CHESHIRE PATHOLOGY SERVICES

Transcription

1 CHESHIRE PATHOLOGY SERVICES Laboratory Department Handbook January 2016 Clinical Lead / Laboratory Director Pathology Service Manager Dr R Rajendran Vikki Sandland Tel No: Tel No: (3453) Leighton Hospital Middlewich Road Crewe CW1 4QJ Tel: (01270) Fax: (01270) Pathology Handbook Page 1 of 94 Version 7

2 TABLE OF CONTENTS Page Contacts List 4 General Information 6 Laboratory and Mortuary Location and Hours, Leighton Hospital laboratory 6 Transport of Samples 7 Completion of request forms and specimen labelling 7 Urgent samples 8 Danger of infection specimens 8 Accessing results 8 Tests sent to other Laboratories 8 Additional tests on samples already submitted for examination 8 Ordering laboratory consumables/request forms 8 Research 8 Emergency out of hour s Laboratory services 9 Range of investigations 10 Laboratory s policy on protection of personal information and complaint procedure 11 Phlebotomy Services 12 Clinical Chemistry 14 Opening hours 15 Urgent requests 15 Reporting times 15 Requests 15 High risk cases 16 Sample containers 16 Reference ranges 16 General test information 17 Drug assays 17 Lipids 18 Blood gases 18 Urine 18 Patient Instructions for 24hour urine collection 19 Faeces 19 Cerebrospinal & other fluids 19 Diabetes diagnosis & monitoring 20 Thyroid function tests 21 Adrenal function 21 Specialised endocrine tests 21 Sex hormone investigations 22 PSA (prostate specific antigen) 23 Renal disease 23 Sweat tests 24 Troponin I 24 Alphabetical list of biochemistry tests 24 Clinically significant changes in results 29 Graph to assess severity of paracetamol overdose 30 Critical abnormal results 31 Sample collection notes 32 Iron studies and ferritin 32 Haematology and Blood Transfusion 33 Specimen requirements for Haematology 34 Normal ranges 35 Turnaround times 36 Telephone results 37 Thrombophilia (Prothrombic) screening 37 Referred test requirements 38 Anticoagulation 43 Pathology Handbook Page 2 of 94 Version 7

3 Blood Transfusion 45 Procedure for requesting Blood and Blood products 45 Specimen requirements 45 Prescribing Blood products 48 Transfusion reactions 48 Management of Severe/Acute Transfusion Reaction 49 Guidelines for Adult Transfusion (non Oncology patients) 50 Maximum blood order schedules 51 Referred Tests 54 Histopathology/Cytology/Morbid Anatomy 57 Histopathology 57 Request forms 57 Tissues for routine Histopathology 57 Formalin spillages 58 Transport of Histology specimens 58 Verbal Reports 58 Accessing reports 59 Frozen section service 59 Immunofluorescence service 59 Muscle biopsies for potential Myopathy 59 Alopecia Biopsies 60 MDT (Multi-Disciplinary Team) Meetings 60 Turnaround times 60 Referral Sites 60 Cytology 64 Diagnostic Cytology 64 Semen Analysis 65 Turnaround times 66 Morbid Anatomy 67 Transfer of deceased persons to the Mortuary 67 Viewing of deceased persons 67 Hospital Post-Mortems 67 Coroners Post-Mortems 68 Common misconceptions and difficulties 68 Cremation Forms 69 Medical Microbiology 70 Test requesting 71 Urgent specimens 72 Urgent investigations available on call 72 Collection and transport of specimens 73 Lumbar Puncture (LP, CSF) 73 MRSA screens 73 Nose, throat and pernasal swabs 74 Respiratory specimens 75 Aspirates (pleural, joint, peritoneal, pelvic) 75 Tissues/biopsies 76 Pus/wound swabs 76 High vaginal, cervical and urethral swabs 77 Specimens for Chlamydia antigen tests 78 Semen analysis 78 Eye specimens 79 Investigation of keratitis/corneal ulcers 80 Cutaneous specimens (hair, skin, nail) for fungal isolation 80 Urine specimens 81 Faecal specimens 83 Collection of enterobius vermicularis eggs 84 Blood cultures 85 Antibiotic assay of blood 86 Therapeutic drug level monitoring reference ranges 86 Serological and immunological investigations 87 Disposal of materials used in specimen collection 88 Turnaround times 89 Appendix 1 List of non-biochemistry tests sent to other laboratories 90 Pathology Handbook Page 3 of 94 Version 7

4 CONTACTS LIST ENQUIRY CONTACT EXTENSION NUMBER Pathology Service Manager Vikki Sandland 3453 Pathology Information Technology Manager Jason Peters 3886 Pathology Service Lead Governance Carol Tonge 3913 Pathology Help Desk General enquiries/routine results 2345 BIOCHEMISTRY Consultant Clinical Scientist Sarah Robinson 2376 Principal Clinical Scientist Sam King 3885 Service Lead Ian Johnson 3454 HAEMATOLOGY/BLOOD TRANSFUSION Consultant Haematologist (Clinical Advice) Dr G Tarkovacs 8019 Secretary Clinical Nurse Specialists Tonia Ward Tracy Howe Karen Bowyer Laboratory (including Senior Biomedical 2645 / Scientists) Service Lead Jack Flevill Blood Transfusion Manager Diane Benson 2647/3726 Transfusion Practitioner Lesley Adams 3217 Oral Anticoagulation Service Julie Salisbury 2781/3285 Anticoagulation Coordinator Ann Jones 3285 MICROBIOLOGY Clinical Advice Line 3370 Consultant Microbiologists Dr M A T O Donoghue 3683 Dr V Panagea 3713 Secretary Claire Norbury 2236 Microbiology enquiries HISTOLOGY/CYTOLOGY Clinical Advice (Consultant Histopathologists) Dr D Butterworth 2642 Dr N Nasir 2624 Dr A Nicol 3762 Dr J Stafford 2627 Histology Laboratory 2629 Diagnostic Cytology Preparation Room 8143 Service Lead Julie Crawford 3730 Histology and Diagnostic Cytology Results and enquires Histology Secretaries Joanne Lauszkin (PA to Dr Stafford, Dr Nasir and Dr Nicol) Wendy Parry (PA to Histopathology Consultant Team) Cheryl Senior (PA to Dr Butterworth) Pathology Handbook Page 4 of 94 Version 7

5 MORTUARY General Enquiries 2250 Coroner s Office Warrington Town Hall Coroner s Officers PHLEBOTOMY Phlebotomy GP appointments (27)3568 Phlebotomy Manager Donna George (27)3592 SUNDRIES ORDERING Non-routine blood tubes, specimen bottles, report forms, etc Path Lab Stores (11am-1pm) Fax number Formalin pots/buckets Histology Lab MCHFT Internet site Information for users can be found using the following link, including; user surveys, newsletters and an additional link for GPs. Pathology Handbook Page 5 of 94 Version 7

6 GENERAL INFORMATION Laboratory and Mortuary Location and Hours, Leighton Hospital Laboratory All Pathology departments are accredited by United Kingdom Accreditation Service (UKAS) against standards for Medical Laboratories Requirements for quality and competency (ISO 15189:2012). Current schedules of tests accredited for each department within Pathology are available on the UKAS web site using the following link: Enter the Accreditation number from the box below for the Department required and press Search. Select Medical Laboratories if given an option. UKAS Accreditation Numbers MCHFT ECHT Haematology 8056 Haematology 8075 Biochemistry 8083 Biochemistry 8047 Cellular Pathology 8039 Microbiology 8064 The laboratory is located on the first floor of the hospital. From the main entrance take the stairs ahead, Pathology is to the left and the route is signposted. The Mortuary is located on the ground floor of the hospital. From the main entrance, walk to the left of the stairs then at the entrance to the corridor turn right. At the crossroads turn left. The Mortuary is on the left hand side half way down the corridor. Microbiology is now provided from a combined Department at Macclesfield District General Hospital. Phlebotomy is located in the main outpatient hall and is signposted with Pathology (Blood Tests) signs. The Laboratory at Leighton is open from 9.00 am to 5.00 pm Monday to Friday for all routine Haematology, Blood Transfusion and Biochemistry services and a reduced service from 9.00am to noon on Saturday morning and Bank Holidays. The Microbiology laboratory at Macclesfield is open from 9.00am to 8.00pm Monday to Friday and 9.00am to 5.30pm at weekends and Bank Holidays. Outside of these hours Haematology, Blood Transfusion and Biochemistry departments are staffed 24 hours per day and Microbiology has an emergency on call service. Haematology, Blood Transfusion and Biochemistry can be contacted via the bleep system; Microbiology staff may be contacted via switchboard. Histopathology and Cytology departments are open 9.00am to 5.00pm from Monday to Friday. No routine service is available outside these hours or Bank Holidays. The Mortuary is open 8.30am to 4.30pm Monday to Friday. Porter access to Mortuary is 24 hours. A Mortuary Technician is on call at all times contactable via switchboard. A Consultant is available for each department to provide clinical advice outside routine hours. They are contactable via switchboard. A clinical advice line for Microbiology is available 9am to 5pm Monday Friday (excluding Bank Holidays). The clinical advice line number is Pathology Handbook Page 6 of 94 Version 7

7 TRANSPORT OF SAMPLES From within the Hospital Specimens should be brought to the pathology specimen reception. They must be transported in sealed plastic bags with the request card placed in the secondary compartment. When the entrance is closed specimens can be posted into a collection box through a letterbox. Please note that histology specimens from main and minor theatres should be brought directly through to Histology lab rather than Pathology specimen reception, and must only be delivered from Monday to Friday, 9am to 5pm. From outside the hospital Specimens are collected daily Monday to Friday from General Practitioners and outlying hospitals by a courier service. All samples are transported in accordance with the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009, which requires that all specimens in biohazard bags are transported appropriately to the laboratory in the approved containers provided. Please ensure the lids are fastened. Times of collection are available from the Pathology Office. Spillages of samples during Transportation In the unlikely event of a spillage during transportation please contact the laboratory immediately for advice on (2345). COMPLETION OF REQUEST FORMS AND SPECIMEN LABELLING NB: Blood samples for cross matching and group/screen MUST be labelled by hand, by the person collecting them computerised labels are NOT accepted. Request forms for all blood and blood products must be handwritten, ICE request forms or computerised labelled request forms will not be accepted. Computerised forms for Group and Save tests, however, will be accepted but the blood samples must still be hand labelled. It is essential that all specimens received in the laboratory have sufficient, clearly legible information to allow positive identification and correct interpretation. All samples must be labelled with: - (a) (b) (c) (d) (e) SURNAME FORENAME Date of birth NHS number (the MCHFT hospital number will only be used if the NHS number is not available) All Blood Transfusion samples must be labelled with the MCHFT hospital number due to the Electronic blood tracking system. NB: Specimens with insufficient data will be rejected except under extenuating circumstances. For Transfusion all identifiers must be provided in hand-written format. Clinicians should usually make requests via the Anglia ICE electronic requesting system. Where this is not available, manually completed paper request forms may be used. STANDARD ADDRESSOGRAPH LABELS MUST NOT BE USED to label blood samples as these labels will get caught up in the analysers. Please use ICE stickers or label the samples manually. All samples must be accompanied by an appropriate request form bearing the following information: - (a) Patient details i.e. first and last name, date of birth, NHS number, Hospital Number and address (b) Ward/location, Consultant/GP for return of report (c) For manual requests, the legible signature/name stamp of the person making the request (please use ID stamp) (d) Appropriate/relevant clinical information as outlined in the Health and Safety Executive Safety Notice HID all staff requesting diagnostic testing must ensure that clinical details supplied on Pathology request forms contain clear information regarding the nature of test being requested and sufficient detail to inform laboratory staff upon the safety precautions they need to take in order to process the specimen without risk of infection. Pathology Handbook Page 7 of 94 Version 7

8 (e) Sample type and date and time of collection (f) If computerised labels are used for patient identification one must be attached to each part of the form The above details are required to protect patients, reduce errors and conform to: - National Patient Safety Agency Guidance Medical laboratories Requirements for quality and competence - ISO 15189:2012 standard Institute of Biomedical Science guidance for specimen acceptance criteria MCHFT Patient Identification Policy HANDWRITTEN AMENDMENTS TO ELECTRONIC REQUESTS WILL NOT BE PROCESSED Urgent Samples If a sample is urgent please ensure that this is marked clearly on the request form and that the laboratory is contacted in advance of the specimen being sent. If the lab is not contacted, samples marked urgent will be prioritised according to workload pressures. Danger of Infection Specimens When a specimen is collected for a patient who may have a disease that could be a hazard to laboratory staff for example, Hepatitis, HIV or TB the request form and specimen MUST carry a yellow Danger of Infection sticker. Such samples must be contained within approved sealed specimen request bags. Please ensure all relevant clinical information (including foreign travel) is included on the request so potential high risk samples can be identified and effective Health and Safety procedures initiated. Please refer to HSE Safety Notice HID ( ACCESSING RESULTS Results can be viewed on the wards via the Clinisys Web Browser; there is a link on the Intranet homepage labelled Pathology. GP results are usually ed, but they can also be accessed using the ICE system which also includes results requested by the hospital. Please refer to specific departmental sections for a guide as to what will be telephoned. TESTS SENT TO OTHER LABORATORIES A list of referred tests and laboratories is available in Appendix 1, but most externally referred biochemistry tests are listed separately in biochemistry section 24. These reports should be filed in the patient s notes and can be viewed within hospital locations using Therefore (previously ADOS). Instructions are available on request. ADDITIONAL TESTS ON SAMPLES ALREADY SUBMITTED FOR EXAMINATION Additional tests on blood samples will only be performed on receipt of an add-on test request form available on the intranet site/frequently used forms/pathology. Samples for Biochemistry examinations are kept for a maximum of 1 week. Haematology samples can only be kept for 24 hours. For blood transfusion tests and all non-blood samples contact the individual laboratories concerned to seek advice on the possibility of performing further tests on specimens already submitted. Incomplete forms may delay processing. D Dimer requests need to be performed within 4 hours of collection. ORDERING LABORATORY CONSUMABLES/REQUEST FORMS Orders for routine blood bottles must be placed with NHS Supplies along with your other ward orders. Non routine bottles can be ordered using the Sundries Order Form for Ward Supply found in Frequently Used Forms on the Intranet. Please do not contact on-call staff. Certain consumables are only issued by individual departments. Formalin pots and Bouin s fixative from Histology, transport medium for FNA samples from Cytology, Corneal scrape kits from Microbiology. Contact the individual department for further supplies. RESEARCH If research projects are undertaken that result in additional work for the laboratory, funding will be required. Please seek advice from the appropriate Consultant Pathologist. Evidence of ethical approval will be required. Pathology Handbook Page 8 of 94 Version 7

9 EMERGENCY OUT OF HOURS LABORATORY SERVICES The service is for URGENT investigations only and must be used only when tests are necessary for the immediate treatment of patients. Specimens that are not urgent should be sent to the laboratory in normal working hours. For Biochemistry and Haematology the out of hours service operates from hrs to hrs on weekdays, from hrs on Friday to hrs on Monday and the whole of bank holidays. Contact during these times is by bleep only. For Microbiology the out of hours service operates from Macclesfield from hrs to hrs on weekdays, from 17:30 to 0900 hours on weekends and bank holidays. Results from Microbiology on-call investigations will be telephoned on completion. Please note that the out of hours Microbiology Service is an emergency on call service and staff are not on site outside routine working hours. Please see Microbiology section for details on how to access the service. Results of routine tests are NOT available by telephone out of hours. Authorised reports can be viewed via the Clinisys Web Browser or ICE Requesting / Reporting system. To contact a Biomedical Scientist (BMS) out of normal hours: - Biochemistry bleep 2920 Haematology bleep 2647 Please see Microbiology section NB: B-hCG please contact the Biochemistry BMS You MUST notify the laboratory before sending Blood Gases, urgent work, Cross Matches or any requests where tests are needed in life-threatening situations. IMPORTANT please observe Do not send urgent samples without first contacting the on-call BMS. If Biochemistry/Haematology samples are semi-urgent (i.e. require analysis soon but not immediately) it is not necessary to bleep staff based on site. Please be aware that the bleep may not be answered immediately as the on-call staff may be busy with tests that cannot be interrupted. Your call will be returned. Pathology Handbook Page 9 of 94 Version 7

10 RANGE OF INVESTIGATIONS Please remember that the fewer tests you request the more quickly the result will be available. By asking for only the absolute minimum of investigations, you will help us to respond more quickly to life-threatening emergencies. Your help in this regard is much appreciated. The following tests can be carried out outside normal laboratory working hours when required for the immediate treatment of the patient. See Appendix 1 for non-biochemistry Referral Tests (for biochemistry, these are listed in section 24). Haematology/Blood Transfusion Blood Groups and antibody screens Issue of red cells Issue of blood products, including fresh frozen plasma, platelets and cryoprecipitate. Issue of batch products (i.e. Albumin, Anti-D, PCC) Direct Coombs Test Full Blood Count (FBC) Reticulocytes ESR Blood Film Prothrombin time Activated Partial Thromboplastin time Fibrinogen (must be requested separately as it is not part of the routine coagulation screen) D-Dimer ** Coagulation samples must be filled to the frosted line. Underfilled/Overfilled samples are unsuitable as they give inaccurate results** Sickle cell screening I.M. Screen Malarial parasites Factor VIII/IX Biochemistry CSF Glucose and Protein Renal, liver, bone and protein profiles Bilirubin neo-natal Glucose Amylase Creatine Kinase (CK) Lactate Dehydrogenase (LDH) Blood gases Salicylate Paracetamol Troponin I hcg CRP Urate Gentamicin Theophylline Digoxin Lithium Ammonia Lactate Iron (for overdose only) Microbiology (at Macclesfield) CSF Ascitic fluids (only for diagnosis of SBP) Joint aspirates Pus from deep head and neck collections (e.g. orbital abscess, retropharyngeal collections) Please note that antibiotic assays other than Gentamicin (now undertaken in Biochemistry) are not available unless agreed with Consultant Microbiologist. Exceptionally other investigations may be carried out if clinical indications justify them and doctors will be asked to discuss the need with the appropriate Consultant Pathologist. Pathology Handbook Page 10 of 94 Version 7

11 COMPLAINT PROCEDURE We realise that there may be times when we do not always get things right. On these occasions we welcome your feedback as this helps us to improve the services we provide. If you have any problems with any aspect of the Pathology Services, please tell us by contacting a member of Pathology staff (refer to contacts list on page 4). If you wish to make a complaint, the Customer Care Team will advise you on what you need to do and who to contact. If you feel that you have made every effort to try and resolve your concerns directly with the staff or through the Customer Care Team, but this has not been successful you may decide to make a formal complaint. If this is what you decide to do then it is important to do this as soon as possible; this should be normally within twelve months of the event. You can make a formal complaint by letter, telephone or by Write to: The Customer Care Manager Leighton Hospital Middlewich Road Crewe, Cheshire CW1 4QJ Telephone: Fax: customercareteam@mcht.nhs.uk Visit the MCHFT website for further information on the customer care team and complaints procedure PROTECTION OF PERSONAL INFORMATION MCHFT takes the security of personal information very seriously. Everyone working for the NHS has a legal duty to keep information about patients confidential. Patients health information is protected through a number of measures; all Trust staff are required to: a. Record patient information accurately and consistently b. Keep patient information private c. Keep patient information physically secure d. Disclose and use information with appropriate care Any breaches of security or incidents relating to Information Governance are investigated, actioned and reported via the Trust s Governance Structure. In order to support our staff in ensuring personal information is kept securely the Trust have a number of policies which set out the requirements staff must fulfil when accessing or sharing personal information. Furthermore, all staff receive Information Governance Training which includes topics such as information security, confidentiality and data protection. Information Governance leaflets are available on the MCHFT website at the following address: You can also contact our Information Governance Department: Information Governance Manager Leighton Hospital Middlewich Road Crewe, Cheshire CW1 4QJ Telephone: information.governance@mcht.nhs.uk Pathology Handbook Page 11 of 94 Version 7

12 PHLEBOTOMY SERVICES Phlebotomy Manager Donna George Tel (3592) GP Appointments Tel (3568) Pathology Handbook Page 12 of 94 Version 7

13 PHLEBOTOMY SERVICES GPs should, in the first instance, use the phlebotomist at their premises, if they have them. After that, the Northwich area GPs may send patients to VIN. Other GPs may send their patients to Leighton but appointments must be made here as there are a limited number of slots available. Appointment telephone number between pm Services at Victoria Infirmary, Northwich A blood collecting room staffed by Phlebotomists is open during the following hours: Monday to Friday 8.30 am to 4.30 pm Services at Leighton Hospital (i) Ward Service The daily ward phlebotomy service is managed by the relevant Divisions. They MUST NOT collect Blood Cultures (must be collected by the Doctor) When patient identification is in doubt (wrist bands obviate this problem) Blood for tests required at times other than those when the ward phlebotomists are on duty must be collected by the Doctors and sent to the laboratory. (ii) Outpatient Service This is located in the main outpatient hall and is signposted with Pathology (Blood Tests) signs. The outpatient service is mainly for patients attending OPD clinics. However as mentioned above there is an appointment system in operation for GP patients. The Phlebotomy Manager manages this service. Opening hours are Monday to Friday Ideally patients on wards should be bled on the ward. Patients should only be sent to outpatients as a last resort. This MUST be by prior arrangement and the patients dress must not compromise their dignity. A phlebotomy service is also provided at many GP practices; this is through a contract with the local CCG. Any enquiries about this service should be directed to the Phlebotomy Manager. Children from GP s under the age of 8 should be referred to the Krishnan Chandran Centre. Pathology Handbook Page 13 of 94 Version 7

14 CLINICAL CHEMISTRY Consultant Clinical Scientist Sarah Robinson Ext 2376 Site Service Lead Ian Johnson Ext 3454 Pathology Handbook Page 14 of 94 Version 7

15 BIOCHEMISTRY DEPARTMENT: THE SERVICE The Biochemistry Department provides a comprehensive service covering a wide range of biochemical estimations including diabetic monitoring, endocrine testing, lipid profiling, therapeutic drug monitoring and screening for drugs of abuse. Arrangements are also in place to refer tests which cannot be performed on site to regional laboratories. The department is led by a consultant chemical pathologist and a consultant clinical scientist, supported by a principal clinical scientist; they are available to discuss clinical aspects of cases and to suggest further tests that may be of value. The department is staffed by a highly qualified and experienced team of biomedical scientists, assisted by medical laboratory assistants. 1. OPENING HOURS The department is open from 9:00 am to 5.00 pm from Monday to Friday. For all out of hours arrangements see the General Section. 2. URGENT REQUESTS For full information on the procedure for requesting urgent estimations see the General Section. Please note that ALL requests for blood gas analysis as well as urgent requests should be pre-notified to the laboratory. 3. REPORTING TIMES We aim to achieve the following turnaround times, from receipt in the laboratory to authorisation of results, on at least 90% of occasions: Urgent requests: Blood gases General biochemistry (U&E/glucose/LFT etc.) Drug assays (including gentamicin) hcg (serum) assays Troponin I assays Routine Inpatient requests: General biochemistry Drug assays (excluding anticonvulsants) Routine Outpatient and GP requests: General biochemistry Drug assays (excluding anticonvulsants) Non-urgent routine assays: Haematinics, PSA & other tumour markers, Thyroid function tests & other endocrine assays Lipids, Albumin/creatinine ratio (urine) HbA1c Anticonvulsants (unless urgent) Serum & Urine Protein Electrophoresis BNP 15 minutes 60 minutes 90 minutes (unless requires referral to Macclesfield) 60 minutes 60 minutes 3 hours by end of same working day unless referral required 1 working day 1 working day 1 working day unless weekend/bank holiday 2 working days unless weekend/bank holiday 1 working day unless weekend/bank holiday 2 working days unless weekend/bank holiday 1 week 1 week 2 weeks Tests referred to external laboratories: For most commonly requested tests such as Vitamin D, the turnaround time is approximately 2-3 weeks from receipt in the local laboratory to the reporting of results. This turnaround time includes the transit time for both samples and reports to/from the external laboratory as well as the analysis there. Results for immunosuppressant drugs (tacrolimus and ciclosporin A) are usually available within 1 week and for certain trace elements (chromium, cobalt, copper, selenium and zinc) within days. Results for some tests, including urine amino/organic acids, faecal elastase, porphyrins and very specialised tests, may take up to 4 weeks to be reported. Once a sample has been dispatched from the laboratory, the estimated due date can be viewed via the LabCentre Browser results enquiry. Results are available for remote enquiry via the Clinisys Web Browser in hospital locations immediately after they have been technically authorised. Hard copy reports for hospital requests are printed every weekday and Pathology Handbook Page 15 of 94 Version 7

16 dispatched the same day to wards and consultants secretaries. Reports for general practitioner requests are currently transmitted electronically thrice daily (at 1215, 2000 and 2345). 4. REQUESTS Clinicians should usually make requests via the Anglia ICE electronic requesting system. Where this is not available, please use the standard combined Haematology/Biochemistry/Serology request form for biochemistry requests. It is essential that all details are clear and legible. Please remember to add the clinic/ward location, consultant and name of the requesting medical officer and date and time of collection, even if an addressograph label is affixed. A label must be attached to all copies of the form. Requesting Additional Tests on Existing Samples Samples are retained for 1 week and in most instances tests can be added after the initial sample has been sent, providing sufficient sample is left. However, certain analytes are less stable; requests for these tests, including ammonia, bicarbonate, ethanol, lactate and PTH, cannot be added to existing samples. Additional requests can only be made by sending a completed update form. Verbal requests will not be accepted unless this form is sent subsequently. The requesting clinician will be notified if the test(s) cannot be done. 5. HIGH RISK CASES Specimens and request forms from patients suspected to be suffering from blood borne diseases must be sent to the laboratory suitably identified with Danger of Infection stickers with a single sample per transport bag. 6. SAMPLE CONTAINERS Gold top plain containers containing gel (SST) are used for most routine serum Biochemistry requests in adults. One sample will usually suffice, but an additional sample is helpful when requesting several externally referred tests at the same time (see alphabetical test list in biochemistry section 24). Requests for glucose, lactate and ethanol must be sent in a fluoride oxalate (grey top) container. HbA1c requests should be sent in an EDTA (lavender top) container. Fill these tubes last to avoid contamination of other tubes. The tube types used for infants differ, but the preservative requirements are as for adults. Gently mix blood samples by 2-3 inversions to ensure contact with the anticoagulant or clot activators. Requests for certain less frequent or specialised investigations and tests not done on blood require special tubes or handling arrangements. Please consult the alphabetical test list (biochemistry section 24) for specific details of sample requirements. Contact the Pathology Help Desk (ext. 2345) if in any doubt. Fasting tests Certain blood tests are preferably done on fasting samples, including calcium/phosphate, glucose and lipids, and other tests as specified in the list in Section 24. For a fasting sample, the patient should be instructed to fast overnight for at least 12 hours and have nothing to eat or drink (except for water) until blood has been collected. Specimen handling and storage prior to receipt in the laboratory Wherever possible, all samples should be sent to the laboratory on the same day as collection to ensure sample integrity is maintained. If a delay in receipt of the sample is anticipated, please contact the laboratory to discuss storage requirements. Refrigeration may not be appropriate, in particular for some general biochemistry tests such as potassium and phosphate. See section 27 for details of other factors that may affect test results. 7. REFERENCE RANGES Adult reference ranges for most tests analysed at Crewe or Macclesfield are shown in the alphabetical test list (biochemistry section 24). Reference ranges are included with reports (paper and electronic) and displayed with results on the Clinisys LabCentre Browser. Unexpected critically abnormal results will be telephoned to the requesting clinician/location as appropriate (see section 26). Pathology Handbook Page 16 of 94 Version 7

17 8. GENERAL TEST INFORMATION One clotted blood sample (SST) will suffice for any combination of the following tests or test groups: Profiles U&E: Bone: LFTs: Proteins: Lipids: Iron studies: Thyroid: Individual Tests General: sodium, potassium, urea, creatinine; estimated GFR in adults over 18y (unless pregnant) calcium, phosphate, alkaline phosphatase, albumin; adjusted calcium also reported if albumin below 40 g/l albumin, bilirubin (total), alkaline phosphatase, ALT (alanine transaminase) total protein, albumin, calculated globulin total cholesterol, HDL cholesterol, triglycerides (fasting sample preferred); calculated LDL cholesterol reported if sample fasting and triglycerides <= 4.0 mmol/l iron, transferrin, calculated transferrin saturation free T4 and TSH; freet3 measured at laboratory s discretion; TPO antibody also available amylase, aspartate transaminase (AST), bicarbonate, bile acids, chloride, creatine kinase (CK), differential bilirubin (conjugated and unconjugated), γ-glutamyl transferase (GGT), lactate dehydrogenase (LDH), magnesium, osmolality, troponin I, urate Drugs: carbamazepine, digoxin, gentamicin, lamotrigine, lithium, paracetamol, phenobarbital, phenytoin, salicylate, theophylline, tobramycin, valproate, vancomycin Endocrine: Haematinics: Proteins: cortisol, FSH, hcg, LH, oestradiol, PTH, prolactin, testosterone and SHBG ferritin, folate, vitamin B12 Beta-2 microglobulin, CRP (C-reactive protein), immunoglobulins, protein electrophoresis Tumour Markers: AFP, CA-125, CA-19-9, CEA, PSA (total) Glucose Please send a separate fluoride oxalate (grey top) tube } but please use the same request HbA1c Please send a separate EDTA (lavender top) tube } form as for the above tests. 9. DRUG ASSAYS Therapeutic Drug Monitoring (TDM) Please give details of dosage, time of last dose and time of sample collection (mandatory for antibiotics) with ALL requests for therapeutic drug monitoring. Generally samples taken pre-dose or at least 6h post dose give optimal information see test list in biochemistry section 24. Therapeutic (target) ranges given are for guidance only. Gentamicin, tobramycin and vancomycin results should be discussed with the Microbiologist. See also the Mid Cheshire Hospitals NHS Foundation Trust Antibiotic Policy and the Microbiology section of the handbook on page 81. Sample Requirements: Drugs listed in biochemistry section 8 SST (gel) tube Ciclosporin A, sirolimus and tacrolimus EDTA blood taken immediately pre-dose Other drugs analysed at external laboratories Plain red top tube (without gel) Paracetamol Samples should be collected at least 4 hours after ingestion, as results obtained before 4 hours may be misleading. Repeated measurements are unnecessary. Results above the following levels are potentially toxic and merit treatment: 100 mg/l at 4 hours, 50 mg/l at 8 hours, 25 mg/l at 12 hours. See graph in biochemistry section 25 for assessing the severity of paracetamol overdose. Salicylate Serum therapeutic range (adults): Concern level associated with toxicity: Severe poisoning occurs at: mg/l 350 mg/l (280 mg/l if <5y) over 700 mg/l Pathology Handbook Page 17 of 94 Version 7

18 10. LIPIDS A fasting sample (taken after a fast of at least 12 hours) is preferred, where practicable. LDL cholesterol will not be reported on random samples and cannot be calculated if triglycerides exceed 4.0 mmol/l. The triglyceride reference range of mmol/l strictly applies to fasting samples only. If the random triglyceride level exceeds 1.7 mmol/l, a repeat fasting sample is recommended. HDL cholesterol reference ranges are as follows: Female mmol/l, Male mmol/l. Low levels are associated with increased cardiovascular risk. Targets For secondary prevention (patients with pre-existing cardiovascular disease or diabetes mellitus), the aim of cholesterol lowering should be to decrease LDL cholesterol to less than 2 mmol/l or by more than 30% from baseline, whichever gives the lower value. The equivalent figures for total cholesterol are a decrease to less than 4 mmol/l or by more than 25% from baseline, whichever gives the lower value. Intervention with lipid-lowering drug therapy may be needed to achieve such cholesterol concentrations, where not attained with dietary measures. For primary prevention, refer to the Joint British Societies Coronary Risk Prediction Chart in the BNF (issues 49 or later for current version). The total/hdl cholesterol ratio will be reported to facilitate risk estimation, unless the patient is known to have pre-existing cardiovascular disease or diabetes mellitus or is coded as already being on statin therapy. A reference range of is quoted for the total/hdl cholesterol ratio; values over 6.0 indicate increased cardiovascular risk per se. Guidance ranges are quoted on reports for total and LDL cholesterol for adults of mmol/l and mmol/l respectively. These are not reference ranges as such, but provided solely to enable high and low cholesterol results to be flagged on reports. Decisions regarding treatment of dyslipidaemia should be based on a full risk assessment of the patient, not just the cholesterol level. 11. BLOOD GASES Please telephone the laboratory before collection to ensure that sample receipt does not coincide with machine maintenance. Blood gas syringes must be sent to the laboratory with the needle removed from the syringe and replaced with a blind hub before despatch. Do not send through the air tube. The standard profile comprises ph, pco2, po2, bicarbonate and base excess. Oxygen saturation, carboxyhaemoglobin and methaemoglobin can be measured on the same sample if requested. Test Reference Range Units Test Ref. Range Units ph Oxygen Saturation % pco kpa Carboxyhaemoglobin % po kpa Methaemoglobin % Bicarbonate (standard) mmol/l Base Excess -2.5 to +2.5 mmol/l 12. URINE Random urine samples For quantitative assays, including albumin/creatinine ratio, protein/creatinine ratio and U&E, a 10 ml Sarstedt Monovette tube, with an incorporated syringe to aspirate urine into the tube, is strongly preferred. For qualitative assays (e.g. protein electrophoresis), please send a plain white top Universal container. Red top bottles containing boric acid are unsuitable for biochemistry tests. 24 hour urine samples Use plain 5 Litre bottles, except for some tests which require a bottle containing an acid preservative. Please contact the laboratory (ext 2345) to obtain bottles and patient instructions for collecting the 24 hour urine sample. Test U&E, Creatinine, Cortisol, Protein, Urate, Trace Elements (e.g. copper) 5-HIAA, Calcium, Citrate, Oxalate, Metadrenalines Preservative in Bottle NONE (plain container) 20 ml 50% HCl Pathology Handbook Page 18 of 94 Version 7

19 PATIENT INSTRUCTIONS FOR COLLECTION OF 24 HOUR URINE SAMPLES PLEASE READ PRIOR TO START OF COLLECTION 1. Collect the container suitable for your particular test from the laboratory. 2. The collection can be started at any convenient hour (say 7am) on one day and finishes at the same time the following day. 3. Container may contain acid or other preservative, do not throw out and avoid contact with this preservative. Read carefully the information stickers on the bottle. Procedure: 1. Supposing you start collecting at 7am on Sunday morning. The 7am Sunday morning specimen must be passed into the toilet, NOT INTO THE BOTTLE, so that at 7am you have an empty bladder. 2. All urine you pass after this, should go into the bottle provided, including the 7am Monday specimen, which is the last. Please ensure you catch, in a suitable clean container (e.g, clean jam jar), any urine passed whilst having your bowels open, and add this to the collection bottle(s) that you have been provided with. If you are likely to require more than one bottle (3 litres), please request an additional bottle before you commence the collection. The laboratory will only accept samples in the bottles that you are provided with. 3. Bring the bottle(s) and request form into the Pathology laboratory between 9 am and 5 pm on the day the test finishes, Monday to Friday (but not Saturday or Sunday). 4. Should you forget to collect any part of a 24 hour urine collection, inform the laboratory personnel. The test may need to be repeated. If the test is done on an incomplete specimen, you will be cheating yourself and the Doctor, and may receive inappropriate treatment, based on the faulty test. 5. If for any reason the test is incomplete, the specimen should still be returned to the laboratory for proper disposal and the laboratory advised. Notes You may be required to have a blood test when you return this container. If you are not intending to return this container yourself, please enquire at your GP Surgery if blood will be required in your case. If blood does need collecting it should be within the 24 hour period or immediately after it. Please ensure that your name, date of birth and the date/time of collection is on every bottle that you have used and that you also return the bottle with a completed request form. Failure to do this may result in the laboratory not being able to process or delay the processing of your sample. Please ensure the cap is tightened on the bottle, on completion of collection. 13. FAECES Please use a sterile collection pot or Universal container for all faecal tests. Occult blood testing is no longer done. 14. CEREBROSPINAL & OTHER FLUIDS CSF Collect samples in a plain white top Universal container, and also a fluoride oxalate tube if glucose is required. Please remember to contact Microbiology on call staff out of hours for CSF microbiology testing. Samples should be sent to the laboratory via a porter. The air tube system must not be used. Xanthochromia determination by spectrophotometry needs an additional sample of at least 1 ml CSF (protected from light) which should be the last sample collected. This test is only available Monday to Friday 09:00 16:00. Samples should be collected at least 12 hours after the suspected subarachnoid haemorrhage and sent to the laboratory (protected from light) within 30 minutes of collection. OTHER FLUIDS Samples for Biochemistry (except ph) should be sent in Vacutainers, which should be filled as far as the top of the label on the tube by attaching a green (21 gauge) needle to the syringe used for fluid aspiration and inserting the needle through the rubber cap so that the tubes will fill using the vacuum. Pathology Handbook Page 19 of 94 Version 7

20 For most biochemistry tests (e.g. protein, LDH), send a gold top SST. For glucose, send a separate grey top Vacutainer (fluoride oxalate preservative). For ph, please send a separate sample in blood gas syringe (ensuring that it contains no air) and process as for blood gases (biochemistry section 11). Pleural fluid samples for general biochemistry tests (except ph) should preferably be sent in SST Vacutainers (Gold Top). It may not be possible to analyse fluids that are especially turbid or viscous. 15. DIABETES DIAGNOSIS AND MONITORING Diagnosis The preferred screening test is fasting venous plasma glucose the patient should fast for at least 12 hours. Fasting Glucose Action <= 6.0 mmol/l Normal. Repeat test may be appropriate if result borderline ( ) & there are symptoms or other features (e.g. high triglycerides) suggesting diabetes mmol/l Repeat. If repeat also raised (>6.0 mmol/l), do an oral glucose tolerance test. >= 7.0 mmol/l Suggests diabetes. If patient asymptomatic, need repeat test for confirmation. Random Glucose Action <= 6.0 mmol/l Normal. No further action mmol/l Probably normal, but consider checking fasting plasma glucose mmol/l Check fasting plasma glucose. If this is raised (>6.0 mmol/l), do an OGTT. >= 11.1 mmol/l Suggests diabetes. If patient asymptomatic, check fasting glucose to confirm. Oral Glucose Tolerance Test (OGTT): Please send a request form to the biochemistry secretary (ext 3405) if you wish to book a test. Procedure: Three days of an unrestricted carbohydrate diet should be allowed before the test. The test should be done in the morning following an overnight fast (at least 12 hours). The patient should have nothing to eat or drink (except for water) until the test is complete. Obtain a fasting blood sample in a grey top Fluoride Oxalate Vacutainer tube and include the time of the specimen on the label and request form. For tests done by Phlebotomy at Leighton Hospital, the patient is required to wait 60 minutes for the initial blood test to be processed. Confirmation of the result is sent to Phlebotomy with the decision to either proceed with the test or to discharge the patient. Give the patient a drink containing 75g of glucose (e.g. 410 ml Lucozade) - chilled to reduce nausea. The drink should be consumed within 10 minutes and the time noted. During the test the patient should rest and should not eat, drink (other than glasses of water) or smoke. Take the second venous blood sample in a grey top Vacutainer tube exactly 2 hours after the patient finished the glucose drink. Label the bottle and request form with the time of the sample. The test is now complete and the patient may eat as normal. Send the 2 blood samples together with a single request form to the laboratory for analysis. Glucose meters are not sufficiently accurate for diagnostic purposes. For glucose tolerance tests arranged via the laboratory, the patient will be sent an information sheet, including instructions about pre-test preparation. This leaflet can be obtained from the laboratory on request. Interpretation of plasma glucose concentrations (mmol/l): Normal Diabetes Impaired Glucose Tolerance Impaired Fasting Glycaemia Fasting <6.1 >=7.0 < and and/or and and 2h Post Load <7.8 >= <7.8 HbA1c (Glycated Haemoglobin) The primary use of HbA1c is for assessing glycaemic control, but it can also be used for diagnosis. Measurements more frequently than every 2 months are of minimal value due to the red cell lifetime of approximately 120 days. Pathology Handbook Page 20 of 94 Version 7

21 While fasting glucose is still recommended as the initial screening test for suspected diabetes, WHO (2011) has now recommended that HbA1c can be used as a diagnostic test for diabetes in most situations. The main exceptions are rapid onset diabetes (as HbA1c reflects glycaemia over the preceding 2 3 months) and some genetic, haematological and other disorders; in particular haemoglobinopathies, anaemia and other diseases associated with changes in red cell turnover (e.g. malaria, drug-induced haemolysis) or glycation rates (e.g. chronic renal disease). In these situations, HbA1c is not recommended as the sole test to diagnose diabetes. An HbA1c of 48 mmol/mol is recommended as the cut point for diagnosing diabetes, and can therefore be used to confirm a diagnosis of diabetes in an asymptomatic individual with a fasting glucose 7.0 mmol/l or random glucose 11.1 mmol/l, precluding the need for a repeat glucose measurement or glucose tolerance test. However, an HbA1c value <48 mmol/mol does not exclude diabetes diagnosed using glucose tests. Criteria for Glycaemic Control using HbA1c in Patients with Type 1 and Type 2 Diabetes Good Borderline Sub-optimal Type 1 < 48 mmol/mol mmol/mol > 58 mmol/mol Low risk Arterial risk Microvascular risk Type 2 < 48 mmol/mol >= 48 mmol/mol > 58 mmol/mol 16. THYROID FUNCTION TESTS (TFTs) Please give full details of drug treatment and also gestation if applicable. Free T4 and TSH are the front line thyroid function tests. Free T3 is assayed at the laboratory s discretion (it is only useful in borderline hyperthyroidism or if the patient is on liothyronine therapy). Thyroid peroxidase antibody will be assayed if the TSH is persistently borderline raised. Thyroid hormone levels change slowly and there is little point in repeating TFTs within 1 month. Test Reference Range Units Free T4 (thyroxine) pmol/l ( in 2 nd & 3 rd trimesters) TSH (thyroid stimulating hormone) mu/l ( in children <5y) Free T3 (tri-iodothyronine) pmol/l TPO (thyroid peroxidase) antibody 0-9 kiu/l 17. ADRENAL FUNCTION Adrenal Cortex Random or midnight serum cortisol levels are generally of minimal value, and measurement of 9 am cortisol has poor sensitivity for adrenal dysfunction. If there is significant clinical suspicion of adrenal disease, it is preferable to do one of the following dynamic function tests. Short Synacthen (Tetracosactide) Test for suspected Hypoadrenalism Take 3.5 ml clotted blood (SST) for serum cortisol between 09:00h and 10:00h. Give 250 ug tetracosactide (Synacthen) by intramuscular injection. Take a further SST sample for cortisol at 30 minutes post tetracosactide injection. A 60 minute sample is not required. Following Synacthen, a response of 475nmol/L at 30 minutes indicates an adequate response Overnight Dexamethasone Suppression Test for suspected Cushing s Syndrome 1 mg dexamethasone should be taken orally at 11 pm (± 1 hour). Take 3.5 ml clotted blood (SST) for serum cortisol at 9 am (± 1 hour) the following morning. This test is preferred to measurement of 24 hour urine free cortisol. Adrenal Medulla Measurement of 24 hour urine metadrenalines is the preferred test for investigating suspected phaeochromocytoma. The sample must be collected into a bottle containing hydrochloric acid preservative, which is available from the laboratory on request. Pathology Handbook Page 21 of 94 Version 7