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Appendix A - Algorithm for the completion of monthly returns

Description: Algorithm for the completion of monthly returns for VZIG, HBIG200IU, HBIG500IU and RIG/rabies vaccine"PHE Colindale", "UHS Pharm
Url: /Media/UHS-website-2019/Docs/Post-Exposure-Prophylaxis-Policy/AppendixA-Algorithmforthecompletionofmonthlyreturns.pdf

MP000 028 Cellular pathology user handbook v24

Description: University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 1 of 24 Cellular
Url: /Media/UHS-website-2019/Docs/Services/Pathology/Cell-path/MP000-028-Cellular-pathology-user-handbook-v24.pdf

Standing Financial Instructions

Description: These Standing Financial Instructions (SFIs) are issued for the regulation of the conduct of Trust members and officers in relation to all financial matters with which they are concerned.
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Finance/StandingFinancialInstructions.pdf

WGLS (combined) user handbook

Description: University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Wessex Genomics Laboratory Service Wessex Genomics Laboratory Service (WGLS) provides a comprehensive range of genomics services to the Trust, general practitioners and also to other external NHS and private sector organisations. Contents: - click the links or scroll down the page Contents Wessex Genomics Laboratory Service............................................................................................. 1 Key contacts.................................................................................................................................. 2 About our services ....................................................................................................................... 2 Service hours ................................................................................................................................ 2 Services offered............................................................................................................................ 2 Postal Address.............................................................................................................................. 3 Consent.......................................................................................................................................... 3 Service Charges ........................................................................................................................... 3 Information Governance.............................................................................................................. 4 User Feedback ............................................................................................................................. 4 Dealing with Complaints.............................................................................................................. 4 Availability of clinical advice........................................................................................................ 4 Completion of the request form.................................................................................................. 4 Specimen Collection .................................................................................................................... 5 Special advice on sample collection.......................................................................................... 5 Results Reporting......................................................................................................................... 6 Quality Assurance ........................................................................................................................ 6 Laboratory Departments..................................................................................................................... 8 Referral Forms ................................................................................................................................ 11 Other Documents:............................................................................................................................. 11 Page 1 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Key contacts Salisbury Laboratory Email Enquiries Telephone Enquiries Southampton Laboratory Email Enquiries Telephone Enquiries Other Key Contacts WGLS Operations Manager WGLS Quality Manager shc-tr.WRGLdutyscientist@nhs.net 023 81 207100 WGLS_cancergenomics@uhs.nhs.uk 023 81 206638 Charlotte.beard@uhs.nhs.uk Bethany.broadbent@uhs.nhs.uk About our services Wessex Genomics Laboratory Service (WGLS) is part of the Central and South Genomics Laboratory Hub. We provide an accredited genetics and genomics service for a core population of 3 million in the South Central (formerly Wessex) region of England, as well as specialist testing for other centres as part of the NHS Genomic Medicine Service (GMS). We accept samples referred by health care professionals from the UK or abroad, and offer high-quality testing, analysis, interpretation and reporting for a wide range of genetic conditions. Service hours Monday to Friday, 9am to 5pm (Southampton Site) Monday to Friday, 9am to 5:30pm (Salisbury Site) Closed Weekends and Bank Holidays Services offered From April 1st 2021, NHS genetic testing in England is specified by the National Genomic Test Directory and referral criteria should comply with the associated eligibility criteria. Referrals outside the scope of the Test Directory and its associated criteria will not be funded by NHS England and will be subject to a charge. Page 2 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Postal Address Salisbury: Salisbury District Hospital (SDH North) Salisbury Wiltshire SP2 8BJ Southampton: Duthie Link Building, Mail point 225 University Hospital Southampton NHS Foundation Trust Tremona Road Southampton Hampshire SO16 6YD Consent Please see the following document available on the UHS website: Consent to Examination or Treatment: Policy Patients attending venesection services will be asked to give verbal consent prior to blood specimens being collected. All consent is inferred by the laboratory when a sample is submitted having been willing collected from the patient, for example venipuncture or biopsy. In addition to the above, the WGLS (Salisbury) referral forms include the statement “in submitting this sample the clinician confirms that consent has been obtained for testing and storage. Anonymised stored samples may be used for quality control procedures including validation of new genetic tests”. As a result, for any samples received on a WGLS referral form, consent for the testing requested is assumed and that the responsibility of obtaining consent lies with the referring clinician. (This, however, does not preclude the laboratory from contacting the referring clinician, even if consent is evident, if there is a question regarding the appropriateness of the requested test). At WGLS we understand the importance of obtaining consent for genomic testing and the consequences of proceeding with genetic analysis in its absence. Any issues relating to consent are picked up at the sample investigation review stage. Service Charges Each request accepted by the laboratory for examination(s) shall be considered an agreement with the sender. Referrals between NHS England according to the National Test Directory will not be subject to direct payment. Services provided outside of the National Test Directory and services provided to Page 3 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 requestors outside of NHS England will be subject to charge and invoiced on completion of work. Details of test pricing is available on request and service level agreements should be requested. Information Governance All staff working for the Pathology have a legal duty to keep information about patients and staff members confidential and to protect the privacy of individuals. All staff adhere to the Trust’s Data Protection and Confidentiality Policy and are mandatorily required to perform annual Information Governance training. User Feedback We welcome user feedback and appraisal of our service by emailing shctr.WRGLdutyscientist@nhs.net or WGLS_cancergenomics@uhs.nhs.uk and the service has a policy for seeking user feedback by survey. Dealing with Complaints WGLS adheres to the Trust Policy for handling concerns and complaints. All complaints, either raised via Patient Support Services or directly to a member of staff from within the department will be thoroughly investigated and actioned to resolve any identified issues. Availability of clinical advice Clinical Scientists are available during routine working hours to provide help with the interpretation of results and other clinical advice. Completion of the request form The appropriate request form should be downloaded from this site and properly completed. A request form must accompany all specimens sent to the laboratory and should clearly state the following information: • Surname and forename • Hospital /NHS Number • Date of birth • Sex • Ward/Clinic and Consultant code • Type of specimen • Date and time of collection • Investigations required including National Genomic Test Directory Code Page 4 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 • Relevant clinical information with evidence for clinical utility where appropriate • Identification of priority status with reasons for urgency based on clinical need Specimen Collection Samples should be collected into appropriate tubes and sent to the laboratory. Please allow tubes to fill to capacity. Pathology Receptions at Salisbury and Southampton Hospitals are open and able to receive samples 24 hours a day, 7 days a week. Samples should be clearly labelled with at least three points of patient identification. A request form that provides patient information as listed above should accompany samples. Special advice on sample collection Specimen rejection Specimens will be rejected if they are unsuitable for the investigations requested or if the identity of the patient is in doubt. High risk specimens and safety All specimens must be collected into leak resistant containers. The container must be appropriate for the purpose, properly closed and not contaminated on the outside. All specimens are regarded as high risk, but if they are taken from a patient who is known to be infected with a blood-borne agent such as Hepatitis B virus and HIV, another serious infectious disease such as tuberculosis or typhoid, or from those at risk of being infected by one of these agents, then extra care should be taken to highlight this. These specimens should be labelled as HIGH RISK on the request form. Specimen transport All sample containers from a single request are to be sealed into a clear plastic specimen bag by the person taking the sample. Specimen request forms/support documents must not be placed in the same compartment as the sample. UHS specimen transport arrangements: Samples are collected from wards on a frequent basis by the portering service. UHS GP Practice specimen transport and collection arrangements: Samples are collected from surgeries and clinics on a daily basis. For details of frequency and times please contact: Transport Department 140 Mauretania Road Nursling Industrial Estate Page 5 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Southampton SO16 6YS Tel: 023 80748027 Postal/Courier Referrals from Other Laboratories: All referrals if sent by road must be sent in accordance with UN 3373 Biological Substance Category B Packing instruction P650. Please send all referral samples using the postal/courier service of your choice. Results Reporting Validated results are reported electronically to UHS results servers eQuest and ICE. Hard copy reports for valid locations are printed and dispatched every working day either by post or email. Quality Assurance We are a ISO15189 accredited medical laboratory service committed to providing users with a service of the highest quality to meet clinical need. We operate a comprehensive quality management system and aim to produce: • Accurate results • Using appropriate testing strategies • In an appropriate timeframe • With appropriate comment and interpretation to assist clinicians in providing the best management of their patients. Our tests are all fully validated and/or verified internally (as appropriate) to include sensitivity, specificity, measurement uncertainty (where applicable), internal quality control and test limitations/interferences. Test limitations and sensitivity are stated on our reports, where appropriate. Information relating to any of the above validation parameters is available on request. As part of our ongoing commitment to quality standards, we participate in all relevant external quality assessment schemes provided by the following EQA bodies: GenQA (formerly UK NEQAS for Molecular Genetics and CEQAS); Leucocyte Immunophenotyping; Blood Coagulation; Histocompatibility and Immunogenetics; European Molecular genetics Quality Network (EMQN), European Research Initiative CLL (ERIC) and EuroClonality for all of which we typically achieve excellent results. Please contact us for further details if required. Page 6 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 We aim to follow all national best practice guidelines and endeavour to meet NHSE recommended turnaround times. Please consult the National Turn Around Targets to find the reporting times you can expect for your referrals. Quality management, accreditation and external quality assessment Wessex Genomics Laboratory Service (Salisbury) UKAS reference number: 9055 The majority of the tests offered by the laboratory are accredited to ISO15189:2022, Tests currently provided outside the UKAS schedule of accreditation: • SNP array (pending Extension to Scope) • Whole Genome Sequencing (pending Extension to Scope) • FLT3-TKD hot spot by fragment analysis (pending Extension to Scope) • Pan-Haematological NGS panel (pending Extension to Scope) • NGS assays on DNA extracted from formalin-fixed paraffin-embedded (FFPE) material (pending Extension to Scope) • Monitoring of FIP1L1::PDGFRA fusion and other rarer gene fusions associated with eosinophilic MPNs by nested RT-PCR or multiplex genomic DNA analysis (pending Extension to Scope) Wessex Genomics Laboratory Service (Southampton) UKAS reference number: 9194 The majority of the tests offered by the laboratory are accredited to ISO15189:2022, Tests currently provided outside the UKAS schedule of accreditation: • Actionable Solid Organ Panel (pending extension to scope) The full UKAS ISO15189 schedules of accreditation are detailed on the UKAS website https://www.ukas.com/find-an-organisation/ Page 7 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Laboratory Departments Oncology Genetics (Salisbury and Southampton Sites) We offer a comprehensive service for the diagnosis and monitoring of a wide range of haematological malignancies, solid tumours and an expanding number of hereditary and somatic mutation cancers using conventional cytogenetics, FISH and molecular techniques as appropriate. For details, please use the appropriate link: • Sample requirements • Sample prioritisation and reporting times • Full list of tests according to disease subtype Contact: Laura Chiecchio (Salisbury) l.chiecchio@nhs.net Nicola Meakin (Southampton) nicola.meakin@uhs.nhs.uk Pharmacogenomics A range of pharmacogenomic tests are offered by the service including DPYD genotyping. Contact: Nicola Meakin (Southampton) nicola.meakin@uhs.nhs.uk Page 8 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Rare and Inherited Disease Genetics (Salisbury) For a full list of tests conducted by WGLS at Salisbury, see our Rare Disease service list. Samples referred for tests not undertaken at our laboratory may be sent to other accredited centres either within or outside the Central and South Genomics Laboratory Hub. We are also happy to accept private and overseas referrals. Please contact Duty Scientist for details and prices. Pregnancy Loss and Solid Tissue Service (Salisbury) Testing is available for referrals that meet the laboratory’s acceptance criteria, with a tiered testing approach dependent upon the referral details and patient’s obstetric history. Referrals are accepted for: • Pregnancy loss or termination with significant fetal malformations (irrespective of gestation). • Pregnancy loss > 24 weeks. Also, in line with the published guidelines of the Royal College of Obstetricians and Gynaecologists (RCOG): • Miscarriages (<24 weeks) for 3rd and subsequent miscarriages. In compliance with RCOG guidelines the laboratory does not routinely accept referrals for parental karyotyping for couples experiencing recurrent miscarriages. Full details of our referral acceptance policy and the available tests are summarised in our solid tissue service guide. Molecular genetics (Salisbury) A wide range of rare disease molecular genetic tests is conducted within our GLH, including nextgeneration sequencing panels, single gene screens, targeted testing for known or common pathogenic variants, analysis of triplet repeat expansions, methylation studies for imprinting disorders and Xinactivation studies. Please note that from 1st July 2021, testing for certain clinical indications' will be carried out by whole-genome sequencing (WGS). Referrals for carrier testing or pre-symptomatic testing for late-onset genetic disorders will only be accepted from a Clinical Geneticist. Cytogenetics (Salisbury) Constitutive cytogenetic testing investigates the whole genome for loss or gain of chromosomal material and structural rearrangements involving chromosomes in neonatal, paediatric, adult and perinatal cases. A range of tests is conducted at WGLS: Page 9 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 • Microarray Genome-wide chromosomal microarray (CMA) testing (refer to our User guide) detects copy number variants (CNVs). It is a high-resolution test used for patients with, dysmorphism or certain congenital abnormalities, and for fetal losses with specified clinical indications. • Karyotyping Conventional G-banded karyotype analysis is provided for certain referral indications e.g. where a balanced chromosome rearrangement, sex chromosome imbalance, mosaicism, or common trisomy is suspected. It is also commonly used as a reflex test for characterisation of chromosome abnormalities detected by other techniques and for follow-up studies to establish recurrence risks. • Fluorescent in situ hybridization (FISH) FISH testing can detect a gain, loss or rearrangement of a specific region of interest. It is a targeted reflex test for the characterisation of chromosome abnormalities detected by other techniques and for follow-up studies to establish inheritance. • Quantitative fluorescent PCR (QF-PCR) This test is primarily used for the rapid diagnosis of common chromosome aneuploidy syndromes in fetal losses, neonates and paediatric cases, or to determine the genetic sex of a patient. Rare Disease Contacts: simon.thomas1@nhs.net (Molecular Genetics) caroline.price4@nhs.net (Cytogenetics) Page 10 University Hospital Southampton NHS Foundation Trust DOC987 Revision 1/ WRGL 33687 V1.0 Referral Forms Rare and Inherited Disease referral form Rare and Inherited Disease referral form RNA analysis referral form BRCA Mainstreaming referral form Oncology Genetics (Salisbury) Oncology referral form Oncology Genetics (Southampton) MPF9 Solid tumour request form MPF12 HaemOnc request form Pregnancy and Solid Tissues Solid Tissues referral form SPIRE Referrals SPIRE referral form Other Documents: WRGL Website Oncology Guide on Sample Requirements WRGL Website Oncology Guide on Sample Prioritisation WRGL Website Oncology Tests Performed According to Disease Entity WRGL Website Solid Tissue Service Guide Clinicians Guide to the Genomic Medicine Service Requesting Genomic tests using the National Genomics Test Directory and PanelApp for Rare Disease Rare Disease service list WRGL Website Microarray User Guide Page 11
Url: /Media/UHS-website-2019/Docs/Services/Pathology/WGLS-combined-user-handbook.pdf

Papers Trust Board - 10 September 2024

Description: Agenda Trust Board – Open Session Date 10/09/2024 Time 9:00 - 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2024-Trust-documents/Papers-Trust-Board-10-September-2024.pdf

UHS Patient safety incident response plan

Description: Patient safety incident response plan Effective date: 2nd October 2023 Estimated refresh date:2nd October 2024 with informal review after th
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Plans-and-strategies/UHS-Patient-safety-incident-response-plan.pdf

Laboratory medicine user handbook rev 22

Description: University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 Laboratory Medicine Laboratory medicine provides a comprehensive range of pathology services to the Trust, general practitioners and also to other external NHS and private sector organisations. It consists of clinical biochemistry, haematology, blood transfusion and immunology departments. Contents: - click the links or scroll down the page Key contacts Specimen transport About our services Adding additional investigations Availability of clinical advice Results reporting Telephoning of significant results Services offered Service hours Useful clinical information Quality assurance Completion of the request form Click on ‘laboratory medicine investigations’ or ‘pathology test information’ in the downloads section (on the right) for information on laboratory tests Specimen collection Special advice on sample collection Specimen rejection Click on ‘specimen rejection’ in the downloads section for the laboratory policy on sample rejection Click on ‘sample storage and disposal’ in the downloads section for details of sample retention times High risk specimens and safety Key contacts Results/General enquiries for all departments 023 8120 6464 labresults@uhs.nhs.uk Specific departmental contacts: If dialling from outside SGH preface 4 digit numbers with 023 8120, unless full number is given Clinical Biochemistry Helpline (24 hrs) 6427 Revision 22 Page 1 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 Clinical advice e-mail uhs.dutybiochemist@uhs.nhs.uk G3.7 Clinical director Dr Paul Cook 6419 Pathology Operations Director Consultant & Deputy Clinical Lead for Biochemistry Linda Sayburn Nicola Merrett 6435 6434 Lab Medicine Operations Rick Allan Manager 6706 POCT coordinator Haematology and Blood Transfusion Will Rivenberg 6721 Haematology Laboratory 4029 Coagulation Laboratory 4823 Blood Transfusion Lab 4620 Phlebotomy Supervisor Phlebotomy services SGH Clinical Lead Shamaila Tahsin Dr M W Jenner 4821 4874 4438 Laboratory Lead Dr M W Jenner 4438 Haematology Lab Director Dr Seonaid Pye 3162 Consultants Dr M W Jenner (Myeloma, Haematological Oncology, Blood and Marrow Transplantation) 4438 Dr S Narayanan (Myeloma, Haematological Oncology, General Haematology) 4438 Dr D S Richardson (Haematological Oncology, Blood and Marrow Transplantation) 6164 Dr K H Orchard (Haematological Oncology, Blood 4118 and Marrow Transplantation) Dr R S Kazmi (Haemostasis & Thrombosis, Blood 8862 Transfusion, General Haematology) Revision 22 Page 2 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 Dr Robert Lown Dr Sara Boyce Dr Tracy Burt (General Haematology) Wessex Immunology Service Immunology lab Flow Cytometry Immunology Clinic Consultant Immunologist Dr Efrem Eren Consultant Immunologist Dr Sapna Srivastava Consultant Clinical Scientist Dr Alison Whitelegg Consultant Clinical Scientist Dr Karen Smith-Baker Honorary Consultant Prof A Williams G3.7 3556 3556 5831 6615 6640 4001 6650 Mob: 07887812703 5929 2043 6976 6670 About our services Laboratory Medicine provides a comprehensive range of Pathology services to the Trust, General Practitioners and also to other external NHS and Private Sector organisations. Consent Please see the following document available on the UHS website: Consent to Examination or Treatment: Policy Patients attending adult venesection services will be asked to give verbal consent prior to blood specimens being collected. Information Governance All staff working for the Pathology have a legal duty to keep information about patients and staff members confidential and to protect the privacy of individuals. All staff adhere to the Trust’s Data Protection and Confidentiality Policy and are mandatorily required to perform annual Information Governance training. Dealing with Complaints Laboratory Medicine adheres to the Trust Policy for handling concerns and complaints. All complaints, either raised via Patient Support Services or directly to a member of staff from within the department will be thoroughly investigated and actioned to resolve any identified issues. Revision 22 Page 3 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust G3.7 LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 http://staffnet/TrustDocsMedia/DocsForAllStaff/GovernanceAndSafety/HandlingConcernsandComplai ntsPolicy/HandlingConcernsandComplaintsPolicy.pdf Availability of clinical advice Consultants within each discipline are available to provide help with the interpretation of results and other clinical advice. Please refer to 'Key Contacts'. Services offered Clinical Biochemistry provides a full range of laboratory and clinical services incorporating routine biochemistry, lipids, toxicology and metabolism, endocrinology, trace metals and the co-ordination of clinical trial work and point-of-care testing. Renal stone, lipid and bone outpatient clinics are also undertaken. Haematology and Blood Transfusion provide routine Haematology, Blood Transfusion and specialised haemostasis and haemoglobinopathy testing in support of regional and national programmes as well as services to support an expanding bone marrow transplant service. The department also supports a Haemophilia service for both adults and children. Consultant and nurse-led outpatient clinics are undertaken at SGH, RSH and Lymington Hospitals. Day care facilities are available on C3 Hamwic day ward at SGH and at Lymington Hospital. Palliative care is available through Countess Mountbatten House at Moorgreen Hospital. Immunology provides routine immunological analysis into allergy, autoimmunity and protein chemistry as well as specialised analysis for the diagnosis of haematological malignancy and immunodeficiency. Follow this link for Clinical Services Outpatient service details Venesection service - see detail in Service hours (below) Point of care testing. We can provide help and advice on the implementation of point of care testing system such as hand held blood glucose meters. Please contact our POCT coordinator for further information. Service hours Clinical Biochemistry, Haematology and Blood Transfusion laboratories 24-hour service List of tests available 24 hours a day in Haematology and Coagulation Haematology: FBC Retics Revision 22 Page 4 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 ESR G3.7 Glandular fever (IM) screen Blood film Malaria parasite screen Sickle cell test Coagulation: Coagulation screen (CS) INR APTR D-dimer derived fibrinogen Factor assays (with approval from Haematology consultant) G6-PD screen ADAMTS13 Specialist laboratories available Monday to Friday, 9am to 5pm Clinical Biochemistry / Haematology Immunology Blood Tests - Service locations and hours (April 2011) Phlebotomy services are available at Southampton General Hospital and Lymington Hospitals. Details of times and venues are given below: - Location Opening times SGH, C level, South Laboratory Block Monday to Friday,0800 to 1645. Appointments can be booked via www.uhs.nhs.uk/bloodtests SGH, children - Butterfly room, C level Monday to Friday by appointment only, Call 023 8120 2024 Lymington Hospital Monday to Friday, 0730 to 1645. Appointments can be booked via www.uhs.nhs.uk/bloodtests Revision 22 Page 5 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 Royal South Hants Community Monday to Friday 0800 to 1800 Diagnostics Centre Saturdays 0800 to 1530 G3.7 Appointments can be booked via www.uhs.nhs.uk/bloodtests Please note that appointments may be necessary for special procedures such as dynamic function tests Completion of the request form Request forms need to be properly completed. A request form must accompany all specimens sent to the laboratory and should clearly state the following information: • Surname and forename • Hospital /NHS Number • Date of birth • Sex • Ward/Clinic and Consultant code • Type of specimen • Date and time of collection • Investigations required • Relevant clinical information • Identification of priority status. eQuest (electronic requesting) is the preferred method for the requesting of tests in Chemical Pathology, Haematology, Coagulation and Immunology as it leads to quicker processing times and reporting. Specimen Collection Samples should be collected into appropriate tubes and sent to the laboratory. Please allow tubes to fill to capacity. This is especially true of coagulation, where underfilled samples are unsuitable for testing and will be rejected. The laboratories at SGH are open and able to receive samples 24 hours a day, 7 days a week. Samples should be clearly labelled with the patient's name and date of birth. A request form that provides patient information, specimen type and tests required should accompany samples. The requirements for samples for Blood Transfusion are more stringent, due to the prescription nature of the request. Both the sample and request should contain a minimum of the following information: • Full name (no abbreviations) Revision 22 Page 6 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 • Hospital number and/or NHS Number G3.7 • Date of birth • Date and time sample taken • Signature of person taking blood Failure to adhere to Blood Transfusion request guidelines WILL result in the rejection of the request, without exception. A table of specimen requirements for commonly requested tests is provided below: Test Anticoagulant Adult tube top colour Routine Biochemical profile, lipids, etc. Serum Separator Tube (SST) with Gel Gold Glucose Fluoride Oxalate Grey HbA1c EDTA Mauve FBC and ESR EDTA Mauve Coagulation Citrate Sky Blue Immunology investigations Serum Separator Tube (SST) with Gel Gold Lithium Serum Separator Tube (SST) with Gel Gold Group and Save/Crossmatch EDTA Pink NT-Pro BNP Lithium Heparin Green ACTH EDTA Mauve PTH Lithium Heparin Green HIT screen Serum Red For all the above tubes, please ensure that the maximum fill is attained. Failure to do this may mean that the laboratories are unable to perform certain tests. When using UHS electronic requesting system eQuest, it is imperative that the request-generated barcodes are of good quality (i.e. they are complete with a clear gap at either end), are attached to the correct sample and are attached straight, along the length of the tube, NOT around it. Failure to observe these instructions WILL lead to delays in processing and testing samples. Revision 22 Page 7 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 Special advice on sample collection The information below is intended to provide advice on patient preparation and specimen collection for specific tests where results may be affected by these factors: Faecal Immunochemical Testing (FIT) Requesting source should contact the lab for FIT sampling kits and advice. Glucose Tolerance Test GTTs on Non-pregnant patients can be performed by the Venesectors in Pathology Outpatients. G.P.s who wish to use this service should send the patient, with a completed request form for a GTT to the Venesectors at Pathology Outpatients at 0845 on Monday, Tuesday, Wednesday and Friday morning. (Please note that Thursday is not possible due to large haematology clinics that morning.) Clinicians with hospital beds should arrange for their juniors to do the tests on the wards. In pregnancy GTT's are carried out at Princess Anne Hospital in the antenatal Day Unit by special arrangement, telephone 023-8079-6303. These are generally requested by the Obstetrician at P.A.H. The patient must have taken an unrestricted diet, including adequate carbohydrate, for at least 3 days prior to the test. The patient must be fasted for 10-16 hours before the test begins (plain water only allowed) and for the duration of the test. It is therefore convenient to commence the test first thing in the morning. Cryoglobulins Prior to taking a blood sample, please contact the immunology lab to collect a flask containing water maintained at 37°C. The sample must be taken and returned to the laboratory within 1 hour of the flask being collected in a plain tube (Red topped) and must arrive by 1.30pm to allow time for processing. Trace Elements sample requirements Urine samples Random urine samples/plain 24-hour urine aliquots should be collected into Sterilin universal containers or other suitable trace element-free containers. Whole blood samples 2mL Teklab lithium heparin tubes (paediatric samples) Greiner sodium heparin for Trace Elements Analysis Vacuettes (adult samples) External laboratories Revision 22 Page 8 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 If sending serum/plasma samples, whole blood samples should be collected as stated above, and then spun and separated into trace-element free polycarbonate tubes (these should not have rubber gaskets/O-rings in the lid as they are sources of contamination). For any queries, please contact the Trace Elements laboratory: uhs.traceelements@uhs.nhs.uk Sweat tests Current Cystic Fibrosis unit sweat collection procedure Sweat Test Process • Identify patient • Select forearm (avoid cuts) • Cleanse skin with steret • Wipe skin with sterile water & gauze • Attach gel discs to each probe (only touch if wearing gloves) • Apply red probe to lower arm and secure with straps • Apply black probe to lower arm but higher than red probe • Switch machine on • Machine will beep when finished (after 5 mins) • Remove black probe • Remove red probe • Throw both gel discs away • Cleanse arm with sterile Water & Gauze • Attach collection plate to area previously covered by the red probe • Push down (should see blue dye appear to confirm working) • Secure with straps • Cover with bandage/cling film • Leave for 30 minutes or until 3-4 clear blue rings seen in window • Flip plastic cover off collection plate • Pull plastic tubing out of collection plate and cut at base • Use plunger to push sweat collected into collection pot • Put small collection pot into specimen bottle & send to Trace Elements lab with specimen form. N.B. We measure sweat chloride only in this laboratory. Creatinine Clearance test Collect a special urine collection bottle from the laboratory; this contains a small amount of thymol as a preservative. Patient empties bladder; discard this urine and note the time on the bottle. Revision 22 Page 9 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 For the next 24 hours every drop of urine passed by the patient must be added to the bottle. Advise the patient to pass urine before opening their bowels if necessary. 24 hours later, empty bladder again and add to the collection, and note the time. The collection does not have to be exactly 24 hours, but we must know the exact times of starting and ending the collection (to the nearest minute). At any time during the urine collection take a venous blood sample into a lithium heparin tube for plasma creatinine estimation. Separate request cards must be written to accompany the urine sample and blood sample. 5-HIAA For 24 hours prior to starting the using collection patients should refrain from eating or drinking any of the items listed below or any food or drink containing these items: Broccoli, Cauliflower, Brussel Sprouts, Egg Plants, Mushrooms, Citrus Fruits and Tomatoes (including juices), Bananas, Avocados, Plums, Passionfruit, Pineapple, Alcohol (wine and beer), Processed meats (loaves, salami, sausages, ham), Fish, Seafood, Nuts, Seeds, Berries and Caffeine (including products containing chocolate). Specimen rejection Specimens will be rejected if they are unsuitable for the investigations requested or if the identity of the patient is in doubt. This is to prevent misleading results being reported that could lead to inappropriate patient management. The Laboratory Medicine specimen rejection policy contains full details and can be accessed using the link located in the downloads section of this web page. High risk specimens and safety All specimens must be collected into leak resistant containers. The container must be appropriate for the purpose, properly closed and not contaminated on the outside. All specimens are regarded as high risk, but if they are taken from a patient who is known to be infected with a blood-borne agent such as hepatitis B virus and HIV, another serious infectious disease such as tuberculosis or typhoid, or from those at risk of being infected by one of these agents, then extra care should be taken to highlight this. These specimens should be labelled as HIGH RISK on the request form. Specimen transport All sample containers from a single request are to be sealed into a clear plastic specimen bag by the person taking the sample. Specimen request forms/support documents must not be placed in the same compartment as the sample. UHS specimen transport arrangements: Samples are collected from wards on a frequent basis by the portering service. However, using the pneumatic tube delivery (POD) system improves sample turnaround times and reduces pressure on Revision 22 Page 10 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 portering staff. The system cannot be used for blood and blood products for transfusion, nor for Cellular Pathology samples that are immersed in liquid formalin fixative. It should also not be used for: - · Sputum samples · CSF samples for xanthochromia (? SAH) The system should be used for all other Pathology samples including blood cultures. All samples for Laboratory Medicine should be sent to POD station number 8355 GP Practice specimen transport and collection arrangements: Samples are collected from surgeries and clinics on a daily basis. For details of frequency and times please contact: Transport Department 140 Mauretania Road Nursling Industrial Estate Southampton SO16 6YS Tel: 023 80748027 Adding Additional Investigations Immunology: Cell based assays only viable for 48 hours. Serological tests - please note that requests for retrospective testing can be made up to 3 weeks ONLY after the sample has been taken, subject to the sample volume remaining being sufficient and the nature of the retrospective request Clinical Biochemistry: Specialist Biochemistry, Endocrinology investigations: 3 weeks Automated investigations: 24 hours Trace Element: 1 Month Urine drug screen - one month Chromatography investigations: 1 month Blood Transfusion: Depends on 'sample validity '. A sample is valid for 7 days when stored at 4C as long as the patient has not been transfused in the last month. If patient has been transfused in last month, the sample is only valid for 72 hours from when the transfusion started or must not be more than 72 hours old when transfusion begins. Kleihaur can be added up to 7-days. Revision 22 Page 11 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 Coagulation: Test to be added INR, CS, DD, Lupus Anticoagulant APTR Thrombophilia screen Factor assays, Protein C/S, Antithrombin, Thrombin Time, Von Willebrand antigen, Collagen Binding assay, Ricof, Platelet aggregation, PFA 100, Thromboelastogram, Any other specialist coagulation test Time limit 12 hours 4 hours Not possible to add 1 hour after venesection Not possible to add Automated Haematology: Test to be added FBC, IM (glandular fever) screen, Haemoglobinopathy screen, Sickle cell screen, Film, ESR, Reticulocyte, nucleated RBC Malaria parasite screen G-6-PD screen Time limit 1 day 1 day Needed fresh 1 day If the required investigation is not listed above, please contact the relevant laboratory Results Reporting • Validated results are reported electronically to UHS results servers eQuest and ICE. • Electronic reports are produced for GP sources every 2 hours 05:00-22:00 for delivery via EDI PMIP services. • Hard copy reports for valid locations are printed and dispatched every working day, including Saturdays. Telephoning of significant results Revision 22 Page 12 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 Samples may be "fast tracked" and results telephoned back when necessary. Results for these samples will normally be available within 2 hours of receipt in the laboratory. Please call ext. 8890 and provide patient's details so that the sample may be identified. Occasionally unexpected abnormal results are produced. If this occurs, laboratory staff will endeavour to telephone these results to the requesting source. Useful clinical information Common causes of spurious results Please ensure that you follow instructions when collecting and storing samples. Inappropriate sample collection, storage and transport can interfere with a number of results. Same examples are given in the table below: Problem Common causes Effect Incorrect tube fill/mixing Delay in separation of plasma overnight storage delay in transit ALL analytes may be compromised Increased K, PO4, LDH Storage Biochemistry samples in a fridge Increased K Haemolysis Expelling blood through a needle into the tube Vigorous shaking Increased K, PO4, ALT, LDH, Mg, Iron Extremes of temperature Inappropriate collection site Sample taken from drip arm Increased drip analyte e.g. K , Glucose Dilution effect low results Incorrect container or anticoagulant No fluoride oxalate E.D.T.A. contamination Decreased glucose Decreased Ca Increased K Li sample collected into Li Heparin Increased Li Revision 22 Page 13 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 Hormone profiles PROBLEM MALE PATIENTS Erectile dysfunction Infertility Gynaecomastia/ galactorrhoea FEMALE PATIENTS ? Menopause {?PCO; hirsutism;virilisation;alopecia Amenorrhoea/oligomenorrhoea Infertility Galactorrhoea APPROPRIATE REQUESTS LH FSH Prolactin Testosterone (08.00-10.00H) LH FSH Prolactin Testosterone (08.00-10.00H) LH FSH Prolactin HCG Testosterone (08.00-10.00H) Oestradiol; thyroid function tests (LFT's & renal profile) For women 11.1 mmol/L or 2) A fasting plasma glucose concentration > 7.0 mmol/L or 3) A 2-hour glucose post 75g oral GTT of > 11.1 mmol/L A GTT should not be necessary if the fasting plasma glucose is > 7.0 mmol/L, but this needs to be confirmed on another occasion if the patient has no symptoms. Patients with impaired fasting glycaemia ("IFG") (fasting plasma glucose > 6.1 but less than 7.0 mmol/L) should be assessed with an oral GTT. Impaired glucose tolerance ("IGT") is defined as a fasting plasma glucose of 7.8 but 5 mmol/L Possible causes (rare genetic causes excluded) Spurious 1. Haemolysed samples Revision 22 Page 15 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED. University Hospital Southampton NHS Foundation Trust LABORATORY MEDICINE G3.7 Laboratory Medicine user handbook rev 22 G3.7 2. Delay in separating plasma from cells - the ideal is within 1 hour of venepuncture. Values after 6 hours are unacceptable 3. Samples refrigerated at 4 C 4. Unusually cold weather - potassium leaks into plasma during transport 5. Collection into inappropriate tubes (e.g. fluoride tubes used for glucose; potassium EDTA tubes for blood counts) 6. Vigorous mixing 7. Patients open and close their fist repeatedly during venesection 8. Very high white cell counts: > 2000 x 109/L (leukaemias) 9. Very high platelet counts: > 1000 x 109/L 10. Abnormally permeability of red cells: cold agglutinins; infectious mononucleosis; inherited red cell membrane defect (rare) True hyperkalaemia Normal kidneys excrete excess potassium promptly - within hours. Hyperkalaemia generally occurs with renal failure plus another factor. Life-threatening hyperkalaemia is almost always encountered in those with impaired renal function. Drugs 1. Potassium supplements 2. Potassium sparing diuretics - triamterene; amiloride; spironolactone 3. Drugs that interfere with the renin/aldosterone axis: a. ACE inhibitors—e.g. captopril; enalapril b. ACE 11 receptor blockers- e.g. losartan; candesartan c. nonsteroidal anti-inflammatory drugs d. heparin; tacrolimus; cyclosporin; trimethoprim-sulphamethoxazole e. Drugs that inhibit membrane ATPase -digoxin; β-Blockers Combinations of the above are particularly risky Diet 1. Potassium-containing salt substitutes (low salt) 2. High potassium foods if end-stage renal failure Acute renal failure: Especially if catabolic—sepsis; injury; intravascular haemolysis; GIT bleed Chronic renal failure: If no other exacerbating factors potassium may be maintained until GFR 7.5 mmol/l) :muscle weakness; paraesthesiae; rarely: flaccid paralysis Risk increases with rising potassium but there is not close correlation - patients with chronic renal failure may be more resistant ECG abnormalities are the best guide to risk plasma potassium (mmol/L): rough correlation [1] 6.5-7.0 Peaked T waves [2] 7.0-8.0 Prolonged P-R interval; flattening then loss of P waves; Widening of QRS complexes with deep S waves [3] > 8.0 Sine wave pattern progressing to ventricular fibrillation then cardiac arrest [4] > 10.0 Generally fatal Can progress rapidly from [1] to [3], particularly if plasma sodium or ionised calcium is low Hyperkalaemia with peaked T waves is serious Hyperkalaemia with more advanced ECG changes is life-threatening Low plasma potassium 3.0 mmol/L Potassium supplements or potassium sparing drugs are advised with diuretics if: · pre-treatment potassium is 3.0 – 3.2 mmol/L · potassium falls to 3.0 – 3.2 mmol/L after 4 weeks on diuretics · the patient has a potassium-losing disorder (e.g. cirrhosis, nephrotic syndrome; chronic diarrhoea) Replacement of a serious body deficit takes a long time. Quality Assurance All Pathology departments have a mature quality management system, as described in the Pathology quality manual. The following departments are UKAS accredited medical laboratories: Department of Haematology & Blood Transfusion. UKAS accreditation number: 8149 Department of Clinical Biochemistry UKAS reference number:8483 Department of Immunology UKAS reference number: 8696 (The UKAS ISO15189 schedule of accreditation are detailed on the UKAS website https://www.ukas.com/find-an-organisation/ Please refer to the attached document G3.7a laboratory medicine investigations for the accreditation status of individual tests We are accredited for training Biomedical Scientists and Clinical Scientists by the Health Care Professions Council (HCPC). Revision 22 Page 19 of 19 IF THE FIRST PAGE OF THE PROCEDURE DOES NOT HAVE RED “APPROVED METHOD” STAMP IN THE FOOTER – THAT PROCEDURE PRINTED COPY IS UNCONTROLLED.
Url: /Media/UHS-website-2019/Docs/Services/Pathology/Lab-med/Laboratory-medicine-user-handbook.pdf

Papers Trust Board - 15 July 2025

Description: Agenda Trust Board – Open Session Date 15/07/2025 Time 9:00 - 13:00 Location Conference Room, Heartbeat Education Centre Chair
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-15-July-2025.pdf

STH816 v1 Department of infection user handbook

Description: Microbiology and Specialist Virology Services User Handbook STH816/02-25 Issued Date 23.07.2025 Authorised by R. Allen Page 1
Url: /Media/UHS-website-2019/Docs/Services/Pathology/STH816-v1-Department-of-infection-user-handbook.pdf

Records management policy

Description: Records Management Policy Date Issued: Review Date: Document Type: 9 May 2018 19 April 2021 Policy Version: 6 Contents Paragraph 1 2 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 4 5 6 7 8 9 Appendices Appendix A Appendix B Appendix C Executive Summary Introduction, Scope and Purpose Definitions Details of Procedure to be followed Regulatory and legal framework The Records Information Lifecycle Record Creation Handling and Using Records Record Closure and Retention Appraisal Disposal Additional Guidance on Specific Record Types Roles and Responsibilities Related Trust Policies Communication Plan Process for Monitoring Compliance/Effectiveness of this Policy Arrangements for Review of this Policy References Page 2 3 4 5 5 6 6 7 9 10 11 11 13 14 14 15 15 15 Page 17 21 22 Record Creation and Filing Procedures Medical Record Keeping Standards List of Record Types listed in NHS retention Schedule Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Page 1 of 26 Executive Summary 1. There is a need to manage Trust records efficiently and effectively to support day to day operational and business activity and meet certain legal requirements. As we create and collect increasing amounts of information about our patients, staff and business activities it is vital that are able to organise, securely store and retrieve this information when required. 2. As we manage the incremental change from traditional/paper based record keeping to electronic/ digital systems we encounter new challenges, however the key principles of records management outlined in this policy continue to apply to these new storage mediums. Where different or additional guidance is required this is provided. 3. This policy is structured to provide staff with guidance on managing records through their life cycle from creation to disposal. Adherence to this guidance will support all aspects of Trust business and help the Trust comply with its duties as a public body subject to the Public Records Act (1958) and the Freedom of information Act (2000). 4. The Records/Information Life Cycle describes a regime designed to ensure information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. The cycle is illustrated in this diagram: 5. In summary this policy: Defines duties and responsibilities in regard to records management in the Trust Outlines the key legal obligations and statutory provisions that apply to records created and used within the Trust Provides a procedural Framework with guidance to encourage best practice in records management within the Trust Describes the `Information Life Cycle' and highlight best practice to be followed at each stage of the cycle from creation to disposal. Page 2 of 26 1. Introduction, Scope and Purpose 1.1 Introduction 1.1.1 Records Management is the process by which an organisation manages all the aspects of records whether internally or externally generated and in any format or media type, from their creation, all the way through to their lifecycle to their eventual disposal The Trust's records are its corporate memory, providing evidence of actions and decisions and representing a vital asset to support daily functions and operations. Records support policy formation and managerial decision-making, protect the interests of the Trust and the rights of patients, staff and members of the public. They support consistency, continuity, efficiency and productivity and help deliver services in consistent and equitable ways. Adherence to the guidance provided in this Policy will provide the Trust with a number of benefits including: better use of physical and server space; better use of staff time; improved control of valuable information resources; compliance with legislation and standards; and reduced costs. This document sets out a framework within which Trust records can be managed and controlled effectively, and at best value, commensurate with legal, operational and information needs. 1.1.2 1.1.3 1.1.4 1.2 Scope 1.2.1 This policy applies to Trust records held in any format including: Paper Photographs slides and other images Microform microfich and microfilm Audio and video tapes, cassettes CD ROM etc Computerised records Scanned records Text messages and social media Websites and intranet sites that provide key information to patients The majority of Trust members of staff will create records during the course of their day to day activity. Aspects of this policy will therefore apply to most members of staff, with specific responsibilities applying to department heads and managers for the management of local records created stored or held in their areas of responsibility. At the time of publication of this policy preparations are being made to ensure the Trusts compliance with the implementation of the European Union General Data Protection Regulation (GDPR) in May 2018. To date no direct impact on the records procedures outlined in this policy has been identified as a consequence of the introduction of GDPR. As these preparations progress any identified changes required to records management policy and procedure will be made. The Trust is also in the process of changing to a digital format of medical record recording and storage using the Onbase Electronic Document Management System (eDMS). An incremental roll out of the system to care groups has started but is at an early stage. 1.2.2 1.2.3 1.2.4 Page 3 of 26 1.2.5 1.2.6 This policy makes an occasional reference to this significant change and the key principles for records management outlined in this policy (storage, retention etc) still apply to the records created and stored in Onbase. As the incremental roll out of Onbase eDMS progresses and operational procedures are finalized this policy will be reviewed and the need for changes to be made or additional operational policies and procedures to be published will be agreed and implemented. 1.3 Purpose 1.3.1 The purpose of this policy is to: Define duties and responsibilities in regard to records management in the Trust Outline the key legal obligations and statutory provisions that apply to records created and used within the Trust Provide a procedural Framework with guidance to encourage best practice in records management within the Trust Describe the `Information Life Cycle' and highlight best practice to be followed at each stage of the cycle from creation to disposal. Definitions 2. Term Records Management Meaning Applied in this Policy A set of activities required for systematically controlling the creation, distribution, use, maintenance, and disposition of recorded information maintained as evidence of business activities and transactions. Record Information created, received and maintained as evidence and information by an organisation and person, in pursuance of legal obligations or in the transaction of business. (ISO Standard 154891:2016). General Data Protection European Union Directive which will replace the Data Protection Act Regulation (GDPR) (1998) in UK law, enforceable from 25th May 2018. Designed to harmonise data protection regulation across the European Union. Electronic Document A software program/system that manages the creation, storage and Management System control of documents electronically. (eDMS) Information Life Cycle A term that describes a controlled regime in which information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. Public Authority An organisation within the categories listed in Schedule 1 to the Freedom of information Act defined as `a body that appears to be exercising functions of a public nature or who are providing, under contract with a public authority, any service whose provision is a function of that authority. The Trust is a Public Authority. Metadata Data that describes information about other data. e.g. author and creation date of a record are elements of its metadata. Record Classification Means by which a record keeping system arranges or organises Scheme records to enable appropriate management controls to be applied and support accurate retrieval of information. e.g. a filing index. Page 4 of 26 Public Records Administrative and departmental records belonging to Her Majesty, in the UK or elsewhere, in right of Her Majesty's Government, and in particular records of or held in any government department and records of offices, commissions or other bodies under HMG in the UK. (Public Records Act 1958). All Trust records are public records subject to the Public Records Act (1958) Data Subjects An individual who is the subject of personal data. Patient Administration Electronic system used to hold non clinical details about Trust System (PAS) patients (demographics, GP details, contacts etc). Electronic Clinical A module of the Trust PAS used to record the movement of patient Record Tracking (eCRT) Health Record Folders within UHS and partner organisations. Record closure The process followed to make a record inactive when it has ceased to be in active use other than for reference purposes. Record retention The process of keeping a record for a period of time for administrative, legal, fiscal, historical, or other purposes. Record appraisal The process of deciding what to do with a record when the business use has ceased. The outcome of record appraisal will be either: destroy/delete, retain for a further period or transfer to a Place of Deposit. The National Archives A non-ministerial department, and the official archive and publisher (TNA) for the UK Government, and for England and Wales. TNA publishes advice and guidance on information and records management. Place of Deposit (POD) Record Archive storage location appointed by the Secretary of State for Culture Media and Sport. Usually a public archive service provided by a Local Authority. Corporate Records Records of business processes such as accounting, procurement, staff management and estates maintenance. In NHS organisations this term covers all records that are not patient/care records. Permanent preservation A process followed to place a record in an archive storage location allowing public access to records of historical administrative or local importance. Record Disposal The destruction, deletion or transfer for permanent preservation of a closed record British Standard 10008- The British Standard that outlines best practice for the 2014 Evidential Weight implementation and operation of electronic information and Legal Admissibility management systems, including the storage and transfer of of Electronic Information information. Information Governance An umbrella term relating to the processes and systems used by organisations to manage the information they hold. In the context of the NHS, it specifically refers to the processes and procedures used to ensue confidentiality, security and accuracy of information. 3. Details of Procedures to be Followed 3.1 Regulatory and Legal Framework 3.1.1 Under the terms of the Public Record Act 1958 all records created in the Trust are regarded as public records. The act imposes a statutory duty on the Trust to make arrangements for the safe keeping and eventual disposal of records. The ownership and copyright of records created within Trust lies with the Trust and not the individual who has created them. Page 5 of 26 3.1.2 3.1.3 3.1.4 As a Public Authority subject to the Freedom of Information Act the Trust has a duty to follow the Code of Practice for Records Management published by the Lord Chancellor in accordance with section 46 of the FOIA. The code provides guidance to public authorities on keeping, managing and destroying records. The Data Protection Act sets in law how personal and sensitive information may be processed and largely influences the way we handle care records. Further guidance on the confidentiality aspects of record keeping is provided in the NHS Confidentiality Code of Practice and the Trust Data Protection and Confidentiality Policy. The Records Management Code of Practice for Health and Social Care 2016 provides records management guidance for NHS and Social Care organisations based on current legal requirements and professional best practice. The Trust is committed to following the guidance issued in the code of practice and the procedures outlined in this policy are largely based on the guidance included in this Code of Practice. 3.2 The Records Information Lifecycle 3.2.1 The records or information lifecycle is a term that describes a controlled regime in which information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. The cycle is illustrated in figure 1 Figure 1. The Information Lifecycle 3.2.2 Procedural guidance associated with each stage of the cycle is included in subsequent sections 3.3 Record Creation 3.3.1 ISO 15489-1:2016 Information and Documentation � Records Management describes the characteristics of `Authoritative Records' as being authentic, reliable integral and useable. Table 1 below expands on these definitions. Page 6 of 26 Table 1. Record Characteristics Record Characteristic Authentic How to Evidence It is what it purports (claims) to be To have been created or sent by the person purported to have created or sent it and To have been created or sent at the time purported. Full and accurate record of the transaction/activity or fact Created close to the time of transaction/activity Created by individuals with direct knowledge of the facts or by instruments routinely involved in the transaction /activity. Complete and unaltered Protected against unauthorised alteration Alterations after creation can be identified as can the persons making the changes. Located, retrieved, presented and interpreted The context can be established through links to other records in the transaction/activity. Reliable Integrity Useable 3.3.2 3.3.3 3.3.4 3.3.5 By organising records in a file system or classification scheme elements of `Metadata' are associated with each record which helps maintain the characteristics described above. Metadata in its simplest form would identify the creator, creation date and subject of a record but can be expanded to include additional information such as destruction date, identifiers and accessibility. Classification schemes can be a simple arrangement of files and folders on a Network drive increasing in sophistication up to a full blown Electronic Document and Records Management System such as the Onbase edMS being introduced to store patient records in the Trust. All Trust records should be stored within an appropriate classification/filing system after creation. This will ensure they remain secure and accessible from the outset and be available to support Trust business activity. A more comprehensive guide for users covering the creation and filing of records is attached at Appendix 1. 3.4 Handling and Using Records 3.4.1 Record Keeping 3.4.1.1 When completing entries in or creating any form of records the following general guidance should be applied: Be factual, consistent and accurate Write clearly and in such a way that text cannot be erased Write in such a way that any alterations or additions are dated, timed and signed in such a way that the original entry can still be read. Page 7 of 26 3.4.1.2 Healthcare professionals may be subject to additional record keeping codes of practice set by their professional bodies. The Academy of Medical Royal Colleges has published a set of generic medical record keeping standards which are reproduced at Appendix 2. All entries in Trust care records should conform to these standards. 3.4.1.3 Rights granted to members of the public by the Freedom of Information Act and to patients and staff under the Data Protection Act can result in copies of corporate records being placed in the public domain and data subjects obtaining copies of records containing information about them. Providing record entries are factual and accurate and personal records do not include any unnecessary and/or derogatory comments record disclosure should not create any additional issues. 3.4.2 Confidentiality and Access 3.4.2.1 All Trust records are public records and thus are subject to a number of statutory provisions regarding confidentiality, access and disclosure. Patients entrust the NHS or allow it to gather sensitive information relating to their health and other matters as part of their seeking treatment. They do so in confidence and they have the legitimate expectation that staff will respect this trust. It is essential, if the legal requirements are to be met and the trust of patients is to be retained, that the NHS provides, and is seen to provide, a confidential service. 3.4.2.2 Specific guidance on patient confidentiality issues is provided in the Trust Data Protection and Confidentiality Policy. Further advice on all aspects of patient confidentiality and the application of the Data Protection Act (1998) on the way we handle records in the Trust can be obtained from the Trust Information Governance Manager. 3.4.2.3 The Data Protection Act (1998) makes provision in law for `data subjects' (e.g. patients and members of staff) to obtain copies of otherwise gain access to information held about them. The Trust Access to Records Policy covers this aspect of records management and further advice on the procedure can be obtained from the Trust Information Governance manager. 3.4.2.4 In 2000 the government introduced the Freedom of information Act providing members of the public with the general right of access to recorded information held by a wide range of bodies across the public sector. The effect of this legislation is to make it possible for people to obtain copies of a wide range of Trust records that in the past would have remained confidential. The Trust Freedom of Information Policy covers this aspect of records management and further advice on the procedure can be obtained from the Trust Information Governance manager. 3.4.3 Record Tracking 3.4.3.1 Ideally the movement and location of all records should be controlled to ensure that a record can be retrieved at any time and there is an auditable trail of record transactions. This is best achieved using some form of record tracking system to record the movement of records between locations. 3.4.3.2 It is the policy of the Trust that patient health record folders are tracked using the PAS record tracking component (electronic casenote record tracking e-CRT.) Users are provided with training to use e-CRT prior to being granted access to the system. 3.4.3.3 While electronic records do not require tracking as such, control must be exercised when hard copies are produced. If separate clinical casenotes are produced from electronic systems to form a filing system individual record movements should be tracked to aid retrieval and avoid loss of data. 3.4.3.4 For most areas, where movement of records is restricted, paper based systems may be employed, using registers or tracer cards to record the relevant information. Page 8 of 26 3.4.3.5 When making arrangements to move records which contain personal or sensitive information to destinations external to the Trust (including archive storage) consideration needs to be given to security and confidentiality and a means of dispatch chosen that affords an adequate level of security. (See Trust Data Protection Policy for further guidance.) 3.4.4 Record Storage 3.4.4.1 When not required for operational purposes records should be kept in a secure storage area. Records in current use should ideally be stored close to the point of use while records no longer in current use can be transferred to secondary or archive storage more remote from the operational area. 3.4.4.2 Records should be stored in an appropriate environment to ensure they remain fit for purpose during their expected period of retention. When evaluating the suitability of a location for record storage the following points should be considered: Environment. Is the location suitable for the type of material being stored? Is the area free from hazards that may cause the records to deteriorate or place at risk staff that may need to access the records? i.e. excessive dust, damp, restricted access. Security. Is the level of security offered by the location acceptable for the type of record being stored? Ease of Access. Can records be easily located and retrieved? Some restrictions on access may be acceptable for records that are not frequently recalled. Layout. Consideration should be given to the design of the storage location to ensure the most cost effective use is made of the space available. 3.4.4.3 External storage companies provide an alternative to local storage and in the short term can prove a cost effective alternative in areas where record storage space is at a premium. The Trust has negotiated a contract for external record storage with a Restore, a national provider with storage premises located a few miles East of Southampton. Advice on external storage options and alternative strategies such as archiving records to digital formats can be obtained from the Trust records manager. 3.4.4.4 A comprehensive record should be maintained of any records sent for commercial storage including a proposed date for review/destruction. A mechanism for reviewing these records for disposal should be developed and implemented to ensure records are not retained longer than necessary. 3.4.4.5 Digital information should be stored in such a way that throughout the lifecycle it can be recovered in an accessible format. Over time such changes as migration to new formats can cause links to other documents and embedded documents to fail to open impacting the integrity of the record. Any changes to the electronic storage systems used to hold Trust records should only take place after full consideration of the impact on the records held and successful testing of retrieval of transferred records from the new version/system. 3.5 Record Closure and Retention 3.5.1 A record should be closed when the business use for that record ceases. Following closure NHS records are subject to a minimum period of retention. The length of the retention period varies by record type and is based on legal and regulatory requirements and the assessed importance of and likely need to access the type of record. Certain types of corporate records (e.g. finance, meeting records etc) will follow annual cycles with existing records closed following year end and new records created for the new year (calendar or financial). 3.5.2 Page 9 of 26 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 Paper record folders should be clearly marked with the date of closure and planned review/disposal date. Closed records in electronic storage systems should hold this information as part of the record's metadata and/or the record moved to another area of the system reserved for closed records. For patient care records the recognised date of record `closure' is normally the date of the patient's last attendance for treatment. Where a patient has died subsequent to treatment at the Trust the retention period applicable to deceased patient records (8 years) may be applied from the date of death, if this results in a shorter retention period. Minimum retention periods for NHS and Social Care records are set out in Appendix 3 of the Code of Practice which can be accessed via this link: https://digital.nhs.uk/codes-of-practice-handling-information Periods of retention between 6 months and 20 years are listed for NHS record types organised by functional groups. A list of the NHS record types with minimum retention periods listed in the Code of practice is reproduced at Appendix 3. The majority of adult patient health records are subject to a minimum retention period of 8 years. Health records for Children, Obstetric records, mental health (including psychology) records, and records recording treatment for cancer are all subject to longer periods of retention. The period of retention is measured from the start of the calendar year following the record closure date. e.g. record closed 1 July 2017 subject to 5 year retention period. Period starts 1 Jan 2018 and ends 31 Dec 2022. The code of practice lists minimum periods of retention and in most cases it will be appropriate to destroy records immediately once the period has expired. Retention beyond the recommended period is permitted with good reason but if personal data is held `longer than necessary' the Trust may breach a provision of the Data Protection Act. The Public Records Act 1958 states no public record can be retained after closure for a period in excess of 20 years without permission from the Sec of State for culture Media and Sport. However, a legal exemption applies for individual NHS staff and patient records to meet the extended (20 years plus) periods of retention listed for these records in the Code of Practice. 3.6 Appraisal 3.6.1 When the minimum retention period for a record or set of records has passed it should be subject to an appraisal. The purpose of the appraisal process is to: Identify records of public interest worthy of permanent preservation by transfer to The National Archives or a local Place of Deposit. Identify records to be retained for a longer period To confirm that records not meeting above criteria should be deleted or destroyed. A small percentage of Trust records will meet the criteria for selection for permanent preservation. The preservation of a small subset of key records is designed to enable the public to understand the working of the Trust and the impact on the population it serves and to preserve information likely to have long term research value. The Code of Practice includes guidance on the records that should be considered for preservation in the schedule of minimum retention periods. The suggestions for consideration include Trust Board and other key committee papers, key policies and strategies and records of major building works. 3.6.2 3.6.3 Page 10 of 26 3.6.4 3.6.5 The process of selection of key corporate records for permanent preservation will be managed by the Trust Records manager and the Director of Corporate Affairs who will agree with the Trust's local Place of Deposit (POD), Southampton City Archives, which Trust records merit transfer. Clinical records are problematic to preserve permanently in an archive and due to confidentiality issues personal health records cannot normally be accessed by the public for considerable periods of time following transfer. This does not prevent appropriate sets of clinical records being considered for permanent preservation and the Code of Practice provides some specific guidance on this process. 3.7 Disposal 3.7.1 Following appraisal any records not selected for permanent preservation or a longer retention period should be disposed of. No information should be destroyed if it is the subject of a request under the DPA and/or FOIA or any other legal process, such as an inquest following a death. Paper records should be destroyed securely through a local process of cross cut shredding or using the Trust confidential waste disposal service or other similar secure disposal service. Destruction of digital information is more challenging. At present there are two ways of permanently destroying digital information and these are either: overwriting the media a sufficient number of times or the physical destruction of the media. Further advice about the destruction of digital records can be obtained from the Trust Informatics service. Where decisions are made to destroy/dispose of a series or bulk number of Trust records a record of the decision and the details of the records disposed of should be maintained. 3.7.2 3.7.3 3.7.4 3.8 Additional Guidance on Specific Record Types 3.8.1 E-Mail 3.8.1.1 Personal e-mail accounts tend to be structured according to personal preference and the data stored is not searchable and organised in a systematic way, making e-mail accounts unsuitable for record storage purposes. 3.8.1.2 E-mail accounts should not be used to file records on a permanent basis but should be regarded as transient storage areas for working documents. E-mails or documents distributed by e-mail that need to be retained as Trust records should be copied to the appropriate paper or electronic registered file system and the e-mail copy destroyed as soon as practicable. 3.8.1.3 Where email is declared as a record or as a component of a record, the entire email must be kept including attachments so the record remains integral - for example an email approving a business case must be saved with the business case file. Emails that are the sole record of an event or issue, for example an exchange between a clinician and a patient, should be copied in to the relevant clinical record rather than being simply deleted. 3.8.2 Scanned Records 3.8.2.1 Where paper records are scanned, the main consideration is that the information can perform the same function as the paper counterpart did, and like any evidence, scanned records can be challenged in a court. This is unlikely to be a problem provided it can be demonstrated that the scan is an authentic record and there are technical and organisational means to ensure the scanned records maintain their integrity, authenticity and usability as records, for the duration of the relevant retention period. Page 11 of 26 3.8.2.2 Complying with the standard, `BS 10008 Electronic Information Management Ensuring the authenticity and integrity of electronic information' provides one method of ensuring and demonstrating that electronic information remains authentic. The scanning of Trust patient records for inclusion in the Onbase eDMS patient record system is being carried out in accordance with this standard. 3.8.2.3 For smaller scale local record scanning projects compliance with the full scope of BS 1008 will not be the appropriate methodology. Methods that can be employed to ensure that scanned records can be considered authentic include: A written procedure outlining the process to scan, quality check and any destruction process for the paper record Evidence that the process has been followed An audit trail or secure system that can show that no alterations have been made to the record after the point they have been digitised Fix the scan into a file format that cannot be edited such as Portable Document Format (PDF). 3.8.2.4 Providing scanning is carried out to an acceptable standard with an element of quality assurance included in the process it is Trust policy and normal practice that original documents should be destroyed after scanning. This prevents issues with two versions of the same record existing (original and scanned) and maximises the benefits accruing from scanning paper records. 3.8.2.5 There may be some local exceptions to this practice with appropriate justification. 3.8.3 Staff Records 3.8.3.1 Staff records should hold sufficient information about a staff member for decisions to be made about employment matters. The nucleus of any staff file will be the paperwork collected through the recruitment process and this will be expanded over time with additional material added by line managers. 3.8.3.2 Upon termination of contract, records must be held up to and beyond the staff member's statutory retirement age. On contract termination line managers should return the employees file to HR department for retention until the employee's 75th birthday or 6 years after leaving whichever is the longer. To reduce the burden of storage a summary record may be prepared and held. 3.8.4 Records of non NHS Funded Patients 3.8.4.1 Records of individuals who are not NHS funded held in the Trust record keeping systems must be kept for the same minimum retention periods as other records outlined in this Code. The same levels of security and confidentiality will also apply. 3.8.5 Adopted Persons Health Records 3.8.5.1 The records of adopted persons can only be placed under a new last name when an adoption order has been granted. Before an adoption order is granted, an alias may be used, but more commonly the birth names are used. 3.8.5.2 Depending on the circumstances of the adoption there may be a need to protect from disclosure any information about a third party. Care must be exercised when disclosing records of adopted patients because of the heightened risk of accidental disclosure. 3.8.5.3 It is important that any new records, if created, contain sufficient information to allow for a continuity of care. At present the patients GP will initiate any change of NHS number or identity if it was considered appropriate to do so, following the adoption. The Trust would then make changes to its own records in line with that initiated by the patient's GP. Page 12 of 26 3.8.6 Health Records of Transgender Patients 3.8.6.1 Patients considering or undergoing gender identity change may ask for changes to their name they are known by to be made and in most cases the Trust will agree to such a request. 3.8.6.2 A patient can request that their gender be changed in a record by a statutory declaration, but this does not give them the same rights as those that can be made by the Gender Recognition Act 2004. 3.8.6.3 The formal legal process (as defined in the Gender Recognition Act 2004) is that a Gender Reassignment Certificate is issued by a Gender Reassignment Panel. At this time a new NHS number can be issued and a new record can be created, if it is the wish of the patient. 3.8.6.4 Except in a limited set of circumstances it is an offence under the gender recognition act to disclose without consent information that would identify that a person has undergone a gender identity change. 3.8.6.5 The key to the successful management of records in these circumstances is to discuss with the patient their choices and agree what they wish to happen in respect to their health record. If a new health record is being created there is a need to identify which records are moved into the new record and to discuss how to link any records held in any other institutions with the new record. 4. Roles and Responsibilities 4.1 Chief Executive 4.1.1 As accountable officer the Chief Executive is responsible for the overall leadership and management of the Trust and its performance in terms of service provision, financial and corporate viability, ensuring that the Trust meets all its quality and safety, statutory and service obligations and for working closely with other partner organisations. The CEO delegates aspects of this responsibility to relevant Executive Directors according to their organisational portfolios. 4.2 Director of Transformation and Improvement 4.2.1 The Director of Transformation and Improvement is the appointed Executive Director with responsibility for Information Governance including records management and is the Trust Senior Information Risk Owner (SIRO). The SIRO is responsible for managing information risk in the Trust and will implement and lead the NHS Information Governance risk assessment and management processes within the Trust and advise the Board on the effectiveness of information risk management. 4.2.2 4.3 Caldicott Guardian 4.3.1 The Trust Caldicott Guardian is the Director of Nursing who has a particular responsibility for reflecting patients' interests regarding the use of patient identifiable information. The Trust Caldicott Guardian is responsible for ensuring patient identifiable information is shared in an appropriate and secure manner. The duties and responsibilities of the Trust Caldicott Guardian are outlined in the Trust Confidentiality and Data protection Policy. 4.3.2 Page 13 of 26 4.4 Trust Records Manager 4.4.1 The Trust Records Manager is responsible for ensuring that this policy is implemented and that the records management system and associated processes are developed, co-ordinated and monitored. The Trust Records Manager is also responsible for the overall development and maintenance of health records management practices and promoting compliance with this policy in such a way as to ensure the easy, appropriate and timely retrieval of patient information. 4.4.2 4.5 Local Managers 4.5.1 The responsibility for local records management is devolved to divisional, care group and department heads whom retain overall responsibility for the management of records generated by their activities, i.e. for ensuring that records created within their unit are managed in a way which meets the aims of the Trust's records management policy and associated procedures. 4.6 Clinical Leads and Matrons 4.6.1 Clinical leads in all professions have a responsibility to ensure clinical staff they manage who contribute to patient health records are adequately trained in record keeping and are aware of and adhere to the standards for record keeping outlined in this policy. 4.7 All Staff 4.7.1 Members of Staff who create, receive and use records have records management responsibilities. In particular all staff must ensure that they keep appropriate records of their work in the Trust and manage those records in keeping with this policy and with any guidance subsequently produced. Staff who make entries in medical records should do so in accordance with the clinical record keeping standards published in this policy. In addition Royal Colleges and other professional bodies publish record keeping guidance for clinical staff and it is the responsibility of clinical staff to ensure they keep up to date with and adhere to relevant legislation, case law and national guidance. Related Trust Policies 4.7.2 5. 5.1 The following Trust policies overlap with or relate to matters covered in this policy Information Governance Policy Data Protection and Confidentiality Policy Freedom of Information Policy Access to Records Policy Subject Access Policy IM&T Security Policy Incident Management Policy Patient Information and Corporate Identity Policy Web Publishing Policy 6. Communication Plan Page 14 of 26 6.1 The publication of this updated policy will be highlighted to staff via an article on the news section of `Staffnet', the Trust intranet. The article will draw attention to the key changes made to the previous policy version. 6.2 A copy of this policy will be available for staff to access via the policies section of Staffnet and links to the policy will also be provided within the records management section of the Information Governance pages of Staffnet. 6.3 Elements of record training and procedure form part of the annual training for information governance (now known as data security training) which forms part of the Trusts annual mandatory training requirement. 7. Process for Monitoring Compliance and Effectiveness 7.1 The purpose of monitoring is to provide assurance that the agreed approach is being followed � this ensures we get things right for patients, use resources well and protect our reputation. Our monitoring will therefore be proportionate, achievable and deal with specifics that can be assessed or measured. Key aspects of the procedural document that will be monitored: What aspects of compliance with the document will be monitored Compliance with Record handling best Practice and guidance What will be reviewed to evidence this How and how often will this be done Detail sample size (if applicable) Who will coordinate and report findings (1) Which group or report will receive findings Incidents reported with record related cause codes Medical records procedures for retrieval and tracking Medical Record Keeping Standards Sample or record movements recorded on Trust PAS Entries in sample of Trust inpatient medical records Ongoing monitoring carried out by local governance leads and Trust Records Manager Quarterly audit carried out by Medical Records Manager Annual Audit as part of Trust Clinical Audit programme. N/A Local governance leads and Trust Records Manager Serious breaches will be reported to the Information Governance Steering Group 25 records per quarter Medical Records Manager Information Governance Steering Group 100 records plus Audit managed by Trust Clinical Audit Manager and local Divisional audit leads Clinical Effectiveness Steering Group Where monitoring identifies deficiencies actions plans will be developed to address them. 8. Arrangements for Review of the Policy 8.1 This policy will be subject to formal review three years after publication unless significant changes in legislation or NHS guidance dictate an earlier review. Minor updates will be made as and when required. Page 15 of 26 8.2 If as a result of the full adoption of GDPR legislation into UK law on the 25th May 2018 a further amendment to this policy is required then this will be carried out. See para 1.2.3 above. 9. References Public Records Act (1958) Freedom of Information Act (2000) Data Protection Act (1998) General Data Protection Regulation Records Management Code of Practice for Health and Social Care 2016 Academy of Medical Royal Colleges' Standards for the clinical structure and content of patient records Chancellor's Code of Practice on the management of records issued under section 46 of the Freedom of Information Act (2000). The National Archives BS 10008 Electronic Information Management - Ensuring the authenticity and integrity of electronic information Appendices A. B. C. Record Creation and Filing Procedures Medical Record Keeping Generic Standards Categories of Records listed in NHS Retention Schedule Page 16 of 26 Appendix A to Records Management Policy User Guide to Record Creation Introduction 1. This guide primarily covers records created for non care purposes as the procedure for creating and filing patient records is part of the training given to users of the Patient Administration System. The key principles apply to all records however. 2. Although most records in the Trust are created and stored electronically some paper based record keeping systems are still in use. Most of the guidance provided in this document can be applied to both forms of records but where this is not the case users will need to exercise judgment when applying the guidance. 3. Common types of documents such as letters, meeting minutes, Job Descriptions etc should be always be created using the Trust Word Templates set up for these document types. When creating documents staff should take note of the guidance about document style contained in the Trust Patient Information and Corporate Identity Policy available on the Trust Intranet. 4. All records created in the Trust should be included in a record keeping filing system and be given a unique title or name to identify it. When creating records users need to consider the need for privacy markings and version control. The guidance set out in the following sections addresses these requirements and provides guidance in their application. Record Filing Systems 5. Records created in both electronic or paper form should be organised in some form of registered fling system so they can be easily located when needed and documents of a similar or linked nature are kept together. Filing systems can be created and organised using a variety of methods. Probably the most common method is a simple alphanumeric system whereby records are grouped together in folders that are given unique names. The folders are then organised/ordered in alphanumeric fashion in draws/cabinets (paper records) or within Trust HQ/Divisional/Care Group hard Drives (electronic records) 6. When designing and developing filing systems the following points should be considered: a. b. c. Retain control and continuity by restricting the number of staff who can create new folders in the system. Organise folders and sub folders in a logical manner that will make sense to those who need to access records within them. e.g. organised by function or teams. Give each folder a clear title that describes the contents within. e.g. `MeetingsDiv Board2009', `ComplaintsPatients200804to200906. Avoid names like `General', `Miscellaneous' or personal titles like `Jane's Folder'. (See next section for more details on file names) Within folders records are normally filed in chronological order by date of creation or receipt. It is good practice to clearly stamp on the front or all documents received the date of receipt. Folders in hard copy filing systems should be marked with the date the folder was opened and when closed the date of closure. When files are closed the date when the folder should be reviewed prior to disposal (usually at the end of the minimum retention period) should be added. In electronic filing systems these pieces of information can often be added to the metadata for the folders created. d. e. Page 17 of 26 f. g. A regular programme of reviews should be established to consider the need for closure and disposal of records/folders. The frequency of these reviews will largely depend on the size and growth rate of the filing system. A summary of the responsibilities, organisation and conventions used for each filing system should be set out in a document that is made available to all those who access the system. Folder and File Naming/Referencing Conventions 4. Names for folders and documents should be kept as short as possible whilst also being meaningful. Long file names create long file paths and links which increase the likelihood of error and are more difficult to remember. Avoid using personal names and codes and abbreviations that are not commonly understood. e.g. use `H&SCtteeTOR.doc' in preference to `Health_&_Safety_Comittee_Terms of_Reference.doc' 5. When creating sub folders and files within electronic filing systems there is no need to include in the file name descriptive information already contained in the parent folder as this will already form part of the filename/file path. e.g. use: not: `/.../DivBoard/agenda20100210' `/.../DivBoard/DivBoardagenda20100210 6. Avoid using spaces and underscores in file names. Some software packages have difficulty recognising file names with spaces. Use capital letters to delimit words. e.g. use `AuditMeetingsAgendas.doc' in preference to `Audit_Meetings_Agendas.doc' 7. When using a number in a file name always give it as a two digit number so that when it is displayed in the file directory in alphanumeric order it will be ranked in the correct order. Organised alphanumerically `ab2' will be listed after `ab10'. e.g. V01, V02, V03 etc not V1, V2, V3. 8. If using a date in the file name always state the date `back to front' and use four digit years, two digit months and two digit days: YYYYMMDD or YYYYMM or YYYY or YYYYYYYY. Writing dates in this way will present the records in chronological order in the file list with the latest record at the end of the list. e.g. use `20100201agenda.doc' not `1Feb2010Agenda.doc' 9. The elements of the file name should be ordered in the most appropriate way to retrieve the record. If records are retrieved by date the date element should appear first, if retrieved according to description then this should appear first. e.g. `20100201agenda.doc' (date retrieval) or `agenda20100201' (subject retrieval). Protective Marking of Documents 10. The NHS has agreed a scheme of classification using two privacy markings; Page 18 of 26 a. NHS CONFIDENTIAL. This classification should be used for paper and electronic documents containing personal identifiable clinical or NHS staff information and other sensitive information the compromise of which could lead to serious consequences for the Trust. The marking should be included at the top centre of every page of the document and documents so marked should be held and transported securely at all times. (The term NHS CONFIDENTIAL should never be used on correspondence to a patient.) b. NHS RESTRICTED. This classification should be used to mark all other sensitive information. Documents marked NHS RESTRICTED may also be endorsed with a suitable descriptor indicating the reason for the classification. A list of these descriptors is shown in the table below. The marking should be included at the top centre of every page of the document and documents so marked should be kept in lockable containers. 11. When classifying documents regard should be paid to the requirements of the Freedom of Information Act 2000. Careful consideration should be given to classifying documents that would be normally be published or disclosed on request.. Protective markings should wherever possible only be applied to documents that would be exempt from disclosure. Table 1 Categories of NHS RESTRICTED Documents Category Appointments Barred Board Commercial Contracts For Publication Management Personal Policy Proceedings Definition Concerning actual or potential appointments not yet announced Statutory prohibition on disclosure exists or disclosure would constitute contempt of court. Documents considered by an organisation's Board of Directors, initially in private. Where disclosure would be likely to damage a third party commercial undertaking's processes or affairs Concerning tenders Where it is planned that the information will be published at a future date. Concerning policy and planning affecting the interests of a groups of staff Concerning matters personal to the sender or recipient Issues of approach or direction on which the organisation needs to take decision. Information the subject of or concerned in a legal
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