http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 1 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ PATHOLOGY SERVICES, ROYAL HOBART HOSPITAL PRIMARY SAMPLE COLLECTION MANUAL EXPIRES JANUARY 2013 CONTENTS INTRODUCTION ................................................................................................................................ 6 LOCATION OF PATHOLOGY DEPARTMENT ............................................................................... 6 PATHOLOGY DEPARTMENT OPENING HOURS ......................................................................... 6 PATHOLOGY SERVICES WEBSITE ................................................................................................ 6 A Typical Response to a Specimen Requirements Enquiry ............................................................. 9 PHLEBOTOMY SERVICE................................................................................................................ 10 Phlebotomy Rounds : ...................................................................................................................... 10 Blood Specimens - Order of Draw.................................................................................................. 10 SPECIMEN COLLECTION PROCEDURE CHECKLIST ........................................................... 12 CENTEPATH SPECIMEN COLLECTION CENTRE ...................................................................... 13 LABORATORY REQUEST FORMS, SAMPLE BOTTLES AND CONTAINERS ....................... 13 General Information ........................................................................................................................ 13 Request Forms/Tests ....................................................................................................................... 13 Collector’s Identity and Collection Date and Time ........................................................................ 13 Clinical Notes.................................................................................................................................. 13 Urgency ........................................................................................................................................... 13 OUR REQUEST FORMS .................................................................................................................. 14 DELIVERY, PACKING, TRANSPORT AND POSTAL REQUIREMENTS OF PATHOLOGY SAMPLES........................................................................................................................................... 15 Transport of Infectious or Suspected Infectious Samples............................................................... 15 Sample Packing and Transport : Health and Safety Issues ............................................................. 15 Sample Delivery within the Hospital .............................................................................................. 17 Sample Delivery from External Centres ......................................................................................... 17 Sample Security .............................................................................................................................. 17 REPORTING OF TEST RESULTS ................................................................................................... 17 Typical Example of Pathology Results as Seen in the DMR.......................................................... 18 Typical Example of Pathology Results as Seen in CIS ................................................................. 19 OBTAINING LABORATORY RESULTS BY PHONE ................................................................... 19 PATHOLOGY SERVICES DEPARTMENTAL TELEPHONE NUMBERS................................... 21 CRITICAL RESULTS POLICIES AND PROCEDURES................................................................. 21 Anatomical Pathology ‘Alert’ And ‘Critical’ Results .................................................................... 21 Clinical Biochemistry Including Special Chemistry ‘Alerts’ And ‘Critical’ Results ..................... 22 Coagulation ‘Alert’ And ‘Critical’ Results ..................................................................................... 22 Cytogenetics ‘Alert’ And ‘Critical’ Results ................................................................................... 22 Endocrinology ‘Alert’ And ‘Critical’ Results................................................................................. 23 Haematology ‘Alert’ And ‘Critical’ Results ................................................................................... 23 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 2 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Transfusion Medicine ‘Alert’ And ‘Critical’ Results ..................................................................... 23 Special Haematology ‘Alert’ And ‘Critical’ Results ...................................................................... 23 Microbiology And Serology ‘Alert’ And ‘Critical’ Results ........................................................... 23 Molecular Medicine ‘Alert’ And ‘Critical’ Results ........................................................................ 24 CORE LABORATORY : INTRODUCTION .................................................................................... 24 TRANSFUSION MEDICINE (Core Laboratory) .............................................................................. 25 Introduction ..................................................................................................................................... 25 Urgent Requests .............................................................................................................................. 25 Sample Tubes .................................................................................................................................. 25 Blood Product Pickup ..................................................................................................................... 25 Blood Product Disposal .................................................................................................................. 26 Policies and Documentation ........................................................................................................... 26 Enquiries 24/7 ................................................................................................................................. 26 HAEMATOLOGY (Core Laboratory) .............................................................................................. 26 Introduction ..................................................................................................................................... 26 Specimen Containers ...................................................................................................................... 26 Stability of Haematology Samples.................................................................................................. 26 Retrospective Testing...................................................................................................................... 26 Reporting Of Results And Result Enquiries ................................................................................... 27 Reference Ranges............................................................................................................................ 27 Haematology Advice ...................................................................................................................... 27 Haematology Clinic ........................................................................................................................ 27 COAGULATION (Core Laboratory) ................................................................................................. 27 Introduction ..................................................................................................................................... 27 Specimens ....................................................................................................................................... 27 Stability of Coagulation Samples.................................................................................................... 27 Retrospective requesting ................................................................................................................. 28 Reporting of Results and Result Enquiries ..................................................................................... 28 Telephoning Results........................................................................................................................ 28 Urgent Coagulation Advice ............................................................................................................ 28 Patients for Coagulation Review .................................................................................................... 28 Reference Values ............................................................................................................................ 28 CLINICAL CHEMISTRY (Core Laboratory)................................................................................... 29 Introduction ..................................................................................................................................... 29 Special Protocols ............................................................................................................................. 29 Sample Guide .................................................................................................................................. 29 Retrospective Testing...................................................................................................................... 29 Reference Ranges............................................................................................................................ 30 Post of Care Testing ........................................................................................................................ 30 MICROBIOLOGY ............................................................................................................................. 30 Introduction ..................................................................................................................................... 30 Out of Hours Emergency Requests ................................................................................................. 31 Tests Available Out of Hours ......................................................................................................... 31 Clinical Consultation ...................................................................................................................... 31 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 3 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ General Guidelines on Microbiological Samples ........................................................................... 31 Sample Storage ............................................................................................................................... 31 Sample Retention Times ................................................................................................................. 31 Referred Tests ................................................................................................................................. 32 Special Investigations ..................................................................................................................... 32 Reporting of Results and Results Enquiries.................................................................................... 32 Turnaround Times ........................................................................................................................... 32 CYTOGENETICS .............................................................................................................................. 32 Laboratory Hours ............................................................................................................................ 33 Specimen Requirements And Tests ................................................................................................ 33 Reporting Of Results And Results Enquiries.................................................................................. 34 Turnaround Times ........................................................................................................................... 34 Urgent Requests .............................................................................................................................. 34 MOLECULAR MEDICINE ............................................................................................................... 35 Introduction ..................................................................................................................................... 35 Laboratory Opening Hours ............................................................................................................. 35 TESTS PERFORMED .................................................................................................................... 35 SPECIMEN REQUIREMENTS AND TEST NOTES ................................................................... 36 Cut-off Times for Sample Processing and Referral ........................................................................ 36 Laboratory Notification of Emergency Samples during Routine Hours ........................................ 37 Tests available outside of routine hours.......................................................................................... 37 Referred Tests ................................................................................................................................. 37 Results and Enquiries ...................................................................................................................... 38 Retention times ............................................................................................................................... 38 Retrospective requesting (Add on tests) ........................................................................................ 38 ENDOCRINOLOGY .......................................................................................................................... 38 Laboratory Opening Hours ............................................................................................................. 38 Tests performed Daily..................................................................................................................... 38 Tests performed weekly or twice weekly ....................................................................................... 39 Tests performed approximately every 2 or 3 weeks ....................................................................... 39 Tests performed approximately 6 – 8 weeks .................................................................................. 39 Referred Samples/Referred Tests ................................................................................................... 39 Special investigations/protocols...................................................................................................... 40 Cut-off Times for Sample Processing and Referral ........................................................................ 40 Storage conditions for samples ....................................................................................................... 40 Telephoning Results........................................................................................................................ 40 Turnaround times ............................................................................................................................ 40 Emergency On-Call ........................................................................................................................ 40 Laboratory Notification of Emergency Samples during Routine Hours ........................................ 41 Laboratory Notification of Emergency Work Outside of Routine hours ....................................... 41 Tests available outside of routine hours.......................................................................................... 41 Point of Care Testing (POCT) ........................................................................................................ 41 Reference Values ............................................................................................................................ 41 Repeat Samples ............................................................................................................................... 41 Reporting of Results and Result Enquiries ..................................................................................... 41 Retention times ............................................................................................................................... 41 Retrospective requesting (Add on tests) ........................................................................................ 42 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 4 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ SPECIAL INVESTIGATIONS .......................................................................................................... 42 Laboratory Hours ............................................................................................................................ 43 On-Call Service ............................................................................................................................... 43 ANATOMICAL PATHOLOGY DEPARTMENT ............................................................................ 43 HISTOPATHOLOGY .................................................................................................................... 44 Laboratory Hours ............................................................................................................................ 44 On Call Service ............................................................................................................................... 44 Tests ................................................................................................................................................ 44 Collection of Samples ..................................................................................................................... 44 Notification of Results .................................................................................................................... 45 Urgent Samples ............................................................................................................................... 45 CYTOLOGY................................................................................................................................... 45 Laboratory Hours ............................................................................................................................ 45 On Call Service ............................................................................................................................... 45 Tests ................................................................................................................................................ 45 Collection of Samples ..................................................................................................................... 45 Gynaecological Cytology (Pap Smears) ......................................................................................... 45 Non-Gynaecological Cytology ....................................................................................................... 45 Fine Needle Aspiration Cytology ................................................................................................... 46 Notification of Results .................................................................................................................... 46 Urgent Samples ............................................................................................................................... 46 Mortuary ......................................................................................................................................... 46 SUPPORT FOR RESEARCH : SAMPLES AND PROTOCOLS ..................................................... 46 PROCEDURE ................................................................................................................................. 47 GUIDE TO THE ORGANISATIONAL STRUCTURE OF RHH PATHOLOGY SERVICES ....... 48 PATHOLOGY SERVICES STAFF PHONE NUMBERS ................................................................ 48 Senior Management ........................................................................................................................ 48 Pathologists ..................................................................................................................................... 49 Senior Staff ..................................................................................................................................... 49 PATHOLOGY SERVICES DEPARTMENTAL FAX NUMBERS .................................................. 50 QUALITY SYSTEMS ........................................................................................................................ 50 LABORATORY ACCREDITATION ................................................................................................ 51 EXTERNAL QUALITY ASSURANCE PROGRAMMES ............................................................... 51 Acknowledgements ............................................................................................................................. 54 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 5 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ INTRODUCTION This document was prepared to comply with the requirements of ISO 15189 Clauses 5.4.2 to 5.4.14 inclusive and Annex C all of Clause C.4. LOCATION OF PATHOLOGY DEPARTMENT : Level 1, D Block, Royal Hobart Hospital PATHOLOGY DEPARTMENT 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 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 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 Centrepath website www.centrepath.dhhs.tas.gov.au QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 6 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 7 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Important online links are marked with arrows. 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 8 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ A Typical Response to a Specimen Requirements Enquiry QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 9 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. Phlebotomy Office 7955 Phlebotomy Courier 0488678582 Phlebotomy Mobile Phlebotomy Mobile Phlebotomy Mobile Phlebotomy Mobile 0439069006 0447502262 0447543589 0447535870 Phlebotomy Rounds : Weekdays : Rounds commence at 7:30, 11:00 and 13:00. The last round finishes by 14:45h Weekends : Rounds commence at 7:30 and finish by 12:00. Blood Specimens - Order of Draw QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 10 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 11 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ ___________________________________________________________________________________________________________ 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. LABEL 5. Label the specimen(s) with o o o o o UR Number Surname Given Name Date of birth Date and Time of Collection NEVER LABEL TUBES BEFORE COLLECTING SPECIMENS NEVER LEAVE FILLED UNLABELLED SPECIMEN TUBES UNATTENDED. 6. Stamp the Request Form with your ID Stamper 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. 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 12 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ CENTREPATH SPECIMEN COLLECTION CENTRE In December 1999 we opened this dedicated Specimen Collection Service which is now on the ground floor of the H Block (Gaha Wing). Further up to the minute details on this service are provided via their website : www.centrepath.dhhs.tas.gov.au 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 UR Number Surname and Given Name Date of Birth All Request Forms and Specimen Containers for Non-Hospital Patients must have two points of positive patient identification Surname and Given Name 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. 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’ 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) QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 13 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ OUR REQUEST FORMS We have six RHH Request Forms and two styles of Centrpath Pathology which can be easily identified by their top coloured stripe design. Supplies are available from 6222 – 8657 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 14 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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.. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 15 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 16 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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. If your Clinic or Practice telephones us we can arrange for them to pick up specimens. 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 17 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Typical Example of Pathology Results as Seen in the DMR QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 18 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. The Table below gives you an outline of our automated call handling menu : QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 19 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 20 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 Centrepath 3058 / 7121 Pathology Administration 8410 Pathology Stores 8347 Phlebotomy Office Phlebotomy Courier 0488678582 0439069006 Phlebotomy Mobile - NSU, 6A, 5 0447535870 0447502262 Phlebotomy Mobile - TCU/GEM 0409565548 0447543589 Phlebotomy Mobile - TCU/GEM 0407872797 7955 Phlebotomy Mobile - 1BS, 1BN, 2BS Phlebotomy Mobile - 2DS, 2DC, 2A Phlebotomy Mobile - MAPU, ASU, 2BS, Dwyer Anatomical Pathology Biochemistry Cytogenetics Cytology Endocrinology Flow Cytometry Haematology 8770 8775 8297 8235 8781 8913 8776 Immunology/Special Haematology Microbiology Molecular Medicine Serology Special Chemistry / Investigations Stem Cell Transplant Transfusion / Bloodbank 8774 8417 8912 8777 8742 8744 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 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 21 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ o The requesting clinician will contact the Anatomical Pathology department to request that a sample is reported urgently, or both. 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 < Value > Value Units Chemistry Sodium Potassium Glucose Calcium Magnesium Creatinine 120 155 2.5 6.0 2.5 20.0 1.90 2.90 0.50 3.00 >10% or significant change within a short period 0.3 Troponin mmol/L mmol/L mmol/L mmol/L mmol/L mol/L 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) 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 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 22 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Endocrinology ‘Alert’ And ‘Critical’ Results Analyte Normal Range 138-690 nmol/L Cortisol FT3 FT4 TSH 2-6 pmol/L 10-24 pmol/L 0.4-4 mU/L Critical Value Alert <50 if not having a Dexamethasone Suppression Test or a Metapyrone Suppression Test >15 (if new patient) >40 (if new patient) >30 if not recognised hypothyroid or not on Thyrogen stimulation Haematology ‘Alert’ And ‘Critical’ Results WCC: Hb: MCV: HCT: PLT: >40 X 109/L <1.0 X 109/L >190 g/L <70 g/L >115 fL >65 L/L >1000 x 109/L <50 x 109/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 Lab to notify ward (or requesting doctor) directly Urgent samples (as requested by requesting Dr) Abnormal CSFs Sterile site isolates MRSA (new isolate) VRE (new isolate) MRGN (new isolate) C. difficile √ QS-Proc-5 Author : Dr Tom Hartley √ √ √ √ Lab staff to notify ID registrar (BH) or ID physician oncall (AH) √ √ √ √ √ √ Authorised by Drs Marsden & Vervaart Page 23 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 Lab to notify ward (or requesting doctor) directly 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 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 QS-Proc-5 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 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 24 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Drugs of Abuse Screening tests Arterial Blood Gases and Electrolytes Near Patient Testing Instrumentation support 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 25 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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 6222 8776 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 26 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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-1500. 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 QS-Proc-5 SAMPLE STABILITY TIMLINES Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 27 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ FROM COLLECTION PT/INR Up to 6 hours at RT. APTT If on heparin within 2 hours D-Dimer Up to 8 hours at RT. Fibrinogen Up to 24 hours if refrigerated (2-8oC) Up to 6 hours at RT Retrospective requesting Add on testing for Coagulation can be done within the time lines above. 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 28 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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 Group 1 : The following tests can be performed on a single Red Top 4mL SST tube AFP (alpha Foetoprotein) Alcohol alpha 1 antitrypsin Amikacin Amylase B12/folate C3, C4 CA-125 C-reactive protein (CRP) CK Caeruloplasmin Calcium group Carbamazepine CEA Cholesterol & Triglyceride Retrospective Testing QS-Proc-5 Cholinesterase Digoxin Ferritin Gentamicin Haptoglobin HCG HDL IPG Iron (Iron Studies) LDH LFT Lipase Lithium Methotrexate Osmolality Paracetamol Phenobarb Procalcitonin Phenytoin PSA Rheumatoid Factor Salicylate Theophylline Tobramycin Transferrin Tricyclics Troponin U&E Urate Valproate Vancomycin SST 4mL (Red top with gel) Serum, urine and fluid samples are retained for seven days. Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 29 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. Location ICU ED NICU THEATRE Na K Cl √ √ √ √ √ √ √ √ √ √ √ √ Ca2+ √ √ √ √ Analytes Measured Glucose Lactate Creat. Bili pH PO2 pCO2 √ √ √ X √ √ √ √ √ X X √ √ √ √ √ X √ √ √ √ √ √ X X √ √ √ Hb √ √ √ √ 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 30 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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 QS-Proc-5 Author : Dr Tom Hartley 7 days 14 days 5 years 2 months Authorised by Drs Marsden & Vervaart Page 31 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. Turnaround Times M, C and S Serum Serology TB testing : : : 48 to 72 hours 1-7 days 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 12 – 18 weeks gestation in order to obtain a fetal karyotype. Prenatal diagnosis is generally performed in high risk pregnancies QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 32 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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. 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 Results Bone Marrow Cytogenetics 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. 15-20ml aseptically collected. Monday – Thursday 08301700 Monday – Friday 0830-1700 5 – 18 days Monday – Friday 0830-1700 5 – 18 days Monday – Friday 0830-1700 5 – 18 days Must be received in the laboratory by 2.00pm Thursday. Will not be sent on Usually within 10 days of receipt of sample. Peripheral Blood Karyotype Tumour and Lymph Node Biopsies FISH testing Amniotic Fluid Karyotype (Referred Test) QS-Proc-5 Author : Dr Tom Hartley 5 – 18 days Authorised by Drs Marsden & Vervaart Page 33 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Chorionic Villi Karyotype (Referred Test) 15-20mg of aseptically collected villi (minimum 5mg) Fetal Tissue / Products of Conception Karyotype (Referred Test) 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 DNA Tests – Including Fragile X, Prader Will/Angelman syndromes and UPD studies. (Referred Test) Microarray – Molecular Karyotype (Referred Test) Adults: 5mL peripheral blood in EDTA tube Child: 1-5mL as above *Consultant signature required for this test* Fridays. Must be received in the laboratory by 2.00pm Thursday. Will not be sent on Fridays. Monday – Thursday 08301700 Usually within 10 days of receipt of sample. Usually within 34 weeks. Monday – Thursday 08301700 Usually within 34 weeks. Monday – Thursday 08301700 Usually within 34 weeks. 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 6222 8297. 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. _________________________________________________________________________________ QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 34 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 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 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 35 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 5mL EDTA blood (pink top Malignancy studies 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 (white top swab). 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. VRE PCR- isolate only Neisseria meningitidis PCR - EDTA blood (pink top), CSF or isolate. Performed as required. Human papilloma virus PCR 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. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 36 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ 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 0438363219). 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 belowTest Viral Load: HIV HCV CMV HIV Genotype Write recent HIV viral load result on form otherwise one should be requested. Record time/date of sample receipt and when plasma removed. HCV Genotype +/- Load Parvovirus B19 PCR Polyomavirus (BK) PCR HHV6/7/8 Enterovirus RT-PCR Adenovirus PCR MTHFR HNPP SCA 1-7 Jak2 Mutation BCR-ABL Cystic Fibrosis Genetic Testing BRCA1/2 Adenovirus PCR Norovirus PCR FAP Genetic Testing QS-Proc-5 Specimen Requirement ACD or EDTA Blood (remove plasma) Serum EDTA Blood ACD or EDTA Blood (plasma removed from same) Refer EDTA Plasma-Send Frozen Author : Dr Tom Hartley Testing Laboratory VIDRL VIDRL VIDRL Clinical Research Laboratory, Macfarlane Burnet Centre for Medical Research Serum Whole Blood CSF/Blood/Urine CSF/Blood CSF/Blood Various EDTA Blood EDTA Blood EDTA Blood EDTA Blood EDTA Blood (x2) EDTA Blood VIDRL VIDRL VIDRL VIDRL VIDRL VIDRL Royal Melbourne VCGS VCGS Royal Melbourne IMVS VCGS EDTA Blood (x2) Various Faeces EDTA Blood Peter MacCallum VIDRL IMVS VCGS Authorised by Drs Marsden & Vervaart Page 37 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Results and Enquiries All results are available via the DMR once authorised. Retention times All samples are retained according to NPAAC requirements. Currently this requires the laboratory to retain material processed for genetic testing indefinitely. Sample for routine infectious disease studies are retained at least until the final result is authorised. Retrospective requesting (Add on tests) Add on tests can be made for samples that have been collected for Molecular studies only. Add on requests for samples that have been collected for and used by other areas of pathology are unacceptable. _________________________________________________________________________________ ENDOCRINOLOGY The Endocrinology Laboratory functions as a tertiary referral centre for the investigation of most endocrine disorders. The service includes : A comprehensive range of basic and specialised hormone assays that are indicated in the areas of Diabetes, Thyroid, Adrenal, Pituitary, Fertility, Growth and Parathyroid disorders. Tests carried out in the dynamic assessments of patients to investigate abnormalities in trophic to target hormone relationships. Biochemical and genetic screening of patients who have Multiple Endocrine Neoplasia Type 1, (MEN1). The Department has strong research commitments in the areas of Thyroid Autoimmunity and metabolism, Diabetes management, MEN1 and other inherited endocrine malignancies, Parathyroid and Calcium metabolism. Both the Laboratory and the RHH Endocrinology Department have significant external funding to support these programmes and have gained significant recognition both nationally and internationally for their research work. The staff contribute significantly to the undergraduate and postgraduate teaching programmes of the RHH and the University of Tasmania. Laboratory Opening Hours 0900 – 1730 Monday to Friday (excluding public holidays) Tests performed Daily QS-Proc-5 TSH, FT4, FT3 LH, FSH Progesterone, Estradiol Prolactin, Growth Hormone Cortisol. Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 38 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Tests performed weekly or twice weekly PTH Vitamin D ACTH Anti-TPO, Thyroglobulin/Anti-thyroglobulin, C-Peptide, Insulin, IGF1 DHEA-SO4, Testosterone/SHBG Chromogranin A Tests performed approximately every 2 or 3 weeks Gastrin, 17OH-Progesterone Aldosterone, Plasma Renin Activity Alpha Sub-unit Urine Corticoids GAD-Ab, IA2-Ab & Thyroid Receptor Ab Tests performed approximately 6 – 8 weeks 11 Deoxycortisol Glucagon Pancreatic Polypeptide & Vasoactive Polypeptide Referred Samples/Referred Tests Tests sent to other laboratories include : Calcitonin TBG Total T4 Sulphoylurea Screening 7 Dehydrocholesterol IGFBP3 Plasma Metanephrines 11 Deoxycorticosterone Urinary Deoxypyridinoline c-AMP Neurotensin Reverse T3 Urinary Iodine Adrenal Abs Plasma Catecholamines IGF2 ADH Urinary Steroid Screen 1,25 Vit D Insulin Abs Ovarian Abs Osteocalcin Androstenedione Genetic Screening for: MEN 2, 1oHyperaldosteronism, VHL, SDHB, Neurofibromatosis MEN1 gene for non-Tasman 1 families. Others by prior arrangement. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 39 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Special investigations/protocols The following special investigations are performed by the Endocrinology Department. Please call the Lab for instructions/protocol on Extn 8781 Addisons disease Cushings syndrome Hypothalamic pituitary adrenal axis Growth Hormone deficiency, Acromagaly Congenital Adrenal Hyperplasia, Hypoglycemia, Diabetes Medullary thyroid carcinoma investigations Pseudo hypoparathyroidism Diabetes Insipidus Pituitary function test Prolactin and prolactinomas Thyroid hormone absorption test Primary hyperaldosteronism A range of special investigations details and protocols are available on request from the endocrine laboratory Ph 6222 8781 Cut-off Times for Sample Processing and Referral Samples for daily assays should reach the laboratory prior to 1530 for processing so results are available the same day. Otherwise next working day turnaround should be expected. Samples for referral to mainland laboratories should reach the laboratory before 12 noon so that they are ready for a 14:00h pick-up on Mondays through to Thursdays. Storage conditions for samples Samples received for hormone testing have to be processed as soon as possible and stored at 4o or minus 20o C as appropriate Telephoning Results Results will be telephoned on special request. Results will normally be provided to medical staff only Turnaround times Routine tests are done everyday whilst low volume test requests are done once a week or once every two weeks depending on the number of requests Emergency On-Call Contact the RHH switchboard for Endocrinology on-call personnel QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 40 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Laboratory Notification of Emergency Samples during Routine Hours Normally endocrine test requests are not done on an urgent basis as most management decisions will not be affected if the test is performed on the next scheduled assay run. If, however, an earlier result is required, the medical officer is to telephone the laboratory (8781) and request that the test(s) be performed urgently. Such requests will be noted and the tests done as soon as possible and the results(s) telephoned when available. Laboratory Notification of Emergency Work Outside of Routine hours Contact the RHH switchboard and discuss your request with the on-call endocrinologist, they will call in an appropriate staff member if required. Tests available outside of routine hours Tests which may be indicated urgently out of hours: TSH, FT4 & FT3 in the case of acute thyroid disease Cortisol in acute adrenal disease Point of Care Testing (POCT) POCT in the Endocrine Unit is administered through Specialist Clinic & Diabetic Education and is overseen by Clinical Chemistry Reference Values A full list of reference values is available in the Endocrinology Lab Handbook. Reports are issued with the reference interval appropriate for the patient’s gender, age and clinical condition. Repeat Samples Abnormal results are assessed and reanalysed if required and the result confirmed. The requesting doctor (or if unavailable the Duty Endocrinologist) is notified when immediate medical action is needed. A repeat sample or additional testing may be indicated to confirm the initial abnormal result. Duplicated requests in other situations may not me analysed. Reporting of Results and Result Enquiries Final results are released into the Kestral Laboratory Information System after verification by an Endocrinologist who will make comments if required. Samples are kept approximately 7 – 10 days post analysis. If additional tests are to be added contact the Endocrine Laboratory (03) 6222-8781 and also send or fax (03) 6222-7537 an add-on form specifying the additional tests required. Tests will be added depending on sufficient serum being available. Retention times Samples are retained by the Endocrine Lab for a maximum time of 2 months. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 41 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Retrospective requesting (Add on tests) Add on tests will be accepted wherever possible provided enough sample is available for doing the tests requested. An add on form signed by the requesting Dr is mandatory for the tests to be performed _________________________________________________________________________________ SPECIAL INVESTIGATIONS This includes the Specialised Haematology, Stem Cell Transplant Service, the Flow Cytometry Laboratory and the Specialised Chemistry Laboratory. This is the major Tasmanian Referral Laboratory for haematology investigations requiring specific expertise and receives specimens from all public and private sector pathology services in Tasmania. The laboratory is divided into four functionally distinct areas. The Stem Cell Transplant Laboratory provides all aspects of the statewide Bone Marrow Transplant Service, as well as expert advice and resources to clinicians. This laboratory receives harvested bone marrow or peripheral blood, processes, tests and cryopreserves the stem cells and maintains the bone marrow cryogenic facilities. The Flow Cytometry Laboratory provides a Statewide Cell Marker service performing the following investigations : Immunophenotyping of lymphoproliferative and myeloproliferative disorders to assist in diagnosis and classification. Measurement of lymphocyte subsets as part of the assessment of immune status in HIV/AIDS and other suspected immune deficiency states Quantitative CD34 assays to evaluate the transplantation of potential stem cell harvests. The Special Haematology Laboratory performs specialist testing including : Haem pigment investigations Red Blood Cell haemolysis investigations Identification of Malarial Parasites ELISA based assays including Anticardiolipin, glycoprotein, Intrinsic Factor antibodies The Specialised Chemistry Laboratory performs a range of specialised, complex and largely nonautomated tests for clients throughout Tasmania including organizations requiring occupational monitoring. Specialist testing includes Trace element analyses : Lead and cadmium, usually for occupational monitoring and copper and zinc, usually for nutritional studies and parenteral nutrition patients A large number of qualitative and quantitative protein assays by QS-Proc-5 Automated immunoassays Electrophoresis Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 42 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ and isoelectric focussing Faecal occult blood Antinuclear antibodies urinary free catecholamine analyses using high performance liquid chromatography, (HPLC), for the diagnosis of phaeochromocytoma as well as neuroblastoma and similar diseases in children. Autoimmune Testing Service The Specialised Investigations Unit provides an autoimmune testing service incorporating ANA, ENA, ANCA, and also coeliac screening. This service is under continuous development. Laboratory Hours The laboratory is routinely open Monday to Friday 0800 to 17:00, excluding public holidays. On-Call Service All requests for after-hours service must be made to the Haematologist on-call via the Royal Hobart Hospital switchboard on 03 6222 8308. Collection of Samples As per on-line Test Information Database. Specific queries may be directed to the laboratory Notification of Results Authorised results on Hospital patients are available on the Royal Hobart Hospital DMR system. If a result does not appear on the hospital DMR system please call Special Investigations laboratory on 6222 8774. Results for non RHH hospital patient will be reported in hard copy and, by request, electronically to the GP’s patient management system Urgent Samples Please inform the laboratory if results are required urgently. This may need to be negotiated with a Haematologist in some cases (on-call if after-hours). _________________________________________________________________________________ ANATOMICAL PATHOLOGY DEPARTMENT This includes Routine Histology, Immunohistology, Cytology, Electron Microscopy, and the Mortuary. This Department is the major public sector specialist referral centre for Anatomical Pathology in Tasmania and provides QS-Proc-5 a surgical biopsy service an autopsy service gynaecological and non-gynaecological cytology services, including fine needle aspirate cytology a statewide renal biopsy service a State Reference Service for specialist techniques such as electron microscopy and immunohistochemistry. Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 43 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ For muscle biopsies and nerve biopsies please contact the histology department at least 24 hours before the procedure on 6222 8298 (ext 8298) to arrange delivery of the required kits. Renal biopsies – place sample in an appropriately labelled empty container and deliver to the laboratory immediately for determination of adequacy. For breast tissue requiring x-ray – place sample in an appropriately labelled empty container and immediately notify the histology department on 6222 8298 (ext 8298). Duodenal biopsies for disaccharidase – obtain liquid nitrogen from the histology department before the procedure. Once the sample is frozen deliver the frozen tissue immediately to the histology department. The Department also has a considerable involvement with undergraduate teaching in anatomical pathology and has trained the majority of specialist anatomical pathologists practising in Tasmania. HISTOPATHOLOGY Laboratory Hours The histology laboratory is open Monday to Friday 08:30 to 17:00. On Call Service To contact the on-call Anatomical Pathologist outside the laboratory opening hours please call the Royal Hobart Hospital switchboard on 03 6222 8308. To contact the on-call scientist outside the laboratory opening hours please call 0417 312 460. Tests The histology department provides a comprehensive histology service including: histopathology immunohistochemistry immunofluorence frozen section electron microscopy Collection of Samples Samples for frozen section – place sample in an appropriately labelled empty container and immediately send fresh sample to the laboratory; Samples for immunofluorence – place sample in an appropriately labelled empty container and immediately send fresh sample to the laboratory; Samples for electron microscopy – place sample in an appropriately labelled empty container and immediately send fresh sample to the laboratory. Samples for routine histology ONLY should be placed into 10% Formalin (available from the histology department) as soon as possible after being removed from the patient and forwarded to the histology department. If in any doubt on how to collect samples please contact the histology laboratory on 6222 8298 (ext. 8298). QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 44 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Notification of Results Authorised results are available on the Royal Hobart Hospital DMR system. If a result does not appear on the hospital DMR system please call the Anatomical Pathology office on 6222 8770 (ext 8770) to discuss results with an Anatomical Pathologist. Urgent Samples If a sample result is required urgently please call the Anatomical Pathology office on 6222 8770 (ext. 8770) to discuss requirements with an Anatomical Pathologist. CYTOLOGY Laboratory Hours The cytology laboratory is open Monday to Friday 08:30 to 17:00. On Call Service To contact the on-call Anatomical Pathologist outside the laboratory opening hours please call the Royal Hobart Hospital switchboard on 03 6222 8308. Tests The Cytology Department provides a comprehensive cytology service including: gynaecological cytology (Cervical Screening Program) non-gynaecological diagnostic cytology fine needle aspiration cytology Collection of Samples Gynaecological Cytology (Pap Smears) Conventional smear labelled with patient`s Surname, Given Name and Date of Birth must be inserted immediately into 95% ethanol ThinPrep specimen should be made after making conventional Pap smear rinsing Cervex sampler well in the ThinPrep solution Non-Gynaecological Cytology All fresh specimens for cytology should be sent to the Cytology Department without delay Samples collected into CytoLyt Preservative Solution should be kept at room temperature and forwarded to the cytology department QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 45 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Fine Needle Aspiration Cytology The Cytology Department within the RHH Department of Anatomical Pathology offers both an inpatient and outpatient fine needle aspiration service. Lesions suitable for free hand fine needle aspiration should be readily palpable lumps of at least 1cm in size. Examples of suitable lesions include lymph nodes and superficial breast lesions. The aspiration will be performed either by one of the staff Specialist Anatomical Pathologists or an appropriately trained Anatomical Pathology Registrar. All referrals for either free hand or image guided fine needle aspiration should be pre-booked by ringing the Cytology Department on 6222 8235 (ext 8235). If in any doubt on how to collect samples please contact the Cytology Laboratory on 6222 8235 (ext. 8235). Notification of Results Authorised results on Hospital patients are available on the Royal Hobart Hospital DMR system. If a result does not appear on the hospital DMR system please call the Cytology Department on 6222 8235 (ext 8235). Results for non RHH hospital patient will be reported in hard copy and, by request, electronically to the GP’s patient management system Urgent Samples If a sample result is required urgently please call the Anatomical Pathology office on 6222 8770 (ext. 8770) to discuss requirements with an Anatomical Pathologist. Mortuary All enquires relating to autopsies requests and reports should be forwarded to an Anatomical Pathologist Monday – Friday, 08:30 – 17:00 on 6222 8770 (ext. 8770). All other mortuary enquires should be forwarded to the Senior Mortuary Technician on 6222 8336 or 6222 8333 (ext. 8336 or 8333). _________________________________________________________________________________ SUPPORT FOR RESEARCH : SAMPLES AND PROTOCOLS Pathology Services at the Royal Hobart Hospital are committed to Clinical Research. We are able to support other Units in the DHHS with their requirements for pathology data in their Research and Development Projects. DHHS staff are encouraged to come to Pathology Services as early as possible in their project planning stage. At that time we can discuss the optimum way of meeting your requirements, set up internal project codes within our IT system, so that your data can be easily extracted at anytime during the project, and organise the financial implications of the anticipated workload. Research work for non DHHS staff and drug trials can also be accommodated the only differences being that we will need to discuss more fully the issues of legal liabilities and costs. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 46 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Please contact Dr Peter Vervaart on 6222-8240 to begin the process of collaboration. PROCEDURE • Investigators are encouraged to seek laboratory input from the Laboratory Director and/or Scientist in Charge during study design to ensure the most appropriate tests, methods and specimens are used. • Discussions should be undertaken with the senior scientist and medical director in the relevant functional unit(s) who will decide whether it is feasible to perform the requested work in their area. However, no undertaking for involvement of Pathology Services can be given until the costing and resource requirements have been approved by the Principal Scientist. The protocol will be examined in terms of: a. tests required, b. number of subjects, c. number of samples, d. special collection parameters, e. storage requirements, f. frequency of testing, g. sample treatment/preparation by laboratory staff, h. development of methods, i. impact of workload on department staff and budget, j. starting date and k. study duration. • If the senior scientist decides it is feasible for their area to be involved, the Investigator or Study Coordinator will be requested to complete the Research Trial/Study Information Proforma and return it to the Principal Scientist, Dr Peter Vervaart along with a copy of the relevant sections of the research protocol. • The Pathology Services Research Trial/Study Information Proforma can be obtained from Peter Vervaart. Please Note: If there are tests to be incorporated in the study that would normally be performed as part of patient investigation or treatment, they will need to be clearly identified on the proforma. To enable Pathology Services to invoice Medicare, these tests will also need to be requested on a separate request form to tests that are only required for the study. • Once the Proforma has been approved by the Principal Scientist, an internal RHH Study Code will be assigned to each project to facilitate management • Cost of (a) specimen collection (if required), (b) testing, transport and (c) storage (if required), based on the cost of these to Pathology Services will be determined, and a written agreement, along with the internal RHH Study Code will be forwarded to the Principal Investigator and the Study Coordinator. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 47 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ • Please quote this RHH Study Code at subsequent enquiries and also display it on Pathology Request Forms accompanying research project specimens. • The above process should occur prior to Investigators seeking Ethics Committee approval so that Pathology Services is able to “sign off” on the protocol. However, Pathology Services involvement in any study will not be able to commence until the study has been approved by the Institutional Ethics Committee. Copy of the Ethics Approval form should be forwarded to the Principal Scientist before the study commences. • The Principal Scientist must be formally notified of the completion of any study involving Pathology Services so that documentation can be completed. • Appropriate recognition of the input from Pathology Services (and/or its staff members) is required. This may range from acknowledgment in publication to co-authorship as appropriate to the level of participation. GUIDE TO THE ORGANISATIONAL STRUCTURE OF RHH PATHOLOGY SERVICES Director of Pathology Services Quality Manager Business Manager Principal Scientist Pathologist Directors of Departmental Laboratories Anatomical Pathology Core Laboratory Cytogenetics Endocrinology Microbiology Molecular Medicine Special Investigations Scientists in Charge of Departmental Laboratories Anatomical Pathology Core Laboratory Cytogenetics Endocrinology Microbiology Molecular Medicine Special Investigations PATHOLOGY SERVICES STAFF PHONE NUMBERS Senior Management Director of Pathology Dr Katherine Marsden 6222 8410 Principal Scientist Dr Peter Vervaart 6222 8240 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 48 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Business Manager Mr Mike Jones 6222 8948 Pathologists Anatomical Pathology Dr David Challis (Director) 6222-8770 Dr Peter Jessup Dr Helene Rees Dr Eileen Long Dr Shaun Donovan Dr John McArdle Clinical Chemistry Dr Udayan Ray (Director) 6222-8234 Endocrinology Dr John Burgess (Director) 6222-8732 Dr Tim Greenaway Haematology Dr Katherine Marsden (Director) 6222-8337 Dr James Daly Dr Liz Tegg Dr Roger Kimber Microbiology Dr Maree O’Sullivan, (Director) 6233-3557 Dr Louise Cooley 6222-8255 Dr Alistair McGregor Dr Tara Anderson (Infection Control) Dr Alison Ratcliffe Sexual Health Service Statewide Director : 6233-3557 Senior Staff Anatomical Pathology Mr Alistair Townsend (Sci. in Charge) 6222-8771 Deanne Lamb (Cytology) 6222-8235 Nino Mele (Mortuary) Core Laboratory Mr Rob White (Sci. in Charge) 6222-8199 Ms Terri Kidd (Haematology) 6222-8776 Mr Michael Robinson (Coagulation) 6222-8776 Mr Michael Smillie (Biochemistry) 6222-8775 Ms Gina Aitken (Transfusion) 6222-8411 Central Specimen Reception Brett Clem : Preanalytical Manager : 6222-8775 Ms Kathy Barry : 6222-8657 QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 49 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Centrepath Reception Desk 6214-3058 or 6222-7121 Jane Stevenson (Business Development Officer) 0419 137 121 Heather Rainbird (Senior Phlebotomist) Cytogenetics Ms Karen Dun (Sci. in Charge) 6222-8297 Endocrinology Dr V (Paramesh) Parameswaran (Sci. in Charge) 6222-7991 IT Support—Pathology Results Lookup System only ) Mr Andrew Hudspeth 6222-8396 Mr Graham Banks (IT Technician) 6222-8941 Microbiology Mr David Jones (Sci. in Charge) 6222-8909 Viral Serology 6222-8777 Molecular Medicine Dr Jan Williamson (Sci. in Charge) 6222-8912 Phlebotomy Service Mrs Claire Beattie 6222-7955 Purchasing Officer : Philip Bakes : 6222-8347 Quality Systems Dr Tom Hartley (Quality Manager) 6222-8780 Special Investigations Mr Andrew Hudspeth (Sci. in Charge) 6222-8396 Dr Scott Ragg (Flow Cytometry and Stem Cell Transplantation) 6222-8431 Ms Janet Bartle 6222-8742(Special Chemistry) PATHOLOGY SERVICES DEPARTMENTAL FAX NUMBERS Pathology Administration : 6222-8996 Central Processing Unit : 6222-7537 Centrepath : 6222-7097 Pathology Stores : 6222-8047 QUALITY SYSTEMS The overall coordination and management of the quality systems in this Department are the responsibility of the Quality Manager under the supervision of the Director of Pathology and the Principal Scientist. The departmental Directors and Scientists in Charge are the line managers with the responsibility for ensuring that these systems are practiced in their areas of responsibility. QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 50 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ The Quality Manager is assisted by a Quality Technician. One of the major cornerstones of our Quality Systems is the Document Control system. All documentation that relates directly to Medical Testing or our Quality Systems is registered within the Document Control System. The purpose of a Document Control System is to ensure that we retain all documentation relevant to medical testing in an orderly and easily retrievable form both for the purposes of keeping staff advised of the documentation required in their work and also to enable us to retrieve documentation relevant to auditing all possible factors in an adverse event. A second major cornerstone is the Corrective Action / Preventative Action system within which we lodge all incidents that relate to adverse events during the Preanalytical, Analytical or Reporting phases of Medical Testing. LABORATORY ACCREDITATION This laboratory is a NATA Accredited Medical Testing Laboratory that meets all the requirements of ISO 151819, ‘Medical Laboratories – Particular Requirements for Quality and Competence.’ We also hold appropriate accreditation from the TGA and the Office of the Gene Technology Regulator. NATA Accreditated Laboartory Number = 3036 Medicare Accreditation Nunmber =38273 EXTERNAL QUALITY ASSURANCE PROGRAMMES The laboratories are enrolled in the following External Quality Assurance Programmes Royal College of Pathologists of Australia Anatomical Pathology General Diagnostic Module Breast Diagnostic Module Oral Diagnostic Module Dermatopathology Diagnostic Module Forensic Diagnostic Module Gynaecological Diagnostic Module Paediatric Diagnostic Module Urological Diagnostic Module Technical Module Transmission Electron Microscopy Immunohistochemistry Modules Immunohistochemistry Diagnostic Module Immunohistochemistry Technical Module Immunohistochemistry Breast Markers Module Immunohistochemistry Lymphoma Markers Module Her2 Brish Biochemistry: QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 51 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Alcohol / Ammonia Blood Gases & CO-oximetry BNP CSF Endocrine General Serum Chemistry Glycohaemoglobin IGF-1 / C-Peptide Neonatal Bilirubin Special Drugs Special Lipids Sweat Electrolytes Tumour Markers Urine Chemistry & Biogenic Amines Urine Pregnancy Testing Urine Toxicology Vitamins (B12 and Folate ) Cytology: Gynaecological Modules General Cytopathology Module Liquid Based Gynaecological Module FNA Module Cytology Performance Measures Module Haematology : FBC Haemostasis D-Dimer Morphology/Differentia Automated Differential Point of Care - INR Oncology Immunophenotyping Specialised Haemostasis CD34+ G6PD Immunology : Antinuclear Antibodies Rheumatic Disease Serology Vasculitis Serology Coeliac Serology Tissue Antibodies Juvenile Onset Type I Diabetes Antibodies C-Reactive Protein Specific Proteins Rheumatoid Factor Paraproteins Immunophenotyping Microbiology : QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 52 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ Bacteriology Mycology Parasitology Synovial Fluid Legionella Urinary Antigen Serology: Cytomegalovirus Epstein Barr Virus Helicobacter pylori Hepatitis A Hepatitis B Hepatitis C HIV Infectious Mononucleosis Rubella IgG / Total Syphilis Toxoplasma Varicella zoster virus Transfusion Medicine : General Compatibility Module Phenotyping Module Antibody Titre Module Foeto Maternal Haemorrhage Program Molecular Medicine : RCPA QAP in Haematology (Molecular Diagnostics) Factor V Leiden Prothrombin gene mutation Haemochromatosis T and B cell gene rearrangements RCPA Serology HPV (from 2008) HCV Avian Influenza Pandemic Influenza RCPA Microbiology (NAT) Bordetella pertussis Chlamydia trachomatis CMV Enterovirus HSV mecA Neisseria meningitidis (from 2006) Mycobacterium tuberculosis (from 2008) VZV (from 2009) National serology reference laboratory HCV HSV QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 53 of 54 http://intra.dhhs.tas.gov.au/dhhs-online/page.php?id=21753 www.centrepath.dhhs.tas.gov.au ________________________________________________________________________________ CMV Chlamydia trachomatis _________________________________________________________________________________ Acknowledgements The author acknowledges the authors of the Naas General Hospital, Co. Kildare, Ireland, for www access to their Primary Sample Collection Manual. This manual has followed their lead in the logical organisation much of the content. http://www.hse.ie/eng/services/Find_a_Service/HospsCancer/Naas/Pathology.pdf QS-Proc-5 Author : Dr Tom Hartley Authorised by Drs Marsden & Vervaart Page 54 of 54