USER S GUIDE TO PATHOLOGY SERVICES EXPIRES MARCH 2014

Transcription

1 USER S GUIDE TO PATHOLOGY SERVICES EXPIRES MARCH 2014 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 1 of 50

2 CONTENTS INTRODUCTION... 6 LOCATION OF RHH PATHOLOGY SERVICES... 6 LOCATIONS OF PATHOLOGY SOUTH : Level 2, Wellington Centre, Argyle Street, Hobart and Clarence Integrated Care Centre, Bayfield Street, Rosny PATHOLOGY SERVICES OPENING HOURS... 6 PATHOLOGY SERVICES WEBSITE... 6 A Typical Response to a Specimen Requirements Enquiry... 8 PHLEBOTOMY SERVICE... 8 Phlebotomy Rounds :... 9 Blood Specimens - Order of Draw (Left to Right in photo below)... 9 SPECIMEN COLLECTION PROCEDURE CHECKLIST PATHOLOGY SOUTH SPECIMEN COLLECTION CENTRES LABORATORY REQUEST FORMS, SAMPLE BOTTLES AND CONTAINERS General Information Request Forms/Tests Requests for Expensive Tests Collector s Identity and Collection Date and Time Clinical Notes Urgency OUR REQUEST FORMS DELIVERY, PACKING, TRANSPORT AND POSTAL REQUIREMENTS OF PATHOLOGY SAMPLES Transport of Infectious or Suspected Infectious Samples Sample Packing and Transport : Health and Safety Issues Sample Delivery within the Hospital Sample Delivery from External Centres Sample Security REPORTING OF TEST RESULTS Typical Example of Pathology Results as Seen in the DMR Typical Example of Pathology Results as Seen in CIS OBTAINING LABORATORY RESULTS BY PHONE PATHOLOGY SERVICES DEPARTMENTAL TELEPHONE NUMBERS CRITICAL RESULTS POLICIES AND PROCEDURES Anatomical Pathology Alert And Critical Results Clinical Biochemistry Including Special Chemistry Alerts And Critical Results Coagulation Alert And Critical Results Cytogenetics Alert And Critical Results Endocrinology Alert And Critical Results Haematology Alert And Critical Results Transfusion Medicine Alert And Critical Results Special Haematology Alert And Critical Results Microbiology And Serology Alert And Critical Results Molecular Medicine Alert And Critical Results CORE LABORATORY : INTRODUCTION TRANSFUSION MEDICINE (Core Laboratory) Introduction Urgent Requests Sample Tubes Blood Product Pickup Blood Product Disposal Policies and Documentation QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 2 of 50

3 Enquiries 24/ HAEMATOLOGY (Core Laboratory) Introduction Specimen Containers Stability of Haematology Samples Retrospective Testing Reporting Of Results And Result Enquiries Reference Ranges Haematology Advice Haematology Clinic COAGULATION (Core Laboratory) Introduction Specimens Stability of Coagulation Samples Retrospective requesting Reporting of Results and Result Enquiries Telephoning Results Urgent Coagulation Advice Patients for Coagulation Review Reference Values CLINICAL CHEMISTRY (Core Laboratory) Introduction Special Protocols Sample Guide Retrospective Testing Reference Ranges Post of Care Testing MICROBIOLOGY Introduction Out of Hours Emergency Requests Tests Available Out of Hours Clinical Consultation General Guidelines on Microbiological Samples Sample Storage Sample Retention Times Referred Tests Special Investigations Reporting of Results and Results Enquiries Turnaround Times CYTOGENETICS Laboratory Hours Specimen Requirements And Tests Reporting Of Results And Results Enquiries Turnaround Times Urgent Requests MOLECULAR MEDICINE Introduction Laboratory Opening Hours TESTS PERFORMED SPECIMEN REQUIREMENTS AND TEST NOTES Cut-off Times for Sample Processing and Referral Laboratory Notification of Emergency Samples during Routine Hours QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 3 of 50

4 Tests available outside of routine hours Referred Tests Results and Enquiries Retention times Retrospective requesting (Add on tests) ENDOCRINOLOGY Laboratory Opening Hours Tests performed Daily Tests performed weekly or twice weekly Tests performed approximately every 2 or 3 weeks Tests performed approximately 6 8 weeks Referred Samples/Referred Tests Special investigations/protocols Cut-off Times for Sample Processing and Referral Storage conditions for samples Telephoning Results Turnaround times Emergency On-Call Laboratory Notification of Emergency Samples during Routine Hours Laboratory Notification of Emergency Work Outside of Routine hours Tests available outside of routine hours Point of Care Testing (POCT) Reference Values Repeat Samples Reporting of Results and Result Enquiries Retention times Retrospective requesting (Add on tests) SPECIAL INVESTIGATIONS Laboratory Hours On-Call Service ANATOMICAL PATHOLOGY DEPARTMENT HISTOPATHOLOGY Laboratory Hours On Call Service Tests Collection of Samples Notification of Results Urgent Samples CYTOLOGY Laboratory Hours On Call Service Tests Collection of Samples Gynaecological Cytology (Pap Smears) Non-Gynaecological Cytology Fine Needle Aspiration Cytology Notification of Results Urgent Samples Mortuary SUPPORT FOR RESEARCH : SAMPLES AND PROTOCOLS PROCEDURE GUIDE TO THE ORGANISATIONAL STRUCTURE OF RHH PATHOLOGY SERVICES QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 4 of 50

5 PATHOLOGY SERVICES STAFF PHONE NUMBERS Senior Management Pathologists Senior Staff PATHOLOGY SERVICES DEPARTMENTAL FAX NUMBERS QUALITY SYSTEMS LABORATORY ACCREDITATION EXTERNAL QUALITY ASSURANCE PROGRAMMES Acknowledgements QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 5 of 50

6 INTRODUCTION This document was prepared to comply with the requirements of ISO Clauses to inclusive and Annex C all of Clause C.4. LOCATION OF RHH PATHOLOGY SERVICES : Level 1, D Block, Royal Hobart Hospital LOCATIONS OF PATHOLOGY SOUTH : Level 2, Wellington Centre, Argyle Street, Hobart and Clarence Integrated Care Centre, Bayfield Street, Rosny. PATHOLOGY SERVICES OPENING HOURS : Core Laboratory Comprises Biochemistry, Haematology, Coagulation and Transfusion Medicine Operates 24 hours a day seven days a week. Urgent samples only between the hours of 20:00h and 08:00h Microbiology : 08:00h to 21:00h Monday to Friday 08:30h to 16:00h Weekends and Public Holidays All other Departments : 09:00h to 17:30 Monday to Friday PATHOLOGY SERVICES WEBSITE This is an intranet web page and cannot be viewed on PCs outside of the DHHS web firewall. All DHHS users are encouraged to use this webpage for the most up to date information and links into important resources such as our specimen requirements database. If you are outside of the DHHS firewall then much of this information is available via the Pathology South website QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 6 of 50

7 The Test Information Database is the location of all our Specimen Requirements information; Pathology Services does not produce a printed list of specimen requirements because with the pace of technological changes in laboratory instruments and assays such a list rapidly becomes out of date. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 7 of 50

8 A Typical Response to a Specimen Requirements Enquiry PHLEBOTOMY SERVICE A team of specialist nurses who provide Phlebotomy Services throughout the RHH Wards and Departments. They provide regular phlebotomy ward rounds on weekdays and a limited service on weekend and public holiday mornings for essential samples only. They have special skills in blood collection appropriate for acute care patients. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 8 of 50

9 Phlebotomy Rounds : Phlebotomy Office 7955 Phlebotomy Courier Phlebotomy Mobile Phlebotomy Mobile Phlebotomy Mobile Weekdays : Rounds commence at 08:00, 11:00 and 13:00. The last round finishes by 14:45h Weekends : Rounds commence at 08:00 and finish by 12:00. Blood Specimens - Order of Draw (Left to Right in photo below) QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 9 of 50

10 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 10 of 50

11 SPECIMEN COLLECTION PROCEDURE CHECKLIST 1. Carry out a Verbal Check of the patient s o Surname o Given Name o Date of birth You must ask the patient to state these details and not prompt them at all. If the patient is unable to give understandable verbal responses then you must check all these details with a responsible other person accompanying the patient 2. Compare these with the details on the Request Form(s) THEY MUST ALL MATCH ALSO Compare these details on the labels on any samples brought in by the patient. COLLECT 3. Collect all the specimens and place them into their appropriate unlabelled tubes 4. Remove collection devices and make the patient comfortable. 5. Label the specimen(s) with o UR Number o Surname o Given Name o Date of birth o Date and Time of Collection LABEL NEVER LABEL TUBES BEFORE COLLECTING SPECIMENS NEVER LEAVE FILLED UNLABELLED SPECIMEN TUBES UNATTENDED. 6. Stamp the Request Form with your ID Stamper (applies to Phlebotomists and Nurse Practitioners) and complete the Date and Time of Collection box 7. Place the Request Form into the open compartment of the BioHazard Bag 8. Place the specimens into the sealable compartment of the BioHazard bag. Some specimens need to be transported on ice or in a hot box or in a thermos those specimens should be placed into those containers instead. Respiratory and faecal samples must be transported in a separate Biohazard Bag from that used for specimens that are collected from that patient at the same time. The bags can be placed one inside the other or held together with a rubber band. DISPATCH Arrange for the transport of the specimens to the Laboratories as soon as possible. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 11 of 50

12 PATHOLOGY SOUTH SPECIMEN COLLECTION CENTRES In December 1999 we opened this dedicated Specimen Collection Service which is now on Level 2, Wellington Centre, Argyle Street and the Clarence Integrated Care Centre, Bayfield Street, Rosny. Further up to the minute details on this service are provided via their website : LABORATORY REQUEST FORMS, SAMPLE BOTTLES AND CONTAINERS General Information This section deals with the requirements for correct of labelling sample containers and Pathology Request Forms Request Forms/Tests All Request Forms and Specimen Containers for Hospital Patients must have three points of positive patient identification 1. UR Number 2. Surname and Given Name 3. Date of Birth All Request Forms and Specimen Containers for Non-Hospital Patients must have two points of positive patient identification 1. Surname and Given Name 2. Date of Birth All combinations of incorrectly completed Request Forms and Specimen Contaners will be rejected for testing. In exceptional circumstances, and only after direct consultation with a Pathologist, incorrect Requests and Specimens will be processed. Even then they will only be reported as a Deidentified Patient report. Requests for Expensive Tests There are a small number of tests that are particularly expensive and will not be performed unless the form has been signed by a RHH Staff Specialist or RHH VMO. The tests currently under this heading are CA 15.3 CA 19.9 PTHRP Serum Free Light Chains Hepatitis B and C viral loads Hepatitis C Genotype HIV Genotypic Resistance Testing Molecular karyotyping Non-Medicare rebatable genetic testing Collector s Identity and Collection Date and Time All Request Forms must indicate the specimen collector s identity and the date and time at which they collected the specimen(s) Clinical Notes These are required but do not have to be extensive. They should include details that you consider may affect the interpretation of the results of testing eg Chronic alcoholic liver disease, Pre dialysis sample, Resection of adhesions post abdominal radiotherapy QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 12 of 50

13 Urgency Writing Urgent on a request form will have no effect on the speed with which we process that sample. If a sample is truly Urgent then the laboratories must be advised by a phone call before the specimen arrives in the laboratory. (NOTE : Specimens from ED, NICU and ICU are automatically handled as Urgent samples) OUR REQUEST FORMS We have six RHH Request Forms and two styles of Pathology South forms which can be easily identified by their top coloured stripe design. Supplies are available from QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 13 of 50

14 DELIVERY, PACKING, TRANSPORT AND POSTAL REQUIREMENTS OF PATHOLOGY SAMPLES Transport of Infectious or Suspected Infectious Samples All specimens must arrive in the laboratory bagged or otherwise wrapped so that they cannot contaminate any persons handling them or their environment. Upon opening all specimens are handled in the laboratory as though they are infectious. That means we use appropriate Universal Precautions gloves, gowns and eye protection. Sample Packing and Transport : Health and Safety Issues Adequate packaging and transport of specimens is the responsibility of the specimen collector s Ward, Unit or Practice. It is their responsibility to ensure that their specimens are packed and dispatched in a way that there is no Health or Safety risk to persons handling them between the point of collection and the Specimen Receipt area of our laboratories. Blood and fluid samples are best packed into the usual two compartment zip plastic bags. The specimens should be placed into the zip compartment and the Request Form into the pocket compartment. Specimen containers should have their lids screwed on tightly. Any leakage or contamination of the outside of the tube must be wiped off with an appropriate disinfectant or alternatively decanted into a fresh plain tube. Respiratory and faecal samples must be transported in a separate Biohazard Bag from that used for specimens that are collected from that patient at the same time. The bags can be placed one inside the other or held together with a rubber band. Decanting an additives specimen into a fresh clean additives tube will nullify the results on that specimen because in effect the specimen will have been exposed to double the quantity of additive. If the Request Form has been splashed with specimen material then this this should be wiped off and the contaminated area covered with clear adhesive tape front and back. Alternatively a fresh Request Form can be completed or the original can be photocopied and that sent along with the original that is completely sealed in a plastic bag.. SPECIMENS THAT ARRIVE IN THE LABORATORY THAT HAVE CLEARLY LEAKED IN TRANSIT WILL NOT BE PROCESSED. All our Specimen Tubes are high impact plastic, however, the Blood Culture bottles are all glass. They are fairly robust however they must be wrapped in bubble wrap or similar if they are to be QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 14 of 50

15 transported via the Vacuum Tube System (Ferrets) or by vehicle in from outside the Royal Hobart Hospital. All specimens that are to be transported from locations outside the Royal Hobart Hospital must be transported inside a esky with a cold chill block. The esky must be placed in the vehicle securely so that it does not slide around the vehicle and be shaded at all times from direct sunlight. Eskies containing specimens must not be left in locked or unattended vehicles. As a rule of thumb most blood specimens do not retain their integrity for longer than four hours after collection; if this is a problem please contact the laboratory and we will advise you as to what preprocessing of the specimens would be appropriate before you dispatch them via a vehicle. Transport of pathology specimens via aircraft are subject to strict IATA Regulations. We can assist with advising you about air transport of pathology specimens. Some specimens require special handling eg at 37 degrees centigrade or with minimal vibration eg platelet aggregation samples. These details are outlined in the Specimen Requirements database for those tests as well as the telephone numbers you need to call, usually before you take the specimen(s), so that the laboratory can prepare to receive these special samples. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 15 of 50

16 Sample Delivery within the Hospital The preferred method of delivery of appropriately bagged tube specimens is via the Vacuum Tube (ferret) system of the Royal Hobart Hospital. Large specimens such as 24 hour urines and faeces and surgical specimens will need to be hand delivered to the laboratory. Sample Delivery from External Centres Our preferred contractor is Mini Messenger who also trade under the name Jet Couriers, Ph If your Clinic or Practice telephones us we can arrange for them to pick up specimens. They have been provided with eskies and chill blocks designed to maintain samples at an optimum cool temperature. Sample Security Specimens must always be kept in a secure area until they are dispatched. Our specimen receipt and storage procedures do not meet the chain of custody requirements. This means that our results do not meet the requirements for forensic evidence. However, where a patient becomes the subject of a legal case then the laboratory should be advised as soon as possible as we may be able to quarantine the specimen material we still retain. AS A GENERAL RULE, TUBE TYPE SPECIMENS ARE ONLY RETAINED FOR SEVEN DAYS POST ANALYSIS. REPORTING OF TEST RESULTS Electronic reporting into the DMR, CIS and GP Practice systems is now the norm. A4 printed reports and faxed reports are also produced as soon as the results have been authorised by the Pathologists or Medical Scientists. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 16 of 50

17 Typical Example of Pathology Results as Seen in the DMR QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 17 of 50

18 Typical Example of Pathology Results as Seen in CIS OBTAINING LABORATORY RESULTS BY PHONE Staff are requested to keep their phone calls for results to a minimum. As soon as results are authorised or interimed on our computer system they are immediately transmitted into the Digital Medical Record. So if you cannot see the results you are after in the DMR or CIS then they are not available. The majority of our GP clients have opted for electronic reporting via the GP system. Again we feed electronic reports into that system as soon as they are ready. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 18 of 50

19 PATHOLOGY SERVICES DEPARTMENTAL TELEPHONE NUMBERS Specific Contacts ( when dialling from outside RHH add 6222 in front of extension number) CPU (Central Processing Unit) 8416 Specimen Reception 8619 Urgent Samples Only 8331 Pathology South 3058 / 7121 Pathology Administration 8410 Pathology Stores 8347 Phlebotomy Office 7955 Phlebotomy Courier Phlebotomy Mobile for 2A,1BS,1BN,7A Phlebotomy Mobile for NSU,APU,2BS Phlebotomy Mobile for 2D,5A,2BO,6A Mobile number for Claire Beattie Anatomical Pathology 8770 Immunology/Special Haematology 8774 Biochemistry 8775 Microbiology 8417 Cytogenetics 8297 Molecular Medicine 8912 Cytology 8235 Serology 8777 Endocrinology 8781 Special Chemistry / Investigations 8742 Flow Cytometry 8913 Stem Cell Transplant 8744 Haematology 8776 Transfusion / Bloodbank 8411 CRITICAL RESULTS POLICIES AND PROCEDURES Anatomical Pathology Alert And Critical Results Results from Anatomical Pathology cases are not regarded as Critical or Alert ; Results on samples classed as Urgent are handled in one of the two following methods: Frozen Section o The clinician/surgeon in charge of a patient calls the Anatomical Pathology department before the surgery to inform the department of the impending specimen. o The sample is taken and sent to the laboratory for analysis and Anatomical Pathologist phones the surgeon with the result. o The result, the date and time the result is phoned to the surgeon and the name of the surgeon and/or person taking the message are recorded on the Frozen Section Report Record by the reporting Anatomical Pathologist. Refer to Document 160 for full details of the procedure. Samples requiring urgent processing or urgent reporting, but not a frozen section, will have notes written on the request form indicating the urgency of the result o The requesting clinician will contact the Anatomical Pathology department to request that a sample is reported urgently, or both. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 19 of 50

20 o The reporting Anatomical Pathologist will attempt to call the clinician directly only if the clinician has requested direct contact and contact details have been provided. o The reporting Anatomical Pathologist will note in the report if this contact is made. Clinical Biochemistry Including Special Chemistry Alerts And Critical Results Chemistry < Value > Value Units Ammonia 100 mol/l Calcium mmol/l Creatinine >10% or significant change mol/l within a short period Digoxin 3.0 nmol/l Glucose mmol/l Li 2.0 mmol/l Magnesium mmol/l Paracetamol Results are checked against nomogram and phoned out if above critical limit for time post dose Phenobarbitone 230 mol/l Phenytoin 150 mol/l Potassium mmol/l Sodium mmol/l Total Bili (Babies 150 mol/l Only) Troponin 0.3 g/l Any results outside these ranges will be checked and phoned through to the ward or doctor immediately. An exception to the rule occurs if there is prior knowledge of any existing condition with serial abnormal results. Coagulation Alert And Critical Results Coagulation Results WILL be phoned in each instance when; The INR is >4.5 (Warfarin Patients) The APTT is >90 sec (Heparinised Patients) For first time patients where; The INR is >1.5 (Non Warfarinised Patients) The APTT is >40 sec (Non Heparinised Patients) The Fibrinogen is <1.5 g/l Any abnormal Coag test pre-operatively (unless pre-admission clinic) QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 20 of 50

21 Cytogenetics Alert And Critical Results A positive t(15;17) or one of the recognised variants, associated with APML must be phoned through to the Requesting Doctor Endocrinology Alert And Critical Results Analyte Normal Range Critical Value Alert Cortisol nmol/l <50 if not having a Dexamethasone Suppression Test or a Metapyrone Suppression Test FT pmol/l >15 (if new patient) FT pmol/l >40 (if new patient) TSH mu/l >30 if not recognised hypothyroid or not on Thyrogen stimulation Haematology Alert And Critical Results WCC: >40 X 10 9 /L <1.0 X 10 9 /L Hb: >190 g/l <70 g/l MCV: >115 fl HCT: >65 L/L PLT: >1000 x 10 9 /L <50 x 10 9 /L Transfusion Medicine Alert And Critical Results Delays in provision of blood products, either due to supply issues or antibodies will be phoned to the Requesting Doctor. Special Haematology Alert And Critical Results Any POSITIVE MALARIA sample will be phoned through to the Requesting Doctor Microbiology And Serology Alert And Critical Results Organism or specimen type Urgent samples (as requested by requesting Dr) Lab to notify ward (or requesting doctor) directly Abnormal CSFs Sterile site isolates MRSA (new isolate) VRE (new isolate) MRGN (new isolate) Lab staff to notify ID registrar (BH) or ID physician oncall (AH) QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 21 of 50

22 C. difficile Rotavirus Influenza serology pos Adenovirus AFB and/or Mycobacteria spp. cultured HIV Acute Hep B Acute Hep A Molecular Medicine Alert And Critical Results Organism or specimen type Urgent samples (as requested by requesting Dr) Positive results from CSFs Positive results from Sterile site isolates Influenza Adenovirus MTB PCR positive All NPA results Lab to notify ward (or requesting doctor) directly Lab staff to notify ID registrar (BH) or ID physician oncall (AH) CORE LABORATORY : INTRODUCTION This includes Clinical Biochemistry, Coagulation, Haematology, Transfusion Medicine. It is also the location of the Central Specimen Receipt and Processing Unit, (CPU). This laboratory provides the critical care and automated services to the RHH, the Hobart Private Hospital, Clinics and General Practitioners. These services include the routine investigations associated with Full Blood Examination Haematomorphology Routine Coagulation tests Coagulation Factor assays Hypercoagulability testing Platelet Function studies Routine Biochemistry - electrolytes, liver function tests, amylase, calcium and magnesium Lipids Cardiac Markers Therapeutic Drug Monitoring Drugs of Abuse Screening tests Arterial Blood Gases and Electrolytes Near Patient Testing Instrumentation support QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 22 of 50

23 Routine Blood Transfusion Services including Antenatal Screening Provision of blood and blood products Red Cell Antibody Identification The laboratory features modern instrumentation and is highly computerised with on-line data acquisition and electronic reporting. The services are offered 24 hours a day, 365 days a year. Routine Tests are completed with as short as possible turn around times within the laboratory to meet their aim of providing Clinical Staff with the rapid and reliable information that they require for their patients' management. The laboratory also coordinates the maintenance, general support and user training for the Near Patient Testing equipment in the RHH Departments of Emergency Medicine, Adult Intensive Care, Neonatal Intensive Care and the Cardiothoracic Operating Theatre. _ TRANSFUSION MEDICINE (Core Laboratory) Introduction The Transfusion laboratory has an automated analyser that allows for high volume throughput of samples for blood group and antibody screens. Blood is issued via a computer crossmatch that allows for almost instantaneous issue of blood in the absence of a positive antibody screen. The transfusion laboratory is supported by highly skilled scientists, transfusion Nurse Consultant and haematologists. Urgent Requests For urgent samples please phone the laboratory or just indicate on the request form the date and time your products are required. Completion of pager or phone numbers will allow for smooth communication if required. If blood is required urgently and you are unable to wait for compatible blood emergency O negative blood can be issued please contact the laboratory. Sample Tubes Preferred samples are 9ml EDTA samples but any EDTA sample is acceptable provided that the label is handwritten and that the collector and witness sign the transfusion Medicine Request form. Blood Product Pickup To collect blood products from the laboratory the collector must carry their own and patients identity with them. Laboratory staff is on hand to assist in the collection of products. Blood Product Disposal Products that have been used can be disposed of into the Medical waste bins on each ward. If for some reason the product has not been used for a patient please contact or return the product to the laboratory. Policies and Documentation For queries regarding the transfusion and documentation of transfusion see the intranet or blood products folders available on each ward or call the Transfusion Nurse consultant. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 23 of 50

24 Enquiries 24/7 Haematology staff are available 24/7 to guide and advise on appropriate product usage and dosing. _ HAEMATOLOGY (Core Laboratory) Introduction The Haematology Laboratory is highly automated and uses state of the art dual Sysmex EX5000 analyzers and a SP1000i slide maker. A combination of automated flagging and sample source criteria are used to refer blood films for manual review by Medical Scientists and Haematologists. Currently about 25% of our daily workload undergoes manual film review. Specimen Containers Pink top EDTA tubes for FBCs, black rubber tops for ESRs, blue top citrate tube for platelet counts on patients known to have persistent clotting abnormalities. Patients who are cold agglutinin positive have to have their haematology specimens transported in a special hot box which maintains the specimens at 37 C. Contact to arrange for the hot box specimen pick up. Stability of Haematology Samples TESTS FBC Differential ESR Blood Film Monospot Reticulocyte count SAMPLE STABILITY TIMELINES Up to 24 hours Up to 24 hours Up to 48 hours Retrospective Testing All samples are retained for at least seven days post receipt. Retrospective testing can only be performed within the Stability Timelines given above. Clinically significant blood films are retained for at least twelve months. Reporting Of Results And Result Enquiries Our systems are all online to the Digital Medical Record and Computerised GP Reporting Systems. As soon as results are authorised by a Scientist or Haematologist they are downloaded into those systems. Consequently it should not be necessary for you to have to call the laboratory for results. Hard copy reports are also provided for those requestors that require them. Reference Ranges All printed and electronic reports are provided with the reference range appropriate for the age, gender and pregnant/non-pregnant situations. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 24 of 50

25 Haematology Advice During normal week day hours contact the Haematology Registrar. Out of hours and at weekends contact the On-Call Haematologist via the RHH Switchboard. Haematology Clinic The RHH Specialist Clinics run the Haematology/Oncology Specialist Clinic every Wednesday. _ COAGULATION (Core Laboratory) Introduction The Department has two automated analysers for performing routine and specialised Coagulation testing; a Siemens CA-1500 optical clot detection system which is the primary analyser for routine Coagulation (PT, INR, APTT and Fibrinogen) and a STAGO STA Compact mechanical clot detection analyser which is used for Factor assays, Thrombophilia testing, Von Willebrands testing and LMWH levels. The STA Compact is also the back up analyser for routine testing during downtime for the CA The department also performs HITTS testing using Diamed PaGIA (Particle Gel Immuno Assay) and platelet function testing with a PFA-100 and Chronolog Platelet Aggregometer. Specimens Freshly obtained patient blood is collected via venepuncture into 2ml or 4ml blue top tubes containing an appropriate volume of 3.2% buffered sodium citrate anticoagulant. Tubes must be mixed gently as soon as possible after collection and transported to the laboratory at room temperature. Note any sample tubes that have not been filled with blood to the ml or 4ml line marked on the tube are rejected. Stability of Coagulation Samples TEST PT/INR APTT D-Dimer SAMPLE STABILITY TIMLINES FROM COLLECTION Up to 6 hours at RT. If on heparin within 2 hours Up to 8 hours at RT. Retrospective requesting Fibrinogen Up to 24 hours if refrigerated (2-8 o C) Up to 6 hours at RT Add on testing for Coagulation can be done within the time lines above. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 25 of 50

26 Reporting of Results and Result Enquiries Our systems are all online to the Digital Medical Record and Computerised GP Reporting Systems. As soon as results are authorised by a Scientist or Haematologist then they are downloaded into those systems. Consequently it should not be necessary for you to have to call the laboratory for results. Hard copy reports are also provided for those requestors that require them. Telephoning Results Patient results will be notified to the Ward staff or Requesting Doctor when a significant change has occurred, or where the patient may be at risk of bleeding. Triggers that initiate a telephoned result include : The INR is > 4.5 (Warfarin Patients) The APTT is > 90s (Heparinised Patients) For first time patients where; The INR is > 1.5 (Non Warfarinised Patients) The APTT is > 40 sec (Non Heparinised patients) The Fibrinogen is < 1.5 g/l Any abnormal Coag test pre-operatively (unless pre-admission clinic) Urgent Coagulation Advice Consult Senior Scientist and / or Haematologist. Patients for Coagulation Review Abnormal results are interim / verified by a Haematologist Reference Values All printed and electronic reports are provided with the appropriate reference ranges for the patients gender, age and clinical condition. _ CLINICAL CHEMISTRY (Core Laboratory) Introduction The Clinical Chemistry Laboratory is highly automated and uses state of the art dual Abbott Architect Ci8200 analyzers. They are fully interfaced to our laboratory computer system which automatically authorises results which are normal. This leaves the operators more time to focus upon specimens with abnormal results. The analysers also detect out of range results and automatically retests the sample in dilution. Special Protocols Samples for BNP analysis must be collected into a pink top tube within four hours of the onset of symptoms. Samples for lipid studies are best collected from fasting patients. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 26 of 50

27 Samples for the diagnosis of diabetes must be collected from fasting patients. Samples for drug overdose prognosis should not be collected earlier than 4 hours post overdose. Samples collected before 4 hours are only useful for drug identification. Requests for serum aminoglycosides should be accompanied by the Pharmacy request form for aminoglycosides. This form provides spaces for you to fill in the additional data essential for the area under the curve pharmacokinetic calculation. Samples for Therapeutic Drug Monitoring must be collected just prior to the next dose. Sample Guide The following tests can be performed on a single Red Top 4mL SST tube Group 1 : ACE AFP (alpha Foetoprotein) Alcohol Alpha 1 antitrypisin Amikacin Amylase ß2-Microglobulin B12/folate (also need Pink Top- EDTA for Red Cell Folate) C3, C4 CA-125 C-reactive protein (CRP) CK Caeruloplasmin Calcium group Carbamezepine CEA Cholesterol & Triglyceride Digoxin Ferritin Fructosamine Gentamicin Haptoglobin HCG HDL IPG Iron (Iron Studies) LDH LFT Lipase Lithium Methotrexate Osmolality Paracetamol Phenobarb Phenytoin Procalcitonin PSA Rheumatoid Factor Salicylate Theophylline Tobramycin Transferrin Tricyclics Troponin U&E Urate Valproate Vancomycin SST 4mL (Red top with gel) Retrospective Testing Serum, urine and fluid samples are retained for seven days. Reference Ranges All printed and electronic reports are provided with the appropriate reference ranges for the patients gender, age and clinical condition. Post of Care Testing The laboratory supervises the quality control, maintenance and staff training of four blood gas analysers located in the clinical areas. These analysers are located in the Emergency Department, Intensive Care Unit, Neonatal Intensive Care Unit and Cardiothoracic Theatre. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 27 of 50

28 Analytes Measured Location Na K Cl Ca 2+ Glucose Lactate Creat. Bili ph PO 2 pco 2 Hb ICU X ED X X NICU X THEATRE X X There are also four Haemoglobin Alc analysers; one in RHH Specialist Clinics and three in the Diabetes Educators Department. _ MICROBIOLOGY Introduction This includes Viral Serology, Infectious Diseases and Sexual Health Services The Microbiology Laboratory supports clinicians managing patients with infections by isolating, identifying and characterising micro-organisms causing disease. A variety of methods are used including direct microscopy, culture, serology The laboratory has particular expertise in diagnostic molecular biology and is the Statewide Reference Laboratory for HIV and Hepatitis C testing. The laboratory works in close collaboration with Public Health and Infection Control Services when and where necessary. Out of Hours Emergency Requests Contact the Medical Scientist on Call via the RHH Switchboard if the specimen is a CSF. Requests for urgent tests on other specimen types must first be approved by the On Call Medical Microbiologist. Tests Available Out of Hours CSF samples will be processed out of hours but all other requests require the prior approval of the On Call Medical Microbiologist. Clinical Consultation Contact the Medical Microbiology Registrar during normal hours or the On Call Medical Microbiologist if out of hours. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 28 of 50

29 General Guidelines on Microbiological Samples Microbiology results depend critically on the type and the quality of the material received. Therefore this material should be both representative and fresh. Meticulous adherence to sterile technique during blood culture and fluid collections is essential. Appropriate cleansing and partial voiding during urine collections is also essential. All samples should have their container lids securely tightened prior to transportation to ensure safe arrival in the laboratory. Package all samples in zip lock bags before being sent through the Pneumatic Tube System (PTS). Blood culture bottles need to be wrapped in bubble wrap or similar padding before sending through the PTS. Sample Storage Local storage of microbiology samples is not recommended. All samples should be delivered as soon as possible to Pathology Services Specimen Reception. The 24 hour staff there will ensure that they are placed in a refrigerator or incubator as appropriate. Sample Retention Times Urine Swabs Fluids Faeces Sputums CSF Serum for Serology TB samples 7 days 14 days 5 years 2 months Referred Tests We do refer some tests to other laboratories for testing. We only do this for those samples for which we lack the appropriate instrumentation/techniques or which are received in very low numbers per year. The majority of our samples are referred to the Victorian Infectious Diseases Research Laboratory (VIDRL). Special Investigations We only process post vasectomy semen samples. Semen samples for fertility testing have to be collected at and tested by Hobart Pathology Reporting of Results and Results Enquiries Our systems are all computerised and online to the Digital Medical Record and Computerised GP Reporting Systems. As soon as results are authorised by a Scientist or Microbiologist then they are downloaded into those systems. Consequently it should not be necessary for you to have to call the laboratory for results. Hard copy reports are also provided for those requestors that require them. HIV testing results are only issued in hard copy. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 29 of 50

30 Turnaround Times M, C and S : 48 to 72 hours Serum Serology : 1-7 days TB testing : 2-8 weeks _ CYTOGENETICS Cytogenetics is the study of chromosome structure, function and pathology. Cytogenetic studies are used for diagnostic purposes in three main areas of medicine: Constitutional karyotyping for congenital disorders. Prenatal diagnosis. Leukaemia diagnosis and prognosis and other cancers. The cytogenetics laboratory at the Royal Hobart Hospital performs constitutional cytogenetics on peripheral blood from patients suspected of having a congenital chromosome abnormality. Such patients may include adolescents with late onset of puberty or adult couples experiencing infertility or recurrent miscarriage. Cytogenetic studies are also performed on cells from bone marrow where leukaemia is suspected and on cells from solid tumours. In cancer, particularly in leukaemia and lymphomas, the cytogenetic findings may be diagnostic or provide prognostic information important for the clinical management of the patient. Prenatal testing is referred to the Victorian Clinical Genetics Service (VCGS) in Melbourne. Amniotic fluid and chorionic villus karyotyping is performed between weeks gestation in order to obtain a fetal karyotype. Prenatal diagnosis is generally performed in high risk pregnancies including patients with previous abnormal pregnancies, advanced maternal age, abnormal ultrasound or adverse risk associated with biochemical screening. Molecular karyotyping (microarray) is performed by VCGS and is primarily used to indentify cytogenetic abnormalities in children or infants with dysmorphic features, developmental delay and autism spectrum disorders including Aspergers syndrome. Laboratory Hours 08:30 17:00 Monday to Friday For after hours information please contact the Haematologist on call via the Royal Hobart Hospital switchboard. Specimen Requirements And Tests Specimen requirements are all detailed in the online Specimen Requirements database described in the general information section of this Users Guide. Because we require fresh viable cells for Cytogenetic study, specimen material should be kept at temperatures not exceeding 25 C or less than 4 C. Transport must be by the quickest means available. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 30 of 50

31 Never place tissue into formalin or freeze any sample that requires cytogenetic testing. Please refer to the table below for testing and sample requirements. Test Requirements Routine Testing Bone Marrow Cytogenetics Peripheral Blood Karyotype Tumour and Lymph Node Biopsies FISH testing Amniotic Fluid Karyotype (Referred Test) Chorionic Villi Karyotype (Referred Test) Fetal Tissue / Products of Conception Karyotype (Referred Test) DNA Tests Including Fragile X, Prader Will/Angelman syndromes and UPD studies. (Referred Test) Microarray Molecular Karyotype 1.0mL heparinised bone marrow (green lithium heparin tube) Adults: 5mL peripheral blood in green lithium heparin tube Child: 1-5mL as above Fresh sample to be received in transport media (available from the laboratory) or sterile isotonic saline No extra sample required if referred with standard cytogenetics/karyotyping. For standalone FISH please contact the laboratory ml aseptically collected mg of aseptically collected villi (minimum 5mg) Fresh placental biopsy (villi, cord etc) or fetal tissue to be received in transport media (available from the laboratory) or sterile isotonic saline. Do not freeze or place in formalin. Adults: 5mL peripheral blood in EDTA tube Child: 1-5mL as above Adults: 5mL peripheral blood in EDTA tube Child: 1-5mL as above Monday Thursday Monday Friday Monday Friday Monday Friday Must be received in the laboratory by 2.00pm Thursday. Will not be sent on Fridays. Must be received in the laboratory by 2.00pm Thursday. Will not be sent on Fridays. Monday Thursday Monday Thursday Monday Thursday Results 5 18 days 5 18 days 5 18 days 5 18 days Usually within 10 days of receipt of sample. Usually within 10 days of receipt of sample. Usually within 3-4 weeks. Usually within 3-4 weeks. Usually within 3-4 weeks. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 31 of 50

32 (Referred Test) *Consultant signature required for this test* Reporting Of Results And Results Enquiries Our systems are all computerised and online to the Digital Medical Record and Computerised GP Reporting Systems. As soon as results are authorised by senior scientists they are downloaded into those systems. Hard copy reports are also provided for those requestors that require them. For result enquiries please contact the laboratory on Turnaround Times Because we use culture techniques before analysis is performed, our turn around times are necessarily longer, typically 9 to 14 days for routine specimens. Urgent requests can be processed within 5 days provided there are no technical complications. Urgent Requests Specimens from neonates aged <2 months and all newly presenting leukaemia patients are handled as Urgents. Other specimens are only handled as Urgents when classified as such by our Pathologist. _ MOLECULAR MEDICINE Introduction The molecular basis of most human disease is being revealed by scientific and technical advances in the fields of molecular biology, genetics and recombinant DNA technology. Modern molecular diagnostics in this laboratory is directed towards three areas : Infectious Diseases Markers of neoplastic diseases Diagnosis of Inherited Disorders and the detection of carrier status. Molecular Pathology Testing is playing an increasingly important role in routine patient management; from initial diagnosis through to monitoring response to specific therapies. The Molecular Diagnostics Laboratory uses progressive technologies and procedures to evaluate infectious disease and inherited disorders and specific studies of T-& B-cell receptor/gene rearrangement assays, Laboratory Opening Hours 8:30 17:30 weekdays only. TESTS PERFORMED Genetic studies - Factor V Leiden - Prothrombin Gene (Factor II) - Haemochromatosis QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 32 of 50

33 Malignancy studies - T&B cell rearrangement Infectious Disease studies - Hepatitis C PCR (qualitative) - Chlamydia PCR - CMV PCR - VZV PCR - Herpes Simplex Virus types 1 and 2 PCR - Bordetella pertussis PCR - Respiratory Virus Multiplex PCR (Includes Influenza A/B, RSV, Parainfluenza, Adenovirus, Picornavirus) H1N1 INFLUENZA CONFIRMATION -VRE PCR -Neisseria meningitidis PCR - Human papilloma virus PCR Fibroblast culture for metabolic studies SPECIMEN REQUIREMENTS AND TEST NOTES Please note that molecular testing requires a dedicated sample. If this is not possible, please call the laboratory to discuss as once the specimen has been processed by another area of Pathology, we are unable to use for Molecular testing. Genetic studies Malignancy studies 5mL EDTA blood (pink top 5mL EDTA blood (pink top). Infectious Disease studies Hepatitis C PCR -10mL serum (white/red top). Performed once weekly. Chlamydia PCR - 1st pass urine (sterile urine container) or urogenital swab (COBAS PCRswab) Performed daily. CMV PCR - 5 ml EDTA blood (pink top), BAL or fluid from sterile site (sterile container). Performed as required. Herpes Simplex and Varicella Zoster virus PCR - fluid from lesion swabs, sterile site or CSF (sterile container). Performed as required. Bordetella pertussis PCR - NPA, nasopharyngeal swab collected in respiratory transport media. Performed as required. Respiratory Virus PCR - Respiratory samples: sputum, BAL,BW (sterile container), NPA, deep nose and throat swabs (respiratory virus collection kits). Performed as required. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 33 of 50

34 Neisseria meningitidis PCR - EDTA blood (pink top), CSF or isolate. Performed as required. Human papilloma virus PCR HIV load (9 ml EDTA (purple top)) HCV viral loads Cut-off Times for Sample Processing and Referral All samples for molecular testing require certain processing procedures to be followed. This takes a fixed amount of time that cannot be changed without affecting results. Therefore, urgent testing must be discussed with the laboratory prior to collection and must be received by midday at the latest if a same day result is to be attempted (where possible). All samples for tests that require referral to another laboratory (see table) must be received by midday on Thursday. Laboratory Notification of Emergency Samples during Routine Hours All significant results will be phoned to the ward during working hours. Notifiable diseases will be reported to Communicable Diseases Prevention Unit in Public Health. RHH Infection Prevention and Control Unit are notified if an infection requiring additional precautions is identified.. Tests available outside of routine hours. Molecular testing is unavailable outside routine hours. Problems or queries should be directed to a Molecular staff member (mobile number ). Please leave a message if no answer on this number as Molecular Biology does not have an on-call roster. For urgent testing outside of these hours, please contact the clinical microbiologist on call via switch. Referred Tests The laboratory performs tests for which a sufficient throughput of requests is obtained to maintain an efficient, cost-effective service. For low volume tests that are not performed locally, specimens are referred for testing by external laboratories. These are included below- Test HIV Load (CSFs) HCV CMV loads Specimen Requirement Testing Laboratory Test Code CSF VIDRL HIVVL Serum VIDRL HCVvl EDTA Blood 2 VIDRL CMVvl HBV loads Serum VIDRL HBVvl HIV Genotype Write recent HIV viral load result on form otherwise one should be requested. Record time/date of sample ACD or EDTA Blood (or plasma removed from same) 4 Refer EDTA Plasma- Send Frozen Clinical Research Laboratory, Macfarlane Burnet Centre for Medical Research HIVgen QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 34 of 50