CHESHIRE PATHOLOGY SERVICES LABORATORY DEPARTMENT HANDBOOK April 2014 Clinical Lead/Laboratory Director Dr R Rajendran Tel No: 01625 66(1832) Pathology Service Manager Tony Currell Tel No: 01270 27(3453) Pathology Department Macclesfield District General Hospital Victoria Road Macclesfield SK10 3BL ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 1 of 77 PATHOLOGY IS LOCATED AT GRID REFERENCE E1 1 2 LOCATION OF PATHOLOGY DEPARTMENT MACCLESFIELD DISTRICT GENERAL HOSPITAL ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 2 of 77 Laboratory Handbook Version 7 April 2014 CONTENTS Section Macclesfield Pathology Service Introduction & General Information Telephone Numbers Urgent Requests Out of Hours Service Phlebotomy Service Working Hours Laboratory Supplies Specimen Acceptance Policy Specimen Transport General Office Complaint Procedure Protection of Personal Information 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 0.10 0.11 0.12 Biochemistry 1.0 Haematology 2.0 Blood Transfusion 3.0 Microbiology 4.0 Cellular Pathology 5.0 Cytology 6.0 Mortuary 7.0 Immunology 8.0 Manual Index 9.0 Addresses of Referral Laboratories ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead 10.0 Version 7.0 Issued April 2014 Page 3 of 77 0.0 MACCLESFIELD PATHOLOGY SERVICE Based at Macclesfield District General Hospital, Cheshire Pathology Services (CPS) offers a comprehensive range of pathology investigations plus a full clinical service in all pathology disciplines. Most investigations are carried out on site, although some are sent out to specialist centres. The aim of CPS is to meet the need of users in all aspects of the service. It is our intention to adopt a flexible approach and to satisfy users' requirements as often as possible. Each CPS department participates in a wide range of internal and external Quality Assurance programmes, including national schemes. The laboratories continually work to maintain Clinical Pathology Accreditation and are currently in the process of implementing the requirements for quality and competence for medical laboratories as specified in the International Standard ISO 15189:2012. Compliance with these standards will result in UKAS accreditation. Address: Pathology Department, Macclesfield District General Hospital, Victoria Road, Macclesfield SK10 3BL Telephone Enquiries: 01625 661802 Fax: 01625 661804 0.1 INTRODUCTION & GENERAL INFORMATION Sample collections There is a district wide transport service which will collect samples and deliver reports and consumables as required. Results reporting Printed reports are despatched daily via the transport system, Monday to Friday. Urgent results may be telephoned by prior arrangement. Any grossly abnormal result which indicates that the patient may require urgent clinical intervention will be telephoned immediately to the requesting clinician (or if contact cannot be made, to a suitable deputy with instructions that the requesting medical officer should be informed urgently of the results) irrespective of whether the sample has been marked as urgent. All GP practices now receive reports electronically. For further information about this facility, contact Mr John Jones via 01625 661825. Clinical advice Advice on all matters relating to the provision and interpretation of results is available from the Consultant staff in the relevant department. Outside routine laboratory opening hours, clinical advice can be obtained by contacting the hospital switchboard, who hold the details of the covering arrangements for each pathology discipline. Workload information Detailed information about requesting patterns and other aspects of the service are available on request. Enquiries For further general information about any aspect of the service, please contact the Pathology Services Manager on 01625 661802. For clinical and technical advice please refer to individual specialities. 0.2 TELEPHONE NUMBERS (STD CODE 01625) General, Management and Office Notification of urgent requests 661809 General enquiries 661802 General enquiries FAX 661804 Specimen reception (supplies) 661046 Phlebotomy Department 661493 Clinical Lead for Pathology (Dr R Rajendran) 661832 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 4 of 77 Pathology Services Manager (Mr T Currell) 661802 Pathology Governance Lead (Miss V Sandland) 661802 Support Functions Manager (Mrs G Walton) 661802 Microbiology Department Reports and general enquiries 661811 Clinical Enquiries 663644 Consultant Microbiologist & Infection Control Doctor (Dr R Rajendran) 661810 Dr Rajendran’s secretary (Miss C Norbury) 661832 Chief BMS Microbiology (Mr K Wright) 661812 Lead Nurse in Infection Control (Mrs A Swaine) 661769 (Bleep 3034) Haematology & Blood Transfusion Department Reports and general Haematology enquiries 661807 Blood Transfusion 661808 Consultant Haematologist (Dr J Hudson) 661806 Dr Hudson's secretary 661801 Chief BMS Haematology (Mr J Flevill) 661017 Senior BMS Haematology 661807 Senior BMS Blood Transfusion 661808 Anticoagulant Clinic 661836 Anticoagulant Service Manager (Mr S Massey) 661198 Phlebotomy Department 661493 Biochemistry Department Reports and general enquiries 661828 Consultant Chemical Pathologist (Dr D Oleesky) 661826 Principal Clinical Scientist (Mrs J Scott) 663941 Dr Oleesky's secretary (Miss D Whyte) 661629 Chief BMS Biochemistry (Miss J Clarke) 661833 Cellular Pathology Department Histology & Non-Gynae Cytology enquiries (Histology Department, Leighton Hospital) 01270 273286 Gynae Cytology enquiries (Cytology Department, UHNS) 01782 674951 Mortuary 661847 Post mortem enquiries 01270 273286 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 5 of 77 0.3 URGENT REQUESTS Requests for truly urgent investigations to be carried out by the Haematology, Biochemistry and Microbiology Departments during working hours should be pre-notified to the laboratory on extension 1809. The results of these estimations will be made available to ward enquiry on an urgent basis. In order to reduce the risks due to incorrect data transmission results will be transmitted by telephone to the requesting clinician only to those locations without ward enquiry facilities. Requests for urgent blood transfusion should always be communicated directly to the Blood Transfusion laboratory on extension 1808. Microbiology urgent specimens coming from the Leighton site should be phoned to the Microbiology Department first. The specimen should be identified as urgent and dispatched to pathology where a decision will be made, dependant on the time until the next scheduled transport, whether to wait for this transport or arrange a taxi through switchboard. 0.4 OUT OF HOURS SERVICE Blood Sciences Requests Outside Routine Hours The blood sciences departments of Biochemistry and Haematology provide 24/7 cover, during weekends and out of normal hours all samples sent to the laboratory will be processed as appropriate. If the tests are of extreme urgency or the request is for blood or blood components, then the department concerned should be contacted with the details of the request. The short code mobile phone number is 4437. Please note this is a mobile phone number and not a pager, please allow time for the Biomedical Scientist on duty to answer your call. Phone calls must be made for the following requests at all times: i. ii. iii. iv. ALL requests for blood and blood components. ALL blood gas requests. True emergency requests requiring immediate results. Requests from locations not on the air tube system. Microbiology On Call Requests All urgent requests outside of normal opening hours must be phoned to the on-call Microbiology Biomedical Scientist via switchboard. 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. 0.5 PHLEBOTOMY SERVICE Service to GPs This excludes patients from Macclesfield Surgeries for whom phlebotomy clinics are available at Waters Green Medical Centre. A blood collection service is available in: MACCLESFIELD In the Blood Test Department on the ground floor of Macclesfield Hospital between 08:45h and 11:45h and 12:30h to 16:45h Monday to Friday, 01625 661493. CONGLETON At Congleton War Memorial Hospital every morning Monday to Friday: 08:30h to 11:15h – All patients 11:15h to 12 noon – Congleton Ward and OPD patients KNUTSFORD At Knutsford District Community Hospital every morning Monday to Friday 08:30h to 11:20h Hospital users A blood collecting service is available to Wards in the DGH each morning Monday to Sunday. Out Patient clinics are covered from the Blood Test Department until 16:45h Monday to Friday. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 6 of 77 0.6 WORKING HOURS All departments are open from 09:00h to 17:30h Monday to Friday. There is an out of normal hours service available at all other times. A full result enquiry service is available from 09:00h to 17:30h Monday to Friday. Microbiology is open from 09:00h to 20:00h Monday to Friday and 09:00 to 17:30 on weekends and Bank Holidays. 0.7 LABORATORY SUPPLIES Request forms and laboratory specimen tubes and pots are available using answer phone number 661046 requisition forms are also available. Standing order arrangements for consumables are possible and are advised for continuity of supply. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 7 of 77 0.8 SPECIMEN ACCEPTANCE POLICY The Pathology Department implements a Specimen Acceptance Policy to ensure the safety of the patient. The policy describes the procedures required to ensure that all specimens are correctly identified and that appropriate reports can be sent to the correct destination. The key points are summarised in the table below: Requirement Action by Laboratory if requirement not met Samples MUST be labelled with 3 unique No analysis will be performed. identifiers from Where the sample is easily repeatable the Surname laboratory will recommend the sample is Forename discarded. Date of birth NHS / Hosp Number Where the risk to the patient of rejection outweighs The request form data MUST match the the risk of acceptance, the sender will be contacted above information on the sample or be by a senior pathology staff member. labelled with another suitable unique identifier. Pathology will accept no responsibility for samples Multiple samples taken at different times tested which initially failed to meet the acceptance on a patient MUST be labelled on the criteria and will issue a disclaimer on such reports. sample container with the time (24 hr clock) when the specimen is taken. The request form should be labelled accordingly. Request forms SHALL also contain: A unique patient identifier (i.e. hospital number / new NHS number) Sending location Name of Consultant or GP Tests required Date and time of sample Time of last dose and dosage information for drug assays Anatomical site and type of specimen (where relevant) Sex Relevant clinical information Lack of information may result in laboratory not conducting the analysis. It may not be possible to issue a report or to interpret results. Appropriate comments will be made on the report where this can be issued. For Blood Transfusion sample labelling please refer to the Hospital Blood Transfusion Policy on the Trust Intranet Please address all queries/enquiries about this policy to Vikki Sandland, Pathology Governance Lead. 0.9 SPECIMEN TRANSPORT The van collection and delivery service covers the district twice daily and all GPs know their own collection times. Alterations to the time table may be possible, but only by application to the Pathology Services Manager in writing. Specimens from hospital wards may be sent via the airtube delivery system. For further, more detailed information, please refer to the appropriate departmental section of this manual. 0.10 PATHOLOGY GENERAL OFFICE The Pathology General office is staffed from 08:30h to 17:30h, Monday to Friday. Staff in the office provide secretarial and clerical support for the consultants and other staff within the laboratory. They are responsible for sending out reports. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 8 of 77 0.11 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 email: Write to: The Customer Care Manager Macclesfield District General Hospital Victoria Road Macclesfield SK10 3BL Telephone: 01625 661449 or 01625 661111 Freephone: 0800 161 3997 Email: [email protected] Visit the ECT website for further information on the customer care team and complaints procedure http://echn2026.sitekit.net/Patients-Visitors/Complaints-and-concerns.htm 0.12 PROTECTION OF PERSONAL INFORMATION The department 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. Further information is available on the ECT website at the following address: http://echn2026.sitekit.net/Patients-Visitors/Patient%20confidentiality.html You can also contact the Information Governance Department: Information Governance Manager Macclesfield District General Hospital Victoria Road Macclesfield SK10 3BL Email: [email protected] Telephone: 01625 661625 or 01625 663813 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 9 of 77 1.0 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, 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. 1.1 OPENING HOURS The department is open from 9:00 am to 5:30 pm from Monday to Friday. For all out of hours arrangements see General section 0.4 1.2 URGENT REQUESTS For full information on the procedure for requesting urgent estimations see General section 0.3. Please note that ALL requests for blood gas analysis should be pre-notified to the laboratory. 1.3 REPORTING TIMES We aim to achieve the following turnaround times, from receipt in the laboratory to authorisation of results, on at least 95% of occasions: Urgent requests: Blood gases General biochemistry (U&E/glucose/LFT etc.) Drug assays (including antibiotics) hCG (serum) assays Troponin I assays 15 minutes 60 minutes 90 minutes 90 minutes 90 minutes Routine Inpatient requests: General biochemistry, hCG, Troponin I Drug assays (excluding anticonvulsants) 3 hours by end of same working day Routine Outpatient and GP requests: General biochemistry, hCG, Troponin I Drug assays (excluding anticonvulsants) 1 working day 1 working day Non-urgent routine assays: Haematinics, PSA, Thyroid Function Tests Other Endocrine assays & Tumour Markers Lipids, HbA1c, Albumin/creatinine ratio (urine) Anticonvulsants (unless urgent) Serum & Urine Protein Electrophoresis BNP 2 working days 1 week 2 working days 1 week 1 week 2 weeks Results are available for remote enquiry via LabCentre Browser in hospital locations immediately after they have been technically authorised. Hard copy reports for hospital requests are printed every weekday at 1400 and dispatched the same day to wards and consultants’ secretaries. Reports for general practitioner requests are currently transmitted electronically thrice daily (at 1200, 1930 and 2345). 1.4 THE REQUEST FORM All Biochemistry requests can be made on the standard combined Haematology/Biochemistry request form. 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. General practitioners should usually make requests via the Anglia ICE electronic requesting system. Handwritten amendments to electronic requests will not be processed. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 10 of 77 Requesting Additional Tests on 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. 1.5 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. 1.6 SAMPLE CONTAINERS Yellow top plain containers containing gel (SST) are used for most routine serum Biochemistry requests. One sample will suffice for tests analysed at Macclesfield (see section 1.8), but please send a separate sample for tests analysed at other laboratories including Leighton Hospital (see alphabetical test list in section 1.24). Requests for HbA1c, glucose, lactate and ethanol assays must be sent in a fluoride oxalate (grey top) container. Fluoride oxalate and EDTA tubes should be filled last to avoid contamination of other tubes. 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 (section 1.24) for specific details of sample requirements. Contact the Department (ext. 1828) if in any doubt. 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 1.27 for details of other factors that may affect test results. 1.7 REFERENCE RANGES Reference ranges are included with reports (paper and electronic) and displayed with results on the Clinisys LabCentre Browser. Adult reference ranges for most tests analysed at Macclesfield are shown in the alphabetical test list (section 1.24). Unexpected critically abnormal results will be telephoned to the requesting clinician/location as appropriate (see section 1.26). 1.8 GENERAL TEST INFORMATION One clotted blood sample (SST) will suffice for any combination of the following tests or test groups: Profiles U&E: sodium, potassium, urea, creatinine; estimated GFR in adults over 18y (unless pregnant) Bone: calcium, phosphate, alkaline phosphatase, albumin; adjusted calcium also reported if albumin below 40 g/L LFTs: albumin, bilirubin (total), alkaline phosphatase, ALT (alanine transaminase) Proteins: total protein, albumin, calculated globulin Lipids: total cholesterol, HDL cholesterol, triglycerides (fasting sample preferred); calculated LDL cholesterol reported if sample fasting and triglycerides <= 4.0 mmol/L Iron studies: iron, transferrin, calculated transferrin saturation Thyroid: free T4 and TSH; free T3 measured at laboratory’s discretion ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 11 of 77 Individual Tests General: amylase, aspartate transaminase (AST), bicarbonate, bile acids, chloride, creatine kinase (CK), direct bilirubin, -glutamyl transferase (GGT), lactate dehydrogenase (LDH), magnesium, osmolarity (calculated), troponin I, urate Drugs: carbamazepine, digoxin, gentamicin, lamotrigine, lithium, paracetamol, phenobarbital, phenytoin, salicylate, theophylline, tobramycin, valproate, vancomycin Endocrine: cortisol, FSH, hCG, LH, oestradiol, prolactin Haematinics: ferritin, folate, vitamin B12 Proteins: CRP (C-reactive protein), immunoglobulins, protein electrophoresis Tumour Markers: CA-125, CEA, PSA (total) Glucose and HbA1c A separate fluoride oxalate tube (grey top) is required, but please use the same request form as for the above tests. 1.9 DRUG ASSAYS Therapeutic Drug Monitoring (TDM) Please give details of dosage, time of last dose and time of sample collection 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 section 1.24. Therapeutic (target) ranges given are for guidance only. Gentamicin, teicoplanin, tobramycin and vancomycin results should be discussed with the Microbiologist. Teicoplanin requests are now handled by the Microbiology Department. See also the East Cheshire NHS Trust Antibiotic Policy. Sample Requirements: Drugs listed in section 1.8 (and teicoplanin) Ciclosporin A, sirolimus and tacrolimus Other drugs analysed at external laboratories SST (gel) tube EDTA blood taken immediately pre-dose 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 section 1.25 for assessing the severity of paracetamol overdose. Salicylate Serum therapeutic range (adults): Concern level associated with toxicity: Severe poisoning occurs at: 150 - 300 mg/L 350 mg/L (280 mg/L if <5y) over 700 mg/L 1.10 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 0.4-1.7 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 1.2-2.1 mmol/L, Male 1.0-1.9 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. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 12 of 77 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 2.0-6.0 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 2.5-5.0 mmol/L and 1.0-3.0 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. 1.11 BLOOD GASES Please phone the laboratory on extension 1828 before collection to ensure that sample receipt does not coincide with machine maintenance. Blood gas syringes must be sent to the laboratory packed in ice, with the needle removed from the syringe and replaced with a blind hub before despatch. The standard profile comprises pH, pCO2, pO2, bicarbonate and base excess. carboxyhaemoglobin and methaemoglobin can be measured on the same sample if requested. Oxygen saturation, Test pH pCO2 pO2 Bicarbonate (standard) Base Excess Ref. Range 92.0 - 99.0 0.0 - 1.5 0.0 - 1.5 Reference Range 7.36 – 7.44 4.5 – 6.1 12.0 – 15.0 22.0 – 26.0 -2.5 to +2.5 Units kPa kPa mmol/L mmol/L Test Oxygen Saturation Carboxyhaemoglobin Methaemoglobin Units % % % 1.12 URINES 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. pregnancy tests and 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 3 Litre bottles, except for some tests which require a bottle containing an acid preservative. Please contact the laboratory (extension 1809) 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 1.13 FAECES For all faecal tests, please use a sterile collection pot or Universal container. Occult blood testing is no longer done. 1.14 CEREBROSPINAL & OTHER FLUIDS CSF Samples should be collected in a plain white top Universal container (don’t need fluoride oxalate tube for glucose). 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 requires 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 - 17:00h. 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. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 13 of 77 For most biochemistry tests (e.g. protein, LDH), send a yellow 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 (section 1.11). Pleural fluid samples for general biochemistry tests (except pH) must be sent in Vacutainers otherwise they will not be analysed. It may not be possible to analyse fluids that are especially turbid or viscous. 1.15 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 <= 6.0 mmol/L 6.1-6.9 mmol/L >= 7.0 mmol/L Action Normal. Repeat test may be appropriate if result borderline (5.8-6.0) & there are symptoms or other features (e.g. high triglycerides) suggesting diabetes. Repeat. If repeat also raised (>6.0 mmol/L), do an oral glucose tolerance test. Suggests diabetes. If patient asymptomatic, need repeat test for confirmation. Random Glucose <= 6.0 mmol/L 6.1-7.7 mmol/L 7.8-11.0 mmol/L >= 11.1 mmol/L Action Normal. No further action. Probably normal, but consider checking fasting plasma glucose. Check fasting plasma glucose. If this is raised (>6.0 mmol/L), do an OGTT. Suggests diabetes. If patient asymptomatic, check fasting glucose to confirm. Oral Glucose Tolerance Test (OGTT) Procedure: The test should be done in the morning following an overnight fast (at least 12 hours). 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. 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 or drink, other than glasses of water. 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. Interpretation of plasma glucose concentrations (mmol/L): Fasting 2h Post Load Normal <6.1 and <7.8 Diabetes >=7.0 and/or >=11.1 Impaired Glucose Tolerance <7.0 and 7.8 - 11.0 Impaired Fasting Glycaemia 6.1-6.9 and <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. 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. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 14 of 77 Criteria for Glycaemic Control using HbA1c in Patients with Type 1 and Type 2 Diabetes Type 1 Good < 48 mmol/mol Borderline 48-58 mmol/mol Sub-optimal > 58 mmol/mol Type 2 Low risk < 48 mmol/mol Arterial risk >= 48 mmol/mol Microvascular risk > 58 mmol/mol 1.16 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 Free T4 (thyroxine) TSH (thyroid stimulating hormone) Free T3 (tri-iodothyronine) TPO (thyroid peroxidase) antibody Reference Range 7.0 - 17.0 0.2 – 4.5 3.5 - 6.5 0-35 Units pmol/L mu/L pmol/L kiu/L (6.0 –15.0 in 2nd & 3rd trimesters) (0.35 - 5.50 in children <5y) (values 36-150 indicate a low titre) 1.17 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. 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. 1.18 SPECIALISED ENDOCRINE TESTS Please phone extension 1826/3941 to discuss requests for the following specialised/dynamic function tests and obtain protocols before collecting samples. Interpretation will be provided with the report. Dexamethasone Suppression Tests (low and high dose) Glucose Tolerance Test with Growth Hormone measurements Growth Hormone stimulation tests (arginine, glucagon) Gut Hormone profile (gastrin, glucagon, PP, somatostatin, VIP) Insulin and C-Peptide measurements Metoclopramide test Pituitary Stimulation tests: Gn-RH (gonadorelin), TRH (pro-tirelin) and Insulin PTH-related Peptide measurement Renin and Aldosterone measurements Water Deprivation test This list is not comprehensive and other tests may be available on request. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 15 of 77 1.19 SEX HORMONE INVESTIGATIONS Adult Reference Ranges FSH* LH* Progesterone Prolactin** hCG Testosterone*** SHBG*** Free Androgen Index (FAI)*** Oestradiol Females 2.5-10.0 (25-185 post-menopause) 1.5-13.0 (20-60 post-menopause) >=30 indicates ovulation 40-530 (40-425 if >=50y) 0-5 (non-pregnant) 0.0-2.1 (0.0-1.7 if >=50y) 20-126 0.0-5.6 (0.0-4.5 if >=50y) follicular 100-600, luteal 100-900 mid-cycle 500-1500 post-menopausal <100 Males 2.5-10.0 1.5-10.0 not applicable 40-360 0-5 (as tumour marker) 8.3–28.7 (lower if >=40y) 14-79 22-70 (11-52 if >=45y) 0-150 Units iu/L iu/L nmol/L mu/L iu/L nmol/L nmol/L pmol/L * In menstruating women, ranges apply to follicular & luteal phases; levels are higher mid-cycle. ** Samples with a significantly raised prolactin (>600) will be tested for presence of macroprolactin. *** In men, testosterone ranges apply to blood taken between 0800h & 1000h; SHBG & FAI not usually measured; ranges (nmol/L) for men ≥40 years are 7.3-26.0 (40-49y), 6.3-25.0 (50-59y), 5.7-24.5 (60-69y), 4.6-23.3 (≥70y). PREGNANCY TESTING Urine hCG is the first-line test for confirming pregnancy; the test is sensitive to 25 iu/L. Serum hCG measurement is useful for investigating/monitoring a suspected non-viable pregnancy (e.g. ectopic). Please include the date of the last menstrual period (LMP) with all requests. INFERTILITY INVESTIGATIONS Mid-luteal phase serum progesterone is useful to define ovulation. In women with a regular 28 day cycle, a day 21 serum progesterone of at least 30 nmol/L indicates an ovulatory cycle (for ovulation, median 60 nmol/L, range 30 - 95 nmol/L). In some cases, several samples for serum progesterone during luteal phase may be helpful, particularly in those with irregular cycles. Progesterone measurement is only indicated for investigating infertility and is inappropriate in the follicular phase or if there is amenorrhoea. In women without clear evidence of ovulation, measurement of FSH at day 2-5 of the cycle is the most helpful investigation available locally for assessing ovarian reserve. For interpretation of serum FSH, LH, progesterone and oestradiol results in menstruating women, please supply the date of the last menstrual period (LMP), due to the cyclicity of these hormones. INVESTIGATION FOR MENOPAUSE Diagnosis of the menopause is primarily clinical, but if laboratory confirmation is required, the preferred biochemical test is serum FSH measurement, at cycle day 2-5 if the woman is menstruating. Please supply the date of the LMP or other relevant menstrual details. The post-menopausal state is usually clearly indicated by high FSH and LH levels. Less pronounced increases, particularly of follicular phase FSH, are characteristic of the peri-menopause. Oestradiol measurement rarely provides extra information, but may be added occasionally at the discretion of laboratory staff. MONITORING HORMONE REPLACEMENT THERAPY (HRT) Before initiating treatment, measure FSH and oestradiol to increase the diagnostic certainty of menopausal transition if the woman is not clearly menopausal. Serum oestradiol measurement is useful to assess the adequacy of oestradiol HRT implants, but with patch or oral therapy it is only useful for testing for non-absorption and non-compliance respectively. Measurement is not appropriate if taking HRT other than oestradiol, as the assay is specific for this steroid and will not measure ethinyloestradiol, oestriol, oestrone or tibolone. Oral conjugated equine oestrogens undergo first pass metabolism in the liver to oestrone as the major circulating oestrogen. HRT reduces FSH & LH levels (by 10-25 %), but they are not restored to basal pre-menopausal levels and their measurement is not useful for monitoring HRT. Please supply the HRT preparation used and the route of administration with the request. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 16 of 77 1.20 PSA (PROSTATE SPECIFIC ANTIGEN) The following age-related reference ranges are in use for total PSA (ug/L): up to 49y 50 to 59y 60 to 69y over 70y 0 - 2.0 0 - 2.75 0 - 3.5 0 - 5.0 Total PSA levels greater than 15 ug/L indicate a high probability of prostatic cancer. Total PSA levels greater than 75 ug/L strongly suggest metastatic disease. In addition to prostatic cancer, elevated serum total PSA levels may be found in patients: With benign prostatic hypertrophy (BPH), prostatitis or prostatic infarction. Undergoing prostate manipulation (prostate massage/rectal examination/prostatectomy/biopsy). With acute retention or constipation. Undergoing catheterisation. 1.21 RENAL DISEASE eGFR: Estimated GFR calculated in adults over 18 y (unless pregnant); a value below 60 mL/min/1.73m2 indicates chronic kidney disease (CKD) stage 3 or worse, providing this persists for at least 3 months. Stage/Category of CKD 1 Normal* 2 Mild impairment* 3 Moderate impairment eGFR (mL/min/1.73m2) >90 60–89 45–59 [CKD stage 3A] 30–44 [CKD stage 3B] 15–29 <15 Recommended Frequency of Testing annually* annually* 6-monthly 6-monthly 3-monthly 3-monthly 4 5 Severe impairment Established renal failure * Stages 1 & 2 are only considered as CKD, needing yearly creatinine with eGFR, if there is other laboratory or clinical evidence of kidney disease Urine Albumin/Creatinine Ratio (“Microalbumin”) This test is recommended as part of the diabetic annual review, along with serum creatinine/eGFR. Non-diabetic subjects who are dipstick negative for protein but found to have CKD stage 3 or worse should also be tested once, with the test repeated again only if there is a significant deterioration in renal function (e.g. progression from CKD stage 3 to 4). In subjects who are dipstick positive for protein, the protein/creatinine ratio is the preferred test. For both albumin/creatinine and protein/creatinine ratios, send 5-10 mL of first morning urine in a container without preservative, preferably a plain 10 mL Sarstedt Monovette tube. Red top bottles containing boric acid are unsuitable. Guidelines for interpretation of Urine Albumin/Creatinine ratio (mg/mmol): Up to 2.5 (male) or 3.5 (female): Normal - rescreen annually. Raised but less than 30.0 indicates “microalbuminuria”. If this finding is new, suggest repeat within 3 months to confirm. To establish “microalbuminuria”, at least 2 out of 3 samples over 3-6 months should test positive. 30.0 or above indicates “macroalbuminuria”. Urine Protein/Creatinine Ratio This will be determined if the urine microalbumin concentration exceeds 1000 mg/L. It is also preferred to a 24 hour urine collection for protein as the initial test for suspected proteinuria. Values over 100 mg/mmol (equivalent to 1.0 g/24h) indicate significant proteinuria and a nephrology referral may be appropriate. 1.22 SWEAT TESTS To aid in the diagnosis of Cystic Fibrosis. Please phone the laboratory (ext 1823) to arrange this test. Interpretation will be provided with the report. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 17 of 77 1.23 TROPONIN I This is now the first-line test for investigating possible acute coronary syndrome or myocardial infarction. Please state the time of the suspected event on the request form. For “rule-out” purposes, samples should be collected at least 12 hours after the event, as the Troponin I level may not increase until then. A raised level over 34 ng/L indicates myocardial injury and supports the diagnosis of acute myocardial infarction, providing there are consistent symptoms or ECG changes. If the Troponin I level has been significantly raised (at least 120 ng/L) in the last week, repeat testing is of minimal value due to its long half-life and is only warranted if myocardial re-infarction is suspected. 1.24 ALPHABETICAL LIST OF BIOCHEMISTRY TESTS The list is not exhaustive; other tests are available on request. Please contact the laboratory about tests that are not listed (extension 1809 for information about tubes, 1826 for more detailed advice). Certain tests are referred to external laboratories, mainly in Birmingham, Crewe, Liverpool, Manchester, Salford and Sheffield, for analysis. However, requests should be referred via the Macclesfield DGH laboratory and not sent directly to the external laboratory. The external laboratories used may change as a consequence of harmonisation of practice with Leighton Hospital, Crewe. Reference ranges will be issued with reports of these tests where appropriate. Analyses are done on blood samples collected in yellow top (SST) containers except where indicated. TEST ACE (Angiotensin Converting Enzyme) Acetylcholine Receptor Ab ACTH (Adrenocorticotrophin) AFP (Alpha-Fetoprotein) Albumin Albumin/Creatinine: urine Alcohol [Ethanol] Aldosterone Alkaline Phosphatase Alk. Phos. Isoenzymes Alpha-1-Antitrypsin & Phenotype ALT (Alanine Trans.) Amiodarone Amino Acids: urine Ammonia Amphetamines: urine Amylase: serum Amylase/Creatinine: urine Androstenedione Apolipoprotein E AST (Aspartate Trans.) Barbiturates: urine Bence Jones Protein: random urine Benzodiazepines: urine Beta-2 Microglobulin Bicarbonate: serum Bile Acids SAMPLE ADULT REF.RANGE / COMMENT / EXTERNAL LAB Separate SST Referred to Wythenshawe Hospital, Manchester Separate SST Referred to Manchester Royal Infirmary Phone lab 1809 before collection & send immediately to lab after taken. Referred to Royal Liverpool Hospital 0-10 ku/L (non-pregnant). Analysed at Leighton Hospital, Crewe 35-50 g/L Female ≤3.5; Male ≤2.5 mg/mmol. See section 1.21 Analysed at Leighton Hospital, Crewe Done with renin. Referred to Royal Liverpool Hospital 30-130 iu/L; levels higher in children and in pregnancy Only done if total high. Referred to King’s College Hosp, London Please specify if phenotyping also required. Referred to Sheffield Immunology Laboratory Female 10-50 iu/L; Male 10-60 iu/L Referred to Llandough Hospital, Penarth, South Wales Referred to Willink Laboratory, Manchester 0-40 umol/L; higher in children <2y. Phone lab 1823 before collection; send immediately to lab after taken Part of drugs of abuse screen 0-110 iu/L 0-9 iu/mmol; values up to 12 are borderline Referred to Salford Royal Hospital Genotype. Referred to Christie Hospital, Manchester Female 5-44 iu/L; Male 10-62 iu/L Full container required. Referred to Salford Royal Hospital Qualitative screen by electrophoresis; positive samples confirmed by immunofixation Part of drugs of abuse screen 0.6-2.4 mg/L. Analysed at Leighton Hospital, Crewe 22-29 mmol/L 0-14 umol/L. Only for use in pregnancy EDTA, on ice Separate SST SST Plain Monovette Fl. Ox. [grey] Li Hep [green] SST Separate SST Separate SST SST Plain red top Plain Universal Li Hep [green], on ice Plain Universal SST Plain Monovette Separate SST 2x EDTA SST Plain Universal Plain Universal [full container] Plain Universal Separate SST SST SST ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 18 of 77 TEST Bilirubin: Total Bilirubin: Direct Blood Gases profile SAMPLE SST SST See para 1.11 BNP Separate EDTA Bone profile Buprenorphine: urine C1 Esterase Inhibitor C3 & C4 Complement CA-125 CA-15-3 CA-19-9 Caeruloplasmin SST Plain Universal Separate SST Separate SST SST Separate SST Separate SST Separate SST Plain red top, on ice SST Bottle with acid Plain Monovette Plain Universal Plain Universal SST Li Hep (green) Li Hep (green) 24h urine in acid bottle Calcitonin (fasting) Calcium: serum Calcium: 24h urine Calcium/Creatinine: urine Calculi (renal stones) Cannabinoids: urine Carbamazepine Carboxyhaemoglobin Carnitine profile Catecholamines: urine (metadrenalines done) CCP Antibody (Cyclic Citrullinated Peptide) CEA Chloride Cholesterol: total, HDL Cholinesterase Chromogranin A Ciclosporin A Separate SST SST SST SST Separate SST SST EDTA Citrate: 24h urine Bottle with acid Cocaine: urine Complement C3 & C4 Copper: serum Copper: 24h urine Plain Universal Separate SST Separate SST Plain bottle Cortisol: serum SST Cortisol: 24h urine C-Reactive Protein Creatine Kinase (CK) Creatinine: serum Creatinine Clearance: serum AND 24h urine Plain bottle SST SST SST 24h urine (plain bottle) and SST Cryoglobulins 2x Plain red top Cystine: urine DHEA Sulphate Digoxin Plain Universal Separate SST SST ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead ADULT REF.RANGE / COMMENT / EXTERNAL LAB 0-21 umol/L. Much higher in neonates 0-10 umol/L pH, pCO2, bicarbonate, base excess & pO2 0-99 ng/L. To lab within 4h. Available for primary care only. Must answer associated clinical questions on electronic requesting. Calcium, phosphate, alkaline phosphatase, albumin Referred to Salford Royal Hospital Immunology test. Referred to Manchester Royal Infirmary Immunology test. Referred to Manchester Royal Infirmary 0-34 ku/L. Females only Referred to Sheffield Immunology Laboratory 0-33 ku/L. Analysed at Leighton Hospital, Crewe Referred to Sheffield Immunology Laboratory Phone lab 1809 before collection & send immediately to lab after taken. Referred to Christie Hospital, Manchester 2.20-2.60 mmol/L. Adjusted value reported if Alb <40 g/L 2.5-7.5 mmol/24h. Phone lab 1809 to obtain container 0.10-0.75 mmol/mmol. Higher in children <18 months Referred to Birmingham City Hospital Qualitative screen 4.0-12.0 mg/L. Collect sample >6h post dose 0.0-1.5 %. Can use heparinised blood gas sample Referred to Willink Laboratory, Manchester Phone lab 1809 to obtain bottle with acid preservative Referred to Salford Royal Hospital For rheumatology use only. Referred to Salford Royal Hospital Immunology Laboratory 0-7 ug/L 95-108 mmol/L See section 1.10 Referred to Manchester Royal Infirmary Referred to Sheffield Immunology Laboratory Collect pre-dose. Referred to Manchester Royal Infirmary Phone lab 1809 to obtain bottle with acid preservative Referred to Wythenshawe Hospital Part of drugs of abuse screen Immunology test. Referred to Manchester Royal Infirmary Referred to Salford Royal Hospital Referred to Royal Liverpool Hospital 215-560 nmol/L at 9am. Random samples are of limited value. Dynamic tests are preferred: see section 1.17 Referred to Salford Royal Hospital 0-7 mg/L Female 25-200 iu/L; Male 40-320 iu/L Female 50-100 umol/L; Male 60-120 umol/L; lower if <18y Female 60-120 mL/min, Male 60-140 mL/min. Generally replaced by estimated GFR derived from serum creatinine Phone lab 1823 before collection, keep warm at 37C & send immediately to lab after taken, NOT via air tube Qualitative screen. Analysed at Leighton Hospital, Crewe Referred to Salford Royal Hospital 0.5-1.0 ug/L. Collect sample >6h post dose Version 7.0 Issued April 2014 Page 19 of 77 TEST Drugs of abuse: urine Elastase: faeces Erythropoietin Ferritin Folate Free Androgen Index (FAI) Free Fatty Acids Free Thyroxine (fT4) Free Tri-iodothyronine FSH Gal-1-Phos. Uridyl Tr: galactosaemia screen Gamma GT (GGT) SAMPLE Plain Universal Plain pot Separate SST SST SST Separate SST Fl. Ox. [grey] SST SST SST Li Hep (green) Gentamicin GFR - Estimated Globulin (calculated) Glucose: plasma SST 2x 6 mL EDTA tubes, on ice SST SST SST Fl. Ox. [grey] Glucose: CSF Plain Universal Glucose: other fluid Glucose tolerance test Glycosaminoglycans Gonadotrophins Growth Hormone Gut Hormone profile (fasting):gastrin, glucagon, somatostatin, PP, VIP Haptoglobin HbA1c [glycated Hb] HCG: serum HCG: urine HDL Cholesterol Fl. Ox. [grey] 2x Fl.Ox. [grey] Plain Universal SST Separate SST 4x 6 mL pink EDTA tubes, on ice Separate SST Fl. Ox. [grey] SST Plain Universal SST Fl. Ox. [grey], on ice Fl. Ox. [grey] 24h urine in acid bottle Separate SST Separate SST Separate SST Gastrin (fasting) Homocysteine (fasting) 3-Hydroxybutyrate 5-Hydroxyindole Acetic Acid (5-HIAA): urine 17-Hydroxy-progesterone IgE & specific IgE IGF-1 IgA Immunoglobulins: IgG IgM Insulin & C-peptide (preferably fasting); also request glucose Intrinsic Factor Antibody Iron Iron Studies SST Plain red top, on ice AND Fl. Ox. [grey] Separate SST SST SST ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead ADULT REF.RANGE / COMMENT / EXTERNAL LAB Qualitative screen Referred to Wythenshawe Hospital, Manchester Referred to King’s College Hospital, London Female <50y 5-85, >50y 10-150 ug/L; Male: 15-200 ug/L 3.0-20.0 ug/L. Measured with vitamin B12 Female 0.0-5.6 (0.0-4.5 if >= 50y), Male 22-70 (11-52 if >= 45y) Calculated from testosterone and SHBG results To lab within 1h. Referred to Sheffield Children’s Hospital 7.0-17.0 pmol/L. Part of Thyroid Function Test Profile 3.5-6.5 pmol/L. Only measured at laboratory’s discretion See 1.19. State LMP if cycle; day 2-5 sample preferred Don’t take on Fridays. Invalid if recent blood transfusion. Referred to Willink Laboratory, Manchester Female 5-40 iu/L; Male 5-56 iu/L Phone lab 1826 before collection & send immediately to lab after taken. Referred to Charing Cross Hospital, London Range depends on dosing regime; state time of last dose >=60 mL/min; not reported if age <18y. See section 1.21 18-36 g/L. Calculated from total protein and albumin Fasting 3.5-6.0 mmol/L; Random 3.5-7.7 mmol/L. 2.5-4.5 mmol/L. Don’t need Fl.Ox. tube if tested within 2h Interpret result against contemporaneous plasma glucose Interpret result against contemporaneous plasma glucose Collect at 0 & 2 hours. Separate form. See section 1.15 Urine sample. Referred to Willink Laboratory, Manchester FSH & LH. State LMP if cycle; day 2-5 sample preferred Only as part of DFT. Referred to Royal Liverpool Hospital Phone lab 1826 to discuss request before collection. Send immediately to laboratory after collected. Referred to Charing Cross Hospital, London Referred to Royal Liverpool Hospital See section 1.15 0-5 iu/L (non-pregnant). State LMP if applicable Qualitative pregnancy test, sensitive to 25 iu/L. State LMP Female 1.2-2.1 mmol/L, Male 1.0-1.9 mmol/L. See 1.10 Phone lab 1809 before collection & send immediately to lab after taken. Referred to Royal Liverpool Hospital To lab within 1h. Referred to Sheffield Children’s Hospital Phone lab 1809 to obtain bottle with acid preservative Referred to Wythenshawe Hospital Referred to Royal Liverpool Hospital (to RMCH for infants <1 year) Immunology test. Referred to Manchester Royal Infirmary Referred to Royal Liverpool Hospital 0.8-4.0 g/L; 0.8-2.8 g/L if 12-45y, lower in children <12y 6.0-16.0 g/L; lower in children <15y 0.5-2.0 g/L; 0.5-1.9 g/L if 12-45y, lower in children <12y Phone lab 1809 before collection Send immediately to laboratory after taken. Referred to Royal Liverpool Hospital Immunology test. Referred to Manchester Royal Infirmary Female 9-30 umol/L; Male 11-30 umol/L Iron, transferrin, calculated transferrin saturation Version 7.0 Issued April 2014 Page 20 of 77 TEST Lactate: plasma, CSF Lamotrigine LDH: serum LDH: fluid LDL Cholesterol Lead LH Lipid profile (preferably fasting) Lithium Liver Function (LFT) Lysosomal Enzymes Magnesium: serum Magnesium: 24h urine Manganese Mercury: blood Mercury: urine Metadrenalines: urine (Catecholamines) Methadone: urine Methaemoglobin “Microalbumin”: urine Mucopolysaccharides Myoglobin: urine Occult Blood: faeces Oestradiol Oligoclonal bands & CSF Immunoglobulins Oligosaccharides Opiates: urine Organic Acids: urine Osmolarity: serum Osmolarity: urine SAMPLE Fl. Ox. [grey], on ice SST SST SST SST EDTA SST SST SST SST 2x EDTA SST Bottle with acid EDTA EDTA Plain Universal 24h urine in acid bottle Plain Universal Li Hep (green) Plain Monovette Plain Universal No longer done Not applicable SST CSF AND blood [SST] Plain Universal Plain Universal Plain Universal SST + Fl. Ox. Plain Monovette Oxalate: 24h urine Bottle with acid Oxygen Saturation P3NP See para 1.11 Plain red top Paracetamol SST Paraprotein testing Paraquat: urine pH: fluid Phenobarbital Phenylalanine Phenytoin Phosphate Phytanic Acid Porphobilinogen (PBG) & Porphyrins: blood, urine & faeces SST AND urine Plain Universal Bl. Gas syringe SST separate SST SST SST 2x EDTA Blood: EDTA Urine & Faeces each Plain pot ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead ADULT REF.RANGE / COMMENT / EXTERNAL LAB Plasma 0.6-2.5 mmol/L, CSF 1.1-2.8 mmol/L. Phone lab 1823 in advance & send immediately to lab after taken 3.0-15.0 mg/L. Collect sample >6h post dose 310-620 iu/L Normally less than 2/3rd of contemporaneous serum level See section 1.10. Only reported if sample fasting Referred to Royal Liverpool Hospital See 1.19. State LMP if cycle; day 2-5 sample preferred total & HDL cholesterol, triglycerides, LDL chol if fasting & total/HDL ratio if primary prevention. See Section 1.10 0.4-1.0 mmol/L. Collect sample at 12h post dose. Albumin, bilirubin (total), alkaline phosphatase, ALT Not Fridays. Referred to Willink Laboratory, Manchester 0.70-1.00 mmol/L 2.4-6.5 mmol/24h. Phone lab 1809 to obtain container Referred to Birmingham City Hospital Organic exposure. Referred to Birmingham City Hospital Inorganic exposure. Referred to Birmingham City Hospital Phone lab 1809 to obtain bottle with acid preservative Referred to Salford Royal Hospital Part of drugs of abuse screen 0.0-1.5 %. Can use heparinised blood gas sample Female ≤3.5; Male ≤2.5 mg/mmol creatinine. See section 1.21 Urine sample. Referred to Willink Laboratory, Manchester Please measure serum creatine kinase (CK) instead Test no longer available See Section 1.19 Need serum as well as CSF. Referred to Sheffield Immunology Laboratory Urine sample. Referred to Willink Laboratory, Manchester If screen positive, referred to Salford Royal Hospital to confirm State drugs. Referred to Willink Laboratory, Manchester 275-295 mmol/L. Calculated from Na/K/urea/glucose Calculated from sodium, potassium, urea & creatinine Phone lab 1809 to obtain bottle with acid preservative Referred to Wythenshawe Hospital 92.0 – 99.0 %. COHb & MetHb also reported Not SST. Referred to Sheffield Immunology Laboratory See sections 1.9 and 1.25. State time after alleged ingestion. Do not collect sample before 4h after suspected overdose See protein electrophoresis (serum and urine) Qualitative screen See sections 1.11/1.14 for sample collection procedure 10.0-40.0 mg/L. Collect sample >6h post dose Referred to Alder Hey Hospital, Liverpool 5.0-20.0 mg/L. Collect sample >6h post dose 0.80-1.50 mmol/L. Higher in children less than 16y Not Fridays. Referred to Willink Laboratory, Manchester Send blood, urine & faeces for full screen Protect from light in transit to laboratory. Referred to Salford Royal Hospital Version 7.0 Issued April 2014 Page 21 of 77 TEST Potassium: serum Pregnancy test: urine Progesterone SAMPLE SST Plain Universal Plain red top [not SST] Prolactin SST Protein: 24h urine Protein/Creatinine: urine Protein electrophoresis (serum) Protein electrophoresis (urine – Bence Jones) Protein (Total): serum Protein (Total): CSF Protein (Total): fluid Protein profile: serum PSA (Total) PTH: Parathyroid hormone PTH-related Peptide (PTHrP) Plain bottle Plain Monovette Reducing Substances: urine, faeces Plain container (e.g. Universal) Renin Rheumatoid Factor Salicylate Selenium SHBG (Sex Hormone Binding Globulin) Sirolimus Sodium: serum Sweat Test (Chloride) Tacrolimus Teicoplanin Testosterone Theophylline Thyroglobulin Thyroid Function (TFT) Thyroid Peroxidase (TPO) Antibody Tobramycin TPMT Transferrin Transferrin Saturation Triglyceride SST Plain Universal [full container] SST Plain Universal SST SST SST Separate SST Special tube, on ice EDTA NOT on ice Separate SST SST Separate SST Separate SST EDTA SST Special EDTA Separate SST Separate SST SST Separate SST SST Separate SST SST EDTA SST SST SST Troponin I SST Tryptase (mast cell) TSH TSH Receptor Antibody Separate SST SST Separate SST ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead ADULT REF.RANGE / COMMENT / EXTERNAL LAB 3.5-5.3 mmol/L Qualitative hCG assay, sensitive to 25 iu/L. State LMP. Females only. Collect in luteal phase only & state LMP. Result >=30 nmol/L indicates ovulation Female 40-530 mu/L if 11-50y, 40-425 mu/L if >=50y Male 40-360 mu/L. Up to 0.15 g/24h. Acidified samples cannot be analysed. Up to 10 mg/mmol Samples with paraproteins quantitated, and also confirmed by immunofixation if paraprotein if not previously known Qualitative screen by electrophoresis; positive samples confirmed by immunofixation if not previously known 60-80 g/L 0.15-0.45 g/L Transudate <25 g/L; Exudate >30 g/L; 25-30 g/L borderline Total protein, albumin, calculated globulin Males only. Age-related ranges quoted: see section 1.20 1.3-6.8 pmol/L. Analysed at Leighton Hospital, Crewe Not routinely available; phone lab 1826 to discuss request and obtain special tube; send immediately to lab after collection Sample must reach laboratory on day collected. Qualitative report. Faecal analysis not routinely available; please phone 1826. Urine samples referred to Leighton Hospital, Crewe for analysis. Phone lab 1826 before collection & send immediately to lab after taken. Referred to Royal Liverpool Hospital 0-12 kiu/L; values between 13-24 borderline. Analysed at Crewe Concern level >350 mg/L (>280 mg/L if <5y). Section 1.9 Referred to Royal Liverpool Hospital Female 20-126 nmol/L; Male 14-79 nmol/L. Used to derive FAI. Analysed at Leighton Hospital, Crewe Collect pre-dose. Referred to Wythenshawe Hospital 133-146 mmol/L For suspected cystic fibrosis. Phone lab 1823 to arrange Collect pre-dose. Referred to Wythenshawe Hospital Collect pre-dose. Microbiology test. Sent to Southmead Hospital. See section 1.17. Analysed at Leighton Hospital, Crewe 10-20 mg/L. Collect sample 4-6h post dose (slow release tablets) Referred to Sheffield Immunology Laboratory free T4 & TSH; free T3 analysed at laboratory’s discretion 0-35 kiu/L. Results in range 36-150 indicate a low titre. Analysed at Leighton Hospital, Crewe Trough < 2 Peak 8-12 mg/L. State time of last dose. Referred to Birmingham City Hospital 2.0-3.6 g/L 15-45 %. Calculated from iron & transferrin levels 0.4-1.7 mmol/L (applies if fasting). See section 1.10 0-34 ng/L; only valid for excluding myocardial infarction if collected >12h post event Immunology test. Referred to Manchester Royal Infirmary 0.20-4.50 mu/L. Part of Thyroid Function Test profile Referred to Royal Liverpool Hospital Version 7.0 Issued April 2014 Page 22 of 77 TEST TTG Antibody (IgA) Urate: serum Urate: 24h urine Urea: serum U&E: random urine U&E: 24h urine SAMPLE Separate SST SST Plain bottle SST Plain Monovette Plain bottle Valproate SST Vancomycin Very Long Chain Fatty Acids (VLCFA) Vitamins A & E Vitamin B12 Vitamin D (25OH-D3) Xanthochromia: CSF SST Zinc 2x EDTA separate SST SST separate SST Plain Universal Special blue top Vacutainer ADULT REF.RANGE / COMMENT / EXTERNAL LAB Immunology test. Referred to Manchester Royal Infirmary Fem. 140-360 umol/L; Male 200-430 umol/L; lower if <12y 1.5-4.5 mmol/24h. Acidified samples cannot be analysed. 2.5-7.8 mmol/L sodium, potassium, urea, creatinine, calculated osmolarity sodium, potassium, urea, creatinine 50-100 mg/L (poorly defined). Measurement only useful to assess compliance. Collect sample 2–4h post dose. 10-15 mg/L (trough). Collect sample pre-dose Do not collect on Fridays. Referred to Willink Laboratory, Manchester Protect from light. Referred to Wythenshawe Hospital 145-910 ng/L; values between 145-179 borderline Referred to Wythenshawe Hospital, Manchester Need 1 mL. Protect from light. Do not send by air tube Phone lab 1809 before collection to obtain tube Referred to Salford Royal Hospital 1.25 GRAPH TO ASSESS SEVERITY OF PARACETAMOL OVERDOSE Patients whose serum paracetamol concentration related to time from ingestion is above the line require specific treatment. This line was revised by the Commission on Human Medicines (MHRA) on 3rd September 2012. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 23 of 77 1.26 CRITICAL ABNORMAL RESULTS Biochemistry results outside the following limits will be telephoned immediately to the requesting clinician/location as soon as the results are confirmed to be analytically correct. Test (serum/blood if not otherwise stated) Ammonia Lower Limit Upper Limit 100 µmol/L Alcohol 300 mg/dL ALT AST 900 iu/L 600 iu/L Amylase 250 iu/L Anticonvulsants: Carbamazepine Lamotrigine Phenobarbital Phenytoin 25.0 mg/L 30.0 mg/L 75.0 mg/L 25.0 mg/L Bilirubin (neonates) 280 µmol/L (35 cord blood) Bile Acids (in pregnancy only) 14 µmol/L Bicarbonate 10 mmol/L 50 mmol/L Calcium (adjusted if albumin <40 g/L) 1.80 mmol/L 3.00 mmol/L } (GP/OP only, } if new/increasing) Carboxyhaemoglobin 20 % C-Reactive Protein 250 mg/L (GP/OP only) Creatine Kinase (CK) 2000 IU/L Creatinine 350 µmol/L (only if a new finding) Digoxin 2.0 µg/L Gases: pH 7.10 7.80 Glucose: plasma (fasting or random) 2.5 mmol/L 20.0 mmol/L Glucose: CSF 1.7 mmol/L 15.0 mmol/L Lithium 1.2 mmol/L Lactate 5.0 mmol/L Magnesium 0.40 mmol/L Paracetamol 40 mg/L Phosphate 0.35 mmol/L Potassium 2.5 mmol/L 6.5 mmol/L Protein: 24 hour urine 2 g/24h (pregnancy) Protein/Creatinine ratio: random urine 200 mg/mmol (pregnancy) Salicylate 350 mg/L Sodium 120 mmol/L 155 mmol/L Theophylline 20.0 mg/L (neonates 15.0) Troponin I 34 ng/L (GP/OP Only) Urea 30.0 mmol/L (only if a new finding) Xanthochromia: CSF Any Positive Result ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 24 of 77 1.27 SAMPLE COLLECTION NOTES Certain substances, drugs and procedures can affect the results of some laboratory tests: 1. Haemolysis Can increase serum levels of potassium, magnesium, phosphate, PTH, zinc, folate and many enzymes, and cause analytical interference with other assays (including lithium and troponin I). 2. Delayed separation As with haemolysis, this may increase serum levels of potassium, magnesium, phosphate, PTH, zinc, folate and many enzymes. 3. EDTA contamination Occurs if samples are tipped from an EDTA tube into another tube - will increase potassium and decrease calcium, magnesium and alkaline phosphatase levels. 4. Intravenous infusions Samples collected from a “drip arm” into which an intravenous infusion is running will give artefactually high results for analytes in the infusion and artefactually low results for any other analytes. 5. Lipaemia Can interfere with many assays - results should be interpreted with caution. 6. Proteins/Calcium Posture and/or prolonged venous stasis can increase concentrations. 7. Uric acid Thiazide diuretics and paracetamol can affect levels. 8. Glucose/Triglycerides Time of food intake should be taken into account. 9. CK (creatine kinase) Injections, trauma, surgery and hypothermia can increase levels. 10. Cortisol Stress, time of day and steroids (e.g. prednisolone) affect levels. 11. Jaundice High levels of bilirubin interfere with creatinine and urate assays at Macclesfield. 12. Ketones High levels interfere with creatinine assays at Macclesfield. In all cases, a repeat sample should be collected if doubt exists regarding the validity of the results. 1.28 IRON STUDIES AND FERRITIN Acute or chronic disease can affect measurements used to assess iron status. In particular, a low serum iron level, which is especially common in hospital inpatients, does not necessarily indicate iron deficiency. A low serum iron with a low transferrin saturation (below 15%) is suggestive of iron deficiency if the transferrin is raised or high normal (≥ 3.0 g/L). However, a low serum iron with a low or low normal transferrin (typically < 2.5 g/L) usually suggests disease due to a cause other than iron deficiency, such as a chronic inflammatory disorder. Therefore, the preferred biochemical test for suspected iron deficiency is serum ferritin. A ferritin value below the lower limit of the reference range supports the diagnosis of iron deficiency. However, as serum ferritin is increased by the acute phase response, an apparently “normal” value in the lower part of the reference range (< 75 µg/L) does not exclude iron deficiency. If a patient is unwell, it is therefore desirable to request a marker of the acute phase response (such as CRP) at the same time as requesting serum ferritin. In addition, a high ferritin value above the reference range does not necessarily indicate iron overload, due to the effect of the acute phase response. Serum ferritin may also exceed the reference range in liver disease not due to haemochromatosis. Therefore, the preferred test for screening for haemochromatosis is serum iron studies. The serum iron and transferrin results are used to calculate the transferrin saturation - a value above 45% is suggestive of this diagnosis, provided that the patient is not on iron therapy, but clinical haemochromatosis is unlikely if the transferrin saturation does not exceed 40%. Please do not directly request haemochromatosis (HFE) genotyping without seeking specialist haematology advice unless the transferrin saturation is above 45% (preferably on at least 2 occasions). Please note that age- and sex-related reference ranges are used for both iron and ferritin results. Where appropriate, senior biochemistry laboratory staff may add additional tests (including CRP) in order to assist with the interpretation of equivocal serum ferritin and iron/transferrin results. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 25 of 77 1.29 CLINICALLY SIGNIFICANT CHANGES IN RESULTS Many of the laboratory tests requested each year are used to monitor patients rather than for diagnosis. Sequential changes in cumulative results, when placed in a clinical context, can be as important as the absolute value of the result. The laboratory undertakes regular quality assurance activities to ensure the reliability of the results, but it must be noted that there will always be some degree of uncertainty associated with all results. When a single specimen from a patient is assayed several times identical results are not found every time. This is due to analytical imprecision. IQC programmes allow the laboratory to calculate and to know the analytical imprecision for each analyte measured. In addition, the concentration of an analyte from any individual subject varies from day to day. This may be termed biological, intra-individual or within subject variation. Biological variation may itself be inherent in nature or dependent on variables such as timing (e.g. cyclical rhythms, which may be daily, monthly or seasonal), diet, stress, and posture. Changes in results may therefore be caused by a combination of: analytical imprecision plus biological variation in addition to deterioration or amelioration of the patient's condition under assessment. The "critical difference" between results, i.e. the change that must occur before significance can be claimed, can be calculated. The critical differences for specific tests are available from the laboratory on request. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 26 of 77 2.0 HAEMATOLOGY DEPARTMENT: THE SERVICE Our highly trained, professional staff combine the use of both manual techniques and automated equipment to provide a comprehensive haematology service. Participation in National Quality Control Programmes ensures compatibility of results with other centres, whilst internal Q.C. provides a continual monitoring of precision. The Consultant Haematologist and the Chief BMS are available to provide clinical and technical advice respectively. 2.1 OPENING HOURS The department is open from 9:00 am to 17:30 pm from Monday to Friday. For all out of hours arrangements see section 0.4. 2.2 URGENT REQUESTS The department must be contacted prior to sending the specimen. Please mark the request card as urgent and state details of to whom results should be rung. Inpatient results will be made available on the laboratory computer system as soon as practicable for ward enquiry. 2.3 REPORTING TIMES Normally routine reports to the wards will be available to ward enquiry within 4 hours of receipt in the laboratory. We endeavour to provide urgent test results for ward enquiry within one hour of receipt of the specimen in the laboratory. Electronic reports to the GP practices are sent out in the early evening for the following working day. Any FBC requiring film examination should be reported by 16:30h the next working day. Any gross or unexpectedly abnormal results will be telephoned to the requesting ward, department or GP practice as soon as possible. 2.4 REQUEST FORM HAEMATOLOGY: Combined Haematology/Biochemistry (White/Red/Green) is used for all Haematology tests and incorporates a bag for the safe transport of specimens. Please tick appropriate box or state test requested in box provided. Where patient is anticoagulated please state drug and dosage. NOTES ON USE OF FORMS A) When using addressograph labels please use a label on each layer of NCR forms and add all other relevant information to the form (e.g. ward is not supplied on the addressograph label alone). DO NOT use addressograph labels on specimens. B) Use ball point pen to ensure transcription through all layers of NCR (multipart) form. C) Forms should be filled in completely and correctly. D) Please ensure there is a ``source'' stated on form otherwise we cannot return the report to you. E) Relevant clinical information is very important in Haematology requests, please state pregnancy gestation period where relevant. F) The Lab will NOT ACCEPT unlabelled samples. G) LABELLING - Please fill in all details on both sample and request form. The hospital number in particular is extremely useful as this is the only search parameter available to Haematology. Where hospital numbers are given, the ``booking in'' process is speeded up making for quicker turnaround times. 2.5 SPECIMEN CONTAINERS Within the main hospital these are available from the Phlebotomy area (Blood Tests) situated near the Cash Office. For other users these are obtained from Pathology Specimen Reception (1809). ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 27 of 77 2.6 HIGH RISK CASES Specimens and request forms from patients suspected or 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. 2.7 COLLECTION OF SPECIMENS All samples must be mixed after collection according to the information provided by BD which is 8 – 10 inversions. Coagulation samples must be filled to the frosted fill line on the bottle as under or over filled samples will give erroneous results. Requests for additional tests should be received on the same day as the original request as sample degradation will occur and render the sample unsuitable for testing. D-dimer requested as an additional test must be received within 4 hours of the sample collection. Minimum sample requirement for an FBC is 0.5ml. 2.8 SPECIMEN REQUIREMENTS TEST SAMPLE BOTTLE Comments Lavender Top 4ml FBC/ESR/IM Screen/Reticulocytes/Malaria Can be stored overnight in refrigerator. Some EDTA or 1.3ml EDTA screens/Blood Film additional tests can be added up to 24 hours. paediatric sample Coagulation Tests: PT (INR)/ APTT/ DDimer Test should be performed immediately, delays Blue Top 2.7ml citrate can seriously affect results. Additional requests – fill exactly to line for D-Dimers can be made up to 4 hours after the time of collection. Haemoglobinopathy studies: Sickle Screen, Lavender Top 4ml Hb electrophoresis, HbA2 & HbF estimation EDTA or 1.3ml EDTA paediatric sample G-6PD screen Thrombophilia screen: antithrombin, Proteins S&C, APCR Lupus anticoagulant 4 x Blue Top 2.7ml citrate – fill exactly to line Factor V Leiden, Prothrombin Gene Variant 2 x 4ml EDTA Haemochromatosis Gene Variant (lavender) ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Not urgent tests, can be sent Monday to Friday 09:00 to 16:00 Sent to referral centre Version 7.0 Issued April 2014 Page 28 of 77 2.9 ADULT NORMAL RANGES TEST / PARAMETER GENERIC MALE FEMALE 130 – 180 g/L 115 – 165g/L RBC 12 4.5 – 6.5 x 10 /L 3.8 – 5.8 x 1012/L HCT 0.4 – 0.52 L/L 0.36 – 0.47 L/L Hb WBC 9 4 – 11 x 10 /L PLTS 9 150 – 450 x 10 /L MCV 80 – 100 fL MCH 27 – 32 pg 9 27 – 93 x10 /L 22 – 76 x109/L 0-14mm/Hr 0-20mm/Hr Protein S (functional) 75-130 iu/dL 60-130 iu/dL Protein S (antigen) 75-130% 60-130% RETICS 9 Neutrophils 1.7 – 7.5 x 10 /L Lymphocytes 9 1.0 – 4.0 x 10 /L Monocytes 0.2 – 0.8 x 10 Eosinophils 9 0.04 – 0.4 x 10 /L Basophils 9 0.00 – 0.1 x 10 /L 9/L ESR HbA2 1.7-3.3% HbF 0.2-1.0% PT 9-12 s INR 0.9-1.2 APTT 21-29 s APTT Ratio 0.8-1.2 FIBRINOGEN 1.5-4.0 g/L d-Dimers <200 g/ml Antithrombin 80-150 iu/dL Protein C 70-150 iu/dL Factor VIII 50-171 iu/dL Factor IX 50-150 iu/dL APCr Ratio >0.8 normal Cold Agglutinins < 1 in 64 G6PD Normal Activity Tests that do not have a numerical value will be reported with interpretative comments dependant on the result. Other tests may also have comments to qualify the result or provide further information relating to that test. Age and sex-related reference range are printed on the final report. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 29 of 77 2.10 TURNAROUND TIMES AND FACTORS AFFECTING TESTING TEST ROUTINE URGENT FACTORS AFFECTING TEST* H, L, C FBC 4 hours from receipt 1 hour from receipt C, U ESR 4 hours from receipt 1 hour from receipt Reticulocyte 4 hours from receipt 1 hour from receipt IM screen Same working day 2 hours from receipt Malaria parasites Same working day 2 hours from receipt PT/INR 4 hours from receipt 1 hour from receipt APTT 4 hours from receipt 1 hour from receipt Coagulation screen 4 hours from receipt 1 hour from receipt R R – Immunological test only H, U, L, O H, U, L, O H, U, L, O Thrombophilia screening Up to 6 weeks depending on results and send away aspects of screen. Not applicable Pt on anticoagulants. H, U, O A Haemoglobinopathy screening Up to 4 weeks depending on results and confirmation at referral laboratory. Sickle screen 1 hour from receipt G6PD Within 3 working day Same working day D-DIMER 4 hours from receipt 1 hour from receipt Raised reticulocyte levels H, U, L, O * H = Haemolysis L = Lipaemia C = Cold Agglutinins U = Underfilled Sample O = Overfilled Sample R = Increased level of Rheumatoid factor A = Aged Sample (> 3 days old) ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 30 of 77 2.11 TELEPHONE RESULTS The following is a guide to what may be telephoned but can vary depending on the clinical information provided. To GPs Hb. < 80 g/L and > 185 g/L. WCC. < 2.0 x10 9/L and > 25.0 x 109 /L. PLTS. < 50 x 10 9 /L. and >1000 x 109 / L Absolute neutrophil count < 1.0 x 109 /L. INR. > 6.0 (patients on Warfarin). To Wards and Departments Hb. < 70 g/L and > 190 g/L. WCC. < 1.5 x 109 /L and > 30.0 x 109 /L. (depends on the ward). Absolute neutrophil count < 1.0 x 109 /L. PLTS. < 30 x 109 /L. INR. > 6.0 APTT clotting times greater than 250 seconds ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Page 31 of 77 2.12 REFERRED TESTS Test Anti Factor Xa BCR/ABL Fusion Gene Product. JAK2 Gene Marker Cell Markers Sample Requirements 1 x 3mL citrated blood (blue top). Pre and 2 hrs post dose 2-3 x fresh EDTA samples if possible. 2-3 x fresh EDTA samples if possible. or Bone marrow Cell Markers CD4, CD8 1x3ml EDTA Cell Markers CD55, CD59 CD52 3 x EDTA samples <24hrs old plus 4-6 labelled but unfixed films Fresh bone marrow or blood in specific transport medium Cytogenetic Testing ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Testing Laboratory Autolab / Coagulation Dept Manchester Royal Infirmary Oxford Road Manchester M13 9WL Tel. No. (0161 276 4082) ask for Coagulation Department. Dr. Abida Awan Molecular Diagnostics Centre Top Floor, Multipurpose building York Place (Gate 3) Manchester Royal Infirmary Oxford Road Manchester M13 9WL Dr Awan 0161 276 4137 0161 276 8039 or 4809 Stem Cell Flow Cytometry Lab, Christie Hospital, Wilmslow Road, Manchester M20 4BX (Tel 0161 918 7337/3286) Immunology Department Manchester Royal Infirmary Oxford Road Manchester M13 9WL Tel. No. (0161 276 8766/6440) HMDS Department Level 3 Bexley Wing St James University Hospital Leeds LS9 7TF Tel 0113 206 7851 Oncology Cytogenetics Pathology Department Christie Hospital Manchester M20 4BX Tel. No. 0161 446 3165. Nick Telford Ext.3163 Turnaround Times 14 days Request Form Copy of request form 35 days Copy of request form Storage Frozen Additional Comments Used to monitor LMW heparin dose in selected patients. o 2 – 8 C. Preferably sent fresh. Sample must be less than 48 hours old when received by Manchester. Samples accepted Monday – Thursday o 2–8 C 12 days Urgent requests shorter. As above. 3 days Copy of request form Room Temperature 21 days Leeds request form (Available from Dr Hudson) 2-8 C Preferably fresh Urgent: up to 5 days 28 days Must be less than 24 hours old when received at Christie. Samples accepted Monday – Friday (14:30 at latest Specific request forms, which are held by Clinical Haematology team Page 32 of 77 o Reports returned directly to requester Must be less than 24 hours old when received at MRI. Samples accepted Monday – Thursday Send by First Class post. Specific cell marker form to be completed for each request. 2 – 8oC. Preferably sent fresh. Sent via Macclesfield Hospital internal transport who go to Manchester each morning @ 09:15 Version 7.0 Issued April 2014 Test DNA analysis for Thal / Hp opathy Factor V Leiden Prothrombin Gene Variant. Haemochromatosis Gene (HFE Gene) Confirmation & speciation of Malaria Plasma Viscosity Sample Requirements 10mL EDTA blood (<5 days old). Testing is possible on 2mL 1 x 3mL citrated or EDTA sample. 1 x 3mL citrated or EDTA sample. The original EDTA sample, 2 unstained thick films, 2 unstained, unfixed thin films and the original Giemsa films EDTA sample (If both ESR and PV requested 2 x EDTA required) ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Testing Laboratory Dr Steve Keeney Molecular Diagnostics Centre, Top Floor Multipurpose Building Manchester Royal infirmary Oxford Road Manchester M13 9WL Tel. No. 0161 276 4809/4880 Steve Keeney Molecular Diagnostics Centre, Top Floor Multipurpose Building Manchester Royal infirmary Oxford Road Manchester M13 9WL Tel. No. 0161 276 4809/4880 Steve Keeney Molecular Diagnostics Centre, Top Floor Multipurpose Building Manchester Royal infirmary Oxford Road Manchester M13 9WL Tel. No. 0161 276 4809/4880 Turnaround Times 8 weeks longer for complex cases Request Form As above. Storage o 2–8 C Additional Comments Samples should be less than 48 hours old. Consent form must be sent with sample – includes ethnic origin. Samples accepted Monday – Thursday Sample forwarded to Oxford for testing. Contact MRI before sending samples. 21 days Copy of request form Room Temperature Whole blood samples are required. Less than 48 hours old when received at Manchester. Samples accepted at Macclesfield Monday - Thursday. 14 days Copy of request form o 2–8 C APCR result should be available before sending Sent via Macclesfield Hospital internal transport who go to Manchester each morning @ 09:15 Less than 48 hours old when received at Manchester. Samples accepted at Macclesfield Monday - Thursday. Diagnostics Laboratory Liverpool School Of Tropical Medicine. Pembroke Place Liverpool L3 5QA Tel.No. 0151 705 3220 Out of hours: 07909 910 899 1 day Department of Haematology Pathology Department University Hospital of North Staffordshire NHS Trust City General Hospital Newcastle Road Stoke-on-Trent ST4 6QG 12 days Copy of request form o 2-8 C Preferably fresh. Malaria is a notifiable disease and the LSOTM will notify the correct body. Clinical and travel information required for HPA request form. Middle copy of request form or photocopy. (Delete any other tests appearing on request) Page 33 of 77 Separate plasma and store at room temperature. Sent by First Class Post Version 7.0 Issued April 2014 Test Pyruvate Kinase Deficiency Sample Requirements 4ml EDTA can be stored at 4 oC for a week Thrombophilia Screening, Protein S, Protein C ATIII, APCR, LUPUS 5 x 3 ml Citrated samples VWF, RICOF, Any other coagulation assays & inhibitor screens 2 x 3 ml citrated blood ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Testing Laboratory Red Cell Laboratory Haematology Dept Kings College Hospital Denmark Hill London SE5 9RS TEL 02032999000 Haematology Department Leighton Hospital, Middlewich Road Crewe CW1 4 QJ 01270 255 141 ext.2646 Autolab / Coagulation Department Manchester Royal Infirmary Oxford Road Manchester M13 9WL Tel. No (0161 276 4082) ask for Coagulation. Department. Turnaround Times 2 weeks Request Form As above Storage 2 – 8oC Additional Comments Avoid posting over weekends. Samples should be received in the lab by 16:30 Monday - Friday 6 weeks Copy of request form Frozen Samples should be received in the lab by 16:30 Monday - Friday 35 days Copy of request form Frozen Samples should be received in the lab by 16:30 Monday - Friday Page 34 of 77 Version 7.0 Issued April 2014 2.13 THROMBOPHILIA (PROTHROMBOTIC) SCREENING Involves a set of assays to measure the level of coagulation inhibitors present in the body. The risk of VTE increases if patent presents with the following thrombophilia results: 1. The presence of Lupus Anticoagulant. 2. Deficiency of coagulation inhibitors: Antithrombin III, Protein C and Protein S. 3. The presence of genetic mutation of Factor V Leiden as measured by the Activated Protein C Resistance screen or the Prothrombin G20210A mutation. 4. A raised factor VIII level (>150 iu/dl). Patients must not be on anticoagulation therapy when thrombophilia screening is requested. In addition, sampling should be avoided during acute episodes, intercurrent illness, pregnancy and use of COCP, HRT. 2.14 ANTICOAGULATION MONITORING OF HEPARIN This is necessary when using standard unfractionated Heparin, for therapeutic purposes the APTT Ratio should be between 1.5 – 2.0. MONITORING OF LOW MOLECULAR WEIGHT HEPARIN, utilising the anti-factor Xa assay, is necessary for the following groups of patients: 1. 2. 3. 4. 5. Patients with morbid obesity. Patients with renal failure. Pregnant women. Children (who might require up to twice the usual dose as calculated from body weight). Patients with malignant disease. The Xa assay is expensive and prior discussion with the lab is essential. MONITORING OF WARFARIN The INR, derived from the Prothrombin Time, is used to monitor oral anticoagulants such as warfarin. The target range will depend on the clinical reason for warfarinisation. There is now a centrally run outreach anticoagulant service. Clinics operate at all the towns within the Central and Eastern Cheshire PCT area. For referral of patients to these clinics please telephone 01625 661836. NEW ORAL ANTICOAGULANTS New oral anticoagulants (NOACs) are now also available. These include: Dabigatran Rivaroxaban Apixaban Information about the use of these anticoagulants can be found in the policies section of the Trust website. There are currently no antidotes for NOACs. In cases of severe blood loss, refer to the Massive Haemorrhage Protocol, appendix 7 of the Blood Transfusion Policy. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 35 of 77 Version 7.0 Issued April 2014 3.0 BLOOD TRANSFUSION Please contact Consultant Haematologist on ext. 1806 for clinical advice regarding blood transfusion. Please contact Transfusion Practitioner on ext. 1236 or bleep 5164 regarding the process of transfusing a patient. 3.1 SPECIMEN COLLECTION FOR TRANSFUSION Two request forms are used in transfusion: a) Pink Group and Screen, Crossmatch or Blood product requests, DAT (coomb's test), Kleihauers, cord sample requests. b) Yellow Antenatal form for booking blood requests (FBC, Antenatal virology testing and Blood Group and antibody screening) and subsequent requests. WITH THE PINK REQUEST FORM The pink transfusion request forms are printed with an attached number, THE TRANSFUSION NUMBER. This serves as an extra, unique identifier but does not supersede the other patient identifiers. 1. 2. 3. 4. Remove bar coded Transfusion number (T number) and place on appropriate space as indicated on Request Card. Place bar code number along length of sample, avoiding patient details on the label. Complete the large sticker and place in case notes. If patient is unconscious or unidentified place 4th T number on patient's wrist band For further information on sample collection refer to the reverse of the request card or the Trust Transfusion Policy Specimens for transfusion request should be taken by the requesting medical officer or appropriately trained, designated representative. The specimen container must be labelled with the patient's full name, DOB, hospital number and/or address / NHS number, and the ward handwritten on the label at the time of collection. The sample must be signed and dated. ADDRESSOGRAPH LABELS ARE NOT ACCEPTABLE ON SAMPLES. DO NOT PRELABEL SPECIMEN CONTAINERS. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 36 of 77 Version 7.0 Issued April 2014 3.2 TRANSFUSION DEPARTMENT INVESTIGATIONS TEST REQUEST SPECIMEN Group and Antibody 6ml EDTA (Pink top)* Screen Crossmatch REPORT TIME NOTES 2 working days Plasma samples normally saved for 7 days but if patient transfused or pregnant in previous 3 months sample for crossmatching must be less than 72 hours 24 hours notice required for provision of blood for elective surgery. Current guidelines require second sample prior to the issue of blood where the patient is not known to the laboratory. Exceptions can be made where blood is required urgently. 6ml EDTA (Pink top)* Alkali Precipitation Various Test 1 day Please contact the laboratory staff where the need to establish whether blood contamination of items is of foetal or maternal origin. Atypical Antibody investigation 2 x 6ml EDTA (Pink top)* 1-2 weeks Referred to Liverpool NHSBT Direct Antiglobulin Test (DAT) EDTA (Pink or purple top)* Same day 1 2 x 6 ml EDTA (Pink Investigation of top)and used/part used Transfusion reaction blood units* Next working day Refer to the Trust Transfusion policy and procedure and complete A4 transfusion reaction form HLA Typing (HLA B27) 2 x EDTA (purple top) 1-2 weeks Referred to Sheffield NHSBT 2 HLA Antibodies 6ml clotted (red top) 1-2 weeks Referred to Sheffield NHSBT 2 Platelet Antibodies 6ml clotted (red top) 1-2 weeks Referred to NHSBT Bristol 3 Cold Agglutinins 6ml clotted (red top) and an EDTA sample. Kept at 1 week 37oC. Ring Dept. for advice 6ml EDTA (Pink top) Antenatal Screening 6ml clotted (Red top) EDTA (Purple top) Post Natal screen for RhD Negative Mothers Maternal - 6ml in pink EDTA 1 hr post delivery Cord 6ml in pink EDTA 2 working days For Group and Antibody Screen Serological investigations FBC 1 working day Mother with Red Cell Maternal - 6ml pink EDTA Antibodies Cord - 6ml purple EDTA 1 working day Kleihauer 2 working days EDTA pink or purple By prior arrangement with laboratory >20 weeks gestation 1. NHS Blood & Transplant Liverpool, 14 Estuary Banks, Speke, Liverpool, L24 8RB. 2. NHS Blood & Transplant Sheffield, FAO Histocompatibility & Immunogenetics, Longley Lane, Sheffield, S5 7JN 3. NHS Blood & Transplant Bristol, 500 North Bristol Park, Northway, Filton, Bristol, BS34 7QH * For paediatrics/ neonates please use appropriate specimen either 3ml/1.3ml EDTA sample ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 37 of 77 Version 7.0 Issued April 2014 3.3 ROUTINE REQUESTS When non-urgent transfusions are planned, requests for cross matching should be made at least 24 hours in advance. This allows time for extra investigations to be made if unknown antibodies are found. Any such finding will be notified to the requesting doctor. 3.4 URGENT REQUESTS Please phone the blood transfusion laboratory (ext 1808) to advise of an urgent request. 3.5 GROUP AND SCREEN REQUESTS We encourage the use of group and screen requests. For many operations it is not necessary to have cross matched blood available. For group and screen requests a screening test is performed to detect irregular antibodies. The finding of any clinically significant antibodies will be notified to the requesting officer/ward. If they are not found there should be no difficulty in providing cross matched blood in an emergency. Updated guidelines insist that where a patient is unknown to the Transfusion laboratory a second sample should be obtained to confirm the blood group prior to the issue of blood components. The plasma will be held for 7 days but if blood is requested for patients who have been transfused or pregnant within the previous 3 months a sample less than 72 hours old is required for crossmatching. 3.6 RECLAIMING CROSSMATCHED BLOOD Unused crossmatched blood will routinely be taken back into stock 24 hours after the time the blood was stated to be required. If blood is likely to be needed longer than this period, the medical officer must inform the Transfusion Department. 3.7 ISSUE OF BLOOD When blood is required for transfusion, it is collected by Nursing staff from the Blood Fridge located at: 1) For Orthopaedic Theatre, wards 5, 6: Outside staff locker rooms within Orthopaedic Theatre Suite. 2) For all other wards and departments at entrance to main theatre suite, First Floor, General Hospital. FOR FURTHER INFORMATION REFER TO THE TRUST’S BLOOD TRANSFUSION POLICY AND PROCEDURES 3.8 WARMING OF BLOOD Blood must only be warmed in special blood warmers specifically designed for the purpose. If there is a need to warm blood it will be indicated on the compatibility statement. 3.9 REACTIONS In all cases of reaction to transfusion, please notify the blood transfusion laboratory immediately. 3.10 IRRADIATED BLOOD/PLATELETS FOR TRANSFUSION It is not always possible for transfusion staff to identify patients who require irradiated blood products from the clinical information provided. It is the responsibility of the requesting Medical Officer to identify any patient who requires irradiated blood products. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 38 of 77 Version 7.0 Issued April 2014 3.11 BLOOD ORDER SCHEDULE PLEASE REFER TO THE TRUST’S BLOOD TRANSFUSION POLICY AND PROCEDURES ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 39 of 77 Version 7.0 Issued April 2014 4.0 MEDICAL MICROBIOLOGY The Microbiology Department provides a diagnostic microbiology service to both Macclesfield and Crewe and the surrounding areas. Clinical advice is offered on 9-5pm Monday to Friday, by a Consultant Medical Microbiologist on a dedicated advice line: From Macclesfield, use extension 3644 (outside line 01625 663644). From Leighton, use extension 3370 (outside line 01270 273370) Both numbers link to the Consultant Microbiologist on duty for clinical calls for both sites, on that day. Outside routine laboratory opening hours, clinical advice can be obtained from a Consultant via the hospital switchboard. Scientific and technical enquiries should be directed towards the Biomedical Scientists of the Department. The Department aims to provide a high quality, comprehensive service to hospital and community users. Full quality control is carried out and the Department strives to achieve and maintain UKAS accreditation status. Tests not available on site are referred to specialist laboratories. In collaboration with the local Infection Control Team and Public Health England, the Department contributes to the surveillance, control and prevention of nosocomial infection and cross infection in the Trust hospitals, the local community and nationally. 4.1 OPENING HOURS The Department is open from 09:00h - 20.00h from Monday to Friday. A service for urgent requests and enquiries is offered on Saturday, Sunday and Bank Holiday mornings from 09:00h to 17:30h. 4.2 URGENT REQUESTS The requesting medical officer must contact the laboratory reception (ext 1809) before sending the specimen and must add a contact number, either bleep or telephone, to the request form. Urgent investigations available on-call: CSF Ascitic Fluids (only for diagnosis of SBP) Joint Aspirates Pus from deep head and neck collections (e.g.orbital abscess, retropharyngeal collections) NB: Blood cultures do not require the attendance of the BMS. Out of hours transport the samples to Pathology as quickly as possible, where the on-site Pathology staff will transfer them to an incubator. Other non-urgent specimens can be left overnight in a fridge until the next day e.g. urine, sputum, but if in doubt please contact the on-call Biomedical Scientist. 4.3 REPORTING TIMES AND SPECIMEN CONTAINERS The reporting times given in the following tables are those for average routine specimens. Occasionally an unusual organism is isolated which may be antibiotic resistant, or difficult to identify, so the report may be delayed in leaving the department. A single yellow top tube will suffice for one of more of the following tests that are referred to serology at Leighton Hospital laboratory: Rubella, Varicella, Syphilis, HIV, Hepatitis A IgM, Hepatitis B surface antigen, Hepatitis B core antigen, Hepatitis B surface antibody, Hepatitis C antibody. For all other serum tests stated to require a yellow top bottle in the table below, please send a separate tube for each test. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 40 of 77 Version 7.0 Issued April 2014 SPECIMEN TYPE CONTAINER STORAGE REPORT TIME Arterial Line Tips Sterile Universal Container Fridge* 3 days Aspergillus pptns Yellow top bottle Referred up to 7 days Fridge REFERRAL LABORATORY Immunology Dept. Manchester Royal Infirmary 3 days Anaerobes Aspirates, Pus, Sterile Universal Container Room Temp. may take up to 10 Pleural Fluid etc. days Avian pptns Yellow top bottle Fridge Referred up to 7 days Immunology Dept. Manchester Royal Infirmary Blood for ASO Yellow top bottle Fridge* Up to one week Microbiology, Leighton Hospital Blood Culture Special bottle At 37oC Min of 5 days (for negative) Chlamydia Special bottles Fridge* Referred up to 7 days C.S.F. Sterile Universal Container Send to Lab. 2 days immediately Faeces 60ml Plain Container Fridge* 3 days See separate section Functional antibodies (pneumococcal, Hib etc..) Yellow top bottle Fridge Referred up to 10 days Gamma Interferon Blood bottles available as part of collection pack (contact Department) Must be at referral lab within 16 hours Referred up to 7 days Gentamicin Yellow top bottle Fridge* Same day Use biochemistry request form Hydatid Serology Yellow top bottle Fridge Referred up to 7 days Liverpool School of Tropical Medicine. Leptospira (Weils) Yellow top bottle Fridge Referred up to 7 days County Hospital, Hereford Lyme Disease Yellow top bottle Fridge Referred up to 14 days Microbiology, Porton Down Measles Yellow top bottle Fridge Referred up to 7 days Manchester Royal Infirmary Meningococcal PCR EDTA bottle Fridge Referred up to 7 days Manchester Royal Infirmary MRSA swabs Charcoal swab Room Temp. 2 days ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 41 of 77 Manchester Royal Infirmary Immunology Dept. Manchester Royal Infirmary Version 7.0 Issued April 2014 SPECIMEN TYPE CONTAINER STORAGE Referred up to 7 days REFERRAL LABORATORY Manchester Royal Infirmary Mumps Yellow top bottle Mycology (Fungi) Microscopy 7 Sterile Universal or Special Room Temp. days/Culture 4 Envelope weeks Seminal Fluid (post vasectomy only) 60ml Plain Container Must be fresh 1 day and warm 60 ml plain container Fridge* 1 week Hepatitis A,B,C Yellow top bottle Fridge Referred, 2 days Serology, Leighton Hospital Hepatitis B or C type/viral load EDTA bottle Fridge Referred up to 7 days Manchester Royal Infirmary Rubella Yellow top bottle Fridge Referred, 2 days Serology, Leighton Hospital Sputum 60ml Plain Container Room Temp. Sputum for A.A.F.B. 60ml Plain Container Fridge* Swabs Transwab Room Temp. 3 days Syphilis Yellow top bottle Fridge Referred, 2 days Tissue 60ml Plain Container Fridge* 3 days Urine Boric Acid Container Room Temp. 2 days Urine for A.A.F.B. 3 x 30ml white topped container Fridge* Referred - 6 weeks (for negative) University Hospital of North Staffs Varicella zoster Yellow top bottle Fridge Referred, 2 days Serology, Leighton Hospital Viral Culture If swabs; must be in transport medium Fridge Referred up to 8 weeks Manchester Royal Infirmary Viral Titres† Yellow top bottle Fridge Referred up to 7 days Manchester Royal Infirmary Helicobacter (faecal sample) Fridge REPORT TIME 3 days Referred - 6 weeks (for negative) University Hospital of North Staffs Serology, Leighton Hospital * If a fridge for patient specimens is not available a cool dark place is preferred † For viral titres please ensure clinical details or specific investigation required indicates type of virus suspected. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 42 of 77 Version 7.0 Issued April 2014 Timeframe for requesting additional investigations For in-house tests, specimens are retained for one week (urines are retained for three days) and cultures are stored for at least two days after the report has been issued. We will attempt to comply with reasonable requests for additional investigations within these limitations. Key factors known to affect performance of Microbiology tests: Specimen inappropriate to the clinical condition Delay in transport to laboratory Environmental conditions during transport Contamination during transport Unsuitable container for specimen Desiccation in large container No, or inappropriate, transport medium Presence of formalin or cytology fixative in container Contamination with antibacterial substances (detergents, antiseptics, antibiotics, preservatives) Incorrect labelling of specimen Wrong patient Wrong site Incomplete or inaccurate clinical details (leading to inappropriate processing of specimen) Insufficient material Container not sterile 4.4 REQUEST FORMS AND SPECIMEN LABELLING If available, use ICE electronic requesting, otherwise use a blue Microbiology request form for all Microbiology investigations. Requests for blood tests including serology and virology tests can be indicated on a blood sciences form. Full patient details (a minimum of surname, forename and DOB as per specimen acceptance policy) must be written on both the request form and the specimen plus the TIME AND DATE OF COLLECTION on the specimen. The laboratory will not examine unlabelled/incompletely labelled specimens. Write clearly and in capital letters. Please help the laboratory by giving the details of onset of the infection, details of foreign travel (if appropriate) and details of any antimicrobial therapy with commencement date. The organisms and antibiotic susceptibilities which are reported depend upon the information given on the request form. Appropriate information is also needed for staff safety. Please refer to the following link from HSE regarding provision of key clinical information on laboratory request form http://www.hse.gov.uk/safetybulletins/clinicalinformation.htm As outlined in the Health and Safety Executive Safety Notice HID 5-2011 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. All samples should be sent to the laboratory without delay. If delay is inevitable then see the enclosed list for suitable temperatures at which to store. The laboratory will not accept specimens more than 48 hours old. 4.5 HIGH RISK CASES Specimens which are classified as `high risk' must be labelled as such. The more frequent agents included in the `high risk' group are Salmonella typhi, HIV, Hepatitis B and Mycobacterium tuberculosis. 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 HID5-2011 http://www.hse.gov.uk/safetybulletins/clinicalinformation.htm ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 43 of 77 Version 7.0 Issued April 2014 4.6 GENERAL ADVICE ON SPECIMEN COLLECTION AND SUITABILITY All disposable equipment used in the collection of Microbiological samples must be disposed of as clinical waste in accordance with current regulations. Particular care must be taken when disposing of sharps to ensure such articles are handled and disposed of in the correct designated containers in such a manner as to prevent injury to any individual. Re-usable equipment must be appropriately disinfected or sterilised after use in accordance with local policies. 4.6.1 ANTIBIOTIC LEVELS ANTIBIOTIC MANAGEMENT GUIDELINES ARE AVAILABLE ON THE TRUST INTRANET Sample collection: Please state the date and time of sample collection, and the date and time of the last dose, on the request form. A minimum of 1ml-clotted blood in a gold top bottle is usually required, but smaller sample volumes may be acceptable for neonates and infants. Please do not use intravenous lines to take the blood sample. Indications: A few antibiotics, e.g. aminoglycosides, chloramphenicol and vancomycin, exhibit a narrow range between the therapeutic and toxic concentrations. Assays of blood antibiotic levels may be required to: confirm that adequate concentrations of antibiotic are being achieved, e.g. in patients with known defective intestinal absorption or in the treatment of meningitis; OR in order to avoid excessive blood concentrations when the drug is known to be toxic, especially if the patient has impaired renal of hepatic function, or in neonates whose renal and hepatic handling of drugs is imperfectly developed. Gentamicin assays are undertaken in the Biochemistry departments at Leighton and Macclesfield Hospitals and are available at all times, including “out of hours”. Please notify the Biochemistry department if the request is urgent. Vancomycin and Tobramycin assays are analysed in the Biochemistry department at Macclesfield Hospital. There is no need to take a peak sample, post vancomycin dose. Teicoplanin assays are referred to a specialist centre for testing. Trough sample only required. Blood should be collected immediately before a dose. This should not be collected until the patient has received treatment for 5-7 days. Treatment with teicoplanin should be continued whilst awaiting the results of the pre-dose level. Please use a microbiology request form for teicoplanin requests. Serum level assays for itraconazole, 5-flucytosine, voriconazole are performed at reference laboratories and should be booked with Microbiology staff in advance. Samples must reach the laboratory by 9am to allow transport to the appropriate laboratory. Please use a biochemistry request form for these “sendaway” tests. Therapeutic drug level monitoring – reference ranges Pre dose Post dose Trough Peak Tobramycin (multiple daily dosing for cystic fibrosis patients only) < 2 mg/L 8 -12 mg/L Tobramycin (multiple daily dosing for NON cystic fibrosis patients) < 2 mg/L 6 - 10 mg/L Vancomycin Gentamicin Teicoplanin On the advice of consultant microbiologist only 10 -15 mg/L See guideline on hospital intranet 20 - 60 mg/L ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 44 of 77 For severe infections only (e.g. MRSA, osteomyelitis, septic arthritis) Version 7.0 Issued April 2014 4.6.2 BLOOD CULTURES In bacteraemic patient the number of viable bacteria in the blood varies from hour to hour and may frequently be as few as one or two organisms per ml., therefore, a relatively large volume of blood (5-10ml) must be used as the inoculum. A specific single bottle (yellow top) is provided for paediatric specimens, this is inoculated with up to 4ml of blood. Blood cultures are required:1) To isolate and identify an organism present in blood and 2) To determine the antibiotic sensitivity of the pathogens isolated so that treatment with the optimal antibiotic or combination of drugs at correct dosage can be used. METHOD OF COLLECTION Disinfection of the skin and good technique are vital in the collection of blood cultures. Ideally, blood for culture should be collected by one venepuncture, while blood for other investigations is collected from another venepuncture site. If this is impractical, inoculate the culture bottles before distributing blood to other containers. Blood culture bottles are available from the main or sub laboratory. If bacterial endocarditis is suspected, it may be advisable to take several sets of cultures at different times and from different sites. 10 ml of blood should be inoculated into each bottle. It is very important that the exact collection time and date is written on the specimen bottles. This is in addition to fully completing the request form with the patient details, full clinical details and any antibiotic therapy given. Blood culture specimens MUST be returned to the laboratory as soon as possible after collection. There is no requirement to inform the laboratory or the on call Biomedical Scientist. 4.6.3 CEREBRO-SPINAL FLUID Please label all samples clearly with the patient’s name, DOB or Hospital number, date and time collected. NB: IT IS VERY IMPORTANT TO SPEAK WITH THE CONSULTANT MICROBIOLOGIST BEFORE ANY SPECIMENS ARE TAKEN FROM PATIENTS SUSPECTED OF TSE/CJD. Please send as large a volume as possible. CSF is normally collected sequentially into three or more separate containers, which should be numbered consecutively. Ideally a minimum volume of 1 ml should be sent if culture for Mycobacterium species is required. Collection of a separate fluoride oxalate sample for glucose estimation is not required. Equipment: As provided by C.S.S.D. Skin preparation: 70% alcohol + povidone-iodine Method: As demonstrated by senior colleague Collect the CSF in sterile screw topped containers, without preservative, label the containers 1-3 in the order in which they are collected. Send specimens 2 and 3 to Microbiology and specimen 1 to Biochemistry. If examination for Xanthochromia is required please collect an extra sample and send this last sample taken (number 4) to Biochemistry. If only one specimen is available, please send to Microbiology where it will be forwarded as required. Meningococcal disease Where Meningococcal meningitis or septicaemia is suspected, blood specimens can be referred for PCR (molecular techniques). Please send 2.7 ml EDTA blood sample. Please discuss any problems with diagnosis, or treatment of meningitis with the Consultant Microbiologist. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 45 of 77 Version 7.0 Issued April 2014 4.6.4 CHLAMYDIA PCR This test is referred. Testing for East and Mid Cheshire PCT is covered by Team Chlamydia who supply all forms and specimen containers. The telephone contact number is 01260 277477. Referred to Aintree Hospital, Liverpool. Other testing, including hospital patients, is referred by pathology at Macclesfield DGH to Manchester Royal Infirmary. Use a blue Microbiology form. Specimen containers are available from pathology at Macclesfield. There are 3 types: Yellow Aptima tube for urine. Orange Aptima tube for swabs Purple Aptima tube for urethral and endocervical swabs Eye swabs can be sent using either the orange or purple kits. Please state which tube type is needed when re-ordering 4.6.5 FAECES Specimens should be collected into a sterile 60ml container. Never completely fill the container. Clinical details must include details of foreign travel, contact with known infected patients and consumption of suspect food, if known. Microscopy All suitable specimens are examined for red and white cells together with obvious infestations with Giardia lamblia. All specimens are routinely examined for Oocysts of Cryptosporidia. Culture Specimens are routinely cultured for: Salmonella Shigella Campylobacter Where indicated by the clinical details, history of foreign travel and with diarrhoeal samples we can also test for: Vibrio cholerae E. coli O157 Yersinia enterocolitica Aeromonas and Plesiomonas Toxin testing for Clostridium difficile is performed on unformed stools from hospital patients who fit Department of Health criteria and patients over the age of 65 and liquid stools from GP patients. The test is not suitable for formed samples. Virology Specimens from all children under the age of 5 years are examined for Rotavirus. Samples from adults will be referred for virology only as part of outbreaks or if specifically agreed with the Consultant Microbiologist Parasitology Routine samples are examined for parasites associated with acute diarrhoea. If there is clinical evidence of chronic intestinal parasitic infection, send stool samples from 3 consecutive days with a single request for OCP and clinical details including foreign travel. For threadworm investigations please send anal washing. Instructions and saline bottle are available from the laboratory. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 46 of 77 Version 7.0 Issued April 2014 METHOD OF COLLECTION a) Inpatients: Adults: The stool is passed into the bedpan without urinating. Using a spatula select (when possible) a suitable portion containing blood and mucus and place in container. Wash your hands! Infants: - Where possible a spatula should be used to collect material from soiled napkins and the specimen transferred to the container as above b) Outpatients: Adults: The patient is issued with a screw capped container and advised to proceed as follows:i. Place in the W.C. pan a few loosely packed toilet papers ii. Defaecate onto the paper in the W.C. pan. iii. Collect a faecal sample from the paper using a spatula and transfer to the screw capped container avoiding contaminating the outside of the container. Screw down the lid tightly, discard the spatula wrapped in paper/polythene bag into the household dustbin. iv. Wash hands with soap and water. Infants: Instruct mothers to collect a specimen from the napkin as above. Where AMOEBIC infection is suspected, please inform the laboratory and send a specimen without delay. METHOD FOR COLLECTING SPECIMENS FOR INVESTIGATION FOR OVA OF ENTEROBIUS VERMICULARIS (THREADWORM EGGS) 1. You will require a cotton tipped swab and a bijou bottle of sterile saline 2. Moisten the swab in the saline and wipe moistened swab around perianal area first thing in the morning (i.e. before defaecation or washing). 3. Break off swab into saline bottle. 4. Label bottle and send to laboratory as soon as possible. 4.6.6 FUNGAL INFECTIONS For superficial infections associated with: 1. Hair please send whole hair complete with roots. Cut hairs are unsuitable. 2. Skin send loose skin scraped from the edge of the lesion. 3. Nail scrapings from discoloured or dystrophic areas. Large specimens collect into a dry sterile plastic container. Smaller specimens use the special Dermopak transport system. Send to the laboratory immediately. METHOD OF COLLECTION Wash hands and put on gloves HAIR: Remove distorted or fractured hairs with forceps. Pluck hair from scalp. DO NOT USE CUT HAIR SKIN: Cleanse with alcohol wipe, before a specimen is collected, to reduce the level of contaminating skin flora. Take shavings of epidermal scales at the active border of the lesion onto a collection envelope using a scalpel. NAIL: Cleanse nail with alcohol wipe The outermost layer of the nail is then removed by scraping with a scalpel onto a paper towel. Deeper scrapings, debris from under the edge of the infected nail, and nail clippings from the infected areas, are also suitable for culture. Put specimens either into “Dermapack” or a screw-capped container and label clearly. 4.6.7 H. PYLORI (Faeces test) The faeces test for Helicobacter pylori antigen detects active infection. It can be used as a test of cure provided proton pump inhibitors are stopped for 2 weeks and antibiotics are stopped for 4 weeks prior to testing. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 47 of 77 Version 7.0 Issued April 2014 4.6.8 LEGIONELLA ANTIGEN TEST A test on urine samples is available for community acquired pneumonias which fulfil the criteria defined by the British Thoracic Society Guidelines. 4.6.9 MYCOBACTERIUM (T.B.) All are referred to the laboratory at Stoke. Urgent Zeihl-Neelson’s for A.A.F.B can be carried out on site but the method is much less sensitive than that used at Stoke and all requests would have to be authorised by the Consultant Microbiologist. Ziehl-Neelsen's for A.A.F.B. are performed on all specimens except urines. Sputum Please collect the first early morning specimen into a sterile 60 ml. Container. Please send specimens on each of three consecutive days. Urine Please collect early morning MSU specimens over 3 consecutive days into 30ml polypropylene urine containers (white tops). Pus It is always preferable to send aspirated pus in a sterile plastic container. Pleural Fluid Use a sterile plastic container. Gastric Washings Use a sterile 60 ml. container. The acid content may kill the bacteria present, so please send these specimens to the laboratory without delay. Tissue Send in a sterile plastic container. If only a very small amount of tissue is available, please cover the tissue with sterile saline to prevent drying. DO NOT ADD FORMALIN FIXATIVE, THIS WILL DESTROY ANY BACTERIA PRESENT 4.6.10 PUS FOR HEALTH & SAFETY REASONS DO NOT SEND PUS IN SYRINGES WITH NEEDLE ATTACHED. Wherever possible, pus should be aspirated from the lesion and collected into a dry, sterile plastic container. This enables a full microbiological examination to be done including TB culture if necessary. Pus swabs are NOT suitable for TB culture. Please give full clinical details especially antimicrobial therapy, as this may influence the interpretation of the results. METHOD OF COLLECTION Aspirated material may be placed directly into the screw capped container, alternatively pus may be transferred directly to the container from a sterile receiver. Do not place the container in contact with the lesion, to avoid contaminating the outside of the container. Aspirates (e.g. pleural, joint, peritoneal, pelvic, spinal fluids, etc) as well as surgical and biopsy specimens requiring microbiological examination are to be placed in sterile screw capped containers with NO ADDED FIXATIVES OR PRESERVATIVES. If the patient is suspected of having T.B. please request this investigation on the accompanying form. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 48 of 77 Version 7.0 Issued April 2014 4.6.11 SEMEN ANALYSIS Semen analysis is only carried out, “in-house” for post vasectomy patients. For fertility testing the patient should be referred to the Patrick Murphy Unit at Leighton (please do not refer patients to the Pathology Department at Leighton). Specimens should be collected into the 60ml plastic containers and should arrive in the laboratory as soon as possible after collection between the hours of 9.00 and 11.00 am, Monday to Friday. These specimens are not accepted on weekends or Bank Holidays. The specimen should be kept as near to body temperature as possible until arrival in the laboratory. It is essential that collection time is written down on the sample and the request form. METHOD OF COLLECTION The essentials are that a fresh specimen is collected without contact with any chemical, to arrive for analysis very quickly at the right temperature. 1. There must be 3 days abstinence before collection of the specimen. 2. The specimen must be collected by masturbation into the small sterilised container provided but the container must be at body temperature. 3. No rubber contraceptives must be used in the collection. 4. The container is kept at body temperature e.g. in trouser pocket or under the clothing and brought to the laboratory immediately. 5. Note the time of collection and please make sure that a request form accompanies the specimen. 6. Please label all specimens with full name and address, date and time of collection and the name of the doctor or surgeon. For checking after vasectomy, the first specimen must be collected three months after the operation and the second specimen one month later still or as directed by the surgeon. 4.6.12 SPUTUM AND BRONCHIAL WASHINGS The laboratory prefers to receive early morning specimens taken by deep productive cough after the patient has rinsed the mouth to remove overnight debris. Specimens taken from the bedside sputum pot MUST NOT be sent. Salivary specimens are NOT suitable. All sputum specimens should arrive in the laboratory on the day of collection. Full clinical details are very important for the investigation of Legionella, fungal infections, lung abscesses, cystic fibrosis and mycobacteria. Specimens for mycobacteria are referred to the University Hospital of North Staffordshire. BAL and associated specimens should be collected according to local protocol. Please send as large a volume as possible. Please note that BAL are examined for AAFB (TB and other Mycobacterium species) only on request. METHOD OF COLLECTION The best time to obtain a sputum specimen is in the morning when the patient awakes. Specimens should be taken before antimicrobial therapy is commenced where possible. Care should be taken to ensure the specimens sent for examination is sputum – NOT SALIVA. Instruct the patient to cough sputum directly into the container avoiding contamination with saliva and contamination of the outside of the container. Encourage the patient to cough deeply. If problems obtaining an expectorated specimen are encountered ask Physiotherapist for assistance. If the patient is suspected of having T.B., wear gloves when handling the container and any waste tissues. Replace the lid of the container immediately. 4.6.13 ASPIRATES (PLEURAL, JOINT, PERITONEAL, PELVIC) Please label all samples clearly with the patient’s name, DOB, NHS or Hospital number, date and time collected and the specimen site. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 49 of 77 Version 7.0 Issued April 2014 Specimens should be collected according to specialist local protocols into a sterile container. Aspirates requiring microbiological examination are to be placed in sterile screw capped containers WITHOUT ADDED FIXATIVES OR PRESERVATIVES. Please note that pleural fluids are examined for AAFB (TB and other Mycobacterium species) only on request. Notes on transport: Specimens should be transported and processed as soon as possible. The volume of specimen influences the transport time that is acceptable. Large volumes of purulent material maintain the viability of anaerobes for longer; however the recovery of anaerobes is compromised if the transport time exceeds 3 hours. If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48 hours will not produce optimum results and are strongly discouraged. 4.6.13 SWABS Sites or lesions should be swabbed accurately avoiding the surrounding areas. It is essential that the site or nature of the wound being swabbed is noted on the request form together with any antimicrobial therapy. If it is a post operative wound the operation and surgeon should be stated. The site of female genital swabs should be identified, e.g. `High Vaginal' or Endocervical', together with the age of the patient, pregnancy and any recent operative procedures. All these factors influence the culture techniques we use on the specimen (see also Chlamydia). METHOD OF COLLECTION Nasal Swab: Moisten the swab with the N/Saline and gentle rotate around the anterior nares. Replace the swab stick into the transport medium. Throat swab: position patient comfortably and arrange for the throat to be properly illuminated. Depress the patients tongue with the spatula. Use the swab to obtain material from both fauces. Transfer the swab into the required transport medium. Pernasal swab: to isolate Bordetella pertussis (Whooping cough). Use special swab available from the microbiology laboratory. Position the patient comfortably. Introduce the pernasal swab below the interior turbinate and into the post nasal space and gently rotate the swab to collect the sample. Transfer the swab into the transport medium. Wound swabs: Place the sterile swabs deep into the wound and collect specimen. Transfer the swab into the transport medium. High vaginal and cervical swabs: Put on gloves Place patient in dorsal position (lying on the back, knees flexed and widely separated). With gloved hand part labia and introduce the speculum into the vagina and under good vision collect material from:a) posterior fornix b) cervical os Carefully withdraw the swab, avoid contamination with lower vaginal and perineal flora. Transfer the swab into the transport medium. Eye Swabs: swabs should always be taken before local anaesthetics are applied to the eye. Hold the swab parallel to the eye with your free hand, part the patient; eyelids and gently rub the conjunctiva of the lower eyelid with the swab, transfer this swab into the transport medium. Repeat with viral or Chlamydia transport media as required. Keratitis/corneal ulcer: kit available from the Microbiology Department. If acanthamoeba is suspected, please contact department so that arrangements can be made for referral to the reference laboratory. Endopthalmitis: Conjunctival cultures are generally regarded as being inadequate. All cases of traumatic and post surgical endopthalmitis should have aqueous and vitreous aspiration for cultures and smears. The material obtained from these taps should be inoculated into a sterile container which should be transported to the laboratory immediately. Two sets of blood cultures must be taken when endopthalmitis is suspected. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 50 of 77 Version 7.0 Issued April 2014 MRSA swabs: The request form has a section for MRSA screening. Tick the boxes as appropriate for the site of the swab and the reason – emergency admission, elective admission, or contact of MRSA. 4.6.14 URINE Please use boric acid containers for all urines for culture. Fill to line marked on container. Do not overfill or underfill (if sufficient urine cannot be obtained then use a plain sterile container and refrigerate if necessary). A mid stream urine is required for accurate results. The patient should be instructed to pass an initial sample into the toilet. Then, without stopping, the bottle should be filled to the line marked on the side. Remaining urine should be passed into the toilet. Catheter specimens should be collected from the drainage sampling port, and not the bag itself. The specimen should arrive in the laboratory on the day of collection. If this is impossible, the specimen should be stored at room temperature overnight. METHOD OF COLLECTION Wash hands and put on gloves. In males: retract the foreskin and clean the glans penis and urethral meatus with soap and water. In females: clean the urethral meatus and vulva with soap and water; swab with cotton wool balls from front to back Ask the patient to micturate into bedpan/toilet/urinal and then collect the mid stream of the urine (20-30mls) into the specimen container (men) receiver (women) Infants Boys – After preliminary cleansing, a sterile tube is strapped to the penis to serve as collecting vessel. Girls – A polythene bag with adhesive fitting is placed over the previously cleansed perineum. (Alternatively a sterile latex glove may be used as a collecting vessel). CATHETER SPECIMEN OF URINE Clamp the drainage bag tubing below the rubber self-sealing sampling port. Wash your hands Cleanse the sleeve/port with alcohol swab. Insert the assembled needle and syringe at a 45º angle into the rubber sleeve and 90º angle into the protected sampling port. (All sampling sleeves are designed to occlude puncture holes when needle is withdrawn). Aspirate catheter urine into the syringe. Withdraw the needle and syringe from the catheter. Re-swab the sampling sleeve/port with alcohol swab. Transfer urine sample into container. REMOVE CLAMP from the drainage bag tubing. 4.6.15 VIROLOGY/SEROLOGY The following virology/serology tests are referred to Serology at Leighton: Rubella, Varicella, Syphilis, HIV, Hepatitis A IgM, Hepatitis B surface antigen, Hepatitis B core antigen, Hepatitis B surface antibody, Hepatitis C antibody and ASO tests. All other tests are referred to accredited specialist centres e.g. Manchester HPA. All requests must be accompanied by a blood sciences request form and include as much clinical detail as possible together with date of onset. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 51 of 77 Version 7.0 Issued April 2014 For virus serology and all other serology send a separate yellow topped bottle with 5 -10ml. of clotted blood. For virus culture there are special transport bottles available from pathology reception. The results are usually available within 10 days but culture may take longer. Any urgent requests eg. hepatitis B or HIV from needle stick injuries must be directed through the Consultant Microbiologist. 4.6.16 MYCOBACTERIUM (T.B.) All are referred to the laboratory at Stoke. Urgent Zeihl-Neelson’s for A.A.F.B can be carried out on site but the method is much less sensitive than that used at Stoke and all requests would have to be authorised by the Consultant Microbiologist. Ziehl-Neelsen's for A.A.F.B. are performed on all specimens except urines. Sputum Please collect the first early morning specimen into a sterile 60 ml. Container. Please send specimens on each of three consecutive days. Urine Please collect early morning MSU specimens over 3 consecutive days into 30ml polypropylene urine containers (white tops). Pus It is always preferable to send aspirated pus in a sterile plastic container. Pleural Fluid Use a sterile plastic container. Gastric Washings Use a sterile 60 ml. container. The acid content may kill the bacteria present, so please send these specimens to the laboratory without delay. Tissue Send in a sterile plastic container. If only a very small amount of tissue is available, please cover the tissue with sterile saline to prevent drying. DO NOT ADD FORMALIN FIXATIVE, THIS WILL DESTROY ANY BACTERIA PRESENT 4.7 INFECTION CONTROL The infection control team is managed by Mrs Anita Swaine, Lead Nurse in Infection Control Infection control link nurses support this team. The team offers a high quality advisory service on many topics including: Hand washing Patient and staff protection Disposal of clinical waste Handling of linen Disinfection and sterilisation procedures Specific infection control precautions/isolation nursing MRSA Advice and training sessions are also available on: Food hygiene Tissue damage minimisation and wound management Management of patients with indwelling urinary catheters Monitoring of infection control practices. Aseptic procedures ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 52 of 77 Version 7.0 Issued April 2014 5.0 CELLULAR PATHOLOGY DEPARTMENT: THE SERVICE The Cellular Pathology Department for East Cheshire NHS Hospital Trust (Macclesfield District General Hospital) provides a Consultant-led diagnostic service for inpatients, outpatients and patients under the care of General Practitioners in the region. As part of a collaborative arrangement with Mid Cheshire Hospitals NHS Foundation Trust (Cheshire Pathology Services), the laboratory receives a variety of specimens which include surgical and post mortem Histology, nongynaecological Cytology, Post Vasectomy Semen Analysis specimens and Autoimmune Serology samples. The Cellular Pathology laboratory is located at Leighton hospital. The Mortuary facility remains located within the main hospital at Macclesfield. The Department comprises a team of Consultant Pathologists who will readily give clinical advice if required. The laboratory is staffed by Biomedical Scientists who are available to provide technical information and advice regarding sample collection and processing where necessary. 5.1 OPENING HOURS The Department is open from 09:00 to 17:00 Monday to Friday. No service is available outside routine working hours or at the weekend. 5.2 THE REQUEST FORM All specimens must be received with a request form. The request form should bear the following clearly legible information: ● Patient details i.e. full name, date of birth, address and hospital number ● Ward / location, Consultant / GP so that the report can be returned to the appropriate individual when available. This is essential as copy reports will not be issued. Where an extra copy of a report is required please ensure that this is noted in the same field on the request form ● Signature and printed name of the person making the request ● Specimen type ● Appropriate clinical information – e.g. any known previous malignancies, any relevant clinical data regarding the patient’s physical state. Please ensure that any relevant clinical information is also available to the Radiologists so that the card can be completed fully. ● Date of specimen collection ● Patient type i.e. NHS, Private Patient It is essential that request forms from General Practitioners have the practitioner's surname and initials on the form. The GP code is not acceptable. 5.3 URGENT REQUESTS Urgent specimens must be clearly marked as such so that they can be given priority. The laboratory should be informed where possible by telephone (01270 273286) that a specimen is urgent so that it can be identified at the earliest opportunity on receipt in the laboratory. 5.4 HISTOLOGY HIGH RISK CASES If the patient is suspected of having a Category 3 infection then the request form must be labelled High Risk - Danger of Infection and details provided as part of the clinical information. The specimen and form must be sent to the laboratory in the approved plastic specimen bag. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 53 of 77 Version 7.0 Issued April 2014 5.5 PRODUCTS OF CONCEPTION (POC) Products of conception (POC) specimens require a completed consent form for examination of foetal material following a miscarriage. The Department will not accept a POC specimen without this consent form being fully completed and will return it to source. A routine Histology request form should also accompany the specimen. Specimens requiring histological examination must be less than 12 completed weeks gestation. Specimens greater than 12 weeks gestation should be sent directly to the Mortuary. 5.6 SPECIMEN CONTAINERS All specimen containers must bear the following clearly legible information: ● Surname in full ● Forename, first name in full and initials of any other ● Date of birth ● Hospital number and date of collection ● Precise nature of the specimen On removal, the tissue should be placed immediately into a suitably sized container which itself should contain 10% buffered formalin. It is important to select a container of adequate size – tissue must never be ‘forced’ into a container which is too small. Ideally, the volume of fixative should be at least 10 times the volume of the specimen and the specimen should be completely immersed. Failure to place the tissue in a suitable container with an adequate volume of formalin may affect the diagnostic process. Ensure that the lids are secure and the specimen container is not leaking. Hazardous specimens must be clearly labelled Urgent specimens should be labelled appropriately and transported to the laboratory immediately. Once tissue has been placed in formalin it is unsuitable for bacteriological investigation. Tissues requiring this type of analysis should be placed in a dry, sterile container and sent to the Microbiology Department. Formalin is a hazardous chemical and should be handled appropriately. Safety data sheets are available from the laboratory on request. Supplies of specimen containers and formalin are available from the Pathology Department at Macclesfield. Formalin Spillages For a small spillage of formalin i.e. no more than 0.5 litres the following action is recommended: (1) Evacuate the room and prevent others from entering. (2) Wear Personal Protective Equipment, gloves and goggles. (3) Ensure adequate ventilation when mopping up the spillage. (4) Use a dishcloth or mop and bucket, which must be washed out well in running water afterwards. (5) Wash formaldehyde down the sink with copious amounts of water. For a larger spillage of Formalin evacuate the room and prevent others entering. Spill kits are available in the main theatre areas. 5.7 TRANSPORT OF HISTOLOGY SPECIMENS Ensure that lids are the correct size and securely placed on the container, the container is not leaking and that the specimen is double-bagged where necessary to contain any possible leakage. Hazardous specimens must be clearly labelled. ECT Pathology Handbook GP023 Page 54 of 77 Author: Pathology Management Committee Approved: Pathology Clinical Lead Version 7.0 Issued April 2014 Operating theatres should deliver specimens to the laboratory immediately after each theatre session. This enables the laboratory to part-dissect large specimens to ensure adequate fixation. Specimens for frozen section or immunofluorescence should be notified to the laboratory, packaged and labelled, then brought to the laboratory immediately. See below for further information. Urgent specimens should be labelled and sent directly to the laboratory to avoid any delay. If an urgent result is required telephone 01270 273286 and ask to speak to a Consultant Pathologist. 5.8 REPORTING TIMES The average reporting times for histology specimens is as follows: Specimen Turnaround Time Specimen Type Urgent Biopsies Within 48 hours Small biopsies Within 5 Working Days Large Lesions and Resections Within 10 Working Days Bone Specimens 2 – 6 Weeks The above reporting turnaround times are for guidance only and may be subject to variation in certain circumstances such as if the case is particularly difficult, further diagnostic tests are required or referral to another Hospital Trust is necessary. Below is a list of the referral laboratories used to provide second opinions or specialist investigations: BONE and JOINT Dr D C Mangham Department of Musculoskeletal Pathology Royal Orthopaedic Hospital 111 Dale Road Sellyoak Birmingham West Midlands B29 6AY Prof A J Malcolm Department of Histopathology Royal Shrewsbury Hospital Mytton Oak Road Shrewsbury SY3 8XQ BREAST Dr I Ellis Department of Pathology City Hospital Hucknall Road Nottingham NG5 1PB ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 55 of 77 Version 7.0 Issued April 2014 BRAIN Dr Duplessis Consultant Neuropathologist Department of Histopathology Hope Hospital Stott Lane Salford Manchester M6 8HD CARDIOVASCULAR Dr J R Gosney University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA CARDIOVASCULAR Dr M Burke Department of Pathology Harefield Hospital Hill End Road Harefield Uxbridge Middlesex UB9 6JH Dr M Shepherd Department of Histopathology National Heart & Lung Institute Royal Brompton Hospital Sydney Street London SW3 6NP CYTOLOGY Dr M Desai Department of Histopathology & Cytopathology Clinical Sciences Building Manchester Royal Infirmary Oxford Road Manchester M13 9WL Dr L Turnbull University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA DENTAL / ORAL Prof P Sloan Unit of Experimental Pathology Turner Dental School Higher Cambridge Street Manchester M15 6FH ENDOCRINE Dr S S Banerjee / Dr J H Shanks / Dr Menasce Department of Histopathology Christie Hospital Wilmslow Road Manchester M20 9BX ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 56 of 77 Version 7.0 Issued April 2014 ENDOCRINE Dr T Stephenson Department of Histopathology E Floor Royal Hallamshire Hospital Glossop Road Sheffield S10 2JF EAR, NOSE AND THROAT Dr S S Banerjee / Dr J H Shanks Department of Histopathology Christie Hospital Wilmslow Road Manchester M20 9BX Dr T Helliwell Department of Pathology University of Liverpool Duncan Building Daulby Street Liverpool Merseyside L69 3GA EYE Dr R E Bonshek Department of Histopathology Clinical Sciences Building Central Manchester Health Care NHS Trust Oxford Road Manchester M13 9WH Dr M A Parsons Ophthalmic Sciences Unit Royal Hallamshire Hospital Glossop Road Sheffield South Yorkshire S10 2JF GASTROINTESTINAL TRACT Dr F Campbell University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA Prof N A Shepherd Department of Histopathology Gloucestershire Royal Hospital Great Western Road Gloucester GL1 3NN GYNAECOLOGICAL Dr T P Rollason Department of Histopathology Birmingham Women’s Hospital Edgbaston Birmingham West Midlands B15 2TJ ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 57 of 77 Version 7.0 Issued April 2014 Dr S Ismail University Hospital of South Manchester Wythenshawe Hospital Southmoor Road Wythenshawe Manchester M23 9LT Dr G E Wilson Department of Histopathology & Cytopathology Clinical Sciences Building Manchester Royal Infirmary Oxford Road Manchester M13 9WL KIDNEY / URETER / BLADDER / PROSTATE / PENIS Dr F Knox University Hospital of South Manchester Wythenshawe Hospital Southmoor Road Wythenshawe Manchester M23 9LT Prof C S Foster University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA LIVER Dr F Campbell University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA Dr S G Hubscher Department of Pathology Medical School University of Birmingham Birmingham West Midlands B15 2TJ Dr A D Burt University Department of Pathology Royal Victoria Infirmary Queen Victoria Road Newcastle Upon Tyne Tyne and Wear NE1 4LP LYMPH NODE / SPLEEN Dr Banerjee / Dr J H Shanks Department of Histopathology Christie Hospital Wilmslow Road Manchester M20 9BX ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 58 of 77 Version 7.0 Issued April 2014 PAEDIATRIC / FOETAL Dr G Kokai Liverpool Children’s Hospital Alder Hey Eaton Road West Derby Liverpool L12 2AP RESPIRATORY Dr P S Hasleton Department of Pathology Wythenshawe Hospital Southmoor Road Manchester M23 9LT Dr B J Addis Department of Pathology Level E South Block Southampton General Hospital Tremona Road Southampton Hampshire SO16 6YD SKIN Dr D N Slater Department of Histopathology Royal Hallamshire Hospital Floor E Glossop Road Sheffield South Yorkshire S10 2JF Dr K Blessing Department of Histopathology Western Infirmary Dumbarton Road Glasgow G11 6NT Dr N Leonard University Department of Pathology Duncan Building Royal Liverpool University Hospital Daulby Street Liverpool Merseyside L69 3GA Dr Eduardo Calonje Director of Diagnostic Dermatopathology Department of Dermato-Histopathology St John’s Institute of Dermatology St Thomas’s Hospital London SOFT TISSUE Dr D C Mangham Department of Musculoskeletal Pathology Royal Orthopaedic Hospital 111 Dale Road Sellyoak Birmingham West Midlands B29 6AY ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 59 of 77 Version 7.0 Issued April 2014 Prof C D M Fletcher Department of Pathology Brigham and Women’s Hospital 75 Francis Street Boston MA 02115 U.S.A EYE SPECIMENS Ophthalmic Specimens Specimen Reception Department of Pathology Royal Liverpool University Hospital th 5 Floor Duncan Building Daulby Street Liverpool L7 8XP FRESH MUSCLE Dr Daniel Crooks Consultant Neuropathologist Department of Neuropathology The Walton Centre for Neurosurgery Lower Lane Fazakerly Liverpool L9 7LJ FIXED MUSCLE Dr Daniel Crooks Consultant Neuropathologist Department of Neuropathology The Walton Centre for Neurosurgery Lower Lane Fazakerly Liverpool L9 7lJ 5.9 FROZEN SECTIONS Frozen sections are available by arrangement. At least 24 hours notice should be given when booking this service. To arrange, please contact the Cellular Pathology Department (01270 273286) detailing the date, time, requesting Consultant, specimen type and any relevant clinical information. Specimens for frozen sections must not be sent in fixative but sent fresh and dry to the laboratory with a completed request form. Frozen sections cannot be cut on material from patients who are infected or potentially infected with any category 3 pathogen i.e. who are regarded as High Risk. Where a frozen section is required in an emergency contact the Histology laboratory directly by telephoning 01270 255141 ext 2629 and they in turn will liaise with a Consultant Pathologist. The Consultant Pathologist will telephone the requesting Clinician in theatre when the result is ready. To avoid unnecessary delay it is vital that the relevant telephone extension number is written clearly on the request form that accompanies the frozen section. 5.10 ACCESSING REPORTS Histopathology reports are available electronically within the hospital via the Labcentre computer system in all areas where terminals are situated. Paper copies of the reports are sent out daily to requesting clinicians and General Practitioners. It is the Departmental policy not to issue extra paper copies of reports except in exceptional circumstances. Giving verbal reports over the telephone for histological specimens is discouraged because of the risk of misinterpretation. Any request for a verbal report will be passed on to a Consultant Pathologist. Laboratory and Clerical staff are not permitted to give out verbal results. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 60 of 77 Version 7.0 Issued April 2014 5.11 SPECIMENS TAKEN AT WEEKENDS These specimens should be immersed in a sufficient volume of formalin to facilitate adequate fixation. The specimen containers must be kept at room temperature and must not be refrigerated. 5.12 IMMUNOFLUORESCENCE SERVICE Where possible 24 hours notice should be given when requiring this service. The Histology laboratory must be notified by telephone on 01270 255141 ext 2629 prior to each specimen being taken. At this point the patients name, hospital number and estimated time of specimen arrival into the laboratory will be required. Two skin biopsies must be taken from the bulla and / or the skin adjacent to the bulla depending on the nature of the disease suspected. Take two 5mm punch biopsies from these areas: ● Biopsy 1 Place the biopsy into a pot of 10% buffered formalin. Label the specimen container. ● Biopsy 2 Place the biopsy into Michel's medium and label the container. Vials of Michel's medium are available from Pathology at East Cheshire, ext 1809. Complete a specimen request form with the specimen type as follows: Biopsy 1 - Punch biopsy from (area) for histological examination Biopsy 2 - Punch biopsy from (area) for Immunofluorescence Both specimens and the specimen request card should be transported immediately to the Cellular Pathology Department via Pathology at East Cheshire. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 61 of 77 Version 7.0 Issued April 2014 6.0 CYTOLOGY The Cytology Department is now based at Mid Cheshire NHS Hospitals Trust at Leighton hospital. It sits within the Cellular Pathology laboratory and provides a routine diagnostic service to inpatients, outpatients and those under the care of their General Practitioner (GP). Post vasectomy semen analysis is also performed in the department. 6.1 URGENT REQUESTS and HIGH RISK SAMPLES URGENT REQUESTS Samples requiring urgent examination must be clearly marked and the laboratory telephoned on 01270 255141 ext 2629. These samples will then be given priority. HIGH RISK SAMPLES Please state clearly on the request form the nature of the risk and attach HIGH RISK stickers to both the specimen request form and the sample. 6.2 NON GYNAECOLOGICAL CYTOLOGY SPECIMENS Non-gynaecological cytology specimens should be submitted to the Department in a tightly closed container within a sealed plastic bag accompanied by a fully completed specimen request form. The type of container used is dependent upon the nature of the specimen (see below). Please state the specimen type clearly on the request form. Clinical data should always be provided as it will help with the interpretation of the sample. In accordance with the Laboratory Acceptance Policy it is essential that patient details, including full surname and forename(s), date of birth and test date are included on both the request form and specimen container and that they match in every detail. The laboratory advises that the details on the sample container be hand written as the use of preprinted labels bearing patient details has been found to be unsafe. If both Histology and Cytology specimens are sent to the laboratory (e.g. bronchial biopsy and bronchial washings) then each specimen must be placed in a separate plastic bag but the bags should be attached to one another. Don’t forget to complete a separate Histology request form for the Histology specimen. Separate specimens and request cards are also required when bacteriological or chemical investigations are needed in addition to cytological examination. Ideally specimens should reach the laboratory on the day they are collected otherwise please refrigerate and send the following morning. High risk specimens must be clearly labelled (both specimen request form and sample container). Specimen request forms, sample containers and transport media are supplied by the Pathology specimen reception at East Cheshire – contact extension 1046. On receipt by specimen reception at East Cheshire Pathology samples are transported to Mid Cheshire Hospitals NHS Foundation Trust (Leighton Hospital, Crewe – part of Cheshire Pathology Services collaborative) for processing, followed by reporting by a Consultant Pathologist. TURNAROUND TIMES Results should be available on the laboratory browser for non-gynaecological cytology specimens within 3 working days. 6.3 SPUTUM Sputum cytology has been shown to give very poor diagnostic results. Sputum samples should not be sent for cytology unless the patient is unsuitable for bronchoscopy. If samples are sent they should be early morning ‘deep cough’ specimens collected before the patient eats, drinks or cleans their teeth. Please use a plain 60ml. collecting pot and sent to the laboratory as soon as possible. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 62 of 77 Version 7.0 Issued April 2014 6.4 URINE Urine for cytology should preferably be an early morning, mid stream sample collected into a 30 ml plain (white top) universal container. Please do not use a boric acid bottle as this renders the specimen unsuitable for cytology. Samples should be sent to the laboratory without delay (preferably within 2 hours of voiding). Urine may be refrigerated for up to 48 hours if necessary but this is not ideal. 6.5 SEROUS EFFUSIONS / CEREBROSPINAL FLUID (CSF) Please collect all pleural, ascitic and cerebrospinal fluids in a 30 ml plain (white top) universal container and send to the laboratory as soon as possible. Samples taken overnight should be refrigerated and sent to the laboratory first thing the following morning. 6.6 FINE NEEDLE ASPIRATES (FNA) A transport medium is available for fine needle aspirate (FNA) specimens, these containers are clearly labelled with an expiry date. Please contact the laboratory for supplies and advice. For reasons of health and safety, the Cytology Department advises that following fine needle aspiration the syringe needle is not sent to the laboratory. However, to maximise cellular yield, please ensure that before disposal the needle is thoroughly flushed out into the specimen container. Nipple Discharges - If the clinician prepares smears on slides they must be air dried as soon as possible and appropriately labelled. 6.7 JOINT FLUIDS Sample should be collected into a lithium / heparin specimen container (available from the specimen reception at East Cheshire Pathology). Joint fluid samples submitted to the Cytology Department are sent to the University of Manchester via Pathology specimen reception at East Cheshire at the following address to be reported: Osteoarticular Pathology, Division of Regenerative Medicine, School of Medicine, The University of Manchester, The Stopford Building, Oxford Road, Manchester M13 9PT The samples are sent using the laboratory courier service leaving the Pathology Department at Macclesfield District General Hospital at 9.30am each day. 6.8 GASTROINTESTINAL TRACT (GI) BRUSHINGS Please place brush tip in a 30 ml (white top) universal specimen container containing buffered electrolyte solution (available from the Cytology Department). ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 63 of 77 Version 7.0 Issued April 2014 6.9 BRONCHIAL WASHINGS / BRONCHIAL BRUSHINGS BRONCHIAL WASHINGS A minimum of 5 ml of specimen in a clean dry container is required. Please send separate specimens and request cards where bacteriological investigation is required in addition to cytological examination. Samples should be sent to the laboratory as soon as possible. BRONCHIAL BRUSHINGS A transport medium is available for bronchial brush specimens. Please contact the laboratory for supplies and advice. Please detach the brush and remove the plastic outer sleeve before placing the brush in transport medium for sending to the laboratory. 6.10 SEMEN ANALYSIS Semen analysis is only carried out, “in-house” for post vasectomy patients. For fertility testing the patient should be referred to the Patrick Murphy Unit at Leighton (please do not refer patients to the Pathology Department at Leighton). Specimens should be collected into the 60ml plastic containers and should arrive in the laboratory as soon as possible after collection between the hours of 9.00 and 11.00 am, Monday to Friday. The specimen should be kept as near to body temperature as possible until arrival in the laboratory. It is essential that collection time is written down on the sample and the request form. METHOD OF COLLECTION The essentials are that a fresh specimen is collected without contact with any chemical, to arrive for analysis very quickly at the right temperature. 1. There must be 3 days abstinence before collection of the specimen. 2. The specimen must be collected by masturbation into the small sterilised container provided but the container must be at body temperature. 3. No rubber contraceptives must be used in the collection. 4. The container is kept at body temperature e.g. in trouser pocket or under the clothing and brought to the laboratory immediately. 5. Note the time of collection and please make sure that a request form accompanies the specimen. 6. Please label all specimens with full name and address, date and time of collection and the name of the doctor or surgeon. For checking after vasectomy, the first specimen must be collected three months after the operation and the second specimen one month later still or as directed by the surgeon. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 64 of 77 Version 7.0 Issued April 2014 7.0 MORTUARY OPENING HOURS The Mortuary is open between 08.00 and 12.00 and between 14.00 and 16.30 Monday to Friday. Mortuary staff provide out of hours cover for advice, urgent requests and special arrangements. Post-mortem examinations are usually carried out between 09.00 and 12.00 during the week when, unless previously agreed with the Mortuary technicians, the removal of bodies and viewing of bodies is not available. Viewing of the deceased should be arranged with the Mortuary staff prior to arrival by telephoning extension 1847. TRANSFER OF DECEASED PERSONS TO THE MORTUARY Deceased persons should be transferred to the mortuary as soon as possible after death. ● Contact the Porters desk (extension 1659) - they will transfer the body appropriately. ● Part 1 of the Hospital Identification of Personal Details of the Deceased Form HI.F079 should be completed by the Nursing staff and given to the Porters. The patient details on the form must match those on the body / shroud. Particular attention should be paid to the accurate recording of the presence of valuables on the body. Unless this form is fully completed, Porters cannot accept the body for removal. ● Part 2 of the form is to be completed by the Porters when transfer to the Mortuary has been carried out. VIEWING OF DECEASED PERSONS Requests to view a deceased person must be made by appointment with the Mortuary Technicians on extension 1847. Apart from exceptional circumstances, viewing should take place between 13.00 and 16.30 Monday to Friday. Please contact the Mortuary Technician on-call for advice if a viewing is requested outside of these hours. To arrange viewing outside of these hours contact the Ward or Bed Manager and they in turn will make arrangements with the Portering staff. During an out-of-hours viewing the Bed Manager must accompany the relatives at all times. A Viewing of Deceased Relatives Form must be completed. 7.1 THE POST-MORTEM Post-mortem examinations usually take place from 09.00 to 12.00 Monday to Friday. Clinicians directly involved in the care of the deceased can arrange to be present during an examination. Mortuary Technicians will contact Clinicians and / or their secretaries prior to the examination beginning. The Mortuary at East Cheshire NHS Hospital Trust (Macclesfield District General Hospital) does not have a viewing gallery therefore staff entering the post mortem examination room will be expected to wear personal protective clothing and overshoes at all times. 7.2 HOSPITAL POST MORTEMS EXAMINATIONS The following are some practical points in connection with requests for hospital post mortem examinations: 1. The senior Clinician concerned should see the relatives and obtain written consent using the appropriate form as soon as possible. It is not desirable for this to be delegated. It is important to point out to relatives the clause in the Post Mortem Consent Form regarding removal and / or retention of organs. A Clinical Summary sheet for Hospital Post Mortems and case notes should be brought personally by the House Officer to the Consultant Pathologist as soon as possible. It is not advisable to put case notes and requests for hospital post-mortems in the internal mail as the Funeral Director may have collected the body before the post mortem request has been received by the Mortuary. Neither the Pathologist nor the Hospital has any power to retain a body once a death certificate has been signed. 2. Signing or issuing of a death certificate must not be held up pending the result of a post-mortem. To do so, is in fact illegal. If the Clinician involved is not prepared to offer a Death Certificate without the results of a post mortem examination, then the case must be referred to the Coroner. Contact the Consultant Histopathologist for advice on Death Certification should a problem arise. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 65 of 77 Version 7.0 Issued April 2014 7.3 PAEDIATRIC POST MORTEM EXAMINATIONS All foetuses and stillbirths are examined at Manchester Children’s Hospital. Full and informed consent is necessary for the examination and a copy of the completed consent form must accompany the body to the mortuary along with a Return to Mortuary form and a Coroners Hospital ID and Conformation form. If cytogenetic investigations are required it is the responsibility of the Clinician or midwife to take relevant tissue samples and arrange transfer. It is hospital policy to provide a Christian burial for all foetuses under 28 weeks gestation if the parents do not wish to arrange their own. All stillbirths should be either buried or cremated. This is the responsibility of the next of kin. 7.4 CORONERS POST MORTEM EXAMINATIONS Any death which may possibly come into the list below must be reported to the Coroner through the Coroner’s Office which can be contacted during normal working hours via General Office (extension 1105 or 1107) or by telephoning (01925) 442483. If in doubt speak to a Coroner’s Officer for advice or contact the Cellular Pathology Department and speak to a Consultant Pathologist (extension 1820). REPORTABLE DEATHS IN CHESHIRE Deaths must be reported in the following circumstances:(i) The cause of death is unknown. Remember, you must know the cause of the death, rather than the mode of dying (heart failure for instance, is not considered a cause of death but a mode of dying). (ii) You did not attend (in the sense of treating or at the least monitoring treatment) the deceased in his or her last illness and to your knowledge, no other doctor so attended or if they did attend, they are not currently available. (iii) The Registration Regulations cannot be satisfied for some other reason (e.g. the name of the deceased is not known). (iv) The deceased has not been seen by you for treatment within the 14 days before death. (v) The death was violent, unnatural, suspicious or unexpected. (vi) The death may be linked to poison or drugs. (vii) The death may be due in whole or in part to an accident, no matter when the accident occurred. (viii) The death may be due to self-neglect or neglect by others, including poor care in a residential or nursing home. (ix) The death may be due to an industrial disease or related to the deceased’s employment or the deceased was in receipt of industrial injury or disablement pension or war pension, even if the death does not appear to be related to the condition for which the pension has been awarded. (x) The death may be due to an abortion. (xi) The death occurred during an operation or before recovering from the effects of an anaesthetic. (xii) The death occurred within 24 hours of admission to hospital. (xiii) The death may be linked to an operation or any other medical procedure or drug (medicinal or otherwise and whether or not prescribed). (xiv) The death may be due to lack of medical care or allegations of medical mismanagement have been made. (xv) The death may be due to the actions of the deceased, including suspected suicide or solvent abuse, etc. (xvi) The death (whether natural or not) occurred during or shortly after detention in police or prison custody. Remember that although a prisoner may die in hospital he is still in custody for these purposes. (xvii) The deceased suffered a recent fracture, fall or other significant injury whether or not you believe that the cause of death was natural or the injury had any bearing on the death. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 66 of 77 Version 7.0 Issued April 2014 (xviii) Deaths involving children under the age of 18 from whatever cause must be reported. (xix) The death was that of a mother and occurred following childbirth. If the case needs reporting to the Coroner then enter the fact in the patient's notes after the entry confirming the death. You do need to ring the Coroner or the Coroner's Officer yourself to report the case. All medical notes are sent to the General Office as soon after death as possible so that relatives can collect Medical Certificates and personal property to be able to register the death and make funeral arrangements. They are asked to attend from 11.00 onwards on the day after death (except Saturdays and Sundays) and it is therefore very important that all paperwork is complete when they arrive. Deaths should be reported to the Coroner's Officer via the General Office before 10.00. In some cases reportable to the Coroner the cause of death will be known (e.g. death in Coronary Care within a few hours of admission where cause is clear) so a Medical Certificate should be completed as normal then await further instructions from the Corner’s Office. Coroners post mortem examinations may be carried out by a Consultant Pathologist from the Cellular Pathology Department at East Cheshire NHS Hospital Trust or may be carried out by a Consultant Pathologist based in another hospital Trust appointed by the Coroner. Under normal circumstances a post mortem examination will be carried out within 48 hours of death. Examinations may be delayed by an additional day where there is an intervening weekend. COMMON MISCONCEPTIONS AND ISSUES The year and a day rule no longer applies. If a death is related to an unlawful, accidental or intentional injury or non-natural cause, it is reportable, no matter how long ago the original event occurred. Industrial diseases and employment deaths often have their counterpart in natural disease processes. Always consider very carefully the possibility of an employment connection, particularly with a respiratory illness or cancer. Refer to the death certificate book for a list of many of the industrial diseases. Do not deprive a family of a legitimate claim for compensation by failure to report. It is inappropriate to rely on viewing the body after death to overcome the fact that the deceased was not seen within 14 days of death. At best this may help to rule out a violent death but will not assist in establishing the cause of death. Death due to alcoholism or smoking or sexually transmitted AIDS is not considered unnatural but please note that death due to the acute effects of alcohol is reportable. It is not a legal requirement for the certifying doctor to view the body before issuing a Death Certificate, but good practice nevertheless. Old age as the cause of death should be avoided unless entirely appropriate in all circumstances and then unless the person is over 80 the death should be reported. Some doctors confuse unnatural with unlawful; a death following a fall, choking on food or through the transfusion of infected blood is as unnatural as a death due to hanging, stabbing or gun shot wounds. Do not guess, you have a duty to report on the cause of death to the best of your knowledge, information and belief. Do not use the formula of myocardial infarction or bronchopneumonia or stroke based on statistical likelihood rather than diagnosis. Families will be much assisted in avoiding unnecessary post mortems and delays if Doctors could plan strategically for their holidays and prolonged absences. If you have a patient who is expected to die while you are away, please ensure that a colleague attends the patient before your departure so that the doctor can issue a death certificate if your patient dies in your absence. If you patient has suffered a recent facture or other significant injury then the death should be reported whether or not you believe that the cause of death was natural. If before completion of the medical certificate as to cause of death you have cause to wonder whether the death should be reported, the answer is likely to be yes because otherwise you would not have had the thought process! IMPORTANT If the doctor is in any doubt whether the death of a patient under his care should be notified to the Coroner or not, please contact the Coroner’s Office or Consultant Histopathologist for advice. This in the long term is very much in the interest of the doctor concerned. The Coroner regards wilful failure to notify appropriate deaths as a serious matter. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 67 of 77 Version 7.0 Issued April 2014 7.5 CONTACT NUMBERS Mortuary Extension 1847 General Office Extension 1105 / 1107 Coroner’s Office (01925) 442483 / 442478 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 68 of 77 Version 7.0 Issued April 2014 8.0 IMMUNOLOGY Pathology Specimen Reception at East Cheshire NHS Hospital Trust administers the referral of Immunology tests to Manchester Royal Infirmary (MRI) for analysis. Samples are transported daily to MRI and the return of the results is monitored. Clinical advice is available on these referred samples should this be required. Contact details for MRI are given below: Immunology Department Clinical Sciences Building Manchester Royal Infirmary Oxford Road Manchester M13 9WL General Result Enquiries: Telephone (0161) 276 8766 Clinical Interpretation: Dr. Matthew Helbert (0161) 276 6468 Managerial Interpretation: Mr. Colin Dennett (0161) 276 6440 Once the reports for Immunology samples are available they will be sent directly to the requesting Clinician. Sample Requirements Send 1 yellow top SST tube for immunology tests listed on the immunology request form with the following exception: A separate SST is required for intrinsic factor antibody and any immunology tests not specified on the form. Please send separate yellow top SST samples with a biochemistry form, for each of the following: Immunoglobulins/protein electrophoresis Rheumatoid factor CCP antibody GAD antibody Thyroid peroxidise antibody TSH receptor antibody Please send separate yellow top SST samples with a microbiology form, for: ASO titre Aspergillus/avian/farmer’s lung precipitins For assays on neonates or on very young children send 1mL clotted samples instead of the above. Request Form A specific Immunology Request form must be used for all Immunology requests. Full patient and clinical details must be given. It is essential that request forms from General Practitioners have the doctor's surname and initials on the form. The GP's code is not acceptable. Supplies of sample request forms can be ordered / obtained from the Pathology Department Specimen Reception – telephone (01625) 661046. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 69 of 77 Version 7.0 Issued April 2014 9.0 MANUAL INDEX Item Manual Section Alpha 1 antitrypsin ACTH AAFB Albumin Alcohol (blood) Aldosterone Alanine aminotransferase (ALT) Alkaline phosphatase Alphafeto protein (tumour marker) Amino acids (urine) Amiodarone Ammonia Amphetamines (urine screen) Amylase Androstenedione Angiotensin converting enzyme Antibiotic levels Antibody to mitochondria Antibody to parietal cells Antibody to smooth muscle Anti-D immunoglobulin Antinuclear antibody Apoproteins (A1,B,E) APTT Ascitic fluid (Cytology) Aspartate aminotransferase (AST) 1.24 1.20 4.18 1.24 1.24 1.18, 1.24 1.24 1.24 1.24 1.24 1.24 1.24 1.24 1.24 1.24 1.24 1.9, 1.24, 4.21 5.12 5.12 5.12 3.16 5.12 1.24 2.9 6.6 1.24 B2 microglobulin 1.24 Barbiturates (urine screen) 1.24 BenceJones protein 1.24 Benzodiazepines (urine screen) 1.24 Bilirubin (total/direct) 1.24 Bleeding time 2.9 Blood/blood products 3.11 Blood cultures 4.6 Blood gases 1.11, 1.24 Blood grouping 3.5 Bone marrow examination 2.10 Breast biopsies 5.11 Breast fine needle aspiration 6.7 Bronchial brushings/washings (Cytology) 6.10 Bronchial washings (Microbiology) 4.14 CA-125 C-peptide C-reactive protein (CRP) 1.24 1.18, 1.24 1.24 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 70 of 77 Version 7.0 Issued April 2014 C-1 esterase inhibitor C3/C4 Caeruloplasmin Calcium Calculi (stone analysis) Cannabinoids (urine screen) Carbamazepine Carboxyhaemoglobin Cardiac enzymes Catecholamines – see Metadrenalines Cell marker studies Cervical smears Chlamydia Chloride Cholesterol total Cholesterol HDL Cholinesterase (pseudo) Coagulation factors Cocaine metabolites (urine screen) Cold agglutinins Copper (serum/urine) Cord blood testing Cortisol (serum/urine free) Creatine kinase (CK) Creatinine Creatinine clearance test Cross infection Cross matching Cryoglobulins CSF (Biochemistry) CSF (Microbiology) Cyclosporin Cystine (urine) 1.24, 5.12 1.24, 5.12 1.24 1.24 1.24 1.24 1.24 1.11, 1.24 1.24 1.17, 1.24 2.9 6.2 4.8 1.24 1.10, 1.24 1.10, 1.24 1.24 2.8 1.24 3.2 1.24 3.2 1.17, 1.24 1.24 1.24 1.24 4.20 3.2 1.24 1.14, 1.24 4.7 1.24 1.24 D-Dimer 2.9 Dexamethasone suppression test 1.17, 1.18 DHEA-sulphate 1.24 Digoxin 1.24 Direct antiglobulin test 3.2 Drugs of abuse in urine screening (DAU) 1.24 EB virus (see IM screening test) Erythropoeitin ESR 2.9 1.24 2.8, 2.9 Faeces (Microbiology) Fetal remains Ferritin FFP Fibrinogen Fibrinolysis 4.9 7.3 1.24, 1.28 3.15 2.9 2.9 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 71 of 77 Version 7.0 Issued April 2014 Folate Free androgen index Free thyroxine (free T4) FSH Full blood count Fungi 1.24 1.19, 1.24 1.16, 1.24 1.19, 1.24 2.8, 2.9 4.10 G6PD screening Gastric washings (Microbiology) Gastrin Gentamicin GFR Glandular fever (see IM screening test) Glucose Glucose tolerance test Glycated haemoglobin (HBA1c) Gamma glutamyl transpeptidase (GGT) Group and save serum Growth hormone/GTT Gut hormones 2.9 4.18 1.20 1.9 1.21, 1.24 2.9 1.15, 1.24 1.15, 1.24 1.15, 1.24 1.24 3.5 1.18 1.18, 1.24 Haematinics 1.18, 1.24 Haemoglobin 2.9 Haemoglobin A1c (Glycated haemoglobin) 1.15, 1.24 BHCG 1.19, 1.24 HDL-cholesterol 1.10, 1.24 Helicobacter 4.11 High risk specimens - Biochemistry 1.5 High risk specimens - Blood Transfusion 2.6 High risk specimens - Haematology 2.6 High risk specimens - Histology 5.7 High risk specimens - Microbiology 4.5 Histology specimens 5.6 HRT monitoring 1.19 IgA IgE IgG IgM Immunology Infection control Infertility investigations - Microbiology Infertility investigations - Biochemistry Insulin Insulin stress test Iron Iron studies 1.24 1.24, 5.12 1.24 1.24 8.0 4.19 4.13 1.19 1.18, 1.24 1.18 1.24, 1.28 1.24, 1.28 Joint fluids for crystals and cytology 6.8 Lactate 1.24 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 72 of 77 Version 7.0 Issued April 2014 Lactate dehydrogenase (LDH) LDL cholesterol Lead LH LH-RH (Gonadorelin) test Lipid profile Lithium Liver function tests 1.24 1.10, 1.24 1.24 1.19, 1.24 1.18 1.10, 1.24 1.24 1.8, 1.24 Magnesium Menopause monitoring Mercury Metadrenalines (urine) Methadone (screening test in urine) Microalbumin (urine) Mucopolysaccharides Mycology 1.24 1.9 1.24 1.17, 1.24 1.24 1.21, 1.24 1.24 4.10 Occult blood (faeces) Oestradiol Opiates (screening test in urine) Organic acids (urine) Oxalate (urine) Not available 1.19, 1.24 1.24 1.24 1.24 Paracetamol Paraquat screen Parasitology Parathyroid hormone (PTH) Parathyroid hormone related protein (PTHrP) Phenobarbitone Phenytoin Phosphate Pleural fluid (Cytology) Pleural fluid (Microbiology) Porphobilinogen (urine) Porphyrin screen (urine) Post mortems Potassium Pregnancy test Progesterone Prolactin Prostate specific antigen (PSA) Protein electrophoresis Protein total Prothrombin time Pus 1.9, 1.24, 1.25 1.24 4.9 1.24 1.18, 1.24 1.24 1.24 1.24 6.6 4.18 1.24 1.24 7.1 1.24 1.19, 1.24 1.19, 1.24 1.19, 1.24 1.20, 1.24 1.24 1.24 2.9 4.12 RAST (specific IgE) Red cell count Reducing substances (urine/faeces) Renin 1.24, 5.12 2.9 1.24 1.18, 1.24 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 73 of 77 Version 7.0 Issued April 2014 Reticulocytes Rhesus typing 2.9 3.5 Salicylate Semen analysis Sickle screen - HbS screen Sodium Sputum (Cytology) Sputum (Microbiology) Swabs Sweat Test Synacthen test 1.9, 1.24 4.13 2.9 1.24 6.4 4.14 4.15 1.22, 1.24 1.17 T3 (Triiodothyronine) 1.16, 1.24 T4 (Thyroxine) 1.16, 1.24 TB (see AFB) 4.18 Testosterone 1.19, 1.24 Theophylline 1.24 Therapeutic drug monitoring 1.9 Thrombin time 2.9 Thrombophilia screen (protein S+C AT III) 2.9 Thyroglobulin 1.24 Thyroid antibodies 1.16, 1.24 Thyroid function tests 1.16, 1.24 Thyroxine 1.16, 1.24 Tissue (Microbiology) 4.18 Transferrin & saturation 1.24, 1.28 Transfusion reaction 3.10 Triglycerides 1.10, 1.24 TRH (protirelin) test 1.18 Troponin I 1.23, 1.24 TSH 1.16, 1.24 Urate Urea Urea/electrolytes (U+E) Urine chemistries Urine (Cytology) Urine (Microbiology) 1.24 1.24 1.8, 1.24 1.12, 1.21, 1.24 6.5 4.16 Valproate Vitamin A Vitamin B12 Vitamin D metabolites Virology/Serology 1.24 1.24 1.24 1.24 4.17 Water Deprivation Test White cell count White cell differential 1.18 2.9 2.9 Zinc 1.24 ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 74 of 77 Version 7.0 Issued April 2014 10.0 ADDRESSES OF REFERRAL LABORATORIES Pathology Department City Hospital NHS Teaching Trust Dudley Road BIRMINGHAM, B18 7QH. HIstocompatibility and Immunogenetics NHS Blood and Transplant Service 500 North Bristol Park Northway Filton BRISTOL, BS34 7QH. Antimicrobial Reference Laboratory Microbiology Department, Lime Walk Building Southmead Hospital Westbury on Trym BRISTOL, BS10 5NB. The Director Carlisle Health Protection Agency CARLISLE, CA2 7HY. Pathology Department Leighton Hospital Middlewich Road CREWE, CW1 4QJ. Reference Laboratory County Hospital Union Walk HEREFORD, HR1 2ER Pathology Department Alder Hey Children’s Hospital Eaton Road LIVERPOOL, L12 2AP. Diagnostic Laboratory School of Tropical Medicine Pembroke Place LIVERPOOL, L31 5QA Pathology Department Royal Liverpool Hospital Prescott Street LIVERPOOL, L7 8XP. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 75 of 77 Version 7.0 Issued April 2014 Pathology Department Charing Cross Hospital Fulham Palace Road LONDON, W6 8RF. Pathology Department Kings College Hospital Denmark Hill LONDON, SE5 9RS. Pathology Department Christie Hospital Wilmslow Road MANCHESTER, M20 4BX. Pathology Department Manchester Royal Infirmary Oxford Road MANCHESTER, M13 9WL. Willink Unit, Genetic Medicine 6th Floor, Pod 1 St. Mary's Hospital Oxford Road MANCHESTER M13 9WL Immunology St Mary’s Hospital MANCHESTER, M13 0JH. Pathology Department Wythenshawe Hospital Southmoor Road MANCHESTER, M23 9LT. Toxicology Laboratory The Academic Centre Llandough Hospital PENARTH, CF64 2XX. Pathology Department Salford Royal Hospital Eccles Old Road SALFORD, M6 8HD Immunology Department PO Box 894 SHEFFIELD, S5 7YT. ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 76 of 77 Version 7.0 Issued April 2014 Histocompatibility and Immunogenetics National Blood Service Sheffield Centre Longley Lane SHEFFIELD, S5 7JN. Pathology Department Sheffield Children’s Hospital Western Bank SHEFFIELD, S10 2TH. Health Protection Agency Southampton Laboratory South Laboratory Block Southampton General Hospital SOUTHAMPTON, SO16 6YD Pathology Department University Hospital North Staffordshire NHS Trust City General Hospital Newcastle Road STOKE-ON-TRENT, ST4 6QG ECT Pathology Handbook GP023 Author: Pathology Management Committee Approved: Pathology Clinical Lead Page 77 of 77 Version 7.0 Issued April 2014
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