.) t ensure that samples are crrectly labelled and request details (frms r electrnic requests) are cmpleted t the required standard. Sample and request details must be cmpatible. 1.5 In sme circumstances typically in accident and emergency departments, full patient details are nt available. In these cases lcal plicy fr labelling f unknwn patients and their samples must be fllwed. 1.6 Befre a clinical specimen is accepted, labratry staff must ensure that the minimum criteria fr sample identificatin are met and that the sample and request frm match crrectly. It is imprtant that the requesting medical fficer/practitiner is identified n the frm and that a cntact number is given in case there is a prblem with the sample r request frm r there is a critically abnrmal result. It therefre is strngly recmmended that a cntact number is given. Page 1 f 16

2 Scpe 2.1 This plicy applies t all Trust staff f all grades wh take samples and specimens frm patients anywhere in clinical areas f the Trust. Althugh nt exhaustive, specimens and samples are bilgical materials that can be bradly classified as fllws: i. Bld ii. Urine iii. Tissues iv. Bne v. Faeces vi. n-bld bdily fluids (e.g. synvial, pleural, ascitic, C.S.F.) vii. Swabs and cultures viii. Nails ix. Hair 2.2 Samples and specimens must be taken by staff wh are cmpetent t d s and althugh nt exhaustive wuld include the fllwing grades: i. Qualified Dctrs ii. Trained Medical Students iii. Qualified Nurses iv. Qualified Midwives v. Qualified Dental Practitiners vi. Qualified Dental Nurses vii. Qualified Operating Department Practitiners viii. Qualified Phlebtmists (this grup is nt eligible t label tissue samples) ix. Healthcare Assistants 3 Aims All the abve staff grups, with the exceptin f Phlebtmists, can label tissue samples but it is imprtant t nte that all tissue samples must be frmally checked and labelled by tw members f staff frm the abve list that are eligible t d s. 3.1 T prvide guidance t Trust staff wh request labratry tests and take samples fr pathlgy investigatins n btaining, crrectly labelling, preserving, packaging and transprting samples requiring pathlgy tests. 3.2 T ensure that the crrect patient is identified befre any specimens are taken fr diagnstic testing, that the Trust labelling plicy is cmpletely fllwed n every ccasin. 3.3 T raise awareness that every test that is perfrmed by the labratry n behalf f a service user is a service agreement between the tw parties. This is nw a Page 2 f 16

stipulated requirement t cnfrm t Pathlgy Quality requirements and cmply with the ISO 15189 standard fr quality and cmpetence in Medical Labratries. 4 Duties (Rles and respnsibilities) 4.1 Trust Bard The Trust Bard is respnsible fr ensuring that a rbust system f risk management is in place within the rganisatin which includes the identificatin f patients and labelling requirements fr pathlgy sample and specimen testing. 4.2 Chief Executive The chief Executive has ultimate accuntability fr ensuring that there are apprpriate prcesses in place fr effective and reliable management f the requirements f this plicy but delegates this respnsibility thrugh Clinical Directrs and Directrate Managers within the rganisatin. 4.3 Directrate Managers and Directrate Directrs All Clinical Directrs and Directrate Managers are respnsible fr ensuring i. Adequate and apprpriate disseminatin and implementatin f this plicy within their areas f respnsibility. ii. iii. Ensuring apprpriate and adequate training f staff t perfrm the tasks cvered by this plicy and maintaining and measuring cntinuing cmpetence in this respect. Identifying the rt causes f nn-cmpliance with this plicy and taking all necessary measures t intrduce crrective and remedial actins as required. 4.4 Heads f Department, Junir Managers and Supervisrs Have a respnsibility t ensure that all staff that they line-manage that undertake the activities cvered by this plicy, perfrm the tasks in full cmpliance with requirements. They must take apprpriate actins t crrect and reprt nncnfrmances with requirements as they present. 4.5 All staff All staff members wh perfrm the tasks cvered within this plicy are persnally respnsible fr their wn actins and must ensure that they are cmply fully with the plicy requirements and remain cmpetent t carry ut the required tasks. Page 3 f 16

They must ntify their line manager immediately if they feel that they are unable t cmply with the requirements. The list abve is nt exhaustive and there may be ccasin where additinal stakehlders/specialist persnnel with a specific rle and r respnsibility shuld be listed. 5 Definitins The fllwing definitins apply in the cntext f this plicy: 5.1 Service Agreement 5.2 Valid A statement that defines the pre analytical requirements f the labratry frm service users and prvided that these are met fully, what the service users in turn can expect with the examinatin results prvided by the labratry. A sample and/r request that is acceptable fr examinatin by the labratry. Althugh nt exhaustive, this will require a sample f apprpriate quality, with psitive and crrect labelling. The request prcess shuld cnfrm t the exact requirements whether hardcpy r electrnic and shuld fllw the exact prgressin steps. 5.3 Sample r specimen A prtin f bilgical fluid r tissue that is remved frm a patient, placed int apprpriate cntainer (s) fr the purpse f labratry examinatin. 5.4 Request A frmal apprach made verbally, in writing r electrnically that asks the labratry t perfrm an examinatin prcess n accmpanying bilgical fluid(s) r tissue (s). 5.5 Reprts The representatin f cllated examinatin results, with apprpriate technical, scientific, clinical and medical interpretatins, in a single electrnic r hard cpy dcument. It is intended t assist service users in the diagnsis and/r clinical management f disrders and ailments. Page 4 f 16

5.6 The labratry One f a number f facilities r areas within the Directrate f Labratry Medicine that is equipped fr perfrming diagnstic testing, experiments, research and teaching. The labratries are split int the fllwing specific disciplines: i. Bld Sciences (n bth Freeman Hspital and RVI sites) ii. Bld Transfusin (n bth Freeman Hspital and RVI sites) iii. Cellular Pathlgy (RVI) iv. Micrbilgy (Freeman Hspital) v. Public Health England-Mlecular (RVI) vi. Public Health England Tuberculsis (Freeman) 5.7 Service users These are any party with the apprpriate authrity t request that the labratries perfrm diagnstic testing f bilgical fluids r tissues n their behalf. Service users will need t cnsider the apprpriateness f all requests made and shuld cntact the labratries t discuss where uncertainty ccurs. Althugh nt exhaustive this includes the fllwing grups: i. Qualified Dctrs ii. Qualified Nurses (delegated respnsibility frm a dctr r sme specialist nurses in their wn right) iii. Qualified Midwives iv. Qualified Dental Practitiners v. General Practitiners r representatives acting n their behalf. 5.8 The Trust The Newcastle upn Tyne Hspitals NHS Fundatin Trust. 6 Prcedure 6.1 Service Agreement Labratry practices are subjected t cmprehensive regulatin and legislatin and the Medical Labratries Requirements fr Quality and Cmpetency Standard (ISO 15189) requires all requests and tests t be deemed a service agreement between the labratries and service users. As such there are expectatins that fall n bth parties and it is a requirement that these are understd and strictly adhered t. They are summarised as fllws: Page 5 f 16

6.1.1 Labratry expectatins and requirements f service users Service users are respnsible fr ensuring that all f the fllwing pints are met and they must: i. Prvide a specimen/sample that is valid and f acceptable quality fr testing. ii. iii. iv. The patient must be crrectly identified at the time f the sample taking and the service user is referred t Trust plicies relating t this. The sample must be fully and crrectly labelled befre sending this t the labratry. Specimens/samples must be taken under the crrect cnditins (refer t the Labratry Medicine intranet page r cntact the labratry where uncertainty exists). v. The sample cntainer must be sealed in rder t prevent spillage. Failure t d s may result in lss f sample r the cntainer being returned fr apprpriate repackaging. vi. vii. viii. ix. Specimens/samples must be taken int the crrect cntainers and be filled t the crrect levels. The labratry must be cntacted if this cannt be dne and they will advise as t whether alternatives wuld be acceptable. Specimens must be crrectly packaged, preserved and transprted in a timely manner t the labratry fr testing. The labratry must be cntacted if this cannt be dne and they will advise as t whether alternatives wuld be acceptable. Requests- Full infrmatin must be prvided n all requests. This will include bth patient and clinical details and any ther infrmatin that will ensure that the crrect tests and fllw up tests are perfrmed as required. Where electrnic requesting is used, the service user must ensure that the exact prcess f rdering and escalatin takes place befre any samples are sent ff fr testing. This is abslutely critical t the prcess and service users must understand the prcess and shuld refer t all Trust plicies and prcedures fr electrnic rdering (e- Recrd). 6.1.2 Service User expectatins f the Labratries Prvided that all f the expectatins in 6.1.1 abve are fully met, the service users can in return expect the fllwing levels f service frm the labratries: Page 6 f 16

i. Requests and tests will be received, registered and prcessed by trained and cmpetent Health Care Science Assistants (HCSA s) r higher grades f labratry staff. ii. Examinatin testing will be perfrmed by qualified and cmpetent Bimedical Scientists (BMS), Health Care Scientists (HCS)/ Clinical Scientists r if apprpriate by HCSA s under direct supervisin. iii. Validatin f examinatin testing will be perfrmed by qualified and cmpetent BMS, HCS /Clinical Scientists. iv. Authrisatin f examinatin results will be perfrmed by qualified and cmpetent BMS/HCS /Clinical Scientists and Medical Staff as apprpriate t the test. v. Where apprpriate, scientific/technical interpretatin will be given verbally and/r in writing by qualified and cmpetent HCS /Clinical Scientists. vi. Where apprpriate, clinical advice and interpretatin will be given verbally and/r in writing by qualified and cmpetent clinical r medical practitiners (HCS/Clinical Scientists, Cnsultants, Specialist Registrars, and F2 grades). The prvider f this infrmatin differs depending n the Labratry Medicine Discipline invlved. vii. Where apprpriate, medical advice and interpretatin will be given verbally and/r in writing by qualified and cmpetent Medical Practitiners (Cnsultants, Specialist Registrars and F2 grades). viii. Labratries will ensure high quality f examinatin testing that will be subjected t cntinued external prficiency testing and regulatry assessment. ix. The labratries will prvide instructins and advice t service users thrugh the Trust Intranet and Web services. x. The labratry will make results available t service users within the turnarund times stated n the intranet and web pages. Service users will be ntified as sn as pssible f any circumstances that adversely affect this. xi. The labratries will infrm service users as quickly as pssible f circumstances that culd impact n the reliability f examinatin results. xii. The labratries will infrm services users f any changes t sample requirements r testing prcesses that impact n examinatin results and/r reference ranges. xiii. Labratry Management will maintain prcesses that ensure and test n ging cmpetence f all grades f staff emplyed in the Directrate. xiv. When samples are rejected the labratry shall issue a reprt that details the reasn(s). Where the request is deemed t be urgent the cmmunicatin may als be by telephne. Page 7 f 16

6.2 Specimens/Samples If the requirements detailed in 6.1.1 f this plicy (service agreement) are nt cmpletely met, the specimen(s)/sample(s) may be rejected by the labratries. 6.2.1 Labratry Medicine (Excluding Cellular Pathlgy) 6.2.1.1 Sample Labels Samples must be labelled prmptly in clse vicinity t the patient, e.g. bedside r ut-patient phlebtmy rm. Essential infrmatin fr the sample label: Patient s Full Name Plus Date f birth Plus Hspital Number r NHS number r ther agreed unique identifier. If knwn bihazard a bihazard sticker r ther alert must be attached t bth request and sample A single unique identifier is permitted nly fr specific agreed services such as: Sexual Health. Health Surveys Unknwn Patients that are emergency admissins Clinical Research and Trials Where prir arrangements have been made with and agreed by the labratry A specifically generated number is allwed fr unknwn unidentified patients seen in emergency departments. The label and request detail shuld state unknwn male r unknwn female tgether with the unique and specific emergency number. Desirable infrmatin: Date and Time f sample is essential fr certain dynamic tests, i.e. is ne f a series Date and Time f sample is essential fr Tissue Specimens and where the sample is perishable r the analyte is unstable (e.g. serum ptassium). Please cnsult the labratry fr infrmatin regarding individual tests. Page 8 f 16

6.2.1.2 Request Infrmatin Essential infrmatin fr all samples: Patient s Full Name Date f birth Hspital Number r NHS number r ther agreed unique identifier. Sex f patient Date f sample Patient s lcatin Respnsible Cnsultant r GP Name f requesting Medical Officer/practitiner Investigatins required Clinical Infrmatin If knwn bihazard a bihazard sticker r ther alert must be attached t bth request and sample. Essential requirements fr Specific Sample type/test e.g. fasting Time f sample: All cellular pathlgy requests. Selected dynamic functin tests Patient s address (fr Cytlgy) Handwritten sample tube details fr all bld grup/crssmatch samples r samples fr referral t the NHSBT. Where requests are nt made electrnically, the exact fficial name f the investigatin and /r the apprved abbreviatin shuld be written legibly in blck capitals n the request frm. Desirable infrmatin: Time sample cllected Date and Time f sample is essential fr Tissue Specimens and where the sample is perishable r the analyte is unstable (e.g. serum ptassium), r is ne f a series (e.g. dynamic tests). Clinical Infrmatin Requesting Medical Officer/Practitiner s cntact telephne r pager number Page 9 f 16

6.2.1.3 Rejectin Criteria Samples may be rejected in the fllwing circumstances: The minimum essential infrmatin is missing frm the sample r request. The sample and request frm infrmatin d nt match. The sample is unlabelled r therwise unsuitable (e.g. wrng tube type). 6.2.1.4 Samples Where the Essential Infrmatin Is Missing Where essential infrmatin is missing frm a sample r request frm, the labratry will attempt t cntact the requesting medical fficer/practitiner identified n the request using the cntact number, where this is given. The labratry may require the requesting medical fficer/practitiner t attend the labratry t cmplete r amend details befre the request is accepted. If the labratry is unable t cntact the requesting medical fficer/practitiner r clleague the sample will be rejected r analysis deferred until cntact is made. When samples are rejected due t insufficient infrmatin, a reprt will be issued thrugh the labratry infrmatin system as sn as practicable, stating that the sample has nt been prcessed and giving details. Where the missing infrmatin includes the Patient s Cnsultant and/r the GP Patient s lcatin and destinatin fr reprt, a printed reprt may be delayed r unavailable. In this case, the reprt may be issued t a default surce (Unknwn Cnsultant/Unknwn Lcatin) n the labratry infrmatin system. Samples that have been rejected and nt prcessed may be stred in the labratry fr up t ne week t allw the requesting practitiner time t get in tuch. This strage will be at the discretin f individual departments. 6.2.1.5 Bld Transfusin The minimum label requirements fr transfusin specimens are a unique identificatin number (Hspital, NHS r A&E), surname, first name and date f birth. The sample tube label must be hand written at the bedside. An addressgraph label n the sample tube will nt be accepted. Electrnically generated sample labels must be affixed t the request frm and nt t the sample. Electrnically generated Page 10 f 16

requests still require a request frm. The persn taking the sample must cmplete and sign the sample taking declaratin n the frm. If details n samples fr bld transfusin are incrrect r incmplete the samples will nt be prcessed until the details are amended by the persn wh btained the samples (minr errrs nly). In the event f majr errrs, new samples will be requested. 6.2.1.6 The Human Tissue Act 2004 This Cmpnent f the Human Tissue Act (HTA) came int effect n 1st September 2006. It is n lnger acceptable t stre human tissue r cells fr research use withut patients cnsent. Once a diagnsis has been made, tissue r cells may still be used fr educatin, audit and quality assurance activities. Cnsent fr research strage f cells/tissue shuld be discussed with patients (a detailed patient leaflet is available fr infrmatin, if required) and the utcme f their decisin apprpriately represented n the specimen request frm. A clearly identifiable specific sectin has been added t Histpathlgy and Cytlgy request frms t recrd this infrmatin. It is the respnsibility f clinicians sending specimen t the labratry t ensure that this sectin is cmpleted crrectly The Trust supprts the imprtance f access t stred diagnstic tissue and cells fr research. Currently, a supplementary cnsent frm fr research strage f these specimens must be cmpleted at the time f btaining cnsent t bipsy and ther surgical prcedures. 6.2.1.7 Samples Which May be Prcessed Even If the Essential Infrmatin Is Missing Certain types f specimen are cnsidered precius r are extremely difficult t repeat (e.g. CSF samples, bipsies, aspirates, etc., r where the sample frms part f a series r dynamic test). In such cases, a senir member f the labratry staff will be respnsible fr deciding if the analysis is justified. The requesting medical fficer/practitiner will be cntacted and may be asked t cme t the department t cmplete the details. Page 11 f 16

If samples are accepted under these circumstances, the details will be recrded n the frm r in the cmputer. The reprt will include a clear disclaimer detailing the shrtcmings f the sample and/r request. The disclaimer will identify the requesting practitiner wh has agreed t take respnsibility fr the results and fr any actin taken as a result f the reprt. 6.2.1.8 Requests generated using an electrnic system, e.g. pwerchart r ICE will print a label fr use n the sample cntainer. Other samples will either be labelled in hand writing r using pre-printed addressgraph labels. 6.2.2 Labelling Labelling f tissue specimens must be cnducted by tw members f staff in rder t minimise the likelihd f errr and ensure patient safety. This plicy details the requirements fr labelling bth the specimen pt and the crrespnding request frm fr tissue specimens and must include all necessary relevant infrmatin as a mandatry requirement. Requests generated using an electrnic system, e.g. pwerchart r ICE will print a label fr use n the sample cntainer. Other samples will either be labelled in hand writing r using pre-printed addressgraph labels. Ensure that this prcedure is dne at the same time r just after the specimen is taken and whilst the patient is still present. Only the identified patient s ntes must be in the clinical area. The patient must have an identity wristband if anaesthetised r sedated (please refer t the Patient Identificatin Plicy). Specimen cntainer(s) r request frm(s) must nt be pre labelled 6.2.2.1 Labelling f Tissue Specimen(s) and request frm Imprtant te: This must be dne by tw members f staff, wh will: Check the details f the specimen with the peratr/surgen Label the specimen pt accurately with patient details using a handwritten (handwriting MUST be legible) r current addressgraph label. Using the patient s ntes cmplete the request frm legibly t include all the fllwing essential infrmatin: Page 12 f 16

Patient s Full Name (r cded identifier where applicable e.g. specimens frm GUM clinics) (mst recent name) Date f Birth Hspital Number Patient s lcatin and destinatin fr reprt Patient s Cnsultant Name f requesting dctr/practitiner and cntact number Clinical infrmatin Ptential risk f infectin Date and time sample cllected In the case f placentas sent fr histlgy, all the abve details will be thse f the mther, nt the baby. equesting dctr/practitiner s cntact number Check the details n the specimen label and n the request frm via ne f the three methds: If the patient is cnscius and cmpetent, by asking the patient their full name, address and date f birth and checking with their identity wristband if present Or If the patient has n identity wristband and is cnsidered incmpetent t give these details these shuld be prvided by the accmpanying parent/guardian/carer wh has signed the cnsent frm fr the prcedure Or If the patient is anaesthetised/sedated details n the labelling shuld be checked with the full name, address, date f birth and hspital number n the identity wristband Where multiple specimens are btained frm a single patient, bth the specimens and the request frms need t be clearly labelled t identify the different areas f rigin f the separate samples. When slides fr cytlgical examinatin are submitted, the slide itself needs t have written n it the patients initial, surname, hspital number and date f birth. 6.2.3 Preparatin fr Transprt f Specimens The same tw members f staff are respnsible fr ensuring that the labelling f specimen(s), cmpletin f request frm and bagging fr transprt are cmpleted. This duty must nt be handed ff t a third party. Fr further infrmatin please refer t the Transprt f Clinical Specimens plicy. Page 13 f 16

6.2.4 Tissue Specimen Lg All clinical areas where tissue specimens are taken must keep a recrd f specimens sent, recrding the surname, frename, MRN, date and time f sending and department sent t. 6.2.5 Health and Safety Fr histlgy requests, samples with knwn r suspected risk f infectin, e.g. hepatitis, HIV r tuberculsis must be labelled as a bihazard. A lack f sufficient clinical detail prvided n the request frm regarding ptential risk f infectin may result in the sample being handled in the wrng bilgical cntainment level with resulting increased risk f infectin t labratry staff. See: Health and Safety Executive 9/12/2011 Prvisin f key clinical infrmatin n labratry specimen requests http://www.hse.gv.uk/safetybulletins/clinicalinfrmatin.htm 6.3 Annymised and Unknwn Patients Sme requests will require that the annymity f the patient be maintained due t the nature f the tests and/r clinical details that will be required. This is necessary t preserve the dignity f the patient. Althugh nt exhaustive an example wuld be requests that require sexual health testing. In these cases the required minimum labelling wuld be: i. A unique reference number r identifier, printed r clearly written n bth sample and request frm. ii. Sex f patient iii. Date f sample iv. Patient s lcatin/destinatin fr reprt v. Respnsible Cnsultant r GP 6.4 Cmplaints and Enquiries 6.4.1. Enquiries can be made directly t the apprpriate labratry and the cntact details are available thrugh the Labratry Medicine intranet and web pages. 6.4.2. Cmplaints shuld be directed t the apprpriate Labratry Manager r Clinical head f service. The cntact details are available thrugh the Labratry Medicine intranet and web pages. 6.4.3 The labratries will undertake full investigatins f all cmplaints and endeavur t determine rt causes where pssible and t ensure that remedial actins are take. The utcmes will be made available t cmplainants where ever pssible. Page 14 f 16

6.4.4 If service users are dissatisfied by the way that the labratries handle cmplaints, they shuld cntact the Clinical Directr f Labratry Medicine t prgress the matter. The cntact details are available thrugh the Labratry Medicine intranet and web pages. 7 Training 7.1 All staff wh request specimens t be sent t the labratry fr tests r investigatins shuld be apprpriately trained in bth the methds f cllecting each type f specimen and in the requirements f making a request t the labratry, whether this be n paper request frms r by electrnic means. 7.2 Details f the use f the labratries and requirements fr specimen cllectin, labelling and transprt t the labratry are available n the trust intranet. 8 Equality and diversity The Trust is cmmitted t ensuring that, as far as reasnably practicable, the way we prvide services t the public and the way we treat ur staff reflects their individual needs and des nt discriminate against individuals r grups n any grunds. This plicy has been apprpriately assessed. 9 Mnitring cmpliance Standard / prcess / issue Cmpliance will be mnitred by Labratry staff. Mnitring and audit Methd By Cmmittee Frequency When nn-cmpliance is nted, apprpriate cdes are placed in the cmputer recrds and a reprt printed. Cmputer searches can mnitr the numbers f each type f nn-cmpliance. Prviding the infrmatin required will ensure the health and safety f labratry persnnel and will lead t accurate and timely reprts. All incidents, accidents r near misses, related t the labelling f tissue specimens shuld be reprted n DATIX Labratry Staff Department f Cellular Pathlgy. The Department will arrange update meetings with thse users wh fail t cmply with this Trust plicy. Clinical Gvernance and Risk Department Labratry Medicine Executive Cmmittee Clinical Plicy Grup and the Trust Cmmunicatin Meeting Clinical Risk Grup Annually Mnthly Six mnthly reprts n themes and trends Page 15 f 16

10 Cnsultatin and review This plicy has been reviewed by the Labratry Medicine Executive Cmmittee prir t ratificatin and implementatin. The plicy will be reviewed three yearly by the Labratry Medicine Executive Cmmittee. 11 Implementatin (including raising awareness) This plicy will be cmmunicated t all Trust staff wh undertakes this prcedure. The plicy will be made available n the intranet. 12 References Institute f Bimedical Sciences. IBMS Prfessinal Guidance. Patient Sample and Request Frm Identificatin Criteria. (Versin 2, 2009) Health and Safety Executive. HID 5-2011. Prvisin f Key Clinical Infrmatin n Labratry Specimen Request Frms. (Dec 2011). Medical Labratries Requirements fr Quality and Cmpetence (ISO 15189). BSN EN ISO 15189:2012. NPSA (2005) Wristband fr hspital inpatients imprves safety. Safer Practice. 1. vember 2005. 13 Assciated dcumentatin The fllwing Trust plicies are assciated: Patient Identificatin - Establishment and Cnfirmatin Prir t Investigative Testing and Treatment Patient Identificatin Plicy Transprt f Clinical Specimens plicy Page 16 f 16

The Newcastle upn Tyne Hspitals NHS Fundatin Trust Equality Analysis Frm A This frm must be cmpleted and attached t any prcedural dcument when submitted t the apprpriate cmmittee fr cnsideratin and apprval. PART 1 1. Assessment Date: 18/12/2015 2. Name f plicy / strategy / service: Sample Acceptance and Rejectin Plicy 3. Name and designatin f Authr: Ian Mellrs, Quality Manager Bld Sciences 4. Names & designatins f thse invlved in the impact analysis screening prcess: Ian Mellrs, Quality Manager Bld Sciences Clintn Blackburn, Labratry Manager Bld Sciences Dave Evans, Labratry Manager Cellular Pathlgy Malclm Hlliday, Labratry Manager Micrbilgy Dr. Jnathan Wallis, Clinical Directr Labratry Medicine 5. Is this a: Plicy x Strategy Service Is this: New Revised x Wh is affected Emplyees x Service Users x Wider Cmmunity x 6. What are the main aims, bjectives f the plicy, strategy, r service and the intended utcmes? (These can be cut and pasted frm yur plicy) This plicy prvides a system fr ensuring that the crrect prcesses are applied fr prcessing, retentin and strage f pathlgical recrds and materials (specimens and samples). T ensure that cnfrmance with guidelines, directives and legislatin is applied and maintained fr this prcedure. T ensure that cdes f ethical cnduct and expected behaviurs are maintained in all prcurement and business matters.

7. Des this plicy, strategy, r service have any equality implicatins? Yes x If, state reasns and the infrmatin used t make this decisin, please refer t paragraph 2.3 f the Equality Analysis Guidance befre prviding reasns: The plicy applies equally and fairly t all users f the Labratry Medicine services and is intended t ensure a cnsistent apprach t sample acceptance and labelling fr all staff, patients and ther service users at all times and under all circumstances. Labratry Medicine is a supprt diagnstic service that will perfrm all tests in its repertire upn request frm service users and will d s impartially and withut prejudice, ensuring equal and fair applicatin t every such apprach made frm whatever authrised and apprved surce. 8. Summary f evidence related t prtected characteristics Prtected Characteristic Race / Ethnic rigin (including gypsies and travellers) Sex (male/ female) Religin and Belief Sexual rientatin including lesbian, gay and bisexual peple Age Disability learning difficulties, physical disability, sensry impairment and mental health. Cnsider the needs f carers in this sectin Gender Re-assignment Marriage and Civil Partnership Maternity / Pregnancy Evidence, i.e. What evidence d yu have that the Trust is meeting the needs f peple in varius prtected Grups The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis The department des nt reject requests n this basis Des evidence/engagement highlight areas f direct r indirect discriminatin? If yes describe steps t be taken t address (by whm, cmpletin date and review date) Des the evidence highlight any areas t advance pprtunities r fster gd relatins. If yes what steps will be taken? (by whm, cmpletin date and review date)

9. Are there any gaps in the evidence utlined abve? If yes hw will these be rectified? 10. Engagement has taken place with peple wh have prtected characteristics and will cntinue thrugh the Equality Delivery System and the Equality Diversity and Human Rights Grup. Please nte yu may require further engagement in respect f any significant changes t plicies, new develpments and r changes t service delivery. In such circumstances please cntact the Equality and Diversity Lead r the Invlvement and Equalities Officer. D yu require further engagement? Yes x 11. Culd the plicy, strategy r service have a negative impact n human rights? (E.g. the right t respect fr private and family life, the right t a fair hearing and the right t educatin? PART 2 Name: Ian Mellrs Date f cmpletin: 18/12/2015 (If any reader f this prcedural dcument identifies a ptential discriminatry impact that has nt been identified, please refer t the Plicy Authr identified abve, tgether with any suggestins fr actin required t avid/reduce the impact.)